Hi everybody! My story is about how I was mistaken, but finally corrected the mistake with the help of a wonderful medicine that I bought in your store.
I have a 9-year-old daughter who often catches cold and virus infections. Not so long ago she had a throat ache, and I thought that it is, as usual, some virus infection like influenza. I gave her usual treatment, including anti-virus pills. But this time it did not cure her. We consulted our doctor and made all necessary labs. And that’s what we’ve found out: except for virus lung infections, there are also bacterial lung infections. That’s what my daughter had. And, what’s more important – antibiorics which kill bacteria won’t kill viruses, and vice versa.
My daughter was prescribed clarithromycin in the form of tablets or extended-release tablets. The doctor recommended CLARITHROMYCIN (Biaxin® or Biaxin® XL) as a safe, powerful, quickly acting antibiotic. As I have already written, Clarithromycin does not work on viruses, but it stops growth of many bacteria. It kills bacteria which evoke ear, lung, sinus, throat and skin infections.
At first, I wanted to buy simple Biaxin®, but consultants here advised me Biaxin® XL tablets. This is an extended-release form of clarithromycin which has prolonged action. It is very convenient because such tablets must only be taken once a day.
Now my daughter is well again, and I thank Biaxin, it is a very good medicine.

Hello, I’d like to thank you because I’ve bought a very useful medicine from you recently. It is Bactrim, a very effective and safe antibiotic – simply wonderful!
When I was planning my trip to India, I thought of an emergency medicaments bag, and consulted my doctor about what to put there. He said that in India, there always exist certain hygiene problems, and, because of high temperature, lots of dirt and bacteria, European tourists often suffer from traveler’s diarrhea and stomach pains. He recommended that I bought several packs of Bactrim, which is a very good antibiotic. It is used to kill lots of bacterial infections, such as stomach infections, urinary tract infections, bronchitis, (otitis), Pneumocystis carinii pneumonia, etc. It fights bacteria really very effectively.
I ordered Bactrim tablets, and they were delivered to me immediately. When I went to India, I felt prepared to everything. Unfortunately, I had an opportunity to use them, because I’ve caught traveller’s diarrhea and had to take these pills for 5 days. I used them as it was prescribed by my doctor, three times a day. I took the first doze with a glass of water, but as the doctor said that one can take it with milk to prevent stomach pains, I took all the next dozes with milk.
The pills were really wonderful, after three pills I felt myself quite healthy! Thank you!

Pronunciation: (byoo-TORE-fan-ahl TAR-trate)
Class: Opioid agonist-antagonist analgesic

Trade Names:
Stadol
- Injection 1 mg/mL (1 mg of tartrate salt is equal to 0.68 mg base)
- Injection 2 mg/mL (1 mg of tartrate salt is equal to 0.68 mg base)
- Nasal Spray 10 mg/mL

Apo-Butorphanol (Canada)
PMS-Butorphanol (Canada)

Pharmacology

Potent analgesic that stimulates and inhibits opiate receptors in CNS. Antagonist effects decrease (but do not eliminate) abuse potential and may cause withdrawal symptoms in patients with opiate dependence.

Pharmacokinetics

Absorption

IM T _max is 20 to 40 min.

Nasal T _max is 30 to 60 min. Absolute bioavailability is 60% to 70% (oral bioavailability 5% to 17% because of extensive first pass metabolism).

Distribution

Butorphanol is about 80% protein bound. Vd is 305 to 901 L. Butorphanol crosses the blood-brain barrier and placenta; it is excreted into human milk.

Metabolism

Metabolized in liver to hydroxybutorphanol and norbutorphanol.

Elimination

70% to 80% excreted in urine (5% as unchanged drug); 15% excreted in feces. The t _½ is 2.1 to 8.8 h (IV) and 2.9 to 9.2 h (intranasal). Cl is 52 to 154 L/h.

Onset

IV A few min. IM Within 15 min. Nasal Within 15 min.

Peak

IV / IM 30 to 60 min. Nasal 1 to 2 h.

Duration

IV / IM 3 to 4 h. Nasal 4 to 5 h.

Special Populations

Renal Function Impairment

For those with Ccr less than 30 mL/min, the t _½ is approximately doubled and the total body Cl is approximately ½.

Hepatic Function Impairment

The t _½ may be tripled and total body Cl is approximately ½.

