Stromectol

Generic Name: ivermectin (eye ver MEK tin)

Brand Names: Stromectol

What is Stromectol (ivermectin)?

Ivermectin is an anti-parasite medication. It causes the death of certain parasitic organisms in the body.

Ivermectin is used to treat infections caused by certain parasites.

Ivermectin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Stromectol (ivermectin)?

Before taking ivermectin, tell your doctor about any other medical conditions that you have, especially liver disease. If you have liver problems, you may not be able to use ivermectin, or you may need a dosage adjustment or special tests during treatment. Treatment with ivermectin usually involves taking a single dose, which should be taken on an empty stomach with a full glass of water.

To be sure this medication is helping your condition, a sample of your stool (bowel movement) will need to be checked on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Avoid drinking alcohol, which can increase some of the side effects of ivermectin.

You may need to be retreated with ivermectin several months to a year after your single dose.

Call your doctor at once if you have any problems with your eyes or your vision.

What should I discuss with my healthcare provider before taking Stromectol (ivermectin)?

Before taking ivermectin, tell your doctor about any other medical conditions that you have, especially liver disease. If you have liver problems, you may not be able to use ivermectin, or you may need a dosage adjustment or special tests during treatment. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Ivermectin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Stromectol (ivermectin)?

Treatment with ivermectin usually involves taking a single dose, which should be taken on an empty stomach with a full glass of water.

To be sure this medication is helping your condition, a sample of your stool (bowel movement) will need to be checked on a regular basis. It is important that you not miss any scheduled visits to your doctor.

You may need to be retreated with ivermectin several months to a year after your single dose.

If you store ivermectin at home, keep it at room temperature away from moisture and heat.

See also: Stromectol dosage (in more detail)

What happens if I miss a dose?

Since ivermectin is usually given as a single dose, you will probably not be on a dosing schedule. If you are taking a repeat dose of ivermectin and you miss the dose, call your doctor for instructions.

What happens if I overdose?

Seek emergency medical attention if you think you have taken too much of this medicine.

An overdose of ivermectin may cause skin rash, swelling, headache, dizziness, weakness, nausea, vomiting, diarrhea, stomach pain, seizure (convulsions), shortness of breath, and numbness or tingling.

What should I avoid while taking Stromectol (ivermectin)?

Avoid drinking alcohol, which can increase some of the side effects of ivermectin.

Stromectol (ivermectin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

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  vision changes or problems with your vision;

  
  


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  urinary or bowel problems;

  
  


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  weakness, confusion, lack of coordination;

  
  


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  eye redness, swelling, or pain; or

  
  


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  seizure (convulsions).

  
  

Other less serious side effects may be more likely to occur, such as:

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  nausea, diarrhea;

  
  


• 
  

  dizziness;

  
  


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  swelling of your hands, ankles, or feet;

  
  


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  swelling or tenderness of your lymph nodes;

  
  


• 
  

  itching or skin rash; or

  
  


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  feeling that something is in your eye(s).

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Stromectol (ivermectin)?

There may be other drugs that can affect ivermectin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Stromectol resources

• Stromectol Side Effects (in more detail)
• Stromectol Dosage
• Stromectol Use in Pregnancy & Breastfeeding
• Drug Images
• Stromectol Drug Interactions
• Stromectol Support Group
• 2 Reviews for Stromectol - Add your own review/rating

• Stromectol Prescribing Information (FDA)


• Stromectol MedFacts Consumer Leaflet (Wolters Kluwer)


• Stromectol Monograph (AHFS DI)


• Stromectol Advanced Consumer (Micromedex) - Includes Dosage Information


• Ivermectin Prescribing Information (FDA)

Compare Stromectol with other medications

• Ascariasis
• Cutaneous Larva Migrans
• Filariasis, Elephantiasis
• Head Lice
• Onchocerciasis, River Blindness
• Scabies
• Strongyloidiasis

Where can I get more information?

• Your pharmacist has more information about ivermectin written for health professionals that you may read.

See also: Stromectol side effects (in more detail)

Sucraid

sacrosidase

Dosage Form: oral solution
Sucraid® (sacrosidase) oral solution:

Sucraid Description

Sucraid® (sacrosidase) oral solution is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).

CHEMISTRY

Sucraid is a pale yellow, clear solution with a pleasant sweet taste. Each milliliter (mL) of Sucraid contains 8,500 International Units (I.U.) of the enzyme sacrosidase, the active ingredient. The chemical name of this enzyme is ß,D-fructofuranoside fructohydrolase. The enzyme is derived from baker’s yeast (Saccharomyces cerevisiae).

It has been reported that the primary amino acid structure of this protein consists of 513 amino acids with an apparent molecular weight of 100,000 g/mole for the glycosolated monomer (Range 66,000-116,000 g/mole). Reports also suggest that the protein exists in solution as a monomer, dimer, tetramer, and octomer ranging from 100,000 g/mole to 800,000 g/mole. It has an isoelectric point of 4 (pl=4.093).

Sucraid may contain small amounts of papain. Papain is known to cause allergic reactions in some people. Papain is a protein-cleaving enzyme that is introduced in the manufacturing process to digest the cell wall of the yeast and may not be completely removed during subsequent process steps.

Sucraid also contains 50% glycerol (w/w) in an aqueous solution. Glycerol (glycerin) in the amount consumed in the recommended doses of Sucraid has no expected toxicity.

This enzyme preparation is fully soluble with water, milk, and infant formula (DO NOT HEAT SOLUTIONS CONTAINING Sucraid). Do not put Sucraid in warm or hot liquids.

Sucraid - Clinical Pharmacology

Congenital sucrase-isomaltase deficiency (CSID) is a chronic, autosomal recessive, inherited, phenotypically heterogeneous disease with very variable enzyme activity. CSID is usually characterized by a complete or almost complete lack of endogenous sucrase activity, a very marked reduction in isomaltase activity, a moderate decrease in maltase activity and normal lactase levels.

Sucrase is naturally produced in the brush border of the small intestine, primarily the distal duodenum and jejunum. Sucrase hydrolyzes the disaccharide sucrose into its component monosaccharides, glucose and fructose. Isomaltase breaks down disaccharides from starch into simple sugars. Sucraid does not contain isomaltase.

In the absence of endogenous human sucrase, as in CSID, sucrose is not metabolized. Unhydrolyzed sucrose and starch are not absorbed from the intestine and their presence in the intestinal lumen may lead to osmotic retention of water. This may result in loose stools.

Unabsorbed sucrose in the colon is fermented by bacterial flora to produce increased amounts of hydrogen, methane and water. As a consequence, excessive gas, bloating, abdominal cramps, nausea and vomiting may occur.

Chronic malabsorption of disaccharides may result in malnutrition. Undiagnosed/untreated CSID patients often fail to thrive and fall behind in their expected growth and development curves. Previously, the treatment of CSID has required the continual use of a strict sucrose-free diet.

CSID is often difficult to diagnose. Approximately 4% to 10% of pediatric patients with chronic diarrhea of unknown origin have CSID. Measurement of expired breath hydrogen under controlled conditions following a sucrose challenge (a measurement of excess hydrogen excreted in exhalation) in CSID patients has shown levels as great as 6 times that in normal subjects.

A generally accepted clinical definition of CSID is a condition characterized by the following: stool pH <6, an increase in breath hydrogen of > 10ppm when challenged with sucrose after fasting and a negative lactose breath test. However, because of the difficulties in diagnosing CSID, it may be warranted to conduct a short therapeutic trial (e.g. one week) to assess response in patients suspected of having CSID.

CLINICAL STUDIES:

A two-phase (dose response preceded by a breath hydrogen phase) double-blind, multi-site, crossover trial was conducted in 28 patients (aged 4 months to 11.5 years) with confirmed CSID. During the dose response phase the patients were challenged with an ordinary sucrose containing diet while receiving each of four doses of sacrosidase: full strength (9000 I.U./mL) and three dilutions (1:10 [900 I.U./mL], 1:100 [90 I.U./mL], and 1:1000 [9 I.U./mL]) in random order for a period of 10 days. Patients who weighed no more than 15 kg received 1 mL per meal; those weighing more than 15 kg received 2 mL per meal. The dose did not vary with age or sucrose intake.

