Novocindol (Suspension) Instructions for Use

Marketing Authorization Holder

Vladivostok Pharmaceutical Factory, JSC (Russia)

ATC Code

D08AD (Boric acid and its preparations)

Active Substances

Zinc oxide (Ph.Eur. European Pharmacopoeia)

Boric acid (Ph.Eur. European Pharmacopoeia)

Procaine (Rec.INN WHO Registered)

Dosage Form

Novocindol

Suspension for external use, bottles

Dosage Form, Packaging, and Composition

Bottles.
Bottles (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antimicrobial, local anesthetic, and drying action for external use

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

A combined agent for topical use that has antiseptic, disinfectant, and local anesthetic action.

Boric acid has antiseptic and fungistatic action. It has a weak irritating effect on granulation tissues.

Procaine is a local anesthetic agent with moderate anesthetic activity and a wide therapeutic range. Being a weak base, it blocks sodium channels, prevents the generation of impulses in the endings of sensory nerves and the conduction of impulses along nerve fibers. It alters the action potential in the membranes of nerve cells without a pronounced effect on the resting potential. It suppresses the conduction of not only pain but also impulses of other modalities.

Zinc oxide is an antiseptic, astringent, and drying agent. It reduces exudation and weeping, which relieves local inflammation and irritation.

Pharmacokinetics

Boric acid is absorbed through damaged skin, wound surfaces, and mucous membranes. In young children, it penetrates especially well through the skin and mucous membranes (fatal outcomes have been described after accidental ingestion or application to damaged skin). It is excreted slowly (accumulates with repeated administration). About 50% is excreted in the urine within 12 hours, the remainder within 5-7 days.

Procaine undergoes complete systemic absorption. The degree of absorption depends on the site and route of administration (especially on the vascularization and blood flow rate in the area of administration) and the final dose (amount and concentration). It is rapidly hydrolyzed by plasma and liver esterases to form two main pharmacologically active metabolites: diethylaminoethanol (has a moderate vasodilating effect) and para-aminobenzoic acid (PABA) (is a competitive antagonist of sulfonamide chemotherapeutic agents and may weaken their antimicrobial effect). T_1/2 is 30-50 s, in the neonatal period – 54-114 s. It is excreted mainly by the kidneys in the form of metabolites, no more than 2% is excreted unchanged.

Indications

• Apply externally for the symptomatic treatment of various forms of dermatitis and eczematous skin conditions to provide antiseptic action, reduce exudation, and relieve local discomfort.
• Use for the management of skin irritation and inflammation where a drying effect and local anesthetic action are clinically indicated.

ICD codes

Dosage Regimen

Apply a thin layer to the affected skin areas one to two times daily. The frequency of application may be adjusted based on the severity of the condition and the clinical response.

Shake the bottle well before each use to ensure a uniform suspension. Use only on intact or damaged skin as directed; avoid application to very large areas, mucous membranes, or open wounds.

Adverse Reactions

Local skin reactions such as redness, itching, burning sensation, or rash may occur, typically indicating hypersensitivity or irritation.

Discontinue use immediately and consult a physician if any signs of an allergic reaction develop. With extensive application, particularly to damaged skin, systemic absorption of components like boric acid can occur, posing a risk of toxicity.

Drug Interactions

Concurrent use with other topical products on the same area is not recommended, as it may increase the risk of local adverse reactions or alter the absorption of active ingredients.

Exercise caution due to the presence of procaine, a metabolite of which is para-aminobenzoic acid (PABA), a known competitive antagonist of sulfonamide antimicrobials that may reduce their therapeutic efficacy if administered systemically.

Contraindications

• Do not use in patients with a known hypersensitivity to any of the components: zinc oxide, boric acid, or procaine, or to other local anesthetics of the ester type.
• Contraindicated for application to large body surface areas, severely damaged skin, or extensive burns due to the risk of systemic absorption and toxicity, particularly from boric acid.
• Avoid use in patients with significant renal impairment, as excretion of the drug’s components may be compromised, leading to accumulation.

Overdose

Symptoms of overdose are primarily related to the systemic absorption of boric acid, which can include nausea, vomiting, diarrhea, abdominal pain, headache, skin rashes, and in severe cases, renal impairment, seizures, or circulatory collapse.

In case of accidental ingestion or suspected systemic absorption, seek immediate medical attention. Treatment is supportive and symptomatic; there is no specific antidote. Hemodialysis may be considered in severe poisoning to enhance elimination.

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.