Hydroxychloroquine (Lexi-Drugs)

Pronunciation

(hye droks ee KLOR oh kwin)

Brand Names: US

Plaquenil

Brand Names: Canada

APO-Hydroxyquine; MINT-Hydroxychloroquine; MYLAN-Hydroxychloroquine [DSC]; Plaquenil; PRO-Hydroxychloroquine-200

Dosing: Adult

Note: Hydroxychloroquine sulfate 200 mg is equivalent to 155 mg hydroxychloroquine base and 250 mg chloroquine phosphate. All doses below expressed as hydroxychloroquine sulfate.

Lupus erythematosus (off-label dose): Oral: 200 to 400 mg daily as a single daily dose or in 2 divided doses (Lam 2016; Tsang-A-Sjoe 2015). Due to the risk of retinal toxicity, do notexceed a daily dose of 5 mg/kg/day using actual body weight or 400 mg (AAO [Marmor 2016]; Plaquenil PI)

Malaria, chemoprophylaxis: Oral:

Manufacturer’s labeling: 400 mg once weekly on same day each week; begin 2 weeks before exposure; if suppressive therapy is not begun prior to exposure, administer an initial loading dose of 800 mg in 2 divided doses, 6 hours apart; continue once weekly treatment for 8 weeks after leaving endemic area

Alternate dosing: 400 mg once weekly on the same day each week; begin 1 to 2 weeks before travel to malarious area, continue therapy while in malarious area and for 4 weeks after leaving the area (CDC 2016)

Malaria, acute attack: Oral: 800 mg initially, followed by 400 mg at 6, 24, and 48 hours

Rheumatoid arthritis (off-label dose): Oral: Initial: 400 mg daily as a single daily dose or in 2 divided doses, with or without concomitant non-biologic disease-modifying antirheumatic drugs (Kumar 2013; O’Dell 2013; Rath 2010; Smolen 2016); Maintenance: 300 mg daily (usually after 3 months of initial dosing) (Kumar 2013). Due to the risk of retinal toxicity, do not exceed a daily dose of 5 mg/kg/day using actual body weight or 400 mg (AAO [Marmor 2016]; Plaquenil PI).

Porphyria cutanea tarda (off-label use): Oral: 100 mg twice weekly; continue until plasma porphyrin levels are normal for at least one month (Singal 2012); however, additional data may be necessary to further define the role of hydroxychloroquine in this condition.

Primary Sjögren syndrome (extraglandular manifestations) (off-label use): Oral: Usual dose: 200 mg daily (Mavragani 2006). Note: Due to the risk of retinal toxicity, do not exceed a daily dose of 5 mg/kg/day using actual body weight or 400 mg (AAO [Marmor 2016]; Plaquenil PI).

Q fever, chronic (off-label use) (CDC 2013): Oral:

Endocarditis or vascular infection: 200 mg every 8 hours in combination with doxycycline for ≥18 months

Noncardiac organ disease: 200 mg every 8 hours in combination with doxycycline (duration based on serologic response; ID consult recommended)

Postpartum with serologic evidence present >12 months after delivery: 200 mg every 8 hours in combination with doxycycline for 12 months

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; dosage reduction may be needed; use with caution.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Dosing: Obesity: Adult

Rheumatic diseases (eg, rheumatoid arthritis, lupus erythematosus, primary Sjögren syndrome [off-label use]): Available data do not specifically address dosing in obese patients; however, some experts recommend standard daily doses (non-weight-based) up to a maximum of 400 mg/day in patients weighing ≥80 kg.

Dosing: Pediatric

Note: All doses below expressed as hydroxychloroquine sulfate. Hydroxychloroquine sulfate 200 mg is equivalent to 155 mg hydroxychloroquine base and 250 mg chloroquine phosphate.

Malaria:

Chemoprophylaxis: Infants, Children, and Adolescents: Oral: 6.5 mg/kg hydroxychloroquine sulfate once weekly on the same day each week; maximum dose: 400 mg/dose hydroxychloroquine sulfate; begin 1 to 2 weeks before exposure; continue for at least 4 weeks after leaving endemic area (CDC 2016). If the initiation of chemoprophylaxis is delayed (ie, 2 weeks of therapy not completed prior to the exposure), the manufacturer recommends initiating therapy by doubling the initial dose (13 mg/kg of hydroxychloroquine sulfate) and administering in 2 divided doses 6 hours apart; maximum single dose: 400 mg/dose hydroxychloroquine sulfate; continue for 8 weeks after leaving endemic area.

Treatment; acute attack; uncomplicated: Infants, Children, and Adolescents: Oral: Initial: 13 mg/kg/dose hydroxychloroquine sulfate (maximum initial dose: 800 mg/dose hydroxychloroquine sulfate); followed by 6.5 mg/kg hydroxychloroquine sulfate at 6, 24, and 48 hours after initial dose; maximum dose: 400 mg/dose hydroxychloroquine sulfate (CDC 2013)

JRA or SLE: Oral: 3 to 5 mg/kg/day divided 1 to 2 times/day to a maximum of 400 mg/day; not to exceed 7 mg/kg/day

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; dosage reduction may be needed; use with caution.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Use: Labeled Indications

Lupus erythematosus: Treatment of chronic discoid erythematosus and systemic lupus erythematosus (SLE) in adults.

Malaria: Treatment of uncomplicated malaria caused by susceptible strains of Plasmodium vivaxP. malariaeP. ovale, and P. falciparum; prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.

Limitations of use: Hydroxychloroquine is not effective against chloroquine or hydroxychloroquine-resistant malaria strains of Plasmodium species; not recommended for the treatment of complicated malaria, for malaria prophylaxis in regions with chloroquine resistance, or for treatment when the Plasmodium species has not been identified; hydroxychloroquine does not prevent relapses of P. vivax and P. ovale infections because it is not effective against the hypnozoite forms of these parasites.

Rheumatoid arthritis: Treatment of acute and chronic rheumatoid arthritis (RA) in adults.

