Norethindrone

Pronunciation: nor-ETH-in-drone
Generic Name: Norethindrone
Brand Name: Aygestin

Norethindrone is used for:

Treating certain menstrual problems or uterine problems (eg, abnormal bleeding, endometriosis). It may also be used for other conditions as determined by your doctor.

Norethindrone is a progestin hormone. It works by altering the lining of the uterus.

Do NOT use Norethindrone if:

• you are allergic to any ingredient in Norethindrone


• you are pregnant or think you may be pregnant


• you have undiagnosed abnormal vaginal bleeding or are postmenopausal


• you have a history of blood clotting problems, severe blood clots (eg, in the lungs, legs, eyes), certain blood vessel problems (eg, bleeding in the brain, heart attack, stroke), or breast cancer


• you have decreased liver function or active liver disease

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

Before using Norethindrone:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are 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 seizures (eg, epilepsy), migraines, heart problems, kidney problems, or a history of depression


• if you have a history of high blood pressure, diabetes, high blood cholesterol, lupus, or blood clots, or if a member of your family has had these problems


• if you smoke or are very overweight

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

• Aprepitant, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, rifampin, St. John's wort, or tetracyclines because they may decrease Norethindrone's effectiveness


• Corticosteroids (eg, prednisone), theophylline, or troleandomycin because the risk of their side effects may be increased by Norethindrone


• Beta-adrenergic blockers (eg, propranolol), lamotrigine, or thyroid medicines because their effectiveness may be decreased by Norethindrone

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

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

• An extra patient leaflet is available with Norethindrone. Talk to your pharmacist if you have questions about this information.


• Take Norethindrone by mouth with or without food.


• Take Norethindrone at the same time every day, with doses not more than 24 hours apart.


• If you miss a dose of Norethindrone, 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 Norethindrone.

Important safety information:

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


• Norethindrone may cause dark skin patches on your face. Avoid the sun, sunlamps, or tanning booths until you know how you react to Norethindrone. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Norethindrone may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Norethindrone.


• Diabetes patients - Norethindrone may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Norethindrone should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Norethindrone if you are pregnant. If you think you may be pregnant, contact your doctor right away. Norethindrone is found in breast milk. If you are or will be breast-feeding while you use Norethindrone, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Norethindrone:

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:

Acne; changes in menstrual flow, including breakthrough bleeding, spotting, or missed periods; dizziness; drowsiness; fever; headache; hot flashes; nausea; nervousness; pain; rash; stomach pain; trouble sleeping; weakness; weight gain or loss.

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; depression; lumps in the breast or under the armpits; migraine headache; partial or complete loss of vision or changes in vision; shortness of breath; slurred speech; sudden loss of coordination; sudden or severe headache; sudden severe headache, dizziness, vomiting, or fainting; swelling of fingers or ankles; tenderness, pain, or swelling of the calf; weakness, numbness, or pain in the arms or legs; yellowing of the skin or eyes.

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: Norethindrone 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.

Proper storage of Norethindrone:

Store Norethindrone in a tightly closed container 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. Keep Norethindrone out of the reach of children and away from pets.

General information:

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


• Norethindrone 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 Norethindrone. 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 Norethindrone resources

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

• norethindrone Concise Consumer Information (Cerner Multum)


• Aygestin Prescribing Information (FDA)


• Aygestin Monograph (AHFS DI)


• Aygestin Oral, Implantation, Parenteral Advanced Consumer (Micromedex) - Includes Dosage Information


• Camila Prescribing Information (FDA)


• Errin Prescribing Information (FDA)


• Jolivette Prescribing Information (FDA)


• Nor-QD Prescribing Information (FDA)


• Nora-BE Prescribing Information (FDA)


• Ortho Micronor Prescribing Information (FDA)

Compare Norethindrone with other medications

• Abnormal Uterine Bleeding
• Amenorrhea
• Birth Control
• Endometriosis

Sulfonylureas

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Sulfonylureas work by stimulating the pancreas to release more insulin and are only effective when there is some pancreatic beta-cell activity still present.

