Frostcream (Cream) Instructions for Use

Marketing Authorization Holder

Biolab, LLC (Russia)

Manufactured By

Interpharma, LLC (Russia)

ATC Code

N01BB20 (Amides in combination)

Active Substances

Lidocaine (Rec.INN registered by WHO)

Prilocaine (Rec.INN registered by WHO)

Dosage Form

Frostcream

Cream for topical and external use 2.5 g+2.5 g/100 g: tubes 5 g, 30 g or 100 g

Dosage Form, Packaging, and Composition

Cream for topical and external use in the form of a homogeneous mass of white or almost white color; a faint specific odor is allowed.

Excipients: PEG-54 hydrogenated castor oil – 1.9 g, carbomer 934R – 1 g, sodium hydroxide – 0.52 g, purified water – up to 100 g.

5 g – aluminum tubes (1) – cardboard packs.
5 g – aluminum tubes (5) – cardboard boxes.
5 g – aluminum tubes (10) – cardboard boxes.
5 g – aluminum tubes (20) – cardboard boxes.
5 g – aluminum tubes (30) – cardboard boxes.
30 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Agent for topical anesthesia of the skin and mucous membranes of the genital organs

Pharmacotherapeutic Group

Local anesthetic agent

Pharmacological Action

Combined local anesthetic agent for external and topical use. It contains Lidocaine and Prilocaine, which are local anesthetics of the amide type. Anesthesia of the skin is caused by the penetration of lidocaine and prilocaine into the layers of the epidermis and dermis.

When applied to the mucous membrane of the genital organs, anesthesia is achieved faster than when applied to intact skin due to faster absorption of the active substances. The degree of anesthesia depends on the dose and duration of application.

Pharmacokinetics

Systemic absorption of the active substances depends on the dose, duration of application and thickness of the skin (depending on the body area), as well as other skin characteristics, such as skin diseases and shaving. When applied to an ulcerative surface of the lower extremities, the absorption of active substances can be influenced by the characteristics of the ulcers, for example, the size (absorption increases with increasing ulcer area).

Intact skin. In adults, after applying an amount of the drug containing this combination in a single dose for 3 hours, the systemic absorption of lidocaine was approximately 3% and prilocaine – 5%. Absorption is slow. The C_max of lidocaine (mean value 0.12 µg/ml) and prilocaine (mean value 0.07 µg/ml) in blood plasma was reached approximately 4 hours after application. The risk of toxic symptoms exists only when the concentration of active substances in blood plasma is 5-10 µg/ml.

Trophic ulcers of the lower extremities. The time to reach C_max of lidocaine (0.05-0.84 µg/ml) and prilocaine (0.02-0.08 µg/ml) in blood plasma is 1-2.5 hours from the moment of application of the drug to the ulcer surface for 30 minutes.

With repeated application to the ulcer surface, no accumulation of prilocaine, lidocaine or their metabolites in the blood plasma was noted.

Mucous membrane of the genital organs. The time to reach C_max of lidocaine and prilocaine in blood plasma (on average 0.18 µg/ml and 0.15 µg/ml, respectively) is approximately 35 minutes from the moment of application to the vaginal mucosa for 10 minutes.

Indications

In adults: superficial anesthesia of the skin for injections (including vaccination), punctures and catheterization of blood vessels and superficial surgical interventions, including minor cosmetic procedures and hair removal; superficial anesthesia of trophic ulcers of the lower extremities during surgical treatment (mechanical cleaning), for example, to remove fibrin, pus and necrotic tissues; superficial anesthesia of the mucous membrane of the genital organs before performing painful manipulations and for pain relief before injections of local anesthetics.

In children: superficial anesthesia of the skin for injections (including vaccination), punctures and catheterization of blood vessels and superficial surgical interventions (including removal of molluscum contagiosum).

ICD codes

Dosage Regimen

Apply externally to the skin or topically to the genital mucous membranes.

Determine the dose and application time based on the indication, clinical situation, and patient age.

For superficial anesthesia of intact skin in adults and children: apply a thick layer of cream to the target area. Cover the area with an occlusive dressing. For adults, apply for at least 1 hour. For children aged 1 to 12 years, apply for at least 30 minutes.