Elderly

Elderly t _½ is increased 25%. Absolute bioavailability of nasal spray is less in elderly women (48%) than in elderly men (75%).

Indications and Usage

Management of pain when use of an opioid analgesic is appropriate (parenteral/nasal); preoperative or preanesthetic medication, as a supplement to balanced anesthesia, and for relief of pain during labor (parenteral).

Contraindications

Hypersensitivity to this medication or the preservative benzethonium chloride.

Dosage and Administration

Pain
Adults

IV 0.5 to 2 mg every 3 to 4 h as needed. IM 1 to 4 mg every 3 to 4 h as needed. Single doses should not exceed 4 mg. Nasal Initial dose is 1 mg (1 spray in 1 nostril). Wait 60 to 90 min before giving second 1 mg dose. Repeat dose sequence in 3 to 4 h after second dose of sequence if needed. For severe pain, in patient able to remain recumbent, initial dose 2 mg (1 spray in each nostril) every 3 to 4 h.

Preoperative/Preanesthetic
Adults

Usual dose: IM 2 mg 60 to 90 min before surgery; IV 2 mg shortly before induction. Maintenance dose in balanced anesthesia: IV 0.5 to 1 mg.

Labor
Adults

IV / IM 1 to 2 mg in early labor at term; repeat after 4 h.

Kidney or Liver Impairment and Elderly
Adults

IM / IV ½ normal dose. Repeat doses determined by patient’s response rather than at fixed intervals, but generally no less often than at 6-h intervals. Nasal Initial dose is 1 mg (1 spray in 1 nostril). Wait 90 to 120 min before giving second 1 mg dose. Repeat dose sequence based on patient response, but generally no less often than 6-h intervals.

General Advice

• IV/IM
• When giving by IM route, use deep, slow injection.
• If accidental skin contact occurs, wash exposed area with cool water.
• Do not administer if solution is discolored, cloudy, or contains particulate matter.

• Nasal
• Pump reservoir must be primed prior to initial use; pump sprayer firmly and quickly until a fine spray appears (up to 7 to 8 strokes).
• Pump reservoir must be reprimed (1 or 2 strokes) if not used for 48 h or longer).
• Butorphanol may be aerosolized during priming process; aim pump sprayer away from yourself, the patient, and other people.
• Insert spray tip into 1 nostril, pointing tip toward back of the nose, close other nostril with finger, and pump spray unit firmly and quickly while patient is gently sniffing with mouth closed. Remove pump unit from nose and have patient tilt head backwards and continue sniffing gently for a few more seconds.
• One bottle will deliver 14 to 15 doses if no repriming is needed. With intermittent use requiring repriming before each dose, 1 bottle may deliver only 8 to 10 doses.
• Follow institutional or organizational policies and procedures to dispose of used pump units. Dispose of used units by unscrewing the cap, rinsing the bottle, and placing parts in waste container.

Storage/Stability

Store at controlled room temperature (59° to 86°F).

Drug Interactions

CNS depressants (eg, alcohol, barbiturates, sedatives, tranquilizers)

Additive CNS depression.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Palpitations, vasodilation (at least 1%).

CNS

Somnolence (43%); dizziness (19%); insomnia (nasal spray; 11%); anxiety, asthenia, confusion, euphoria, floating feeling, headache, lethargy, nervousness, paresthesia, tremor (at least 1%); convulsions, delusions, difficulty speaking, difficulty executing purposeful movements, drug dependence, vertigo (postmarketing).

Dermatologic

Pruritus, sweating/clamminess (at least 1%).

EENT

Nasal congestion (nasal spray; 13%); blurred vision, ear pain, pharyngitis, rhinitis, tinnitus, unpleasant taste (at least 1%).

GI

Nausea, vomiting (nasal spray; 13%); anorexia, constipation, dry mouth, stomach pain (at least 1%).

Respiratory

Bronchitis, cough, dyspnea, epistaxis, nasal congestion, nasal irritation, sinus congestion, sinusitis, upper respiratory infection (at least 1%).

Miscellaneous

Sensation of heat (at least 1%); apnea (postmarketing).

Precautions

Monitor Take vital signs and auscultate heart and lungs before administration.

Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established.

Elderly

More sensitive to effects; reduce dose.

Labor and Delivery

Rare reports of infant respiratory distress/apnea following butorphanol administration within 2 h of delivery, multiple butorphanol doses, use with other analgesic/sedative drugs, or in preterm pregnancies. Use with caution in presence of abnormal fetal heart rate patterns.