A dose-response relationship was shown between the two higher and the two lower doses. The two higher doses of sacrosidase were associated with significantly fewer total stools and higher proportions of patients having lower total symptom scores, the primary efficacy end-points. In addition, higher doses of sacrosidase were associated with a significantly greater number of hard and formed stools as well as with fewer watery and soft stools, the secondary efficacy end-points.

Analysis of the overall symptomatic response as a function of age indicated that in CSID patients up to 3 years of age, 86% became asymptomatic. In patients over 3 years of age 77% became asymptomatic. Thus, the therapeutic response did not differ significantly according to age.

A second study of similar design and execution as the first used 4 different dilutions of sacrosidase 1:100 (90 I.U./mL), 1:1000 (9 I.U./mL,) 1:10,000 (0.9 I.U./mL), and 1:100,000 (0.09 I.U./mL). There were inconsistent results with regards to the primary efficacy parameters.

In both trials however, patients showed a marked decrease in breath hydrogen output when they received sacrosidase in comparison to placebo.

Indications and Usage for Sucraid

Sucraid (sacrosidase) oral solution is indicated as oral replacement therapy of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency. (CSID)

Contraindications

Patients known to be hypersensitive to yeast, yeast products, glycerin (glycerol), or papain.

Warnings

Severe wheezing, 90 minutes after a second dose of sacrosidase, necessitated admission into the ICU for a 4-year old boy. The wheezing was probably caused by sacrosidase. He had asthma and was being treated with steroids. A skin test for sacrosidase was positive.

Other serious events have not been linked to Sucraid.

Precautions

Care should be taken to administer initial doses of Sucraid near (within a few minutes’ travel) a facility where acute hypersensitivity reactions can be adequately treated. Alternatively, the patient may be tested for hypersensitivity to Sucraid through skin abrasion testing. Should symptoms of hypersensitivity appear, discontinue medication and initiate symptomatic and supportive therapy.

Skin testing as a rechallenge has been used to verify hypersensitivity in one asthmatic child who displayed wheezing after oral sacrosidase.

GENERAL

Although Sucraid provides replacement therapy for the deficient sucrase, it does not provide specific replacement therapy for the deficient isomaltase. Therefore, restricting starch in the diet may still be necessary to reduce symptoms as much as possible. The need for dietary starch restriction for patients using Sucraid should be evaluated in each patient.

It may sometimes be clinically inappropriate, difficult or inconvenient to perform a small bowel biopsy or breath hydrogen test to make a definitive diagnosis of CSID. If the diagnosis is in doubt, it may be warranted to conduct a short therapeutic trial (e.g. one week) with Sucraid to assess response in a patient suspected of sucrase deficiency.

The effects of Sucraid have not been evaluated in patients with secondary (acquired) disaccharidase deficiencies.

INFORMATION FOR PATIENTS:

See Patient Package Insert. Patients should be instructed to discard bottles of Sucraid 4 weeks after opening due to the potential for bacterial growth. For the same reason, patients should be advised to rinse the measuring scoop with water after each use.

Sucraid is fully soluble with water, milk and infant formula, but it is important to note that this product is sensitive to heat. Sucraid should not be reconstituted or consumed with fruit juice, since its acidity may reduce the enzyme activity.

USE IN DIABETICS:

The use of Sucraid will enable the products of sucrose hydrolysis - glucose and fructose to be absorbed. This fact must be carefully considered in planning the diet of diabetic CSID patients using Sucraid.

LABORATORY TESTS:

The definitive test for diagnosis of CSID is the measurement of intestinal disaccharidases following small bowel biopsy.

Other tests used alone may be inaccurate: for example, the breath hydrogen test (high incidence of false-negatives) or oral sucrose tolerance test (high incidence of false positives). Differential urinary disaccharide testing has been reported to show good agreement with small intestinal biopsy for diagnosis of CSID.

DRUG INTERACTIONS:

Neither drug-drug nor drug-food interactions are expected or have been reported with the use of Sucraid. However, Sucraid should not be reconstituted or consumed with fruit juice, since its acidity may reduce the enzyme activity.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:

Long-term studies in animals with Sucraid have not been performed to evaluate the carcinogenic potential. Studies to evaluate the effect of Sucraid on fertility or its mutogenic potential have not been performed.

PREGNANCY:

Teratogenic effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Sucraid. Sucraid is not expected to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity. Sucraid should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS:

The Sucraid enzyme is broken down in the stomach and intestines and the component amino acids and peptides are then absorbed as nutrients.

PEDIATRIC USE:

Sucraid has been used in patients as young as 5 months of age. Evidence in one controlled trial in primarily pediatric patients shows that Sucraid is safe and effective for the treatment of the genetically acquired sucrase deficiency, which is part of CSID.

Adverse Reactions

Adverse experiences with Sucraid in clinical trials were generally minor and were frequently associated with the underlying disease.

In clinical studies of up to 54 months duration, physicians treated a total of 52 patients with Sucraid. The adverse experiences and respective number of patients reporting each event (in parenthesis) were as follows: abdominal pain (4), vomiting (3), nausea (2), diarrhea (2), constipation (2), insomnia (1) headache (1) nervousness (1) and dehydration (1).

Note: diarrhea and abdominal pain can be a part of the clinical presentation of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).

One asthmatic child experienced a serious hypersensitivity reaction (wheezing) probably related to sacrosidase (see Warnings). The event resulted in withdrawal of the patient from the trial but resolved with no sequelae.

Overdosage

Over dosage with Sucraid has not been reported.

Sucraid Dosage and Administration

The recommended dosage is 1 or 2 mL (8,500 to 17,000 I.U.) or 1 or 2 full measuring scoops (each full measuring scoop equals 1mL; 28 drops from the Sucraid container tip equals 1mL) taken orally with each meal or snack diluted with 2 to 4 ounces of water, milk or infant formula. The beverage or infant formula should be served cold or at room temperature. The beverage or infant formula should not be warmed or heated before or after addition of Sucraid because heating is likely to decrease potency. Sucraid should not be reconstituted or consumed with fruit juice since its acidity may reduce the enzyme activity.

It is recommended that approximately half of the dosage be taken at the beginning of the meal or snack and the remainder be taken during the meal or snack.

The recommended dosage is as follows:

1 mL (8,500 I.U.) (one full measuring scoop or 28 drops) per meal or snack for patients up to 15 kg in body weight.

2mL (17,000 I.U.) (two full measuring scoops or 56 drops) per meal or snack for patients over 15 kg in body weight.

Dosage may be measured with the 1 mL measuring scoop (provided) or by drop count method (1mL equals 28 drops from the Sucraid container tip).

How is Sucraid Supplied

Sucraid is available in 118 mL (4 fluid ounces) translucent plastic bottles, packaged two bottles per box. Each mL of solution contains 8,500 International Units (I.U.) of sacrosidase. A 1 mL measuring scoop is provided with each bottle. A full measuring scoop is 1 mL.

Store in a refrigerator at 2°- 8°C (36°- 46°F). Discard four weeks after first opening due to the potential for bacterial growth. Protect from heat and light.

RX only.

Manufactured by:

PrimaPharm, Inc.

San Diego, CA 92121

Distributed by:

QOL Medical, LLC

Kirkland, WA 98033

To order, or for any questions call 1-866-528-4750

www.Sucraid.net

NDC# 67871-111-04

PATIENT PACKAGE INSERT: INFORMATION FOR PATIENTS

Sucraid® (sacrosidase) oral solution

Please read this leaflet carefully before you take Sucraid® (sacrosidase) oral solution or give Sucraid to a child. Please do not throw away this leaflet. You may need to read it again at a later date. This leaflet does not contain all the information on Sucraid. For further information or advice, ask your doctor or pharmacist.

BEFORE TAKING Sucraid:

WARNING: Sucraid may cause a serious allergic reaction. If you notice any swelling or have difficulty breathing, get emergency help right away. Before taking your first and second doses, be sure that there are health professionals nearby (within a few minutes travel) just in case there is an allergic reaction.

INFORMATION ABOUT YOUR MEDICINE

The name of your medicine is Sucraid (sacrosidase) oral solution. It can be obtained only with a prescription from your doctor.

The purpose of your medicine:

Sucraid is an enzyme replacement therapy for the treatment of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID). CSID is a condition where your body lacks the enzymes needed to break down and absorb sucrose (table sugar) and other sugars from starch.

