Celestone

Betamethasone dipropionate is the generic name of Diprolene and Diprolene AF, used to relieve skin discomfort caused by rashes, itching, and irritation.

Betamethasone comes in a topical cream, lotion, and ointment, as well as a solution for injection. It has many uses, depending on the form your doctor prescribes.

Although betamethasone topical cream and lotion are used to treat irritation and inflammation of the skin, doctors prescribe the injectable form of betamethasone, Celestone Soluspan, for multiple sclerosis flares and to help mature the lungs of babies born prematurely.

Other uses of various forms of betamethasone include treating the following allergic reactions:

• asthma
• seasonal allergies
• transfusion reactions
• rashes, eczema, and contact dermatitis on areas of the skin that have touched certain substances

Betamethasone is in a class of drugs known as steroids. It's not clear how betamethasone works, but scientists know that it stops your body from producing certain proteins that cause inflammation and allergic reactions.

The Food and Drug Administration (FDA) originally approved betamethasone under the brand name Celestone in 1961, and Schering Pharmaceuticals manufactured the drug.

This original version of Celestone is no longer on the market. However, Celestone Soluspan injectable was approved by the FDA in 1965 and Diprolene was approved in 1983. Both are manufactured by Merck.

Betamethasone Warnings

You should not take betamethasone in any of its formulations if you're allergic to betamethasone or any other ingredient in the drug.

Pregnancy and Betamethasone

Betamethasone is a FDA Pregnancy Category C drug, because steroids are known to cause birth defects in animals but the effects in pregnant humans haven't been studied adequately.

You should tell your doctor if you are pregnant or plan to become pregnant before taking this medication in any of its forms.

Betamethasone, like most steroids, is found in breast milk and may stunt your baby's growth.

You should tell your doctor if you are breastfeeding or planning to breastfeed before using betamethasone in any form.

Betamethasone topical comes in a 0.05 percent ointment or lotion.

After you've applied betamethasone topical to the affected area, expose it to air: Do not cover the area with a bandage or other material.

Don't apply betamethasone topical to your face, underarms, or groin unless your doctor tells you to do so.

Apply no more than 50 grams of betamethasone topical to your skin a week. You can stop using betamethasone when you no longer have symptoms.

Betamethasone Overdose

If you suspect an overdose, you should contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at (800) 222-1222.

Missed Dose of Betamethasone

If you miss applying betamethasone topical, try to use it as soon as you remember.

If it's almost time for the next dose, skip the missed dose and use your next dose at the regular time. Do not use two applications of the medication at the same time.

• Tell all of your health care providers that you take Celestone. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Have your eye pressure checked if you are on this medicine for a long time. Talk with your doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like Celestone. Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.
• This medicine may lower how much natural steroid is in your body. If you have a fever, an infection, surgery, or you are hurt, talk with your doctor. You may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you need extra steroids.
• Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
• This medicine may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
• Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
• You may need to lower how much salt is in your diet and take extra potassium. Talk with your doctor.
• If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
• Check your blood sugar as you have been told by your doctor.
• Talk with your doctor before you drink alcohol.
• If you are 65 or older, use Celestone with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness.

Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).

Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.

Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance.

Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.

Hematologic Disorders Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, selected cases of secondary thrombocytopenia.

Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.

Neoplastic Diseases For the palliative management of leukemias and lymphomas.

Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury.

Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.

Renal Diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.

Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.

Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.

The initial dosage of Celestone® Oral Solution may vary from 0.6 to 7.2 mg per day depending on the specific disease entity being treated.

IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT.

After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of betamethasone for a week followed by 12 mg every other day for 1 month are recommended (see PRECAUTIONS, Neuropsychiatric section).

In pediatric patients, the initial dose of betamethasone may vary depending on the specific disease entity being treated. The range of initial doses is 0.02 to 0.3 mg/kg/day in 3 or 4 divided doses (0.6–9 mg/m2 bsa/day).

For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids:

These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

Celestone® Oral Solution, 0.6 mg per 5 mL, orange-red colored liquid, bottle of 4 fluid ounces (118 mL) (NDC 0085-0942-05). Protect from light.

Store 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
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA

Rev. 10/10

31471311T

Copyright © 1968, 2007 Schering Corporation, a subsidiary of Merck & Co., Inc. All rights reserved.