Hazardous Tasks

May cause drowsiness, dizziness, or hypotension during first hour of dosing.

CV disease

Drug increases cardiac workload. Severe hypertension has occurred.

Drug dependency

Although potential for physical dependence is low, abuse may occur. Tolerance and psychological and physical dependence may occur with long-term use. Use in patients physically dependent on opiate agonists may precipitate withdrawal symptoms.

Head injury and increased intracranial pressure

May cause C0 ₂ retention and secondary elevation of CSF pressure, drug-induced miosis, and alterations in mental status that could obscure interpretation of clinical course of patients with head injuries.

Respiratory depression

May occur, especially in patients on other CNS drugs or in patients with CNS disease or respiratory impairment.

Special populations

Use with caution in patients with hepatic or renal disease.

Overdosage

Symptoms

CV insufficiency, coma, death, hyperventilation.

Patient Information

• Advise patient to review the Medication Guide carefully before starting therapy and to read and check for new information each time the medication is refilled.
• Advise patient that medication may be habit forming and to take exactly as prescribed and not increase the dose or frequency of use unless advised by health care provider. Instruct patient to notify health care provider if prescribed dose does not adequately control pain.
• Review dosing schedule for 1 mg dose: 1 spray into 1 nostril only. Dose may be repeated after 60 to 90 min if prescribed by health care provider. Sequence may be repeated after 3 to 4 h if prescribed and needed for pain.
• Review dosing schedule for 2 mg dose: 1 spray into each nostril. Dose may be repeated every 3 to 4 h if prescribed and needed for pain.
• Ensure patient understands how to use nasal spray: prime pump prior to initial use (7 to 8 strokes or until fine mist appears) or reprime (1 or 2 strokes) if unit has not been used for 48 h or longer); insert spray tip into 1 nostril, pointing tip toward back of the nose, close other nostril with finger, and pump spray unit firmly and quickly while gently sniffing with mouth closed; remove pump unit from nose, tilt head backwards, and continue sniffing gently for a few more seconds.
• Caution patient that butorphanol may be aerosolized during priming process and to aim pump sprayer away from themselves, other people, and animals.
• Advise patient that 1 bottle will deliver 14 to 15 doses if no repriming needed but with intermittent use requiring repriming before each dose; 1 bottle may deliver only 8 to 10 doses.
• Instruct patient regarding proper disposal of used spray units: unscrew cap, rinse bottle, and place parts in waste container.
• Caution patient that medication may cause drowsiness or dizziness and to use caution while performing potentially hazardous tasks (eg, driving, operating machinery) until tolerance is determined.
• Caution patient to avoid alcohol and other depressants (eg, sleep medications, tranquilizers) because dangerous additive effects may occur.

Copyright © 2009 Wolters Kluwer Health.

Generic name: Exenatide
Brand names: Byetta

Why is Byetta prescribed?

Byetta is an injectable antidiabetic medication used to improve blood sugar control in people with type 2 diabetes whose current medications alone do not adequately control their blood sugar levels. Byetta is prescribed along with oral antidiabetic medications to enhance their effectiveness. It may be used with metformin alone or with metformin and sulfonylurea combined.

Type 2 diabetes occurs in people who are unable to produce or cannot properly utilize insulin. Insulin helps carry sugar from the bloodstream into the body’s cells. In diabetes, the unused sugar causes abnormally high sugar levels in the bloodstream. Byetta is in a class of drugs known as incretin mimetics because it mimics the action of incretins—natural substances found in the body that help maintain normal blood sugar levels. Byetta stimulates cells that produce insulin in the pancreas, while also decreasing the amount of sugar the produced by the liver. In addition, it slows the passage of food from the stomach, thus slowing the rate that sugar is absorbed into the bloodstream. Byetta also decreases the appetite, which can help with weight control.

Most important fact about Byetta

Your doctor has prescribed Byetta for your type 2 diabetes in addition to a plan that includes other antidiabetic medications and very specific dietary and exercise guidelines, and careful blood sugar monitoring. Failure to follow these guidelines or to take all of your medications as prescribed can result in serious and potentially life-threatening complications. Byetta cannot be used as a substitute for insulin in people with type 1 diabetes who need insulin to control their diabetes.

How should you take Byetta?