The symptoms of CSID often include frequent watery diarrhea, abdominal pain, bloating, and gas. In many cases, the symptoms of CSID are similar to other medical problems. Only your doctor can make a definite diagnosis of CSID.

Sucraid can help improve the breakdown and absorption of sucrose (table sugar) from the intestine and can help relieve the gastrointestinal symptoms of CSID.

Sucraid does not break down some sugars resulting from the digestion of starch. Therefore, you may need to restrict the amount of starch in your diet. Your doctor will tell you if you should restrict the amount of starch in your diet.

Discuss the following important information with your doctor before you begin to take Sucraid:

Tell your doctor if you are allergic to, have ever had a reaction to, or have ever had difficulty taking yeast, yeast products, papain or glycerin (glycerol).

Tell your doctor if you have diabetes. With Sucraid, sucrose (table sugar) can be absorbed from your diet and your blood glucose levels may change. Your doctor will tell you if your diet or diabetes medicines need to be changed.

Side effects to watch for:

Some patients may have worse abdominal pain, vomiting, nausea, or diarrhea. Constipation, difficulty sleeping, headache, nervousness, and dehydration have also occurred. Other side effects may also occur. If you notice these or any other side effects during treatment with Sucraid, check with your doctor.

Stop taking Sucraid and get emergency help immediately if any of the following side effects occur: difficulty breathing, wheezing, or swelling of the face.

How to take your medicine:

Each bottle of Sucraid is supplied with a plastic screw cap which covers a dropper dispensing tip. Remove the outer cap and measure out the required dose. Reseal the bottle after each use by replacing and twisting the cap until tight.

Write down the date the sealed bottle is first opened in the space provided on the bottle label. Always throw away the bottle four weeks after first opening it because Sucraid contains no preservatives. For the same reason, you should rinse the measuring scoop with water after each time you finish using it.

To get the full benefits of this medicine, it is very important to take Sucraid as your doctor has prescribed. The usual dosage is 1 to 2 milliliters (mL) with each meal or snack:

1mL = 1 full measuring scoop (28 drops from the bottle tip) and 2 mL = 2 full measuring scoops (56 drops from the bottle tip).

Measure your dose with the measuring scoop provided (see Figure 1). Do not use a kitchen teaspoon or other measuring device since it will not measure an accurate dose.

Figure 1. Measure dose with measuring scoop.

Mix your dose in 2 to 4 ounces of water, milk, or infant formula (see Figure 2). Sucraid should not be dissolved in or taken with fruit juice.

NEVER HEAT Sucraid OR PUT IT IN WARM OR HOT BEVERAGES OR INFANT FORMULA. Heating Sucraid causes it to lose its effectiveness. The beverage or infant formula should be taken cold or at room temperature.

Figure 2. Mix dose in beverage or infant formula.

It is recommended that approximately half of your dosage be taken at the beginning of each meal or snack and the remainder of your dosage be taken during the meal or snack.

Storing your medicine:

Sucraid is available in 4 fluid ounce (118 mL) see-through plastic bottles, packaged two bottles per box. A 1 mL measuring scoop is provided with each bottle. Always store Sucraid in a refrigerator at 36°F - 46°F (2°C - 8°C). Protect Sucraid from heat and light.

If your bottle of Sucraid has expired (the expiration date is printed on the bottle label), throw it away.

Keep this medicine in a safe place in your refrigerator where children cannot reach it.

QOL Medical, LLC

Kirkland, WA 98033

www.Sucraid.net

For questions call 1-866-528-4750

Rev 12/08

Part No. 0110

PACKAGE LABEL

Carton Panel, Front:

Carton Panel, Back:

Bottle Label:

Sucraid  sacrosidase  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67871-111 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sacrosidase (sacrosidase) sacrosidase 8500 [iU]  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 67871-111-04 2 BOTTLE In 1 CARTON contains a BOTTLE (67871-111-01) 1 67871-111-01 118 mL In 1 BOTTLE This package is contained within the CARTON (67871-111-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020772	04/09/1998

Labeler - QOL Medical, LLC (140026258)

Revised: 05/2010QOL Medical, LLC

More Sucraid resources

• Sucraid Side Effects (in more detail)
• Sucraid Dosage
• Sucraid Use in Pregnancy & Breastfeeding
• Sucraid Support Group
• 0 Reviews · Be the first to review/rate this drug

• Sucraid Concise Consumer Information (Cerner Multum)


• Sucraid Monograph (AHFS DI)


• Sucraid Advanced Consumer (Micromedex) - Includes Dosage Information


• Sucraid MedFacts Consumer Leaflet (Wolters Kluwer)

Suboxone

Pronunciation: BUE-pre-NOR-feen/nal-OX-one
Generic Name: Buprenorphine/Naloxone
Brand Name: Suboxone

Suboxone is used for:

Treating opioid dependence. It should be used as part of a complete narcotic dependence treatment plan. It may also be used for other conditions as determined by your doctor.

Suboxone is an opioid (narcotic) partial agonist-antagonist. It works by binding to receptors in the brain and nervous system to help prevent withdrawal symptoms in someone who has stopped taking narcotics.

Do NOT use Suboxone if:

• you are allergic to any ingredient in Suboxone


• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Suboxone:

Some medical conditions may interact with Suboxone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of blood or electrolyte problems, breathing or lung problems (eg, asthma, chronic obstructive pulmonary disease [COPD]), a curvature of the spine (eg, kyphoscoliosis), certain heart problems (eg, cor pulmonale), an underactive thyroid, adrenal gland problems (eg, Addison disease), liver problems (eg, hepatitis B or C), abnormal liver enzyme tests, kidney problems, an enlarged prostate gland, trouble urinating, a blockage of your bladder or urethra, seizures, or gallbladder problems


• if you have a history of stomach or bowel problems (eg, inflammatory bowel disease), blockage, or surgery


• if you have slow or shallow breathing, severe drowsiness, stomach problems, or severe or persistent diarrhea caused by antibiotic use (pseudomembranous colitis)


• if you have a history of a recent head injury, growths in the brain (eg, tumor, lesion), or increased pressure in the brain


• if you have a history of mental or mood problems, suicidal thoughts or behaviors, drug or alcohol abuse, or if you are in alcohol withdrawal

Some MEDICINES MAY INTERACT with Suboxone. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Benzodiazepines (eg, diazepam), cimetidine, narcotic pain medicine (eg, codeine), phenothiazines (eg, chlorpromazine), or sodium oxybate (GHB) because the risk of severe drowsiness, severe breathing problems, or seizures may be increased


• Azole antifungals (eg, ketoconazole, voriconazole), delavirdine, HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, erythromycin) because they may increase the risk of Suboxone's side effects


• Carbamazepine, naltrexone, certain nonnucleoside reverse transcriptase inhibitors (NNRTIs) (eg, efavirenz, etravirine, nevirapine), phenobarbital, phenytoin, or rifamycins (eg, rifampin) because they may decrease Suboxone's effectiveness or withdrawal symptoms may occur


• Methadone because its effectiveness may be decreased by Suboxone

This may not be a complete list of all interactions that may occur. Ask your health care provider if Suboxone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Suboxone:

Use Suboxone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not swallow, crush, or chew sublingual tablets. Place the tablet under your tongue and allow it to slowly dissolve. Do not eat, drink, or smoke while the tablet is dissolving.


• Take Suboxone on a regular schedule to get the most benefit from it.


• Taking Suboxone at the same time each day will help you remember to take it.


• If you miss a dose of Suboxone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Suboxone.

Important safety information:

• Suboxone may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Suboxone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Suboxone; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not inject Suboxone. Doing so may cause severe withdrawal symptoms, severe breathing problems, and death.


• Suboxone may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do NOT take more than the recommended dose, use more often than prescribed, or suddenly stop taking Suboxone without checking with your doctor.


• Tell your doctor or dentist that you take Suboxone before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including liver function, may be performed while you use Suboxone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Suboxone with caution in the ELDERLY; they may be more sensitive to its effects, especially decreased breathing and drowsiness.


• Suboxone should not be used in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Suboxone may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Suboxone while you are pregnant. Suboxone is found in breast milk. Do not breast-feed while taking Suboxone.

