Plaquenil 200mg Tablets
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.
Drug Class
Antimalarial, Disease-modifying Antirheumatic Drug (DMARD)
Pharmacologic Class
Aminoquinoline
Pregnancy Category
Not available
FDA Approved
Mar 1955
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydroxychloroquine is a medication used to treat certain autoimmune diseases like lupus and rheumatoid arthritis, and also to prevent or treat malaria. It works by calming down the overactive immune system in autoimmune conditions and by killing malaria parasites.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
For all uses of this medication:
+ Take your dose with food or milk to help your body absorb the medication.
+ Swallow the tablet whole - do not chew, break, or crush it.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Avoid taking antacids or kaolin within 4 hours of taking this medication, as they may interfere with its effectiveness.
If you are taking this medication to prevent malaria, make sure you understand when to start taking it. If you're unsure, consult with your doctor.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications out of the reach of children and pets.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose:
Take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed one.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
For all uses of this medication:
+ Take your dose with food or milk to help your body absorb the medication.
+ Swallow the tablet whole - do not chew, break, or crush it.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Avoid taking antacids or kaolin within 4 hours of taking this medication, as they may interfere with its effectiveness.
If you are taking this medication to prevent malaria, make sure you understand when to start taking it. If you're unsure, consult with your doctor.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications out of the reach of children and pets.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose:
Take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take with food or milk to reduce stomach upset.
- Do not exceed the prescribed dose, as higher doses increase the risk of serious side effects.
- Avoid excessive sun exposure and use sunscreen, as this medication can increase sun sensitivity.
- Regular eye exams are crucial to monitor for a rare but serious side effect called retinopathy, which can lead to vision loss.
- Report any new or worsening vision changes immediately to your doctor.
- Keep out of reach of children, as even a small overdose can be fatal for a child.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For chronic conditions like RA/SLE, typically 200-400 mg daily.
Dose Range:
200 - 400 mg
Condition-Specific Dosing:
Rheumatoid Arthritis:
400 mg daily initially, then reduced to 200-400 mg daily. Max 5 mg/kg/day (ideal body weight).
Systemic Lupus Erythematosus:
200-400 mg daily. Max 5 mg/kg/day (ideal body weight).
Malaria Prophylaxis:
400 mg once weekly on the same day each week, starting 1-2 weeks before exposure and continuing for 4 weeks after leaving the endemic area.
Acute Malaria Treatment:
Initial dose of 800 mg, followed by 400 mg at 6 hours, 24 hours, and 48 hours after the initial dose (total 2000 mg over 3 days).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Dosing for malaria prophylaxis/treatment and juvenile idiopathic arthritis/SLE is weight-based. Max 6.5 mg/kg/day (ideal body weight) or 400 mg/day, whichever is lower.
Adolescent:
Dosing for malaria prophylaxis/treatment and juvenile idiopathic arthritis/SLE is weight-based. Max 6.5 mg/kg/day (ideal body weight) or 400 mg/day, whichever is lower.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but monitor for increased adverse effects.
Moderate:
Consider dose reduction (e.g., 50%) or increased dosing interval. Monitor closely.
Severe:
Avoid or significantly reduce dose (e.g., 50% or less) and monitor closely. Data are limited.
Dialysis:
Not significantly dialyzable. Use with caution, consider dose reduction.
Hepatic Impairment:
Mild:
No specific adjustment recommended, but monitor for increased adverse effects.
Moderate:
Use with caution. Consider dose reduction and monitor closely.
Severe:
Use with extreme caution or avoid. Data are limited.
Pharmacology
Mechanism of Action
Hydroxychloroquine is an antimalarial and immunomodulatory agent. Its exact mechanism in autoimmune diseases is not fully understood but is thought to involve: 1. Interference with lysosomal activity and antigen processing/presentation by increasing lysosomal pH in antigen-presenting cells. 2. Inhibition of toll-like receptor (TLR) signaling, particularly TLR9, which reduces interferon-alpha production. 3. Inhibition of enzyme activity (e.g., phospholipase A2, cholinesterase). 4. Stabilization of lysosomal membranes. 5. Inhibition of DNA and RNA synthesis. 6. Anti-inflammatory effects by inhibiting neutrophil chemotaxis and superoxide production.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 74%
Tmax:
1-3 hours (for parent drug), 3-10 hours (for active metabolites)
FoodEffect:
Food may increase bioavailability and reduce GI upset.