Use the Byetta prefilled injection pen exactly as prescribed. A medical professional who is knowledgeable in the education and management of diabetes will instruct you in the use of Byetta. You should inject your dose of Byetta in the thigh, abdomen, or upper arm within the one-hour period (60 minutes) before your morning and evening meals. Do not inject Byetta after a meal.

Your doctor may adjust your dose of Byetta or the other antidiabetic medications you take along with Byetta, depending on your response. Do not increase or decrease the dose on your own.

Pen needles for Byetta are not included with your prescription; you must purchase them separately.

• If you miss a dose…
  If you miss a dose of Byetta, skip the one you missed and return to your regular schedule. Do not take two doses at once or increase your next dose.

• Storage instructions…
  Store the Byetta pen in the refrigerator away from light and according to label instructions. Do not freeze Byetta or use product that has been frozen. Discard the pen after 30 days, even if there is still some medication left. Be sure to remove the needle from the Byetta pen before returning it to the refrigerator for storage. Medication can leak out through the needle and air bubbles can form in the cartridge.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe to continue using Byetta.

• Side effects may include:
  Diarrhea, dizziness, headache, feeling jittery, nausea, upset stomach, vomiting

Why should Byetta not be prescribed?

Do not take Byetta if you have ever had an allergic reaction to it or any of its other ingredients.

Special warnings about Byetta

Byetta used in combination with sulfonylurea antidiabetic drugs may result in dangerously low blood sugar. If you experience symptoms of headache, drowsiness, weakness, dizziness, confusion, irritability, confusion, hunger, fast heartbeat, sweating, or feeling jittery, follow your doctor’s instructions for treating low blood sugar right away.

Byetta cannot be used as a substitute for insulin and is not recommended for use in type 1 diabetes or to treat diabetic ketoacidosis, a condition in which extremely high blood sugar levels and a lack of insulin, if left untreated, can lead to coma and death.

Byetta should not be used if you have severe kidney disease or severe digestive, intestinal, or stomach problems, especially when food empties from the stomach too slowly (gastroparesis).

Possible food and drug interactions when taking Byetta

Byetta slows the rate that food passes from the stomach and may affect the absorption of other medications that you take by mouth. Your doctor may change the timing of your oral medicines and have you take them either on an empty stomach between meals or with a snack in between breakfast and dinner—not at the same mealtime as Byetta.

Special information if you are pregnant or breastfeeding

The effects of Byetta in pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, you should not use Byetta unless your doctor determines that the benefits outweigh the risks.

It is not known whether Byetta appears in human breast milk or poses a risk to your breastfeeding child. If Byetta is essential to your health, your doctor may advise you to stop nursing until your treatment is finished.

Recommended dosage for Byetta

ADULTS

The usual starting dose of Byetta is 5 micrograms, injected twice daily in the one-hour period before eating breakfast and dinner. Each dose should be injected into the thigh, abdomen, or upper arm. Do not use Byetta after a meal. Depending on your response, your doctor may increase your dose to 10mcg. The maximum daily dose is 20 micrograms.

Byetta is supplied in 5-microgram and 10 microgram prefilled injection pens. Each pen contains 60 doses for a 30-day supply.

Byetta is a clear liquid and should be not be used if it contains particles or appears cloudy or discolored.

Overdosage

If you suspect an overdose, seek emergency treatment immediately.

• Symptoms of overdose may include:
  Extremely low blood sugar, severe nausea, and severe vomiting

Generic Name: nebivolol (ne BIV oh lol)
Brand Names: Bystolic

What is nebivolol?

Nebivolol is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Nebivolol is used to treat hypertension (high blood pressure).

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

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

Do not skip doses or stop taking nebivolol without first talking to your doctor. Stopping suddenly may make your condition worse or cause other serious heart problems such as severe chest pain or heart attack. You may need to use less and less before you stop the medication completely. If you need to have any type of surgery, tell the surgeon ahead of time that you are using nebivolol. You may need to stop using the medicine for a short time. Nebivolol 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.

Nebivolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Hypertension often has no symptoms, so you may not even feel that you have high blood pressure. Continue using this medicine as directed, even if you feel well. You may need to use blood pressure medication for the rest of your life.

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

Do not use this medication if you are allergic to nebivolol or if you have:

• severe liver disease; or

• a heart problem such as heart block, sick sinus syndrome, slow heart rate, or heart failure.