Some people who use Suboxone for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Suboxone, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Suboxone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Chills; constipation; diarrhea; dizziness; drowsiness; flushing; headache; nausea; sleeplessness; stomach pain; sweating; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety or nervousness; blurred vision; confusion; dark urine; decreased attention; fainting; irregular heartbeat; loss of appetite; loss of coordination; mental or mood changes (eg, depression); pale stools; persistent trouble sleeping; severe or persistent dizziness or drowsiness; severe or persistent stomach pain or constipation; slow or shallow breathing; slowed reflexes; slurred speech; swelling of the hands, ankles, or feet; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Suboxone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive drowsiness; severe dizziness or fainting; very slow and shallow breathing; very small pupils.

Proper storage of Suboxone:

Store Suboxone at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Suboxone out of the reach of children and away from pets.

General information:

• If you have any questions about Suboxone, please talk with your doctor, pharmacist, or other health care provider.


• Suboxone is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Suboxone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Suboxone resources

• Suboxone Side Effects (in more detail)
• Suboxone Use in Pregnancy & Breastfeeding
• Drug Images
• Suboxone Drug Interactions
• Suboxone Support Group
• 287 Reviews for Suboxone - Add your own review/rating

• Suboxone Prescribing Information (FDA)


• Suboxone Advanced Consumer (Micromedex) - Includes Dosage Information


• Suboxone Consumer Overview

Compare Suboxone with other medications

• Opiate Dependence

Strongid T

Dosage Form: FOR ANIMAL USE ONLY
Strongid® T

(pyrantel pamoate)

Equine Anthelmintic Suspension

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Strongid T Description

Strongid T is a suspension of pyrantel pamoate in a palatable caramel-flavored vehicle. Each mL contains 50 mg of pyrantel base as pyrantel pamoate.

Pyrantel pamoate is a compound belonging to a family classified chemically as tetrahydropyrimidines. It is a yellow, water-insoluble crystalline salt of the tetrahydropyrimidine base and pamoic acid containing 34.7% base activity. The chemical structure and name are given below:

(E)-1,4,5,6-Tetrahydro-1-methyl-2-[2-(2-thienyl) vinyl] pyrimidine 4,4' methylenebis[3-hydroxy-2-naphthoate] (1:1)

Indications and Usage for Strongid T

For the removal and control of mature infections of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); pinworms (Oxyuris equi); large roundworms (Parascaris equorum); and small strongyles in horses and ponies.

Contraindications

It is recommended that severely debilitated animals not be treated with this preparation.

Warnings

Do not use in horses intended for human consumption. Keep out of reach of children.

PRECAUTION

This product is a suspension and as such will separate. To insure uniform resuspension and to achieve proper dosage, it is extremely important that the product be shaken and stirred thoroughly before every use.

Strongid T Dosage and Administration

Administer 3 mg pyrantel base per lb of body weight (6 mL Strongid T per 100 lb of body weight). For maximum control of parasitism, it is recommended that foals (2–8 months of age) be dosed every 4 weeks. To minimize potential hazard that the mare may pose to the foal, she should be treated 1 month prior to anticipated foaling date followed by retreatment 10 days to 2 weeks after birth of foal. Horses over 8 months of age should be routinely dosed every 6 weeks.

Directions for use

Strongid T may be administered by means of a stomach tube, dose syringe or by mixing into the feed.

Stomach Tube

Measure the appropriate dosage of Strongid T and mix in the desired quantity of water. Protect drench from direct sunlight and administer to the animal immediately following mixing. Do not attempt to store diluted suspension.

Strongid T is inactive against the common horse bot (Gasterophilus spp.) However, Strongid T may be administered concurrently with carbon disulfide observing the usual precautions with carbon disulfide.

Dose Syringe

Draw the appropriate dosage of Strongid T into a dose syringe and administer to the animal. Do not expose Strongid T to direct sunlight.

Feed

Mix the appropriate dosage of Strongid T in the normal grain ration. Fasting of animals prior to or following treatment is not required.

EFFICACY

Critical (worm-count) studies in horses demonstrated that Strongid T administered at the recommended dosage was efficacious against mature infections of Strongylus vulgaris (>90%), S. edentatus (69%), S. equinus (>90%), Oxyuris equi (81%), Parascaris equorum (>90%), and small strongyles (90%).

SAFETY

Strongid T is well tolerated by horses and ponies of all ages. No adverse drug response was observed when dose rates up to 60 mg of pyrantel base per lb of body weight were administered by stomach tube nor when 3 mg base per lb was given by intratracheal injection. The reproductive performance of pregnant mares and stud horses dosed with Strongid T has not been affected.

RECOMMENDED STORAGE

Store below 30°C (86°F).

How is Strongid T Supplied

Strongid T is supplied in 1 quart (946 mL) bottles.

NADA #91-739, Approved by FDA

Distributed by:

Pfizer Animal Health

Div. of Pfizer Inc

NY, NY 10017

10232100

81463930

Printed in USA

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

Strongid® T

(pyrantel pamoate)

Equine

Anthelmintic

Suspension

Active Ingredient: 50 mg of pyrantel

base as pyrantel pamoate per mL

Caution: Federal law restricts this

drug to use by or on the order of

a licensed veterinarian.

Net Contents: 1 quart (946 mL)

NADA #91-739, Approved by FDA

Pfizer

Strongid T  pyrantel pamoate  suspension

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 61106-2384 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength pyrantel pamoate (pyrantel) pyrantel 50 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor CARAMEL Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 61106-2384-1 946 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA091739	10/19/1973

Labeler - Pfizer Animal Health (039055157)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Animal Health		039055157	MANUFACTURE

Revised: 08/2010Pfizer Animal Health

sucralfate

Generic Name: sucralfate (oral) (soo KRAL fate)

Brand Names: Carafate

What is sucralfate?

Sucralfate is an anti-ulcer medication.

Sucralfate is not greatly absorbed into the body through the digestive tract. It works mainly in the lining of the stomach by adhering to ulcer sites and protecting them from acids, enzymes, and bile salts.

Sucralfate is used to treat an active duodenal ulcer. Sucralfate can heal an active ulcer, but it will not prevent future ulcers from occurring.

Sucralfate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about sucralfate?

Before taking sucralfate, tell your doctor if you have diabetes, kidney disease, or if you are on dialysis.

Take sucralfate on an empty stomach, at least 1 hour before or 2 hours after a meal. Take this medicine for the full prescribed length of time. Your symptoms may improve before the ulcer is completely healed. Avoid taking any other medications within 2 hours before or after you take sucralfate. Sucralfate can make it harder for your body to absorb other medications you take by mouth. Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for sucralfate to work in your stomach. If your doctor does recommend using an antacid, avoid taking it within 30 minutes before or after taking sucralfate.

What should I discuss with my healthcare provider before taking sucralfate?

To make sure you can safely take sucralfate, tell your doctor if you have any of these other conditions:

• 
  

  diabetes;

  
  


• 
  

  kidney disease; or

  
  


• 
  

  if you are on dialysis.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether sucralfate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take sucralfate?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take sucralfate on an empty stomach, at least 1 hour before or 2 hours after a meal. Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Take this medicine for the full prescribed length of time. Your symptoms may improve before the ulcer is completely healed. Store at room temperature away from moisture and heat.

See also: Sucralfate dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking any other medications within 2 hours after you take sucralfate. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking sucralfate?

Avoid taking any other medications within 2 hours before or after you take sucralfate. Sucralfate can make it harder for your body to absorb other medications you take by mouth. Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for sucralfate to work in your stomach. If your doctor does recommend using an antacid, avoid taking it within 30 minutes before or after taking sucralfate.

Sucralfate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• 
  

  nausea, vomiting, upset stomach;

  
  


• 
  

  stomach pain;

  
  


• 
  

  constipation, diarrhea;

  
  


• 
  

  mild itching or skin rash;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  dizziness, drowsiness, spinning sensation;

  
  


• 
  

  headache; or

  
  


• 
  

  back pain.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sucralfate Dosing Information

Usual Adult Dose for Duodenal Ulcer:

1 g orally on an empty stomach 4 times a day or alternatively,
2 g orally on an empty stomach 2 times a day.

Usual Adult Dose for Duodenal Ulcer Prophylaxis:

1 g orally on an empty stomach twice a day.

Usual Adult Dose for Gastric Ulcer:

1 g orally on an empty stomach 4 times a day.

Usual Adult Dose for Gastroesophageal Reflux Disease:

1 g orally on an empty stomach 4 times a day.

