hydroxychloroquine sulfate (Rx)

Brand and Other Names:Plaquenil
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 200mg

Malaria

Prophylaxis

  • Indicated for prophylaxis of malaria in geographic areas where chloroquine resistance is not reported
  • 400 mg (310 mg base) PO weekly, starting 2 weeks before exposure and continued for 4 weeks after departure from endemic area OR
  • Weight-based dosing: 6.5 mg/kg (5 mg/kg base) PO once weekly, not to exceed 400 mg (310 mg base), starting 2 weeks before exposure and continued for 4 weeks after leaving the endemic area  

Acute treatment

  • Indicated for treatment of uncomplicated malaria due to P falciparum, P malariae, P ovale, and P vivax
  • 800 mg (620 mg base) PO, then 400 mg (310 mg base) PO at 6 hr, 24 hr, and 48 hr after initial dose
  • Weight-based dosing: 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), PO at 6 hr, 24 hr, and 48 hr after initial dose  

Rheumatoid Arthritis

Indicated for treatment of acute and chronic rheumatoid arthritis

400-600 mg/day (310-465 mg base/day) PO as a qDay or in BID

When a good response is obtained, reduce dosage by 50% and continue maintenance dose of 200-400 mg/day (155-310 mg base/day) PO as a qDay or in BID; 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

Use corticosteroids and salicylates in conjunction with hydroxychloroquine; gradually decrease dosage or eliminate after a maintenance dose has been achieved

Systemic Lupus Erythematosus

Indicated for treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus

200-400 mg/day (155-310 mg base/day) PO as a single daily dose or in two divided doses

Doses >400 mg/day are not recommended

Incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded

Coronavirus Disease 2019 (COVID-19) (Off-label)

Data available as of June 15, 2020

FDA revoked the emergency use authorization (EUA) that hydroxychloroquine donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible

Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that hydroxychloroquine is unlikely to be effective in treating COVID-19 for the authorized uses in the EUA; additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of hydroxychloroquine no longer outweigh the known and potential risks for the EUA

While additional clinical trials may continue to evaluate potential benefit, the FDA determined the EUA was no longer appropriate

For more information, see the FDA news release: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine

Additional Medscape COVID-19 references are available

Porphyria Cutanea Tarda (Off-label)

100-200 mg (77.5-155 mg base) PO 2-3 times/wk

Dosing Considerations

A reduction in dosage may be necessary for patients with hepatic or renal disease

Before prescribing hydroxychloroquine for treatment or prophylaxis of malaria, consult the Centers for Disease Control and Prevention (CDC) Malaria website (link http://www.cdc.gov/malaria)

Limitations of use in malaria

  • Not recommended for treatment of complicated malaria
  • Not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species
  • Not recommended for treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified
  • Not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs
  • Does not prevent relapses of P vivax or P ovale because it is not active against the hypnozoite forms of these parasites
  • For radical cure of P vivax and P ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary

Dosage Forms & Strengths

tablet

  • 200mg

Malaria

Prophylaxis

  • Indicated for prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
  • 6.5 mg/kg (5 mg/kg base) PO once weekly, not to exceed 400 mg (310 mg base), starting 2 weeks before exposure and continued for 4 weeks after leaving the endemic area  

Acute treatment

  • Indicated for treatment of uncomplicated malaria due to P falciparum, P malariae, P ovale, and P vivax
  • 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), PO at 6 hr, 24 hr, and 48 hr after initial dose  

Porphyria Cutanea Tarda (Off-label)

Dosing schedules not well established in children

A case report describes 3 mg/kg PO twice weekly over 14 months reported as safe and effective in a child aged 4 yr

Dosing Considerations

Before to prescribing hydroxychloroquine for treatment or prophylaxis of malaria, consult the Centers for Disease Control and Prevention (CDC) Malaria website (link http://www.cdc.gov/malaria)

Limitations of use in malaria

  • Not recommended for treatment of complicated malaria
  • Not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species
  • Not recommended for treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified
  • Not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs
  • Does not prevent relapses of P vivax or P ovale because it is not active against the hypnozoite forms of these parasites
  • For radical cure of P vivax and P ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary
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Interactions

Interaction Checker

and hydroxychloroquine sulfate

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            Contraindicated (1)

            • lefamulin

              lefamulin will increase the level or effect of hydroxychloroquine sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Lefamulin is contraindicated with CYP3A substrates know to prolong the QT interval.

            Serious - Use Alternative (179)

            • adalimumab

              adalimumab and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • albuterol

              albuterol and hydroxychloroquine sulfate both increase QTc interval. Avoid or Use Alternate Drug.

            • alefacept

              alefacept and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • alfuzosin

              hydroxychloroquine sulfate and alfuzosin both increase QTc interval. Avoid or Use Alternate Drug.

              alfuzosin and hydroxychloroquine sulfate both increase QTc interval. Avoid or Use Alternate Drug.

            • amiodarone

              hydroxychloroquine sulfate and amiodarone both increase QTc interval. Avoid or Use Alternate Drug.

            • amitriptyline

              hydroxychloroquine sulfate and amitriptyline both increase QTc interval. Avoid or Use Alternate Drug.