Before taking nebivolol, tell your doctor if you are allergic to any drugs, or if you have:

• asthma, bronchitis, emphysema;

• liver or kidney disease;

• diabetes;

• a thyroid disorder;

• problems with circulation (such as Raynaud’s syndrome);

• pheochromocytoma; or

• if you have recently had a heart attack.

If you have any of these conditions, you may not be able to use nebivolol, or you may need a dose adjustment or special tests during treatment.

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

How should I take nebivolol?

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

Take nebivolol at the same time every day. You may take the medication with or without food.

Do not skip doses or stop taking nebivolol without first talking to your doctor. Stopping suddenly may make your condition worse or cause other serious heart problems such as severe chest pain or heart attack. You may need to use less and less before you stop the medication completely.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Do not miss any scheduled appointments.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using nebivolol. You may need to stop using the medicine for a short time.

Nebivolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Hypertension often has no symptoms, so you may not even feel that you have high blood pressure. Keep using this medicine as directed, even if you feel well. You may need to use blood pressure medication for the rest of your life.

Store nebivolol at room temperature away from moisture and heat.

See also: Bystolic dosage in more detail

What happens if I miss a dose?

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 the 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.

Overdose symptoms may include slow heart rate, dizziness, vomiting, trouble breathing, or feeling like you might pass out.

What should I avoid while taking nebivolol?

Nebivolol 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.

Nebivolol 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:

• feeling short of breath, even with mild exertion;

• swelling of your ankles or feet;

• slow or uneven heartbeats; or

• numbness or cold feeling in your hands and feet.

Less serious side effects may include:

• headache;

• tired feeling;

• nausea, stomach pain;

• diarrhea; or

• sleep problems (insomnia).

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 nebivolol?

Before taking nebivolol, tell your doctor if you are using:

• digitalis (digoxin, Lanoxin);

• clonidine (Catapres);

• reserpine;

• guanethidine (Ismelin);

• a heart medication such as nifedipine (Procardia, Adalat), reserpine (Serpasil), verapamil (Calan, Verelan, Isoptin), diltiazem (Cartia, Cardizem);

• heart rhythm medicine such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quinidex, Quin-Release Quin-G), and others;

• an antidepressant such as fluoxetine (Prozac), paroxetine (Paxil), and others; or

• another beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), or timolol (Blocadren), and others.

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

Where can I get more information?

• Your pharmacist can provide more information about nebivolol.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 4/12/2009 4:45:30 PM.

bue-TEN-a-feen

Commonly used brand name(s):

In the U.S.

• Mentax

Available Dosage Forms:

• Cream

Therapeutic Class: Antifungal

Chemical Class: Benzylamine

Uses For butenafine

Butenafine is used to treat fungus infections. It works by killing the fungus or preventing its growth. Butenafine is applied to the skin to treat:

• athlete’s foot (ringworm of the foot; tinea pedis);
• jock itch (ringworm of the groin; tinea cruris);
• ringworm of the body (tinea corporis);
• fungal infection on the skin of the chest, back and shoulders (tinea versicolor).

butenafine is available only with your doctor’s prescription.

Before Using butenafine

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 butenafine, the following should be considered:

Allergies

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

There is no specific information comparing use of butenafine in children with use in other age groups.

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 butenafine in the elderly with use in other age groups, clinical studies included older patients. No differences in effects of butenafine were seen in the elderly compared with younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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.

Proper Use of butenafine

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

After applying butenafine, wash your hands to remove any medicine that may be on them.

Keep butenafine away from the eyes and mucous membranes such as the inside of the nose, mouth, or vagina.

Do not bandage or apply an occlusive dressing (airtight covering such as kitchen plastic wrap) over butenafine unless otherwise directed by your doctor. If you have any questions about this, check with your doctor.

To help clear up your skin infection completely, keep using butenafine for the full time of treatment. It may sometimes take quite a while for a fungus infection to be cured. If you stop using butenafine too soon, your symptoms will return.

Dosing

The dose of butenafine 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 butenafine. 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 form (cream):
  • For fungus infections:
    • Adults and teenagers—Apply to the affected area(s) of the skin once or twice a day, as ordered by your doctor.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of butenafine, 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 butenafine

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

Tinea versicolor may cause skin to appear darker or lighter, or spots of both. These changes in color can last for months even when the fungal infection has been eliminated. Continuing treatment longer than recommended will not cause skin color to return to normal faster. Consult your physician if you believe the fungal infection may have returned.

