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PRASCO LABS
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66993005702

hydroxychloroquine 200 mg tab

Generic
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Uses

Malaria

Hydroxychloroquine is used for prevention or chemoprophylaxis of malaria caused by Plasmodium malariae, P. ovale, chloroquine-susceptible P. vivax, or chloroquine-susceptible P. falciparum and for treatment of uncomplicated malaria caused by P. malariae, P. ovale, chloroquine-susceptible P. vivax, and chloroquine-susceptible P. falciparum.

Chloroquine has historically been considered the drug of choice for prevention of malaria in travelers to areas where chloroquine-resistant P. falciparum malaria has not been reported and for treatment of malaria acquired in areas where chloroquine resistance has not been reported. Hydroxychloroquine may be used when chloroquine is unavailable and may be better tolerated than chloroquine. The fact that chloroquine-resistant P. falciparum has now been confirmed in all areas with P. falciparum malaria, except the Caribbean, Central America west of the Panama Canal, and some countries in the Middle East, should be considered when selecting an antimalarial for prevention or treatment of malaria. Chloroquine-resistant P. falciparum also are resistant to hydroxychloroquine.

Because hydroxychloroquine is active only against the asexual erythrocytic forms of Plasmodium (not exoerythrocytic stages), the drug cannot prevent delayed primary attacks or relapse of P. ovale or P. vivax malaria and cannot provide a radical cure in malaria caused by these species. Therefore, terminal prophylaxis with a 14-day regimen of primaquine phosphate may be indicated in addition to hydroxychloroquine prophylaxis if travelers were exposed in areas where P. ovale or P. vivax is endemic and a 14-day regimen of primaquine phosphate also is indicated in conjunction with hydroxychloroquine for treatment of P. ovale or P. vivax malaria.

Patients with severe malaria require aggressive antimalarial treatment with a parenteral regimen of IV quinidine gluconate in conjunction with doxycycline, tetracycline, or clindamycin initiated as soon as possible after the diagnosis.

Information on the risk of malaria transmission in specific countries, information on mosquito avoidance measures, recommendations regarding whether chemoprophylaxis of malaria is indicated, and information on the choice of antimalarials for prevention of malaria are available from the US Centers for Disease Control and Prevention (CDC) at http://wwwnc.cdc.gov/travel and http://www.cdc.gov/malaria.

Assistance with diagnosis or treatment of malaria is available by contacting the CDC Malaria Hotline at 770-488-7788 or 855-856-4713 from 9:00 a.m. to 5:00 p.m. Eastern Standard Time or the CDC Emergency Operation Center at 770-488-7100 after hours and on weekends and holidays.

Rheumatoid Arthritis

Hydroxychloroquine is used in the treatment of rheumatoid arthritis. Hydroxychloroquine is one of several disease-modifying antirheumatic drugs (DMARDs) that can be used when DMARD therapy is appropriate. If 4-aminoquinoline derivatives are used for prolonged periods in the treatment of rheumatoid arthritis, the risk of severe and sometimes irreversible toxicity should be considered.(See Cautions.)

Lupus Erythematosus

Hydroxychloroquine is used as an adjunct to topical corticosteroid therapy in the treatment of discoid lupus erythematosus and as an adjunct to systemic corticosteroids and/or salicylate therapy in the treatment of systemic lupus erythematosus. Hydroxychloroquine therapy may lead to the regression of skin lesions of discoid or systemic lupus erythematosus and may also have a beneficial effect in patients with systemic lupus erythematosus in whom arthritis is a prominent feature. If 4-aminoquinoline derivatives are used for prolonged periods in the treatment of lupus erythematosus, the risk of serious and sometimes irreversible toxicity should be considered.(See Cautions.)

Q Fever

Although doxycycline usually is the drug of choice for the treatment of acute Q fever caused by Coxiella burnetii, a regimen of doxycycline and hydroxychloroquine is recommended for the treatment of Q fever endocarditis.

