What Should I Know About Storage And Disposal Of This Medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture . Do not freeze it..
It is important to keep all medication out of sight and reach of children as many containers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location â one that is up and away and out of their sight and reach.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website for more information if you do not have access to a take-back program.
How Is This Drug Best Taken
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Use as you have been told, even if your signs get better. Do not take this drug by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes . Do not use coverings unless told to do so by the doctor. Wash your hands before and after use. Do not wash your hands after use if putting this on your hand. Clean affected part before use. Make sure to dry well. Put a thin layer on the affected skin and rub in gently. Do not put on the face, underarms, or the groin area unless told to do so by the doctor.
Betamethasone Ointment Augmented Description
Betamethasone dipropionate ointment USP , 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone.
Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6 and the following structural formula:
It is a white to cream-white, odorless powder practically insoluble in water, freely soluble in acetone, in methylene chloride and in chloroform, sparingly soluble in ethanol .
Each gram of betamethasone dipropionate ointment USP , 0.05% contains 0.643 mg betamethasone dipropionate USP , in a white to off-white opaque ointment base of propylene glycol, propylene glycol monopalmitostearate, white petrolatum and white wax.
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Intermittent Corticosteroid Maintenance Treatment Of Psoriasis: A Double
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How Do I Store And/or Throw Out This Drug
Store at room temperature. Do not freeze. Protect from light. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
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What Do I Need To Tell My Doctor Before I Take This Drug
If you are allergic to this drug any part of this drug or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have thinning of the skin where you are putting this drug. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Combining Calcipotriol And Corticosteroids
Using a combination of calcipotriol and a corticosteroid has been reported previously.9-14 In these trials, calcipotriol and the steroid were applied at different times of the day, in alternate weeks or in alternate days. All these trials demonstrated a higher speed of psoriasis improvement with the dual regimen. Most of them also showed a higher success rate and a better side-effect profile for the combination regimens.
Extemporaneous compounding of calcipotriol with a corticosteroid is tempting. However this may rapidly lead to deleterious alterations of the active molecules.15 Calcipotriol needs a basic pH, whereas betamethasone dipropionate requires an acidic one. Satisfactory, stable mixing of these components that were previously considered unmixable was obtained by creating an entirely new vehicle. In this new vehicle, betamethasone dipropionate remains unchanged, as does the calcipotriol molecule,16 and demonstrates full antipsoriatic activity.17 At room temperature, the shelf life of this compound is 2 years.
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What Are Some Things I Need To Know Or Do While I Take This Drug
Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. Do not use longer than you have been told by the doctor. Use care when using on a large part of the skin. Talk with the doctor. Do not use to treat diaper rash or redness. Avoid putting this drug in the diaper area. This drug may raise the chance of cataracts or glaucoma. Talk with the doctor. This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor. Use with care in children. Talk with the doctor. Different brands of this drug may be for use in different ages of children. Talk with the doctor before giving this drug to a child. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby. If you are breast-feeding, do not put this drug right on the nipple or the area right around it.
Carcinogenesis Mutagenesis Impairment Of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.
Betamethasone was negative in the bacterial mutagenicity assay , and in the mammalian cell mutagenicity assay . It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.
Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.
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What Are Some Side Effects That I Need To Call My Doctor About Right Away
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, swallowing, or talking unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat. Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss. Signs of Cushing’s disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing. 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 . Skin irritation. Thinning of the skin. Change in eyesight.
What Other Information Should I Know
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body’s response to betamethasone.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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Psoriasis Topicals Continue To Fill Pipeline
Options for topical treatment of psoriasis continue to expand with the development of products featuring novel vehicles or new molecules. Active research addresses this need.
Development of new topical therapies for psoriasis remains an area of active research that addresses an ongoing need considering that topical treatment continues to be a cornerstone of patient care, says Linda Stein Gold, M.D.
With all of the excitement surrounding new biologics, it is sometimes overlooked that about 80% of patients with psoriasis are being managed with a topical agent, and even patients with more extensive disease use topicals to treat lesions that are resistant lesions, says Dr. Gold, head, division of dermatology, Henry Ford Hospital, Detroit, Mich.
Having new treatment options is important and always welcome for enabling better patient care, he notes.
The two most recent topical product introductions are aerosol foam formulations of older drugs in novel vehicles that are cosmetically elegant and designed to enhance drug delivery.
Traditional thinking was that drugs had to be occlusive in order to get the best penetration and efficacy. Newer vehicles demonstrate benefits that have changed our mindset, and so clinicians should not overlook the potential for changing vehicles rather than molecules to achieve better outcomes, Dr. Stein says.