Sulfonylureas block ATP sensitive potassium channels in Beta cells of the islets, and reduce the potassium permeability of Beta cells. This causes depolarization of the cells, calcium entry into the cell, which causes increased insulin secretion. The insulin released reduces plasma glucose concentrations.

Sulfonylureas are only indicated for treatment of Type 2 diabetes.

See also

Medical conditions associated with sulfonylureas:

• Diabetes, Type 2

Drug List:

Glucotrol

Amaryl

Diabinese

Glynase-Tablets-Micronized

Diabeta

Glipizide-Xl

Dymelor

Glucotrol-Xl-Extended-Release-Tablets

Glycron-Tablets-Micronized

Glynase-Prestab

Micronase

Orinase

Tol-Tab

Tolinase

Flagyl Tablets 200 mg

1. Name Of The Medicinal Product

Flagyl 200mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 200mg metronidazole.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Film-coated tablets

White to off-white, circular biconvex, film coated tablets impressed 'FLAGYL 200' on one face, plain reverse.

4. Clinical Particulars

4.1 Therapeutic Indications

Flagyl is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected to be the cause.

Flagyl is active against a wide range of pathogenic micro-organisms notably species of Bacteroides, Fusobacteria, Clostridia, Eubacteria, anaerobic cocci and Gardnerella vaginalis.

It is also active against Trichomonas, Entamoeba histolytica, Giardia lamblia and Balantidium coli.

Flagyl is indicated in adults and children for the following indications:

1. The prevention of post-operative infections due to anaerobic bacteria, particularly species of Bacteroides and anaerobic streptococci.

2. The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis, and post-operative wound infections from which pathogenic anaerobes have been isolated.

3. Urogenital trichomoniasis in the female (trichomonal vaginitis) and in the male.

4. Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginosis or Gardnerella vaginitis).

5. All forms of amoebiasis (intestinal and extra-intestinal disease and that of symptomless cyst passers).

6. Giardiasis.

7. Acute ulcerative gingivitis.

8. Anaerobically-infected leg ulcers and pressure sores.

9. Acute dental infections (e.g. acute pericoronitis and acute apical infections).

Considerations should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology And Method Of Administration

Oral route of administration.

Flagyl tablets should be swallowed with water (not chewed). It is recommended that the tablets be taken during or after a meal.

Prophylaxis against anaerobic infection: Chiefly in the context of abdominal (especially colorectal) and gynaecological surgery.

Adults

400 mg 8 hourly during 24 hours immediately preceding operation followed by postoperative intravenous or rectal administration until the patient is able to take tablets.

Children

Children < 12 years: 20-30mg/kg as a single dose given 1-2 hours before surgeryNewborns with a gestation age < 40 weeks: 10mg/kg body weight as a single dose before operation

Anaerobic infections: The duration of a course of Flagyl treatment is about 7 days but it will depend upon the seriousness of the patient's condition as assessed clinically and bacteriologically.

Treatment of established anaerobic infection:

Adults

800 mg followed by 400 mg 8 hourly.

Children

Children > 8 weeks to 12 years of age: The usual daily dose is 20-30mg/kg/day as a single dose or divided into 7.5mg/kg every 8 hours. The daily dose may be increased to 40mg/kg, depending on the severity of the infection. Duration of treatment is usually 7 days.

Children < 8 weeks of age: 15mg/kg as a single dose daily or divided into 7.5mg/kg every 12 hours. In newborns with a gestation age < 40 weeks, accumulation of metronidazole can occur during the first week of life, therefore the concentrations of metronidazole in serum should preferable be monitored after a few days therapy.

