HAIRMAX SPRAY 2% Topical Solution

DESCRIPTION:

Hair Max helps to stimulate hair growth in individuals with androgenetic alopecia, expressed as baldness of the vertex of the scalp, in males and in females, as diffuse hair loss or thinning of frontoparietal areas. Hair Max (Minoxidil 2 %) has shown to be effective in clinical studies conducted by physicians in 27 U.S. Medical centers involving 2300 patients with male pattern baldness (top of the head). Clinical results suggest hair growth may not be expected before a minimum use of four months. After four months, hair count showed that on an average, the patients using Minoxidil 2% topical solution had significantly more hair growth as compared to those who used placebo.

COMPOSITION:

Each ml. contains Minoxidil USP 20.0 mg, Denatured spirit 0.6ml, Propylene glycol USP 0.1 ml, Purified Water q.s to 1.0 ml.

CLINICAL PHARMACOLOGY:

Minoxidil 2% when topically applied is poorly absorbed from normal intact scalp with an average of 1.4 % of the total applied dose reaching systemic circulation Local abrasion or dermatitis may enhance absorption. Serum Minoxidil levels resulting from topical application are governed by the drug’s percutaneous absorption rate. Following cessation of topical administration, approximately 95% of systemically absorbed Minoxidil is eliminated within 4 days.

INDICATIONS:

Hair Max Topical Solution is indicated for the treatment of androgenetic alopecia, expressed in males as baldness of the vertex of scalp and in females as diffuse hair loss or thinning of frontoparietal area. At least four months of twice daily applications of Hair Max are generally required before evidence of hair growth can be expected.

PRECAUTIONS & WARNINGS:

Although the following effects have not been associated with the topical use of Minoxidil 2% solution, however, due to some absorption (average 1.4 %) from the scalp, may cause mild systemic effects such as tachycardia, angina and oedema. In the event of the systemic side effects or dermatological reaction, the administration of drugs should be discontinued.

In the event of accidental contact with sensitive surfaces such as eyes, abraded skin, mucous membrane, the area should be bathed with large amounts of cool tap water to avoid burning and irritation. Hair Max (Minoxidil 2%) should not be used in conjunction with other topical agents including corticosteroids, retinoids and petrolatum or agents that are known to enhance cutaneous drug absorption.

USE DURING PREGNANCY & LACTATION:

Hair Max (Minoxidil 2 %) like other drugs should not be used by pregnant and nursing women.

PEDIATRIC USE:

Safety and effectiveness of Minoxidil 2% solution in patients under 18 years of age have not been established.

INTERACTION:

There are currently no known interactions associated with the use of Minoxidil 2% topical solution.

OVERDOSAGE AND ACCIDENTAL INGESTION:

Accidental ingestion may produce systemic effects related to the vasodilatory action of Minoxidil. Signs and symptoms of drug overdose would most likely be cardiovascular effects associated with fluid retention, lowered blood pressure and tachycardia. Sympathomimetic drugs such as norepinephrine and epinephrine should be avoided because of their excessive cardiac stimulating activity.