Distribution:
Vd:
High (5800 L), indicating extensive tissue distribution (e.g., liver, kidney, lung, spleen, retina, brain)
ProteinBinding:
Approximately 45% (to plasma proteins)
CnssPenetration:
Limited, but detectable levels in CSF
Elimination:
HalfLife:
Terminal elimination half-life is long and variable, ranging from 32 to 50 days (for parent drug and metabolites).
Clearance:
Not readily available, but primarily renal.
ExcretionRoute:
Renal (approximately 50% unchanged drug and metabolites), some biliary/fecal.
Unchanged:
Approximately 23-25% of the dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Weeks to months for full therapeutic effect in autoimmune diseases (e.g., 6-12 weeks for RA/SLE).
PeakEffect:
Not applicable for chronic conditions; for acute malaria, within hours.
DurationOfAction:
Due to long half-life, effects persist for weeks after discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Seizures
New or worsening behavioral or mood changes, such as depression or suicidal thoughts
Confusion
Hallucinations (seeing or hearing things that are not there)
Bad dreams
Ringing in the ears, hearing loss, or changes in hearing
Balance problems
Trouble controlling body movements
Shakiness
Muscle weakness
Inability to control eye movements
Severe eye problems, which may lead to lasting vision problems, especially if you have pre-existing eye or kidney problems, take high doses, use the medication for more than 5 years, or take certain other medications like tamoxifen. Seek medical help immediately if you experience:
+ Blurred or foggy vision
+ Trouble focusing or reading
+ Difficulty seeing in dim light
+ Loss of vision
+ Dark spots or partial vision
Heart problems, including heart failure and abnormal heartbeat (prolonged QT interval), which can be life-threatening. Seek medical help immediately if you experience:
+ Fast or abnormal heartbeat
+ Severe dizziness or fainting
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs
Low blood cell counts, which can increase the risk of bleeding, infection, or anemia. Seek medical help immediately if you experience:
+ Signs of infection, such as fever, chills, or sore throat
+ Unexplained bruising or bleeding
+ Feeling extremely tired or weak
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, eyes, genitals, or skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
Dizziness
Tiredness
Weakness
Headache
Nervousness or excitability
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Weight loss
Changes in skin color
Changes in hair color
* Hair loss
Reporting Side Effects
If you have questions about side effects or want to report a side effect, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Seizures
New or worsening behavioral or mood changes, such as depression or suicidal thoughts
Confusion
Hallucinations (seeing or hearing things that are not there)
Bad dreams
Ringing in the ears, hearing loss, or changes in hearing
Balance problems
Trouble controlling body movements
Shakiness
Muscle weakness
Inability to control eye movements
Severe eye problems, which may lead to lasting vision problems, especially if you have pre-existing eye or kidney problems, take high doses, use the medication for more than 5 years, or take certain other medications like tamoxifen. Seek medical help immediately if you experience:
+ Blurred or foggy vision
+ Trouble focusing or reading
+ Difficulty seeing in dim light
+ Loss of vision
+ Dark spots or partial vision
Heart problems, including heart failure and abnormal heartbeat (prolonged QT interval), which can be life-threatening. Seek medical help immediately if you experience:
+ Fast or abnormal heartbeat
+ Severe dizziness or fainting
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs
Low blood cell counts, which can increase the risk of bleeding, infection, or anemia. Seek medical help immediately if you experience:
+ Signs of infection, such as fever, chills, or sore throat
+ Unexplained bruising or bleeding
+ Feeling extremely tired or weak
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, eyes, genitals, or skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
Dizziness
Tiredness
Weakness
Headache
Nervousness or excitability
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Weight loss
Changes in skin color
Changes in hair color
* Hair loss
Reporting Side Effects
If you have questions about side effects or want to report a side effect, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any changes in vision (blurred vision, difficulty reading, blind spots, changes in color vision)
- Muscle weakness or pain
- Unusual tiredness or fatigue
- Skin rash, itching, or changes in skin color
- Hair loss
- Nausea, vomiting, severe stomach pain
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Pale stools
- Fever, sore throat, or other signs of infection
- Unusual bleeding or bruising
- Palpitations, shortness of breath, chest pain, or fainting spells
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of abnormal heart rhythms, including a prolonged QT interval on an electrocardiogram (ECG).