To help clear up your skin infection completely and to help make sure it does not return, the following good health habits are important:

• For patients using butenafine for athlete’s foot, these measures will help keep the feet cool and dry:
  • Carefully dry the feet, especially between the toes, after bathing.
  • Avoid wearing socks made from wool or synthetic materials (for example, rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if your feet sweat very much.
  • Wear well-ventilated shoes (for example, shoes with holes on top or on the side) or sandals.
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder freely between the toes, on the feet, and in socks and shoes once or twice a day. Be sure to use the powder after butenafine has been applied and has disappeared into the skin. Do not use the powder as the only treatment for your fungus infection.
• For patients using butenafine for jock itch, these measures will help reduce chafing and irritation and will also keep the groin area cool and dry:
  • Carefully dry the groin area after bathing.
  • Avoid wearing underwear that is tight-fitting or made from synthetic materials (for example, rayon or nylon). Instead, wear loose-fitting, cotton underwear.
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder freely once or twice a day. Be sure to use the powder after butenafine has been applied and has disappeared into the skin. Do not use the powder as the only treatment for your fungus infection.
• For patients using butenafine for ringworm of the body, these measures will help keep the affected area cool and dry:
  • Carefully dry yourself after bathing.
  • Avoid too much heat and humidity if possible. Try to keep moisture from building up on affected areas of the body.
  • Wear loose-fitting clothing.
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder freely once or twice a day. Be sure to use the powder after butenafine has been applied and has disappeared into the skin. Do not use the powder as the only treatment for your fungus infection.

butenafine 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:

Rare

• Blistering, burning, itching, oozing, stinging, swelling, or other signs of skin irritation not present before use of butenafine
• rash
• redness

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.

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Generic Name: Butenafine (byoo-TEN-a-feen)
Brand Name: Mentax

Butenafine Cream is used for:

Treating certain fungal infections of the skin. It may also be used to treat other conditions as determined by your doctor, which may not be listed in the professional package insert.

Butenafine Cream is a topical antifungal. It works by killing sensitive fungi by interfering with the formation of the fungal cell membrane and weakening it.

Do NOT use Butenafine Cream if:

• you are allergic to any ingredient in Butenafine Cream

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

Before using Butenafine Cream:

Some medical conditions may interact with Butenafine 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

Some MEDICINES MAY INTERACT with Butenafine Cream. However, no specific interactions with Butenafine 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 Butenafine 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 Butenafine Cream:

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

• Butenafine Cream works best if it is used at the same time(s) each day.
• Wash and completely dry the affected area. Gently rub the medicine in until it is evenly distributed.
• Use enough cream to cover the affected areas and the healthy skin close to the affected areas.
• Wash your hands immediately after using Butenafine Cream.
• Do not cover the area with bandages or other dressings unless directed by your health care provider.
• Continue to use Butenafine Cream for the full treatment time recommended by your health care provider, even though symptoms have gotten better.
• If you miss a dose of Butenafine 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 Butenafine Cream.

Important safety information:

• Do not use Butenafine Cream for other skin conditions at a later time.
• Butenafine Cream is for external use only. Avoid contact with nose, mouth, and eyes. If you get Butenafine Cream in your eyes, immediately rinse out with cool tap water.
• Butenafine Cream is not for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you are pregnant or plan on becoming pregnant, discuss with your doctor the benefits and risks of using Butenafine Cream during pregnancy. It is unknown if Butenafine Cream is excreted in breast milk. If you are or will be breast-feeding, check with your doctor to discuss the benefits and risks to your baby.

Possible side effects of Butenafine 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:

Burning; inflammation; irritation; itching; redness; stinging.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Butenafine Cream may be harmful if swallowed.

Proper storage of Butenafine Cream:

Store Butenafine Cream at room temperature between 59 and 86 degrees F (15 and 30 degrees C) in a tightly-closed container, away from heat, moisture, and light. Do not store in the bathroom. Keep Butenafine Cream out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Butenafine 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.

Pronunciation: (byoo-TEN-ah-feen HIGH-droe-KLOR-ide)
Class: Antifungal agent

Trade Names:
Lotrimin Ultra
- Cream 1%

Trade Names:
Mentax
- Cream 1%

Pharmacology

Appears to inhibit biosynthesis of the ergosterol component of fungal cell membranes.

