MEDIVEN CREAM – Is it Safe? Uses, Side-Effects, Dosage
What is Mediven Cream?
Mediven Cream is a topical corticosteroid available in the market as a 15 gm tube. It contains Betamethasone dipropionate BP 0.05% as the active ingredient and is mainly indicated for the treatment of skin conditions like eczema, seborrhea, psoriasis, allergic dermatoses, neurodermatitis. It is strictly advised for external use only and avoid contact with eyes.
Other brands widely available in Indian markets are Betasone cream, Betnovate cream, Ursone Cream, Betadip Cream etc. They are also available as combination products namely Luxiq, Lotrisone, Taclonex.
The topical steroids are classified into various categories based on potency as:
- Mild steroid – Alclometasone, Fluocinolone, Hydrocortisone base.
- Intermediate Potency steroid – Desonide, Fluticasone, Flurandrenolide.
- Potent steroid – Betamethasone valerate, Amcinonide, Triamcinolone.
- Super potent steroids – Betamethasone Dipropionate, Clobetasol Propionate, Diflorasone.
- Anti-itch – Doxepin.
- Immunomodulatory – Pimecrolimus.
MEDIVEN CREAM – Is it Safe? Uses, Side-Effects, Dosage
What is the generic name(s)?
How does it work?
What are its uses?
How effective is this medicine?
Is it addictive?
What is the dosage?
What if I miss a dose?
What to do in case of over-dosage?
What to do if there is an allergic reaction?
What are the side effects?
Does this medicine has any drug interactions?
Precautions
Is it safe to use if I’m pregnant?
Is it safe to use if I’m breastfeeding?
Can this medicine be given to Children and Infants?
Is this medicine available as over the counter (OTC) product?
Frequently Asked Questions
Reference
What is the generic name(s)?
The generic name of Mediven cream is Betamethasone dipropionate BP 0.05% which is a topical corticosteroid available as a 15 gm tube package.
Apart from this dosage form, betamethasone is also available in the market as an ointment, lotion and gel. Betamethasone dipropionate was patented by Merck in the year 1987.
How does it work?
Topical corticosteroids are found to exert anti-inflammatory, antipruritic and vasoconstrictive effects when applied locally by inhibiting the formation and release of pro-inflammatory mediators, depressing the activity of other endogenous chemical mediators of inflammation like kinins, histamine, liposomal enzymes and prostaglandins. The immunological response is exerted through interaction with the glucocorticoid receptor which leads to the down-regulation of expression of pro-inflammatory proteins and up-regulation of the expression of anti-inflammatory proteins. The following effects are exerted by the induction of lipocortins and sequential inhibition of the release of arachidonic acid. They are also found to block the production of prostaglandins which otherwise is responsible for itching and redness.
What are its uses?
Mediven cream has been indicated for the prevention, treatment, mitigation and improvement of the following conditions:
- Dermatitis
- Inflammation in nose
- Psoriasis
- Eczema
- Scalp irritation
- Anogenital pruritus
- Allergic dermatoses
How effective is this medicine?
Variable degree of effectiveness is observed in each patient with mediven cream. Maximum effect is produced when applied topically as a thin film layer to the affected area twice or thrice. It requires no dosage adjustments in renally and hepatically compromised individuals. A systemic review conducted by the Department of Medicine, Washington concluded that betamethasone is beneficial and safe for a wide variety of infections. But, courses longer than 3 weeks should be withheld from patients with low CD4 counts and concomitant human immunodeficiency virus infection.
The product is currently unavailable in the U.S.
Is it addictive?
The medicines don’t come with a potential for addiction or abuse. The medication doesn’t fall under Schedule H or X and thus is not listed as a controlled substance.
Even then regular steroid users are reported with the complaints of Steroid dependence. This situation can be ruled out by gradually and slowly decreasing the exposure of the skin to the medication. A patient applying medication once or twice a day can switch the frequency to once every alternative day followed by twice weekly and stop completely on the further go.
Apart from this, there is another alternative way by switching to a different mild dose of same medication which has an additional benefit of much easily manageable side effects and needless to taper the dose as in the previous case.
