Minoxidil fort for treatment of alopecia androgenetica male pattern baldness

Minoxidil Forte 5 % Topical Gel

Composition :

Each 100 gm contain:
Active ingredients:
Minoxidil 5 gm
In-active ingredients :
Hydroxy ethyl cellulose, Ethanol 96%, Tween 80 , Crematest oil flavor ,FD&C yellow, Purified Water.

Pharmacological Action :

When applied topically, Minoxidil F ortetopical gel has been shown to stimulate hair growth in individuals with alopecia androgenetica (male pattern baldness). Although the exact mechanism of action of Minoxidil in the treatment of alopecia androgenetica is not known, there may be more than one mechanism by which Minoxidil stimulates hair growth; they include: vasodilation ofthe microcirculation around the hair follicles which may stirnulatehair growth; direct stimulation ofthe hair follicle cells to enterinto a proliferative phase: resting hase telogen follicles being-stimulated to pass into-1fCtiVepfia-se (anagen) follic es; a era IOn otthe effect ofimarogens 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.

Pharmacokinetics :

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.
Elemination :                                                                             Approximately 95% of the systemically absorbed Minoxidil from topical dosing is eliminated within 4 days.
Metabolism:                                                                                       The metabolic biotransformation ofMinoxidil 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 applications of Minoxidil Forte topical gel for 4 or more 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.

Indications And Clinical Uses :

The treatment of alopecia androgenetica (male pattern baldness).

Contra-Indications :

Hypersensitivity to minoxidil or any of the ingredients of the f0rmulation

Precautions :

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.

Geriatrics :

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.

Pregnancy and Lactation :

Minoxidil Forte topical gel should not be used by pregnant or nursing women.

Adverse Reactions :

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 disturbances have been reported. Rarely reported adverse reactions included alopecia, hair abnormalities, chest pain, blood pressure changes, pulse changes, hepatitis, and kidney stones.

Drug Interactions :

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.

Dosage And Administration :

For external use only. Use only as directed. A total dose of I ml Minoxidil Forte topical gel should be applied twice per day to the scalp, beginning at the centre 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 hairdryer 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.
Packaging: Plastic container of 60 gm in a carton box with insert leaflet.

Storage :

Keep away from light and heat.
Keep out of the reach of children.

Produced by :

Egyptian Group for Pharmaceutical Industries
For Pharmacare Egypt for Trading Agency