MINOXIDIL 2%
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 centres involving 2300 patients with male pattern
baldness (top of the head). Clinical result suggests 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 drugs
per cutaneous 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 drug should be discontinued.
In
the event of accidental contact with sensitive surface such as eyes, abraded
skin, mucous membrane, the area should be bathed with large amount 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
overdosage 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 theirDOSAGE &
ADMINISTRATION: (For External Use only) Hair Max should be used only as
directed and should not be applied to other areas of the body. A total dose of
1 ml. (5 strokes will deliver approximately 1 ml) Hair Max should be applied
twice daily on the scalp, beginning at the center of the affected area. This
dose should be used regardless of the size of the affected area. The total
daily dose should not exceed 2 ml. To avoid any systemic absorption, wash hands
thoroughly after applying Hair Max Topical Solution. Apply Hair Max when hair
and scalp are thoroughly dried. Do not use hair dryer to speed up the drying of
Hair Max Solution, because blowing air on the scalp may decrease the
effectiveness of Hair Max.
DURATION
OF USAGE: Individuals who respond to treatment will need to continue using Hair
Max to maintain or increase hair growth. If there is no response to treatment
after four months, it is advisable to discontinue use of Hair Max. If response
of treatment with Hair Max is satisfactory, continue the usage, because in some
cases if the treatment is stopped, the new hair may probably shed.
INSTRUCTIONS
FOR USE: Hair Max 1 ml. (5 strokes will deliver approximately 1 ml which is one
dose) should be applied to the affected areas of the scalp twice daily. The
hair and scalp should be dry before each application of Hair Max.
Applicators
are enclosed in each pack of Hair Max.
HOW SUPPLIED: Available in bottle of 60 ml with 2 applicators
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