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Hydroxychloroquine Sulfate

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Overview

What is Plaquenil?

Hydroxychloroquine sulfate is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1).

PLAQUENIL (hydroxychloroquine sulfate) tablets contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration.

Inactive Ingredients:



What does Plaquenil look like?



What are the available doses of Plaquenil?

Sorry No records found.

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

Sorry No records found

How should I use Plaquenil?

PLAQUENIL is indicated for the suppressive treatment and treatment of acute attacks of malaria due to , , , and susceptible strains of . It is also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis.


What interacts with Plaquenil?

Use of this drug is contraindicated (1) in the presence of retinal or visual field changes attributable to any 4-aminoquinoline compound, (2) in patients with known hypersensitivity to 4-aminoquinoline compounds, and (3) for long-term therapy in children.



What are the warnings of Plaquenil?

Sorry No Records found


What are the precautions of Plaquenil?

Sorry No Records found


What are the side effects of Plaquenil?

Psychiatric disorders:

Nervous system disorders:

Eye disorders:

To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email

; or FDA at 1-800-FDA-1088 or

.


What should I look out for while using Plaquenil?

Use of this drug is contraindicated (1) in the presence of retinal or visual field changes attributable to any 4-aminoquinoline compound, (2) in patients with known hypersensitivity to 4-aminoquinoline compounds, and (3) for long-term therapy in children.

PLAQUENIL is not effective against chloroquine-resistant strains of .

Before starting a long-term treatment, both eyes should be carefully examined for visual acuity, central visual field, and color vision. Examination should also include fundoscopy. These examinations should be repeated at least annually. Retinal toxicity is largely dose-related

The risk of retinal damage is small with daily doses of up to 6.5 mg/kg body weight. Exceeding the recommended daily dose sharply increases the risk of retinal toxicity. This examination should be more frequent and adapted to the patient in the following situations:

If any visual disturbance occurs (visual acuity, color vision), the drug should be immediately discontinued and the patient closely observed for possible progression of the abnormality. Retinal changes (and visual disturbances) may progress even after cessation of the therapy. (see ).

Suicidal behavior has been reported in very rare cases in patients treated with hydroxychloroquine.

Children are especially sensitive to the 4-aminoquinoline compounds. A number of fatalities have been reported following the accidental ingestion of chloroquine, sometimes in relatively small doses (0.75 g or 1 g in one 3-year-old child). Patients should be strongly warned to keep these drugs out of the reach of children.

Use of PLAQUENIL in patients with psoriasis may precipitate a severe attack of psoriasis. When used in patients with porphyria the condition may be exacerbated. The preparation should not be used in these conditions unless in the judgment of the physician the benefit to the patient outweighs the possible hazard.


What might happen if I take too much Plaquenil?

The 4-aminoquinoline compounds are very rapidly and completely absorbed after ingestion, and in accidental overdosage, or rarely with lower doses in hypersensitive patients, toxic symptoms may occur within 30 minutes. The symptoms of overdosage may include headache, drowsiness, visual disturbances, cardiovascular collapse, convulsions, hypokalemia, rhythm and conduction disorders including QT prolongation, torsade de pointe, ventricular tachycardia and ventricular fibrillation, followed by sudden potentially fatal respiratory and cardiac arrest. Immediate medical attention is required, as these effects may appear shortly after the overdose. Treatment is symptomatic and must be prompt with immediate evacuation of the stomach by emesis (at home, before transportation to the hospital) or gastric lavage until the stomach is completely emptied. If finely powdered, activated charcoal is introduced by the stomach tube, after lavage, and within 30 minutes after ingestion of the tablets, it may inhibit further intestinal absorption of the drug. To be effective, the dose of activated charcoal should be at least five times the estimated dose of hydroxychloroquine ingested. Convulsions, if present, should be controlled before attempting gastric lavage. If due to cerebral stimulation, cautious administration of an ultrashort-acting barbiturate may be tried but, if due to anoxia, it should be corrected by oxygen administration, artificial respiration or, in shock with hypotension, by vasopressor therapy. Because of the importance of supporting respiration, tracheal intubation or tracheostomy, followed by gastric lavage, may also be necessary. Exchange transfusions have been used to reduce the level of 4-aminoquinoline drug in the blood.

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 and sensitivity.


How should I store and handle Plaquenil?

Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [].PLAQUENIL tablets are white, to off-white, film coated tablets imprinted "PLAQUENIL" on one face in black ink. Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). Bottles of 90 tablets ((NDC 42291-335-90).Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children.Store at room temperature up to 30° C (86° F).Manufactured for:AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 08/15AV 07/16 (P)PLAQUENIL tablets are white, to off-white, film coated tablets imprinted "PLAQUENIL" on one face in black ink. Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). Bottles of 90 tablets ((NDC 42291-335-90).Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children.Store at room temperature up to 30° C (86° F).Manufactured for:AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 08/15AV 07/16 (P)PLAQUENIL tablets are white, to off-white, film coated tablets imprinted "PLAQUENIL" on one face in black ink. Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). Bottles of 90 tablets ((NDC 42291-335-90).Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children.Store at room temperature up to 30° C (86° F).Manufactured for:AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 08/15AV 07/16 (P)PLAQUENIL tablets are white, to off-white, film coated tablets imprinted "PLAQUENIL" on one face in black ink. Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). Bottles of 90 tablets ((NDC 42291-335-90).Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children.Store at room temperature up to 30° C (86° F).Manufactured for:AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 08/15AV 07/16 (P)PLAQUENIL tablets are white, to off-white, film coated tablets imprinted "PLAQUENIL" on one face in black ink. Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). Bottles of 90 tablets ((NDC 42291-335-90).Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children.Store at room temperature up to 30° C (86° F).Manufactured for:AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 08/15AV 07/16 (P)PLAQUENIL tablets are white, to off-white, film coated tablets imprinted "PLAQUENIL" on one face in black ink. Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). Bottles of 90 tablets ((NDC 42291-335-90).Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children.Store at room temperature up to 30° C (86° F).Manufactured for:AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 08/15AV 07/16 (P)PLAQUENIL tablets are white, to off-white, film coated tablets imprinted "PLAQUENIL" on one face in black ink. Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). Bottles of 90 tablets ((NDC 42291-335-90).Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children.Store at room temperature up to 30° C (86° F).Manufactured for:AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 08/15AV 07/16 (P)