Protozoal and other infections:

Dosage is given in terms of metronidazole or metronidazole equivalent
	Duration of dosage in days	Adults and children over 10 years	Children
7 to 10 years	3 to 7 years	1 to 3 years
Urogenital trichomoniasis Where re-infection is likely, in adults the consort should receive a similar course of treatment concurrently	7    or	2000mg as a single dose or 200 mg three times daily or	40mg/kg orally as a single dose or 15-30 mg/kg/day divided in 2-3 doses; not to exceed 2000mg/dose
5- 7	400mg twice daily
Bacterial vaginosis	5-7 or	400 mg twice daily
	1	2000mg as a single dose
Amoebiasis (a) Invasive intestinal disease in susceptible subjects	5	800 mg three times daily	400 mg three times daily	200 mg four times daily	200 mg three times daily
(b) Intestinal disease in less susceptible subjects and chronic amoebic hepatitis	5-10	400 mg three times daily	200 mg three times daily	100 mg four times daily	100 mg three times daily
(c) Amoebic liver abscess also other forms of extra-intestinal amoebiasis	5	400 mg three times daily	200 mg three times daily	100 mg four times daily	100 mg three times daily
(d) Symptomless cyst passers	5-10	400-800 mg three times daily	200-400 mg three times daily	100-200 mg four times daily	100-200 mg three times daily
Alternatively, doses may be expressed by body weight 35 to 50mg/kg daily in 3 divided doses for 5 to 10 days, not to exceed 2400mg/day
Giardiasis	3	2000mg once daily or	1000mg once daily	600-800 mg once daily	500 mg once daily
5	400mg three times daily or
7-10	500mg twice daily
Alternatively, as expressed in mg per kg of body weight: 15-40mg/kg/day divided in 2-3 doses.

Dosage is given in terms of metronidazole or metronidazole equivalent
	Duration of dosage in days	Adults and children over 10 years	Children
7 to 10 years	3 to 7 years	1 to 3 years
Acute ulcerative gingivitis	3	200 mg three times daily	100 mg three times daily	100 mg twice daily	50 mg three times daily
Acute dental infections	3-7	200 mg three times daily
Leg ulcers and pressure sores	7	400 mg three times daily
Children and infants weighing less than 10 kg should receive proportionally smaller dosages. Elderly: Flagyl is well tolerated by the elderly but a pharmacokinetic study suggests cautious use of high dosage regimens in this age group.

Eradication of Helicobacter pylori in paediatric patients:

As a part of a combination therapy, 20mg/kg/day not to exceed 500mg twice daily for 7-14 days. Official guidelines should be consulted before initiating therapy.

4.3 Contraindications

Known hypersensitivity to nitroimidazoles, metronidazole or any of the excipients.

4.4 Special Warnings And Precautions For Use

Regular clinical and laboratory monitoring (especially leucocyte count) are advised if administration of Flagyl for more than 10 days is considered to be necessary and patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paraesthesia, ataxia, dizziness, convulsive seizures).

Metronidazole should be used with caution in patients with active or chronic severe peripheral and central nervous system disease due to the risk of neurological aggravation.

There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might persist.

The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present.

In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis.

No routine adjustment in the dosage of Flagyl need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Flagyl should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily.

Patients should be warned that metronidazole may darken urine.

Due to inadequate evidence on the mutagenicity risk in humans (see section 5.3), the use of flagyl for longer treatment than usually required should be carefully considered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Patients should be advised not to take alcohol during metronidazole therapy and for at least 48 hours afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction. Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.

Some potentiation of anticoagulant therapy has been reported when metronidazole has been used with the warfarin type oral anticoagulants. Dosage of the latter may require reducing. Prothrombin times should be monitored. There is no interaction with heparin.

Lithium retention accompanied by evidence of possible renal damage has been reported in patients treated simultaneously with lithium and metronidazole. Lithium treatment should be tapered or withdrawn before administering metronidazole. Plasma concentrations of lithium, creatinine and electrolytes should be monitored in patients under treatment with lithium while they receive metronidazole.

Patients receiving phenobarbital or phenytoin metabolise metronidazole at a much greater rate than normally, reducing the half-life to approximately 3 hours.

Metronidazole reduces the clearance of 5 fluorouracil and can therefore result in increased toxicity of 5 fluorouracil.