Use: Off-Label: Adult

  Porphyria cutanea tardaLevel of Evidence [C]

Data from a randomized, nonblinded pilot study supports the use of hydroxychloroquine in the treatment of porphyria cutanea tarda Ref. Additional trials are necessary to further define the role of hydroxychloroquine in this condition.

  Primary Sjögren Syndrome – extraglandular manifestationsLevel of Evidence [C]

Data from small noncontrolled studies have suggested benefit of hydroxychloroquine in the treatment of myalgia and arthralgia (extraglandular symptoms) of primary Sjögren syndrome. However, randomized, placebo-controlled trials demonstrated no significant improvement in symptoms associated with Sjögren syndrome, including fatigue and chronic pain. Inconsistent criteria for patient inclusion and patient response, small numbers of patients, and the abbreviated study length of some of the published studies may have contributed to the conflicting results. Additional trials are needed to define the role of hydroxychloroquine for extraglandular symptoms. Access Full Off-Label Monograph

  Q fever (chronic)Level of Evidence [G]

Based on the Centers for Disease Control and Prevention (CDC) recommendations for the diagnosis and management of Q fever (Coxiella burnetti), hydroxychloroquine (in combination with doxycycline) is effective and recommended for the treatment of chronic Q fever.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Infective Endocarditis:

British Society for Antimicrobial Chemotherapy (BSAC), “Guidelines for the Diagnosis and Antibiotic Treatment of Endocarditis in Adults,” 2012

Juvenile Idiopathic Arthritis:

American College of Rheumatology, “Recommendations for the Treatment of Juvenile Idiopathic Arthritis,” 2011

Malaria

CDC, “Guidelines for Treatment of Malaria in the United States,” Table – September 2011

CDC, “Health Information for National Travel, 2012 ” (The Yellow Book)

CDC, “Treatment of Malaria (Guidelines for Clinicians),” April 2011

Q Fever:

CDC, “Diagnosis and Management of Q Fever,” March 2013

Rheumatoid Arthritis:

American College of Rheumatology, “2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis,” 2016

Administration: Oral

Administer with food or milk. Do not crush or divide film-coated tablets.

Administration: Pediatric

Oral: Administer with food or milk. Do not crush or divide film-coated tablets.

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

Extemporaneously Prepared

A 25 mg/mL hydroxychloroquine sulfate oral suspension may be made with tablets. With a towel moistened with alcohol, remove the coating from fifteen 200 mg hydroxychloroquine sulfate tablets. Crush tablets in a mortar and reduce to a fine powder. Add 15 mL of Ora-Plus and mix to a uniform paste; add an additional 45 mL of vehicle and mix until uniform. Mix while adding sterile water for irrigation in incremental proportions to almost 120 mL; transfer to a calibrated bottle, rinse mortar with sterile water, and add sufficient quantity of sterile water to make 120 mL. Label “shake well”. A 30-day expiration date is recommended, although stability testing has not been performed.

Pesko LJ, “Compounding: Hydroxychloroquine,” Am Druggist, 1993, 207(4):57.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, anxiety, lack of appetite, weight loss, diarrhea, nausea, vomiting, or abdominal pain. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), vision changes, bruising, bleeding, abnormal movements, twitching, difficulty swallowing, difficulty speaking, unable to control eye movements, seizures, mood changes, suicidal ideation, nightmares, hearing impairment, tinnitus, change in balance, chills, pharyngitis, muscle weakness, severe loss of strength and energy, tachycardia, abnormal heartbeat, severe dizziness, passing out, shortness of breath, excessive weight gain, swelling of arms or legs, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

Known hypersensitivity to hydroxychloroquine, 4-aminoquinoline derivatives, or any component of the formulation.

Canadian labeling: Additional contraindications (not in the US labeling): Preexisting retinopathy; use in children <6 years or weighing <35 kg

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular effects: Cardiomyopathy resulting in cardiac failure, sometimes fatal, has been reported (symptoms may present as atrioventricular block, pulmonary hypertension, sick sinus syndrome, or as cardiac complications), and may appear during acute or chronic therapy. Monitor for signs/symptoms of cardiac compromise; discontinue treatment promptly if signs and symptoms of cardiomyopathy occur. In a scientific statement from the American Heart Association, hydroxychloroquine has been determined to be an agent that may either cause direct myocardial toxicity or exacerbate underlying myocardial dysfunction (magnitude: major) (AHA [Page 2016]). Consider chronic toxicity if conduction disorders (eg, bundle branch block, atrioventricular heart block) as well as biventricular hypertrophy are diagnosed. May also be associated with QT interval prolongation; ventricular arrhythmia and torsades de pointes have been reported (avoid concurrent use of other medications which may prolong the QT interval).

• Dermatologic effects: Skin reactions to hydroxychloroquine may occur; use with caution in patients on concomitant medications with a propensity to cause dermatitis.

• Hematologic effects: Bone marrow suppression (eg, agranulocytosis, anemia, aplastic anemia, leukopenia, thrombocytopenia) have been reported; periodically monitor CBC during prolonged therapy. Discontinue treatment if signs/symptoms of severe blood disorder not attributable to the underlying disease occur.

• Hypoglycemia: Severe hypoglycemia, including life-threatening loss of consciousness, has been reported in patients with and without concomitant use of antidiabetic agents. Advise patients of risk of hypoglycemia and associated signs/symptoms; discontinue use in patients who develop severe hypoglycemia.

• Neuromuscular effects: Proximal myopathy or neuromyopathy, leading to progressive weakness, proximal muscle atrophy, depressed tendon reflexes, and abnormal nerve conduction may occur, especially with long-term therapy. Curvilinear bodies and muscle fiber atrophy with vacuolar changes have been noted on muscle or nerve biopsy. Muscle strength (especially proximal muscles) and reflexes should be assessed periodically during long term therapy.

• Psychiatric effects: Suicidal behavior has been reported rarely.