            • amoxapine

              hydroxychloroquine sulfate and amoxapine both increase QTc interval. Avoid or Use Alternate Drug.

            • anakinra

              anakinra and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • anthrax vaccine

              hydroxychloroquine sulfate decreases effects of anthrax vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • antithymocyte globulin equine

              antithymocyte globulin equine and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • antithymocyte globulin rabbit

              antithymocyte globulin rabbit and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • apomorphine

              hydroxychloroquine sulfate and apomorphine both increase QTc interval. Avoid or Use Alternate Drug.

            • arformoterol

              hydroxychloroquine sulfate and arformoterol both increase QTc interval. Avoid or Use Alternate Drug.

            • aripiprazole

              aripiprazole and hydroxychloroquine sulfate both increase QTc interval. Avoid or Use Alternate Drug.

            • arsenic trioxide

              hydroxychloroquine sulfate and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • artemether

              artemether and hydroxychloroquine sulfate both increase QTc interval. Avoid or Use Alternate Drug.

            • artemether/lumefantrine

              hydroxychloroquine sulfate and artemether/lumefantrine both increase QTc interval. Avoid or Use Alternate Drug.

            • asenapine

              hydroxychloroquine sulfate and asenapine both increase QTc interval. Avoid or Use Alternate Drug.

            • atomoxetine

              atomoxetine and hydroxychloroquine sulfate both increase QTc interval. Avoid or Use Alternate Drug.

            • azathioprine

              azathioprine and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • azithromycin

              hydroxychloroquine sulfate and azithromycin both increase QTc interval. Avoid or Use Alternate Drug.

            • basiliximab

              basiliximab and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • BCG vaccine live

              hydroxychloroquine sulfate decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • bedaquiline

              hydroxychloroquine sulfate and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.

            • canakinumab

              canakinumab and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • chlorpromazine

              hydroxychloroquine sulfate and chlorpromazine both increase QTc interval. Avoid or Use Alternate Drug.

            • ciprofloxacin

              hydroxychloroquine sulfate and ciprofloxacin both increase QTc interval. Avoid or Use Alternate Drug.

            • cisapride

              hydroxychloroquine sulfate increases toxicity of cisapride by QTc interval. Avoid or Use Alternate Drug.

            • citalopram

              hydroxychloroquine sulfate and citalopram both increase QTc interval. Avoid or Use Alternate Drug.

            • clarithromycin

              hydroxychloroquine sulfate and clarithromycin both increase QTc interval. Avoid or Use Alternate Drug.

            • clofazimine

              hydroxychloroquine sulfate and clofazimine both increase QTc interval. Avoid or Use Alternate Drug.

            • clomipramine

              hydroxychloroquine sulfate and clomipramine both increase QTc interval. Avoid or Use Alternate Drug.

            • clozapine

              hydroxychloroquine sulfate and clozapine both increase QTc interval. Avoid or Use Alternate Drug.

            • crizotinib

              hydroxychloroquine sulfate and crizotinib both increase QTc interval. Avoid or Use Alternate Drug.

            • dapsone topical

              hydroxychloroquine sulfate, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

            • dasatinib

              hydroxychloroquine sulfate and dasatinib both increase QTc interval. Avoid or Use Alternate Drug.

            • degarelix

              hydroxychloroquine sulfate and degarelix both increase QTc interval. Avoid or Use Alternate Drug.

            • desipramine

              hydroxychloroquine sulfate and desipramine both increase QTc interval. Avoid or Use Alternate Drug.

            • deutetrabenazine

              hydroxychloroquine sulfate and deutetrabenazine both increase QTc interval. Avoid or Use Alternate Drug.

            • digoxin

              hydroxychloroquine sulfate increases levels of digoxin by unknown mechanism. Avoid or Use Alternate Drug.

            • diphtheria & tetanus toxoids

              hydroxychloroquine sulfate decreases effects of diphtheria & tetanus toxoids by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • diphtheria & tetanus toxoids/ acellular pertussis vaccine

              hydroxychloroquine sulfate decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine

              hydroxychloroquine sulfate decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • disopyramide

              hydroxychloroquine sulfate and disopyramide both increase QTc interval. Avoid or Use Alternate Drug.

            • dofetilide

              hydroxychloroquine sulfate and dofetilide both increase QTc interval. Avoid or Use Alternate Drug.

              dofetilide increases toxicity of hydroxychloroquine sulfate by QTc interval. Avoid or Use Alternate Drug.

            • dolasetron

              hydroxychloroquine sulfate and dolasetron both increase QTc interval. Avoid or Use Alternate Drug.

            • dronedarone

              hydroxychloroquine sulfate and dronedarone both increase QTc interval. Avoid or Use Alternate Drug.

            • droperidol

              hydroxychloroquine sulfate and droperidol both increase QTc interval. Avoid or Use Alternate Drug.

            • encorafenib

              encorafenib and hydroxychloroquine sulfate both increase QTc interval. Avoid or Use Alternate Drug. Encorafenib is associated with dose-dependent QTc interval prolongation. Avoid with drugs known to prolong QT interval.

              hydroxychloroquine sulfate and encorafenib both increase QTc interval. Avoid or Use Alternate Drug.

            • entrectinib

              hydroxychloroquine sulfate and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.

