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Plaquenil

Generic Name: Hydroxychloroquine Sulfate
Class: Antimalarials
- Disease-Modifying Antirheumatic Drugs
- DMARDS
VA Class: AP101
CAS Number: 747-36-4

Medically reviewed by Drugs.com. Last updated on Jun 15, 2020.

Warning

Special Alerts:

For additional information on the use of this drug in patients with coronavirus disease 2019 (COVID-19), see the document “Assessment of Evidence for COVID-19-Related Treatments” on ASHP's COVID-19 Resource Center. To view this document, please click here: [Web]

Effective June 15, 2020, FDA has revoked the emergency use authorization (EUA) they had previously issued on March 28, 2020 to facilitate the availability of chloroquine and hydroxychloroquine for the treatment of certain hospitalized patients during the COVID-19 pandemic.230 Based on a review of new information and reevaluation of information available at the time the EUA was issued, FDA now concludes that the original criteria for issuance of the EUA for these drugs are no longer met.230 FDA states that the suggested chloroquine and hydroxychloroquine dosage regimens as detailed in the EUA fact sheets for healthcare providers are unlikely to produce an antiviral effect; earlier observations of decreased viral shedding with chloroquine or hydroxychloroquine treatment have not been consistently replicated and recent data from a randomized controlled trial assessing probability of negative conversion showed no difference between hydroxychloroquine and standard of care alone; current US treatment guidelines do not recommend the use of the chloroquine or hydroxychloroquine in hospitalized patients with COVID-19 outside of a clinical trial and the NIH guidelines now recommend against such use outside of a clinical trial; and recent data from a large, randomized, controlled trial showed no evidence of benefit in mortality or other outcomes such as hospital length of stay or need for mechanical ventilation for hydroxychloroquine treatment in hospitalized patients with COVID-19.230 FDA concluded that, based on the totality of scientific evidence available, it is unlikely that chloroquine and hydroxychloroquine may be effective in treating COVID-19 and, in light of ongoing reports of serious cardiac adverse events and several newly reported cases of methemoglobinemia in COVID-19 patients, the known and potential benefits of chloroquine and hydroxychloroquine do not outweigh the known and potential risks associated with the use authorized in the EUA.230 (For information on the EUA that has now been revoked, see Coronavirus Disease 2019 [COVID-19] under Uses.)

Serious adverse events and medication errors associated with chloroquine or hydroxychloroquine must be reported to the FDA MedWatch program at [Web].224 225 226

CDC issued a health advisory concerning inappropriate use of chloroquine and hydroxychloroquine.222 (See Inappropriate Use under Cautions.)

Introduction

Antimalarial; 4-aminoquinoline derivative.109

Uses for Plaquenil

Malaria

Prevention (prophylaxis) of malaria caused by Plasmodium malariae, P. ovale, chloroquine-susceptible P. vivax, and chloroquine-susceptible P. falciparum.109 115 Alternative when chloroquine is unavailable.115 121 134

Treatment of uncomplicated malaria caused by P. malariae, P. ovale, chloroquine-susceptible P. vivax, or chloroquine-susceptible P. falciparum.109 134 143 144 Alternative when chloroquine is unavailable.134 143 144

Do not use for prevention or treatment of malaria in areas where chloroquine resistance has been reported.115 134 143 144 (See Chloroquine-resistant Plasmodium under Cautions.)

Active only against asexual erythrocytic forms of Plasmodium (not exoerythrocytic stages) and cannot prevent delayed primary attacks or relapse of P. ovale or P. vivax malaria or provide a radical cure; 14-day regimen of primaquine usually also indicated to eradicate hypnozoites and prevent relapse in patients exposed to or being treated for P. ovale or P. vivax malaria.109 115 143 144

Information on risk of malaria in specific countries and mosquito avoidance measures and recommendations regarding whether prevention of malaria indicated and choice of antimalarials for prevention available from CDC at [Web] and [Web].115

Assistance with diagnosis or treatment of malaria available by contacting 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 CDC Emergency Operation Center at 770-488-7100 after hours and on weekends and holidays.143 144

Coronavirus Disease 2019 (COVID-19)

Being investigated for and has been used in the management of COVID-19 caused by SARS-CoV-2.197 200 211 218 220 221