Usual Adult Dose for Stress Ulcer Prophylaxis:

1 g orally on an empty stomach every 4 to 6 hours.

Usual Adult Dose for Stomatitis:

1 g (10 mL) topically as a suspension 4 times a day.

Usual Adult Dose for Hyperphosphatemia of Renal Failure:

1 g orally on an empty stomach twice a day.
This dose may be titrated based on serum phosphate levels.

Usual Pediatric Dose for Stomatitis:

Safety and effectiveness of sucralfate in pediatric patients have not been established. However, the use of sucralfate may be appropriate in some situations.

Greater than 1 year: 250 to 500 mg (2.5 to 5 mL) topically as a suspension 4 times a day for treatment of stomatitis.

What other drugs will affect sucralfate?

Sucralfate can make it harder for your body to absorb other medications you take by mouth. Tell your doctor if you are taking:

• 
  

  cimetidine (Tagamet);

  
  


• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  levothyroxine (Synthroid);

  
  


• 
  

  phenytoin (Dilantin);

  
  


• 
  

  quinidine (Quin-G);

  
  


• 
  

  ranitidine (Zantac);

  
  


• 
  

  tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl, and others);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven); or

  
  


• 
  

  certain antibiotics such as ciprofloxacin (Cipro), levofloxacin (Levaquin), lomefloxacin (Maxaquin), ketoconazole (Nizoral), and others.

  
  

This list is not complete and other drugs may interact with sucralfate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More sucralfate resources

• Sucralfate Side Effects (in more detail)
• Sucralfate Dosage
• Sucralfate Use in Pregnancy & Breastfeeding
• Drug Images
• Sucralfate Drug Interactions
• Sucralfate Support Group
• 16 Reviews for Sucralfate - Add your own review/rating

• sucralfate Advanced Consumer (Micromedex) - Includes Dosage Information


• Sucralfate Prescribing Information (FDA)


• Sucralfate Professional Patient Advice (Wolters Kluwer)


• Sucralfate Monograph (AHFS DI)


• Sucralfate MedFacts Consumer Leaflet (Wolters Kluwer)


• Carafate Prescribing Information (FDA)


• Carafate Consumer Overview

Compare sucralfate with other medications

• Duodenal Ulcer
• Duodenal Ulcer Prophylaxis
• GERD
• Hyperphosphatemia of Renal Failure
• Stomach Ulcer
• Stomatitis
• Stress Ulcer Prophylaxis

Where can I get more information?

• Your pharmacist can provide more information about sucralfate.

See also: sucralfate side effects (in more detail)

streptomycin Intramuscular

strep-toe-MYE-sin

Intramuscular route(Powder for Solution)

The risk of severe neurotoxic reactions (eg, disturbance of vestibular and cochlear function, optic nerve dysfunction, peripheral neuritis, arachnoiditis, and encephalopathy) is sharply increased in patients with impaired renal function or prerenal azotemia. The incidence of irreversible vestibular damage is particularly high in patients treated with streptomycin. Careful monitoring of renal function and dose reduction may be warranted. Avoid the concurrent or sequential use of other neurotoxic or nephrotoxic drugs with streptomycin. Neurotoxicity can result in respiratory paralysis from neuromuscular blockage, especially when the drug is given soon after the use of anesthesia or muscle relaxants. Parenteral streptomycin should be reserved for patients with adequate laboratory and audiometric testing available during therapy .

Available Dosage Forms:

• Solution


• Powder for Solution

Therapeutic Class: Antitubercular

Chemical Class: Aminoglycoside

Uses For streptomycin

Streptomycin injection is used to treat moderate to severe bacterial infections in many different parts of the body.

Streptomycin belongs to the class of medicines known as aminoglycoside antibiotics. It works by killing bacteria or preventing their growth. However, streptomycin will not work for colds, flu, or other virus infections.

Streptomycin injection is usually used for serious bacterial infections for which other medicines may not work. However, it may also cause some serious side effects, including damage to your hearing and sense of balance. These side effects may be more likely to occur in elderly patients and newborn infants. You and your doctor should talk about the benefits of streptomycin as well as the risks.

streptomycin is to be administered only by or under the immediate supervision of your doctor.

Before Using streptomycin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For streptomycin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to streptomycin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of streptomycin injection in children. However, streptomycin should be used with caution in young infants.

Geriatric

No information is available on the relationship of age to the effects of streptomycin injection in geriatric patients. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving streptomycin injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving streptomycin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using streptomycin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alcuronium


• Atracurium


• Cidofovir


• Cisatracurium


• Colistimethate Sodium


• Decamethonium


• Doxacurium


• Ethacrynic Acid


• Fazadinium


• Furosemide


• Gallamine


• Hexafluorenium


• Lysine


• Metocurine


• Mivacurium


• Pancuronium


• Pipecuronium


• Rapacuronium


• Rocuronium


• Succinylcholine


• Tacrolimus


• Tubocurarine


• Vecuronium

Using streptomycin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bumetanide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of streptomycin. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease (e.g., prerenal azotemia)—Higher blood levels of streptomycin may result, which increases the risk of serious side effects.

• Hearing problems or


• Muscle problems or


• Nerve problems—Use with caution. May make these conditions worse.

Proper Use of streptomycin

A nurse or other trained health professional will give you streptomycin. streptomycin is given as a shot into one of your muscles (usually in the buttocks, middle thighs, or upper arms).

To help clear up your infection completely, keep using streptomycin for the full time of treatment, even if you begin to feel better after a few days. Also, streptomycin works best when there is a constant amount in the blood. To help keep the amount constant, you must receive streptomycin on a regular schedule.

To keep your kidneys working well and help prevent kidney problems, drink extra fluids so you will pass more urine while you are receiving streptomycin.

Precautions While Using streptomycin

Your doctor will check your progress closely while you or your child are receiving streptomycin. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to receive it. Blood, urine, nerve, and hearing tests may be needed to check for unwanted effects.

You will need to see your doctor after finishing streptomycin to make sure your infection is gone. You may also need to see your doctor again in four months to have a repeat blood test done for other infections such as syphilis.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using streptomycin while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

streptomycin may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive streptomycin.

High doses of streptomycin injection may cause serious reactions (e.g., syndrome of CNS depression) for a young infant. Infants should not receive a dose of streptomycin that is higher than the recommended dose.

Stop using streptomycin and check with your doctor right away if you or your child have sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. Tell your doctor if you or your child have dizziness or lightheadedness; feeling of constant movement of self or surroundings; or sensation of spinning. These may be symptoms of damage to your hearing or sense of balance.

Make sure your doctor knows that you or your child are using streptomycin before having a surgery or other procedures that require you to receive a numbing medicine (e.g., anesthetics, neuromuscular blocking agents). Using streptomycin injection together with numbing medicines may increase your risk of having difficulty in breathing, drowsiness, inability to breath without assistance, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

streptomycin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Black, tarry stools


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest pain


• chills


• clumsiness


• cough


• dizziness or lightheadedness


• feeling of constant movement of self or surroundings


• fever


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• nausea


• painful or difficult urination


• sensation of spinning


• shortness of breath


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• swollen glands


• unsteadiness


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting

Less common

• Back, leg, or stomach pains


• bleeding gums


• bloody or cloudy urine


• blurred vision


• change in vision


• dark urine


• deafness


• difficulty with breathing


• difficulty with swallowing


• dry mouth


• fast heartbeat


• general body swelling


• headache


• hives


• impaired vision


• itching


• loss of appetite


• muscle weakness


• nosebleeds


• pain in lower back or side


• pale skin


• pinpoint red spots on the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• skin rash


• thirst


• tightness in the chest


• wheezing


• yellowing of the eyes or skin

Rare

• Change in the frequency of urination or amount of urine


• drowsiness


• increased thirst


• swelling of the feet or lower legs


• weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Hives or welts


• redness of the skin

Less common

• Impaired vision

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: streptomycin Intramuscular side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More streptomycin Intramuscular resources

• Streptomycin Intramuscular Side Effects (in more detail)
• Streptomycin Intramuscular Use in Pregnancy & Breastfeeding
• Streptomycin Intramuscular Drug Interactions
• Streptomycin Intramuscular Support Group
• 0 Reviews for Streptomycin Intramuscular - Add your own review/rating