            • eribulin

              hydroxychloroquine sulfate and eribulin both increase QTc interval. Avoid or Use Alternate Drug.

            • erythromycin base

              hydroxychloroquine sulfate and erythromycin base both increase QTc interval. Avoid or Use Alternate Drug.

            • erythromycin ethylsuccinate

              hydroxychloroquine sulfate and erythromycin ethylsuccinate both increase QTc interval. Avoid or Use Alternate Drug.

            • erythromycin lactobionate

              hydroxychloroquine sulfate and erythromycin lactobionate both increase QTc interval. Avoid or Use Alternate Drug.

            • erythromycin stearate

              hydroxychloroquine sulfate and erythromycin stearate both increase QTc interval. Avoid or Use Alternate Drug.

            • escitalopram

              hydroxychloroquine sulfate and escitalopram both increase QTc interval. Avoid or Use Alternate Drug.

              escitalopram increases toxicity of hydroxychloroquine sulfate by QTc interval. Avoid or Use Alternate Drug.

            • etanercept

              etanercept and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • everolimus

              everolimus and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • ezogabine

              hydroxychloroquine sulfate and ezogabine both increase QTc interval. Avoid or Use Alternate Drug.

            • fexinidazole

              fexinidazole and hydroxychloroquine sulfate both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels and/or prolong QT interval.

            • flecainide

              hydroxychloroquine sulfate and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • fluconazole

              hydroxychloroquine sulfate and fluconazole both increase QTc interval. Avoid or Use Alternate Drug.

            • fluoxetine

              hydroxychloroquine sulfate and fluoxetine both increase QTc interval. Avoid or Use Alternate Drug.

            • fluphenazine

              hydroxychloroquine sulfate and fluphenazine both increase QTc interval. Avoid or Use Alternate Drug.

            • formoterol

              hydroxychloroquine sulfate and formoterol both increase QTc interval. Avoid or Use Alternate Drug.

            • foscarnet

              hydroxychloroquine sulfate and foscarnet both increase QTc interval. Avoid or Use Alternate Drug.

            • gemifloxacin

              hydroxychloroquine sulfate and gemifloxacin both increase QTc interval. Avoid or Use Alternate Drug.

            • gemtuzumab

              hydroxychloroquine sulfate and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug.

            • glasdegib

              hydroxychloroquine sulfate and glasdegib both increase QTc interval. Avoid or Use Alternate Drug.

            • glatiramer

              glatiramer and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • golimumab

              golimumab and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • haloperidol

              hydroxychloroquine sulfate and haloperidol both increase QTc interval. Avoid or Use Alternate Drug.

            • hepatitis A vaccine inactivated

              hydroxychloroquine sulfate decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • hepatitis a/b vaccine

              hydroxychloroquine sulfate decreases effects of hepatitis a/b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • hepatitis a/typhoid vaccine

              hydroxychloroquine sulfate decreases effects of hepatitis a/typhoid vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • hepatitis b vaccine

              hydroxychloroquine sulfate decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • human papillomavirus vaccine, nonavalent

              hydroxychloroquine sulfate decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

            • human papillomavirus vaccine, quadrivalent

              hydroxychloroquine sulfate decreases effects of human papillomavirus vaccine, quadrivalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

            • ibutilide

              hydroxychloroquine sulfate and ibutilide both increase QTc interval. Avoid or Use Alternate Drug.

            • iloperidone

              hydroxychloroquine sulfate and iloperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • indacaterol, inhaled

              hydroxychloroquine sulfate and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug.

            • indapamide

              hydroxychloroquine sulfate and indapamide both increase QTc interval. Avoid or Use Alternate Drug.

            • infliximab

              hydroxychloroquine sulfate and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • influenza virus vaccine quadrivalent

              hydroxychloroquine sulfate decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • influenza virus vaccine quadrivalent, cell-cultured

              hydroxychloroquine sulfate decreases effects of influenza virus vaccine quadrivalent, cell-cultured by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • influenza virus vaccine quadrivalent, intranasal

              hydroxychloroquine sulfate decreases effects of influenza virus vaccine quadrivalent, intranasal by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • influenza virus vaccine trivalent

              hydroxychloroquine sulfate decreases effects of influenza virus vaccine trivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • inotuzumab

              hydroxychloroquine sulfate and inotuzumab both increase QTc interval. Avoid or Use Alternate Drug.

            • isradipine

              hydroxychloroquine sulfate and isradipine both increase QTc interval. Avoid or Use Alternate Drug.

            • Japanese encephalitis virus vaccine

              hydroxychloroquine sulfate decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • lapatinib

              hydroxychloroquine sulfate and lapatinib both increase QTc interval. Avoid or Use Alternate Drug.

            • leflunomide

              hydroxychloroquine sulfate and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • levofloxacin

              hydroxychloroquine sulfate and levofloxacin both increase QTc interval. Avoid or Use Alternate Drug.

            • lofexidine

              hydroxychloroquine sulfate and lofexidine both increase QTc interval. Avoid or Use Alternate Drug.

            • lopinavir

              hydroxychloroquine sulfate and lopinavir both increase QTc interval. Avoid or Use Alternate Drug.

