Silvamax Cream

Composition
Contains Silver Sulfadiazine U.S.P 1% w/w and Chlorhexidine Gluconate solution B.P. equivalent to Chlorhexidine Gluconate 0.2%w/w.

Pharmaceutical Form
Cream for topical application on human beings.

Therapeutic Indications
For the treatment of minor burns and scalds, scratches, cuts, and abrasions, sunburns blisters and infected cracked skin. It may also be used as an aid to short term treatment of infection in leg ulcers and pressure sores, and for the prophylaxis of infection in skin graft donor sites and extensive abrasions.

Posology and Method of Administration

• To be applied topically. Cleansing and debriding should be performed before application .Apply freely and smooth gently into the skin . For cuts abrasions, burns etc. Spread freely and, if necessary, cover with dressing. There are no recommended dosage schedules as the product is for use as needed.
• Silvamax cream is recommended for use in leg or pressure ulcers that are very exudative.

Contra – Indications
As sulphonamides are known to cause kernicterus, Silvamax cream should not be used during pregnancy, on premature infants or on newborn infants during the first months of life. It is also contra indicated in patients known to be hypersensitive to silver sulfadiazine or to other components of the preparation such as cetyl alcohol or propylene glycol.

Special Warnings and Precautions For Use

• Keep away from the eyes .Avoid contact with the brain, meninges and the middle ear. Not for use in body cavities.
• Interaction with other Medicaments and other Forms of Interaction
• As silver may inactivate enzymatic debriding agents, their concomitant use maybe  inappropriate

Pregnancy and Lactation
Should not be used during pregnancy , or premature infants or new born infants during the first months of life.

Undesirable Effects
Application site burning and site rash(including eczema and contact dermatitis ), pruritis . And rarely Argyria.

Overdose
Not likely to occur with normal usage.  However gastric lavage followed by supportive measures may be used as appropriate

Pharmacodynamic Properties
Silvamax has bacteriostatic and bactericidal properties .This combination provides a wide spectrum of antimicrobial activity.

Pharmacokinetic Properties

• There is evidence that in large area wounds and /or after prolonged application , systematic absorption of silver can occur causing clinical argyria .The sulfadiazine readily diffuses across wounds and enters the general circulation . The degree of uptake will significantly depend upon the nature of the wound and dosing regime. Sulfadiazine is excreted in the urine.
• Any chlorhexidine gluconate absorbed percutaneously following topical application to the skin appears to be mainly excreted unchanged in faeces.

Storage
Do not store above 30°C.Protect from direct sunlight. Keep away from the reach of children

Presentation

• Available in 25gm collapsible aluminium tubes  packed in unit boxes.
• Pack size of 250 gms  black plastic jars in unit boxes.

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