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Tuesday, October 11, 2016

Elon Dual Defense Anti-Fungal Liquid

Pronunciation: un-deh-sil-EN-ik AS-id
Generic Name: Undecylenic Acid
Brand Name: Examples include Elon Dual Defense Anti-Fungal and Trifungol

Elon Dual Defense Anti-Fungal Liquid is used for:

Treating athlete's foot and ringworm. It may also be used for other conditions as determined by your doctor.

Elon Dual Defense Anti-Fungal Liquid is an antifungal. It works by preventing fungal growth.

Do NOT use Elon Dual Defense Anti-Fungal Liquid if:

you are allergic to any ingredient in Elon Dual Defense Anti-Fungal Liquid

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

Before using Elon Dual Defense Anti-Fungal Liquid:

Some medical conditions may interact with Elon Dual Defense Anti-Fungal Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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

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

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

if you have diabetes or blood vessel problems in your arms or legs

Some MEDICINES MAY INTERACT with Elon Dual Defense Anti-Fungal Liquid. Because little, if any, of Elon Dual Defense Anti-Fungal Liquid is absorbed into the blood, the risk of interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Elon Dual Defense Anti-Fungal Liquid 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 Elon Dual Defense Anti-Fungal Liquid:

Use Elon Dual Defense Anti-Fungal Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Elon Dual Defense Anti-Fungal Liquid is for external use only. Do not get Elon Dual Defense Anti-Fungal Liquid in your eyes, ears, nose, or mouth. If you get Elon Dual Defense Anti-Fungal Liquid in your eyes, rinse immediately with cool tap water.

Wash your hands immediately before and after using Elon Dual Defense Anti-Fungal Liquid.

Wash and completely dry the affected area.

Apply a thin layer of medicine to the affected area. For athlete's foot, pay special attention to the spaces between the toes.

Do not cover with a bandage or dressing unless directed otherwise by your doctor.

If you miss a dose of Elon Dual Defense Anti-Fungal Liquid, 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 Elon Dual Defense Anti-Fungal Liquid.

Important safety information:

If your symptoms do not improve within 4 weeks or if they become worse, check with your doctor.

Do not use Elon Dual Defense Anti-Fungal Liquid on blistered or oozing skin or over deep puncture wounds.

For athlete's foot, it may be helpful to wear well-fitting, well-ventilated shoes and to change shoes and socks at least once daily.

Do not use Elon Dual Defense Anti-Fungal Liquid on the scalp or the nails. It is not effective on these areas.

It is important to use Elon Dual Defense Anti-Fungal Liquid for the full course of treatment. Failure to do so may decrease the effectiveness of Elon Dual Defense Anti-Fungal Liquid and may increase the risk that the fungus will no longer be sensitive to Elon Dual Defense Anti-Fungal Liquid and will not be able to be treated by this or certain other antifungals in the future.

Overuse of topical products may worsen your condition.

Elon Dual Defense Anti-Fungal Liquid may be harmful if swallowed. If you or someone you know may have taken Elon Dual Defense Anti-Fungal Liquid by mouth, contact your local poison control center or emergency room immediately.

CHILDREN younger than 18 years of age or patients with sensitive skin should use Elon Dual Defense Anti-Fungal Liquid only as directed by a doctor.

Supervise CHILDREN who are using Elon Dual Defense Anti-Fungal Liquid.

Use of Elon Dual Defense Anti-Fungal Liquid is not recommended in CHILDREN younger than 2 years of age without first checking with your doctor. Safety and effectiveness in this age group have not been confirmed.

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

Possible side effects of Elon Dual Defense Anti-Fungal Liquid:

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:

Mild stinging.

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); blistering, burning, itching, peeling, swelling, or reddening of your skin not present when you began using Elon Dual Defense Anti-Fungal Liquid.

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: Elon Dual Defense Anti-Fungal 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. Elon Dual Defense Anti-Fungal Liquid may be harmful if swallowed.

Proper storage of Elon Dual Defense Anti-Fungal Liquid:

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

General information:

If you have any questions about Elon Dual Defense Anti-Fungal Liquid, please talk with your doctor, pharmacist, or other health care provider.

Elon Dual Defense Anti-Fungal Liquid 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 Elon Dual Defense Anti-Fungal Liquid. 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

More Elon Dual Defense Anti-Fungal resources

Elon Dual Defense Anti-Fungal Side Effects (in more detail)
Elon Dual Defense Anti-Fungal Use in Pregnancy & Breastfeeding
0 Reviews for Elon Dual Defense Anti-Fungal - Add your own review/rating

Compare Elon Dual Defense Anti-Fungal with other medications

Onychomycosis
Tinea Corporis
Tinea Pedis

Emsam System

Pronunciation: se-LE-ji-leen
Generic Name: Selegiline
Brand Name: Emsam

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Emsam System outweigh the risks.

Family and caregivers must closely watch patients who take Emsam System. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Emsam System is not approved for use in CHILDREN. Emsam System should not be used in children younger than 12 years old at any dose; safety and effectiveness in these children have not been confirmed.

Emsam System is used for:

Treating depression. It may also be used for other conditions as determined by your doctor.

Emsam System is a monoamine oxidase inhibitor (MAOI). Exactly how Emsam System works to treat depression is unknown.

Do NOT use Emsam System if:

you are allergic to any ingredient in Emsam System

you are taking fluoxetine or have taken it within the past 5 weeks

you are taking bupropion, buspirone, cyclobenzaprine, dextromethorphan, meperidine, methadone, a norepinephrine reuptake inhibitor (eg, atomoxetine), propoxyphene, a selective serotonin reuptake inhibitor (SSRI) (eg, paroxetine), a serotonin-norepinephrine reuptake inhibitor (SNRI) (eg, duloxetine, venlafaxine), St. John's wort, a tetracyclic antidepressant (eg, mirtazapine), tramadol, or a tricyclic antidepressant (eg, amitriptyline). You will need to wait for a period of time after you stop these medicines before you start taking Emsam System. If you have been taking 1 of these medicines, check with your doctor to see when you should start Emsam System

you are taking oral selegiline; another MAOI (eg, phenelzine); linezolid; methylene blue; a sympathomimetic, including an amphetamine, a cold product, or certain diet pills or preparations (eg, ephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine); or sibutramine. You will need to wait for a period of time after you stop these medicines before you start taking Emsam System. If you have been taking 1 of these medicines, check with your doctor to see when you should start Emsam System

you are taking a 5-HT₁ agonist (eg, sumatriptan), apraclonidine, carbamazepine, methylphenidate, oxcarbazepine, or nefazodone

you will be undergoing elective surgery with general anesthesia or will be receiving cocaine or local anesthesia containing sympathomimetic vasoconstrictors

you have certain adrenal gland problems (eg, pheochromocytoma)

