Hydroxychloroquine Sulfate 200 MG Oral Tablet
Generic Name: HYDROXYCHLOROQUINE SULFATE
Brand Name: Hydroxychloroquine Sulfate
- Substance Name(s):
- HYDROXYCHLOROQUINE SULFATE
WARNINGS
, General Hydroxychloroquine sulfate tablets are not effective against chloroquine-resistant strains of P.
falciparum.
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: daily dosage exceeding 6.5 mg/kg ideal body weight.
Absolute body weight used as a guide to dosage could result in an overdosage in the obese; renal insufficiency; cumulative dose more than 200 g; elderly; impaired visual acuity.
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 ADVERSE REACTIONS).
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 Hydroxychloroquine sulfate tablets 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.
Usage in Pregnancy- Usage of this drug during pregnancy should be avoided except in the suppression or treatment of malaria when in the judgment of the physician the benefit outweighs the possible hazard.
It should be noted that radioactively-tagged chloroquine administered intravenously to pregnant, pigmented CBA mice passed rapidly across the placenta.
It accumulated selectively in the melanin structures of the fetal eyes and was retained in the ocular tissues for five months after the drug had been eliminated from the rest of the body.
OVERDOSAGE
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.
DESCRIPTION
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).
Hydroxychloroquine sulfate tablets contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration.
Inactive Ingredients: Dibasic Calcium Phosphate, Hydroxypropyl Methylcellulose, Magnesium Stearate, Polyethylene glycol 400, Polysorbate 80, Corn Starch, Titanium Dioxide.
HOW SUPPLIED
Hydroxychloroquine sulfate 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 100 tablets (NDC 66993-057-02) and 500 tablets (NDC 66993-057-04).
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).
Distributed by Prasco Laboratories Mason, OH 45040 USA Revised July 2015 ©2015 Prasco Laboratories All rights reserved.
50113998
INDICATIONS AND USAGE
INDICATIONS Hydroxychloroquine sulfate tablets are indicated for the suppressive treatment and treatment of acute attacks of malaria due to Plasmodium vivax, P.
malariae, P.
ovale, and susceptible strains of P.
falciparum.
It is also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis.
BOXED WARNING
WARNING PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING HYDROXYCHLOROQUINE.
DOSAGE AND ADMINISTRATION
Dosage and Administration One tablet of 200 mg of hydroxychloroquine sulfate is equivalent to 155 mg base.
Malaria: Suppression- In adults, 400 mg (=310 mg base) on exactly the same day of each week.
In infants and children, the weekly suppressive dosage is 5 mg, calculated as base, per kg of body weight, but should not exceed the adult dose regardless of weight.
If circumstances permit, suppressive therapy should begin two weeks prior to exposure.
However, failing this, in adults an initial double (loading) dose of 800 mg (=620 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.
Treatment of acute attack- In adults, an initial dose of 800 mg (= 620 mg base) followed by 400 mg (=310 mg base) in six to eight hours and 400 mg (=310 mg base) on each of two consecutive days (total 2 g hydroxychloroquine sulfate or 1.55 g base).
An alternative method, employing a single dose of 800 mg (=620 mg base), has also proved effective.
The dosage for adults may also be calculated on the basis of body weight; this method is preferred for infants and children.
A total dose representing 25 mg of base per kg of body weight is administered in three days, as follows: First dose: 10 mg base per kg (but not exceeding a single dose of 620 mg base).
Second dose: 5 mg base per kg (but not exceeding a single dose of 310 mg base) 6 hours after first dose.
Third dose: 5 mg base per kg 18 hours after second dose.
Fourth dose: 5 mg base per kg 24 hours after third dose.
For radical cure of vivax and malariae malaria concomitant therapy with an 8-aminoquinoline compound is necessary.