Targeted for investigation based on evidence of in vitro activity against SARS-CoV-2198 212 220 and on initial anecdotal reports and preliminary information from small trials.197 218 220 In addition, 4-aminoquinoline derivatives (chloroquine, hydroxychloroquine) have immunomodulatory activity that theoretically could contribute to anti-inflammatory responses in patients with viral infections.193 198 213 215 216

Although efficacy and safety not clearly established,220 224 hydroxychloroquine has been included in some guidelines as an option for treatment of COVID-19.211 220

Various clinical trials evaluating use of hydroxychloroquine (alone or in conjunction with other antivirals or other drugs) have been initiated in the US and other countries.194 200 221 Information on the status of some clinical trials evaluating hydroxychloroquine for treatment or prevention of COVID-19 is available at [Web].200

For some preliminary information on results of initial trials evaluating hydroxychloroquine for management of COVID-19, see the document “Assessment of Evidence for COVID-19-Related Treatments” on ASHP's COVID-19 Resource Center at [Web].

On March 28, 2020, FDA issued an emergency use authorization (EUA) that permits chloroquine and hydroxychloroquine to be distributed from the Strategic National Stockpile (SNS) to public health authorities to facilitate availability of the drugs during the COVID-19 pandemic for use only in hospitalized adults and adolescents weighing ≥50 kg for whom a clinical trial is not available or participation not feasible.224 FDA concluded that emergency use of chloroquine and hydroxychloroquine for treatment of COVID-19 met criteria for issuance of an EUA because SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness; based on the totality of scientific evidence available to FDA, it is reasonable to believe that the drugs may be effective in treating COVID-19 and, when used under EUA conditions, known and potential benefits outweigh known and potential risks; and there are no adequate, approved, and available alternatives to emergency use of chloroquine and hydroxychloroquine for treatment of COVID-19.224 To request chloroquine and/or hydroxychloroquine under the EUA, healthcare providers should contact their local or state health departments;225 226 distribution to states will be managed by the Office of the Assistant Secretary for Preparedness and Response (ASPR) and Federal Emergency Management Agency (FEMA).229 To mitigate risks of this unapproved use, the EUA includes certain mandatory requirements (including adverse event reporting to the FDA MedWatch program).224 225 226 For additional information, consult the EUA,224 EUA fact sheets for healthcare providers,225 226 and EUA fact sheets for patients and parent/caregivers227 228 available at the FDA website.

Lupus Erythematosus

Treatment of discoid lupus erythematosus and systemic lupus erythematosus.109

Consider risk of severe and sometimes irreversible toxicity if used for prolonged periods in treatment of lupus erythematosus.109 (See Cautions.)

Rheumatoid Arthritis

Treatment of rheumatoid arthritis.103 104 109

One of several disease-modifying antirheumatic drugs (DMARDs) that can be used when DMARD therapy is appropriate.103 104

Consider risk of severe and sometimes irreversible toxicity if used for prolonged periods in treatment of rheumatoid arthritis.109 (See Cautions.)

Q Fever

Treatment of Q fever endocarditis caused by Coxiella burnetii; used in conjunction with doxycycline.111 112 113

CDC recommends a 2- to 3-week regimen of doxycycline for treatment of acute Q fever, a 1-year regimen of doxycycline and hydroxychloroquine for 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 treatment of chronic Q fever.113

Porphyria Cutanea Tarda and Polymorphous Light Eruptions

Has been used in treatment of porphyria cutanea tarda.114 116 117 (See Patients with Psoriasis or Porphyria under Cautions.)

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

Plaquenil Dosage and Administration

Administration

Oral Administration

Administer orally with a meal or glass of milk.109 110

Dosage

Available as hydroxychloroquine sulfate; dosage expressed as hydroxychloroquine sulfate or as the base (hydroxychloroquine).109 110

Each 200-mg tablet of hydroxychloroquine sulfate contains 155 mg of hydroxychloroquine.109 110

Pediatric Patients

Malaria
Prevention of Malaria in Areas Without Chloroquine-resistant Plasmodium
Oral

5 mg/kg (6.5 mg/kg of hydroxychloroquine sulfate) once weekly on same day each week.109 115

Initiate prophylaxis 1–2 weeks prior to entering malarious area and continue during stay and for 4 weeks after leaving the area.115

