Cotab A

Generic Name: chlorpheniramine and codeine (KLOR fen IR a meed and KOE deen)

Brand Names: Cotab A, Cotab AX, Notuss-AC, Z-Tuss AC, Zodryl AC 25, Zodryl AC 30, Zodryl AC 35, Zodryl AC 40, Zodryl AC 50, Zodryl AC 60, Zodryl AC 80

What is Cotab A (chlorpheniramine and codeine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Codeine is a narcotic cough suppressant. It affects the signals in the brain that trigger cough reflex.

The combination of chlorpheniramine and codeine is used to treat runny or stuffy nose, sneezing, watery eyes, and cough caused by allergies or the common cold.

Chlorpheniramine and codeine will not treat a cough that is caused by smoking, asthma, or emphysema.

Chlorpheniramine and codeine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Cotab A (chlorpheniramine and codeine)?

Do not take a cough and cold if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough and cold medicine before the MAO inhibitor has cleared from your body. You should not take this medication if you are allergic to chlorpheniramine or codeine, or if you have severe high blood pressure or coronary artery disease, ischemic heart disease, a stomach ulcer, narrow-angle glaucoma, if you are having an asthma attack, if you are pregnant or breast-feeding, or if you are unable to urinate.

Before taking this medication, tell your doctor if you have asthma or other breathing disorder, glaucoma, heart disease, high blood pressure, seizures, a thyroid disorder, diabetes, urination problems, stomach problems, liver or kidney disease, Addison's disease, mental illness, or a history of drug or alcohol addiction.

Codeine may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not give this medicine to a child younger than 6 years old.

What should I discuss with my healthcare provider before taking Cotab A (chlorpheniramine and codeine)?

Do not take a cough and cold if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough and cold medicine before the MAO inhibitor has cleared from your body. You should not take this medication if you are allergic to chlorpheniramine or codeine, or if you have:

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  severe or uncontrolled high blood pressure;

  
  


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  severe coronary artery disease;

  
  


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  ischemic heart disease;

  
  


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  a stomach ulcer;

  
  


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  narrow-angle glaucoma;

  
  


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  if you are having an asthma attack;

  
  


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  if you are unable to urinate; or

  
  


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  if you are pregnant or breast-feeding.

  
  

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

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  asthma, COPD, emphysema, or other breathing disorder;

  
  


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  glaucoma;

  
  


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  heart disease, high blood pressure;

  
  


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  a history of head injury or brain tumor;

  
  


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  epilepsy or other seizure disorder;

  
  


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  a thyroid disorder;

  
  


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  diabetes;

  
  


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  enlarged prostate or urination problems;

  
  


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  stomach or intestinal problems;

  
  


• liver or kidney disease;


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  Addison's disease;

  
  


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  mental illness; or

  
  


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  a history of drug or alcohol addiction.

  
  

FDA pregnancy category C. It is not known whether chlorpheniramine and codeine is harmful to an unborn baby. Codeine can cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults are more likely to have side effects from this medicine.

Do not give chlorpheniramine and codeine to a child younger than 6 years old. Codeine may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

How should I take Cotab A (chlorpheniramine and codeine)?

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

Do not take this medication more often than you doctor has prescribed. An overdose of chlorpheniramine and codeine can cause life-threatening side effects. Take chlorpheniramine and codeine with a full glass of water.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Chlorpheniramine and codeine can be taken with food if it upsets your stomach.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you also have a fever, headache, or skin rash.

Store chlorpheniramine and codeine at room temperature away from moisture and heat. Keep track of how much of this medicine has been used from each new bottle. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Cough or cold medicine is usually taken only as needed, so you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of chlorpheniramine and codeine can be fatal, especially to a child.

Overdose symptoms may include feeling restless or nervous, sleep problems, extreme drowsiness, weak or limp feeling, confusion, hallucinations, chest pain, shortness of breath, uneven heartbeats, pinpoint pupils, cold and clammy skin, fainting, seizure (convulsions), weak pulse, shallow breathing, or breathing that stops.

What should I avoid while taking Cotab A (chlorpheniramine and codeine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol while using chlorpheniramine and codeine. Alcohol may increase drowsiness and dizziness.

Cotab A (chlorpheniramine and codeine) 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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  weak or shallow breathing;

  
  


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  chest tightness, fast heart rate;

  
  


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  painful urination;

  
  


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  urinating less than usual or not at all; or

  
  


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  confusion, hallucinations, or unusual behavior.