            • maprotiline

              hydroxychloroquine sulfate and maprotiline both increase QTc interval. Avoid or Use Alternate Drug.

            • measles (rubeola) vaccine

              hydroxychloroquine sulfate decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • measles mumps and rubella vaccine, live

              hydroxychloroquine sulfate decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • measles, mumps, rubella and varicella vaccine, live

              hydroxychloroquine sulfate decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • mefloquine

              hydroxychloroquine sulfate and mefloquine both increase QTc interval. Avoid or Use Alternate Drug.

            • meningococcal A C Y and W-135 polysaccharide vaccine combined

              hydroxychloroquine sulfate decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • methadone

              hydroxychloroquine sulfate and methadone both increase QTc interval. Avoid or Use Alternate Drug.

            • mifepristone

              hydroxychloroquine sulfate and mifepristone both increase QTc interval. Avoid or Use Alternate Drug.

            • moxifloxacin

              hydroxychloroquine sulfate and moxifloxacin both increase QTc interval. Avoid or Use Alternate Drug.

            • muromonab CD3

              hydroxychloroquine sulfate and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • mycophenolate

              hydroxychloroquine sulfate and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • nilotinib

              hydroxychloroquine sulfate and nilotinib both increase QTc interval. Avoid or Use Alternate Drug.

            • nortriptyline

              hydroxychloroquine sulfate and nortriptyline both increase QTc interval. Avoid or Use Alternate Drug.

            • octreotide

              hydroxychloroquine sulfate and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • ofloxacin

              hydroxychloroquine sulfate and ofloxacin both increase QTc interval. Avoid or Use Alternate Drug.

            • olanzapine

              hydroxychloroquine sulfate and olanzapine both increase QTc interval. Avoid or Use Alternate Drug.

            • ondansetron

              hydroxychloroquine sulfate and ondansetron both increase QTc interval. Avoid or Use Alternate Drug.

            • osimertinib

              hydroxychloroquine sulfate and osimertinib both increase QTc interval. Avoid or Use Alternate Drug.

            • paliperidone

              hydroxychloroquine sulfate and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • panobinostat

              hydroxychloroquine sulfate and panobinostat both increase QTc interval. Avoid or Use Alternate Drug.

            • pasireotide

              hydroxychloroquine sulfate and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.

            • pazopanib

              hydroxychloroquine sulfate and pazopanib both increase QTc interval. Avoid or Use Alternate Drug.

            • pentamidine

              hydroxychloroquine sulfate and pentamidine both increase QTc interval. Avoid or Use Alternate Drug.

            • perphenazine

              hydroxychloroquine sulfate and perphenazine both increase QTc interval. Avoid or Use Alternate Drug.

            • pimavanserin

              hydroxychloroquine sulfate and pimavanserin both increase QTc interval. Avoid or Use Alternate Drug.

            • pimozide

              hydroxychloroquine sulfate and pimozide both increase QTc interval. Avoid or Use Alternate Drug.

            • pitolisant

              hydroxychloroquine sulfate and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.

            • pneumococcal vaccine 13-valent

              hydroxychloroquine sulfate decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • pneumococcal vaccine heptavalent

              hydroxychloroquine sulfate decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • pneumococcal vaccine polyvalent

              hydroxychloroquine sulfate decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • posaconazole

              hydroxychloroquine sulfate and posaconazole both increase QTc interval. Avoid or Use Alternate Drug.

            • procainamide

              hydroxychloroquine sulfate increases toxicity of procainamide by QTc interval. Avoid or Use Alternate Drug.

            • propafenone

              hydroxychloroquine sulfate and propafenone both increase QTc interval. Avoid or Use Alternate Drug.

            • protriptyline

              hydroxychloroquine sulfate and protriptyline both increase QTc interval. Avoid or Use Alternate Drug.

            • quetiapine

              hydroxychloroquine sulfate and quetiapine both increase QTc interval. Avoid or Use Alternate Drug.

            • quinidine

              hydroxychloroquine sulfate and quinidine both increase QTc interval. Avoid or Use Alternate Drug.

            • quinine

              hydroxychloroquine sulfate and quinine both increase QTc interval. Avoid or Use Alternate Drug.

            • rabies vaccine

              hydroxychloroquine sulfate decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants may interfere with development of active immunity.

            • rabies vaccine chick embryo cell derived

              hydroxychloroquine sulfate decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • ranolazine

              hydroxychloroquine sulfate and ranolazine both increase QTc interval. Avoid or Use Alternate Drug.

            • remdesivir

              hydroxychloroquine sulfate decreases effects of remdesivir by unspecified interaction mechanism. Avoid or Use Alternate Drug. Coadministration not recommended owing to antagonistic effect on remdesivir?s intracellular metabolic activation and antiviral activity.

            • ribociclib

              hydroxychloroquine sulfate and ribociclib both increase QTc interval. Avoid or Use Alternate Drug.

              ribociclib increases toxicity of hydroxychloroquine sulfate by QTc interval. Avoid or Use Alternate Drug.

            • rilonacept

              hydroxychloroquine sulfate and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • rilpivirine

              hydroxychloroquine sulfate and rilpivirine both increase QTc interval. Avoid or Use Alternate Drug.