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

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Emsam System:

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

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

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

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

if you have a history of bipolar disorder, mania, mood or mental problems, suicidal thoughts or attempts, or uncontrolled muscle movements (eg, twitching of the face and tongue, involuntary movements of the arms and legs)

if you have a history of ulcer, heart problems, recent heart attack, seizures, blood problems, or a metabolism disorder

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

Bupropion, cyclobenzaprine, dextromethorphan, linezolid, MAOIs (eg, phenelzine), meperidine, methadone, methylene blue, norepinephrine reuptake inhibitors (eg, atomoxetine), oral selegiline, propoxyphene, sibutramine, SNRIs (eg, duloxetine, venlafaxine), SSRIs (eg, fluoxetine, paroxetine), St. John's wort, sympathomimetics (eg, amphetamine, ephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine), tetracyclic antidepressants (eg, mirtazapine), or tricyclic antidepressants (eg, amitriptyline) because serotonin syndrome (eg, fever, muscle stiffness or rigidity, vital sign changes, mental or mood changes, coma) may occur

Apraclonidine or buspirone because severe high blood pressure may occur

Nefazodone or tryptophan because nausea, dizziness, mental or mood changes, seizures, fever, or breathing or heart problems may occur

Tramadol because the risk of seizures may be increased

Carbamazepine or oxcarbazepine because they may increase the risk of Emsam System's side effects

5-HT₁ agonists (eg, sumatriptan), insulin, a meglitinide antidiabetic (eg, nateglinide), methylphenidate, or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Emsam System

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

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

Emsam System comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Emsam System refilled.

Wear only 1 patch at a time. Remove a used patch before applying a new one. Change the patch at about the same time each day.

Do not cut or tear the patch. Do not apply to an area of skin that is hairy, oily, irritated, broken, scarred, or calloused. Do not place the patch under tight clothing.

Apply to dry, smooth, intact skin on the upper torso, upper thigh, or outer surface of the upper arm. Use a new application site with each new patch.

Wash the area gently with soap and warm water before applying the patch. Rinse until all soap is removed. Dry the area with a clean, dry towel.

Apply the patch as directed by your doctor or on the package labeling. Apply the patch immediately upon removal from the protective pouch. If you have questions about how to apply the patch, check with your doctor or pharmacist.

Wash your hands thoroughly with soap and water after applying the patch. Do not touch your eyes until after you have washed your hands.

Avoid exposing the application site to direct heat, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight.

After 24 hours, remove the used patch. After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets. Wash your hands with soap and water after removing the patch.

If your doctor tells you to stop taking Emsam System, you will need to wait at least 14 days before beginning to take certain other medicines (eg, medicines for depression, anxiety, pain, cough, congestion, weight loss, seizures, or Parkinson disease; muscle relaxants). Ask your doctor if you are unsure when you should start to take your new medicines after you have stopped taking Emsam System.

Continue to use Emsam System even if you feel well. Do not miss any doses.

If your patch falls off or if you miss a dose of Emsam System, apply a new patch to a new site and resume your previous schedule.

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

Important safety information:

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

Do not drink alcohol while you are using Emsam System.

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

Do not suddenly stop using Emsam System. The risk of side effects may be increased if Emsam System is suddenly stopped. Check with your doctor before you change your dose or stop Emsam System.

Some people have experienced new, unusual, or increased urges (eg, gambling, sexual) while using Emsam System. Tell your doctor right away if you notice such effects.

Children, teenagers, and young adults who take Emsam System may be at increased risk for suicidal thoughts or actions. Watch patients who take Emsam System closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.

The oral form of Emsam System is used to treat Parkinson disease. Patients with Parkinson disease have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if Emsam System may contribute to the increased risk of melanoma. You may need to have skin exams while you are using Emsam System. Discuss any questions or concerns with your doctor.

Serotonin syndrome is a possibly fatal syndrome that can occur if you take Emsam System with certain other medicines (eg, dextromethorphan, SSRIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.

Eating foods high in tyramine (eg, aged cheeses, red wines, beer, certain meats and sausages, liver, sour cream, soy sauce, raisins, bananas, avocados) while you use an MAOI may cause severe high blood pressure. This could occur for up to 2 weeks after you stop taking an MAOI. Do not eat foods high in tyramine while you take Emsam System. Ask your health care provider for a complete list of foods you should avoid. Seek medical attention at once if symptoms of severe high blood pressure occur. These may include severe headache, fast or irregular heartbeat, sore or stiff neck, nausea, vomiting, sweating, enlarged pupils, or sensitivity to light.

Avoid dietary supplements containing tyramine or nonprescription products containing dextromethorphan, pseudoephedrine, or phenylephrine while you are using Emsam System.

Tell your doctor or dentist that you take Emsam System before you receive any medical or dental care, emergency care, or surgery. Emsam System should be discontinued at least 10 days before elective surgery.

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

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

Use Emsam System with caution in the ELDERLY; they may be more sensitive to its effects, especially rash.

Use Emsam System with extreme caution in children younger than 18 years old; safety and effectiveness in these children have not been confirmed.

Emsam System should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Emsam System while you are pregnant. It is not known if Emsam System is found in breast milk. If you are or will be breast-feeding while you use Emsam System, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Emsam System:

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:

Diarrhea; dizziness; dry mouth; mild redness at the application site; sleeplessness.

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); abnormal thinking; changes in sexual ability or desire; chest pain; confusion; dark or unusual growths on the skin or any skin changes; enlarged pupils; fast, slow, or irregular heartbeat; fever; increased sweating; memory loss; nausea; neck stiffness or soreness; new or worsening agitation, aggressiveness, anxiety, depression, exaggerated feeling of well-being, hostility, impulsiveness, inability to sit still, irritability, panic attacks, or sleeplessness; painful menstruation; rigid muscles; sensitivity to light; severe or persistent dizziness or headache; severe or persistent redness or itching at the application site; suicidal thoughts or actions; swelling of the arms or legs; tremor; unusual or intense urges (eg, gambling, sexual); vomiting.

See also: Emsam side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; cool, clammy skin; difficulty breathing; excessive sweating; fast or irregular heartbeat; fever; hallucinations; hyperactivity; seizures; severe dizziness, drowsiness, or headache.

Proper storage of Emsam System:

Store Emsam System at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not store the patch outside of the sealed pouch. Store away from heat, moisture, and light. Keep Emsam System out of the reach of children and away from pets.

