Plaquenil

Plaquenil

hydroxychloroquine

Manufacturer:

sanofi-aventis

Distributor:

Distriphil
Concise Prescribing Info
Contents
Hydroxychloroquine sulfate
Indications/Uses
RA, discoid & SLE & dermatological conditions caused or aggravated by sunlight in adults. Juvenile idiopathic arthritis (in combination w/ other therapies), discoid & SLE in childn.
Dosage/Direction for Use
Adult & elderly Employ min effective dose not exceeding 6.5 mg/kg/day (calculated from ideal body wt & not actual body wt); either 200 or 400 mg/day. In patient able to receive 400 mg daily Initially, 400 mg daily in divided doses; may reduce dose to 200 mg when no further improvement is evident. Maintenance: Increase to 400 mg daily if response lessens. Childn Employ min effective dose not exceeding 6.5 mg/kg/day based on ideal body wt.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to hydroxychloroquine sulfate & 4-aminoquinoline compd. Preexisting maculopathy of the eye. Childn <6 yr (200-mg tab not adapted for <35 kg) or for ideal body wt <31 kg.
Special Precautions
Carry out ophth exam before treatment & at least every 12 mth, but more frequently in treatment w/ daily dosage >6.5 mg/kg, renal insufficiency, visual acuity below 6/8, elderly >65 yr, cumulative dose >200 g. Discontinue if patient develops pigmentary abnormality, visual field defect or other abnormalities not explained by difficulty in accommodation. Concomitant use w/ tamoxifen is not recommended. Risk of hypoglycemia in patients treated w/ or w/o antidiabetics. Patients w/ congenital or documented acquired QT prolongation &/or known risk factors for prolongation of the QT interval eg, cardiac disease (eg, heart failure, MI), proarrhythmic conditions (eg, bradycardia <50 bpm), history of ventricular dysrhythmias, uncorrected hypokalemia &/or hypomagnesemia, during concomitant administration w/ QT interval prolonging agents. Discontinue if cardiac arrhythmia occurs during treatment. Cardiomyopathy resulting in cardiac failure. Patients taking medicines which may cause adverse ocular or skin reactions. Patients w/ hepatic or renal disease; severe GI, neurological, or blood disorders. Sensitivity to quinine, G6PD deficiency, porphyria cutanea tarda, psoriasis. Perform periodic blood counts & exam of skeletal muscle function & tendon reflexes in patients on long-term therapy. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Extrapyramidal disorders may occur. Not to be used in the treatment & prophylaxis, or prevention of relapse of malaria due to chloroquine-resistant strains of P. falciparum & the exo-erythrocytic form of P. vivax, P. ovale & P. malariae. Potential carcinogenic risk. Suicidal behavior has been reported (in very rare cases). May affect ability to drive & operate machinery. Pregnancy & lactation. Childn.
Adverse Reactions
Abdominal pain, nausea. Anorexia; affect lability; headache; blurring of vision due to a disturbance of accommodation which is dose dependent & reversible; diarrhea, vomiting; skin rash, pruritus. Nervousness; dizziness; retinopathy, w/ changes in pigmentation & visual field defects; vertigo, tinnitus; abnormal LFTs; pigmentation disorders in skin & mucous membranes bleaching of hair, alopecia; sensorimotor disorders.
Drug Interactions
Enhanced hypoglycemic effect of insulin or antidiabetics. Increased risk of ventricular arrhythmias w/ drugs known to prolong QT intervals eg, class IA & III antiarrhythmics, TCA, antipsychotics, some anti-infectives. Not to be administered w/ halofantrine. Increased risk of convulsions w/ other antimalarials eg, mefloquine. Impaired activity of antiepileptics. May inhibit intracellular α-galactosidase activity w/ agalsidase. Reduced absorption w/ Mg-containing antacids or kaolin (administer at least 2 hr apart). Increased exposure w/ cimetidine. Lack of efficacy w/ rifampicin. Strong or moderate inhibitors (eg, gemfibrozil, clopidogrel, ritonavir, itraconazole, clarithromycin, grapefruit juice) & strong inducers (eg, rifampicin, St. John's Wort, carbamazepine, phenobarb) of CYP2C8 & CYP3A4. Increased serum digoxin levels. Potential increased conc of P-gp substrates. Increased AUC & Cmax of metoprolol. CYP2D6 substrates (eg, flecainide, propafenone) May reduce bioavailability of praziquantel.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
ATC Classification
P01BA02 - hydroxychloroquine ; Belongs to the class of aminoquinoline antimalarials.
Presentation/Packing
Form
Plaquenil FC tab 200 mg
Packing/Price
60's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in