PILOMIN-5
Composition :
| Each ml contains : |
| Minoxidil USP | | 50mg |
| Alcohol (95%) | | IP |
| Equivalent to Absolute Alcohol | | 63% v/v |
Category : Hair growth stimulant,androgenetic alopecia, topical.
Description : PILOMIN-5 contains Minoxidil 5%, which on topical application shows significant improvement in hair growth in individual (male and female) with Androgenetic Alopecia.
The chemical name for Minoxidil is 2,4-Diamino-6 piperidinopyrimidine 3-oxide.Empirical formula is C9H15N5O. Molecular Weight is 209.25
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 the 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 stage (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.
Pharmacokinetics : Minoxidil is poorly absorbed from normal intact skin with only 0.2%-4.5% of the total applied dose being detacted in plasma.Steady state is achieved by the end of the third dosing interval (36 hours) when the drug is applied twice daily.Approximately 95% of the systemically absorbed Minoxidil from topical dosing is eliminated within 4 days.
Indication : PILOMIN-5 has been indicated for the treatment of Androgenetic Alopecia
(male pattern baldness) expressed in males as baldness of the vertex of the scalp.
Contraindications : Hypersensitivity to Minoxidil or any other component of this preparation.
Use in Elderly : Safety and efficacy of topically administrated PILOMIN-5 in patients over 65 years of age has not been established.
Pregnancy and Lactation : PILOMIN-5 is contraindicated in pregnancy and lactation.
Children : Safety & efficacy of topically administered PILOMIN-5 is patients under 18 years of age has not yet been established.
Adverse effects : Adverse effect associated with Minoxidil topical solution are local skin manifestations e.g.Dermatitis,Skin rash,pruritus and erythema.Infrequent reported adverse reaction include irritant dermatitis,allergic reaction,urticaria,allergic rhinitis,facial swelling, sensitivity , shortness of breath, headache, dizziness etc.
Drug interaction : There are currently no known drug interaction associated with the use of
PILOMIN-5.However there exists the possibility of potentiating orthostatic hypotension in patients concurrently taking guanethidine.
Dosage & Administration : PILOMIN-5 is for external use only.It should be used only as directed. PILOMIN-5 is intented for external application to the scalp only.
A total dose of 1 ml minoxidil topical solution should be applied twice daily ( at 12 hour interval) to the hair loss area starting at the centre of the affected area,and spreading to cover the entire affected area.This dose should be used regardless of the size of the affected area.The total daily dose should not exceed 2 ml.
PILOMIN-5 should be applied when the hair and scalp are thoroughly dry.
A hair dryer should not be used to speed the drying of PILOMIN-5,because blowing air on the scalp may decrease the effectiveness of PILOMIN-5.
PILOMIN-5 topical solution should not be used to any other area of the body.
PILOMIN-5 must remain in contact with scalp for several hours ( 4 hours) at a time.The scalp should not be washed or wet for atleast 4 hours after use.The night time application should occur 2 to 4 hours before going to bed to allow drying.
PILOMIN-5 should not be used more frequently than 2 times a day or should not be taken by mouth or applied to any other part of the body to avoid risk of adverse effect,and unwanted hair growth.
Hands should be washed immediately if PILOMIN-5 is applied with finger tips.
In case,the patient forgets to use PILOMIN-5 once or twice,he/she has to start twice daily application again and return to usual schedule.The patient in such a circumstance should not apply more than 1ml of PILOMIN-5 and should not use more than twice daily to make up for the dose missed.
Twice daily dosing schedule with PILOMIN-5 may be required for 4 months or longer before evidence of hair growth is apparent.Onset and degree may vary among patients.
New hairs grown during therapy may be expected to be lost 3-4 months after withdrawal of PILOMIN-5,and progressive hair loss will resume.
Storage :
- The solution should be kept in a cool place where the temperature stays below 25 degree C.
- PILOMIN-5 is very inflammable, and must be kept away from heat,sparks,and naked flames. PILOMIN-5 should never be used while smoking.
- PILOMIN-5 should be kept in a place where children can not reach,such as in a cupboard.
- The expiry date is printed on the bottles and carton. PILOMIN-5 should not be used after this date.
Presentation : 60 ml bottle with a 1 ml graduated filler.
