INDICATIONS AND USAGE:Minoxin (Minoxidil Topical Solution USP) is
indicated for treatment of androgenetic alopecia, expressed in males as
baldness of the vertex of the scalp and in females as diffuse hair loss
or thinning of frontoparietal area. At least, 4 (four) months of twice
daily application of Minoxin (Minoxidil Topical Solution USP) are
generally required before evidence of hair growth can be expected.CONTRA-INDICATION:Minoxin
(Minoxidil Topical Solution USP) is contra-indicated in those patients
with a history of hypersensitivity to any component of the preparation.PRECAUTIONS
AND WARNINGS:Although the following effects have not been associated
with the topical use of Minoxidil solution there is some absorption (on
average 1.4 %) from the scalp. The potential exists for systemic effects
such as tachycardia, angina, oedema and potentiation of orthostatic
hypotension produced by guanethidine. Patients should be observed
periodically for any such systemic effects. In the event of systemic
side-effect or severe dermatologic reaction discontinue administration
of the drug.Minoxin (Minoxidil Topical Solution USP) will cause burning
and irritation to the eye. In the event of accidental contact with
sensitive surface (eye, abraded skin, mucous membranes), the area should
be bathed with copious amounts of cool tap water. Minoxin (Minoxidil
Topical Solution USP) 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 AND LACTATION:Minoxin (Minoxidil Topical Solution USP)
like other drugs should not be used by pregnant and nursing women.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.
Fluid retention can be managed with appropriate diuretic therapy.
Tachycardia can be controlled by administration of a beta adrenergic
blocking agent.Hypotension should be treated by intravenous
administration of normal saline. Sympathomimetic drugs, such as
norepinephrine and epinephrine should be avoided because of their
excessive cardiac stimulating activity.DOSAGE AND ADMINISTRATION:For external use only. Use Minoxin only as
directed. Do not apply to any other area of the body. A total dose of 1
ml Minoxin 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. Six pumps of the applicator release approx. 1
ml of Minoxin. The total daily dose should not exceed 2 ml. To avoid
any systemic absorption, wash hands thoroughly after applying Minoxin.
Apply Minoxin when the hair and scalp are thoroughly dried. Don’t use a
hairdryer to speed the drying of Minoxin solution because blowing air on
the scalp may decrease the effectiveness of Minoxin.