• Retinal toxicity: Retinal toxicity, potentially causing irreversible retinopathy, is predominantly associated with high daily doses and a duration of >5 years of use of chloroquine or hydroxychloroquine in the treatment of rheumatic diseases. Other major risk factors include concurrent tamoxifen use, renal impairment, lower body weight, and the presence of macular disease. Daily hydroxychloroquine (base) doses >5 mg/kg actual body weight were associated with an ~10% risk of retinal toxicity within 10 years of treatment and an almost 40% risk after 20 years of therapy. Risk is most accurately assessed on the basis of duration of use relative to daily dose/body weight (Marmor [AAO 2016]; Melles 2014). Based on these risks, the American Academy of Ophthalmology (AAO) recommends not exceeding a daily hydroxychloroquine dosage of 5 mg/kg using actual body weight. Previous recommendations to use ideal body weight are no longer advised; very thin patients in particular were at increased risk for retinal toxicity using this practice. Current AAO guidelines do not specifically address dosing in obese patients. AAO also recommends baseline screening for retinal toxicity and annual screening beginning after 5 years of use (or sooner if major risk factors are present) (Marmor [AAO 2016]). If ocular toxicity is suspected, discontinue and monitor closely; retinal changes and visual disturbances may progress after discontinuation. A baseline ocular exam is recommended within the first year of initiating hydroxychloroquine treatment.

Disease-related concerns:

• G6PD deficiency: Although the manufacturer’s labeling recommends hydroxychloroquine be used with caution in patients with G6PD deficiency due to a potential for hemolytic anemia, there is limited data to support this risk. Many experts consider hydroxychloroquine, when given in usual therapeutic doses to WHO Class II and III G6PD deficient patients, to probably be safe (Cappellini 2008; Glader 2017; Luzzatto 2016; Youngster 2010). Safety in Class I G6PD deficiency (ie, severe form of the deficiency associated with chronic hemolytic anemia) is generally unknown (Glader 2017). In a retrospective chart review, no incidence of hemolytic anemia was found among the 11 patients identified with G6PD deficiency receiving hydroxychloroquine therapy, despite >700 months of exposure (all patients were African-American and located in the US) (Mohammad 2017). In addition, the ACR Rheumatology guidelines do not mention the need to evaluate G6PD levels prior to initiation of therapy (Singh 2015).

• Gastrointestinal disorders: Use with caution in patients with gastrointestinal disorders.

• Hepatic impairment: Use with caution in patients with hepatic impairment, alcoholism, or concurrent therapy with hepatotoxic agents.

• Porphyria: Use with extreme caution in patients with porphyria; may exacerbate or precipitate disease.

• Psoriasis: Use with extreme caution in patients with psoriasis; may exacerbate or precipitate disease.

• Renal impairment: Use with caution in patients with renal impairment; dosage reduction may be needed.

Special populations:

• Pediatric: Pediatric patients have an increased sensitivity to aminoquinolines. Safety and efficacy have not been established for chronic use in children for juvenile idiopathic arthritis or for systemic lupus erythematosus.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Geriatric Considerations

No specific recommendations for dosing.

Pregnancy Considerations

Hydroxychloroquine can be detected in the cord blood at delivery in concentrations similar to those in the maternal serum (Costedoat-Chalumeau 2002). In animal reproduction studies with chloroquine, accumulation in fetal ocular tissues was observed and remained for several months following drug elimination from the rest of the body. Based on available human data, an increased risk of fetal ocular toxicity has not been observed following maternal use of hydroxychloroquine, but additional studies are needed to confirm (Osadchy 2011).

Maternal lupus is associated with adverse maternal and fetal events; however, pregnancy outcomes may be improved if conception does not occur until the disease has been inactive for ≥6 months. Hydroxychloroquine is one of the medications recommended for the management of lupus and lupus nephritis in pregnant women. If pregnancy is detected during therapy, it should not be stopped (could precipitate a flare in maternal disease and exposure to the fetus will still continue for 6 to 8 weeks due to tissue binding) (Baer 2011; Bertsias 2012; Hahn 2012; Levy 2001). Maternal use of hydroxychloroquine may also decrease the incidence of cardiac malformations associated with neonatal lupus (Izmirly 2012).

Malaria infection in pregnant women may be more severe than in nonpregnant women and has a high risk of maternal and perinatal morbidity and mortality. Therefore, pregnant women and women who are likely to become pregnant are advised to avoid travel to malaria-risk areas. Hydroxychloroquine is recommended as an alternative treatment of pregnant women for uncomplicated malaria in chloroquine-sensitive regions (refer to current guidelines) (CDC 2011).

Women exposed to hydroxychloroquine for the treatment of rheumatoid arthritis or systemic lupus erythematosus during pregnancy may be enrolled in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases Study pregnancy registry (877-311-8972).

Breast-Feeding Considerations

Hydroxychloroquine is present in breast milk (Costedoat-Chalumeau 2002; Nation 1984; Ostensen 1985).

The relative infant dose (RID) of hydroxychloroquine was ~2% when calculated by the authors of a study following a maternal dose of hydroxychloroquine sulfate 400 mg daily for 6 weeks. Calculations were made based on actual maternal and infant weight and the milk consumption of an average 9-month old (Nation 1984).

In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).

Infants exposed to hydroxychloroquine via breast milk following chronic maternal administration, including one infant who was exposed for 30 months (Cimaz 2004), have been monitored for adverse effects; no negative impact on vision, growth, development, or otherwise has been noted (Cimaz 2004; Motta 2002; Motta 2005; Tincani 2001).

