Videstim^® (Ointment) Instructions for Use

Marketing Authorization Holder

Retinoids JSC (Russia)

ATC Code

D10AD02 (Retinol)

Active Substance

Retinol (Rec.INN registered by WHO)

Dosage Form

Videstim®

Ointment for external use 0.5%: 10 g, 15 g, 20 g or 35 g tubes

Dosage Form, Packaging, and Composition

Ointment for external use homogeneous, from white to light yellow in color.

Excipients: butylated hydroxytoluene – 0.5 mg, butylated hydroxyanisole – 0.25 mg, emulsifying wax – 80 mg, mineral oil – 80 mg, glycerol (glycerin) – 100 mg, ethanol 95% – 100 mg, purified water – up to 1 g.

10 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
35 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for moisturizing and protecting the cornea

Pharmacotherapeutic Group

Vitamin

Pharmacological Action

Vitamin A belongs to the fat-soluble vitamins.

When applied externally, it stimulates skin regeneration, enhances the proliferation of skin epithelial cells, inhibits keratinization processes, and prevents the development of hyperkeratosis. The action is due to the presence of specific retinol-binding receptors on the surface of epithelial cells.

Pharmacokinetics

Retinol easily penetrates the skin. C_max is reached 3-4 hours after application and is maintained for 12 hours. T_1/2 is 5.5 hours.

Indications

Inflammatory and degenerative diseases and conditions of the skin accompanied by dryness and slow healing (as part of complex therapy or as monotherapy): dermatitis, eczema, atopic dermatitis without exacerbation, cheilitis, fissures (including nipple fissures) and abrasions, age-related skin changes, as well as diseases associated with impaired keratinization processes. Used to activate reparative processes in various dermatoses after discontinuation of corticosteroid therapy. Frostbite, burns, wounds, ichthyosis.

ICD codes

Dosage Regimen

Apply a thin layer of ointment to the affected skin areas twice daily, in the morning and evening.

Prior to application, cleanse and dry the affected skin area thoroughly.

The duration of treatment is determined by the severity of the condition and the rate of clinical improvement.

For chronic dermatoses and ichthyosis, apply the ointment for several weeks.

For cracked nipples, apply after each feeding; wash off thoroughly before the next feeding.

For wounds, burns, and frostbite, apply under a sterile gauze dressing.

Avoid contact with eyes, mucous membranes, and open wounds.

Discontinue use and consult a physician if severe skin irritation or signs of an allergic reaction occur.

Do not use concurrently with other topical retinoid preparations to prevent overdose.

For external use only.

Adverse Reactions

In some cases increased itching and redness of the skin at the application site.

Possible allergic reactions.

Contraindications

Hypersensitivity to retinol, hypervitaminosis A, acute inflammatory skin diseases.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus and breastfed infant.

Use in Renal Impairment

.

Pediatric Use

Contraindicated for use in children under 7 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

No more than one preparation containing Retinol should be used simultaneously to avoid overdose.

Drug Interactions

Incompatible with tetracycline antibiotics.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°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.