            • risperidone

              hydroxychloroquine sulfate and risperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • ritonavir

              hydroxychloroquine sulfate and ritonavir both increase QTc interval. Avoid or Use Alternate Drug.

            • romidepsin

              hydroxychloroquine sulfate and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.

            • rotavirus oral vaccine, live

              hydroxychloroquine sulfate decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • rubella vaccine

              hydroxychloroquine sulfate decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • saquinavir

              hydroxychloroquine sulfate and saquinavir both increase QTc interval. Avoid or Use Alternate Drug.

            • sertraline

              hydroxychloroquine sulfate and sertraline both increase QTc interval. Avoid or Use Alternate Drug.

            • sirolimus

              hydroxychloroquine sulfate and sirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • smallpox (vaccinia) vaccine, live

              hydroxychloroquine sulfate decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • solifenacin

              hydroxychloroquine sulfate and solifenacin both increase QTc interval. Avoid or Use Alternate Drug.

            • sorafenib

              hydroxychloroquine sulfate and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.

            • sotalol

              hydroxychloroquine sulfate and sotalol both increase QTc interval. Avoid or Use Alternate Drug.

            • sunitinib

              hydroxychloroquine sulfate and sunitinib both increase QTc interval. Avoid or Use Alternate Drug.

            • tacrolimus

              hydroxychloroquine sulfate and tacrolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              hydroxychloroquine sulfate and tacrolimus both increase QTc interval. Avoid or Use Alternate Drug.

            • telavancin

              hydroxychloroquine sulfate and telavancin both increase QTc interval. Avoid or Use Alternate Drug.

            • temsirolimus

              hydroxychloroquine sulfate and temsirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • tetanus toxoid adsorbed or fluid

              hydroxychloroquine sulfate decreases effects of tetanus toxoid adsorbed or fluid by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • tetrabenazine

              hydroxychloroquine sulfate and tetrabenazine both increase QTc interval. Avoid or Use Alternate Drug.

            • thioridazine

              hydroxychloroquine sulfate and thioridazine both increase QTc interval. Avoid or Use Alternate Drug.

            • thiothixene

              hydroxychloroquine sulfate and thiothixene both increase QTc interval. Avoid or Use Alternate Drug.

            • tick-borne encephalitis vaccine

              hydroxychloroquine sulfate decreases effects of tick-borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • tocilizumab

              tocilizumab and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • tofacitinib

              hydroxychloroquine sulfate, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • tongkat ali

              hydroxychloroquine sulfate and tongkat ali both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • toremifene

              hydroxychloroquine sulfate and toremifene both increase QTc interval. Avoid or Use Alternate Drug.

            • travelers diarrhea and cholera vaccine inactivated

              hydroxychloroquine sulfate decreases effects of travelers diarrhea and cholera vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • trimipramine

              hydroxychloroquine sulfate and trimipramine both increase QTc interval. Avoid or Use Alternate Drug.

            • typhoid polysaccharide vaccine

              hydroxychloroquine sulfate decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • typhoid vaccine live

              hydroxychloroquine sulfate decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • ustekinumab

              hydroxychloroquine sulfate and ustekinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • vandetanib

              hydroxychloroquine sulfate and vandetanib both increase QTc interval. Avoid or Use Alternate Drug.

            • vardenafil

              hydroxychloroquine sulfate and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.

            • varicella virus vaccine live

              hydroxychloroquine sulfate decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • vemurafenib

              hydroxychloroquine sulfate and vemurafenib both increase QTc interval. Avoid or Use Alternate Drug.

            • vilanterol/fluticasone furoate inhaled

              hydroxychloroquine sulfate and vilanterol/fluticasone furoate inhaled both increase QTc interval. Avoid or Use Alternate Drug.

            • voriconazole

              hydroxychloroquine sulfate and voriconazole both increase QTc interval. Avoid or Use Alternate Drug.

            • vorinostat

              hydroxychloroquine sulfate and vorinostat both increase QTc interval. Avoid or Use Alternate Drug.

            • yellow fever vaccine

              hydroxychloroquine sulfate decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • ziprasidone

              hydroxychloroquine sulfate and ziprasidone both increase QTc interval. Avoid or Use Alternate Drug.

            • zoster vaccine live

              hydroxychloroquine sulfate decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            Monitor Closely (24)

            • astragalus

              hydroxychloroquine sulfate increases and astragalus decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • bupivacaine implant

              hydroxychloroquine sulfate, bupivacaine implant. Either increases effects of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.

            • cholera vaccine

              hydroxychloroquine sulfate decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

            • cyclosporine

              hydroxychloroquine sulfate will increase the level or effect of cyclosporine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • dengue vaccine

              hydroxychloroquine sulfate decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

            • denosumab

              hydroxychloroquine sulfate, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

            • echinacea

              hydroxychloroquine sulfate increases and echinacea decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • fostemsavir

              hydroxychloroquine sulfate and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.

            • influenza virus vaccine quadrivalent, recombinant

              hydroxychloroquine sulfate decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • influenza virus vaccine trivalent, recombinant

              hydroxychloroquine sulfate decreases effects of influenza virus vaccine trivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • maitake

              hydroxychloroquine sulfate increases and maitake decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • mercaptopurine

              hydroxychloroquine sulfate and mercaptopurine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • methotrexate

              hydroxychloroquine sulfate decreases levels of methotrexate by unknown mechanism. Use Caution/Monitor. Hydroxychloroquine may reduce the renal clearance of methotrexate; the exact mechanism of this interaction is unknown. .

