Hydroxy ethyl cellulose, Ethanol 96%, Tween 80, Crematest oil flavor, FD&C yellow, Water purified.

When applied topically, Minoxidil Forte topical gel has been shown to stimulate hair growth in individuals with alopecia androgenetica (male pattern baldness). Although the exact mechanism of action of Minoxidil is not known, there may be more than one mechanism by which Minoxidil stimulates hair growth; they include vasodilation of microcirculation around the hair follicles which may stimulate hair growth; direct stimulation of the hair follicle cells to enter into a proliferative phase; resting phase (telogen) follicles being stimulated to pass into active (anagen) follicles; alteration of the effect of androgens on genetically predetermined hair follicles; Minoxidil may affect the androgen metabolism in the scalp by inhibiting the capacity of androgens to affect the hair follicles.

Absorption:

Following topical application of Minoxidil Forte topical gel, Minoxidil is poorly absorbed from normal intact skin, with an average of 1.4% (range 0.3 to 4.5%) of the total applied dose reaching the systemic circulation. The effects of concomitant dermal diseases or occlusion on absorption are unknown. Serum Minoxidil levels resulting from topical administration are governed by the drug`s percutaneous absorption rate; increases in surface area of application do not result in proportionate increases in the serum Minoxidil level. Steady state is achieved by the end of the third dosing interval (36 hours) when the drug is administered twice daily.

Elimination: Approximately 95% of the systemically absorbed Minoxidil from topical dosing is eliminated within 4 days.

Metabolism: The metabolic biotransformation of Minoxidil absorbed following topical application has not been fully determined. Increased hair growth has not been associated with increased systemic absorption of topical Minoxidil. The onset of hair growth stimulation requires twice daily applicators of Minoxidil Forte topical gel for 4 or 5 months, and is variable among patients. Upon discontinuation of topically applied Minoxidil, new hair growth has been anecdotally reported to stop and restoration of pretreatment appearance to occur within 3 to 4 months.

The treatment of alopecia androgenetica (male pattern baldness).

Hypersensitivity to Minoxidil, or any of the ingredients of formulation.

Minoxidil Forte topical gel will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), the area should be bathed with copious amounts of cool tap water.

Studies involving subjects over the age of 65 years have not been performed hence the safety and effectiveness of Minoxidil Forte topical gel in these patients has not been established.

The most frequently encountered adverse effects in clinical trials with Minoxidil Forte topical gel were minor dermatologic reactions. In light of the findings that systemic levels of Minoxidil from topical application are low in relation to systemic levels from oral dosing. Local irritation was the most common adverse reaction reported, including scaling, erythema/flushing, dermatitis, dry skin, hypertrichosis (in areas other than where Minoxidil Forte topical gel was applied), burning sensation and rash.

Infrequent adverse reactions including allergic reactions (sensitivity, hives, generalized erythema and facial swelling); dizziness; tingling sensation; headache; weakness; neuritis; edema; eye irritation; altered taste; ear infection (otitis externa); and visual disturbance have been reported. Rarely reported adverse reactions including alopecia, hair abnormalities, chest pain, blood pressure changes, pulse changes, hepatitis, and kidney stones.

There are currently no known drug interactions associated with the use of Minoxidil Forte topical gel. Although it has not been clinically demonstrated, there exists the possibility of potentiating orthostatic hypotension in patients concurrently taking guanethidine.   

For external use only. Use only as directed.

A total dose of 1 mL Minoxidil Forte topical gel should be applied twice per day to the scalp, beginning at the center of the affected area. The total daily dose should not exceed 2 mL. The method of application varies according to the disposable applicator used, as indicated below. After applying Minoxidil Forte topical gel, wash hands thoroughly. Do not apply the topical gel to any other area of the body.

Apply Minoxidil Forte topical gel when the hair and scalp are thoroughly dry. Do not use a hair dryer to speed the drying of the topical gel, because blowing air on the scalp may decrease the effectiveness of the drug.

Clinical experience with Minoxidil Forte topical gel indicates that twice daily application for 4 or more months may be required before evidence of hair growth stimulation can be expected. Onset and degree may be variable among patients. Relapse to pretreatment appearance following discontinuation of medication has been reported to occur within 3 to 4 months.

Plastic container of 60 gm in a carton box with insert leaflet.

Keep away from light and heat.

Keep out of reach of children.