Patients receiving ciclosporin are at risk of elevated ciclosporin serum levels. Serum ciclosporin and serum creatinine should be closely monitored when coadministration is necessary.

Plasma levels of busulfan may be increased by metronidazole which may lead to severe busulfan toxicity.

4.6 Pregnancy And Lactation

There is inadequate evidence of the safety of metronidazole in pregnancy but it has been in wide use for many years without apparent ill consequence. Nevertheless Flagyl, like other medicines, should not be given during pregnancy or during lactation unless the physician considers it essential; in these circumstances the short, high-dosage regimens are not recommended.

4.7 Effects On Ability To Drive And Use Machines

Patients should be warned about the potential for drowsiness, dizziness, confusion, hallucinations, convulsions or transient visual disorders, and advised not to drive or operate machinery if these symptoms occur.

4.8 Undesirable Effects

The frequency of adverse events listed below is defined using the following convention:

very common (

Serious adverse reactions occur rarely with standard recommended regimens. Clinicians who contemplate continuous therapy for the relief of chronic conditions, for periods longer than those recommended, are advised to consider the possible therapeutic benefit against the risk of peripheral neuropathy.

Blood and lymphatic system disorders:
	Very rare: agranulocytosis, neutropenia, thrombocytopenia, pancytopenia
	Not known: leucopenia.
Immune system disorders:
	Rare: anaphylaxis
	Not known: angiodema, urticaria, fever.
Metabolism and nutrition disorders:
	Not known: anorexia.
Psychiatric disorders:
	Very rare: psychotic disorders, including confusion and hallucinations.
	Not known: depressed mood
Nervous system disorders:
	Very rare:
	• encephalopathy (eg. confusion, fever, headache, hallucinations, paralysis, light sensitivity, disturbances in sight and movement, stiff neck) and subacute cerebellar syndrome (eg. ataxia, dysathria, gait impairment, nystagmus and tremor) which may resolve on discontinuation of the drug.
	• drowsiness, dizziness, convulsions, headaches
	Not known: during intensive and/or prolonged metronidazole therapy, peripheral sensory neuropathy or transient epileptiform seizures have been reported. In most cases neuropathy disappeared after treatment was stopped or when dosage was reduced.
Eye disorders:
	Very rare: vision disorders such as diplopia and myopia, which, in most cases, is transient.
Gastrointestinal disorders:
	Not known: taste disorders, oral mucositis, furred tongue, nausea, vomiting, gastro-intestinal disturbances such as epigastric pain and diarrhoea.
Hepatobiliary disorders:
	Very rare: abnormal liver function tests, cholestatic hepatitis, jaundice and pancreatitis which is reversible on drug withdrawal.
Skin and subcutaneous tissue disorders:
	Very rare: skin rashes, pustular eruptions, pruritis, flushing
	Not known: erythema multiforme.
Musculoskeletal, connective tissue and bone disorders:
	Very rare: myalgia, arthralgia.
Renal and urinary disorders:
	Very rare: darkening of urine (due to metronidazole metabolite).

4.9 Overdose

Single oral doses of metronidazole, up to 12g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosage. In cases of suspected massive overdose, symptomatic and supportive treatment should be instituted.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antibacterials for systemic use, ATC code: J01X D01

Metronidazole has antiprotozoal and antibacterial actions and is effective against Trichomonas vaginalis and other protozoa including Entamoeba histolytica and Giardia lamblia and against anaerobic bacteria.

5.2 Pharmacokinetic Properties

Metronidazole is rapidly and almost completely absorbed on administration of Flagyl tablets; peak plasma concentrations occur after 20 min to 3 hours.

The half-life of metronidazole is 8.5 ± 2.9 hours. Metronidazole can be used in chronic renal failure; it is rapidly removed from the plasma by dialysis. Metronidazole is excreted in milk but the intake of a suckling infant of a mother receiving normal dosage would be considerably less than the therapeutic dosage for infants.