The manufacturer recommends that caution be exercised when administering hydroxychloroquine to breastfeeding women. However, hydroxychloroquine is considered to be compatible with breastfeeding or low risk in breastfeeding mothers with autoimmune and systemic inflammatory diseases (Flint 2016; Gotestam 2016; Kavanaugh 2015; Sammaritano 2014). Clinicians should note that when hydroxychloroquine is administered to breastfeeding women for malaria, insufficient amounts are transferred via breast milk to provide chemoprophylaxis to the infant (CDC 2016).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Frequency not defined:

Central nervous system: Ataxia, dizziness, emotional disturbance, emotional lability, headache, irritability, lassitude, nervousness, nightmares, psychosis, seizure, sensorineural hearing loss, suicidal tendencies, vertigo

Dermatologic: Acute generalized exanthematous pustulosis, alopecia, bleaching of hair, bullous rash, dyschromia (skin and mucosal; black-blue color), erythema (annulare centrifugum), erythema multiforme, exacerbation of psoriasis (nonlight sensitive), exfoliative dermatitis, lichenoid eruption, maculopapular rash, morbilliform rash, pruritus, skin photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Endocrine & metabolic: Exacerbation of porphyria, weight loss

Gastrointestinal: Anorexia, diarrhea, nausea, stomach cramps, vomiting

Hematologic & oncologic: Agranulocytosis, anemia, aplastic anemia, hemolysis (in patients with glucose-6-phosphate deficiency), leukopenia, purpuric rash, thrombocytopenia

Hepatic: Acute hepatic failure (rare), hepatic insufficiency (rare)

Hypersensitivity: Angioedema

Neuromuscular & skeletal: Myopathy (including palsy or neuromyopathy, leading to progressive weakness and atrophy of proximal muscle groups; may be associated with mild sensory changes, loss of deep tendon reflexes, and abnormal nerve conduction)

Ophthalmic: Accommodation disturbance, corneal changes (transient edema, punctate to lineal opacities, decreased sensitivity, deposits, visual disturbances, blurred vision, photophobia [reversible on discontinuation]), decreased visual acuity, macular edema, nystagmus, optic disk disorder (pallor/atrophy), retinal pigment changes, retinal vascular disease (attenuation of arterioles), retinitis pigmentosa, retinopathy (early changes reversible [may progress despite discontinuation if advanced]), scotoma, vision color changes, visual field defect

Otic: Tinnitus

Respiratory: Bronchospasm

<1%, postmarketing, and/or case reports: Cardiomyopathy, epithelial keratopathy (Dosso 2007), hypoglycemia (Cansu 2008; Unübol 2011), macular degeneration, maculopathy

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

None known.

Drug Interactions 

Androgens: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Exceptions: Danazol. Risk C: Monitor therapy

Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Antipsychotic Agents (Phenothiazines): Antimalarial Agents may increase the serum concentration of Antipsychotic Agents (Phenothiazines). Risk C: Monitor therapy

Artemether: May enhance the adverse/toxic effect of Antimalarial Agents. Management: Artemether/Lumefantrine (combination product) should not be used with other antimalarials unless there is no other treatment option. Risk X: Avoid combination

Beta-Blockers: Aminoquinolines (Antimalarial) may decrease the metabolism of Beta-Blockers. Exceptions: Atenolol; Carteolol (Ophthalmic); Levobunolol; Metipranolol; Nadolol; Sotalol. Risk C: Monitor therapy

Cardiac Glycosides: Aminoquinolines (Antimalarial) may increase the serum concentration of Cardiac Glycosides. Risk C: Monitor therapy

Dapsone (Systemic): May enhance the adverse/toxic effect of Antimalarial Agents. Specifically, concomitant use of dapsone with antimalarial agents may increase the risk for hemolytic reactions. Antimalarial Agents may enhance the adverse/toxic effect of Dapsone (Systemic). Specifically, concomitant use of antimalarial agents with dapsone may increase the risk of hemolytic reactions. Management: Closely monitor patients for signs/symptoms of hemolytic reactions with concomitant use of dapsone and antimalarial agents, particularly in patients deficient in glucose-6-phosphate dehydrogenase (G6PD), methemoglobin reductase, or with hemoglobin M. Risk D: Consider therapy modification

Dapsone (Topical): Antimalarial Agents may enhance the adverse/toxic effect of Dapsone (Topical). Specifically, the risk of hemolytic reactions may be increased. Management: Closely monitor for signs/symptoms of hemolytic reactions with concomitant use of topical dapsone and antimalarial agents. Patients with glucose-6-phosphate dehydrogenase deficiency may be at particularly high risk for adverse hematologic effects. Risk D: Consider therapy modification

Haloperidol: QT-prolonging Agents (Indeterminate Risk – Avoid) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy

Herbs (Hypoglycemic Properties): May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Hypoglycemia-Associated Agents: May enhance the hypoglycemic effect of other Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Lumefantrine: Antimalarial Agents may enhance the adverse/toxic effect of Lumefantrine. Management: Artemether/Lumefantrine (combination product) should not be used with other antimalarials unless there is no other treatment option. Risk X: Avoid combination

Maitake: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Mefloquine: Aminoquinolines (Antimalarial) may enhance the adverse/toxic effect of Mefloquine. Specifically, the risk for QTc-prolongation and the risk for convulsions may be increased. Mefloquine may increase the serum concentration of Aminoquinolines (Antimalarial). Management: Avoid concurrent use, and delay administration of mefloquine until at least 12 hours after the last dose of an aminoquinoline antimalarial when possible. Risk X: Avoid combination

Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Prothionamide: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk – Avoid) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Quinolones: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolones may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Tamoxifen: May enhance the adverse/toxic effect of Hydroxychloroquine. Specifically, concomitant use of tamoxifen and hydroxychloroquine may increase the risk of retinal toxicity. Risk C: Monitor therapy

Genes of Interest
Monitoring Parameters

CBC at baseline and periodically; liver function; renal function (in patients at risk for ocular toxicity); blood glucose (if symptoms of hypoglycemia occur); muscle strength (especially proximal, as a symptom of neuromyopathy) during long-term therapy

Ophthalmologic exam at baseline (fundus examination within the first year plus visual fields and spectral-domain optical coherence tomography [SD OCT] if maculopathy is present) to screen for retinal toxicity, followed by annual screening beginning after 5 years of use (or sooner if major risk factors are present) (Marmor [AAO 2016]). Additionally, the manufacturer recommends an ocular exam include best corrected distance visual acuity and an automated threshold visual field of the central 10 degrees (24 degrees in patients of Asian ancestry as retinal toxicity may appear outside of the macula). Consider annual exams (without deferring 5 years) in patients with significant risk factors.