If not initiated prior to entering malarious area, manufacturer recommends a loading dose of 10 mg/kg (13 mg/kg of hydroxychloroquine sulfate) given in 2 equally divided doses 6 hours apart followed by usual dosage.109

If exposure occurred in areas where P. ovale or P. vivax is endemic, terminal prophylaxis with 14-day regimen of primaquine may be indicated;115 give during final 2 weeks of hydroxychloroquine prophylaxis or, if not feasible, give after hydroxychloroquine prophylaxis discontinued.115

Treatment of Uncomplicated Chloroquine-susceptible Malaria
Oral

Initial dose of 10 mg/kg (13 mg/kg of hydroxychloroquine sulfate) followed by 5 mg/kg (6.5 mg/kg of hydroxychloroquine sulfate) given at 6, 24, and 48 hours after initial dose.109 144

Adults

Malaria
Prevention of Malaria in Areas Without Chloroquine-resistant Plasmodium
Oral

310 mg (400 mg of hydroxychloroquine sulfate) once weekly on same day each week.109 115

Initiate prophylaxis 1–2 weeks prior to entering malarious area and continue during stay and for 4 weeks after leaving the area.115

If not initiated prior to entering malarious area, manufacturer recommends a loading dose of 620 mg (800 mg of hydroxychloroquine sulfate) followed by usual dosage.109

If exposure occurred in areas where P. ovale or P. vivax is endemic, terminal prophylaxis with 14-day regimen of primaquine may be indicated;115 give during final 2 weeks of hydroxychloroquine prophylaxis or, if not feasible, give after hydroxychloroquine prophylaxis discontinued.115

Treatment of Uncomplicated Chloroquine-susceptible Malaria
Oral

Initial dose of 620 mg (800 mg of hydroxychloroquine sulfate) followed by 310 mg (400 mg of hydroxychloroquine sulfate) given at 6–8 hours, 24, and 48 hours after initial dose.109 144 Alternatively, manufacturer states that a single 620-mg dose (800 mg of hydroxychloroquine sulfate) may be effective.109

Coronavirus Disease 2019 (COVID-19)
Treatment of COVID-19
Oral

Efficacy and safety not established;224 optimal dosage and duration of treatment not known.220 226

The EUA for hospitalized adults and adolescents weighing ≥50 kg (see Coronavirus Disease 2019 [COVID-19] under Uses) suggests 800 mg of hydroxychloroquine sulfate on day 1, then 400 mg daily for 4–7 days of total treatment based on clinical evaluation.226

Various other dosage regimens recommended in other countries or being investigated are presented below:194 197 198 200 218 220

400 mg of hydroxychloroquine sulfate twice daily on day 1, then 200 mg twice daily on days 2–5.198 220

400 mg of hydroxychloroquine sulfate once or twice daily for 5–10 days.200 218

600 mg of hydroxychloroquine sulfate twice daily on day 1, then 400 mg daily on days 2–5.220

100 or 200 mg of hydroxychloroquine sulfate twice daily for 5–14 days.194

200 mg of hydroxychloroquine sulfate 3 times daily for 10 days.197

Lupus Erythematosus
Oral

310 mg (400 mg of hydroxychloroquine sulfate) once or twice daily for several weeks or months depending on response of the patient.109 For prolonged maintenance therapy, 155–310 mg (200–400 mg of hydroxychloroquine sulfate) daily may be adequate.109

Rheumatoid Arthritis
Oral

Initiate treatment with 310–465 mg (400–600 mg of hydroxychloroquine sulfate) daily.109 If adverse effects occur, dosage may be temporarily reduced; after 5–10 days, increase dosage gradually until an optimum response occurs without recurrence of adverse effects.109

A response may not occur until after 4–12 weeks and several months of therapy may be required to attain optimum response.109 When a good response is obtained, decrease dosage by 50% and continue treatment with a maintenance dosage of 155–310 mg (200–400 mg of hydroxychloroquine sulfate) daily.109

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.109

If objective improvement of rheumatoid arthritis (e.g., reduced joint swelling, increased mobility) does not occur within 6 months, hydroxychloroquine should be discontinued.109