5.3 Preclinical Safety Data

Metronidazole has been shown to be carcinogenic in the mouse and in the rat following chronic oral administration however similar studies in the hamster have given negative results. Epidemiological studies have provided no clear evidence of an increased carcinogenic risk in humans.

Metronidazole has been shown to be mutagenic in bacteria in vitro. In studies conducted in mammalian cells in vitro as well as in rodent or humans in vivo, there was inadequate evidence of a mutagenic effect of metronidazole, with some studies reporting mutagenic effects, while others studies were negative.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Calcium hydrogen phosphate (E341),

Starch maize,

Povidone K30 (E1201),

Magnesium stearate (E572),

Tablet coat

Pharmacoat 615 (E464),

Macrogol 400 Ph. Eur.

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

5 years

6.4 Special Precautions For Storage

Store in the original package in order to protect from light.

This medicinal product does not require any special temperature storage conditions.

6.5 Nature And Contents Of Container

Flagyl tablets 200 mg are available in aluminium/plastic blisters of 21 tablets and HDPE bottles of 100 and 250 tablets.

Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Winthrop Pharmaceuticals UK Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

8. Marketing Authorisation Number(S)

PL 17780/0276

9. Date Of First Authorisation/Renewal Of The Authorisation

03 January 2007

10. Date Of Revision Of The Text

16.03.2011

LEGAL CATEGORY

POM

Up and Up Nicotine

Dosage Form: lozenge
Target Corp. Nicotine Polacrilex Lozenge 4 mg (Nicotine) Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex, 4 mg (nicotine)

Purpose

Stop smoking aid

Uses

• reduces withdrawal symptoms, including nicotine craving associated with quitting smoking

Warnings

If you are pregnant or breast-feeding,

only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Do not use

• if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products

Ask a doctor before use if you have

• a sodium-restricted diet


• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.


• high blood pressure not controlled with medication. Nicotine can increase your blood pressure.


• stomach ulcer or diabetes

Ask a doctor or pharmacist before use if you are

• using a non-nicotine stop smoking drug


• taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

• mouth problems occur


• persistent indigestion or severe sore throat occurs


• irregular heartbeat or palpitations occur


• you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat

Keep out of reach of children and pets.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• if you are under 18 years of age, ask a doctor before use


• before using this product, read the enclosed User’s Guide for complete directions and other important information


• stop smoking completely when you begin using the lozenge


• if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge


• if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 lozenge every 1 to 2 hours	1 lozenge every 2 to 4 hours	1 lozenge every 4 to 8 hours

• nicotine lozenge is a medicine and must be used a certain way to get the best results


• place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge.


• you may feel a warm or tingling sensation


• occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes)


• do not eat or drink 15 minutes before using or while the lozenge is in your mouth


• to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks


• do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects


• do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.


• stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.

Other information

• each lozenge contains: sodium 15 mg


• Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge


• sugar alcohol content: 1 g mannitol per lozenge


• store at 20-25°C (68-77°F)


• keep vial closed and {VIAL PACKAGING CONFIGURATION ONLY} protect from light

Inactive ingredients

aspartame, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

Questions or comments?

call toll-free 1-866-751-9303

Principal Display Panel

Nicotine Polacrilex Lozenge 4 mg (nicotine)

Stop Smoking Aid

Compare to active ingredient in Commit®

Includes User’s Guide

For those who smoke their first cigarette within 30 minutes of waking up.