  
  

Less serious side effects may include:

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  feeling restless or excited (especially in children);

  
  


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  dizziness, drowsiness, loss of coordination;

  
  


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  ringing in your ears;

  
  


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  constipation or diarrhea;

  
  


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  nausea, vomiting, loss of appetite;

  
  


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  dry mouth, nose, or throat; or

  
  


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  mild itching or skin rash.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Cotab A (chlorpheniramine and codeine)?

Narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by chlorpheniramine and codeine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medicine.

Tell your doctor about all other medications you use, especially:

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  atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  
  


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  bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);

  
  


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  glycopyrrolate (Robinul);

  
  


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  mepenzolate (Cantil);

  
  


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  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  
  


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  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine); or

  
  


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  an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

  
  

This list is not complete and there may be other drugs that can interact with chlorpheniramine and codeine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Cotab A resources

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

• Cotab A MedFacts Consumer Leaflet (Wolters Kluwer)


• Codeprex Prescribing Information (FDA)


• Codeprex Consumer Overview


• EndaCof-C Prescribing Information (FDA)


• Notuss-AC Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Cotab A with other medications

• Cough and Nasal Congestion
• Hay Fever

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine and codeine.

See also: Cotab A side effects (in more detail)

Corzide

Pronunciation: BEN-droe-FLOO-me-THYE-a-zide/NAY-doe-lol
Generic Name: Bendroflumethiazide/Nadolol
Brand Name: Corzide

Do not suddenly stop taking Corzide. Sharp chest pain, irregular heartbeat, and sometimes heart attack may occur if you suddenly stop Corzide. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking it. This should be done even if you only take Corzide for high blood pressure. Heart disease is common and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Corzide again.

Corzide is used for:

Treating high blood pressure.

Corzide is a beta-blocker and diuretic combination. It works by decreasing the force and slowing down the heartbeat, helping the heart beat more regularly and reducing the amount of work the heart has to do. It also increases the elimination of excess fluid, which helps to decrease blood pressure.

Do NOT use Corzide if:

• you are allergic to any ingredient in Corzide or to sulfonamide medicines (eg, glyburide, probenecid, sulfamethoxazole)


• you have uncontrolled heart failure or a very slow and irregular heartbeat (eg, heart block)


• you are unable to urinate


• you have a history of asthma


• you are taking dofetilide or mibefradil

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

Before using Corzide:

Some medical conditions may interact with Corzide. 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 bronchitis, lung disease (eg, chronic obstructive pulmonary disease [COPD]), diabetes, gout, an overactive thyroid, low blood levels of potassium or sodium, heart problems (eg, congestive heart failure[CHF]), blood vessel problems, pheochromocytoma, lupus, liver disease, or kidney problems


• if you are having surgery or receiving anesthesia

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

• Dofetilide or mibefradil because the risk of serious heart side effects may be increased


• Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, heart problems, irregular heartbeat, diabetes, depression, mental or mood problems, immune system suppression, allergic reactions, asthma, high cholesterol, seizures), multivitamin products, and herbal or dietary supplements (eg, herbal teas, garlic, ginseng, ginkgo, St. John's wort) may interact with Corzide, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Corzide 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 Corzide:

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

• Take Corzide by mouth with or without food.


• Corzide may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.


• If you miss a dose of Corzide, take the missed dose if you remember the same day. Skip the missed dose if you do not remember the same day. Do not take 2 doses at once.

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

Important safety information:

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


• Corzide 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.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Corzide may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Corzide. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


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


• If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.


• Diabetes patients - Corzide may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including blood pressure and heart rate, may be performed while you use Corzide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Corzide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


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

Possible side effects of Corzide:

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:

Dizziness; lightheadedness; tiredness.

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); chest pain; irregular heartbeat; muscle pain or weakness; swelling of ankles or feet; unusual thirst or fatigue; unusually slow or irregular heartbeat.

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: Corzide 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 coughing; dizziness; drowsiness; fainting; loss of consciousness; low blood pressure; muscular weakness; nausea; seizures; slow heart rate; trouble breathing; upset stomach; vomiting; weakness.

Proper storage of Corzide:

Store Corzide at room temperature, between 68 and 77 degrees F (20 and 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 Corzide out of the reach of children and away from pets.