            • osilodrostat

              osilodrostat and hydroxychloroquine sulfate both increase QTc interval. Use Caution/Monitor.

              hydroxychloroquine sulfate and osilodrostat both increase QTc interval. Use Caution/Monitor.

            • ozanimod

              ozanimod and hydroxychloroquine sulfate both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.

              ozanimod, hydroxychloroquine sulfate. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.

            • ponesimod

              ponesimod and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • selpercatinib

              selpercatinib increases toxicity of hydroxychloroquine sulfate by QTc interval. Use Caution/Monitor.

            • siponimod

              siponimod and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • sipuleucel-T

              hydroxychloroquine sulfate decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

            • sodium sulfate/?magnesium sulfate/potassium chloride

              sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of hydroxychloroquine sulfate by QTc interval. Use Caution/Monitor. Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. .

            • sodium sulfate/potassium sulfate/magnesium sulfate

              sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of hydroxychloroquine sulfate by QTc interval. Use Caution/Monitor. Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. .

            • tobramycin inhaled

              tobramycin inhaled and hydroxychloroquine sulfate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity

            • voclosporin

              voclosporin, hydroxychloroquine sulfate. Either increases effects of the other by QTc interval. Use Caution/Monitor.

            • zoster vaccine recombinant

              hydroxychloroquine sulfate decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.

            Minor (2)

            • chloroquine

              chloroquine increases toxicity of hydroxychloroquine sulfate by QTc interval. Minor/Significance Unknown.

            • praziquantel

              hydroxychloroquine sulfate increases levels of praziquantel by unspecified interaction mechanism. Minor/Significance Unknown.

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            Adverse Effects

            Frequency Not Defined

            Blood and lymphatic system disorders: Bone marrow failure, anemia, aplastic anemia, agranulocytosis, leukopenia, and thrombocytopenia; hemolysis reported in individuals with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency

            Cardiac disorders: Cardiomyopathy, QT interval prolongation, and ventricular arrhythmias and torsade de pointes

            Ear and labyrinth disorders: Vertigo, tinnitus, nystagmus, nerve deafness, deafness

            Eye disorders: Irreversible retinopathy with retinal pigmentation changes (bull’s eye appearance), visual field defects (paracentral scotomas) and visual disturbances (visual acuity), maculopathies (macular degeneration), decreased dark adaptation, color vision abnormalities, corneal changes (edema and opacities) including corneal deposition of drug with or without accompanying symptoms (halo around lights, photophobia, blurred vision)

            Gastrointestinal disorders: Nausea, vomiting, diarrhea, abdominal pain

            General disorders and administration site conditions: Fatigue

            Hepatobiliary disorders: Liver function tests abnormal, hepatic failure acute

            Immune system disorders: Urticaria, angioedema, bronchospasm

            Metabolism and nutrition disorders: Decreased appetite, hypoglycemia, porphyria, weight decreased

            Musculoskeletal and connective tissue disorders: Sensorimotor disorder, skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, depression of tendon reflexes and abnormal nerve conduction

            Nervous system disorders: Headache, dizziness, seizure, ataxia and extrapyramidal disorders such as dystonia, dyskinesia, tremor

            Psychiatric disorders: Affect/emotional lability, nervousness, irritability, nightmares, psychosis, suicidal behavior

            Skin and subcutaneous tissue disorders: Rash, pruritus, pigmentation disorders in skin and mucous membranes, hair color changes, alopecia; dermatitis bullous eruptions including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity, dermatitis exfoliative, acute generalized exanthematous pustulosis (AGEP)

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            Warnings

            Contraindications

            Hypersensitivity to 4-aminoquinoline derivatives

            Cautions

            Not effective against chloroquine-resistant strains of P falciparum

            Skeletal muscle myopathy or neuropathy leading to progressive weakness and atrophy of proximal muscle groups, depressed tendon reflexes, and abnormal nerve conduction, have been reported

            Rare suicidal behavior has been reported

            May cause severe hypoglycemia including loss of consciousness that could be life-threatening in patients treated with or without antidiabetic medications; check blood glucose and adjust treatment if necessary

            Exercise caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs; a dosage reduction may be necessary in patients with hepatic or renal disease, as well as in those taking medicines known to affect these organs

            Antimalarial compounds should be used with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs; perform periodic blood cell counts if patients are given prolonged therapy; if any severe blood disorder (eg, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia) appears which is not attributable to the disease under treatment, consider discontinuing treatment

            Use with caution in patients having glucose-6-phosphate dehydrogenase (G-6-PD) deficiency

            Dermatologic reactions may occur

            Cardiac effects

            • Postmarketing cases of life-threatening and fatal cardiomyopathy have been reported
            • May present with AV block, pulmonary hypertension, sick sinus syndrome or with cardiac complications
            • ECG findings include atrioventricular, right or left bundle branch block
            • Monitor for signs and symptoms of cardiomyopathy is advised
            • If cardiotoxicity is suspected, promptly discontinue treatment

