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Chloroquine

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Overview

What is Chloroquine?

Chloroquine Phosphate, USP, is a 4-aminoquinoline compound for oral administration. It is a white, odorless, bitter tasting, crystalline substance, freely soluble in water.

Chloroquine Phosphate Tablets are an antimalarial and amebicidal drug.

Each tablet, for oral administration, contains 250 mg chloroquine phosphate (equivalent to 150 mg base) or 500 mg chloroquine phosphate (equivalent to 300 mg base).

Inactive ingredients 250 mg: Calcium Stearate, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Microcrystalline Cellulose, and Talc.

Inactive ingredients 500 mg: Colloidal Silicon Dioxide, Corn Starch, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyvinylpyrrolidone, Sodium Starch Glycolate, and Titanium Dioxide. Film Coating and Polishing Solution contains: D&C Red #27 Aluminum Lake, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, Hypromellose, Polyethylene Glycol, Polysorbate 80 and Titanium Dioxide.

Chemically, it is 7-chloro-4-[[4-(diethylamino)-1-methylbutyl]amino] quinoline phosphate (1:2) and has the following structural formula:



What does Chloroquine look like?



What are the available doses of Chloroquine?

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What should I talk to my health care provider before I take Chloroquine?

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How should I use Chloroquine?

Chloroquine Phosphate Tablets are indicated for suppressive treatment and for acute attacks of malaria due to and susceptible strains of The drug is also indicated for the treatment of extraintestinal amebiasis.

Chloroquine Phosphate Tablets do 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

The dosage of chloroquine phosphate is often expressed in terms of equivalent chloroquine base. Each 250 mg tablet of chloroquine phosphate is equivalent to 150 mg base and each 500 mg tablet of chloroquine phosphate is equivalent to 300 mg base. In infants and children the dosage is preferably calculated by body weight.

Malaria:

Adult Dose:

Pediatric Dose:

If circumstances permit, suppressive therapy should begin two weeks prior to exposure. However, failing this in adults, an initial double (loading) dose of 1 g (= 600 mg base), or in children 10 mg base/kg may be taken in two divided doses, six hours apart. The suppressive therapy should be continued for eight weeks after leaving the endemic area.


What interacts with Chloroquine?

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.



What are the warnings of Chloroquine?

In rats receiving large doses of bupropion chronically, there was an increase in incidence of hepatic hyperplastic nodules and hepatocellular hypertrophy. In dogs receiving large doses of bupropion chronically, various histologic changes were seen in the liver, and laboratory tests suggesting mild hepatocellular injury were noted.

It has been found that certain strains of 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 basin.

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 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 slit-lamp, funduscopic, and visual field tests) should be performed.

If there is any indication (past or present) of 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 Phosphate Tablets 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.

Array

Radioactively tagged chloroquine administered intravenously to pregnant pigmented CBA mice passed rapidly across the placenta and accumulated selectively in the melanin structures of the fetal eyes. It was retained in the ocular tissues for five months after the drug had been eliminated from the rest of the body. There are no adequate and well-controlled studies evaluating the safety and efficacy of chloroquine in pregnant women. Usage of chloroquine during pregnancy should be avoided except in the suppression or treatment of malaria when in the judgement of the physician the benefit outweighs the potential risk to the fetus.


What are the precautions of Chloroquine?

Hematological Effects/Laboratory Tests:

Complete blood cell counts should be made periodically if patients are given prolonged therapy. If any severe blood disorder appears which is not attributable to the disease under treatment, discontinuance of the drug should be considered.

The drug should be administered with caution to patients having G-6-PD (glucose-6 phosphate dehydrogenase) deficiency.

Auditory Effects:

In patients with preexisting auditory damage, chloroquine should be administered with caution. In case of any defects in hearing, chloroquine should be immediately discontinued, and the patients closely observed (see ).

Hepatic Effects:

Since this drug is known to concentrate in the liver, it should be used with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs.

Central Nervous System Effects:

Patients with a history of epilepsy should be advised about the risk of chloroquine provoking seizures.