Reference Range

Data suggest that individual blood concentrations do not correlate closely with dosage, weight, or clinical effectiveness. However, blood levels may be useful in patients with renal disease or as an aid in assessing compliance (Melles 2014).

Advanced Practitioners Physical Assessment/Monitoring

Obtain CBC (baseline and periodically), renal function tests, and liver function tests. Obtain ophthalmologic exam at baseline and annually after 5 years of use. Assess muscle strength during prolonged therapy. Assess for signs of cardiomyopathy, bone marrow suppression, neuromuscular effects, and retinal toxicity.

Nursing Physical Assessment/Monitoring

Check ordered labs and report abnormalities. Instruct patient on importance of ophthalmic exams. Monitor for neuromuscular [deep tendon reflexes, muscle weakness] and ocular changes; instruct patient to report.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as sulfate:

Plaquenil: 200 mg

Generic: 200 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as sulfate:

Plaquenil: 200 mg

Generic: 200 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • P01BA02
Generic Available (US)

Yes

Pricing: US

Tablets (Hydroxychloroquine Sulfate Oral)

200 mg (per each): $4.09 – $4.36

Tablets (Plaquenil Oral)

200 mg (per each): $11.42

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Interferes with digestive vacuole function within sensitive malarial parasites by increasing the pH and interfering with lysosomal degradation of hemoglobin; inhibits locomotion of neutrophils and chemotaxis of eosinophils; impairs complement-dependent antigen-antibody reactions

Pharmacodynamics/Kinetics

Onset of action: Rheumatic disease: May require several weeks to respond

Absorption: Incomplete and variable (~70% [range: 25 to 100%]) (Tett 1993)

Protein binding: ~40%, primarily albumin (Tett 1993)

Metabolism: Hepatic; metabolites include bidesethylchloroquine, desethylhydroxychloroquine, and desethylchloroquine (McChesney 1966)

Half-life elimination: ~40 days (Tett 1993)

Excretion: Urine (15% to 25% [Tett 1993]; as metabolites and unchanged drug [up to 60%, McChesney 1966]); may be enhanced by urinary acidification

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

Hematologic adverse effects such as anemia, aplastic anemia, and thrombocytopenia are rare.

Index Terms

Hydroxychloroquine Sulfate

FDA Approval Date
April 18, 1955
References

Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52.[PubMed 27060684]

Baer AN, Witter FR, and Petri M, “Lupus and Pregnancy,” Obstet Gynecol Surv, 2011, 66(10):639-53.[PubMed 22112525]

Bernstein HN, “Ocular Safety of Hydroxychloroquine (Plaquenil),” South Med J, 1992, 85(3):274-9.[PubMed 1546352]

Bertsias GK, Tektonidou M, Amoura Z, et al, “Joint European League Against Rheumatism and European Renal Association-European Dialysis and Transplant Association (EULAR/ERA-EDTA) Recommendations For the Management of Adult and Paediatric Lupus Nephritis,” Ann Rheum Dis, 2012, 71(11):1771-82.[PubMed 22851469]

Cansu DU, Korkmaz C. Hypoglycaemia induced by hydroxychloroquine in a non-diabetic patient treated for RA. Rheumatology (Oxford). 2008; 47(3):378-379.[PubMed 18222983 ]

Cappellini MD, Fiorelli G. Glucose-6-phosphate dehydrogenase deficiency. Lancet. 2008;371(9606):64-74. doi: 10.1016/S0140-6736(08)60073-2. Review.[PubMed 18177777]

Centers for Disease Control and Prevention. CDC Health Information for International Travel 2016. New York, NY: Oxford University Press; 2016. http://wwwnc.cdc.gov/travel/page/yellowbook-home.

Centers for Disease Control and Prevention (CDC), Anderson A, Bijlmer H, Fournier PE, et al. Diagnosis and management of Q fever–United States, 2013: recommendations from CDC and the Q Fever Working Group. MMWR Recomm Rep. 2013;62(RR-03):1-30.[PubMed 23535757]

Centers for Disease Control and Prevention (CDC), “Guidelines for Treatment of Malaria in the United States.” Available at http://www.cdc.gov/malaria/resources/pdf/treatmenttable.pdf

Centers for Disease Control and Prevention (CDC), “Treatment of Malaria (Guidelines for Clinicians).” Available at http://www.cdc.gov/malaria/resources/pdf/clinicalguidance.pdf

Cimaz R, Brucato A, Meregalli E, Muscará M, Sergi P. Electroretinograms of children born to mothers treated with hydroxychloroquine during pregnancy and breast-feeding: comment on the article by Costedoat-Chalumeau et al. Arthritis Rheum. 2004;50(9):3056-3057; author reply 3057-3058.[PubMed 15457485]

Costedoat-Chalumeau N, Amoura Z, Aymard G, et al, “Evidence of Transplacental Passage of Hydroxychloroquine in Humans,” Arthritis Rheum, 2002, 46(4):1123-4.[PubMed 11953993]

Dosso A, Rungger-Brändle E. In vivo confocal microscopy in hydroxychloroquine-induced keratopathy. Graefes Arch Clin Exp Ophthalmol. 2007; 245(2):318-320.[PubMed 16738856 ]

“Drugs for Parasitic Infections,” Med Lett Drugs Ther, 1993, 35(911):111-22.[PubMed 8246830]

Emery H, “Clinical Aspects of Systemic Lupus Erythematosus in Childhood,” Pediatr Clin North Am, 1986, 33(5):1177-90.[PubMed 3763254]

Flint J, Panchal S, Hurrell A, et al. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2016;55(9):1693-1697.[PubMed 26750124]