General information:

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


• Corzide 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 Corzide. 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 Corzide resources

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

Compare Corzide with other medications

• High Blood Pressure

Cutivate

fluticasone propionate

Dosage Form: ointment
Cutivate®

(fluticasone propionate ointment)

Ointment, 0.005%

For Dermatologic Use Only—Not for Ophthalmic Use.

Rx Only

Cutivate Description

Cutivate® (fluticasone propionate ointment) Ointment, 0.005% contains fluticasone propionate [(6α,11β,16α,17α) - 6,9, - difluoro - 11 - hydroxy - 16 - methyl - 3 - oxo - 17 - (1 - oxopropoxy)androsta - 1,4 - diene - 17 - carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:

Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water.

Each gram of Cutivate® Ointment contains fluticasone propionate 0.05 mg in a base of liquid paraffin, microcrystalline wax, propylene glycol, and sorbitan sesquioleate.

Cutivate - Clinical Pharmacology

Like other topical corticosteroids, fluticasone propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Fluticasone propionate is lipophilic and has a strong affinity for the glucocorticoid receptor. It has weak affinity for the progesterone receptor, and virtually no affinity for the mineralocorticoid, estrogen, or androgen receptors. The therapeutic potency of glucocorticoids is related to the half-life of the glucocorticoid-receptor complex. The half-life of the fluticasone propionate-glucocorticoid receptor complex is approximately 10 hours.

Studies performed with Cutivate® Ointment indicate that it is in the medium range of potency as compared with other topical corticosteroids.

Pharmacokinetics:Absorption: The activity of Cutivate® is due to the parent drug, fluticasone propionate. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

In a study of 6 healthy volunteers applying 25 g of fluticasone propionate ointment 0.005% twice daily to the trunk and legs for up to 5 days under occlusion, plasma levels of fluticasone ranged from 0.08 to 0.22 ng/mL.

In an animal study using radiolabeled 0.05% fluticasone propionate cream and ointment preparations, rats received a topical dose of 1 g/kg for a 24-hour period. Total recovery of radioactivity was approximately 80% at the end of 7 days. The majority of the dose (73%) was recovered from the surface of the application site. Less than 1% of the dose was recovered in the skin at the application site. Approximately 5% of the dose was absorbed systemically through the skin. Absorption from the skin continued for the duration of the study (7 days), indicating a long retention time at the application site.

Distribution: Following intravenous administration of 1 mg of fluticasone propionate in healthy volunteers, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding. The apparent volume of distribution averaged 4.2 L/kg (range, 2.3 to 16.7 L/kg). The percentage of fluticasone propionate bound to human plasma proteins averaged 91%. Fluticasone propionate is weakly and reversibly bound to erythrocytes. Fluticasone propionate is not significantly bound to human transcortin.

Metabolism: No metabolites of fluticasone propionate were detected in an in vitro study of radiolabeled fluticasone propionate incubated in a human skin homogenate. The total blood clearance of systemically absorbed fluticasone propionate averages 1,093 mL/min (range, 618 to 1,702 mL/min) after a 1-mg intravenous dose, with renal clearance accounting for less than 0.02% of the total. Fluticasone propionate is metabolized in the liver by cytochrome P450 3A4-mediated hydrolysis of the 5-fluoromethyl carbothioate grouping. This transformation occurs in 1 metabolic step to produce the inactive 17-β-carboxylic acid metabolite, the only known metabolite detected in man. This metabolite has approximately 2,000 times less affinity than the parent drug for the glucocorticoid receptor of human lung cytosol in vitro and negligible pharmacological activity in animal studies. Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man.

Excretion: Following an intravenous dose of 1 mg in healthy volunteers, fluticasone propionate showed polyexponential kinetics and had an average terminal half-life of 7.2 hours (range, 3.2 to 11.2 hours).

Indications and Usage for Cutivate

Cutivate® Ointment is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients.

Contraindications

Cutivate® Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Precautions

General: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use).

Fluticasone propionate ointment, 0.005% may cause local cutaneous adverse reactions (see ADVERSE REACTIONS).

If irritation develops, Cutivate® Ointment should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Cutivate® Ointment should be discontinued until the infection has been adequately controlled.

Cutivate® Ointment should not be used in the treatment of preexisting skin atrophy and should not be used where infection is present at the treatment site. Cutivate® Ointment should not be used in the treatment of rosacea and perioral dermatitis.

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.


2. This medication should not be used for any disorder other than that for which it was prescribed.


3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.