Compare streptomycin Intramuscular with other medications

• Brucellosis
• Endocarditis
• Mycobacterium avium-intracellulare, Treatment
• Plague
• Rabbit Fever
• Tuberculosis, Active

Strattera

Generic Name: Atomoxetine Hydrochloride
Class: Central Nervous System Agents, Miscellaneous
VA Class: CN900
Chemical Name: (-)-N-Methyl-3-phenyl-3-(otolyloxy) propylamine hydrochloride
Molecular Formula: C₁₇H₂₁NO•HCl
CAS Number: 82248-59-7

• 
  

  Increased risk of suicidal ideation observed in short-term clinical trials in children and adolescents with attention deficit hyperactivity disorder (ADHD).¹ (See Suicidality Risk and also see Pediatric Use, under Cautions.) Balance risk of suicidality against the clinical need for the drug.¹

  
  


• 
  

  Closely monitor patients initiating atomoxetine therapy; advise family members and caregivers of the need for close observation and communication with the clinician.¹

  
  


• 
  

  Indicated for treatment of ADHD in pediatric patients and adults; not approved for treatment of major depressive disorder.¹

  
  

Introduction

Selective norepinephrine reuptake inhibitor.^{1 2 3 4 5 6 7 8 9 10 11 19}

Uses for Strattera

Attention Deficit Hyperactivity Disorder

Treatment of ADHD, alone or combined with behavioral treatment, as an adjunct to psychological, educational, social, and other remedial measures in carefully selected adults^{1 11} and children ≥6 years of age.^{1 4 10 12}

Strattera Dosage and Administration

General

• 
  

  Can discontinue atomoxetine without tapering dosage.¹

  
  

Administration

Oral Administration

Administer orally once daily in the morning or in 2 equally divided doses in the morning and late afternoon/early evening.^{1 2 19}

Administer without regard to meals.^{1 2}

Ocular irritant; swallow capsules whole, do not open capsules or sprinkle contents on food.^{1 2 19}

If a dose is missed, take the missed dose as soon as it is remembered, but the amount taken within a 24-hour period should not exceed the prescribed total daily dosage.¹

Dosage

Available as atomoxetine hydrochloride; dosage expressed in terms of atomoxetine.¹

Pediatric Patients

ADHD

Oral

Children and adolescents weighing ≤70 kg: Initially, approximately 0.5 mg/kg daily.¹ Increase dosage after ≥3 days to target dosage of approximately 1.2 mg/kg daily (do not exceed 100 mg daily).¹

Children and adolescents weighing >70 kg: Initially, 40 mg daily.¹ Increase dosage after ≥3 days to target dosage of approximately 80 mg daily.¹ If optimum response has not been achieved after 2–4 additional weeks of therapy, may increase dosage to maximum of 100 mg daily.¹

Adults

ADHD

Oral

Initially, 40 mg daily.¹ Increase dosage after ≥3 days to target dosage of approximately 80 mg daily.¹ If optimum response has not been achieved after 2–4 additional weeks of therapy, may increase dosage to maximum of 100 mg daily.¹

Prescribing Limits

Pediatric Patients

ADHD

Oral

Children and adolescents weighing ≤70 kg: Maximum 100 mg or 1.4 mg/kg daily (whichever is less); dosages >1.2 mg/kg daily have not been shown in clinical trials to result in additional therapeutic benefit.¹

Children and adolescents weighing >70 kg: Maximum 100 mg daily; dosages >100 mg daily have not been shown in clinical trials to result in additional therapeutic benefit.¹ Safety of single doses >120 mg and total daily dosages >150 mg has not been established.¹

Long-term efficacy (i.e., >12 months in pediatric patients 6–15 years of age or >9 weeks in pediatric patients 16–18 years of age) not established.^{1 13 18} If used for extended periods, periodically reevaluate the usefulness of long-term therapy.¹

Adults

ADHD

Oral

Maximum 100 mg daily; dosages >100 mg daily have not been shown in clinical trials to result in additional therapeutic benefit.¹ Safety of single doses >120 mg and total daily dosages >150 mg has not been established.¹

Long-term efficacy (i.e., >10 weeks) not established.^{1 13} If used for extended periods, periodically reevaluate the usefulness of long-term therapy.¹

Special Populations

Hepatic Impairment

Reduce initial and target dosages by 50% in patients with moderate hepatic impairment (Child-Pugh class B) and by 75% in those with severe hepatic impairment (Child-Pugh class C).¹

Cautions for Strattera

Contraindications

• 
  

  Known hypersensitivity to atomoxetine or any ingredient in the formulation.¹

  
  


• 
  

  Current or recent (within 2 weeks) therapy with MAO inhibitor.¹ Allow ≥2 weeks to elapse after discontinuing atomoxetine before initiating MAO inhibitor therapy.¹ (See Specific Drugs under Interactions.)

  
  


• 
  

  Angle-closure glaucoma.¹

  
  

Warnings/Precautions

Warnings

Suicidality Risk

Increased risk of suicidal thinking observed in a pooled analysis of short-term clinical trials in children and adolescents with ADHD.^{1 17} (See Pediatric Use under Cautions.) Not known whether risk extends to long-term use of the drug.¹

Similar analysis of data from adults with ADHD or major depressive disorder found no increased risk of suicidal ideation or behavior in those receiving atomoxetine.^{1 17}

Balance risk of suicidality against the clinical need for the drug.¹

Monitor pediatric patients closely for clinical worsening, suicidal ideation or behaviors, or unusual changes in behavior, particularly during the first few months of therapy and following dosage adjustment.^{1 16 17 19} Monitoring should include daily observation by family members and caregivers and frequent contact with the prescribing clinician, particularly if the patient’s behavior changes or is a concern.^{1 17}

Manufacturer recommends face-to-face contact between clinicians and patients or their family members or caregivers at least weekly during the first 4 weeks of therapy and then every other week for the next 4 weeks, with subsequent face-to-face contact at 12 weeks and as clinically indicated thereafter; additional contact via telephone may be appropriate between visits.¹

Consider discontinuance of therapy in patients with emergent suicidality or manifestations that may be precursors to emerging suicidality (e.g., anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania), particularly if such manifestations are severe or abrupt in onset or were not part of the patient’s presenting symptoms.¹

Sensitivity Reactions

Hypersensitivity Reactions

Angioedema, urticaria, and rash reported rarely.¹

Other Warnings and Precautions

Severe Hepatic Injury

Severe hepatic injury rarely reported; manifested by increased hepatic enzymes (up to 40 times ULN) and jaundice (bilirubin up to 12 times ULN).^{1 15} Risk of progression to acute hepatic failure resulting in death or requiring liver transplantation in a small percentage of patients.^{1 15} Adverse hepatic effects may occur several months after atomoxetine initiation; laboratory abnormalities may continue to worsen for several weeks after discontinuance.¹

Determine hepatic enzyme concentrations after first manifestation of hepatic dysfunction (e.g., pruritus, dark urine, jaundice, right upper quadrant tenderness, unexplained flu-like symptoms).^{1 15} Discontinue atomoxetine in patients with jaundice or laboratory evidence of hepatic injury and do not reinitiate.^{1 15}

Sudden Death and Serious Cardiovascular Events

Sudden unexplained death, stroke, and MI reported in adults with ADHD receiving usual dosages of atomoxetine; sudden death also reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of the drug.¹

Thoroughly review medical history (including evaluation for family history of sudden death or ventricular arrhythmia) and perform physical examination in all children, adolescents, and adults being considered for atomoxetine therapy; if initial findings suggest presence of cardiac disease, perform further cardiac evaluation (e.g., ECG, echocardiogram).¹

In general, avoid use in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, CAD, or other serious cardiac conditions.¹

Patients who develop exertional chest pain, unexplained syncope, or other manifestations suggestive of cardiac disease during atomoxetine therapy should undergo prompt cardiac evaluation.¹

Precipitation of Psychotic Symptoms

Psychotic symptoms (e.g., hallucinations, delusional thinking) may occur with usual dosages in children and adolescents without prior history of psychotic illness.¹ If psychotic symptoms occur, consider causal relationship to atomoxetine, and discontinue therapy as appropriate.¹

Precipitation of Manic Symptoms

May precipitate mixed or manic episodes in ADHD patients with comorbid bipolar disorder; use with caution in these patients.¹ Prior to initiating therapy, carefully screen patients with ADHD and comorbid depressive symptoms to identify risk for bipolar disorder; screening should include a detailed psychiatric history (e.g., family history of suicide, bipolar disorder, or depression).¹

Manic symptoms may occur with usual dosages in children and adolescents without prior history of mania.¹ If manic symptoms occur, consider causal relationship to atomoxetine, and discontinue therapy as appropriate.¹

Cardiovascular Effects

Increased BP and heart rate reported in children, adolescents, and adults.^{1 4 7 9 10 11} Use with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease.¹ Measure BP and pulse rate before initiation of atomoxetine, following any increase in dosage, and periodically during therapy.¹

Orthostatic hypotension and syncope reported;¹ use with caution in patients with conditions that would predispose them to hypotension.¹

Peripheral Vascular Effects

Exacerbation or precipitation of Raynaud’s phenomenon reported.¹

GU Effects

Possible urinary retention and urinary hesitation.¹

Growth Effects

Monitor growth of pediatric patients receiving atomoxetine.¹ Potential for temporary suppression of normal height and/or weight patterns following initiation of therapy.¹ (See Pediatric Use under Cautions.)