            Ocular toxicity

            • Irreversible retinal damage observed; significant risk factors for retinal damage include daily doses of hydroxychloroquine sulfate >6.5 mg/kg (5 mg/kg base) of actual body weight, durations of use >5 years, subnormal glomerular filtration, use of some concomitant drug products such as tamoxifen citrate and concurrent macular disease
            • Recommend an ocular exam within first year of therapy; baseline exam should include: best corrected distance visual acuity (BCVA), an automated threshold visual field (VF) of the central 10 degrees (with retesting if an abnormality is noted), and spectral domain ocular coherence tomography (SD-OCT)
            • In individuals of Asian descent, retinal toxicity may first be noticed outside macula; in patients of Asian descent, perform visual field testing in central 24 degrees instead of central 10 degrees
            • Discontinue if ocular toxicity is suspected and closely observe any retinal changes (and visual disturbances) even after cessation of therapy

            Drug interaction overview

            • Avoid use with other drugs that have potential to prolong QT interval; hydroxychloroquine prolongs QT interval; ventricular arrhythmias and torsades de pointes reported in patients taking hydroxychloroquine
            • Concomitant use with hydroxychloroquine and digoxin therapy may result in increased serum digoxin levels: closely monitor serum digoxin levels in patients receiving combined therapy
            • May enhance the effects of a hypoglycemic treatment, a decrease in doses of insulin or antidiabetic drugs may be required
            • Coadministration with other antimalarials known to lower the convulsion threshold (eg, mefloquine) may increase the risk of convulsions
            • Activity of antiepileptic drugs might be impaired if coadministered with hydroxychloroquine
            • An increased plasma cyclosporine level was reported when cyclosporine and hydroxychloroquine were coadministered
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            Pregnancy & Lactation

            Pregnancy

            There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to drug during pregnancy; encourage patients to register by contacting 1-877-311-8972

            Prolonged clinical experience over decades of use and available data from published epidemiologic and clinical studies with use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal, or fetal outcomes

            There are risks to mother and fetus associated with untreated or increased disease activity from malaria, rheumatoid arthritis, and systemic lupus erythematosus in pregnancy

            Animal reproduction studies were not conducted with hydroxychloroquine

            Clinical considerations

            • Malaria during pregnancy increases risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth
            • Published data on rheumatoid arthritis suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth
            • Pregnant women with systemic lupus erythematosus, especially those with increased disease activity, are at increased risk of adverse pregnancy outcomes, including spontaneous abortion, fetal death, preeclampsia, preterm birth, and intrauterine growth restriction; passage of maternal auto-antibodies across placenta may result in neonatal illness, including neonatal lupus and congenital heart block
            • Embryonic deaths and malformations of anophthalmia and microphthalmia in the offspring have been reported when pregnant rats received large doses of chloroquine

            Lactation

            Exercise caution when administering hydroxychloroquine to nursing women

            Published lactation data report that hydroxychloroquine is present in human milk at low levels; no adverse reactions have been reported in breastfed infants; no retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities observed in children exposed to hydroxychloroquine through breastmilk

            There is no information on effect of hydroxychloroquine on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

            When administered to nursing women, hydroxychloroquine is excreted in human milk and it is known that infants are extremely sensitive to the toxic effects of 4-aminoquinolines

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Malaria

            • Precise mechanism of action against Plasmodium is unknown
            • Hydroxychloroquine, like chloroquine, is a weak base and may exert its effect by concentrating in the acid vesicles of the parasite and by inhibiting polymerization of heme
            • It can also inhibit certain enzymes by its interaction with DNA

            Rheumatoid arthritis and systemic lupus erythematosus

            • Mechanisms underlying the anti-inflammatory and immunomodulatory effects of hydroxychloroquine are unknown

            Absorption

            Peak plasma concentration: 129.6 ng/mL (single 200-mg dose)

            Peak plasma time: 3.26 hr (single 200-mg dose); 3-4 hr (chronic PO administration)

            Metabolism

            Metabolites: Desethylhydroxychloroquine, desethylchloroquine

            Elimination

            Half-life: 40-50 days

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            Administration

            Oral Administration

            Take with a meal or a glass of milk

            Do not crush or split tablets

            Storage

            Dispense in a tight, light-resistant container

            Keep out of the reach of children

            Store at room temperature (20-25ºC [68-77ºF]), allows excursions at 15-30ºC (59-86ºF)

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Plaquenil oral
            -
            200 mg tablet
            hydroxychloroquine oral
            -
            200 mg tablet
            hydroxychloroquine oral
            -
            200 mg tablet
            hydroxychloroquine oral
            -
            200 mg tablet
            hydroxychloroquine oral
            -
            200 mg tablet
            hydroxychloroquine oral
            -
            200 mg tablet
            hydroxychloroquine oral
            -
            200 mg tablet
            hydroxychloroquine oral
            -
            200 mg tablet
            hydroxychloroquine oral
            -
            200 mg tablet
            hydroxychloroquine oral
            -
            200 mg tablet
            hydroxychloroquine oral
            -
            200 mg tablet
            hydroxychloroquine oral
            -
            200 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            hydroxychloroquine oral

            HYDROXYCHLOROQUINE - ORAL

            (hi-DROX-ee-KLOR-oh-kwin)

            COMMON BRAND NAME(S): Plaquenil

            USES: Hydroxychloroquine is used to prevent or treat malaria caused by mosquito bites. The United States Center for Disease Control provides updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before traveling to areas where malaria occurs.This medication is also used to treat certain auto-immune diseases (lupus, rheumatoid arthritis). It belongs to a class of medications known as disease-modifying antirheumatic drugs (DMARDs). It can reduce skin problems in lupus and prevent swelling/pain in arthritis.Hydroxychloroquine is not recommended for coronavirus infection, also known as COVID-19, unless you are enrolled in a study. Talk to your doctor about the risks and benefits.

