Alerana^® (Spray) Instructions for Use

ATC Code

D11AX01 (Minoxidil)

Active Substance

Minoxidil (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug for the treatment of alopecia in men and women

Pharmacotherapeutic Group

Other drugs used in dermatology

Pharmacological Action

A treatment for baldness. It has a stimulating effect on hair growth in men and women with androgenic alopecia (male pattern baldness). Signs of hair growth are noted after 4 months or more of using the drug 2 times/day. The onset and degree of the effect may vary among different patients.

After discontinuation of minoxidil, the growth of new hair stops, and within 3-4 months, the original appearance may be restored.

The exact mechanism of action of minoxidil as a hair growth stimulant in patients with androgenic alopecia is unknown.

When used systemically, Minoxidil has a vasodilating effect. In controlled clinical studies, after topical application of minoxidil in patients with both normal and elevated blood pressure, no systemic side effects associated with the systemic absorption of minoxidil were noted.

Pharmacokinetics

When applied topically, Minoxidil is poorly absorbed through normal, intact skin: on average, 1.4% (0.3-4.5%) of the total applied dose enters the systemic bloodstream.

With topical application, the concentration of minoxidil in the serum is determined by the rate of its absorption through the skin. After discontinuation of use, approximately 95% of the minoxidil that underwent systemic absorption is eliminated within 4 days.

Indications

• Androgenic alopecia in men and women for the purpose of restoring hair growth.
• Androgenic alopecia in men and women for the purpose of stabilizing the process of hair loss.

ICD codes

Dosage Regimen

Apply the spray to the skin of the scalp twice daily, once in the morning and once in the evening.

Ensure the scalp is dry and intact before application. Use the recommended dose as exceeding the application frequency or amount does not accelerate hair growth and may increase the risk of adverse effects.

Adverse Reactions

Frequently reported adverse reactions include dermatological effects such as redness, itching, and peeling of the scalp skin.

In some cases, hypertrichosis (unwanted hair growth on the body, including facial hair in women) and arterial hypotension may occur.

Observe a temporary increase in hair loss during the transition from the resting phase to the growth phase, typically occurring 2-6 weeks after initiation of therapy and subsiding within two weeks.

Contraindications

• Hypersensitivity to minoxidil or any component of the formulation.
• Presence of scalp conditions including redness, inflammation, infection, soreness, or sunburn.
• Use in children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Should not be used during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated in childhood and adolescence under 18 years of age.

Special Precautions

If systemic side effects occur (chest pain, palpitations, dizziness, decreased blood pressure, sudden weight gain, swelling of the hands and/or feet), as well as redness and irritation at the application site, Minoxidil should be discontinued and, if necessary, appropriate therapy prescribed.

Some patients experienced changes in hair color and texture after using minoxidil.

Drug Interactions

Concomitant topical application with agents that alter skin integrity, such as tretinoin or anthralin/dithranol, may increase the systemic absorption of minoxidil.

Exercise caution when using other topical scalp preparations simultaneously, as they may affect the absorption or efficacy of the treatment.

Overdose

Excessive topical application can lead to systemic effects due to increased absorption. Monitor for symptoms of cardiovascular involvement, including tachycardia, hypotension, and fluid retention.

In case of accidental ingestion, seek immediate medical attention. Symptoms of oral overdose may include profound hypotension and tachycardia. Provide symptomatic and supportive care.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.