General information:

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

Emsam System 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 Emsam System. 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

More Emsam resources

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

Compare Emsam with other medications

Depression

Monday, October 10, 2016

Emend

Generic Name: Aprepitant/Fosaprepitant Dimeglumine
Class: Antiemetics, Miscellaneous
VA Class: GA605
Chemical Name: 5-[[(2R,3S)-2-[(1R)-1-[3,5,bis (trifluoromethyl)phenyl]ethoxy] - 3 - (4 - fluorophenyl) - 4 - morpholinyl]methyl] - 1,2, - dihydro - 3H - 1,2,4, - triazol - 3 - one
Molecular Formula: C₂₃H₂₁F₇N₄O₃C₂₃H₂₂F₇N₄O₆P•2C₇H₁₇NO₅
CAS Number: 170729-80-3

Introduction

Antiemetic; aprepitant is a selective, high-affinity antagonist at substance P/neurokinin-1 (NK₁) receptors; fosaprepitant dimeglumine is a lyophilized prodrug of aprepitant.¹ ² ³ ⁴ ⁷ ⁸ ⁹ ¹¹ ¹² ¹⁶

Uses for Emend

Cancer Chemotherapy-induced Nausea and Vomiting

Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin therapy.¹ ⁴ ⁷ ⁸ ⁹ ¹² ¹⁶ Used in combination with other antiemetic agents.¹ ⁴ ⁷ ⁸ ⁹ ¹² ¹⁶

Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.¹ ¹¹ ¹² ¹⁶ Used in combination with other antiemetic agents.¹ ¹¹ ¹² ¹⁶

For prevention of nausea and vomiting associated with chemotherapy with a high emetic risk (>90% incidence of emesis without antiemetics) and for combination anthracycline and cyclophosphamide chemotherapy, ASCO recommends a 3-drug antiemetic regimen consisting of aprepitant, a type 3 serotonin (5-HT₃) receptor antagonist (e.g., dolasetron, granisetron, ondansetron, palonosetron), and dexamethasone.⁷ For chemotherapy regimens of moderate emetic risk (>30% and ≤90% incidence of emesis without antiemetics), ASCO prefers a 2-drug antiemetic regimen consisting of a 5-HT₃ receptor antagonist and dexamethasone.⁷ For chemotherapy with a low emetic risk (>10% and ≤30% incidence of emesis without antiemetics), ASCO recommends dexamethasone alone on the first day of chemotherapy.⁷

For prevention of delayed emesis in patients receiving cisplatin or other chemotherapy associated with a highemetic risk, ASCO recommends a 2-drug combination of aprepitant and dexamethasone.⁷

Safety and efficacy for chronic use or for treatment of established nausea and vomiting not established.¹ ² ¹²

Postoperative Nausea and Vomiting

Prevention of postoperative nausea and vomiting.¹ ² ⁶ ¹⁴ ¹⁵

Safety and efficacy for chronic use or for treatment of established nausea and vomiting not established.¹ ²

Emend Dosage and Administration

Administration

Dispensing and Administration Precautions

Because of similarities in spelling and/or pronunciation between Emend (the trade name for aprepitant) and Amen (a former trade name for medroxyprogesterone acetate; no longer commercially available under this trade name in the US) or Vfend (the trade name for voriconazole), exercise extra care in ensuring the accuracy of prescriptions for these drugs.⁵ (See Possible Prescribing and Dispensing Errors under Cautions.)

Oral Administration

Administer aprepitant orally without regard to meals.¹ ² ⁴

IV Administration

Administer fosaprepitant dimeglumine by IV infusion.¹²

For solution and drug compatibility information, see Compatibility under Stability.

Reconstitution and Dilution

Reconstitute powder for injection with 5 mL of 0.9% sodium chloride for injection; avoid jetting saline into the vial.¹² Gently swirl solution; do not shake.¹²

Withdraw entire volume from vial and transfer into infusion bag containing 110 mL of 0.9% sodium chloride, yielding a total volume of 115 mL (1 mg/mL).¹² Mix solutions by gentle inversion of the bag 2–3 times.¹²

Rate of Administration

Infuse over 15 minutes.¹²

Dosage

Dosage of fosaprepitant dimeglumine is expressed in terms of fosaprepitant.¹²

Adults

Cancer Chemotherapy-induced Nausea and Vomiting

Administer as part of a regimen that includes a 5-HT₃ receptor antagonist and a corticosteroid.¹ ² ⁴ ¹²

Highly Emetogenic Cancer Chemotherapy

Oral

Administer 125 mg of aprepitant 1 hour before chemotherapy on day 1, and follow with 80 mg once daily in the morning on days 2 and 3 of the treatment regimen.¹ ² ⁴ ⁷

In clinical studies, aprepitant was administered with IV ondansetron (32 mg 30 minutes before chemotherapy on day 1) and oral dexamethasone (12 mg 30 minutes before chemotherapy on day 1, followed by 8 mg once daily in the morning on days 2–4).¹ ⁴

Administer 115 mg of fosaprepitant over 15 minutes, 30 minutes prior to chemotherapy as an alternative to oral aprepitant (125-mg) on day 1 only of 3-day regimen.¹ ¹² Follow fosaprepitant with oral aprepitant 80 mg once daily in the morning on days 2 and 3 of the treatment regimen.¹²

Moderately Emetogenic Cancer Chemotherapy

Oral

Administer 125 mg of aprepitant 1 hour before chemotherapy on day 1, and follow with 80 mg once daily in the morning on days 2 and 3 of the treatment regimen.¹ ⁷

In a clinical study, aprepitant was administered with oral ondansetron (8 mg 30–60 minutes before chemotherapy on day 1, followed by 8 mg 8 hours after the first dose) and oral dexamethasone (12 mg 30 minutes before chemotherapy on day 1).¹

Postoperative Nausea and Vomiting

Oral

Administer 40 mg of aprepitant within 3 hours before induction of anesthesia.¹

Special Populations

Hepatic Impairment

No dosage adjustment necessary in patients with mild to moderate hepatic impairment.¹ Not adequately studied in patients with severe hepatic impairment (Child-Pugh score >9).¹

Renal Impairment

No dosage adjustment necessary in patients with renal impairment or end-stage renal disease requiring hemodialysis.¹ ⁴

Geriatric Patients

No dosage adjustment necessary.¹ ⁴

Cautions for Emend

Contraindications

Concomitant use with astemizole (no longer commercially available in the US), cisapride (currently commercially available in the US only under a limited-access protocol), pimozide, or terfenadine (no longer commercially available in the US).¹ ² ⁴ ¹²

Known hypersensitivity to fosaprepitant, aprepitant, polysorbate 80, or any ingredient in the formulations.¹ ² ⁴ ¹²