Q Fever
Acute Q Fever in Patients with Preexisting Valvular Heart Disease
Oral

CDC recommends 465 mg (600 mg of hydroxychloroquine sulfate) daily in conjunction with oral doxycycline (200 mg daily) for 1 year.113 Adjust hydroxychloroquine dosage to maintain plasma hydroxychloroquine concentrations at 1 ± 0.2 mcg/mL.113

Chronic Q Fever
Oral

CDC recommends 465 mg (600 mg of hydroxychloroquine sulfate) daily in conjunction with oral doxycycline (200 mg daily) for 1.5–3 years.113

Prescribing Limits

Pediatric Patients

Malaria
Prevention of Malaria in Areas Without Chloroquine-resistant Plasmodium
Oral

Maximum 310 mg (400 mg of hydroxychloroquine sulfate) daily, regardless of weight.115

Special Populations

Hepatic Impairment

Dosage may need to be reduced;110 manufacturer makes no specific recommendations.109 110 (See Hepatic Impairment under Cautions.)

Renal Impairment

Dosage may need to be reduced;110 manufacturer makes no specific recommendations.109 110 (See Renal Impairment under Cautions.)

Cautions for Plaquenil

Contraindications

  • Hypersensitivity to 4-aminoquinoline derivatives.109

Warnings/Precautions

Warnings

Inappropriate Use

CDC issued a health advisory concerning inappropriate use of chloroquine and hydroxychloroquine.222 At least 1 death reported in individuals who ingested non-pharmaceutical chloroquine (marketed for aquarium use) in an attempt to prevent or treat COVID-19.222 Advise patients and the public to not ingest aquarium products or any other chemical products that contain chloroquine since these products are not intended for human consumption and can lead to serious health consequences, including death.222

Advise patients and the public that chloroquine and hydroxychloroquine should be used only under supervision of a healthcare provider.222 Inappropriate uses of chloroquine and hydroxychloroquine include taking any commercially available non-pharmaceutical preparations of the drugs, taking the drugs without a prescription or without supervision of a healthcare provider, and taking additional doses of the drugs not recommended by a healthcare provider.222

Chloroquine-resistant Plasmodium

Chloroquine-resistant P. falciparum 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.115

High prevalence of chloroquine-resistant P. vivax confirmed in Papua New Guinea and Indonesia;115 143 also reported in Burma (Myanmar), India, and Central and South America.143

Do not use for prevention of malaria in individuals traveling to malarious areas where chloroquine-resistant P. falciparum or chloroquine-resistant P. vivax malaria reported.115 134

Do not use for treatment of uncomplicated P. falciparum malaria or uncomplicated malaria caused by unidentified plasmodial species if the infection was acquired in areas with chloroquine resistance.143 144

Ocular Effects

Dose-related retinopathy reported, which may progress even after the drug is discontinued.109 Irreversible retinal damage has occurred in some patients who received long-term or high-dosage 4-aminoquinoline therapy for treatment of discoid and systemic lupus erythematosus or rheumatoid arthritis.109

Whenever long-term therapy contemplated, perform initial (base line) and periodic (every 3 months) ophthalmologic examinations, including visual acuity, slit-lamp, funduscopic, and visual field tests.109

Immediately discontinue hydroxychloroquine and closely observe patient 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.109

Cardiac Effects

Life-threatening and fatal cardiomyopathy reported in patients receiving 4-aminoquinolines, including hydroxychloroquine and chloroquine.110 Hydroxychloroquine prolongs QT interval and ventricular arrhythmias and torsades de pointes reported.110

Signs or symptoms of cardiac compromise reported with both acute and chronic hydroxychloroquine treatment.110 Patients may present with AV block, pulmonary hypertension, sick sinus syndrome, or with cardiac complications; ECG findings may include AV block or right or left bundle branch block.110 Consider chronic toxicity when conduction disorders (bundle branch block/AV heart block) or biventricular hypertrophy diagnosed.110

Monitor for signs and symptoms of cardiomyopathy (e.g., ECGs) and avoid concomitant use with other drugs that have potential to prolong QT interval.110

If cardiotoxicity suspected, prompt discontinuance of hydroxychloroquine may prevent life-threatening complications.110

Hypoglycemic Effects

May cause severe hypoglycemia, including loss of consciousness, that could be life threatening; reported in patients receiving or not receiving treatment with antidiabetic agents.110