Certain health conditions, such as:
+ Low levels of magnesium or potassium in your blood
+ A slow heartbeat
+ Eye problems, including retinopathy
+ Heart failure (a weakened heart) or a history of heart attack
+ Previous eye or vision changes caused by this medication or similar drugs
+ Porphyria or psoriasis
Concurrent use of specific medications, including:
+ Cimetidine or rifampicin
+ Drugs that can cause abnormal heart rhythms (prolonged QT interval). There are many medications that can have this effect; consult your doctor or pharmacist if you are unsure.
* All your current medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information is crucial to avoid potential interactions.
To ensure your safety, it is vital to discuss all your medications and health conditions with your doctor and pharmacist. Do not start, stop, or modify the dosage of any medication without first consulting your doctor. This will help you verify that it is safe to take this medication with your existing treatments and health conditions.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of abnormal heart rhythms, including a prolonged QT interval on an electrocardiogram (ECG).
Certain health conditions, such as:
+ Low levels of magnesium or potassium in your blood
+ A slow heartbeat
+ Eye problems, including retinopathy
+ Heart failure (a weakened heart) or a history of heart attack
+ Previous eye or vision changes caused by this medication or similar drugs
+ Porphyria or psoriasis
Concurrent use of specific medications, including:
+ Cimetidine or rifampicin
+ Drugs that can cause abnormal heart rhythms (prolonged QT interval). There are many medications that can have this effect; consult your doctor or pharmacist if you are unsure.
* All your current medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information is crucial to avoid potential interactions.
To ensure your safety, it is vital to discuss all your medications and health conditions with your doctor and pharmacist. Do not start, stop, or modify the dosage of any medication without first consulting your doctor. This will help you verify that it is safe to take this medication with your existing treatments and health conditions.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. Regular monitoring is crucial, so be sure to undergo blood tests, eye exams, and electrocardiograms (ECGs) as directed by your doctor to assess your heart's functioning.
If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you may be at a higher risk of developing anemia. This deficiency is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent. Your doctor will closely monitor your condition to prevent any potential complications.
This medication can increase your sensitivity to sunlight, making you more prone to sunburn. Take necessary precautions when exposed to the sun, and inform your doctor if you experience any unusual sunburn or sensitivity.
There is a risk of hypoglycemia (low blood sugar) associated with this medication, which can be severe and potentially life-threatening. It is crucial to monitor your blood sugar levels as advised by your doctor and discuss any concerns with them.
Before consuming alcohol, consult your doctor to understand any potential risks or interactions. Additionally, keep this medication out of reach of children, as accidental ingestion can be fatal. If a child accidentally takes this medication, seek immediate medical attention.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women should discuss the benefits and risks of this medication with their doctor before taking it.
Preventing Malaria
When using this medication to prevent malaria, it is essential to combine it with other preventive measures, including:
Using window screens and bed nets
Applying insect repellents containing 10% to 35% DEET
Spraying permethrin on clothing and nets (avoid spraying insect repellents on children)
Reducing outdoor activities during evening and nighttime hours
If you experience a fever while in or after leaving a malaria-infested area, contact your doctor immediately. Pregnant women traveling to areas with malaria should consult their doctor to discuss the risks and necessary precautions before taking this medication.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. Regular monitoring is crucial, so be sure to undergo blood tests, eye exams, and electrocardiograms (ECGs) as directed by your doctor to assess your heart's functioning.
If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you may be at a higher risk of developing anemia. This deficiency is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent. Your doctor will closely monitor your condition to prevent any potential complications.
This medication can increase your sensitivity to sunlight, making you more prone to sunburn. Take necessary precautions when exposed to the sun, and inform your doctor if you experience any unusual sunburn or sensitivity.
There is a risk of hypoglycemia (low blood sugar) associated with this medication, which can be severe and potentially life-threatening. It is crucial to monitor your blood sugar levels as advised by your doctor and discuss any concerns with them.