Fox RI, Dixon R, Guarrasi V, Krubel S. Treatment of primary Sjögren’s syndrome with hydroxychloroquine: a retrospective, open-label study. Lupus. 1996;5(suppl 1):S31-S36.[PubMed 8803908]

Furst DE, “Rational Use of Disease-Modifying Antirheumatic Drugs,” Drugs, 1990, 39(1):19-37.[PubMed 2178910]

Giannini EH and Cawkwell GD, “Drug Treatment in Children With Juvenile Rheumatoid Arthritis. Past, Present, and Future,” Pediatr Clin North Am, 1995, 42(5):1099-125.[PubMed 7567188]

Glader B. Diagnosis and management of glucose-6-phosphate dehydrogenase deficiency. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed November 20, 2017.[PubMed 7567188]

Götestam Skorpen C, Hoeltzenbein M, Tincani A, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75(5):795-810.[PubMed 26888948]

Gould FK, Denning DW, Elliott TS, et al, “Guidelines for the Diagnosis and Antibiotic Treatment of Endocarditis in Adults: A Report of the Working Party of the British Society for Antimicrobial Chemotherapy,” J Antimicrob Chemother, 2012, 67(2):269-89.[PubMed 22086858]

“Guidelines for the Management of Rheumatoid Arthritis. American College of Rheumatology Ad Hoc Committee on Clinical Guidelines,” Arthritis Rheum, 1996, 39(5):713-22.[PubMed 8639167]

Hahn BH, McMahon MA, Wilkinson A, et al, “American College of Rheumatology Guidelines For Screening, Treatment, and Management of Lupus Nephritis,” Arthritis Care Res (Hoboken), 2012, 64(6):797-808.[PubMed 22556106]

Hart LE and Tugwell P, “The Use of Disease-Modifying Antirheumatic Drugs in the Management of Rheumatoid Arthritis,” Postgrad Med J, 1989, 65(770):905-12.[PubMed 2694146]

Hazes JM, Coulie PG, Geenen V, et al, “Rheumatoid Arthritis and Pregnancy: Evolution of Disease Activity and Pathophysiological Considerations For Drug Use,” Rheumatology (Oxford), 2011, 50(11):1955-68.

Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126.[PubMed 10891521]

Izmirly PM, Costedoat-Chalumeau N, Pisoni CN, et al, “Maternal Use of Hydroxychloroquine Is Associated With a Reduced Risk of Recurrent Anti-SSA/Ro-Antibody-Associated Cardiac Manifestations of Neonatal Lupus,” Circulation, 2012, 126(1):76-82.[PubMed 22626746]

Jones SK, “Ocular Toxicity and Hydroxychloroquine: Guidelines for Screening,” Br J Derm, 1999, 140(1):3-7.[PubMed 10215761]

Kavanaugh A, Cush JJ, Ahmed MS, et al. Proceedings from the American College of Rheumatology Reproductive Health Summit: the management of fertility, pregnancy, and lactation in women with autoimmune and systemic inflammatory diseases. Arthritis Care Res (Hoboken). 2015;67(3):313-325.[PubMed 25385050]

Kumar P, Banik S. Pharmacotherapy options in rheumatoid arthritis. Clin Med Insights Arthritis Musculoskelet Disord. 2013;6:35-43. doi: 10.4137/CMAMD.S5558. eCollection 2013.[PubMed 23997576]

Kutz DC and Bridges AJ, “Bullous Rash and Brown Urine in a Systemic Lupus Erythematosus Patient Treated With Hydroxychloroquine,” Arthritis Rheum, 1995, 38(3):440-3.[PubMed 7880200]

Lam NC, Ghetu MV, Bieniek ML. Systemic lupus erythematosus: primary care approach to diagnosis and management. Am Fam Physician. 2016;94(4):284-294.[PubMed 27548593]

Levy RA, Vilela VS, Cataldo MJ, et al, “Hydroxychloroquine (HCQ) in Lupus Pregnancy: Double-Blind and Placebo-Controlled Study,” Lupus, 2001, 10(6):401-4.[PubMed 11434574]

Luzzatto L, Nannelli C, Notaro R. Glucose-6-Phosphate Dehydrogenase Deficiency. Hematol Oncol Clin North Am. 2016;30(2):373-93. doi:10.1016/j.hoc.2015.11.006. Review.[PubMed 27040960]

Makol A, Wright K, and Amin S, “Rheumatoid Arthritis and Pregnancy: Safety Considerations in Pharmacological Management,” Drugs, 2011, 71(15):1973-87.[PubMed 21985166]

Marmor MF, Kellner U, Lai TY, Lyons JS, Mieler WF; American Academy of Ophthalmology. Revised recommendations on screening for chloroquine and hydroxychloroquine retinopathy. Ophthalmology. 2011;118(2):415-422.[PubMed 21292109]

Marmor MF, Kellner U, Lai TY, Melles RB, Mieler WF; American Academy of Ophthalmology. Recommendations on screening for chloroquine and hydroxychloroquine retinopathy (2016 revision). Ophthalmology. 2016;123(6):1386-1394. doi: 10.1016/j.ophtha.2016.01.058.[PubMed 26992838]

Mavragani CP, Moutsopoulos NM, Moutsopoulos HM. The management of Sjögren’s syndrome. Nat Clin Pract Rheumatol. 2006;2(5):252-261. Review.[PubMed 16932698]

McChesney EW, Conway WD, Banks WF, et al. Studies of the metabolism of some compounds of the 4-amino-7-chloroquinolone series. J Pharmacol Exp Ther. 1966;151(3): 482-493.[PubMed 4957157]

Melles RB, Marmor MF. The risk of toxic retinopathy in patients on long-term hydroxychloroquine therapy [published correction appears in JAMA Ophthalmol. 2014;132(12):1493]. JAMA Ophthalmol. 2014;132(12):1453-1460.[PubMed 25275721]

Mohammad S, Clowse MEB, Eudy AM, Criscione-Schreiber LG. Hydroxychloroquine is Not Associated with Hemolytic Anemia in Glucose-6-Phosphate Dehydrogenase (G6PD) Deficient Patients. [published online ahead of print May 26, 2107]. Arthritis Care Res (Hoboken). 2017. doi:10.1002/acr.23296.[PubMed 28556555]

Motta M, Tincani A, Faden D, Zinzini E, Chirico G. Antimalarial agents in pregnancy. Lancet. 2002;359(9305):524-525.[PubMed 11853823]

Motta M, Tincani A, Faden D, et al. Follow-up of infants exposed to hydroxychloroquine given to mothers during pregnancy and lactation. J Perinatol. 2005;25(2):86-89.[PubMed 15496869]

Nation RL, Hackett LP, Dusci LJ, Ilett KF. Excretion of hydroxychloroquine in human milk. Br J Clin Pharmacol. 1984;17(3):368-369.