Drug Interactions:

Antacids and kaolin: Antacids and kaolin can reduce the absorption of chloroquine; an interval of at least 4 hours between intake of these agents and chloroquine should be observed.

Cimetidine: Cimetidine can inhibit the metabolism of chloroquine, increasing its plasma level. Concomitant use of cimetidine should be avoided.

Ampicillin: In a study of healthy volunteers, chloroquine significantly reduced the bioavailability of ampicillin. An interval of at least two hours between intake of this agent and chloroquine should be observed.

Cyclosporine: After introduction of chloroquine (oral form), a sudden increase in serum cyclosporine level has been reported. Therefore, close monitoring of serum cyclosporine level is recommended and, if necessary, chloroquine should be discontinued.

Mefloquine: Co-administration of chloroquine and mefloquine may increase the risk of convulsions.

The blood concentrations of chloroquine and desethylchloroquine (the major metabolite of chloroquine, which also has antimalarial properties) were negatively associated with log antibody titers. Chloroquine taken in the dose recommended for malaria prophylaxis can reduce the antibody response to primary immunization with intradermal human diploid-cell rabies vaccine.

Pregnancy:

See .

Nursing Mothers:

Because of the potential for serious adverse reactions in nursing infants from chloroquine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the potential clinical benefit of the drug to the mother.

The excretion of chloroquine and the major metabolite, desethylchloroquine, in breast milk was investigated in eleven lactating mothers following a single dose of chloroquine (600 mg base). The maximum daily dose of the drug that the infant can receive from breastfeeding was about 0.7% of the maternal start dose of the drug in malaria chemotherapy. Separate chemoprophylaxis for the infant is required. See .

Pediatric Use:

See  and .

Geriatric Use:

Clinical studies of Chloroquine Phosphate Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.


What are the side effects of Chloroquine?

Special Senses: Ocular:

Auditory:

Musculoskeletal System:

Gastrointestinal system:

Skin and appendages:

Hematologic system:

Nervous system:

Cardiovascular system:

To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001, and the FDA at 1-800-FDA-1088 or .


What should I look out for while using Chloroquine?

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.

It has been found that certain strains of 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 basin.

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 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 slit-lamp, funduscopic, and visual field tests) should be performed.

If there is any indication (past or present) of 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 Phosphate Tablets 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.


What might happen if I take too much Chloroquine?

Symptoms:

Treatment:

Convulsions, if present, should be controlled before attempting gastric lavage. If due to cerebral stimulation, cautious administration of an ultra short-acting barbiturate may be tried but, if due to anoxia, it should be corrected by oxygen administration and artificial respiration. Monitor ECG. In shock with hypotension, a potent vasopressor should be administered. Replace fluids and electrolytes as needed. Cardiac compressing or pacing may be indicated to sustain the circulation. Because of the importance of supporting respiration, tracheal intubation or tracheostomy, followed by gastric lavage, may also be necessary. Peritoneal dialysis and exchange transfusions have also been suggested to reduce the level of the drug in the blood.

Intervention options can involve: diazepam for life-threatening symptoms, seizures and sedation, epinephrine for treatment of vasodilation and myocardial depression, potassium replacement with close monitoring of serum potassium levels.

A patient who survives the acute phase and is asymptomatic should be closely observed for at least six hours. Fluids may be forced, and sufficient ammonium chloride (8 g daily in divided doses for adults) may be administered for a few days to acidify the urine to help promote urinary excretion in cases of both overdosage or sensitivity.