Advise patients about risk of hypoglycemia and associated clinical signs and symptoms.110 If clinical symptoms suggestive of hypoglycemia occur during hydroxychloroquine treatment, assess blood glucose and review treatment as clinically indicated.110 In patients already receiving insulin or other antidiabetic agents, consider that decreased dosage of these drugs may be required.110

Neuropsychiatric Events

Neuropsychiatric events (affect/emotional lability, nervousness, irritability, nightmares, psychosis, suicidality) reported rarely.110

CNS Effects

Headache, dizziness, seizures, ataxia, and extrapyramidal disorders (e.g., dystonia, dyskinesia, tremor) reported with 4-aminoquinolines.110

Neuromuscular Effects

Skeletal muscle palsies or skeletal muscle myopathy or neuromyopathy reported.109 May lead to progressive weakness and atrophy of proximal muscle groups and may be associated with mild sensory changes, depression of tendon reflexes, and abnormal nerve conduction.109

Patients receiving prolonged therapy should be questioned and examined periodically for evidence of muscular weakness; test knee and ankle reflexes.109

Discontinue hydroxychloroquine if muscular weakness occurs.109

Patients with Psoriasis or Porphyria

May exacerbate psoriasis and precipitate a severe attack in patients with the disease.109 Use in psoriasis patients only if potential benefits outweigh risks.109

May exacerbate porphyria.109 Use in patients with porphyria only if potential benefits outweigh risks.109

Sensitivity Reactions

Hypersensitivity Reactions

Erythema multiforme,109 Stevens-Johnson syndrome,109 toxic epidermal necrolysis,109 exfoliative dermatitis,109 and photosensitivity109 reported rarely.

General Precautions

Dermatologic Effects

Dermatologic reactions may occur; use with caution in patients with tendency for dermatitis.109

Hematologic Effects

Aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia (hemolysis in patients with G-6-PD deficiency) reported rarely.109

Periodically monitor CBCs in patients receiving prolonged treatment.109 Consider discontinuing hydroxychloroquine if any severe blood disorder occurs and is not attributable to the disease being treated.109

Use with caution in patients with G-6-PD deficiency.109

Specific Populations

Pregnancy

Category C.b

Chloroquine has been used for prevention and treatment of malaria in pregnant women without evidence of adverse effects on the fetus.115 134

Manufacturer states avoid during pregnancy, except for prevention or treatment of malaria when clinician determines that possible benefits of the drug outweigh potential risks to fetus.109

CDC states pregnancy not a contraindication when hydroxychloroquine indicated for prevention or treatment of malaria.115 143

Lactation

Distributed into milk.102 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.115 When prevention of malaria indicated, such infants should receive recommended dosages of appropriate antimalarial agent(s).115

Pediatric Use

Pediatric patients are especially sensitive to 4-aminoquinoline derivatives.109 Fatalities reported following accidental ingestion of relatively small doses.109

Safety and efficacy for treatment of systemic lupus erythematosus or juvenile idiopathic arthritis in pediatric patients not established.109 110

Hepatic Impairment

May concentrate in the liver;a use with caution in patients with hepatic disease or alcoholism and in those receiving other hepatotoxic drugs.109

Renal Impairment

Possible increased risk of toxicity in patients with impaired renal function;109 use with caution in individuals with impaired renal function and/or metabolic acidosis.109

Common Adverse Effects

Ocular effects; skeletal muscle myopathy or neuromyopathy; GI effects (anorexia, diarrhea, nausea, abdominal cramps, vomiting); CNS effects (headache, dizziness); dermatologic effects.109

Interactions for Plaquenil

Drugs that Prolong QT Interval

Concomitant use with drugs known to prolong QT interval may increase risk of QT interval prolongation and ventricular arrhythmias;110 concomitant use not recommended.110

Specific Drugs

Drug

Interaction

Comments

Ampicillin

Possible reduced ampicillin bioavailability based on reports with chloroquine110

Antacids

Possible reduced GI absorption based on reports with chloroquine110

Anticonvulsants

Possible decreased anticonvulsant effects if used with hydroxychloroquine110

Antidiabetic agents (insulin, other antidiabetic agents)

Possible enhanced hypoglycemic effects if used with hydroxychloroquine110

May need to decrease dosage of insulin or other antidiabetic agents110

Cimetidine

Studies using chloroquine indicate possible inhibition of chloroquine metabolism and increased concentrations of the drug110

