Chloxiperazine (Lyophilisate) Instructions for Use

Marketing Authorization Holder

St. Petersburg Research Institute of Vaccines and Sera of the FMBA, FSUE (Russia)

ATC Code

L01AA (Nitrogen mustard analogues)

Active Substance

Prospidium chloride (Rec.INN registered by WHO)

Dosage Form

Chloxiperazine

Lyophilizate for the preparation of solution for injections 100 mg: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

100 mg – ampoules (10) – plastic contour packs (1) – cardboard packs.
100 mg – ampoules (5) – plastic contour packs (1) – cardboard packs.

Clinical-Pharmacological Group

Antineoplastic drug

Pharmacotherapeutic Group

Antineoplastic agent, alkylating compound

Pharmacological Action

Antineoplastic agent of alkylating action. The mechanism of action is associated with a decrease in the ionic permeability of the plasma membranes of tumor cells.

It is believed that Prospidium chloride enters into direct interaction with DNA, disrupting its synthesis.

Pharmacokinetics

Prospidium chloride is excreted by the kidneys.

Indications

For parenteral use: laryngeal cancer and other types of squamous cell carcinoma of the head, skin cancer, Kaposi’s sarcoma, cutaneous reticuloses, retinoblastoma.

For topical use: papillomas, skin basal cell carcinomas, cancer of the skin and mucous membranes of the oral cavity.

ICD codes

Dosage Regimen

Establish the dosage individually based on the tumor type, disease stage, and treatment protocol.

For intravenous administration, reconstitute the 100 mg lyophilisate with 5-10 ml of sterile water for injection or 0.9% sodium chloride solution.

Administer the solution slowly intravenously or by drip infusion in 100-150 ml of 0.9% sodium chloride solution.

The typical single dose for adults is 100 mg. The weekly dose is 200-400 mg.

Administer the drug daily or every other day, or 2-3 times per week, to achieve a total course dose of 2-4 grams.

Repeat treatment courses after a 3-4 week interval, based on hematological parameters and patient tolerance.

For local use in skin malignancies, apply a 0.5% ointment or solution daily or every other day.

For intratumoral administration, use a 0.05-0.1% solution, injecting 30-100 ml directly into the tumor tissue.

Monitor complete blood count and renal function before and during therapy. Discontinue treatment if signs of significant cumulative toxicity appear.

Adverse Reactions

From the CNS and peripheral nervous system with parenteral use, paresthesias, numbness of the facial skin, fingers, a feeling of tingling in them, dizziness, fainting, drowsiness, headache are possible.

From the urinary system with parenteral use, manifestations of nephrotoxicity are possible – proteinuria, cylindruria, increased levels of creatinine, urea, and uric acid.

From the digestive system with parenteral use, worsening of appetite, nausea are possible.

With topical use – redness and swelling in the area of application.

Contraindications

Heart failure in the decompensation phase, impaired liver and kidney function, vertebrobasilar vascular insufficiency.

Use in Pregnancy and Lactation

The use of prospidium chloride should be avoided during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in case of impaired liver function.

Use in Renal Impairment

Contraindicated in case of impaired kidney function.

Special Precautions

Paresthesias (a manifestation of vascular disorders) and nephrotoxicity occur as a result of cumulation; in such cases, Prospidium chloride should be discontinued.

Drug Interactions

With simultaneous use with other cytostatic agents, potentiation of their action is possible.

Prospidium chloride potentiates the nephrotoxic effect of other 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.