📌 COMPOSITION

Each 5 ml contains: Chloroquine phosphate B.P. 120 mg – equivalent to Chloroquine 75 mg.
Each tablet contains: Chloroquine phosphate B.P. 250 mg – equivalent to Chloroquine 150 mg.

📌 DESCRIPTION

Chloroquine-Shiba is an antimalarial and amebicidal drug. Chloroquine has a high effect on the erythrocytic forms of plasmodium vivax, P. ovale, P. malariae and P. falciparum. This will lead to rapid control of parasitaemia and acute attack of malaria caused by these species. Chloroquine-Shiba also has anti‑inflammatory properties and some immunosuppressive effects which are used in a range of inflammatory conditions which often have an immunological basis; therefore, chloroquine can be used in the treatment of rheumatoid arthritis. It is rapidly and almost completely absorbed from the GIT, reaching a maximum serum concentration within 1-6 hours. It is widely distributed into body tissues. Chloroquine accumulates in high concentrations in some tissues such as the kidney, liver, lungs and spleen. It crosses the placenta and is excreted in breast milk. It is extensively metabolised in the liver. Chloroquine and its metabolites are excreted mainly in the urine.

📌 INDICATIONS

• Prophylaxis and treatment of malaria.
• Extraintestinal (hepatic) amoebiasis.
• Treatment of discoid and systemic lupus erythematosus.
• Treatment of rheumatoid arthritis.

📌 DOSAGE & ADMINISTRATION

Prophylaxis from malaria: Weekly dose:

Treatment of malaria:

• For extraintestinal (hepatic) amoebiasis: Adults: 1 tablet 4 times daily for 2 days, followed by 1 tablet twice daily for 2-3 weeks.
• For lupus erythematosus and rheumatoid arthritis: Adults: 150 mg (base) daily (maximum 2.5 mg/kg daily). Children: Up to 3 mg/kg daily.

📌 RESTRICTIONS ON USE

Contraindications

Known or suspected hypersensitivity to chloroquine.

Use in Pregnancy and Lactation

Chloroquine is not associated with fetal abnormalities if it is used in the recommended dose for prophylaxis during pregnancy. Chloroquine is safe during breast‑feeding for the treatment of malaria. The amount excreted in milk is too small to constitute a risk to infants. It is not necessary to withdraw an antimalarial drug during pregnancy if the rheumatic disease is well controlled. Chloroquine is present in breast milk and breast‑feeding should be avoided when it is used to treat rheumatic disease.

Precautions

• Care is necessary when administering chloroquine to patients with: impaired renal or hepatic functions, porphyria, psoriasis, history of epilepsy, blood disorders and cardiac conduction disturbance.
• Ophthalmic examination should be done to avoid irreversible retinal damage and corneal changes during long‑term therapy.
• Caution is advised in patients with glucose‑6‑phosphate dehydrogenase deficiency.
• Chloroquine should be used with caution in neurological disorders (especially in those with a history of epilepsy), in severe gastrointestinal disorders and in the elderly.
• Chloroquine may exacerbate psoriasis and aggravate myasthenia gravis.
• Full blood counts should be performed at regular intervals during treatment with chloroquine.
• Caution is needed in the use of chloroquine for long‑term high‑dosage therapy and such use should only be considered when no other drug is available. Patients on long‑term therapy should also be monitored for cardiomyopathy.

📌 DRUG INTERACTIONS

• Taking cyclosporin then chloroquine may cause an increase in cyclosporin levels.
• Chloroquine reduces levels of praziquantel.
• Antacids may reduce the absorption of chloroquine.
• Concurrent use of chloroquine and amiodarone is contraindicated due to the increased risk of cardiac arrhythmias.
• Use of chloroquine with other antimalarials increases the risk of convulsions.
• Chloroquine increases the symptoms of myasthenia gravis.
• Cimetidine inhibits the metabolism of chloroquine.

📌 ADVERSE EFFECTS

Adverse effects are rare at the recommended doses for prophylaxis and treatment and are reversible on withdrawal of the drug. These include headache, various skin eruptions, pruritus, urticaria, occasional depigmentation or loss of hair, photosensitivity, pigmentation of the skin. Gastro‑intestinal disturbances (such as nausea, vomiting and diarrhoea). Bone marrow depression and anaemia. Changes in liver function (hepatitis). Reversible visual disturbances and retinal pigmentation and blindness. Tinnitus and reduced hearing. Neuromyopathy and myopathy. The adverse reactions which may occur where prolonged high dosage is required, i.e. in the treatment of rheumatoid arthritis, are serious.

• Cardiovascular: hypotension and ECG changes (at high doses), cardiomyopathy.
• Central nervous system: convulsions and psychotic reactions including hallucinations (rare), anxiety, personality changes.
• Eye disorders: retinal degeneration, macular defects of colour vision, pigmentation, optic atrophy, scotomas, defects, blindness, corneal opacities and pigmented deposits, blurring of vision, difficulty in accommodation, diplopia.
• Gastro‑intestinal: gastro‑intestinal disturbances, nausea, vomiting, diarrhoea, abdominal cramps.
• Others: headache.
• Haematological: bone marrow depression, aplastic anaemia, agranulocytosis, thrombocytopenia.
• Hepatic: changes in liver function, including hepatitis and abnormal liver function tests, have been reported rarely.
• Hypersensitivity: allergic reactions, including urticaria, angioedema and vasculitis.
• Hearing disorders: tinnitus, reduced hearing, nerve deafness.
• Muscular: neuromyopathy and myopathy.
> neuromyopathy and myopathy.
• Skin: macular, urticarial and purpuric skin eruptions, occasional depigmentation or loss of hair, erythema multiforme, Stevens‑Johnson syndrome, precipitation of psoriasis, pruritus, photosensitivity, pigmentation of the skin and mucous membranes (long‑term use).

📌 OVERDOSE

Chloroquine is highly toxic in overdose. The symptoms of overdosage include circulatory collapse, respiratory arrest and coma. Symptoms may progress rapidly after initial nausea and vomiting. Death may result from circulatory or respiratory failure or cardiac arrhythmia. If no demonstrable cardiac output due to arrhythmias, asystole or electromechanical dissociation, external chest compression should be persisted with as long as necessary. Gastric lavage should be carried out urgently and artificial ventilation instituted if necessary. Activated charcoal left in the stomach may reduce absorption of any remaining chloroquine from the gut. DC shock is indicated for ventricular tachycardia and ventricular fibrillation.

In case of serious poisoning:

• Adrenaline infusion 0.25 microgram/kg/min initially, with increments of 0.25 microgram/kg/min until adequate systolic blood pressure is restored (more than 100 mmHg).
• Diazepam infusion 2 mg/kg over 30 minutes as a loading dose, followed by 1-2 mg/kg/day for up to 2-4 days.

* Chloroquine is excreted very slowly; therefore, cases of overdosage require observation for several days.

📌 STORAGE INSTRUCTIONS

• Tablets: Store below 25°C in a dry place. Protect from light.
• Syrup: Store in a tightly closed container. Store below 25°C, protect from light.

📌 PHARMACEUTICAL FORMS

• Chloroquine-Shiba Tablets: Pack of 10 tablets and hospital packs of different sizes.
• Chloroquine-Shiba Syrup: Bottle of 60 ml.