Warnings/Precautions

Sensitivity Reactions

Stevens-Johnson syndrome reported in 1 patient receiving aprepitant with antineoplastic agents.¹ ⁴ Hypersensitivity reactions, including anaphylaxis, hives, rash, itching, and urticaria reported in patients receiving aprepitant or fosaprepitant; may be serious and can cause difficulty in breathing or swallowing.¹ ² ¹² ¹⁷ Angioedema reported in 1 patient.¹ ⁴

General Precautions

Drug Interaction Potential

Drug-interaction potential could be altered with chronic use (see Interactions); safety of chronic use not established.¹

Possible Prescribing and Dispensing Errors

Ensure accuracy of prescription; similarity in spelling and/or pronunciation of Emend (trade name for aprepitant) and Amen (former trade name for medroxyprogesterone acetate) or Vfend (trade name for voriconazole) may result in errors.⁵

Specific Populations

Pregnancy

Category B.¹ ² ⁴ ¹²

Lactation

Aprepitant is distributed into milk in rats; not known whether distributed into human milk.¹ ² Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy of fosaprepitant and aprepitant not established in children <18 years of age.¹ ⁴ ⁶ ¹²

Geriatric Use

No substantial differences in safety, efficacy, or pharmacokinetics of oral aprepitant relative to younger adults, but increased sensitivity cannot be ruled out.¹ ⁴

Hepatic Impairment

Oral aprepitant has not been adequately studied in patients with severe hepatic impairment (Child-Pugh score >9); caution advised in these patients.¹ ⁴ ¹²

Fosaprepitant metabolized by extrahepatic tissue; hepatic insufficiency not expected to alter conversion of fosaprepitant to aprepitant.¹²

Common Adverse Effects

Aprepitant capsules: Asthenia and/or fatigue, dizziness, hypoesthesia, nausea, anorexia, diarrhea, constipation, heartburn, abdominal pain, epigastric discomfort, dyspepsia, gastritis, stomatitis, pharyngolaryngeal pain, hiccups, perforating duodenal ulcer, enterocolitis, neutropenia, dehydration, hot flush, pruritus, hypotension, hypertension, sinus tachycardia, neutropenic sepsis, pneumonia, alopecia, bradycardia.¹ ²

Fosaprepitant injection: Infusion site reactions (e.g., pain, induration), headache.¹² ¹³ ¹⁶ Since fosaprepitant dimeglumine for injection is converted into aprepitant, adverse effects associated with aprepitant also may be expected to occur with the injection.¹²

Interactions for Emend

Drug interactions following fosaprepitant administration likely to occur with agents that interact with aprepitant.¹²

Aprepitant is extensively metabolized, principally by CYP3A4 and to a lesser extent by CYP1A2 and CYP2C19.¹ ¹² ¹⁶ The drug is a weak-to-moderate, dose-dependent inhibitor and an inducer of CYP3A4;¹ ⁴ ¹² also an inducer of CYP2C9.¹ ⁴ ¹²

Drugs Metabolized by Hepatic Microsomal Enzymes

CYP3A4 substrates: Possible altered metabolism of CYP3A4 substrates.¹ ⁴ Aprepitant may inhibit or induce CYP3A4.¹ ⁴ Inhibition of CYP3A4 is dose-dependent and moderate with the 125-mg/80-mg aprepitant regimen and weak with the single-dose, 40-mg regimen.¹ Possible increased plasma concentrations of concomitantly administered drugs, especially possible with higher aprepitant dosages (i.e., in a regimen consisting of 125 mg on day 1 followed by 80 mg on days 2 and 3) or with repeat administration at any aprepitant dose.¹ ⁴ ⁶ ¹⁶ Aprepitant (at a dosage level of 125 mg on day 1 followed by 80 mg on days 2 and 3) may increase plasma concentrations of a CYP3A4 substrate to lesser extent when the substrate is given IV rather than orally.¹ ⁶ ¹⁸ Use with caution; dosage adjustment of the CYP3A4 substrate may be necessary.¹ ⁴ ¹²

CYP2C9 substrates: Possible increased metabolism and decreased plasma concentrations of the CYP2C9 substrate.¹ ⁴ ⁶ ¹²

Drugs Affecting Hepatic Microsomal Enzymes

CYP3A4 inhibitors: Possible decreased aprepitant metabolism, resulting in increased plasma aprepitant concentrations.¹ ⁴ ¹² Use with caution.¹ ⁴ ¹² ¹⁶

CYP3A4 inducers: Possible increased aprepitant metabolism.¹ ⁴ Potential for decreased aprepitant efficacy with strong CYP3A4 inducers.¹ ⁴ ¹²

Specific Drugs

Drug	Interaction	Comments
Antiemetics, 5-HT₃ receptor antagonists (e.g., dolasetron, granisetron, ondansetron)	No clinically important effects on 5-HT₃ receptor antagonist pharmacokinetics¹ ¹² ¹⁶
Antifungals, azoles (e.g., itraconazole, ketoconazole)	Possible increased plasma aprepitant concentrations¹ ⁴	Use with caution¹ ⁴
Antineoplastic agents (e.g., etoposide, ifosfamide, imatinib, irinotecan, paclitaxel, vinblastine, vincristine)	Possible increased plasma concentrations of antineoplastic agents metabolized by CYP3A4¹ ⁴	Use caution; careful monitoring required¹ ⁴
Astemizole (no longer commercially available in US)	Increased plasma astemizole concentrations;¹ ⁴ potential for serious or life-threatening reaction¹ ² ⁴	Concomitant use contraindicated¹ ⁴
Benzodiazepines (e.g., alprazolam, midazolam, triazolam)	Possible increased plasma concentrations of benzodiazepines metabolized by CYP3A4¹ ⁴	Consider potential effect of increased plasma benzodiazepine concentrations¹ ⁴ ¹² ¹⁶ IV midazolam: Dosage adjustment may be necessary when concurrently administered with oral aprepitant regimen of 125 mg on day 1 followed by 80 mg on days 2 and 3¹ Interaction not clinically important when midazolam administered with single dose of fosaprepitant 100 mg or single 40-mg dose of aprepitant ¹ ⁶ ¹²
Carbamazepine	Possible decreased plasma concentrations and decreased efficacy of aprepitant¹ ⁴
Cisapride (commercially available in US only under limited-access protocol)	Increased plasma cisapride concentrations;¹ ⁴ potential for serious or life-threatening reaction¹ ² ⁴	Concomitant use contraindicated¹ ⁴
Contraceptives, oral	Possible decreased plasma steroid concentrations and reduced contraceptive efficacy¹ ⁴	Use alternative or additional contraceptive methods during fosaprepitant or aprepitant treatment and for 1 month after last dose¹ ⁴ ⁶ ¹² ¹⁶
Corticosteroids (e.g., dexamethasone, methylprednisolone)	Possible increased plasma concentrations of corticosteroids metabolized by CYP3A4, particularly when given oral aprepitant regimen of 125 mg on day 1 followed by 80 mg on days 2 and 3¹ ⁴ ¹²	Decrease dosage of oral and IV corticosteroids if necessary.¹ ⁴ ¹² Decrease dosage of oral dexamethasone and methylprednisolone by 50% and IV methylprednisolone by 25% in patients receiving oral aprepitant regimen of 125 mg on day 1 followed by 80 mg on days 2 and 3;¹ ⁶ ¹² ¹⁶ dosage adjustment not recommended in patients receiving the single-dose, 40-mg regimen⁶
Digoxin	Pharmacokinetic interaction unlikely¹ ⁴ ¹² ¹⁶
Diltiazem	Possible increased plasma aprepitant and diltiazem concentrations; no clinically important changes in ECG, heart rate, or BP observed¹ ⁴ ¹⁶ Small, but clinically meaningful, decrease in DBP, and possibly SBP, reported with concomitant fosaprepitant therapy; no clinically important changes in heart rate or PR interval observed¹²	Use with caution¹ ⁴ ¹²
Docetaxel	No effects on docetaxel pharmacokinetics with oral aprepitant regimen of 125 mg on day 1 followed by 80 mg on days 2 and 3¹ ⁶
HIV protease inhibitors (nelfinavir, ritonavir)	Possible increased plasma aprepitant concentrations¹ ⁴	Use with caution¹ ⁴
Macrolide antibiotics (e.g., clarithromycin, troleandomycin)	Possible increased plasma aprepitant concentrations¹ ⁴	Use with caution¹ ⁴

