Elocon

Pregnancy Category: C

Lactation: use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Mometasone is a prescription medication available in several forms to be used to treat a variety of conditions including: 

• a nasal spray for nasal allergy symptoms such as runny, stuffy, itchy nose and sneezing related to allergies. It is also used to treat nasal polyps
• an inhaled form used to prevent asthma attacks
• a cream, lotion, and an ointment used to treat eczema, psoriasis, atopic dermatitis, and other inflammatory skin conditions

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Do not use mometasone if you are allergic to any of the ingredients in mometasone. 

Taking steroids may put you at a higher risk for infections. Mometasone is a nasal steroid and may suppress the immune system. Oral steroids (those taken by mouth) are more likely to cause immune suppression, but it is possible with mometasone. Before starting mometasone, let your doctor know if you have ever had tuberculosis or a herpes infection of the eye, as mometasone may allow these infections to worsen by weakening the immune system.

Mometasone, like all steroids, may slow the growth rate of children and teenagers.

Mometasone can cause glaucoma or cataracts or worsen these conditions.

Avoid exposure to measles and chicken pox. If you are exposed to measles or chicken pox while using mometasone, call your doctor right away.

Mometasone comes in a nasal spray that is sprayed into the nose, usually once or twice daily, depending on whether it is being used for allergies or nasal polyps.

Mometasone inhaler is inhaled into the lungs, usually once or twice daily.

Mometasone cream, lotion, and ointment are applied to the skin, usually once daily. Avoid contact with the eyes.

Mometasone Nasal Spray

• Use mometasone exactly as prescribed by your doctor.
• This medicine is for use in the nose only. Do not spray it into your mouth or eyes.
• Shake the pump before each use.
• An adult should help a young child use this medicine.
• For best results, you should keep using mometasone regularly each day without missing a dose. If you do miss a dose of mometasone, take it as soon as you remember. However, do not take more than the daily dose prescribed by your doctor.
• Do not use mometasone more often than prescribed.

Before you use mometasone the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you how to use it. To use the nasal inhalation, follow these steps:

1. Gently blow your nose to clear the nostrils.

2. Close one nostril. Tilt your head forward slightly and keep the bottle upright while inserting the nasal applicator into the other nostril.

3. For each spray, press down firmly once on the shoulders of the white applicator using your forefinger and middle finger. Support the base of the bottle with your thumb. Breathe gently inward through the nostril.

4. Breathe out through the mouth.

5. Repeat in the other nostril.

6. Replace the plastic cap.

Before using a new pump of mometasone for the first time, prime the pump by spraying ten times or until a fine spray appears. If you do not use the pump for more than 1 week, prime it again by spraying two times or until a fine spray appears.

If you have taken too much mometasone, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store mometasone between 15° and 30°C (59° to 86°F).

When Mometasone Nasal Spray, 50 mcg is removed from its cardboard container, prolonged exposure of the product to direct light should be avoided. Brief exposure to light, as with normal use, is acceptable. SHAKE WELL BEFORE EACH USE.

Keep mometasone and all medications out of the reach of children.

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mometasone topical cream and ointment in children 2 years of age and older, and topical lotion in children 12 years of age and older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. Use of the topical cream and ointment in children younger than 2 years of age, and the topical lotion in children younger than 12 years of age, is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mometasone topical in the elderly.

Pregnancy

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Very bad skin irritation.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Inform patients of the following:

• Use Elocon Ointment as directed by the physician. It is for external use only.
• Avoid contact with the eyes.
• Do not use Elocon Ointment on the face, underarms, or groin areas.
• Do not use Elocon Ointment 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.
• Report any signs of local adverse reactions to the physician.
• Advise patients not to use Elocon Ointment in the treatment of diaper dermatitis. Do not apply Elocon Ointment in the diaper area, as diapers or plastic pants may constitute occlusive dressing.
• Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
• Do not use other corticosteroid-containing products with Elocon Ointment without first consulting with the physician.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by: Bayer Inc.
Pointe Claire, Quebec H9R 1B4, Canada

For patent information: www.merck.com/product/patent/home.html

Copyright © 1987, 2008, 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-mk0887-ot-1509r007

PRINCIPAL DISPLAY PANEL - 15 g Tube Box

NDC 0085-0370-01

15 g

Elocon®
(mometasone
furoate)
Ointment, 0.1%

For topical
use only.

Not for
ophthalmic use.

Rx only