4. Patients should report to their physician any signs of local adverse reactions.


5. This medication should not be used on the face, underarms, or groin areas unless directed by a physician.


6. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Laboratory Tests: The following tests may be helpful in evaluating patients for HPA axis suppression:

 

ACTH stimulation test

 

A.M. plasma cortisol test

 

Urinary free cortisol test

A concentrated fluticasone propionate ointment, 0.05% (10 times that of the marketed fluticasone propionate ointment, 0.005%) suppressed 24-hour urinary free cortisol levels in 2 of 6 patients when used at a dose of 30 g/day for a week in patients with psoriasis or atopic eczema. No suppression of A.M. plasma cortisol was observed. In a second study of the same concentrated formulation of fluticasone propionate ointment, 0.05%, depression of A.M. plasma cortisol levels was noted in 2 of 8 normal volunteers when applied at doses of 50 g/day for 21 days. Morning plasma levels returned to normal levels within 4 days upon discontinuation of fluticasone propionate. In this study there was no corresponding decrease in 24-hour urinary free cortisol levels.

In a study of 35 pediatric patients treated with fluticasone propionate ointment, 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 patients who had normal testing prior to treatment. It is not known if these patients had recovery of adrenal function because follow-up testing was not performed (see PRECAUTIONS: Pediatric Use and ADVERSE REACTIONS). Adrenal suppression was indicated by either a 5 mcg/dL prestimulation cortisol, or a cosyntropin poststimulation cortisol ≤18 mcg/dL, and/or an increase of <7 mcg/dL from the baseline cortisol level.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Two 18-month studies were performed in mice to evaluate the carcinogenic potential of fluticasone propionate when given topically (as a 0.05% ointment) and orally. No evidence of carcinogenicity was found in either study.

Fluticasone propionate was not mutagenic in the standard Ames test, E. coli fluctuation test, S. cerevisiae gene conversion test, or Chinese Hamster ovarian cell assay. It was not clastogenic in mouse micronucleus or cultured human lymphocyte tests.

In a fertility and general reproductive performance study in rats, fluticasone propionate administered subcutaneously to females at up to 50 mcg/kg/day and to males at up to 100 mcg/kg/day (later reduced to 50 mcg/kg/day) had no effect upon mating performance or fertility. These doses are approximately 150 and 300 times, respectively, the human systemic exposure following use of the recommended human topical dose of fluticasone propionate ointment, 0.005%, assuming human percutaneous absorption of approximately 3% and the use in a 70-kg person of 15 g/day.

Pregnancy:Teratogenic Effects: Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Teratology studies in the mouse demonstrated fluticasone propionate to be teratogenic (cleft palate) when administered subcutaneously in doses of 45 mcg/kg/day and 150 mcg/kg/day. This dose is approximately 140 and 450 times, respectively, the human topical dose of fluticasone propionate ointment, 0.005%. There are no adequate and well-controlled studies in pregnant women. Cutivate® Ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cutivate® Ointment is administered to a nursing woman.

Pediatric Use: Use of Cutivate® Ointment in pediatric patients is not recommended.

In a study of 35 pediatric patients treated with fluticasone propionate ointment, 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 patients who had normal testing prior to treatment. It is not known if these patients had recovery of adrenal function because follow-up testing was not performed (see PRECAUTIONS: Laboratory Tests and ADVERSE REACTIONS). The decreased responsiveness to cosyntropin testing was not correlated to age of patient, amount of fluticasone propionate ointment used, or serum levels of fluticasone propionate. Plasma fluticasone propionate were not performed in a 6-month-old patient who demonstrated an abnormal response to cosyntropin stimulation testing.

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing syndrome than mature patients because of a larger skin surface to body weight ratio.

HPA axis suppression, Cushing syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels and an absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use: A limited number of patients above 65 years of age (n = 203) have been treated with Cutivate® Ointment in US and non-US clinical trials. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of Cutivate® in geriatric patients is warranted.

Adverse Reactions

In controlled clinical trials, the total incidence of adverse reactions associated with the use of Cutivate® Ointment was approximately 4%. These adverse reactions were usually mild, self-limiting, and consisted primarily of pruritus, burning, hypertrichosis, increased erythema, hives, irritation, and lightheadedness. Each of these events occurred individually in less than 1% of patients.

In a study of 35 pediatric patients treated with fluticasone propionate ointment, 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 patients who had normal testing prior to treatment. It is not known if these patients had recovery of adrenal function because follow-up testing was not performed (see PRECAUTIONS: Laboratory Tests and PRECAUTIONS: Pediatric Use). Telangiectasia on the face was noted in 1 patient on the eighth day of a 4-week treatment period. Facial use was discontinued and the telangiectasia resolved.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids, including fluticasone propionate, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. Also, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical corticosteroid products.