O’Dell JR, Mikuls TR, Taylor TH, et al; CSP 551 RACAT Investigators. Therapies for active rheumatoid arthritis after methotrexate failure. N Engl J Med. 2013;369(4):307-318. doi: 10.1056/NEJMoa1303006.[PubMed 23755969]

Osadchy A, Ratnapalan T, and Koren G, “Ocular Toxicity in Children Exposed in utero to Antimalarial Drugs: Review of the Literature,” J Rheumatol, 2011, 38(12):2504-8.[PubMed 22002012]

Østensen M, Brown ND, Chiang PK, et al, “Hydroxychloroquine in Human Breast Milk,” Eur J Clin Pharmacol, 1985, 28(3):357.[PubMed 4007043]

Page RL 2nd, O’Bryant CL, Cheng D, et al; American Heart Association Clinical Pharmacology and Heart Failure and Transplantation Committees of the Council on Clinical Cardiology; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Drugs That May Cause or Exacerbate Heart Failure: A Scientific Statement From the American Heart Association [published correction appears in Circulation. 2016;134(12):e261]. Circulation. 2016;134(6):e32-e69.[PubMed 27400984]

Panisko DM and Keystone JS, “Treatment of Malaria – 1990,” Drugs, 1990, 39(2):160-89.[PubMed 2183998]

Plaquenil (hydroxychloroquine) [prescribing information]. St. Michael, Barbados: Concordia Pharmaceuticals Inc; June 2018.

Plaquenil (hydroxychloroquine) [product monograph]. Laval, Quebec, Canada: Sanofi-aventis Canada; January 2018.

Rath T, Rubbert A. Drug combinations with methotrexate to treat rheumatoid arthritis. Clin Exp Rheumatol. 2010;28(5)(suppl 61):S52-S57.[PubMed 21044434]

Sammaritano LR, Bermas BL. Rheumatoid arthritis medications and lactation. Curr Opin Rheumatol. 2014;26(3):354-360.[PubMed 24614280]

Seguin P, Camus C, Leroy JP, et al, “Respiratory Failure Associated With Hydroxychloroquine Neuromyopathy,” Eur Neurol, 1995, 35(4):236-7.[PubMed 7671986]

Singal AK, Kormos-Hallberg C, Lee C, et al. Low-dose hydroxychloroquine is as effective as phlebotomy in treatment of patients with porphyria cutanea tarda. Clin Gastroenterol Hepatol. 2012; 10(12):1402-1409.[PubMed 22985607]

Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American college of rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2016;68(1):1-26. Epub 2015 Nov 6. Review.[PubMed 26545940]

Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis [published online May 3, 2016]. Lancet. doi: 10.1016/S0140-6736(16)30173-8.[PubMed 27156434]

Stojan G and Baer AN, “Flares of Systemic Lupus Erythematosus During Pregnancy and the Puerperium: Prevention, Diagnosis and Management,” Expert Rev Clin Immunol, 2012, 8(5):439-53.[PubMed 22882219]

Tett SE. Clinical pharmacokinetics of slow-acting antirheumatic drugs. Clin Pharmacokinet. 1993; 25(5): 392-407.[PubMed 7904547]

Tett SE, Cutler DJ, Day RO, et al, “Bioavailability of Hydroxychloroquine Tablets in Healthy Volunteers,” Br J Clin Pharmacol, 1989, 27(6):771-9.[PubMed 2757893]

Tincani A, Faden D, Lojacono A, et al. Hydroxychloroquine in pregnant patients with rheumatic disease. Arthritis Rheum. 2001;44 (Suppl 9):S397.

Tsang-A-Sjoe MW, Bultink IE. Systemic lupus erythematosus: review of synthetic drugs. Expert Opin Pharmacother. 2015;16(18):2793-2806. doi: 10.1517/14656566.2015.1101448.

Unübol M, Ayhan M, Guney E. Hypoglycemia induced by hydroxychloroquine in a patient treated for rheumatoid arthritis. J Clin Rheumatol. 2011; 17(1):46-47.[PubMed 21169846 ]

Wang R, “Hydroxychloroquine Cardiotoxicity,” Clin Toxicol, 1995, 33(5):548.

White NJ, “The Treatment of Malaria,” N Engl J Med, 1996, 335(11):800-6.[PubMed 8703186]

Youngster I, Arcavi L, Schechmaster R, Akayzen Y, et al. Medications and glucose-6-phosphate dehydrogenase deficiency: an evidence-based review. Drug Saf. 2010;33(9):713-726. doi:10.2165/11536520-000000000-00000. Review.[PubMed 20701405]