Behavioral Effects

Aggressive behavior and hostility frequently are observed in pediatric patients with ADHD and have been reported in patients receiving drug therapy (including atomoxetine) for the disorder.¹

Monitor patients beginning treatment for ADHD for the appearance or worsening of aggressive behavior or hostility.¹

Priapism

Priapism reported rarely in pediatric and adult patients; requires prompt medical attention.¹ (See Advice to Patients.)

Tics

In a controlled study, atomoxetine did not worsen tics in patients with ADHD and comorbid Tourette’s disorder.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Distributed into milk in rats; not known whether atomoxetine is distributed into human milk.¹ Caution if used in nursing women.¹

Pediatric Use

Safety and efficacy not established in children <6 years of age.¹

Increased risk of suicidal ideation observed in a pooled analysis of 12 short-term controlled clinical trials in pediatric patients with ADHD (11 studies) or enuresis (1 study); risk of suicidal ideation was about 0.4% in those receiving atomoxetine versus 0% in those receiving placebo.^{1 17} One child receiving the drug attempted suicide; no completed suicides were reported.^{1 17} All events representing suicidal behavior or thinking occurred in children ≤12 years of age and occurred during the first month of therapy.¹ Not known whether the risk extends to long-term use of the drug.¹ Balance risk of suicidality against the clinical need for the drug.¹ (See Suicidality Risk under Cautions.)

Sudden death reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of stimulants.¹ (See Sudden Death and Serious Cardiovascular Events under Cautions.)

Potential for temporary (e.g., 9–12 months) suppression of normal height and/or weight patterns following initiation of atomoxetine therapy in pediatric patients; rebound in height and weight gains reported with continued therapy.¹ Pattern observed regardless of metabolizer phenotype (poor or extensive metabolizer of the drug) or pubertal status upon initiation of therapy.¹ Monitor growth of patients receiving atomoxetine therapy.^{1 19}

Geriatric Use

Safety and efficacy not established.¹

Hepatic Impairment

Increased systemic exposure to atomoxetine in patients with moderate or severe hepatic impairment.¹ (See Hepatic Impairment under Dosage and Administration and Special Populations under Pharmacokinetics.)

Common Adverse Effects

In children and adolescents, abdominal pain, decreased appetite, vomiting, somnolence, nausea, fatigue, irritability, dizziness.¹

In adults, dry mouth, nausea, insomnia, decreased appetite, constipation, fatigue, erectile dysfunction, hot flush, urinary hesitation and/or retention, dysmenorrhea.¹

Interactions for Strattera

Metabolized principally by CYP2D6.¹ Does not cause clinically important inhibition or induction of CYP enzymes, including 1A2, 3A, 2D6, and 2C9.¹

Drugs Affecting Hepatic Microsomal Enzymes

Potential for increased plasma atomoxetine concentrations during concomitant therapy with CYP2D6 inhibitors in individuals with extensive metabolizer CYP2D6 phenotype (concentrations may be similar to those achieved in poor metabolizers).¹

If used concomitantly with a potent CYP2D6 inhibitor or in patients with poor metabolizer CYP2D6 phenotype, initiate atomoxetine therapy at usual initial daily dosage (approximately 0.5 mg/kg daily in children and adolescents weighing ≤70 kg; 40 mg daily in adults and children and adolescents weighing >70 kg); increase dosage to usual target dosage (approximately 1.2 mg/kg daily [maximum 100 mg daily] in children and adolescents weighing ≤70 kg; 80 mg daily in adults and children and adolescents weighing >70 kg) only if ADHD symptoms fail to improve after 4 weeks of therapy and initial dosage is well tolerated.¹

Specific Drugs

Drug	Interaction	Comments
Albuterol	Potentiation of cardiovascular effects (e.g., increased heart rate and BP)1	Use with caution1
Alcohol	No change in intoxicating effects of alcohol1
Antacids	No change in atomoxetine bioavailability1
Aspirin	No change in protein binding of atomoxetine or aspirin1
Desipramine	No effect on desipramine pharmacokinetics1	Dosage adjustment not necessary1
Diazepam	No change in protein binding of atomoxetine or diazepam1
Fluoxetine	Possible increase in plasma atomoxetine concentrations;1 however, no change in plasma atomoxetine concentrations when administered to patients with poor-metabolizer phenotype1	Initiate atomoxetine therapy at usual initial daily dosage; increase atomoxetine dosage to usual target dosage only if ADHD symptoms fail to improve after 4 weeks of therapy and initial dosage is well tolerated1 (see Drugs Affecting Hepatic Microsomal Enzymes under Interactions)
MAO inhibitors	Inhibition of catecholamine metabolism; severe, potentially fatal, reactions (e.g., hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes)1	Contraindicated1 (see Contraindications under Cautions)
Methylphenidate	No increase in cardiovascular effects relative to use of methylphenidate alone1
Midazolam	Increased AUC of midazolam1	Dosage adjustment not necessary1
Omeprazole	No change in atomoxetine bioavailability1
Paroxetine	Possible increase in plasma atomoxetine concentrations;1 however, no change in plasma atomoxetine concentrations when administered to patients with poor-metabolizer phenotype1	Initiate atomoxetine therapy at usual initial daily dosage; increase atomoxetine dosage to usual target dosage only if ADHD symptoms fail to improve after 4 weeks of therapy and initial dosage is well tolerated1 (see Drugs Affecting Hepatic Microsomal Enzymes under Interactions)
Phenytoin	No change in protein binding of atomoxetine or phenytoin1
Pressor agents (e.g., dopamine, dobutamine)	Possible increased hypertensive effects1	Use with caution1
Quinidine	Possible increase in plasma atomoxetine concentrations;1 however, no change in plasma atomoxetine concentrations when administered to patients with poor-metabolizer phenotype1	Initiate atomoxetine therapy at usual initial daily dosage; increase atomoxetine dosage to usual target dosage only if ADHD symptoms fail to improve after 4 weeks of therapy and initial dosage is well tolerated1 (see Drugs Affecting Hepatic Microsomal Enzymes under Interactions)
Warfarin	No change in protein binding of atomoxetine or warfarin1

Strattera Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following oral administration, with peak plasma concentration attained in approximately 1–2 hours.¹

Absolute bioavailability is 63% in extensive metabolizers of CYP2D6 substrates and 94% in poor metabolizers.¹

In patients with the poor metabolizer CYP2D6 phenotype, AUC and peak plasma concentrations of atomoxetine are 10- and 5-fold greater, respectively, than in extensive metabolizers.¹

Food

Standard high-fat meal decreases rate but not extent of absorption in adults.¹ In children and adolescents, food reduces peak plasma concentration by 9%.¹

Special Populations

In patients with moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment, systemic exposure is increased twofold or fourfold, respectively.¹

Distribution

Extent

Distributed into milk in animals; not known whether atomoxetine distributes into human milk or crosses the placenta.¹

Plasma Protein Binding

98% (principally albumin).¹

Elimination

Metabolism

Principally metabolized by CYP2D6 to an equipotent metabolite (4-hydroxyatomoxetine) that circulates in plasma at much lower concentrations; undergoes subsequent conjugation with glucuronic acid.¹