Indications and Usage

Interdigital tinea pedis (athlete’s foot); tinea corporis (ringworm); tinea cruris (jock itch); tinea (pityriasis) versicolor caused by susceptible organisms.

Contraindications

Standard considerations.

Dosage and Administration

Tinea Pedis
Adults and Children 12 yr of age and older

Topical Apply to affected and surrounding area(s) twice daily for 7 days or every day for 4 wk.

Tinea Corporis, Tinea Cruris, and Tinea (Pityriasis) Versicolor
Adults and Children 12 yr of age and older

Topical Apply every day for 2 wk.

General Advice

• For topical use only. Not for ophthalmic, oral, or intravaginal use.
• Avoid contact with eyes, eyelids, lips, and mucus membranes.
• Apply enough cream to cover affected area(s) and the immediately surrounding skin and gently massage cream into skin.

Storage/Stability

Store at controlled room temperature or in refrigerator (41° to 86°F). Keep tube tightly capped.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Dermatologic

Worsening of condition, burning, stinging, itching (1%).

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy in children younger than 12 yr of age not established.

Patient Information

• Advise patient that medication is applied topically to skin lesions every day or twice daily.
• Teach patient proper technique for applying cream: wash hands; ensure that area to be treated is dry; apply a thin film of cream to cover affected area(s) and immediately surrounding skin areas; gently massage into skin; wash hands after applying medication.
• Advise patient that improvement may take several days to weeks to occur and to continue applying the medication for entire treatment time recommended by health care provider.
• Instruct patient to notify health care provider if improvement is not noted after the end of the treatment period, or sooner if condition worsens.
• Caution patient not to cover treated areas with bandages or dressings unless advised by health care provider.
• Advise patient that if an application is missed to not try to make it up but to return to normal application schedule as soon as possible.
• Warn patient to avoid contact with the eyes, eyelids, lips, and mucous membranes.
• Advise patient that if cream comes in contact with the eyes to wash eyes with large amounts of cool water and to contact health care provider if eye irritation persists.
• Advise patient that local stinging, burning, itching, and redness are most common adverse reactions and to notify health care provider if they become bothersome.
• Advise patient to stop using the medication and contact health care provider if severe skin reactions occur (eg, blistering, swelling, oozing).

Copyright © 2009 Wolters Kluwer Health.

Generic Name: butenafine topical (byoo TEN ah fine)
Brand names: Mentax, Lotrimin Ultra Athlete’s Foot, Lotrimin Ultra Jock Itch

What is butenafine topical?

Butenafine topical is an antifungal medication. Butenafine topical prevents fungus from growing on your skin.

Butenafine topical is used to treat athlete’s foot, jock itch, and ringworm.

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

What is the most important information I should know about butenafine topical?

Use this medication for the full amount of time prescribed by your doctor even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

Who should not use butenafine topical?

Do not use butenafine topical if you have had an allergic reaction to it in the past.

It is not known whether butenafine topical will harm an unborn baby. Do not use butenafine topical without first talking to your doctor if you are pregnant. It is not known whether butenafine passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I use butenafine topical?

Use butenafine topical exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the cream once daily as directed by your doctor for the specified length of time. Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth. Store butenafine topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of butenafine topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of butenafine topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that butenafine topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using butenafine topical?

Avoid wearing tight-fitting, synthetic clothing that doesn’t allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Butenafine topical side effects

Serious side effects of butenafine topical use are not expected. Stop using butenafine topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, swelling, or irritation of the skin.

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

Butenafine topical Dosing Information

Usual Adult Dose for Tinea Pedis:

Apply butenafine topical cream in a quantity sufficient to cover the affected area and immediately surrounding skin once daily for 4 weeks.

Usual Adult Dose for Tinea Corporis:

Apply butenafine topical cream in a quantity sufficient to cover the affected area and immediately surrounding skin once daily for 2 weeks, depending on the nature and severity of the infection.

Usual Adult Dose for Tinea Cruris:

Apply butenafine topical cream in a quantity sufficient to cover the affected area and immediately surrounding skin once daily for 2 weeks, depending on the nature and severity of the infection.

What other drugs will affect butenafine topical?

Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of butenafine topical

Where can I get more information?

• Your pharmacist has additional information about butenafine topical written for health professionals that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.05. Revision Date: 4/12/2009 4:42:33 PM.