Cyclosporine

Increased cyclosporine concentrations reported110

Digoxin

Possible increased digoxin concentrations if used with hydroxychloroquine

Monitor digoxin concentrations110

Mefloquine

Increased risk of seizures if used with hydroxychloroquine; both drugs lower seizure threshold110

Methotrexate

Concomitant use with hydroxychloroquine not studied; possible increased risk of adverse effects110

Praziquantel

Possible decreased praziquantel concentrations based on reports with chloroquine110

Plaquenil Pharmacokinetics

Distribution

Extent

Distributed into milk.102

Elimination

Metabolism

Partially metabolized; major metabolites are desethylhydroxychloroquine and desethylchloroquine.100 Bisdesethylchloroquine, a carboxylic acid derivative, also formed in small amounts.100

Elimination Route

Hydroxychloroquine and its metabolites slowly excreted by the kidneys.100

Half-life

Mean elimination half-life of about 40 days;106 110 considerable interindividual variation.106

Stability

Storage

Oral

Tablets

Room temperature ≤30°C in tight, light-resistant container.109

Actions and Spectrum

  • A blood schizonticidal agent active against asexual erythrocytic forms of most strains of Plasmodium malariae, P. ovale, P. vivax, and susceptible P. falciparum.a Not active against preerythrocytic or exoerythrocytic forms of plasmodia.a Gametocidal for P. malariae and P. vivax, but has no direct activity against gametocytes of P. falciparum.a

  • Chloroquine-resistant P. falciparum confirmed in all areas where P. falciparum malaria occurs, except the Caribbean, Central America west of the Panama Canal, and some countries in the Middle East.115

  • High prevalence of chloroquine-resistant P. vivax confirmed in Papua New Guinea and Indonesia.115 143 Chloroquine-resistant P. vivax also documented in Burma (Myanmar), India, and Central and South America.143

  • To date, no widespread evidence of chloroquine resistance in P. malariae, P. ovale, or P. knowlesi.143 161

  • Chloroquine-resistant P. falciparum also are resistant to hydroxychloroquine109 and may be cross-resistant to pyrimethamine or quinine.a Cross-resistance between chloroquine and mefloquine reported in P. falciparum and P. vivax in vitro.152 153

  • Has in vitro activity against various viruses, including coronaviruses.195 198 212 213 214

  • Evidence of in vitro activity against SARS-CoV-2 (causative agent of COVID-19).198 212 In addition to in vitro activity in Vero E6 cells infected with SARS-CoV-2, there is some evidence the drug may block infection when uninfected cells are exposed to SARS-CoV-2.198 212

  • Has anti-inflammatory activity.a

  • Mechanism(s) of action in the treatment of rheumatoid arthritis and lupus erythematosus not fully determined.a

Advice to Patients

  • Importance of keeping hydroxychloroquine out of reach of children since they are especially sensitive to 4-aminoquinoline derivatives.109

  • For prevention of malaria, necessity of starting hydroxychloroquine prophylaxis 1–2 weeks before arriving in an area with malaria and continuing during and for 4 weeks after leaving the area.115

  • Necessity of taking protective measures to reduce contact with mosquitoes (protective clothing, insect repellents, mosquito nets, remaining in air-conditioned or well-screened areas).115 121 134

  • Possibility of contracting malaria during travel, regardless of prophylactic regimen used.115 121 134

  • Importance of seeking medical attention as soon as possible if febrile illness develops during or after return from a malaria-endemic area and of informing clinician of possible malaria exposure.115 121 134

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.109

  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.109

  • Importance of advising patients of other important precautionary information.109 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Hydroxychloroquine Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

200 mg (155 mg of hydroxychloroquine base)*

Hydroxychloroquine Sulfate Tablets

Plaquenil

Concordia

AHFS DI Essentials™. © Copyright 2020, Selected Revisions June 15, 2020. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

100. McChesney EW. Animal toxicity and pharmacokinetics of hydroxychloroquine sulfate. Am J Med. 1983; 75(Suppl. 1A):11-8. http://www.ncbi.nlm.nih.gov/pubmed/6408923?dopt=AbstractPlus

101. Janssen NM, Genta MS. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation. Arch Inter Med. 2000; 160:610-9.

102. American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 1989; 84:924-36. http://www.ncbi.nlm.nih.gov/pubmed/2677964?dopt=AbstractPlus