What is the dosage?
The dosage will always depend upon the severity of the condition and response of the patient. It is always advised to use the lowest available dose for the shortest period of time.
ADULT DOSE
For Dermatoses: Augmented formulation – Apply once or twice daily (maximum: 50 g weekly)
Unaugmented formulation – Apply once daily; may increase to twice daily if needed
For Psoriasis: Apply 2.25 mg to each affected area once daily (maximum: 11.25mg/day); maximum duration of therapy: 30 days.
PEDIATRIC DOSING
The dosing remains the same as that in the adult but the course of the treatment should not exceed 5 days.
Use of augmented formulations in patients <13 years of age is not recommended.
GERIATRIC DOSE
Systemic corticosteroids should be used cautiously used in the elderly, due to the risk of adverse effects. It is always advised to use them in the smallest possible dose, and for the shortest possible time.
DOSE IN RENAL AND HEPATIC IMPAIRMENT
There are no dosage adjustment recommendations in renal and hepatic impairment.
FINGER TIP UNIT DOSE
Physicians recommend Finger Tip Unit (FTU) for topical medication administration.
One FTU (finger tip unit) is that amount of cream which fits from the edge of an adult index finger till the first crease.
For adults, the generally recommended FTUs to be applied in one single dose is:
- Hands and knees – 1 FTU
- Feet, including the soles – 1.5 FTU
- Face and neck – 2.5 FTU
- Scalp – 3 FTU
- Hand and arm together, or the buttocks – 4 FTU
- Legs and chest, or legs and back – 8 FTU
For children, the recommended FTUs will depend on their age.
What if I miss a dose?
If you have missed taking a dose, put on the missed dose as soon as you remember it; but if you are close to the next dosing time you are advised to skip the missed dose and then you may continue with your normal course.
DO NOT PUT ON TWO DOSES AT THE SAME TIME OR DOUBLE THE DOSE.
What to do in case of over-dosage?
It’s always judicious to keep in mind that taking more than the prescribed dose is not going to improve your symptoms fast but rather would lead you to more danger which can be life-threatening as well. In case of overdosage, don’t panic. Visit the emergency facility of the nearest hospital and if possible take the medicine or label with you to help doctors provide more reliable information for fast and better care. Be prepared to quickly and correctly tell or show the doctor what was taken, how much, and when it happened.
What to do if there is an allergic reaction?
Immediately discontinue the medication if you develop any kind of skin irritation or allergy.
It is not advised to use Mediven cream in people having decreased skin circulation.
Consult the doctor if skin irritation persists and if you need an alternative medicine for your condition.
In case of any ocular irritation, wash your eyes in running tap water.
It is always better to perform a special allergy test known as the patch test if you are advised to take steroids for long-term indication. A positive test reaction to budesonide and tixocortol-21-pivalate indicate corticosteroid allergy. These two steroids fall under the standard panel and hence chosen for a patch test.
A patch test can also be performed with corticosteroid series as well. The standard series include:
- Budesonide
- Betamethasone
- Triamcinolone acetonide
- Tixocortol-21-pivalate
- Alclomethasone-17, 21-dipropionate
- Clobetasol-17-propionate
- Dexamethasone-21-phosphate disodium salt
- Hydrocortisone-17-butyrate
A positive patch test for both the commercial product and active ingredient confirms the diagnosis.
What are the side effects?
Greater than 10% showed application site local reactions. They include:
- Burning
- Stinging
- Itching
A frequency of 1-10% showed these side effects:
- Central nervous system: Paresthesia (2%)
- Dermatologic: Acne vulgaris (2%), alopecia (2%), pruritus (≤2%)
- Ophthalmic: Conjunctivitis (2%)
Less than 1% showed
- Cataract
- Hyperglycemia
- Increased Intraocular Pressure
- Retinopathy
Does this medicine has any drug interactions?
Aldesleukin; One of the major drug interactions found and to be avoided is with Aldesleukin.
Corticosteroids will diminish the anti-neoplastic effect of Aldesleukin.
Ceritinib; Monitor the therapy while administering corticosteroids with ceritinib since it will cause hyperglycemia.
