Betamysan

Betamysan

betamethasone + neomycin

Manufacturer:

Sanbe
Full Prescribing Info
Contents
Betamethasone valerate, neomycin sulfate.
Description
Each gram of cream contains Betamethasone Valerate equivalent to Betamethasone 1 mg and Neomycin Sulfate 5 mg.
Action
Pharmacology: Pharmacodynamics: Betamethasone Valerate is an active topical corticosteroid that has a rapid response to inflammatory dermatitis that is responsive to topical corticosteroid therapy and is often effective in less responsive conditions such as psoriasis.
Neomycin Sulfate is a broad spectrum bactericidal antibiotic that is effective against most bacteria associated with skin infections.
Indications/Uses
BETAMYSAN cream is indicated for the treatment where there is a secondary bacterial infection, presumably present or resembling, among others: eczema in adults and children, including atopic and discoid eczema; prurigo nodularis; psoriasis (except widespread plaque psoriasis); neurodermatoses, seborrhoeic dermatitis; contact sensitivity reaction.
Preparations BETAMYSAN cream can also be used to treat secondary infections due to insect bites, anal and genital intertrigo.
Overdosage
Acute overdose is very rare. However, in cases of chronic overdose or incorrect use, Cushing's syndrome may occur. In such circumstances, the topical steroid should be discontinued gradually under medical supervision.
Contraindications
Rosacea, acne, and perioral dermatitis.
Perianal and genital pruritus.
Primary viral infections of the skin (herpes simplex, chickenpox).
Hypersensitivity to the components of the preparation.
Treatment of primary skin infection lesions caused by fungi or bacteria, primary or secondary infections due to fungi, or secondary infections due to Pseudomonas or Proteus species.
Dermatosis in children under 2 years, including dermatitis and napkin eruptions.
Not used for the treatment of external otitis when there is perforation of the eardrum, because of the risk of ototoxicity.
It is not recommended to use BETAMYSAN cream in large quantities or on large areas for a long time due to the ototoxic and nephrotoxic potential of Neomycin Sulfate.
Not recommended in pregnancy or lactation.
Special Precautions
Long-term continuous topical therapy should be avoided as much as possible, especially in infants and children, due to adrenal suppression, with or without clinical signs of Cushing's symptoms.
In case of persistent infection, systemic treatment is required.
Avoid long-term use on the face. If used on the eyelids, ensure that no preparation enters the eye.
If used for psoriasis therapy, patient monitoring is required.
Prolonged use may increase the risk of contact sensitization.
Persistent infection may occur due to the masking effect of steroids.
After significant systemic absorption, aminoglycosides such as Neomycin Sulfate have nephrotoxic potential.
Plasma clearance of Neomycin Sulfate is reduced in renal failure.
Adverse Reactions
Prolonged use of large amounts or therapy over large areas may result in sufficient systemic absorption to produce suppression of the HPA axis and clinical signs of Cushing's symptoms.
Burning of the skin, pruritus, pigmentation changes, allergic contact dermatitis, and hypertrichosis.
If signs of hypersensitivity appear, administration should be discontinued immediately.
There may be severity of symptoms.
Drug Interactions
After significant systemic absorption, Neomycin Sulfate may enhance and prolong the respiratory depressant effect of neuromuscular blocking agents.
Storage
Store at temperature below 30°C, protected from light.
Use within 3 months after opening.
Patient Counseling Information
Direction for Use: As directed by the physician, usually: 2-3 times a day is applied to the affected skin.
MIMS Class
Topical Anti-Infectives with Corticosteroids
ATC Classification
D07CC01 - betamethasone and antibiotics ; Belongs to the class of potent (group III) corticosteroids, in combination with antibiotics. Used in the treatment of dermatological diseases.
Presentation/Packing
Form
Betamysan cream
Packing/Price
5 g x 1's (Rp17,000/boks)
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