If you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Lozenge, 2 mg

Mint Flavor

4 mg

# Lozenges {Replace "#" with the number of lozenges in the package}

4 mg each

(# QuitTube™ containers of #) {VIAL PACKAGING CONFIGURATION ONLY}

Shown Actual Size Above

Nicotine Polacrilex Lozenge 4 mg (Nicotine) Carton

Up and Up Nicotine  nicotine polacrilex  lozenge

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-873 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 4 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score no score Shape ROUND Size 16mm Flavor MINT Imprint Code L873 Contains

Packaging # NDC Package Description Multilevel Packaging 1 11673-873-08 9 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 12 LOZENGE In 1 BLISTER PACK This package is contained within the CARTON (11673-873-08) 2 11673-873-16 6 VIAL In 1 CARTON contains a VIAL 2 24 LOZENGE In 1 VIAL This package is contained within the CARTON (11673-873-16) 3 11673-873-05 3 VIAL In 1 CARTON contains a VIAL 3 24 LOZENGE In 1 VIAL This package is contained within the CARTON (11673-873-05) 4 11673-873-10 4 VIAL In 1 CARTON contains a VIAL 4 27 LOZENGE In 1 VIAL This package is contained within the CARTON (11673-873-10) 5 11673-873-06 4 VIAL In 1 CARTON contains a VIAL 5 24 LOZENGE In 1 VIAL This package is contained within the CARTON (11673-873-06)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077007	07/01/2009

Labeler - Target Corporation (006961700)

Revised: 06/2009Target Corporation

More Up and Up Nicotine resources

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

Compare Up and Up Nicotine with other medications

• Smoking Cessation

urofollitropin Intramuscular, Subcutaneous, Injection

ure-oh-FOL-li-troe-pin

Commonly used brand name(s)

In the U.S.

• Bravelle


• Fertinex

In Canada

• Fertinorm Hp


• Metrodin

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Female Reproductive Agent

Pharmacologic Class: Human Follicle Stimulating Hormone

Uses For urofollitropin

Urofollitropin is a fertility drug that is identical to the hormone called follicle-stimulating hormone (FSH) that is produced naturally by the pituitary gland.

FSH is primarily responsible for stimulating growth of the ovarian follicle, which includes the developing egg, the cells surrounding the egg that produce the hormones needed to support a pregnancy, and the fluid around the egg. As the ovarian follicle grows, an increasing amount of the hormone estrogen is produced by the cells in the follicle and released into the bloodstream. Estrogen causes the endometrium (lining of the uterus) to thicken before ovulation occurs. The higher blood levels of estrogen will also provide a cue to the hypothalamus and pituitary gland to slow the production and release of FSH.

Another pituitary hormone, luteinizing hormone (LH), also helps to increase the amount of estrogen produced by the follicle cells. However, the main function of LH is to cause ovulation. The sharp rise in the blood level of LH that triggers ovulation is sometimes called the LH surge. After ovulation, the group of hormone-producing follicle cells become what is called the corpus luteum and will produce estrogen and large amounts of another hormone, progesterone. Progesterone causes the endometrium to mature so that it can support the egg after it is fertilized. If implantation of a fertilized egg does not occur, the levels of estrogen and progesterone decrease, the endometrium sloughs off, and menstruation occurs.

Urofollitropin is usually given in combination with human chorionic gonadotropin (hCG). The actions of hCG are almost identical to those of LH. It is given to simulate the natural LH surge. This results in predictable ovulation.

Urofollitropin is often used in women who have low levels of FSH and too-high levels of LH. Women with polycystic ovary syndrome usually have hormone levels such as this and are treated with urofollitropin to make up for the low amounts of FSH. Many women being treated with urofollitropin have already tried clomiphene (e.g., Serophene) and have not been able to conceive yet. Urofollitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

Urofollitropin is to be given only by or under the supervision of your doctor.

Before Using urofollitropin

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 urofollitropin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to urofollitropin 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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 urofollitropin. Make sure you tell your doctor if you have any other medical problems, especially:

• Cyst on ovary—Urofollitropin can cause further growth of cysts on the ovary

• Unusual vaginal bleeding—Some irregular vaginal bleeding is a sign that the endometrium is growing too rapidly, possibly of endometrial cancer, or some hormone imbalances; the increases in estrogen production caused by urofollitropin can make these problems worse. If a hormonal imbalance is present, it should be treated before beginning menotropins therapy

Proper Use of urofollitropin

Dosing

The dose of urofollitropin 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 urofollitropin. 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 injection dosage form:
  
  • For becoming pregnant while having a condition called polycystic ovary syndrome:
    
    • Adults—75 Units injected under the skin or into a muscle once a day for seven or more days. Usually, another medicine called chorionic gonadotropin (hCG) will be given the day after the last dose. If needed, your doctor may then increase your dose of urofollitropin to 150 Units a day for another seven or more days. Higher doses may be prescribed by your doctor.
    
