Hydroxychloroquine 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); Immunosuppressant
Pharmacologic Class
Aminoquinoline
Pregnancy Category
Category C
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 the malaria parasite. It's important to take it exactly as prescribed, usually with food to help with stomach upset. Regular eye exams are crucial while taking this medication because, in rare cases, it can affect your vision.
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 medication and follow the instructions carefully.
For all uses of this medication:
+ Take your medication with food or milk to help your body absorb it.
+ Swallow the medication whole; do not chew, break, or crush it.
+ Continue taking your medication as instructed 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.
If you are taking this medication to prevent malaria:
+ Make sure you understand when to start taking your medication. If you are unsure, consult with your doctor.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store your medication 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 medications properly. Do not flush them down the toilet or pour them 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 of your medication:
Take the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
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 medication and follow the instructions carefully.
For all uses of this medication:
+ Take your medication with food or milk to help your body absorb it.
+ Swallow the medication whole; do not chew, break, or crush it.
+ Continue taking your medication as instructed 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.
If you are taking this medication to prevent malaria:
+ Make sure you understand when to start taking your medication. If you are unsure, consult with your doctor.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store your medication 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 medications properly. Do not flush them down the toilet or pour them 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 of your medication:
Take the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take with food or milk to reduce stomach upset.
- Do not crush or chew tablets.
- Avoid excessive sun exposure and use sunscreen, as hydroxychloroquine can increase photosensitivity.
- Limit alcohol intake, especially if you have liver issues.
- Report any visual changes immediately to your doctor.
- Do not stop taking the medication without consulting your doctor, even if you feel better.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication
Condition-Specific Dosing:
Rheumatoid Arthritis:
400 mg daily initially, then 200-400 mg daily (or 200 mg twice daily) as maintenance. Max 6.5 mg/kg/day or 400 mg/day, whichever is lower.
Systemic Lupus Erythematosus:
400 mg daily initially, then 200-400 mg daily (or 200 mg twice daily) as maintenance. Max 6.5 mg/kg/day or 400 mg/day, whichever is lower.
Malaria Prophylaxis:
400 mg (310 mg base) once weekly on the same day each week, starting 1-2 weeks before exposure, continuing during exposure, and for 4 weeks after leaving the endemic area.
Acute Malaria Treatment:
Initial dose of 800 mg (620 mg base), followed by 400 mg (310 mg base) 6 hours later, then 400 mg (310 mg base) 24 hours later, and 400 mg (310 mg base) 48 hours later (total 2000 mg over 3 days).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Rheumatoid Arthritis/Lupus: 3-6.5 mg/kg/day (max 400 mg/day or 6.5 mg/kg/day, whichever is lower). Malaria Prophylaxis: 6.5 mg/kg (base) once weekly (max 400 mg). Acute Malaria Treatment: 10 mg/kg (base) initial dose, then 5 mg/kg (base) at 6, 24, and 48 hours after initial dose (total 25 mg/kg base).
Adolescent:
Same as adult dosing for weight-based indications, otherwise adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
Consider dose reduction or increased monitoring, especially with long-term use.
Moderate:
Reduce dose by 25-50% or increase dosing interval. Monitor for toxicity.
Severe:
Reduce dose by 50% or more, or avoid if possible. Monitor closely.
Dialysis:
Hydroxychloroquine is not significantly removed by dialysis. Dose adjustment based on GFR.
Hepatic Impairment:
Mild:
Use with caution; monitor for toxicity.
Moderate:
Consider dose reduction; monitor closely for toxicity.
Severe:
Avoid or use with extreme caution and significant dose reduction; monitor closely.
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 presentation in immune cells, leading to reduced T-cell activation. 2. Inhibition of toll-like receptor 9 (TLR9) signaling, reducing interferon-alpha production. 3. Stabilization of lysosomal membranes and inhibition of enzyme activity. 4. Accumulation in acidic vesicles, raising intracellular pH, which can affect protein processing and secretion. 5. Anti-inflammatory effects by inhibiting prostaglandin synthesis and platelet aggregation. In malaria, it concentrates in the parasite's food vacuole, inhibiting heme detoxification, leading to accumulation of toxic heme and parasite death.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 74%
Tmax:
3-4 hours (for parent drug); 10-12 hours (for active metabolite desethylhydroxychloroquine)
FoodEffect:
Absorption is not significantly affected by food, but taking with food may reduce GI upset.