In a limited study in patients with confirmed C. burnetii infection and chronic endocarditis, a regimen of doxycycline and hydroxychloroquine was associated with a lower relapse rate than a regimen of doxycycline and ofloxacin. Although both regimens require long-term therapy, the mean duration of therapy for cured patients was 55 months for those who received the doxycycline and quinolone regimen compared with 31 months for those who received the doxycycline and hydroxychloroquine regimen. Prolonged therapy (at least 18 months) with the doxycycline and hydroxychloroquine regimen is necessary to prevent relapse. The CDC recommends a 2- to 3-week regimen of doxycycline for the treatment of acute Q fever, a 1-year regimen of doxycycline and hydroxychloroquine for the treatment of acute Q fever in patients with preexisting valvular heart disease (to prevent progression of acute disease to endocarditis), and a 1.5- to 3-year regimen of doxycycline and hydroxychloroquine for the treatment of chronic Q fever.

Porphyria Cutanea Tarda and Polymorphous Light Eruptions

Hydroxychloroquine has been used with some success in the treatment of porphyria cutanea tarda.

Hydroxychloroquine has been effective in some cases when used in the treatment of polymorphous light eruptions.

Dosage and Administration

Administration

Hydroxychloroquine sulfate is administered orally.

When hydroxychloroquine sulfate is used in the treatment of rheumatoid arthritis, the drug should be administered with a meal or glass of milk.

Dosage

Dosage of hydroxychloroquine sulfate is frequently expressed in terms of hydroxychloroquine.

Each 200-mg tablet of hydroxychloroquine sulfate contains 155 mg of hydroxychloroquine.

Malaria

Prevention of Malaria in Areas Without Chloroquine-resistant Plasmodium

If hydroxychloroquine is used as an alternative to chloroquine for prevention of malaria in travelers to areas where chloroquine-resistant Plasmodium has not been reported, hydroxychloroquine prophylaxis should be initiated 1-2 weeks prior to entering the malarious area and continued during the stay and for 4 weeks after leaving the area. Hydroxychloroquine prophylaxis is given once weekly and should be administered on the same day each week.

For prevention of malaria, the usual adult dosage of hydroxychloroquine is 310 mg (400 mg of hydroxychloroquine sulfate) once weekly, and the usual pediatric dosage is 5 mg/kg (6.5 mg/kg of hydroxychloroquine sulfate) once weekly. Pediatric dosage of hydroxychloroquine should not exceed 310 mg (400 mg of hydroxychloroquine sulfate) daily regardless of weight. If hydroxychloroquine therapy was not initiated prior to entering a malarious area, the manufacturer recommends that adults receive a loading dose of hydroxychloroquine of 620 mg (800 mg of hydroxychloroquine sulfate) followed by the usual adult dosage regimen and that children receive a loading dose of 10 mg/kg (13 mg/kg of hydroxychloroquine sulfate) given in 2 equally divided doses 6 hours apart followed by the usual pediatric dosage regimen.

Because hydroxychloroquine cannot prevent delayed primary attacks or relapse of P. ovale or P. vivax malaria and cannot provide a radical cure in malaria caused by these species, terminal prophylaxis with a 14-day regimen of primaquine phosphate may be indicated if exposure to malaria occurred in areas where P. ovale or P. vivax is endemic. Primaquine terminal prophylaxis should be given during the final 2 weeks of hydroxychloroquine prophylaxis or, if that is not feasible, it should be given after hydroxychloroquine prophylaxis has been discontinued.

Treatment of Uncomplicated Chloroquine-susceptible Malaria

For the treatment of uncomplicated malaria caused by P. malariae, P. ovale, chloroquine-susceptible P. vivax, or chloroquine-susceptible P. falciparum, adults should receive an initial hydroxychloroquine dose of 620 mg (800 mg of hydroxychloroquine sulfate) followed by 310 mg (400 mg of hydroxychloroquine sulfate) given at 6-8, 24, and 48 hours after the initial dose. Alternatively, the manufacturer states that a single 620-mg dose of hydroxychloroquine (800 mg of hydroxychloroquine sulfate) may be effective.

For the treatment of uncomplicated malaria in children, an initial dose of 10 mg/kg (13 mg/kg of hydroxychloroquine sulfate) is given followed by 5 mg/kg (6.5 mg/kg of hydroxychloroquine sulfate) given at 6, 24, and 48 hours after the initial dose.

