Lokinal Intim (Spray) Instructions for Use

Marketing Authorization Holder

Kirov Pharmaceutical Factory, JSC (Russia)

ATC Code

D06BB (Antiviral drugs)

Active Substance

Ammonium glycyrrhizate (Ph.Eur. European Pharmacopoeia)

Dosage Form

Lokinal Intim

Spray for topical and external use 0.1%: 15 ml or 60 ml bottle.

Dosage Form, Packaging, and Composition

Spray for topical and external use in the form of a transparent solution from light yellow to light brown in color, with a characteristic odor.

Excipients: malic acid – 30 mg, fumaric acid – 20 mg, ascorbic acid – 3 mg, folic acid – 0.8 mg, propylene glycol – 500 mg, Tween-80 (polysorbate-80) – 9 mg, purified water – up to 1 ml.

15 ml – bottles (1) – cardboard packs.
60 ml – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Antiviral drug for external and topical use

Pharmacotherapeutic Group

Antiviral and immunostimulating agent

Pharmacological Action

Ammonium glycyrrhizate has a complex therapeutic effect ( antiviral, anti-inflammatory, immunostimulating, antipruritic, and regenerating).

Ammonium glycyrrhizate has an antiviral effect on various types of DNA and RNA viruses in vitro and in vivo ( Varicella Zoster, herpes simplex virus types I and II, cytomegalovirus, various types of human papillomavirus, including oncogenic ones).

Ammonium glycyrrhizate interrupts virus replication at early stages, causes the virion to exit the capsid, thereby preventing its penetration into cells.

It inactivates the specified viruses at concentrations that are non-toxic to normally functioning cells.

Mutant virus strains resistant to acyclovir and iodouridine are highly sensitive to the drug, as are non-mutant strains.

Ammonium glycyrrhizate has anti-inflammatory activity, which is combined with a stimulating effect on humoral and cellular immunity.

It significantly inhibits the release of kinins and the synthesis of prostaglandins by connective tissue cells in the inflammation zone.

The immunostimulating effect is manifested by an increase in the number and activity of T-lymphocytes, a decrease in the concentration of immunoglobulin G, and an increase in the concentration of immunoglobulins A and M.

It induces the production of its own interferons.

The regenerating action is due to the improvement of skin and mucous membrane repair.

Pharmacokinetics

With topical and external application, Ammonium glycyrrhizate is deposited in the lesions. Systemic absorption occurs slowly. The drug is detected in the blood in trace amounts.

Indications

Viral infection caused by human papillomavirus, including asymptomatic excretion of high oncogenic risk human papillomavirus as part of combined and complex therapy; viral infection caused by herpes simplex virus types I and II as part of complex therapy; viral infection caused by Varicella Zoster virus (herpes zoster) as part of complex therapy; viral infection caused by cytomegalovirus as part of complex therapy; prevention of recurrences of viral infections caused by herpes simplex virus types I and II, Varicella Zoster virus, human papillomavirus, cytomegalovirus; prevention and treatment of anogenital warts and cervical pathologies caused by human papillomavirus, cytomegalovirus; prevention and treatment of conditions accompanied by decreased local immunity, including nonspecific vulvovaginitis, candidal vulvovaginitis and bacterial vaginosis, as part of complex therapy; for symptoms of discomfort in the genital area, accompanied by itching, burning and dryness of the mucous membranes, including after sexual intercourse; for symptoms of discomfort in the genital area, accompanied by itching, burning and dryness of the mucous membranes in ovarian insufficiency.

ICD codes

Dosage Regimen

Apply externally, intravaginally, or intraurethrally as directed.

For human papillomavirus (HPV) infection, including high oncogenic risk types and anogenital warts, apply the spray to the affected area 2-3 times daily for a minimum of 4 weeks.

For herpes simplex virus (HSV) types I and II and for Varicella Zoster (herpes zoster), apply to lesions 3-4 times daily. Continue application for 5-7 days or until symptoms resolve.

For cytomegalovirus (CMV) infection, apply the spray 2 times daily for a duration determined by the physician.

For the prevention of viral infection recurrences (HSV, HPV, CMV, Varicella Zoster), apply once daily for 1-2 weeks during inter-episodic periods.

For the prevention and treatment of cervical pathologies and anogenital warts, use intravaginally. Administer 1-2 spraysonce or twice daily.

For conditions with decreased local immunity (nonspecific vulvovaginitis, candidal vulvovaginitis, bacterial vaginosis), apply 1-2 times daily as part of complex therapy until clinical improvement.

For symptoms of discomfort (itching, burning, dryness) in the genital area, apply to the affected mucosa as needed to relieve symptoms.

The duration of therapy is determined by the severity of the condition and clinical response. Do not discontinue application prematurely. If no improvement is observed, consult a physician.

Adverse Reactions

Local reactions: allergic reactions, including in the form of contact dermatitis.

Contraindications

Hypersensitivity to the active substance.

Use in Pregnancy and Lactation

Approved for use throughout the entire period of pregnancy and the period of breastfeeding.

Use in Hepatic Impairment

The drug is approved for use in hepatic impairment.

Use in Renal Impairment

The drug is approved for use in renal impairment.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

In case of signs of intolerance, application should be discontinued.

Drug Interactions

With simultaneous use of ammonium glycyrrhizinate and other antiviral drugs, in particular derivatives of acyclovir, iodouridine, interferon, and immunomodulators, its action is enhanced.

Storage Conditions

Store at 15°C (59°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.