103. Singh JA, Furst DE, Bharat A et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012; 64:625-39. http://www.ncbi.nlm.nih.gov/pubmed/22473917?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=4081542&blobtype=pdf

104. . Drugs for rheumatoid arthritis. Treat Guidel Med Lett. 2012; 10:37-44; quiz 2 p following 44. http://www.ncbi.nlm.nih.gov/pubmed/22538522?dopt=AbstractPlus

105. Clark P, Casas E, Tugwell P et al. Hydroxychloroquine compared with placebo in rheumatoid arthritis: a randomized controlled trial. Ann Intern Med. 1993; 119:1067-71. http://www.ncbi.nlm.nih.gov/pubmed/8239224?dopt=AbstractPlus

106. Tett SE, Cutler DJ, Day RO et al. A dose-ranging study of the pharmacokinetics of hydroxy-chloroquine following intravenous administration to healthy volunteers. Br J Clin Pharmacol. 1988; 26:303-13. http://www.ncbi.nlm.nih.gov/pubmed/3179169?dopt=AbstractPlus

107. Harris ED Jr. Hydroxychloroquine is safe and probably useful in rheumatoid arthritis. Ann Intern Med. 1993; 119:1146-7. http://www.ncbi.nlm.nih.gov/pubmed/8239236?dopt=AbstractPlus

108. Makin AJ, Wendon J, Fitt S. Fulminant hepatic failure secondary to hydroxychloroquine. Gut. 1994; 35:569-70. http://www.ncbi.nlm.nih.gov/pubmed/8175002?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=1374814&blobtype=pdf

109. Sanofi-Aventis US. Plaquenil (hydroxychloroquine sulfate) tablets prescribing information. Bridgewater, NJ; 2012 Apr.

110. Actavis Pharma. Hydroxychloroquine sulfate tablets prescribing information. Parsippany, NJ; 2017 Nov.

111. Raoult D, Houpikian P, Dupont HT et al. Treatment of Q fever endocarditis: comparison of 2 regimens containing doxycycline and ofloxacin or hydrochloroquine. Arch Intern Med. 1999; 159:167-73. http://www.ncbi.nlm.nih.gov/pubmed/9927100?dopt=AbstractPlus

112. Lupoglazoff JM, Brouqui P, Magnier S et al. Q fever tricuspid valve endocarditis. Arch Dis Child. 1997; 77:448-9. http://www.ncbi.nlm.nih.gov/pubmed/9487972?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=1717388&blobtype=pdf

113. Centers for Disease Control and Prevention. Q fever—California, Georgia, Pennsylvania, and Tennessee, 2000-2001. MMWR Morb Mortal Wkly Rep. 2002; 51:924-5. http://www.ncbi.nlm.nih.gov/pubmed/12403408?dopt=AbstractPlus

114. Bruce AJ, Ahmed I. Childhood-onset porphyria cutanea tarda: successful therapy with low-dose hydroxychloroquine (Plaquenil). J Am Acad Dermatol. 1998; 38(5 pt 2):810-3. http://www.ncbi.nlm.nih.gov/pubmed/9591792?dopt=AbstractPlus

115. Centers for Disease Control and Prevention. CDC health information for international travel, 2014. Atlanta, GA: US Department of Health and Human Services. Updates may be available at CDC website. http://wwwnc.cdc.gov/travel/page/yellowbook-home-2014.htm

116. Wallace DJ. The use of chloroquine and hydroxychloroquine for non-infectious conditions other than rheumatoid arthritis or lupus: a critical review. Lupus. 1996; 5(Suppl 1):S59-64.

117. Petersen CS, Thomsen K. High-dose hydroxychloroquine treatment of porphyria cutanea tarda. J Am Acad Dermatol. 1992; 26:614-9. http://www.ncbi.nlm.nih.gov/pubmed/1597548?dopt=AbstractPlus

121. . Advice for travelers. Treat Guidel Med Lett. 2012; 10:45-56. http://www.ncbi.nlm.nih.gov/pubmed/22777212?dopt=AbstractPlus

134. Anon. Drugs for parasitic infections. Treat Guidel Med Lett. 2010; 8:e1-16. http://www.medletter.com

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