Nefazodone	Possible increased plasma aprepitant concentrations¹ ⁴	Use with caution¹ ⁴
Paroxetine	Possible decreased plasma aprepitant and paroxetine concentrations¹ ⁴
Phenytoin	Possible decreased plasma concentrations and decreased efficacy of aprepitant; possible decreased plasma phenytoin concentrations¹ ⁴
Pimozide	Increased plasma pimozide concentrations;¹ ⁴ potential for serious or life-threatening reaction¹ ² ⁴	Concomitant use contraindicated¹ ⁴
Rifampin	Possible decreased plasma concentrations and decreased efficacy of aprepitant¹ ⁴
Terfenadine (no longer commercially available the US)	Increased plasma terfenadine concentrations;¹ ⁴ potential for serious or life-threatening reaction¹ ² ⁴	Concomitant use contraindicated¹ ⁴
Tolbutamide	Possible decreased plasma tolbutamide concentrations¹ ⁴
Vinorelbine	No effects on vinorelbine pharmacokinetics with oral aprepitant regimen of 125 mg on day 1 followed by 80 mg on days 2 and 3¹
Warfarin	Possible decreased plasma S-warfarin concentrations and decreased PT¹ ⁴	Monitor PT closely for 2 weeks (particularly 7–10 days) after initiation of fosaprepitant followed by aprepitant, the 3-day oral aprepitant regimen or administration of the single-dose aprepitant regimen¹ ⁴ ⁶ ¹² ¹⁶

Emend Pharmacokinetics

Absorption

Bioavailability

Absolute mean oral bioavailability at doses of 80–125 mg is approximately 60–65%.¹ ¹⁶ Absolute oral bioavailability of 40-mg dose not established.¹

Peak plasma concentrations achieved approximately 3–4 hours after oral administration.¹ ¹⁶

Fosaprepitant undergoes hepatic and extrahepatic metabolism to aprepitant (the active moiety).¹²

Plasma concentrations of fosaprepitant were below limits of quantification within 30 minutes following infusion completion.¹²

Mean aprepitant plasma concentration 24 hours postdose similar between oral aprepitant (125-mg) dose and IV fosaprepitant (115-mg) dose.¹²

Food

Standard breakfast does not appreciably alter bioavailability.¹ ¹⁶

Special Populations

In patients with mild to moderate hepatic impairment, no clinically meaningful changes in systemic exposure relative to healthy individuals.¹ Not studied in patients with severe hepatic impairment (Child-Pugh score >9).¹

In patients with severe renal impairment or end-stage renal disease requiring hemodialysis, total (protein bound and unbound) aprepitant AUCs and peak plasma concentrations are decreased, but AUC of active unbound drug is unaffected.¹

In geriatric patients, no clinically meaningful changes in systemic exposure relative to younger adults.¹

Distribution

Extent

Crosses the placenta in animals; crosses the blood-brain barrier in humans.¹

Plasma Protein Binding

>95%.¹

Elimination

Metabolism

Fosaprepitant rapidly metabolized to aprepitant in liver by CYP3A4 and to lesser extent by CYP1A2 and 2C19; also metabolized in extrahepatic tissues.¹² ¹⁶

Aprepitant extensively metabolized to weakly active metabolites, principally by CYP3A4 and to a lesser extent by CYP1A2 and CYP2C19.¹

Elimination Route

Eliminated principally by metabolism; not renally excreted.¹

Following a single IV dose of radiolabeled fosaprepitant in healthy individuals, 57 and 45% of radioactivity recovered in urine and feces, respectively.¹⁶

Half-life

Terminal half-life is approximately 9–13 hours.¹ ¹⁶

Special Populations

Not removed by hemodialysis.¹ ⁴

Stability

Storage

Oral

Capsules

20–25°C.¹ Desiccant should remain in original bottle.¹

Parenteral

Injection

2–8°C.¹²

Following reconstitution and dilution to final concentration of 1 mg/mL in 0.9% sodium chloride injection, store at room temperature (≤25°C); use within 24 hours.¹²

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Do not mix or reconstitute with solutions containing divalent cations (e.g., lactated Ringer’s solution, Hartmann’s solution).¹²

Solution Compatibility

Incompatible
Ringer’s injection, Lactated¹²
Hartmann’s solution¹²

ActionsActions

Fosaprepitant is a prodrug; pharmacologically active once metabolized to aprepitant.¹² ¹⁶

Aprepitant occupies NK₁ receptors in the brain.¹ ³ ⁴ Acts in the CNS to inhibit cancer chemotherapy-induced nausea and vomiting (including both acute and delayed emesis induced by cisplatin) and postoperative nausea and vomiting.¹ ³ ⁴

Augments the antiemetic activity of ondansetron and dexamethasone.¹ ³ ⁴

Advice to Patients

Importance of reading the fosaprepitant and aprepitant patient information provided by the manufacturer before beginning therapy and rereading each time the prescription is renewed.¹ ² ¹²

