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Chloroquine phosphate Injection IP L A R I A G O
 
DESCRIPTION

Chloroquine is 4-aminoquinoline antimalarial drug. It is a rapid acting blood schizontocide.

COMPOSITION

Lariago Injection - 2ml/5ml
Each ml contains chloroquine phosphate IP 64.5mg
(equivalent to 40mg of chloroquine base)

Chloroquine Phosphate Injection IP
Lariago 30ml

Each ml contains chloroquine phosphate IP 64.5mg
equivalent to chloroquine 40mg

Benzyl alcohol IP 2% v/v (as preservative)

INDICATIONS

LARIAGO injectable may be used in the treatment of severe malaria, especially severe falciparum malaria when Plasmodium falciparum is sensitive to chloroquine. Unconsciousness, repeated vomiting and inability to swallow also makes the parenteral treatment necessary. As soon as the patient's condition permits, the parenteral therapy with LARIAGO should be replaced by oral therapy (LARIAGO Tablets/Liquid).

CONTRAINDICATIONS

- Hypersensitivity to 4-aminoquinoline compounds or to any of its derivatives.
- Retinal or visual field changes attributable to the drug or any other etiology.

PRECAUTIONS

Risk benefit should be considered when the following medical problems exist:

Severe blood disorders, glucose 6-phosphate dehydrogenase (G6PD) deficiency, hepatic function impairment, alcoholism and in patients receiving other hepatotoxic drugs, severe neurological disorders, porphyria, psoriasis and presence of retinal or visual field changes.

Usage in pregnancy and lactation

Chloroquine crosses the placenta. Safe use of chloroquine during pregnancy has not been definitely established and the drug should be used in pregnant women only when clearly needed.

However, chloroquine has been used for treatment of malaria in pregnant women without evidence of adverse effects on the fetus and as per WHO experts, the benefits of chloroquine therapy in pregnant women suffering from malaria outweigh the potential risks of the drug to the fetus.

Small amounts of chloroquine and desethylchloroquine are distributed into breast milk. Because of the potential for serious adverse effects from chloroquine in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the woman.

Usage in paediatrics

Children are extremely susceptible to overdosage of parenteral chloroquine. Severe reactions and sudden death have been reported following parenteral administration of chloroquine in children. If chloroquine injection is given intravenously in pediatric patients, it should be diluted and administered very slowly by intravenous infusion. Oral therapy is preferred and should be initiated as soon as possible.

ADVERSE EFFECTS

Cardiovascular reactions : Hypotension, ECG changes, cardiomyopathy (rare).

CNS reactions
: Mild transient headache, psychic stimulation, psychotic episodes, convulsions (rare).

GI reactions
: Anorexia, nausea, vomiting, diarrhoea, abdominal cramps.

Ophthalmic - Irreversible retinal damage, visual disturbances, nyctalopia, scotomatous vision with field defects.

Miscellaneous - Agranulocytosis, blood dyscrasias, hair loss, pruritus, neuromyopathy, lichen planus like eruptions, skin/mucosal pigment changes, pleomorphic skin eruptions. A few cases of a nerve-type deafness have occurred after prolonged high doses.

DOSAGE AND ADMINISTRATION

For adults and children the initial dose of 10mg/Kg (base) should be administered over a period of not less than 8 hours by very slow intravenous infusion. Subsequent infusions of 5mg/Kg (slowly over 8 hours) should be administered every 8 hours until a total dose of 25mg/Kg has been given.

NaCl 0.9% (Normal saline) is used as a diluent.

Infusions should be discontinued as soon as the patient is able to take chloroquine by mouth.

Excessive rapid administration results in toxic peak plasma concentrations and a danger of fatal cardiovascular collapse. Respiratory depression, hypotension, cardiovascular collapse and seizures can follow excessively rapid parenteral administration. Hence, very slow IV infusion is recommended

Where facilities for intravenous infusion are not available, chloroquine can be administered by intramuscular or subcutaneous injection at a dosage of 2.5mg/Kg every 4 hours or 3.5mg/Kg every 6 hours until a total of 25mg/Kg has been given.

Intramuscular injection (Ampoules & Vials) LARIAGO should be given deep intramuscularly (outer and upper quadrant of the gluteal muscle) and slowly. The injectable dose should be divided between two injection sites. After the injection the patient should rest for 15 to 30 minutes.

Storage

Store in cool dry dark place.

Presentation

Ampoule of 2ml and 5ml (IM/IV*)
Vial of 30ml (For IM use only)

* IV use by very slow intravenous infusion only

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