How should I store and handle Chloroquine?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Chloroquine Phosphate Tablets USP 250 mg: White, Round, Scored Compressed Tablet; Debossed "West-ward 195".Bottles of 50 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Unit Dose Boxes of 100 tablets.Chloroquine Phosphate Tablets USP 500 mg: Pink Color, Round Tablets Debossed "WW 125".Bottles of 25 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Unit Dose Boxes of 100 tablets.Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chloroquine Phosphate Tablets USP 250 mg: White, Round, Scored Compressed Tablet; Debossed "West-ward 195".Bottles of 50 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Unit Dose Boxes of 100 tablets.Chloroquine Phosphate Tablets USP 500 mg: Pink Color, Round Tablets Debossed "WW 125".Bottles of 25 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Unit Dose Boxes of 100 tablets.Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chloroquine Phosphate Tablets USP 250 mg: White, Round, Scored Compressed Tablet; Debossed "West-ward 195".Bottles of 50 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Unit Dose Boxes of 100 tablets.Chloroquine Phosphate Tablets USP 500 mg: Pink Color, Round Tablets Debossed "WW 125".Bottles of 25 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Unit Dose Boxes of 100 tablets.Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chloroquine Phosphate Tablets USP 250 mg: White, Round, Scored Compressed Tablet; Debossed "West-ward 195".Bottles of 50 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Unit Dose Boxes of 100 tablets.Chloroquine Phosphate Tablets USP 500 mg: Pink Color, Round Tablets Debossed "WW 125".Bottles of 25 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Unit Dose Boxes of 100 tablets.Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chloroquine Phosphate Tablets USP 250 mg: White, Round, Scored Compressed Tablet; Debossed "West-ward 195".Bottles of 50 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Unit Dose Boxes of 100 tablets.Chloroquine Phosphate Tablets USP 500 mg: Pink Color, Round Tablets Debossed "WW 125".Bottles of 25 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Unit Dose Boxes of 100 tablets.Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chloroquine Phosphate Tablets USP 250 mg: White, Round, Scored Compressed Tablet; Debossed "West-ward 195".Bottles of 50 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Unit Dose Boxes of 100 tablets.Chloroquine Phosphate Tablets USP 500 mg: Pink Color, Round Tablets Debossed "WW 125".Bottles of 25 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Unit Dose Boxes of 100 tablets.Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Chloroquine is rapidly and almost completely absorbed from the gastrointestinal tract, and only a small proportion of the administered dose is found in the stools. Approximately 55% of the drug in the plasma is bound to nondiffusible plasma constituents. Excretion of chloroquine is quite slow, but is increased by acidification of the urine. Chloroquine is deposited in the tissues in considerable amounts. In animals, from 200 to 700 times the plasma concentration may be found in the liver, spleen, kidney, and lung; leukocytes also concentrate the drug. The brain and spinal cord, in contrast, contain only 10 to 30 times the amount present in plasma.

Chloroquine undergoes appreciable degradation in the body. The main metabolite is desethylchloroquine, which accounts for one fourth of the total material appearing in the urine; bisdesethylchloroquine, a carboxylic acid derivative, and other metabolic products as yet uncharacterized are found in small amounts. Slightly more than half of the urinary drug products can be accounted for as unchanged chloroquine.

Non-Clinical Toxicology
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.

It has been found that certain strains of 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 basin.

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 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 slit-lamp, funduscopic, and visual field tests) should be performed.

If there is any indication (past or present) of 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 Phosphate Tablets 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.

See concerning solutions containing a vasoconstrictor.

If sedatives are employed to reduce patient apprehension, use reduced doses, since local anesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect.

Vivacaine™ (bupivacaine hydrochloride and epinephrine injection, USP) should be used cautiously in persons with known drug allergies or sensitivities, particularly to the amide-type local anesthetics.

Serious dose-related cardiac arrhythmias may occur if preparations containing a vasoconstrictor such as epinephrine are employed in patients during or following the administration of chloroform, halothane, cyclopropane, trichloroethylene, or other related agents. In deciding whether to use these products concurrently in the same patient, the combined action of both agents upon the myocardium, the concentration and volume of vasoconstrictor used, and the time since injection, when applicable, should be taken into account.

Complete blood cell counts should be made periodically if patients are given prolonged therapy. If any severe blood disorder appears which is not attributable to the disease under treatment, discontinuance of the drug should be considered.

The drug should be administered with caution to patients having G-6-PD (glucose-6 phosphate dehydrogenase) deficiency.

Special Senses: Ocular:

Auditory:

Musculoskeletal System:

Gastrointestinal system:

Skin and appendages:

Hematologic system:

Nervous system:

Cardiovascular system:

To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001, and the FDA at 1-800-FDA-1088 or .

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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