Because hydroxychloroquine cannot prevent relapse of P. ovale or P. vivax malaria, a 14-day regimen of primaquine phosphate is indicated to provide a radical cure whenever hydroxychloroquine is used for the treatment of malaria caused by these species.

Rheumatoid Arthritis

For the treatment of rheumatoid arthritis in adults, the manufacturer recommends an initial hydroxychloroquine dosage of 310-465 mg (400-600 mg of hydroxychloroquine sulfate) daily. In some individuals, adverse effects may require a temporary reduction in dosage of the drug; after 5-10 days, dosage may then be increased gradually until an optimum response occurs without recurrence of adverse effects.

A response to hydroxychloroquine may not occur until after 4-12 weeks of therapy with the drug and several months of therapy may be required to attain optimum response. When a good response is obtained, the manufacturer recommends that dosage be decreased by 50% and that a maintenance dosage of 155-310 mg (200-400 mg of hydroxychloroquine sulfate) daily be used. If relapse occurs after hydroxychloroquine is discontinued, the drug can be reinitiated or continued on an intermittent schedule if there is no evidence of adverse ocular effects. If objective improvement of rheumatoid arthritis (e.g., reduced joint swelling, increased mobility) does not occur within 6 months, hydroxychloroquine should be discontinued.

Lupus Erythematosus

For the treatment of lupus erythematosus, the manufacturer recommends that hydroxychloroquine be given in a dosage of 310 mg (400 mg of hydroxychloroquine sulfate) once or twice daily for several weeks or months depending on the response of the patient. For prolonged maintenance therapy, 155-310 mg (200-400 mg of hydroxychloroquine sulfate) daily may be adequate.

Q Fever

For the treatment of acute Q fever in patients with preexisting valvular heart disease, the US Centers for Disease Control and Prevention (CDC) recommends that hydroxychloroquine be given in a dosage of 465 mg (600 mg of hydroxychloroquine sulfate) daily in conjunction with oral doxycycline (200 mg daily) for 1 year. The dosage of hydroxychloroquine should be adjusted to maintain plasma hydroxychloroquine concentrations at 1 +/- 0.2 mcg/mL. For the treatment of chronic Q fever, the same regimen of hydroxychloroquine and doxycycline should be given for 1.5-3 years.

Dosage in Renal and Hepatic Impairment

The manufacturer makes no specific recommendations regarding the need for dosage adjustment in individuals with renal impairment; however, hydroxychloroquine should be used with caution in such individuals.(See Cautions: Precautions and Contraindications.)

The manufacturer makes no specific recommendations regarding the need for dosage adjustment in individuals with hepatic impairment; however, hydroxychloroquine should be used with caution in individuals with hepatic disease.(See Cautions: Precautions and Contraindications.)

Cautions

Adverse Effects

In dosages used for prevention and treatment of malaria, adverse effects of 4-aminoquinoline derivatives are usually mild and reversible. However, prolonged therapy or high dosage of the drugs, as used in the treatment of rheumatoid arthritis or lupus erythematosus, has been associated with serious and sometimes irreversible toxicity including retinopathy. Although prolonged therapy with high dosages of hydroxychloroquine has been reported to be associated with fewer adverse effects than prolonged use of equivalent dosages of chloroquine, there are no well-controlled studies to substantiate these reports.

Adverse reactions reported with hydroxychloroquine are the same as those reported for chloroquine and include ocular effects (retinopathy), GI effects (anorexia, diarrhea, nausea, abdominal cramps, vomiting), CNS effects (headache, dizziness), and dermatologic effects. Cardiomyopathy has been reported rarely in patients receiving high dosage of hydroxychloroquine. For information on adverse effects associated with the use of 4-aminoquinoline derivatives, see .

Precautions and Contraindications

Hydroxychloroquine is contraindicated in patients who are hypersensitive to 4-aminoquinoline derivatives. Hydroxychloroquine also is contraindicated in patients with retinal or visual field changes attributable to 4-aminoquinoline derivatives or any other etiology.