For procedures on the genital mucous membranes in adult women: apply up to 10 g of cream for 5 to 10 minutes. Remove the cream prior to the procedure. Do not use on children’s genital mucous membranes.

For anesthesia of trophic ulcers on the lower extremities in adults: apply a thick layer (approximately 2 g per 10 cm² of ulcer surface) for at least 30 minutes before mechanical cleaning or debridement.

Do not apply to open wounds, damaged eardrums, or areas where middle ear penetration is possible.

Reduce application time to 15-30 minutes for patients with atopic dermatitis.

For children under 1 year of age, especially those receiving methemoglobin-inducing agents, use the minimum required dose and application area. Do not use on premature newborns under 37 weeks gestation or newborns weighing less than 3 kg.

The maximum application area and maximum daily dose are dependent on patient age and body weight. Adhere strictly to these limits to avoid systemic toxicity.

Adverse Reactions

Local reactions: transient local reactions are possible in the application area, such as pallor, redness and swelling; immediately after application – mild burning, itching and a feeling of warmth. Hemorrhagic rash or petechiae, especially after prolonged application in children with atopic dermatitis or molluscum contagiosum.
Corneal irritation due to accidental contact of the drug in the eyes.

General reactions: allergic reactions, in the most severe cases – anaphylactic shock. Methemoglobinemia and/or cyanosis.

Contraindications

Premature newborns born at less than 37 weeks of gestation; newborns weighing less than 3 kg; hypersensitivity to local anesthetics of the amide type.

Use in Pregnancy and Lactation

Animal studies have not revealed any direct or indirect negative effects of this combination on pregnancy, intrauterine fetal development, the process of childbirth or postnatal development. Lidocaine and Prilocaine cross the placental barrier and can be absorbed into fetal tissues. No specific disturbances of the reproductive process, such as an increased frequency of malformations or other direct or indirect negative effects on the fetus, have been reported.

Lidocaine and Prilocaine are excreted in breast milk in amounts that do not pose a risk to the child when drugs containing this combination are used according to the indications in recommended doses.

Use in Hepatic Impairment

There are no special instructions for use restrictions.

Use in Renal Impairment

There are no special instructions for use restrictions.

Pediatric Use

Premature newborns born at less than 37 weeks of gestation; newborns weighing less than 3 kg.

Geriatric Use

Use with caution to avoid exacerbation of concomitant diseases.

Special Precautions

Use with caution: glucose-6-phosphate dehydrogenase deficiency, hereditary or idiopathic methemoglobinemia, widespread neurodermatitis (atopic dermatitis), patients taking class III antiarrhythmic drugs (e.g., amiodarone).

Patients with glucose-6-phosphate dehydrogenase deficiency or hereditary or idiopathic methemoglobinemia are more susceptible to drug-dependent methemoglobinemia.

Caution should be exercised when applying the drug to the skin in atopic dermatitis; the application time should be reduced (15-30 min).

Patients taking class III antiarrhythmic drugs (e.g., amiodarone) should be under constant supervision and ECG monitoring, as an effect on cardiac activity is possible.

The drug should not be applied to a damaged eardrum or in other cases of possible penetration of the drug into the middle ear.

The drug containing this combination should not be applied to open wounds.

Lidocaine and Prilocaine in concentrations above 0.5-2% have bactericidal and antiviral properties. In this regard, special attention is recommended when using the drug before subcutaneous administration of a live vaccine (e.g., BCG).

Due to lack of data on absorption, application to the mucous membrane of the genital organs in children is not recommended.

Drug Interactions

In patients receiving drugs that induce the development of methemoglobinemia (for example, drugs containing a sulfogroup), the use of drugs containing this combination may contribute to an increase in the concentration of methemoglobin in the blood.

When treating with other local anesthetics and structurally similar drugs (including tocainide), the risk of increased systemic effects when using this combination in high doses should be taken into account.

No specific studies have been conducted to evaluate the interaction of lidocaine/prilocaine with class III antiarrhythmic drugs; caution should be exercised when using the drugs concomitantly.

Drugs that reduce the clearance of lidocaine (for example, cimetidine or beta-blockers) can cause potentially toxic plasma concentrations when repeated high doses of lidocaine are used over a prolonged period of time.

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.