Hydroxychloroquine Sulfate (Page 3 of 3)

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, torsades de pointes, ventricular tachycardia and ventricular fibrillation, followed by sudden potentially fatal respiratory and cardiac arrest. Treatment is symptomatic and must be prompt. Immediate gastric lavage until the stomach is completely emptied is indicated. After lavage, activated charcoal is introduced by the stomach tube within 30 minutes of ingestion of the drug may inhibit further intestinal absorption. To be effective, the dose of activated charcoal should be at least five times the estimated dose of hydroxychloroquine ingested.

Consideration should be given to administering diazepam parenterally since studies suggest that it may be beneficial in reversing chloroquine and hydroxychloroquine cardiotoxicity.

Respiratory support and shock management should be instituted as necessary.

Exchange transfusions are 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. This will promote urinary excretion in cases of both overdosage and sensitivity. However, caution must be exercised in patients with impaired renal function and/or metabolic acidosis.

DOSAGE AND ADMINISTRATION

One hydroxychloroquine sulfate tablet contains 200 mg of hydroxychloroquine sulfate, which is equivalent to 155 mg base.

Take hydroxychloroquine sulfate with a meal or a glass of milk.

Malaria

Prophylaxis

Adults: 400 mg (310 mg base) once weekly on the same day of each week starting 2 weeks prior to exposure, and continued for 4 weeks after leaving the endemic area.

Weight-based dosing in adults and pediatric patients:

6.5 mg/kg (5 mg/kg base), not to exceed 400 mg (310 mg base), once weekly on the same day of the week starting 2 weeks prior to exposure, and continued for 4 weeks after leaving the endemic area.

Treatment of Uncomplicated Malaria

Adults:

800 mg (620 mg base) followed by 400 mg (310 mg base) at 6 hours, 24 hours and 48 hours after the initial dose (total 2000 mg hydroxychloroquine sulfate or 1550 mg base).

Weight based dosage in adults and pediatric patients

13 mg/kg (10 mg/kg base), not to exceed

800 mg (620 mg base) followed by 6.5 mg/kg (5 mg/kg base), not to exceed 400 mg (310 mg base), at 6 hours, 24 hours and 48 hours after the initial dose. Hydroxychloroquine sulfate filmcoated tablets cannot be divided, therefore they should not be used to treat patients who weigh less than 31 kg.

For radical cure of P. vivax and P. malariae infections, concomitant therapy with an

8-aminoquinoline compound is necessary.

Lupus Erythematosus

The recommended adult dosage is 200 to 400 mg (155 to 310 mg base) daily, administered as a single daily dose or in two divided doses. Doses above 400 mg a day are not recommended.

The incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded.

Rheumatoid Arthritis

The action of hydroxychloroquine is cumulative and may require weeks to months to achieve the maximum therapeutic effect (see CLINICAL PHARMACOLOGY).

Initial adult dosage

400 mg to 600 mg (310 to 465 mg base) daily, administered as a single daily dose or in two divided doses. In a small percentage of patients, side effects may require temporary reduction of the initial dosage.

Maintenance adult dosage:

When a good response is obtained, the dosage may be reduced by 50 percent and continued at a maintenance level of 200 mg to 400 mg (155 to 310 mg base) daily, administered as a single daily dose or in two divided doses.

Do not exceed 600 mg or 6.5 mg/kg (5 mg/kg base) per day, whichever is lower, as the incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded.

Corticosteroids and salicylates may be used in conjunction with hydroxychloroquine sulfate, and they can generally be decreased gradually in dosage or eliminated after a maintenance dose of hydroxychloroquine sulfate has been achieved.

HOW SUPPLIED

Hydroxychloroquine Sulfate Tablets, USP contain 200 mg of hydroxychloroquine sulfate, equivalent to 155 mg base, are white to off-white, capsule-shaped, biconvex, film-coated tablets debossed with “ZC38” on one side and plain on other side, and are supplied as follows:

Overbagged with 10 tablets per bag, NDC 55154-2074-0

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children.

Do not crush or divide hydroxychloroquine sulfate film-coated tablets (see DOSAGE AND ADMINISTRATION).

Manufactured by:

Cadila Healthcare Ltd.

India

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Distributed by:

Cardinal Health

Dublin, OH 43017

L43672560419

Rev.: 04/20

Package/Label Display Panel

Hydroxychloroquine Sulfate Tablets, USP

200 mg

10 Tablets

bag label
(click image for full-size original)
HYDROXYCHLOROQUINE SULFATE
hydroxychloroquine sulfate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-2074(NDC:68084-269)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE) HYDROXYCHLOROQUINE SULFATE 200 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
STARCH, CORN
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape OVAL (CAPSULE) Size 13mm
Flavor Imprint Code ZC38
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-2074-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BAG (55154-2074-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040657 08/05/2008
Labeler — Cardinal Health (603638201)

Revised: 06/2020 Cardinal Health

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