Because retinopathy and maculopathy have been reported, ophthalmologic examinations, including visual acuity, slit-lamp, funduscopic, and visual field tests, should be performed prior to initiation of hydroxychloroquine therapy and periodically during therapy whenever long-term use of the drug is contemplated. Hydroxychloroquine should be discontinued immediately and the patient observed for possible progression if there is any indication of abnormalities in visual acuity or visual field, abnormalities in the retinal macular area such as pigmentary changes or loss of foveal reflex, or if any other visual symptoms (e.g., light flashes and streaks) occur which are not fully explainable by difficulties of accommodation or corneal opacities. Retinal changes and visual disturbances may continue to progress even after the drug is discontinued.

Hydroxychloroquine should be used with caution in individuals with impaired renal function and/or metabolic acidosis.

Because hydroxychloroquine may concentrate in the liver, the drug should be used with caution in patients with hepatic disease or alcoholism and in patients receiving other hepatotoxic drugs.

Complete blood cell counts (CBCs) should be performed periodically in patients receiving prolonged hydroxychloroquine therapy. Hydroxychloroquine should be discontinued if there is evidence of any severe blood disorder not attributable to the disease being treated. The manufacturer states that hydroxychloroquine should be administered with caution to patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.

Patients receiving prolonged hydroxychloroquine therapy should be questioned and examined periodically for evidence of muscular weakness; knee and ankle reflexes should be tested. If muscular weakness occurs during hydroxychloroquine therapy, the drug should be discontinued.

Hydroxychloroquine has precipitated severe attacks of psoriasis in patients with the disease and should be used in patients with psoriasis only if potential benefits outweigh risks. In addition, because dermatologic reactions may occur, hydroxychloroquine should be used with caution in patients with a tendency for dermatitis.

Because hydroxychloroquine may exacerbate porphyria in patients with the condition, the manufacturer states that the drug should not be used in patients with porphyria unless potential benefits outweigh risks.

Pediatric Precautions

Children are especially sensitive to 4-aminoquinoline derivatives, and fatalities have been reported following accidental ingestion of relatively small doses of chloroquine. Patients should be strongly warned to keep hydroxychloroquine out of the reach of children.

Prolonged therapy with hydroxychloroquine is contraindicated in children; safe use of the drug for the treatment of juvenile arthritis has not been established.

Pregnancy and Lactation

Pregnancy

The manufacturer states that hydroxychloroquine should be avoided during pregnancy, except for prevention or treatment of malaria when the clinician has determined that possible benefits of the drug outweigh potential risks to the fetus.

The US Centers for Disease Control and Prevention (CDC) states that pregnancy is not a contraindication to use of hydroxychloroquine when the drug is indicated for prevention or treatment of malaria.

Some clinicians suggest that it may be prudent to avoid use of hydroxychloroquine in pregnant women with rheumatoid arthritis since these women can be managed with corticosteroids. For pregnant women receiving hydroxychloroquine for the management of systemic lupus erythematosus, some clinicians state that benefits of hydroxychloroquine therapy outweigh potential risks to the fetus.

Studies in pregnant mice using chloroquine indicate that the drug readily crosses the placenta, accumulates selectively in the melanin structures of the fetal eyes, and is retained in the ocular tissue for 5 months after the drug has been eliminated from the rest of the body. However, chloroquine has been used for the prevention and treatment of malaria in pregnant women without evidence of adverse effects on the fetus.

Lactation

The fact that hydroxychloroquine is distributed into human milk should be considered if the drug is used in nursing women. The CDC states that the amount of drug present in human milk does not appear to be harmful to nursing infants, but is insufficient to provide adequate protection against malaria in these infants. If prevention of malaria is necessary, such infants should receive recommended dosages of appropriate antimalarial agent(s).

Pharmacokinetics

Little information is available on the absorption, distribution, and elimination of hydroxychloroquine; however, the pharmacokinetics of hydroxychloroquine and chloroquine appear to be similar.

Hydroxychloroquine is distributed into human milk.

Hydroxychloroquine is partially metabolized; the major metabolites are desethylhydroxychloroquine and desethylchloroquine. Bisdesethylchloroquine, a carboxylic acid derivative, is also formed in small amounts. The excretory patterns are not well characterized, but hydroxychloroquine and its metabolites are slowly excreted by the kidneys.

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