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Basic Drug Info
Drug Name:Chloroquine Phosphate
Manufacturer:Global Pharmaceuticals
Other Info:07/03350-01



Clinical Trials:


Indications and Usage

Chloroquine phosphate tablets are indicated for the suppressive treatment and for acute attacks of malaria due to P.

vivax, P.

malariae, P.

ovale, and susceptible strains of P.

falciparum.

The drug is also indicated for the treatment of extraintestinal amebiasis.Chloroquine does not prevent relapses in patients with vivax or malariae malaria because it is not effective against exoerythrocytic forms of the parasite, nor will it prevent vivax or malariae infection when administered as a prophylactic.

It is highly effective as a suppressive agent in patients with vivax or malariae malaria, in terminating acute attacks, and significantly lengthening the interval between treatment and relapse.

In patients with falciparum malaria it abolishes the acute attack and effects complete cure of the infection, unless due to a resistant strain of P.

falciparum.
Malaria -- A protozoan disease caused in humans by four species of the PLASMODIUM genus: PLASMODIUM FALCIPARUM; PLASMODIUM VIVAX; PLASMODIUM OVALE; and PLASMODIUM MALARIAE; and transmitted by the bite of an infected female mosquito of the genus ANOPHELES. Malaria is endemic in parts of Asia, Africa, Central and South America, Oceania, and certain Caribbean islands. It is characterized by extreme exhaustion associated with paroxysms of high FEVER; SWEATING; shaking CHILLS; and ANEMIA. Malaria in ANIMALS is caused by other species of plasmodia.

Amebiasis -- Infection with any of various amebae. It is an asymptomatic carrier state in most individuals, but diseases ranging from chronic, mild diarrhea to fulminant dysentery may occur.

Quartan Malaria --

Communicable Diseases -- broad class of diseases whose causative agents may be passed between individuals in many different ways.

Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Recurrent disease -- The return of signs and symptoms of cancer after a period of improvement.

Falciparum Malaria -- Malaria caused by PLASMODIUM FALCIPARUM. This is the severest form of malaria and is associated with the highest levels of parasites in the blood. This disease is characterized by irregularly recurring febrile paroxysms that in extreme cases occur with acute cerebral, renal, or gastrointestinal manifestations.

strain symptom --

Contraindications

Use of this drug is contraindicated in the presence of retinal or visual field changes either attributable to 4-aminoquinoline compounds or to any other etiology, and in patients with known hypersensitivity to 4-aminoquinoline compounds.

However, in the treatment of acute attacks of malaria caused by susceptible strains of plasmodia, the physician may elect to use this drug after carefully weighing the possible benefits and risks to the patient.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Malaria -- A protozoan disease caused in humans by four species of the PLASMODIUM genus: PLASMODIUM FALCIPARUM; PLASMODIUM VIVAX; PLASMODIUM OVALE; and PLASMODIUM MALARIAE; and transmitted by the bite of an infected female mosquito of the genus ANOPHELES. Malaria is endemic in parts of Asia, Africa, Central and South America, Oceania, and certain Caribbean islands. It is characterized by extreme exhaustion associated with paroxysms of high FEVER; SWEATING; shaking CHILLS; and ANEMIA. Malaria in ANIMALS is caused by other species of plasmodia.

Warnings

It has been found that certain strains of P.

falciparum have become resistant to 4-aminoquinoline compounds (including chloroquine and hydroxychloroquine).Chloroquine resistance is widespread and, at present, is particularly prominent in various parts of the world including sub-Saharan Africa, Southeast Asia, the Indian subcontinent, and over large portions of South America, including the Amazon basin1.Before using chloroquine for prophylaxis, it should be ascertained whether chloroquine is appropriate for use in the region to be visited by the traveler.

Chloroquine should not be used for treatment of P.

falciparum infections acquired in areas of chloroquine resistance or malaria occurring in patients where chloroquine prophylaxis has failed.Patients infected with a resistant strain of plasmodia as shown by the fact that normally adequate doses have failed to prevent or cure clinical malaria or parasitemia should be treated with another form of antimalarial therapy.Irreversible retinal damage has been observed in some patients who had received long-term or high-dosage 4-aminoquinoline therapy.

Retinopathy has been reported to be dose related.When prolonged therapy with any antimalarial compound is contemplated, initial (base line) and periodic ophthalmologic examinations (including visual acuity, expert slitlamp, funduscopic, and visual field tests) should be performed.If there is any indication (past or present) or abnormality in the visual acuity, visual field, or retinal macular areas (such as pigmentary changes, loss of foveal reflex), or any visual symptoms (such as light flashes and streaks) which are not fully explainable by difficulties of accommodation or corneal opacities, the drug should be discontinued immediately and the patient closely observed for possible progression.

Retinal changes (and visual disturbances) may progress even after cessation of therapy.All patients on long-term therapy with this preparation should be questioned and examined periodically, including testing knee and ankle reflexes, to detect any evidence of muscular weakness.

If weakness occurs, discontinue the drug.A number of fatalities have been reported following the accidental ingestion of chloroquine, sometimes in relatively small doses (0.75 g or 1 g chloroquine phosphate in one 3-year-old child).

Patients should be strongly warned to keep this drug out of the reach of children because they are especially sensitive to the 4-aminoquinoline compounds.Use of chloroquine in patients with psoriasis may precipitate a severe attack of psoriasis.

When used in patients with porphyria the condition may be exacerbated.

The drug should not be used in these conditions unless in the judgment of the physician the benefit to the patient outweighs the potential risks.
Branded Drugs
The following US Branded drugs contain Chloroquine Phosphate


ARALEN -- SANOFI AVENTIS US LLC

ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE -- SANOFI AVENTIS US LLC


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