Brand Names: International

Advaquenil (JO); Arthroquin (IN); Axokine (AR); Chloguin (TW); Diclor (IN); Dimard (CO, EC); Dolquine (ES, LB); Duloc (KR); Duroc (KR); Ercoquin (DK); Evoquin (AR, UY); Fen Le (CN); Futarhomal (EG); Geniquin (TW); Haloxin (SG); HCQS (IN, PE, TH, ZW); Hydroquin (TH); Hydroquine (TW); Hyquin (BD, LK); Ilinol (CL); Immard (UA); Metirel (UY); Oxcq (LK); Oxiklorin (FI, KR); Planil (BD); Plaquenil (CN, CR, CY, DO, EG, GT, IS, JP, KW, LT, LU, LV, MX, NI, PA, QA, RO, SA, SG, SV, UA, VN); Plaquenil Sulfate (AR, AU, BB, BE, BF, BG, BJ, BM, BS, BZ, CH, CI, CZ, DK, EE, ET, FR, GH, GM, GN, GR, GY, HK, HN, IE, IL, IT, JM, KE, LR, MA, ML, MR, MT, MU, MW, MY, NE, NG, NL, NO, NZ, PH, RU, SC, SD, SE, SK, SL, SN, SR, TH, TN, TR, TT, TW, TZ, UG, ZA, ZM); Plaquinol (BR, CL, CO, EC, PE, PT, PY, VE); Quensyl (DE); Quinnel (TH); Quinoric (MT); Reconil (BD); Reuquinol (BR); Roquin (BD); Supretic (PY); Winflam (LK); Yuma (KR); Zyq (LK)

Hydroxychloroquine (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(hye droks ee KLOR oh kwin)

Brand Names: US

Plaquenil

Brand Names: Canada

Plaquenil

What is this drug used for?
  • It is used to treat or prevent malaria.
  • It is used to treat lupus.
  • It is used to treat rheumatoid arthritis.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to hydroxychloroquine or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have had any eye changes or changes in eyesight due to this drug or drugs like this one.
  • If you have psoriasis.
  • If you have porphyria.
  • If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • For all uses of this drug:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Use care when driving or doing other tasks that call for clear eyesight.
  • Have an eye exam as you have been told by your doctor.
  • Have your blood work checked if you are on this drug for a long time. Talk with your doctor.
  • Be careful if you have G6PD deficiency. Anemia may happen.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
  • Low blood sugar has happened with this drug. Sometimes, this has been very bad and could be life-threatening. Talk with the doctor.
  • Talk with your doctor before you drink alcohol.
  • Keep away from children. Accidental exposure may cause death. If a child takes this drug by accident, get medical help right away.
  • Use with care in children. Talk with the doctor.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • Malaria:
  • If you are a pregnant woman and traveling to a malaria infested place, talk to your doctor about the risks first.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
  • Any unexplained bruising or bleeding.
  • Seizures.
  • Mood changes.
  • If you are planning to harm yourself or the want to harm yourself gets worse.
  • Bad dreams.
  • Change in hearing.
  • Ringing in ears.
  • Hearing loss.
  • Change in balance.
  • Fever or chills.
  • Sore throat.
  • Feeling very tired or weak.
  • Muscle weakness.
  • Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
  • Not able to control eye movements.
  • Call your doctor right away if you have any changes in eyesight. Rarely, this may not go away.
  • Heart problems like heart failure and a certain abnormal heartbeat (prolonged QT interval) have happened with this drug. Sometimes, these heart problems have been deadly. Call your doctor right away if you have a fast or abnormal heartbeat; very bad dizziness or passing out; or shortness of breath, a big weight gain, or swelling in the arms or legs.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Dizziness.
  • Headache.
  • Feeling nervous and excitable.
  • Not hungry.
  • Weight loss.
  • Diarrhea.
  • Upset stomach or throwing up.
  • Stomach pain.
  • Feeling tired or weak.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Take this drug with food or milk.
  • Swallow whole. Do not chew, break, or crush.
  • If antacids are used, they may need to be taken at some other time than this drug. Talk with your doctor or pharmacist.
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Hydroxychloroquine (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(hye droks ee KLOR oh kwin)

Brand Names: US

Plaquenil

Brand Names: Canada

Plaquenil

What is this drug used for?
  • It is used to treat or prevent malaria.
  • It is used to treat lupus.
  • It is used to treat rheumatoid arthritis.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has had any eye changes or changes in eyesight due to this drug or drugs like this one.
  • If your child has psoriasis, talk with the doctor.
  • If your child has porphyria.
  • If your child is taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask the doctor or pharmacist if you are not sure.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • For all uses of this drug:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for clear eyesight until you see how this drug affects your child.
  • Get your child an eye exam as you have been told by the doctor.
  • Be careful if your child has G6PD deficiency. Anemia may happen.
  • Have your child’s blood work checked if he/she is on this drug for a long time. Talk with your child’s doctor.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • Your child may get sunburned more easily. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects him/her from the sun.
  • Low blood sugar has happened with this drug. Sometimes, this has been very bad and could be life-threatening. Talk with the doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • Keep away from children. Accidental exposure may cause death. If a child takes this drug by accident, get medical help right away.
  • Use with care in children. Talk with the doctor.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
  • Malaria:
  • If your child is pregnant and is traveling to a malaria-infested place, talk to the doctor about the risks first.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
  • Feeling very tired or weak.
  • Any unexplained bruising or bleeding.
  • Seizures.
  • Mood changes.
  • If your child is planning to harm him/herself. If the want to harm him/herself gets worse.
  • Bad dreams.
  • Change in hearing.
  • Ringing in ears.
  • Hearing loss.
  • Change in balance.
  • Fever or chills.
  • Sore throat.
  • Muscle weakness.
  • Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
  • Not able to control eye movements.
  • Call the doctor right away if your child has any changes in eyesight. Rarely, this may not go away.
  • Heart problems like heart failure and a certain abnormal heartbeat (prolonged QT interval) have happened with this drug. Sometimes, these heart problems have been deadly. Call your child’s doctor right away if your child has a fast or abnormal heartbeat; very bad dizziness or passing out; or shortness of breath, a big weight gain, or swelling in the arms or legs.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Dizziness.
  • Feeling nervous and excitable.
  • Not hungry.
  • Weight loss.
  • Diarrhea.
  • Upset stomach or throwing up.
  • Stomach pain.
  • Feeling tired or weak.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Give this drug with food or milk.
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • If antacids are used, they may need to be taken at some other time than this drug. Talk with your doctor or pharmacist.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.