Importance of using fosaprepitant and aprepitant only as directed by the clinician.¹ ² ¹²

Importance of taking first oral aprepitant (125-mg) dose 1 hour before initiation of antineoplastic chemotherapy.¹ ²

Advise patients that aprepitant may be taken with or without food.² ¹² ¹⁷

Importance of taking aprepitant (40-mg) dose within 3 hours prior to induction of anesthesia for prevention of postoperative nausea and vomiting.¹

Importance of discontinuing aprepitant and promptly contacting a clinician if symptoms of an allergic reaction occur.² ¹² ¹⁷

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ ² Importance of women using alternative or additional contraceptive methods during fosaprepitant or aprepitant use (and for 1 month after last dose) if oral contraceptives are being taken.¹ ² ¹²

Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products.¹ ² ¹² Importance of closely monitoring prothrombin time in patients receiving chronic warfarin therapy during the 2 weeks (particularly 7–10 days) after initiation of fosaprepitant followed by aprepitant, or the 3-day oral aprepitant regimen for each antineoplastic chemotherapy cycle, or administration of aprepitant for prevention of postoperative emesis.¹ ² ¹²

Importance of informing patients of other important precautionary information.¹ ² (See Cautions.)

Preparations

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

Aprepitant
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	40 mg	Emend	Merck
		80 mg	Emend	Merck
		125 mg	Emend	Merck

Fosaprepitant Dimeglumine
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For IV infusion only	115 mg (of fosaprepitant)	Emend	Merck

Comparative Pricing

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

Emend 125MG Capsules (MERCK SHARP & DOHME): 6/$920.99 or 18/$2638.97

Emend 40MG Capsules (MERCK SHARP & DOHME): 5/$269.45 or 15/$763.43

Emend 80MG Capsules (MERCK SHARP & DOHME): 2/$211.33 or 6/$608.57

Emend 80MG Capsules (MERCK SHARP & DOHME): 6/$617.99 or 18/$1735.98

Disclaimer

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

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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Merck. Emend (aprepitant) capsules prescribing information. Whitehouse Station, NJ; 2008 Feb.

2. Merck. Emend (aprepitant) capsules patient information. Whitehouse Station, NJ; 2008 Apr.

3. Sorbera LA, Castaner J, Bayes M at al. Aprepitant and L-758298. Drugs Fut. 2002; 27:211-22.

4. Merck. Emend (aprepitant) product information form for the American Hospital Formulary Service. 2003.

5. Merck. Dear pharmacist letter regarding Emend (aprepitant). 2003 Apr.

6. Merck, Whitehouse Station, NJ: Personal communication.

7. Kris MG, Hesketh PJ, Somerfield MR et al. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006; 24:2932-2947. [PubMed 16717289]

8. Hesketh PJ, Grunberg SM, Gralla RJ et al. The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin—the Aprepitant Protocol 052 Study Group. J Clin Oncol. 2003; 21:4112-9. [PubMed 14559886]

9. Poli-Bigelli S, Rodrigues-Pereira J, Carides AD et al. Addition of the neurokinin 1 receptor antagonist aprepitant to standard antiemetic therapy improves control of chemotherapy-induced nausea and vomiting: results from a randomized, double-blind, placebo-controlled trial in Latin America. Cancer. 2003; 97:3090-8. [PubMed 12784346]

11. Warr DG, Hesketh PJ, Gralla RJ. et al. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol. 2005; 23:2822-30. [PubMed 15837996]

12. Merck. Emend (fosaprepitant dimeglumine) for injection prescribing information. Whitehouse Station, NJ; 2008 Feb.

13. Lasseter KC, Gambale J, Jin B et al. Tolerability of fosaprepitant and bioequivalency to aprepitant in healthy subjects. J Clin Pharmacol. 2007; 47:834-40. [PubMed 17525168]

14. Diemunsch P, Gan TJ, Philip BK et al. Single-dose aprepitant vs ondansetron for the prevention of postoperative nausea and vomiting: a randomized, double-blind Phase III trial in patients undergoing open abdominal surgery. Br J Anesth. 2007; 99:202-11.

15. Gan TJ, Apfel CC, Kovac A et al. A randomized, double-blind comparison of the NK₁ antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting. Anesth Anal. 2007; 104:1082-9.

16. Navari RM. Fosaprepitant (MK-0517): a neurokinin-1 receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting. Expert Opin. Investig. Drugs. 2007; 16:1977-85.

17. Merck. Emend (fosaprepitant dimeglumine) for injection patient information. Whitehouse Station, NJ; 2009 Feb.

18. Merck. Whitehouse Station, NJ: Personal communication.

More Emend resources

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

Emend Prescribing Information (FDA)

Emend Consumer Overview

Emend Advanced Consumer (Micromedex) - Includes Dosage Information

Emend MedFacts Consumer Leaflet (Wolters Kluwer)

Aprepitant Professional Patient Advice (Wolters Kluwer)

Compare Emend with other medications

Nausea/Vomiting, Chemotherapy Induced
Nausea/Vomiting, Postoperative

Emcin Topical

Generic Name: erythromycin (Topical route)

e-rith-roe-MYE-sin

Commonly used brand name(s)

In the U.S.

A/T/S

Akne-Mycin

Emcin

Emgel

Erycette

Eryderm

Erygel

Theramycin Z

In Canada

Sans-Acne

Staticin

Available Dosage Forms:

Gel/Jelly

Ointment

Solution

Swab

Lotion

Therapeutic Class: Antiacne

Chemical Class: Macrolide

Uses For Emcin

Erythromycin belongs to the family of medicines called antibiotics. Erythromycin topical preparations are used on the skin to help control acne. They may be used alone or with one or more other medicines that are applied to the skin or taken by mouth for acne. They may also be used for other problems, such as skin infections, as determined by your doctor.

Erythromycin is available only with your doctor's prescription.

Before Using Emcin

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

Erythromycin topical solution has been tested in children 12 years of age and older 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 erythromycin 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.

Interactions with Medicines

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

Using this medicine with any of the following medicines is 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.

Clindamycin

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 erythromycin

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

Before applying this medicine, thoroughly wash the affected area with warm water and soap, rinse well, and pat dry. After washing or shaving, it is best to wait 30 minutes before applying the pledget (swab), topical gel, or topical liquid form. The alcohol in them may irritate freshly washed or shaved skin.

For patients using the pledget (swab), topical gel, or topical liquid form of erythromycin:

These forms contain alcohol and are flammable. Do not use near heat, near open flame, or while smoking.

It is important that you do not use this medicine more often than your doctor ordered. It may cause your skin to become too dry or irritated.