Overdosage

Topically applied Cutivate® Ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Cutivate Dosage and Administration

Apply a thin film of Cutivate® Ointment to the affected skin areas twice daily. Rub in gently.

Cutivate® Ointment should not be used with occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with Cutivate® Ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

How is Cutivate Supplied

Cutivate® (fluticasone propionate ointment) Ointment, 0.005% is supplied in:

 

15-g tubes (NDC 0462-0333-15),

 

30-g tubes (NDC 0462-0333-30), and

 

60-g tubes (NDC 0462-0333-60).

Store between 2°and 30°C (36°and 86°F).

PharmaDerm®

A division of Nycomed US Inc.

Melville, NY 11747 USA

www.pharmaderm.com

I8333B

R6/08

#144

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER

Pharma Derm®     NDC 0462-0333-15

Cutivate® Ointment, 0.005%

(fluticasone propionate ointment)

For dermatologic use only — Not for ophthalmic use.

Rx only         15 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON

NDC 0462-0333-15

Pharma Derm®

Cutivate® Ointment, 0.005%

(fluticasone propionate ointment)

For dermatologic use only — Not for ophthalmic use.

Rx only         15 g

Cutivate  fluticasone propionate  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0462-0333 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength fluticasone propionate (fluticasone) fluticasone propionate 0.05 mg  in 1 g

Inactive Ingredients Ingredient Name Strength propylene glycol   mineral oil

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0462-0333-15 15 g In 1 TUBE None 2 0462-0333-30 30 g In 1 TUBE None 3 0462-0333-60 60 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073030	12/14/1990

Labeler - PHARMADERM, A division of Nycomed US Inc. (043838424)

Registrant - Nycomed US Inc. (043838424)

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		174491316	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		043838424	ANALYSIS

Revised: 11/2009PHARMADERM, A division of Nycomed US Inc.

More Cutivate resources

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

• Cutivate Concise Consumer Information (Cerner Multum)


• Cutivate Advanced Consumer (Micromedex) - Includes Dosage Information


• Cutivate Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Cutivate with other medications

• Atopic Dermatitis
• Dermatologic Lesion
• Lichen Sclerosus

Creomulsion

Generic Name: dextromethorphan (Oral route)

dex-troe-meth-OR-fan

Commonly used brand name(s)

In the U.S.

• Babee Cof Syrup


• Benylin Pediatric Formula


• Children's Pedia Care


• Creomulsion


• Creo-Terpin


• Delsym


• Dexalone


• ElixSure Cough Children's


• Father John's Medicine


• Miltuss


• Nycoff


• Pediacare


• Pediacare Long-Acting Cough


• Robafen Cough


• Robitussin


• Silphen DM


• Simply Cough


• St. Joseph


• Vicks 44 Cough Relief

Available Dosage Forms:

• Suspension, Extended Release


• Solution


• Capsule


• Syrup


• Lozenge/Troche


• Elixir


• Liquid


• Tablet


• Capsule, Liquid Filled


• Suspension

Therapeutic Class: Antitussive

Uses For Creomulsion

Dextromethorphan is used to relieve coughs due to colds or influenza (flu). It should not be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (flem) with the cough.

Dextromethorphan relieves cough by acting directly on the cough center in the brain.

This medicine is available without a prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Creomulsion

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Although there is no specific information comparing use of dextromethorphan in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children 4 years of age and older than it does in adults.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of dextromethorphan in the elderly with use in other age groups.

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 taking this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Clorgyline


• Iproniazid


• Isocarboxazid


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Toloxatone


• Tranylcypromine

Using this medicine 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.

• Abiraterone


• Amitriptyline


• Amoxapine


• Citalopram


• Clomipramine


• Desipramine


• Desvenlafaxine


• Doxepin


• Duloxetine


• Escitalopram


• Fluoxetine


• Fluvoxamine


• Imipramine


• Linezolid


• Milnacipran


• Nortriptyline


• Paroxetine


• Protriptyline


• Sertraline


• Sibutramine


• Trimipramine


• Venlafaxine

Using this medicine 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.

