INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PERSIVATE® OINTMENT
PERSIVATE® CREAM

SCHEDULING STATUS:
S4

PROPRIETARY NAME:
(and dosage form)

PERSIVATE® OINTMENT
PERSIVATE® CREAM

COMPOSITION:
Each 5 g ointment contains
betamethasone valerate equivalent to 5 mg betamethasone.
Each 5 g cream contains betamethasone valerate equivalent of 5 mg betamethasone.
Persivate cream is preserved with 0,1% m/m chlorocresol.

PHARMACOLOGICAL CLASSIFICATION:
A 13.4.1 Corticosteroids with or without anti-infective agents.

PHARMACOLOGICAL ACTION:
Betamethasone valerate is a potent topical corticosteroid which exhibits anti-inflammatory and anti-allergic properties when applied to the skin and mucosa. The mechanism of action is related to causing vasoconstriction, stabilizing lysosomal membranes, suppressing cell division and suppressing the immune response.

INDICATIONS:
Non-infected steroid responsive dermatoses.

CONTRA-INDICATIONS:
Betamethasone valerate is contra-indicated in the treatment of herpes simplex, vaccinia or varicella.
Long, term use is contra-indicated in patients with diabetes mellitus or tuberculosis.

WARNING:
FOR EXTERNAL USE ONLY.
KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE.
Persivate®Ointment: Apply to the affected areas 2 or 3 times daily by gentle inunction or use with occlusive dressings.
Persivate®Cream: Apply to the affected areas 2 or 3 times daily by gently inunction.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local effects include atrophy of the epidermis and dermal collagen (causing atrophic striae), drying and thinning of the skin, loss of elasticity, dilatation of superficial blood vessels, telangiectasiae and ecchymoses. Increased fragility of cutaneous vessels may result in bruising and purpura. Rosacea-like dermatitis, perioral dermatitis, hypopigmentation and acneiform eruptions occur. These changes are particularly likely to occur on the face and when occlusive dressings are used. Occlusive dressings are associated with maceration of the skin and miliaria. Local infection may be worsened and spread enhanced.
Systemic absorption of topically applied Persivate
® may occur, particularly under the following conditions; when large quantities are used, or when application is made to wide areas of the body or to damaged skin, and when the occlusive dressing technique is applied. Depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland may occur and may be precipitated by an infection or trauma. These effects are most likely to be severe in children. Growth retardation in children has been reported and a Cushingoid state may be produced. Benign intracranial hypertension has been reported.

SPECIAL PRECAUTIONS:
The use of steroids during pregnancy is not recommended.
The treatment should be discontinued if unfavourable reactions are seen. Regular review should be made of the necessity for continuing therapy.
If a secondary microbial skin infection is present suitable concomitant antimicrobial therapy should be instituted.
Persivate
® should not be used to treat infections and ulcers of the leg. It causes delayed wound healing and increased liability to infections.
Persivate
® should not be applied to any skin crease areas.
Persivate
® should be used with caution near the eyes and should be used for short courses only. Application to the eyes has produced corneal ulcers, raised intraocular pressure, and reduced visual function.
The treatment of psoriasis with Persivate
® may provoke the pustular form of the disease. Persivate® should not be used on infants and young children.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions". Treatment is supportive and symptomatic.

IDENTIFICATION:
Persivate®Ointment:         A soft, smooth, translucent ointment (whitish).
Persivate®Cream:         A soft, smooth, white cream.

PRESENTATION:
Persivate
®Ointment and Persivate®Cream: 15 g Tube and 500 g Jar.

STORAGE INSTRUCTIONS:
Store below 25°C. Store in well closed containers. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Persivate®Ointment:         L/13.4.1/395
Persivate®Cream:         L/13.4.1/382

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
28/11/1978

        D274
                        A & S PRINTERS

Updated on this site: May 2000
Current: September 2004
Source: Community Pharmacy

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