Also, you should avoid washing the acne-affected areas too often. This may dry your skin and make your acne worse. Washing with a mild, bland soap 2 or 3 times a day should be enough, unless you have oily skin. If you have any questions about this, check with your doctor.

To use:
- The topical liquid form of this medicine may come in a bottle with an applicator tip, which may be used to apply the medicine directly to the skin. Use the applicator with a dabbing motion instead of a rolling motion (not like a roll-on deodorant, for example). If the medicine does not come in an applicator bottle, you may moisten a pad with the medicine and then rub the pad over the whole affected area. Or you may also apply this medicine with your fingertips. Be sure to wash the medicine off your hands afterward.
- Apply a thin film of medicine, using enough to cover the affected area lightly. You should apply the medicine to the whole area usually affected by acne, not just to the pimples themselves. This will help keep new pimples from breaking out.
- The pledget (swab) form should be rubbed over the whole affected area. You may use extra pledgets (swabs), if needed, to cover larger areas.
- Since these medicines contain alcohol, they may sting or burn. Therefore, do not get these medicines in the eyes, nose, mouth, or on other mucous membranes. Spread the medicine away from these areas when applying. If these medicines do get in the eyes, wash them out immediately, but carefully, with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

This medicine will not cure your acne. However, to help keep your acne under control, keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. You may have to continue using this medicine every day for months or even longer in some cases. If you stop using this medicine too soon, your symptoms may return. It is important that you 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 acne:
- For gel dosage form:
  - Adults—Apply to the affected area(s) of the skin two times a day, morning and evening.
  - Children—Dose must be determined by your doctor.
- For ointment dosage form:
  - Adults, teenagers, and children—Apply to the affected area(s) of the skin two times a day, morning and evening.
- For pledgets dosage form:
  - Adults, teenagers, and children—Apply to the affected area(s) of the skin two times a day.
- For topical solution dosage form:
  - Adults, teenagers, and children 12 years of age and over—Apply to the affected area(s) of the skin two times a day, morning and evening.
  - Children up to 12 years of age—Dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Emcin

If your acne does not improve within 3 to 4 weeks, or if it becomes worse, check with your health care professional. However, treatment of acne may take up to 8 to 12 weeks before you see full improvement.

For patients using the pledget (swab), topical gel, or topical liquid form of erythromycin:

If your doctor has ordered another medicine to be applied to the skin along with this medicine, it is best to wait at least 1 hour before you apply the second medicine. This may help keep your skin from becoming too irritated. Also, if the medicines are used too close together, they may not work properly.

After application of this medicine to the skin, mild stinging or burning may be expected and may last up to a few minutes or more.

This medicine may also cause the skin to become unusually dry, even with normal use. If this occurs, check with your doctor.

You may continue to use cosmetics (make-up) while you are using this medicine for acne. However, it is best to use only ``water-base'' cosmetics. Also, it is best not to use cosmetics too heavily or too often. They may make your acne worse. If you have any questions about this, check with your doctor.

Emcin 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.

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:

For erythromycin ointmentLess common

Peeling

redness

For erythromycin pledget (swab), topical gel, or topical liquid form More common

Dry or scaly skin

irritation

itching

stinging or burning feeling

Less common

Peeling

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.

See also: Emcin 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.

Compare Emcin Topical with other medications

Acne
Perioral Dermatitis

Emgel

Generic Name: erythromycin topical (ee RITH roe MYE sin)

Brand Names: A/T/S, Akne-Mycin, Emcin Clear, Emgel, Eryderm, Erygel, Erymax, Romycin, Theramycin Z

What is Emgel (erythromycin topical)?

Erythromycin topical is an antibiotic that fights skin infection caused by bacteria.

Erythromycin topical (for the skin) is used to treat bacterial infections such as severe acne.

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

What is the most important information I should know about Emgel (erythromycin topical)?

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

Wash your hands before and after using this medicine.

Avoid using other medications on the areas you treat with erythromycin topical unless you doctor tells you to.

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, rinse with water. It may take up to 12 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 6 weeks of treatment.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking erythromycin topical and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

What should I discuss with my healthcare provider before using Emgel (erythromycin topical)?

You should not use erythromycin topical if you are allergic to it. FDA pregnancy category C. It is not known whether erythromycin topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Erythromycin topical can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 18 years old without the advice of a doctor.

How should I use Emgel (erythromycin topical)?

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

Do not use erythromycin topical to treat any skin condition that has not been checked by your doctor. Wash your hands before and after using this medicine.

Clean and dry the skin area before you apply erythromycin topical. Spread the medicine on lightly, without rubbing it in.

Erythromycin topical is usually applied once or twice daily. Follow your doctor's instructions.

It may take up to 12 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 6 weeks of treatment. Store at room temperature away from moisture and heat. Keep the tube or bottle tightly closed when not in use.

The gel form of this medicine is flammable. Do not use near high heat or open flame.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Emgel (erythromycin topical)?

Avoid using other medications on the areas you treat with erythromycin topical unless you doctor tells you to.

Avoid using skin products that can cause irritation, such as harsh soaps or skin cleansers, or skin products with alcohol, spices, astringents, or lime.

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, rinse with water.

Emgel (erythromycin topical) 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. Stop using erythromycin topical and call your doctor at once if you have any of these serious side effects:

severe burning, stinging, or redness;

oozing or other signs of skin infection;

worsening of your skin condition; or

diarrhea that is watery or bloody.

Less serious side effects may include:

mild skin irritation or tenderness;

dry or oily skin;

itching;

peeling; or

mild eye irritation.

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

What other drugs will affect Emgel (erythromycin topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied erythromycin. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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Acne
Perioral Dermatitis

Where can I get more information?

Your pharmacist can provide more information about erythromycin topical.

See also: Emgel side effects (in more detail)

Elocon Lotion

mometasone furoate

Dosage Form: topical solution (lotion)
ELOCON® Lotion, 0.1%

brand of (mometasone furoate topical solution USP)

For Dermatologic Use Only

Not for Ophthalmic Use

Elocon Lotion Description

ELOCON® Lotion, 0.1% brand of (mometasone furoate topical solution USP) contains mometasone furoate USP for dermatologic use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity.

Chemically, mometasone furoate is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula:

Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.

Each gram of Elocon Lotion, 0.1% contains: 1 mg mometasone furoate USP in a lotion base of isopropyl alcohol (40%); propylene glycol; hydroxypropyl cellulose; sodium phosphate monobasic monohydrate; and purified water. May also contain phosphoric acid used to adjust the pH to approximately 4.5.

