Delagil (Tablets) Instructions for Use

Marketing Authorization Holder

Meda Pharma, GmbH & Co. KG (Germany)

ATC Code

P01BA01 (Chloroquine)

Active Substance

Chloroquine (Rec.INN registered by WHO)

Dosage Form

Delagil

Tablets 250 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets are flat, with a beveled edge, white or almost white in color, and odorless.

Excipients: hydrophobic colloidal silicon dioxide (aerosil R972), polyacrylic acid (carbomer 934P), magnesium stearate, talc, polyvinyl butyral (movital B30T), corn starch.

10 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

A 4-aminoquinoline derivative. An antimalarial and amoebicidal drug. An immunosuppressant

Pharmacotherapeutic Group

Antimalarial agent

Pharmacological Action

An antiprotozoal agent, it also has an immunosuppressive and anti-inflammatory effect. It causes the death of asexual erythrocytic forms of all types of plasmodia.

It has a gametocidal effect, with the exception of Plasmodium falciparum (it exhibits an anti-gametocidal effect).

Pharmacokinetics

After oral administration, it is rapidly and almost completely absorbed from the gastrointestinal tract. C_max in the blood is reached after 2-6 hours. It is 55% bound to plasma albumins.

It rapidly distributes throughout the organs and tissues of the body (liver, kidneys, spleen, lungs). It easily penetrates the blood-brain barrier and the placenta. It is metabolized in small quantities (25%).

It is excreted by the kidneys (70% unchanged) slowly. T_1/2 is 1-2 months. In renal failure, it may accumulate.

Indications

• Malaria (prophylaxis and treatment of all types);
• Extraintestinal amebiasis;
• Amebic liver abscess;
• Systemic lupus erythematosus (chronic and subacute forms);
• Rheumatoid arthritis;
• Scleroderma;
• Photodermatosis.

ICD codes

Dosage Regimen

Orally, for malaria prophylaxis – 0.5 g twice in the first week, then once always on the same day of the week.

Treatment of malaria is carried out according to the following scheme: day 1, a single dose of 1 g, after 6-8 hours – 0.5 g, on days 2 and 3 of treatment – 0.75 g daily in a single dose.

For amebiasis – 0.5 g 3 times/day for 7 days, then – 0.25 g 3 times/day for another 7 days, thereafter – 0.75 g twice a week for 2-6 months.

For rheumatoid arthritis – 0.5 g twice/day for 7 days, then – 0.5 g daily for 12 months.

For systemic lupus erythematosus – daily, 0.25-0.5 g.

For photodermatosis – 0.25 g daily for a week, then – 0.5-0.75 g weekly.

Adverse Reactions

From the digestive system: nausea, vomiting, gastralgia.

From the nervous system: dizziness, headache, sleep disorders, psychoses, epileptic seizures.

From the cardiovascular system: myocardial damage with ECG changes, decreased blood pressure.

From the sensory organs: with prolonged use – corneal opacity, retinal damage, visual impairment, ringing in the ears.

Allergic reactions: dermatitis, photosensitization.

Other: myalgia, leukopenia, changes in skin and hair color.

Contraindications

• Hypersensitivity;
• Hepatic insufficiency;
• Renal insufficiency;
• Suppression of bone marrow hematopoiesis;
• Severe rhythm disturbances;
• Psoriatic arthritis;
• Neutropenia;
• Porphyrinuria;
• Pregnancy;
• Lactation.

With caution – glucose-6-phosphate dehydrogenase deficiency, retinopathy, epilepsy.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency.

Use in Renal Impairment

Contraindicated in renal insufficiency.

Special Precautions

During treatment, systematic examinations by an ophthalmologist and general blood tests are necessary.

Overdose

Symptoms: vomiting, impaired consciousness, visual disturbance, convulsions, collapse, depression of the respiratory center, up to a fatal outcome (within 2 hours from the onset of respiratory depression).

Treatment: induction of vomiting, gastric lavage, oral administration of activated charcoal in a dose 5 times the estimated dose of chloroquine; peritoneal dialysis, plasmapheresis.

Drug Interactions

Concomitant use with phenylbutazone, gold preparations, penicillamine, cytostatics, levamisole increases the likelihood of bone marrow aplasia and skin lesions.

Antacids impair absorption, cimetidine increases the concentration of the drug in the blood.

Combination with other antimalarial drugs may be accompanied by an antagonistic effect.

When combined with corticosteroids, the risk of myopathy and cardiomyopathy increases; with MAO inhibitors – the risk of neurotoxicity increases; with ethanol – hepatotoxicity; with cardiac glycosides – glycoside intoxication increases.

Storage Conditions

List B. In a place inaccessible to children, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 5 years. Do not use the drug after the expiration date.

Dispensing Status

By prescription.

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.