Before consuming alcohol, consult your doctor to understand any potential risks or interactions. Additionally, keep this medication out of reach of children, as accidental ingestion can be fatal. If a child accidentally takes this medication, seek immediate medical attention.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women should discuss the benefits and risks of this medication with their doctor before taking it.
Preventing Malaria
When using this medication to prevent malaria, it is essential to combine it with other preventive measures, including:
Using window screens and bed nets
Applying insect repellents containing 10% to 35% DEET
Spraying permethrin on clothing and nets (avoid spraying insect repellents on children)
Reducing outdoor activities during evening and nighttime hours
If you experience a fever while in or after leaving a malaria-infested area, contact your doctor immediately. Pregnant women traveling to areas with malaria should consult their doctor to discuss the risks and necessary precautions before taking this medication.
Overdose Information
Overdose Symptoms:
- Headache
- Drowsiness
- Blurred vision
- Cardiovascular collapse (hypotension, shock)
- Cardiac arrhythmias (e.g., QT prolongation, Torsades de Pointes, ventricular fibrillation)
- Seizures
- Respiratory depression
- Hypokalemia
- Coma
- Death
What to Do:
Seek immediate emergency medical attention. Call 911 or Poison Control (1-800-222-1222). Management includes gastric lavage, activated charcoal, supportive care, and close monitoring of cardiac function (ECG) and electrolytes. Diazepam may be used for seizures. Vasopressors for hypotension. Potassium supplementation for hypokalemia.
Drug Interactions
Major Interactions
- Amiodarone (increased risk of cardiac toxicity, QT prolongation)
- Digoxin (increased digoxin levels)
- Mefloquine (increased risk of seizures)
- Drugs that prolong QT interval (e.g., antiarrhythmics, antipsychotics, macrolides, fluoroquinolones) - increased risk of torsades de pointes
- Insulin/Oral Hypoglycemics (enhanced hypoglycemic effect)
- Tamoxifen (increased risk of retinopathy)
Moderate Interactions
- Cyclosporine (increased cyclosporine levels)
- Cimetidine (may inhibit metabolism of hydroxychloroquine)
- Antacids/Kaolin (may reduce absorption of hydroxychloroquine; separate administration by at least 4 hours)
- Praziquantel (reduced praziquantel levels)
- Ampicillin (reduced ampicillin absorption)
Monitoring
Baseline Monitoring
Ophthalmologic examination (visual acuity, fundoscopy, automated visual fields, spectral domain optical coherence tomography (SD-OCT))
Rationale: To detect pre-existing macular disease and establish a baseline for potential retinopathy.
Timing: Within the first year of starting therapy.
Complete Blood Count (CBC)
Rationale: To monitor for potential hematologic abnormalities (e.g., bone marrow suppression, agranulocytosis, aplastic anemia).
Timing: Before starting therapy.
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function, as the drug is metabolized in the liver.
Timing: Before starting therapy.
Renal Function Tests (Creatinine, BUN)
Rationale: To assess baseline renal function, as the drug is primarily renally excreted.
Timing: Before starting therapy.
Electrocardiogram (ECG)
Rationale: To assess baseline cardiac rhythm and QT interval, especially in patients with pre-existing cardiac conditions or on other QT-prolonging drugs.
Timing: Before starting therapy, if clinically indicated.
Routine Monitoring
Ophthalmologic examination (visual acuity, fundoscopy, automated visual fields, SD-OCT)
Frequency: Annually after 5 years of therapy, or sooner if high-risk factors (e.g., daily dose >5 mg/kg, renal/hepatic impairment, concomitant tamoxifen, pre-existing retinal disease) are present.
Target: Normal retinal structure and function.
Action Threshold: Any new or worsening visual symptoms, or objective changes on ophthalmic exam, require immediate evaluation and consideration of drug discontinuation.
Complete Blood Count (CBC)
Frequency: Periodically (e.g., every 3-6 months initially, then annually) or as clinically indicated.
Target: Within normal limits.
Action Threshold: Significant drops in cell counts (e.g., leukopenia, thrombocytopenia, anemia) may require dose reduction or discontinuation.
Liver Function Tests (LFTs)
Frequency: Periodically (e.g., every 6-12 months) or as clinically indicated.
Target: Within normal limits.