Distribution:
Vd:
High (5800 L to 815 L/kg), indicating extensive tissue distribution, especially in liver, kidney, spleen, lung, and retina.
ProteinBinding:
Approximately 45% (to plasma proteins)
CnssPenetration:
Limited, but can cross the blood-brain barrier and accumulate in CNS tissues over time.
Elimination:
HalfLife:
Terminal elimination half-life is long and variable, ranging from 32 to 50 days (for parent drug and metabolites).
Clearance:
Approximately 96 mL/min (total body clearance)
ExcretionRoute:
Renal (approximately 50% unchanged) and hepatic/biliary.
Unchanged:
Approximately 50% (renal excretion)
Pharmacodynamics
OnsetOfAction:
Rheumatoid Arthritis/Lupus: Weeks to months (typically 6-12 weeks for initial effect, up to 6 months for full benefit). Malaria: Rapid (within hours for acute treatment).
PeakEffect:
Rheumatoid Arthritis/Lupus: 3-6 months. Malaria: Within 24-48 hours.
DurationOfAction:
Due to long half-life, effects persist for weeks after discontinuation. Malaria prophylaxis requires weekly dosing.
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Seizures
New or worsening behavioral or mood changes, such as depression or thoughts of suicide
Confusion
Hallucinations (seeing or hearing things that are not there)
Bad dreams
Ringing in the ears, hearing loss, or other changes in hearing
Balance problems
Trouble controlling body movements
Shakiness
Muscle weakness
Inability to control eye movements
Eye problems, including blurred or foggy vision, trouble focusing or reading, or difficulty seeing in dim light
Loss of vision, dark spots, or partial vision loss
Eye Problems: There is a risk of severe eye problems, including lasting vision loss, especially if you have pre-existing eye or kidney problems, take high doses of this medication, use it for more than 5 years, or take certain other medications like tamoxifen. If you experience any changes in your vision, contact your doctor immediately.
Heart Problems: This medication can cause heart problems, including heart failure and abnormal heart rhythms (prolonged QT interval), which can be life-threatening. If you experience any of the following symptoms, seek medical help right away:
Fast or abnormal heartbeat
Severe dizziness or fainting
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Low Blood Cell Counts: This medication can cause low blood cell counts, which can increase the risk of bleeding, infection, or anemia. If you experience any of the following symptoms, contact your doctor immediately:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling very tired or weak
Severe Skin Reactions: This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. If you experience any of the following symptoms, seek medical help right away:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands
Other Side Effects
Most people do not experience serious side effects, but some may occur. 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 experience any side effects not listed here, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Seizures
New or worsening behavioral or mood changes, such as depression or thoughts of suicide
Confusion
Hallucinations (seeing or hearing things that are not there)
Bad dreams
Ringing in the ears, hearing loss, or other changes in hearing
Balance problems
Trouble controlling body movements
Shakiness
Muscle weakness
Inability to control eye movements
Eye problems, including blurred or foggy vision, trouble focusing or reading, or difficulty seeing in dim light
Loss of vision, dark spots, or partial vision loss
Eye Problems: There is a risk of severe eye problems, including lasting vision loss, especially if you have pre-existing eye or kidney problems, take high doses of this medication, use it for more than 5 years, or take certain other medications like tamoxifen. If you experience any changes in your vision, contact your doctor immediately.