To Start Withwhich Is Which
Generic betamethasone dipropionate 0.05% is currently available in cream, ointment, and lotion forms. The brand name, Diprosone, has been discontinued, but it was also available in the same forms.
Generic betamethasone dipropionate 0.05% is also available in cream, ointment, and lotion forms, along with a gel form. However, brand names Diprolene and Diprolene AF are still available.
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Effects On Endocrine System
Betamethasone dipropionate ointment can produce reversible hypothalamic-pituitary-adrenal axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone stimulation test.
In a trial evaluating the effects of betamethasone dipropionate ointment on the HPA axis, at 14 g per day, betamethasone dipropionate ointment was shown to suppress the plasma levels of adrenal cortical hormones following repeated application to diseased skin in subjects with psoriasis. These effects were reversible upon discontinuation of treatment. At 7 g per day, betamethasone dipropionate ointment was shown to cause minimal inhibition of the HPA axis when applied 2 times daily for 2 to 3 weeks in healthy subjects and in subjects with psoriasis and eczematous disorders.
With 6 g to 7 g of betamethasone dipropionate ointment applied once daily for 3 weeks, no significant inhibition of the HPA axis was observed in subjects with psoriasis and atopic dermatitis, as measured by plasma cortisol and 24-hour urinary 17-hydroxy-corticosteroid levels.
How Should This Medicine Be Used
Betamethasone comes in ointment, cream, lotion, gel, and aerosol in various strengths for use on the skin and as a foam to apply to the scalp. It is usually applied once or twice daily. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use betamethasone exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. Do not apply it to other areas of your body or use it to treat other skin conditions unless directed to do so by your doctor.
Your skin condition should improve during the first 2 weeks of your treatment. Call your doctor if your symptoms do not improve during this time.
To use betamethasone topical, apply a small amount of ointment, cream, solution, gel, or lotion to cover the affected area of skin with a thin even film and rub it in gently.
To use the foam on your scalp, part your hair, apply a small amount of the medicine on the affected area, and rub it in gently. You may wash your hair as usual but not right after applying the medicine.
Betamethasone foam may catch fire. Stay away from open fire, flames, and do not smoke while you are applying betamethasone foam, and for a short time afterward.
This medication is only for use on the skin. Do not let betamethasone topical get into your eyes or mouth and do not swallow it. Avoid use in the genital and rectal areas and in skin creases and armpits unless directed by your doctor.
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A New Calcipotriol/betamethasone Dipropionate Formulation Is An Effective Once
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If You Experience Any Of The Following Symptoms Call Your Doctor Immediately:
- severe rash
- redness, swelling, or other signs of skin infection in the place where you applied betamethasone
Children who use betamethasone topical may have an increased risk of side effects including slowed growth and delayed weight gain. Talk to your child’s doctor about the risks of applying this medication to your child’s skin.
Betamethasone topical may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s MedWatch Adverse Event Reporting program online or by phone .
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Frequency Of Administration And Duration Of Treatment
Once-or twice-daily application is recommended for most preparations.21 More frequent administration does not provide better results.27 The optimal dosing schedule can be determined by trial and error, titrating to the minimum frequency of application that still provides relief.
Chronic application of topical steroids can induce tolerance and tachyphylaxis. Ultra-high-potency steroids should not be used for more than three weeks continuously.21 If a longer duration is needed, the steroid should be gradually tapered to avoid rebound symptoms, and treatment should be resumed after a steroid-free period of at least one week. This intermittent schedule can be repeated chronically or until the condition resolves. Side effects are rare when low- to high-potency steroids are used for three months or less, except in intertriginous areas, on the face and neck, and under occlusion.21
The amount of steroid the patient should apply to a particular area can be determined by using the fingertip unit method.28 A fingertip unit is defined as the amount that can be squeezed from the fingertip to the first crease of the finger. Table 3 describes the number of fingertip units needed to cover specific areas of the body.28 One hand-size area of skin requires 0.5 fingertip units or 0.25 g of steroid. The amount dispensed and applied should be considered carefully because too little steroid can lead to a poor response, and too much can increase side effects.
| Area of the body |
|---|
| 14 |
Betamethasone Ointment Augmented Dosage And Administration
Apply a thin film of betamethasone dipropionate ointment USP to the affected skin areas once or twice daily.
Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Betamethasone dipropionate ointment USP is a super-high-potency topical corticosteroid. Treatment with betamethasone dipropionate ointment USP should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal axis .
Betamethasone dipropionate ointment USP should not be used with occlusive dressings unless directed by a physician.
Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
Avoid contact with eyes. Wash hands after each application.
Betamethasone dipropionate ointment USP is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
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Consumer Information Use And Disclaimer
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.