    
  
  
  • For becoming pregnant while using other pregnancy-promoting methods (assisted reproductive technology [ART]):
    
    • Adults—150 Units injected under the skin or into a muscle once a day. Your treatment will probably begin on Day 2 or Day 3 after your menstrual period begins. Usually, another medicine called chorionic gonadotropin (hCG) will be given the day after the last dose.
    
    
  
  

Precautions While Using urofollitropin

It is very important that your doctor check your progress at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will likely want to monitor the development of the ovarian follicle(s) by measuring the amount of estrogen in your bloodstream and by checking the size of the follicle(s) with ultrasound examinations.

If your doctor has asked you to record your basal body temperature (BBT) daily, make sure that you do this every day. It is important that intercourse take place around the time of ovulation to give you the best chance of becoming pregnant.

urofollitropin 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:

More common

• Abdominal or pelvic pain


• bloating (mild)


• redness, pain, or swelling at the injection site

Less common or rare

• Abdominal or stomach pain (severe)


• bloating (moderate to severe)


• decreased amount of urine


• feeling of indigestion


• fever and chills


• nausea, vomiting, or diarrhea (continuing or severe)


• pelvic pain (severe)


• shortness of breath


• skin rash or hives


• swelling of lower legs


• weight gain (rapid)

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

• Breast tenderness


• diarrhea (mild)


• nausea


• vomiting

After you stop using urofollitropin, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Abdominal or stomach pain (severe)


• bloating (moderate to severe)


• decreased amount of urine


• feeling of indigestion


• nausea, vomiting, or diarrhea (continuing or severe)


• pelvic pain (severe)


• shortness of breath


• swelling of lower legs


• weight gain (rapid)

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: urofollitropin Intramuscular, Subcutaneous, Injection 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 urofollitropin Intramuscular, Subcutaneous, Injection resources

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

Compare urofollitropin Intramuscular, Subcutaneous, Injection with other medications

• Female Infertility
• Follicle Stimulation

phenoxybenzamine

fen-ox-ee-BEN-za-meen

Commonly used brand name(s)

In the U.S.

• Dibenzyline

Available Dosage Forms:

• Capsule

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Alpha-Adrenergic Blocker

Uses For phenoxybenzamine

Phenoxybenzamine belongs to the general class of medicines called antihypertensives. It is used to treat high blood pressure (hypertension) due to a disease called pheochromocytoma.

Phenoxybenzamine blocks the effects of certain chemicals in the body. When these chemicals are present in large amounts, they cause high blood pressure.

Phenoxybenzamine may also be used for other conditions as determined by your doctor.

Phenoxybenzamine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, phenoxybenzamine is used in certain patients with the following medical condition:

• Benign prostatic hypertrophy

Before Using phenoxybenzamine

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 phenoxybenzamine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to phenoxybenzamine 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 about the use of phenoxybenzamine in children, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Dizziness or lightheadedness may be more likely to occur in the elderly, who are more sensitive to the effects of phenoxybenzamine. In addition, phenoxybenzamine may reduce tolerance to cold temperatures in elderly patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 phenoxybenzamine, 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 phenoxybenzamine 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.

• Tadalafil

Using phenoxybenzamine 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.