Elocon Lotion - Clinical Pharmacology

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

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Studies in humans indicate that approximately 0.7% of the applied dose of ELOCON® Ointment, 0.1% enters the circulation after 8 hours of contact on normal skin without occlusion. A similar minimal degree of absorption of the corticosteroid from the lotion formulation would be anticipated. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Studies performed with Elocon Lotion, 0.1% indicate that it is in the medium range of potency as compared with other topical corticosteroids.

In a study evaluating the effects of mometasone furoate lotion on the hypothalamic-pituitary-adrenal (HPA) axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to four adult patients with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the four patients remained within the normal range and changed little from baseline.

Sixty-five pediatric patients ages 6 to 23 months, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study. Elocon Lotion, 0.1% was applied once daily for approximately 3 weeks over a mean body surface area of 40% (range 16%–90%). In approximately 29% of patients who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with Elocon Lotion, 0.1%. The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the patients, demonstrated suppressed HPA axis function in one patient, using these same criteria.

Indications and Usage for Elocon Lotion

ELOCON® Lotion, 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Since safety and efficacy of Elocon Lotion, 0.1% have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended (see PRECAUTIONS, Pediatric Use section).

Contraindications

ELOCON® Lotion, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Precautions

General

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

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

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

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

If irritation develops, ELOCON® Lotion, 0.1% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Elocon Lotion, 0.1% should be discontinued until the infection has been adequately controlled.

Information for Patients

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

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

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

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

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

Parents of pediatric patients should be advised not to use Elocon Lotion, 0.1% in the treatment of diaper dermatitis. Elocon Lotion, 0.1% should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressing (see DOSAGE AND ADMINISTRATION).

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

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

Other corticosteroid-containing products should not be used with Elocon Lotion, 0.1% without first consulting with the physician.

Laboratory Tests

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

: ACTH stimulation test
: A.M. plasma cortisol test
: Urinary-free cortisol test

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Elocon Lotion, 0.1%. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley® rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from Elocon Lotion, 0.1% on an mcg/m2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from Elocon Lotion, 0.1% on an mcg/m2 basis).

Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from Elocon Lotion, 0.1% on an mcg/m2 basis).

Pregnancy

Teratogenic Effects

Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy.

In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from Elocon Lotion, 0.1% on an mcg/m2 basis.)

In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from Elocon Lotion, 0.1% on an mcg/m2 basis.)

In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from Elocon Lotion, 0.1% on an mcg/m2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from Elocon Lotion, 0.1% on an mcg/m2 basis.)

When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from Elocon Lotion, 0.1% on an mcg/m2 basis.)

There are no adequate and well-controlled studies of teratogenic effects from topically applied corticosteroids in pregnant women. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Elocon Lotion, 0.1% is administered to a nursing woman.

Pediatric Use

Since safety and efficacy of Elocon Lotion, 0.1% have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended.

Elocon Lotion, 0.1% caused HPA axis suppression in approximately 29% of pediatric patients ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 40% (range 16%–90%). The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the patients, demonstrated suppressed HPA axis function in one patient, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population (see CLINICAL PHARMACOLOGY, Pharmacokinetics section).

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression.

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

Elocon Lotion, 0.1% should not be used in the treatment of diaper dermatitis.

Geriatric Use

Clinical studies of Elocon Lotion, 0.1% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

Adverse Reactions

In clinical studies involving 209 patients, the incidence of adverse reactions associated with the use of ELOCON® Lotion, 0.1% was 3%. Reported reactions included acneiform reaction, 2; burning, 4; and itching, 1. In an irritation/sensitization study involving 156 normal subjects, the incidence of folliculitis was 3% (4 subjects).

The following adverse reactions were reported to be possibly or probably related to treatment with Elocon Lotion, 0.1% during a clinical study, in 14% of 65 pediatric patients 6 months to 2 years of age: decreased glucocorticoid levels, 4; paresthesia, 2; dry mouth,1; an unspecified endocrine disorder, 1; pruritus, 1; and an unspecified skin disorder, 1. The following signs of skin atrophy were also observed among 65 patients treated with Elocon Lotion, 0.1% in a clinical study: shininess, 4; telangiectasia, 2; loss of elasticity, 2; and loss of normal skin markings, 3. Striae, thinness, and bruising were not observed in this study.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: irritation, dryness, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Overdosage

Topically applied ELOCON® Lotion, 0.1% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Elocon Lotion Dosage and Administration

Apply a few drops of ELOCON® Lotion, 0.1% to the affected skin areas once daily and massage lightly until it disappears. For the most effective and economical use, hold the nozzle of the bottle very close to the affected areas and gently squeeze. Since safety and efficacy of Elocon Lotion, 0.1% have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended (see PRECAUTIONS, Pediatric Use section).

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Elocon Lotion, 0.1% should not be used with occlusive dressings unless directed by a physician. Elocon Lotion, 0.1% should not be applied in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing.

How is Elocon Lotion Supplied

ELOCON® Lotion, 0.1% is supplied in 30-mL (27.5 g) (NDC 0085-0854-01) and 60-mL (55 g) (NDC 0085-0854-02) bottles; boxes of one.

Store Elocon Lotion, 0.1% at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].

Manufactured by: Schering-Plough Canada, Inc.,

Pointe Claire, Quebec, Canada.

Distributed by: Schering Corporation, a subsidiary of

The trademarks depicted in this piece are owned by their respective companies.

Rev. 4/10

34304807T

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

NDC 0085-0854-01

30 mL (27.5 g)

Elocon®

Lotion, 0.1%

brand of

(mometasone furoate

topical solution USP)

For dermatologic

use only.

Not for

ophthalmic use.

Rx only

DO NOT USE IN EYES

ELOCON
mometasone furoate lotion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0085-0854
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mometasone Furoate (Mometasone Furoate)	Mometasone Furoate	1 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
isopropyl alcohol
propylene glycol
hydroxypropyl cellulose
sodium phosphate, monobasic, monohydrate
water
phosphoric acid

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0085-0854-01	1 BOTTLE In 1 BOX	contains a BOTTLE
1		30 mL In 1 BOTTLE	This package is contained within the BOX (0085-0854-01)
2	0085-0854-02	1 BOTTLE In 1 BOX	contains a BOTTLE
2		60 mL In 1 BOTTLE	This package is contained within the BOX (0085-0854-02)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019796	08/19/2009

Labeler - Schering Corporation (001317601)

Establishment
Name	Address	ID/FEI	Operations
Schering Plough Canada Inc.		207093332	MANUFACTURE

Revised: 03/2011Schering Corporation

More Elocon Lotion resources

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

Compare Elocon Lotion with other medications

Atopic Dermatitis
Dermatitis
Eczema
Psoriasis