Chloroquine phosphate tablets
Product Name: Chloroquine phosphate tablet
Nombre del Producto: Fosfato de Cloroquina, tableta
Specification: 250mg, 500mg
Package: 10tablets/blister/box, 1blister/box, 10blister/box
Standard: BP & USP
It is not active against intrahepatic forms.
Absorption is efficient following oral administration and peak plasma concentrations occur within 2-3 hours. The drug and its metabolites can be detected in the plasma for up to 2 months and in the urine for up to 4 months after a single dose.
Treatment of acute malarial attacks:
• P. malariae and susceptible P. falciparum infections are eliminated by treatment with chloroquine alone.
• When there is little or no likelihood of immediate reinfection, elimination of naturally acquired P. vivax and P. ovale infections requires subsequent administration of primaquine to eliminate persistent intrahepatic forms (hypnozoites). These forms do not occur in infection acquired congenitally, or from transfusions or other contaminated injections.
Chloroquine is also used for prophylaxis for pregnant women and non-immune individuals at risk.
Dosage and administration
To avoid nausea and vomiting chloroquine should be administered after meals. If part or all of a dose is vomited, the same amount must immediately be readministered.
Adults, including pregnant women, and children:
Total dose: 25 mg/kg given over 3 days.
Day 1: 10 mg/kg, followed by 5 mg/kg 6-8 hours later.
Days 2 and 3: 5 mg/kg in a single dose.
A more practical, but pharmacokinetically inferior, regimen is used in many areas:
Days 1 and 2: 10 mg/kg.
Day 3: 5 mg/kg.
The above regimens are sufficient to eliminate susceptible P. falciparum infections since effective antimalarial plasma concentrations are sustained for several weeks.
• Known hypersensitivity.
• Chloroquine should not be taken for prophylaxis by patients with a history of epilepsy.
If the condition of the patient deteriorates after administration of chloroquine, resistance must be suspected and quinine must be administered intravenously as an emergency measure.
Use in pregnancy
There is no evidence that chloroquine is harmful in prophylactic doses during pregnancy. Because of the susceptibility of pregnant women to falciparum malaria, it should be used at the recommended dosage for both prophylaxis and treatment wherever chloroquine-sensitive malaria is prevalent.
Serious adverse effects are rare at the dosages used for malaria, but pruritus, which may be intolerable, is common among Africans and has also been reported from South and Central America and south-east Asia. It can often be alleviated by calamine lotion but if it compromises compliance it may be necessary to use an alternative antimalarial.
Transient headaches and gastrointestinal symptoms are occasionally troublesome. In susceptible individuals, severe attacks of acute intermittent porphyria and of psoriasis may be precipitated. The former may simulate an attack of cerebral malaria. When the diagnosis is in doubt the urine should be tested for porphobilinogen.
Where self-medication is common and chloroquine is used without supervision to treat virtually any febrile condition, chloroquine abuse has been claimed to be a common cause of cardiac atrio-ventricular block. These patients are also at risk of developing chloroquine retinopathy.
Irreversible visual impairment resulting from accumulation of chloroquine in the retina is a recognized complication of long-term, high-dosage therapy. Total lifetime exposure to chloroquine should not exceed 100g of the base. Retinopathy has rarely, if ever, resulted from doses currently recommended for malaria prophylaxis.
Acute chloroquine poisoning is often fatal: oral doses as low as 50 mg base/kg can be lethal. Nausea, vomiting and drowsiness occur rapidly and are followed by slurring of speech, agitation, breathlessness due to pulmonary oedema, convulsions, coma, impaired vision and cardiac dysrhythmias.
If the patient is seen within a few hours of the event, emesis must be induced or gastric lavage undertaken as rapidly as possible. Otherwise, treatment is symptomatic and is directed particularly to sustaining cardiovascular and respiratory function. Diazepam may help to control convulsions.
Tablets should be kept in well-closed containers, protected from light and moisture.
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