• Acebutolol


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Dilevalol


• Esmolol


• Labetalol


• Levobunolol


• Mepindolol


• Metipranolol


• Metoprolol


• Nadolol


• Nebivolol


• Oxprenolol


• Penbutolol


• Pindolol


• Propranolol


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Vardenafil

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 phenoxybenzamine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (chest pain) or


• Heart or blood vessel disease—Some kinds may be worsened by phenoxybenzamine

• Kidney disease—Effects may be increased

• Lung infection—Symptoms such as stuffy nose may be worsened

• Recent heart attack or stroke—Lowering blood pressure may make problems resulting from stroke or heart attack worse

Proper Use of phenoxybenzamine

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

Dosing

The dose of phenoxybenzamine 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 phenoxybenzamine. 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 oral dosage form (capsules):
  
  • For high blood pressure caused by pheochromocytoma:
    
    • Adults—At first, 10 milligrams (mg) two times a day. Then, your doctor may increase your dose to 20 to 40 mg two or three times a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 0.2 mg per kilogram (kg) (0.09 mg per pound) of body weight taken once a day. Then, your doctor may increase your dose to 0.4 to 1.2 mg per kg (0.18 to 0.55 mg per pound) of body weight a day. This is divided into three or four doses.
    
    
  
  

Missed Dose

If you miss a dose of phenoxybenzamine, 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 phenoxybenzamine

It is important that your doctor check your progress at regular visits to make sure that phenoxybenzamine is working properly and to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may interfere with the effects of phenoxybenzamine.

Phenoxybenzamine may cause some people to become dizzy, drowsy, or less alert than they are normally. This is more likely to happen when you begin to take it or when you increase the amount of medicine you are taking. Make sure you know how you react to phenoxybenzamine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help, but if the problem continues or gets worse, check with your doctor.

The dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for a long time, exercise, or if the weather is hot. While you are taking phenoxybenzamine, be careful in the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for a long time.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using phenoxybenzamine.

Phenoxybenzamine may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

phenoxybenzamine Side Effects

In rats and mice, phenoxybenzamine has been found to increase the risk of development of malignant tumors. It is not known if phenoxybenzamine increases the chance of tumors in humans.

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.

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

• Dizziness or lightheadedness, especially when getting up from a lying or sitting position


• fast heartbeat


• pinpoint pupils


• stuffy nose

Less common

• Confusion


• drowsiness


• dryness of mouth


• headache


• lack of energy


• sexual problems in males


• unusual tiredness or weakness

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: phenoxybenzamine 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 phenoxybenzamine resources

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

• phenoxybenzamine Concise Consumer Information (Cerner Multum)


• Phenoxybenzamine MedFacts Consumer Leaflet (Wolters Kluwer)


• Dibenzyline Prescribing Information (FDA)


• Dibenzyline Monograph (AHFS DI)

Compare phenoxybenzamine with other medications

• Pheochromocytoma

Mycelex Topical

Generic Name: clotrimazole (Topical route)

kloe-TRIM-a-zole

Commonly used brand name(s)

In the U.S.

• Clotrim Antifungal


• Cruex Prescription Strength


• Lotrimin


• Lotrimin AF


• Mycelex

In Canada

• Canesten


• Clotrimaderm


• Desenex


• Myclo-Derm


• Neo-Zol

Available Dosage Forms:

• Lotion


• Solution


• Cream

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Uses For Mycelex

Clotrimazole topical preparations are used to treat fungus infections on the skin.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Mycelex

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

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

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. Although there is no specific information comparing use of topical clotrimazole in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 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.

• Fentanyl


• Tacrolimus


• Trimetrexate

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.

Proper Use of clotrimazole

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

Apply enough clotrimazole to cover the affected and surrounding skin areas, and rub in gently.

Keep this medicine away from the eyes.

When clotrimazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over the medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses .

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 topical dosage forms (cream, lotion, and solution):
  
  • Fungal infections (treatment):
    
    • Adults and children—Use two times a day, morning and evening.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

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 Mycelex

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your doctor.

Mycelex 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:

• Skin rash, hives, blistering, burning, itching, peeling, redness, stinging, swelling, or other sign of skin irritation not present before use of this medicine

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: Mycelex Topical 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 Mycelex Topical resources

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

Compare Mycelex Topical with other medications

• Cutaneous Candidiasis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor
• Vaginal Yeast Infection