Valisone (Betamethasone Valerate)

VALISONE-G®

Schering

Betamethasone Valerate – Gentamicin

Sulfate

Topical Corticosteroid – Antibiotic

Action And Clinical Pharmacology: Valisone-G provides the combined anti-inflammatory, anti-allergic, and antipruritic actions of betamethasone valerate with the antibacterial topical effect of gentamicin.

Indications And Clinical Uses: The topical management of secondarily infected allergic or inflammatory dermatoses responsive to corticosteroid therapy, such as contact dermatitis, seborrheic dermatitis, neurodermatitis, intertrigo, exfoliative dermatitis, stasis dermatitis and psoriasis. Secondary infections caused by gram positive or gram negative bacteria including Streptococci, Staphylococci, and Pseudomonas, Aerobacter, Escherichia and Klebsiella, which are susceptible organisms to the topical action of gentamicin. The ointment may be preferred for the treatment of dry, scaling and fissured lesions.

Contra-Indications: Tuberculosis of the skin, chickenpox, herpes simplex, and vaccinia. Application in or near the eyes should be avoided.

Precautions: Gentamicin is not effective against fungi, yeasts or viruses. Patients with superficial fungus or yeast infections also must receive specific therapy and the use of the drug may have to be discontinued.

Corticosteroids and gentamicin are known to be absorbed percutaneously in patients under prolonged treatment, with extensive body surface treatment and particularly in those using the occlusive dressing technique on large areas of the body. In such cases, it is recommended that kidney function studies such as BUN be carried out prior to treatment and regularly throughout the course of the treatment.

Pregnancy and Lactation: The use of any drug during pregnancy and the lactation period or in women of childbearing age requires that the potential benefits of the drug be weighed against the possible hazards to the fetus or infant. Although topical steroids have not been reported to have had an adverse effect on the fetus, the safety of their use in pregnant patients has not been definitely established. Accordingly, they should not be used extensively or for prolonged periods of time in pregnant patients.

Children: Any of the side effects that have been reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.

Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. Use of topical corticosteroids in children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with growth and development of children.

Causal factors should be sought and eliminated whenever possible and the sensitivity of an infecting organism to gentamicin should be verified.

Percutaneous absorption of the corticosteroid can produce systemic effects such as adrenal suppression, moon facies, striae, suppression of growth in children. When longterm topical treatment under occlusive dressings is necessary, small dosages, rotation of sites and intermittent therapy should be considered.

Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.

While no systemic effects have been observed following the topical application of gentamicin, toxic systemic concentrations can cause permanent impairment of vestibular function in the presence of renal insufficiency or existing 8th cranial nerve damage.

Caution should be exercised if gentamicin is used in individuals who are known to be sensitive to topically applied antibacterials.

The possibility of sensitivity reactions to any of the product’s components should be kept in mind.

Adverse Reactions: The following local adverse reactions have been reported rarely with the use of topical corticosteroids: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation.

The following may occur more frequently with occlusive dressings: maceration of the skin, secondary infection, skin atrophy, striae, miliaria.

In patients with dermatoses treated with gentamicin, mild irritation (erythema and pruritus) that did not usually require discontinuance of treatment, has been reported in a small percentage of cases. There was no evidence of irritation or sensitization, however, in any of these patients patch tested subsequently with gentamicin on normal skin. Possible photosensitization has been reported in several patients but could not be elicited in these patients by reapplication of gentamicin followed by exposure to u.v. radiation.

Symptoms And Treatment Of Overdose: Symptoms and Treatment (accidental ingestion): No known antidote. Gastric lavage should be performed. tag_DosageDosage

Dosage: Apply a small amount on the affected area 2 or 3 times daily. Refractory lesions of psoriasis and deep-seated dermatoses which have been secondarily infected may respond better to topical corticosteroids and antibiotics when used with the hydration technique or occlusive dressing method described as follows: Apply a thick layer of medication over the entire surface of the lesion under a light gauze dressing and cover it with a pliable, transparent, impermeable, plastic material well beyond the edges of the treated area. Seal the edges to the normal skin by adhesive tape or other means. Leave the dressing in place 1 to 3 days and repeat the procedure 3 or 4 times as needed. With this method of treatment, marked improvement often is seen in a few days. However, this technique requires closer supervision of the patient since occasionally miliary eruptions or folliculitis develop in the skin under an occlusive dressing, requiring removal of the plastic cover and/or discontinuance of this method of treatment.

Availability And Storage: Cream: Each g of cream contains: betamethasone 1 mg (as valerate USP) and gentamicin 1 mg (as sulfate USP) in a water miscible base. Nonmedicinal ingredients: cetostearyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, phosphoric acid, polyethylene glycol 1000 monocetyl ether, sodium hydroxide, water and white petrolatum. Tubes of 15 and 30 g.

Ointment: Each g of ointment contains: betamethasone 1 mg (as valerate USP) and gentamicin 1 mg (as sulfate USP) in a lanolin-free base. Nonmedicinal ingredients: petrolatum USP. Tubes of 15 and 30 g.

Store at 2 to 30°C.

VALISONE-G® Schering Betamethasone Valerate – Gentamicin Sulfate Topical Corticosteroid – Antibiotic

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