• Clobazam


• Haloperidol


• Quinidine


• Vemurafenib

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

• Asthma—Since dextromethorphan decreases coughing, it makes it difficult to get rid of the mucus that collects in the lungs and airways during asthma

• Diabetes (sugar diabetes)—Some products contain sugar and may affect control of blood glucose monitoring

• Liver disease—Dextromethorphan may build up in the body and cause unwanted effects

• Chronic bronchitis or


• Emphysema or


• Mucus or phlegm with cough—Since dextromethorphan decreases coughing, it makes it difficult to get rid of the mucus that may collect in the lungs and airways with some diseases

• Slowed breathing—Dextromethorphan may slow the rate of breathing even further

Proper Use of dextromethorphan

This section provides information on the proper use of a number of products that contain dextromethorphan. It may not be specific to Creomulsion. Please read with care.

Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than their active ingredient, and many liquid medicines contain alcohol.

Use this medicine only as directed by your doctor or the directions on the label. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor or the label says. Although this effect has happened only rarely, dextromethorphan has become habit-forming (causing mental or physical dependence) in some persons who used too much for a long time.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For lozenge dosage form:
  
  • For cough:
    
    • Adults and children 12 years of age and older—5 to 15 mg every two to four hours, as needed.
    
    
    • Children 6 to 12 years of age—5 to 15 mg every two to six hours, as needed.
    
    
    • Children 4 to 6 years of age—5 mg every four hours, as needed.
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  


• For syrup dosage form:
  
  • For cough:
    
    • Adults and children 12 years of age and older—30 mg every six to eight hours, as needed.
    
    
    • Children 6 to 12 years of age—7 mg every four hours or 15 mg every six to eight hours, as needed.
    
    
    • Children 4 to 6 years of age—3.5 mg every four hours or 7.5 mg every six to eight hours, as needed.
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  


• For extended-release oral suspension dosage form :
  
  • For cough:
    
    • Adults and children 12 years of age and older—60 mg every twelve hours, as needed.
    
    
    • Children 6 to 12 years of age—30 mg every twelve hours, as needed.
    
    
    • Children 4 to 6 years of age—15 mg every twelve hours, as needed.
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Creomulsion

If your cough has not improved after 7 days, if sore throat has not improved after 2 days, if you have a high fever, skin rash, or continuing headache with the cough, or if asthma or high blood pressure is present, check with your doctor. These signs may mean that you have other medical problems.

Dissolve lozenges in the mouth with caution, to lessen the risk of choking.

Creomulsion 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 as soon as possible if any of the following side effects occur:

Symptoms of overdose

• Blurred vision


• confusion


• difficulty in urination


• drowsiness or dizziness


• nausea or vomiting (severe)


• shakiness and unsteady walk


• slowed breathing


• unusual excitement, nervousness, restlessness, or irritability (severe)

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:

Less common or rare

• Confusion


• constipation


• dizziness (mild)


• drowsiness (mild)


• headache


• nausea or vomiting


• stomach pain

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: Creomulsion 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 Creomulsion resources

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

• Creomulsion Concise Consumer Information (Cerner Multum)


• Delsym Extended-Release Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• DexAlone MedFacts Consumer Leaflet (Wolters Kluwer)


• Dextromethorphan Hydrobromide Monograph (AHFS DI)


• ElixSure Cough Gel Syrup MedFacts Consumer Leaflet (Wolters Kluwer)


• Robitussin Maximum Strength Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Triaminic Long Acting Cough Orally Disintegrating Strips MedFacts Consumer Leaflet (Wolters Kluwer)


• Tussin Pediatric Elixir MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Creomulsion with other medications

• Cough

Crotamiton Lotion

Pronunciation: kroe-TAM-ih-ton
Generic Name: Crotamiton
Brand Name: Eurax

Crotamiton Lotion is used for:

Treating scabies and relieving itching.

Crotamiton Lotion is a scabicidal antipruritic. Exactly how it works is unknown.

Do NOT use Crotamiton Lotion if:

• you are allergic to any ingredient in Crotamiton Lotion


• you develop severe irritation after applying Crotamiton Lotion


• you experience irritation when applying topical medicines

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

Before using Crotamiton Lotion:

Some medical conditions may interact with Crotamiton Lotion. 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 irritated, inflamed, raw, or weeping skin

Some MEDICINES MAY INTERACT with Crotamiton Lotion. However, no specific interactions with Crotamiton Lotion are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Crotamiton Lotion 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 Crotamiton Lotion:

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

• Before using Crotamiton Lotion, bathe and dry your skin completely.


• Shake well before using a dose.