Action Threshold: Significant elevation of liver enzymes may require dose reduction or discontinuation.
Renal Function Tests (Creatinine, BUN)
Frequency: Periodically (e.g., every 6-12 months) or as clinically indicated.
Target: Within normal limits.
Action Threshold: Significant impairment may require dose adjustment.
ECG (QTc interval)
Frequency: Periodically, especially if new cardiac symptoms develop or if co-administered with other QT-prolonging drugs.
Target: <450 ms (men), <470 ms (women)
Action Threshold: QTc >500 ms or increase of >60 ms from baseline requires immediate evaluation and consideration of drug discontinuation.
Symptom Monitoring
- Visual changes (blurred vision, difficulty reading, missing parts of vision, light flashes, halos, color vision changes)
- Muscle weakness or atrophy
- Nausea, vomiting, diarrhea, abdominal cramps
- Skin rash, itching, pigmentation changes
- Headache, dizziness, nervousness
- Hair loss
- Signs of infection (fever, sore throat, unusual bruising/bleeding)
- Signs of hypoglycemia (sweating, tremor, confusion)
- Signs of cardiac issues (palpitations, shortness of breath, chest pain, fainting)
Special Patient Groups
Pregnancy
Hydroxychloroquine is generally considered compatible with pregnancy for the treatment of autoimmune diseases like lupus and rheumatoid arthritis, as uncontrolled disease poses greater risks to mother and fetus. The American College of Rheumatology (ACR) and American College of Obstetricians and Gynecologists (ACOG) support its continued use during pregnancy for these conditions. Risk of fetal ocular toxicity is very low.
Trimester-Specific Risks:
First Trimester:
No increased risk of major congenital malformations observed in studies.
Second Trimester:
Considered safe; continued use is generally recommended to prevent disease flares.
Third Trimester:
Considered safe; continued use is generally recommended to prevent disease flares.
Lactation
Hydroxychloroquine is excreted into breast milk in small amounts. The American Academy of Pediatrics considers it compatible with breastfeeding. Infant exposure is low, and adverse effects are rare. Monitor breastfed infants for signs of adverse effects (e.g., rash, GI upset).
Infant Risk:
Low risk (L3 - Moderately Safe)
Pediatric Use
Used in pediatric patients for juvenile idiopathic arthritis, systemic lupus erythematosus, and malaria. Dosing is weight-based. Close monitoring for retinopathy is essential, similar to adults. Risk of acute overdose is particularly high and potentially fatal in children.
Geriatric Use
Use with caution in elderly patients due to potential for age-related decreases in renal and hepatic function, which may lead to increased drug accumulation and toxicity. Start with lower doses and monitor closely for adverse effects, especially ocular and cardiac toxicity.
Clinical Information
Clinical Pearls
- Hydroxychloroquine is a cornerstone therapy for lupus and rheumatoid arthritis due to its efficacy and relatively favorable safety profile compared to other DMARDs.
- The most critical long-term side effect is retinopathy, which is dose- and duration-dependent. Adherence to recommended dosing (max 5 mg/kg/day ideal body weight) and regular ophthalmic screening are paramount to minimize this risk.
- Ocular toxicity is rare in the first 5 years of treatment if the dose is appropriate, but risk increases significantly after 5-7 years of continuous use.
- Patients should be advised that the therapeutic effects for autoimmune conditions are slow, often taking 3-6 months to become apparent.
- Hydroxychloroquine has mild immunosuppressive effects, making it generally safer than other DMARDs regarding infection risk.
- It may have additional benefits in lupus, such as reducing thrombosis risk and improving lipid profiles.
- Acute overdose is extremely dangerous and potentially fatal, especially in children. Emphasize safe storage.
Alternative Therapies
- Methotrexate (for RA)
- Sulfasalazine (for RA)
- Leflunomide (for RA)
- Biologic DMARDs (e.g., TNF inhibitors, IL-6 inhibitors, B-cell depleters for RA/SLE)
- Corticosteroids (for acute flares in RA/SLE)
- Mycophenolate mofetil (for SLE)
- Azathioprine (for RA/SLE)
- Chloroquine (another antimalarial, similar but higher toxicity profile)
Cost & Coverage
Average Cost:
$30 - $100 per 30 tablets (200mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.