Elimination Route

Excreted mainly as metabolites in urine (80%) and in feces (<17%).¹

Half-life

Extensive metabolizers: about 5 hours.¹

Poor metabolizers: about 22 hours.¹

Stability

Storage

Oral

Capsules

25°C (may be exposed to 15–30°C).¹

ActionsActions

• 
  

  Mechanism of action in the management of ADHD appears to be related to selective inhibition of the presynaptic norepinephrine transporter.^{1 2 3 4 5 6 7 8 9 10 11}

  
  


• 
  

  Minimal affinity for other noradrenergic receptors or for other neurotransmitter transporters or receptors.^{1 2 3 4 5 6 7 8 9 10 11}

  
  


• 
  

  Not considered a stimulant.^{1 2 3 4 5 6 7 8 9 10 11}

  
  

Advice to Patients

• 
  

  Provide patient or caregiver with a copy of the manufacturer’s patient information (medication guide); discuss and answer questions about its contents as needed.¹ Instruct patient or caregiver to read and understand contents of medication guide before initiating therapy and each time the prescription is refilled.^{1 16}

  
  


• 
  

  Risk of suicidal thinking.^{1 16} Importance of daily observation by family members and caregivers and of close communication with clinician.^{1 16} Importance of immediately informing clinician if clinical worsening, anxiety, agitation, panic attacks, insomnia, irritability, aggressive behaviors, hostility, impulsivity, restlessness, mania, depression, suicidal ideation or behaviors, or unusual changes in behavior occur, particularly during the first few months after initiation of therapy or following dosage adjustments.^{1 16 17}

  
  


• 
  

  Hepatic dysfunction may rarely develop.^{1 16} Importance of informing clinician immediately if symptoms of hepatic injury (e.g., pruritus, jaundice, dark urine, upper right-sided abdominal tenderness, unexplained flu-like symptoms) occur.^{1 15 16}

  
  


• 
  

  Importance of informing clinician immediately if adverse cardiovascular effects (e.g., chest pain, shortness of breath, fainting) occur.¹⁶

  
  


• 
  

  Importance of informing clinician immediately if precipitation of psychotic (e.g., hallucinations, delusional thinking) or manic symptoms occurs.¹⁶

  
  


• 
  

  Potential for drug to impair patient’s ability to perform potentially hazardous activities; use caution when driving or operating machinery until the effects of the drug on the individual are known.^{1 16}

  
  


• 
  

  Risk of priapism.^{1 16} Importance of seeking immediate medical attention if erection persists for >4 hours.^{1 16}

  
  


• 
  

  Importance of taking atomoxetine exactly as prescribed.^{2 16} (See Oral Administration under Dosage and Administration.)

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 16}

  
  


• 
  

  Importance of advising patient or caregiver that the drug is an ocular irritant and that the capsules should not be opened; if eye contact occurs, flush affected eye(s) with water immediately, obtain medical advice, and wash hands and potentially contaminated surfaces as soon as possible.^{1 16}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, dietary supplements, and herbal products, as well as any concomitant illnesses/conditions (e.g., glaucoma, suicidal ideation or behaviors, cardiac/cardiovascular disease, mental/psychiatric disorder, hepatic disease).^{1 16}

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Atomoxetine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	10 mg (of atomoxetine)	Strattera	Lilly
		18 mg (of atomoxetine)	Strattera	Lilly
		25 mg (of atomoxetine)	Strattera	Lilly
		40 mg (of atomoxetine)	Strattera	Lilly
		60 mg (of atomoxetine)	Strattera	Lilly
		80 mg (of atomoxetine)	Strattera	Lilly
		100 mg (of atomoxetine)	Strattera	Lilly

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Strattera 10MG Capsules (LILLY): 30/$176.05 or 90/$485.59

Strattera 100MG Capsules (LILLY): 30/$205.45 or 90/$579.48

Strattera 18MG Capsules (LILLY): 30/$187.59 or 90/$538.2

Strattera 25MG Capsules (LILLY): 30/$176.54 or 90/$487.48

Strattera 40MG Capsules (LILLY): 30/$188.78 or 90/$527.87

Strattera 60MG Capsules (LILLY): 30/$185.68 or 90/$529.12

Strattera 80MG Capsules (LILLY): 30/$202.81 or 90/$574.15

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Eli Lilly and Company. Strattera (atomoxetine hydrochloride) capsules prescribing information. Indianapolis, IN; 2008 May 7.

2. Eli Lilly and Company. Frequently asked questions about Strattera. Indianapolis, IN: 2002. From the Eli Lilly website.

3. Kratochvil CJ, Bohac D, Harrington M et al. An open-label trial of tomoxetine in pediatric attention deficit hyperactivity disorder. J Child Adolesc Psychopharmacol. 2001; 11:167-70. [PubMed 11436956]

4. Michelson D, Allen AJ, Busner J et al. Once daily atomoxetine treatment for children and adolescents with attention deficit hyperactivity disorder: a randomized, placebo-controlled study. Am J Psychiatry. 2002; 159:1896-901. [IDIS 494196] [PubMed 12411225]

5. Spencer T, Biederman J, Wilens T et al. Effectiveness and tolerability of tomoxetine in adults with attention deficit hyperactivity disorder. Am J Psychiatry. 1998; 155:693-5. [IDIS 404883] [PubMed 9585725]

6. Spencer T, Biederman J, Wilens TE et al. Adults with attention-deficit/hyperactivity disorder: a controversial diagnosis. J Clin Psychiatry. 1998; 59(suppl 7):59-68. [IDIS 409837] [PubMed 9680054]

7. Spencer T, Biederman J, Heiligenstein J et al. An open-label, dose-ranging study of atomoxetine in children with attention deficit hyperactivity disorder. J Child Adolesc Psychopharmacol. 2001; 11:251-65. [PubMed 11642475]

8. Biederman J, Heiligenstein JH, Faries DE et al. Efficacy of atomoxetine versus placebo in school-age girls with attention-deficit/hyperactivity disorder. Pediatrics. 2002; 110:e75. Available at Pediatrics website. [IDIS 490311] [PubMed 12456942]

9. Kratochvil CJ, Heiligenstein JH, Dittmann R et al. Atomoxetine and methylphenidate treatment in children with ADHD: a prospective, randomized, open-label trial. J Am Acad Child Adolesc Psychiatry. 2002; 41:776-84. [IDIS 482668] [PubMed 12108801]

10. Spencer T, Heiligenstein JH, Biederman J et al. Results from 2 proof-of- concept, placebo-controlled studies of atomoxetine in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2002; 63:1140-7. [IDIS 491627] [PubMed 12523874]

11. Michelson D, Adler L, Spencer T et al. Atomoxetine in adults with ADHD: two randomized, placebo-controlled studies. Biol Psychiatry. 2003;53:112-20.

12. Michelson D, Faries D, Wernicke J et al. Atomoxetine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, dose-response study. Pediatrics. 2001; 108:e83. [IDIS 474839] [PubMed 11694667]

13. Eli Lilly and Company, Indianapolis, IN: Personal communication.

15. Anon. New warning for Strattera. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2004 Dec 17.

16. Eli Lilly and Company. Strattera (atomoxetine hydrochloride) medication guide. Indianapolis, IN; 2007 May 10.

17. Food and Drug Administration. FDA alert for healthcare professionals. Atomoxetine (marketed as Strattera). Rockville, MD; September 2005. From FDA Website.

18. Michelson D, Buitelaar JK, Danckaerts M et al. Relapse prevention in pediatric patients with ADHD treated with atomoxetine: a randomized, double-blind, placebo-controlled study. J Am Acad Child Adolesc Psychiatry. 2004; 43:896-904. [PubMed 15213591]

19. American Academy of Child and Adolescent Psychiatry. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. Washington, DC; 2007. From the AACAP website. Accessed 2008 Jul 16.

More Strattera resources

• Strattera Side Effects (in more detail)
• Strattera Use in Pregnancy & Breastfeeding
• Drug Images
• Strattera Drug Interactions
• Strattera Support Group
• 92 Reviews for Strattera - Add your own review/rating

• Strattera Prescribing Information (FDA)


• Strattera Consumer Overview


• Strattera Advanced Consumer (Micromedex) - Includes Dosage Information


• Strattera MedFacts Consumer Leaflet (Wolters Kluwer)


• Atomoxetine Prescribing Information (FDA)

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