            HOW TO USE: Take this medication by mouth, usually with food to prevent stomach upset, exactly as directed by your doctor. The dosage and length of treatment are based on your medical condition and response to treatment. In children, dosage is also based on weight.To prevent malaria, take this medication by mouth as directed by your doctor, usually once a week on the same day each week. Mark a calendar to help you remember. This drug is usually started 1 to 2 weeks before entering the malarious area. Continue to take it weekly while in the area and for 4 to 8 weeks after leaving the area, or as directed by your doctor. To treat malaria, follow your doctor's instructions.For lupus or rheumatoid arthritis, take this medication by mouth as directed by your doctor, usually once or twice daily. Your doctor may gradually increase your dose. Once you have been taking the medication for a while and your condition has improved, your doctor may instruct you to lower your dose until you find the dose that works best with the fewest side effects.If you are also taking a certain drug for diarrhea (kaolin) or taking antacids (such as magnesium/aluminum hydroxide), take hydroxychloroquine at least 4 hours before or after these products. These products may bind with hydroxychloroquine, preventing your body from fully absorbing it.Use this medication regularly in order to get the most benefit from it. If you are taking it on a daily schedule, take it at the same time(s) each day. Take this medication exactly as prescribed. Do not stop taking it without talking with your doctor, especially if you are taking it for malaria. It is important to continue taking this for the length of time prescribed. Stopping prevention or treatment too soon may lead to infection or a return of the infection.Tell your doctor if your condition lasts or gets worse. It may take several weeks or months to see improvement if you are taking this for lupus or arthritis. Hydroxychloroquine may not prevent malaria in all cases. If you experience fever or other symptoms of illness, get medical help right away (especially while in the malarious area and for 2 months after returning from the area). You may need a different medication. Avoid exposure to mosquitoes. (See also Notes section.)

            SIDE EFFECTS: Nausea, vomiting, loss of appetite, diarrhea, dizziness, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: slow heartbeat, symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), mental/mood changes (such as anxiety, depression, rare thoughts of suicide, hallucinations), hearing changes (such as ringing in the ears, hearing loss), easy bruising/bleeding, signs of infection (such as sore throat that doesn't go away, fever), signs of liver disease (such as severe stomach/abdominal pain, yellowing eyes/skin, dark urine), muscle weakness, unwanted/uncontrolled movements (including tongue/face twitching), hair loss, hair/skin color changes.This medication may cause low blood sugar (hypoglycemia). Tell your doctor right away if you develop symptoms of low blood sugar, such as sudden sweating, shaking, hunger, blurred vision, dizziness, or tingling hands/feet. If you have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication.Get medical help right away if you have any very serious side effects, including: severe dizziness, fainting, fast/irregular heartbeat, seizures.This medication may cause serious eye/vision problems. The risk for these side effects is increased with long-term use of this medication and with taking this medication in high doses. Get medical help right away if you have any symptoms of serious eye problems, including: sensitivity to light, vision changes (such as light flashes/streaks, blurred vision, difficulty reading, missing areas of vision).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking hydroxychloroquine, tell your doctor or pharmacist if you are allergic to it; or to chloroquine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain enzyme problem (glucose-6-phosphate dehydrogenase deficiency-G6PD), vision/eye problems, hearing problems, kidney disease, liver disease, regular alcohol use/abuse, skin problems (such as psoriasis), a certain blood disorder (porphyria), seizures.If you have diabetes, this product may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of low blood sugar (see Side Effects section). Your doctor may need to adjust your diabetes medication, exercise program, or diet.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Alcohol can also increase your risk of liver problems while you are taking this drug.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Hydroxychloroquine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using hydroxychloroquine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using hydroxychloroquine safely.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: penicillamine, remdesivir.Many drugs besides hydroxychloroquine may affect the heart rhythm (QT prolongation). Some examples are amiodarone, azithromycin, disopyramide, dronedarone, pimozide, quinidine, among others.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/irregular heartbeat, fainting, slow/shallow breathing, seizures.

            NOTES: Do not share this medication with others.Lab and/or medical tests (such as eye exams, reflex tests, liver function, EKG, complete blood counts) should be done if you are taking hydroxychloroquine for a long time. Keep all medical and lab appointments. Consult your doctor for more details.When traveling in an area at risk for malaria, use protective clothing, insect repellent, and bed nets. Remain indoors or in well-screened areas when possible. If you are taking this medication to prevent or treat malaria, use it for your current travel or condition only. Do not use it later to prevent or treat another infection unless your doctor tells you to.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from moisture and light. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.