• For scabies - Apply enough medicine to cover the entire body from the chin down. Make sure that you apply medicine in all folds and creases of your body, such as between the fingers and toes, under the arms, and to the groin area. Rub the medicine in completely. Apply the medicine a second time after 24 hours has passed, unless directed otherwise by your doctor. Do not bathe before applying the second dose. Change clothing and bed linen the next morning. Clothing and bed linen should be dry-cleaned or washed in the hot cycle of the washing machine. Bathe to remove the medicine 48 hours after the second dose.


• For itching - Rub medicine gently into the affected areas until it is completely rubbed in. Wash hands after use unless your hands are part of the treated area.


• If you miss a dose of Crotamiton Lotion, use 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 use 2 doses at once.

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

Important safety information:

• Do not use Crotamiton Lotion on inflamed, raw, or weeping skin.


• Itching may continue for up to several weeks due to sensitivity to mites. This does not indicate treatment failure. Contact your doctor before using Crotamiton Lotion again.


• Crotamiton Lotion may be harmful if swallowed. If you or someone you know may have taken Crotamiton Lotion by mouth, contact your local poison control center or emergency room immediately.


• Avoid getting Crotamiton Lotion in your eyes, nose, or mouth. If you get Crotamiton Lotion in your eyes, rinse immediately with cool water.


• Use Crotamiton Lotion with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Crotamiton Lotion during pregnancy. It is unknown if Crotamiton Lotion is excreted in breast milk. If you are or will be breast-feeding while you are using Crotamiton Lotion, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Crotamiton Lotion:

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:

Irritated skin.

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); severe irritation.

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: Crotamiton 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 burning or irritation of the mouth or throat, nausea, vomiting, and abdominal pain.

Proper storage of Crotamiton Lotion:

Store Crotamiton Lotion at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Crotamiton Lotion out of the reach of children and away from pets.

General information:

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


• Crotamiton Lotion 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 Crotamiton Lotion. 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 Crotamiton resources

• Crotamiton Side Effects (in more detail)
• Crotamiton Use in Pregnancy & Breastfeeding
• Crotamiton Support Group
• 1 Review for Crotamiton - Add your own review/rating

Compare Crotamiton with other medications

• Pruritus
• Scabies

Crotamiton Cream

Pronunciation: kroe-TAM-ih-ton
Generic Name: Crotamiton
Brand Name: Eurax

Crotamiton Cream is used for:

Treating scabies and relieving itching.

Crotamiton Cream is a scabicidal antipruritic. Exactly how it works is unknown.

Do NOT use Crotamiton Cream if:

• you are allergic to any ingredient in Crotamiton Cream


• you develop severe irritation after applying Crotamiton Cream


• you experience irritation when applying topical medicines

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

Before using Crotamiton Cream:

Some medical conditions may interact with Crotamiton Cream. 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 irritated, inflamed, raw, or weeping skin

Some MEDICINES MAY INTERACT with Crotamiton Cream. However, no specific interactions with Crotamiton Cream are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Crotamiton Cream 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 Crotamiton Cream:

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

• Before using Crotamiton Cream, bathe and dry your skin completely.


• For scabies - Apply enough medicine to cover the entire body from the chin down. Make sure that you apply medicine in all folds and creases of your body, such as between the fingers and toes, under the arms, and to the groin area. Rub the medicine in completely. Apply the medicine a second time after 24 hours has passed, unless directed otherwise by your doctor. Do not bathe before applying the second dose. Change clothing and bed linen the next morning. Clothing and bed linen should be dry-cleaned or washed in the hot cycle of the washing machine. Bathe to remove the medicine 48 hours after the second dose.


• For itching - Rub medicine gently into the affected areas until it is completely rubbed in. Wash hands after use unless your hands are part of the treated area.


• If you miss a dose of Crotamiton Cream, use 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 use 2 doses at once.

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

Important safety information:

• Do not use Crotamiton Cream on inflamed, raw, or weeping skin.


• Itching may continue for up to several weeks due to sensitivity to mites. This does not indicate treatment failure. Contact your doctor before using Crotamiton Cream again.


• Crotamiton Cream may be harmful if swallowed. If you or someone you know may have taken Crotamiton Cream by mouth, contact your local poison control center or emergency room immediately.


• Avoid getting Crotamiton Cream in your eyes, nose, or mouth. If you get Crotamiton Cream in your eyes, rinse immediately with cool water.


