Novartis Consumer Health
Heparin Sodium – Zinc Sulfate
Symptomatic Treatment of Herpes Simplex I
Action And Clinical Pharmacology: Lipactin is composed of heparin and zinc for topical application. Topical application of heparin produces accumulation of the heparin molecules in the corium of the skin while insignificant amounts are absorbed through the skin. Oral administration of heparin is associated with negligible anticoagulant effect as heparin is immediately metabolized in the gastrointestinal tract and not absorbed from aqueous solution.
Absorption of zinc through broken skin when applied in the concentrations used in Lipactin does not produce significant increases in serum and tissue concentrations of zinc.
Clinical studies have indicated Lipactin significantly reduces the duration of pain associated with HSV I infections when compared with placebo. There is also a statistically significant increase in the rate of healing of perioral and lip lesions when compared to placebo preparations.
One study compared Lipactin to placebo in 54 patients with Herpes labialis. In the Lipactin treated group (n=23), 96% had resolution of at least 2 of their initial symptoms within 3 days. This compared to the placebo group (n=31) in which only 45% of patients had resolution of 2 or more symptoms within the first 3 days. The same study demonstrated that 83% of the patients in the Lipactin group were completely healed within 7 days, compared to 26% in the placebo group.
Indications And Clinical Uses: For the relief and management of symptoms due to lip and perioral infections of Herpes Simplex Virus type I. This includes Herpes labialis, Herpes febrilis, fever blisters and cold sores.
Early initiation of therapy, within 3 days of the onset of signs and symptoms of infection or re-infection, has been found to produce faster healing than treatment commenced after 3 days of symptoms.
Treatment should be continued until healing is complete or to a maximum of 14 days, whichever comes first.
Contra-Indications: In individuals who are hypersensitive to heparin sodium, zinc sulfate or parabens.
Manufacturers’ Warnings In Clinical States: For external use only. The gel is not for ophthalmic use.
Children and Pregnancy: Safe use of the gel in children or in pregnant women has not been established. Use only as directed by a physician in children and pregnant women.
Precautions: If the symptoms of the infection persist or become more severe or wide-spread with treatment, use of the medication should be discontinued and a physician consulted.
Adverse Reactions: In a few cases, a mild transient burning sensation has been experienced at the site of application.
Isolated cases of local hypersensitivity reactions have been reported; in such cases, use of the product should be discontinued.
Dosage And Administration: Apply Lipactin to the affected area(s) 3 to 6 times a day. A sufficient quantity of the gel should be applied to adequately cover all lesions and a margin of healthy skin surrounding them.
Therapy should be initiated as early as possible following the onset of signs and/or symptoms, i.e. tingling, burning, vesiculation etc. Treatment should be continued until healing is complete or to a maximum of 14 days, whichever comes first.
Availability And Storage: Each g of clear, colorless, odorless gel contains: heparin sodium 160 USP units and zinc sulfate 5 mg. Nonmedicinal ingredients: glycerin, methyl parahydroxybenzoate, polysorbate, propyl parahydroxybenzoate, sodium carboxymethylcellulose and water. Alcohol- and bisulfite-free. Tubes of 3 g.
LIPACTIN® Novartis Consumer Health Heparin Sodium – Zinc Sulfate Symptomatic Treatment of Herpes Simplex I
Posted by RxMed