Vartocid^® (Cream) Instructions for Use

Marketing Authorization Holder

MBNPK Cytomed, JSC (Russia)

ATC Code

D06BB10 (Imiquimod)

Active Substance

Imiquimod (Rec.INN)

Dosage Form

Vartocid®

Cream for external use 5%: tubes 5 g or 10 g

Dosage Form, Packaging, and Composition

Cream for external use white or white with a yellowish tint.

Excipients: oleic acid – 350 mg, diethylene glycol monoethyl ether – 35 mg, carbomer (carbomer copolymer) – 2.5 mg, polysorbate-20 – 2.5 mg, trolamine – 2 mg, phenoxyethanol – 2 mg, methylparaben – 2 mg, carbomer (carbomer interpolymer) – 1.5 mg, propylparaben – 1 mg, purified water – up to 1000 mg.

5 g – aluminum tubes with first opening control (1) – cardboard packs.
10 g – aluminum tubes with first opening control (1) – cardboard packs.

Clinical-Pharmacological Group

Immunomodulator for topical use. Interferon synthesis inducer

Pharmacotherapeutic Group

Antibiotics and antimicrobial agents used in dermatology; antimicrobial agents for topical use; antiviral agents

Pharmacological Action

Immunomodulator, immune response modifier. Imiquimod does not have a direct antiviral effect; its action is due to the induction of interferon alpha and other cytokines.

Pharmacokinetics

Less than 0.9% of radioisotope-labeled imiquimod is absorbed through human skin after a single dose application.

The small amount of the drug that enters the systemic circulation is excreted from the body without delay by the kidneys and through the intestines in a ratio of approximately 3:1.

The concentration of the drug in the blood serum after single or multiple topical applications did not reach a quantifiable level (> 5 ng/ml).

Indications

Treatment of external anogenital warts located on the external genitalia or in the perianal area in adults.

ICD codes

Dosage Regimen

Apply the cream externally three times per week, such as Monday, Wednesday, Friday, prior to bedtime.

Wash hands before and after application. Apply a thin layer to cover the entire wart area and rub in until the cream is no longer visible.

Leave the cream on the skin for 6 to 10 hours. Avoid covering the treated area with occlusive dressings.

After the 6-10 hour period, wash the treated area thoroughly with mild soap and water to remove the cream.

Continue application until complete clearance of external anogenital warts is achieved.

Do not exceed a maximum treatment duration of 16 weeks.

If a severe local skin reaction occurs, temporarily discontinue use until the skin recovers. Treatment may then be resumed.

Avoid application on open wounds or broken skin. Do not use for the treatment of urethral, intravaginal, cervical, rectal, or intra-anal warts.

Adverse Reactions

Local skin reactions: very common – itching and pain at the application site; common – infection, erythema, erosion, excoriation/flaking and edema; uncommon – skin itching, dermatitis, folliculitis, erythematous rash, eczema, urticaria; rare – induration, ulceration, scabbing and blistering, local hypopigmentation and hyperpigmentation.

From the central and peripheral nervous system: common – headache, dizziness; uncommon – insomnia, depression, irritability, paresthesia, migraine, drowsiness, ringing in the ears.

From the digestive system: common – nausea; uncommon – abdominal pain, diarrhea, vomiting, anorexia, anal pain, rectal lesions.

From the reproductive system: uncommon – fungal and bacterial infection, herpes simplex, vaginitis, vulvitis, painful sexual intercourse, pain in the penis, vagina, atrophic vaginitis.

From the hematopoietic system: very rare – decreased hemoglobin, leukopenia, absolute neutropenia and thrombocytopenia.

From the musculoskeletal system: uncommon – back pain, arthralgia.

From the respiratory system: uncommon – pharyngitis, rhinitis.

From the body as a whole: common – infection, myalgia, fever, flu-like symptoms, fatigue; uncommon – increased sweating, lymphadenopathy.

Contraindications

Childhood and adolescence under 18 years of age; hypersensitivity to imiquimod.

Use in Pregnancy and Lactation

Use during pregnancy is possible only for strict indications, if the expected benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use imiquimod during lactation, breastfeeding should be discontinued.

Special Precautions

Apply only to the affected areas.

It is not recommended to use until the skin has healed after other types of drug or surgical treatment.

Do not start treatment with imiquimod on areas with open sores or wounds until they have healed.

During treatment, exposure to sunlight (including sunlamps) should be avoided or minimized due to the threat of sunburn.

Since Imiquimod does not have a direct antiviral and cytotoxic effect, the occurrence of new genital and perianal warts is possible after the therapy.

Based on the currently available data, treatment of urethral, intravaginal, cervical, rectal or intra-anal anogenital warts with imiquimod is not recommended.

Drug Interactions

The minimal absorption of imiquimod through the skin is believed to limit interaction with systemic drugs.

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

Rx Only

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.