Precautions
- Priorly inform your physician if you had previously developed any kind of allergy with betamethasone.
- Inform the doctor or the pharmacist about all your medicines and health problems.
- If your symptoms don’t improve in 2-4 weeks, inform your doctor.
- Don’t bandage the treated skin areas.
- Don’t use the cream in huge amount. Follow the fingertip unit.
- Avoid contact with eyes. Not for oral, ophthalmic, or intravaginal use.
- Contact the doctor immediately if you experience blurred vision or any difficulty in reading or sight after taking the medication.
- Avoid fire, flame and smoking during and immediately following administration.
- Take care not to use any other cosmetic products on the affected area other than the medication.
- Do not put Mediven cream for long, without doctor’s supervision.
- Discontinuation of therapy: Withdraw therapy with gradual tapering of dose by reducing the frequency of application or substitution of a less potent steroid.
Is it safe to use if I’m pregnant?
The drug falls under Pregnancy Category C.
FDA defines category C as, “Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.”
FDA explains the clinical application of Category C drugs as, they have not been shown to be harmful to fetuses (as if they had been, they wouldn’t be Category C drugs). However, there are some reasons to be more concerned about these drugs than Category B drugs.
If the pregnant patient will benefit from a Category C drug, it is generally used, although most obstetricians are likely to prefer a Category B drug if it will give equivalently good results.
Is it safe to use if I’m breastfeeding?
The effect of betamethasone on breastfeeding after systemic and topical administration has not been studied and analyzed well till date. Very few studies carried out have reported that systemic maternal use of Corticosteroid has resulted in potential adverse events in nursing infants. Studies have also found that betamethasone administration 35 days prior to the pre-term infant delivery has resulted in reduced post-partum milk production.
Keeping these events in light, topical administration should be cautiously carried out in nursing women.
Can this medicine be given to Children and Infants?
Yes, the drug is safe for pediatric use. Use the medicine as directed by the physician.
In the year 2001, the patent pharmaceutical industry of Betamethasone Dipropionate carried out a clinical trial and also filed for Pediatric Exclusivity to prove the safety of the drug in the pediatric population.
But no appropriate studies have performed to date which has explained pediatric-specific problems related to the drug in children 13 years of age and older. Due to increased tissue sensitivity, children absorb more amount of the medication than an adult, which increases the risk of toxicity. Consult a physician before starting the medication and if your child is already under the medication follow the physician’s instruction as directed.
NOT INDICATED FOR CHILDREN LESS THAN 12 YEARS OF AGE
Is this medicine available as over the counter (OTC) product?
Mediven Cream is a very easily available over the counter cream. Pharmacists widely promote the sale without a prescription. The demand for steroids for skin conditions increases as it produces immediate relief. It is always instructed by the physicians and the manufacturers to avail the drug with prescription only.
Frequently asked questions (FAQs)
- Is mediven cream safe?
Mediven cream is safe when used for the prescribed indication in the prescribed dose. - Does Mediven cause weight gain?
For short-term use, they do not cause weight gain, but long-term usage has reported gradual weight gain. - It safe to drive or operate heavy machinery when using this product?
Usually, the medication doesn’t cause drowsiness or a headache, but If you experience any, don’t drive or operate heavy machinery. - Can I stop the medication immediately?
No, the dose needs to be tapered and stopped, otherwise will cause withdrawal symptoms. - Does Mediven cream lighten skin/ bleach skin?
It may cause skin pigmentation in a few patients. It would either lighten or darken the skin, so it is always advisable to use this medicine under doctor’s supervision only. - Will excess of cream cure the disease fast?
No, this remains as one of the biggest misconceptions that; higher the amount, faster is the cure. All topical administration standardly follows finger tip unit. A simple tip of cream in your index finger will suffice. - How long does it take Mediven cream to work?
Generally, it takes around 2-7 days to work. But the effect greatly depends on the severity and stage of the condition. - Is Bethamethasone an Antifungal?
Betamethasone is a topical steroid but the combination of betamethasone with clotrimazole is used to treat fungal infections like jock itch and ringworm.
Reference
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