• Use Crotamiton Cream with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Crotamiton Cream during pregnancy. It is unknown if Crotamiton Cream is excreted in breast milk. If you are or will be breast-feeding while you are using Crotamiton Cream, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Crotamiton Cream:

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:

Irritated skin.

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); severe irritation.

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: Crotamiton 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 burning or irritation of the mouth or throat, nausea, vomiting, and abdominal pain.

Proper storage of Crotamiton Cream:

Store Crotamiton Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Crotamiton Cream out of the reach of children and away from pets.

General information:

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


• Crotamiton Cream 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 Crotamiton Cream. 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 Crotamiton resources

• Crotamiton Side Effects (in more detail)
• Crotamiton Dosage
• Crotamiton Use in Pregnancy & Breastfeeding
• Crotamiton Support Group
• 1 Review for Crotamiton - Add your own review/rating

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Cotab AX

Pronunciation: KLOR-fen-IR-a-meen/KOE-deen
Generic Name: Chlorpheniramine/Codeine
Brand Name: Examples include Cotab A and Cotab AX

Cotab AX is used for:

Relieving runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Cotab AX is an antihistamine and narcotic cough suppressant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex, which reduces a dry cough.

Do NOT use Cotab AX if:

• you are allergic to any ingredient in Cotab AX or any other codeine- or morphine-related medicine (eg, oxycodone)


• you have severe high blood pressure, severe heart blood vessel disease, angle-closure glaucoma, or peptic ulcers


• you are unable to urinate or are having an asthma attack


• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Cotab AX:

Some medical conditions may interact with Cotab AX. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following

• 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 heart blood vessel problems, irregular heartbeat, or any other heart problems (eg, cor pulmonale)


• if you have a history of high blood pressure; diabetes; liver or kidney problems; stroke; glaucoma or increased pressure in the eye; a blockage of your bladder, stomach, or bowels; ulcers; trouble urinating; an enlarged prostate or other prostate problems; or thyroid problems


• if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea, slow or irregular breathing), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have severe drowsiness, recent head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)


• if you are dehydrated, have very poor health, have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent stomach, bowel, or urinary surgery


• if you have a history of alcohol or substance abuse or suicidal thoughts or behavior


• if you are taking medicine for high blood pressure or depression

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

• Anticholinergics (eg, scopolamine) because a serious bowel motility problem (paralytic ileus) may occur


• Cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Cotab AX's side effects


• Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Cotab AX's effectiveness


• Narcotic pain medicines (eg, hydrocodone) because the risk of their side effects may be increased by Cotab AX

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cotab AX 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 Cotab AX:

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

• Take Cotab AX by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you miss a dose of Cotab AX and you are taking it regularly, 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 Cotab AX.

Important safety information:

• Cotab AX may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Cotab AX 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 Cotab AX; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Cotab AX 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 use Cotab AX for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Cotab AX has chlorpheniramine in it. Before you start any new medicine, check the label to see if it has chlorpheniramine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your cough or other symptoms persist for more than 5 days or come back, or if you also have fever, rash, or persistent headache, check with your doctor.


• Cotab AX may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Cotab AX for a few days before the tests.


• Cotab AX may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Cotab AX. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


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


• Use Cotab AX with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, low blood pressure, excitability, dry mouth, and trouble urinating.


• Caution is advised when using Cotab AX in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Cotab AX should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cotab AX while you are pregnant. Do not take Cotab AX if you are in the third trimester of pregnancy. It is not known if Cotab AX is found in breast milk. Do not breast-feed while taking Cotab AX.

When used for long periods of time or at high doses, Cotab AX may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Cotab AX stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Cotab AX. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Cotab AX, 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; trouble sleeping.

Possible side effects of Cotab AX:

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:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; thickening of mucus secretions; upset stomach; vomiting.

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); blurred vision, double vision, or other vision changes; confusion; difficulty urinating or inability to urinate; fast, slow, or irregular heartbeat; loss of coordination; mood or mental changes; nervousness; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; trouble sleeping; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness or tiredness.

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: Cotab AX 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 blurred vision; chest pain; cold or clammy skin; confusion; difficult or very slow breathing; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Cotab AX:

Store Cotab AX at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cotab AX out of the reach of children and away from pets.

General information:

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


• Cotab AX 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 Cotab AX. 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 Cotab AX resources

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

• Codeprex Consumer Overview


• Codeprex Prescribing Information (FDA)


• EndaCof-C Prescribing Information (FDA)

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