API

Minoxidil (5% w/v)

Drug classification

Kera XL M Solution is a vasodilator; specifically, a topical antihypertensive used for hair growth.

Dosage form

Topical solution containing 5% w/v minoxidil for scalp application.

API strength per dosage

Dose

For adults, apply 1 mL of 5% minoxidil solution to the affected scalp area twice daily. Not recommended for use in children. Safety and dosing adjustments for renal or hepatic impairment have not been established. Avoid exceeding 2 mL per day. Use only as directed on intact scalp; discontinue if irritation or adverse effects occur.

Mechanism of action

Minoxidil acts as a potassium channel opener, specifically activating ATP-sensitive K+ channels in vascular smooth muscle. This causes hyperpolarization, leading to vasodilation and increased blood flow to hair follicles, prolonging the anagen (growth) phase of the hair cycle and stimulating hair regrowth in androgenetic alopecia.

Indications

Treatment of Hair loss

Side effects

Itching Chest pain Headache Hypertrichosis excessive hair growth Rash Dermatitis Hypersensitivity Weight gain Fluid retention Tachycardia

Pregnancy category

Minoxidil topical use in pregnancy is not recommended due to limited human data and potential fetal risk; use only if clearly needed and prescribed.

Precautions

Avoid contact with eyes and mucous membranes, apply only to dry scalp, discontinue if scalp irritation or hypersensitivity occurs, monitor for unwanted facial/body hair growth, avoid use in pregnancy and breastfeeding, do not use on broken or inflamed skin, monitor for systemic effects in case of excessive absorption.

Contraindications

Hypersensitivity to minoxidil or any component, scalp dermatoses, broken or inflamed scalp skin, concomitant use with other topical agents on the scalp, pregnancy, lactation, pediatric patients, known cardiovascular disease.