Heart Problems: This medication can cause heart problems, including heart failure and abnormal heart rhythms (prolonged QT interval), which can be life-threatening. If you experience any of the following symptoms, seek medical help right away:
Fast or abnormal heartbeat
Severe dizziness or fainting
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Low Blood Cell Counts: This medication can cause low blood cell counts, which can increase the risk of bleeding, infection, or anemia. If you experience any of the following symptoms, contact your doctor immediately:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling very tired or weak
Severe Skin Reactions: This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. If you experience any of the following symptoms, seek medical help right away:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands
Other Side Effects
Most people do not experience serious side effects, but some may occur. 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 experience any side effects not listed here, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Blurred vision, difficulty reading, blind spots, or changes in color vision (signs of retinopathy)
- Muscle weakness, difficulty walking, or unusual fatigue (signs of myopathy or neuropathy)
- Severe dizziness, fainting, or irregular heartbeat (signs of cardiac effects)
- Unexplained bleeding or bruising, fever, sore throat (signs of blood disorders)
- Severe skin rash, blistering, or peeling (signs of severe skin reactions)
- Yellowing of skin or eyes, dark urine, severe abdominal pain (signs of liver problems)
- Sweating, shakiness, confusion, extreme hunger (signs of hypoglycemia)
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. Be sure to 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 magnesium or potassium levels
+ Slow heartbeat
+ Eye problems like retinopathy
+ Heart failure (weak heart) or a history of heart attack
+ Porphyria or psoriasis
Any changes in your vision or eye health that have occurred while taking this medication or similar drugs.
Concurrent use of certain medications, including:
+ Cimetidine
+ Rifampicin
+ Drugs that can cause abnormal heart rhythms (prolonged QT interval). There are many medications that can have this effect, so it is crucial to consult your doctor or pharmacist if you are unsure.
To avoid potential interactions, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins
Existing health problems
This information will help your doctor determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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. Be sure to 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 magnesium or potassium levels
+ Slow heartbeat
+ Eye problems like retinopathy
+ Heart failure (weak heart) or a history of heart attack
+ Porphyria or psoriasis
Any changes in your vision or eye health that have occurred while taking this medication or similar drugs.
Concurrent use of certain medications, including:
+ Cimetidine
+ Rifampicin
+ Drugs that can cause abnormal heart rhythms (prolonged QT interval). There are many medications that can have this effect, so it is crucial to consult your doctor or pharmacist if you are unsure.
To avoid potential interactions, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins
Existing health problems
This information will help your doctor determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Precautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
To ensure your safety, your doctor will recommend regular blood tests, eye exams, and an electrocardiogram (ECG) to monitor your heart rhythm.
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.
This medication can increase your sensitivity to the sun, making you more prone to sunburn. Be cautious when spending time outdoors, and notify your doctor if you experience excessive sunburn.
There is a risk of low blood sugar (hypoglycemia) associated with this medication, which can be severe and potentially life-threatening. Consult with your doctor and monitor your blood sugar levels as advised.
Before consuming alcohol, discuss the potential risks with your doctor.
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.
If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to discuss the benefits and risks of this medication to you and your baby.
Preventing Malaria
In addition to taking this medication, it is crucial to implement other preventive measures against malaria, including:
Using window screens and bed netting
Applying insect repellent (containing 10% to 35% DEET) to skin and clothing
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.
If you are pregnant and planning to travel to an area with a high risk of malaria, consult with your doctor to discuss the potential risks and necessary precautions.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
To ensure your safety, your doctor will recommend regular blood tests, eye exams, and an electrocardiogram (ECG) to monitor your heart rhythm.
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.
This medication can increase your sensitivity to the sun, making you more prone to sunburn. Be cautious when spending time outdoors, and notify your doctor if you experience excessive sunburn.
There is a risk of low blood sugar (hypoglycemia) associated with this medication, which can be severe and potentially life-threatening. Consult with your doctor and monitor your blood sugar levels as advised.
Before consuming alcohol, discuss the potential risks with your doctor.
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.
If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to discuss the benefits and risks of this medication to you and your baby.
Preventing Malaria
In addition to taking this medication, it is crucial to implement other preventive measures against malaria, including:
Using window screens and bed netting
Applying insect repellent (containing 10% to 35% DEET) to skin and clothing
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.
If you are pregnant and planning to travel to an area with a high risk of malaria, consult with your doctor to discuss the potential risks and necessary precautions.
Overdose Information
Overdose Symptoms:
- Headache
- Drowsiness
- Visual disturbances
- Cardiovascular collapse (hypotension, shock)
- Cardiac arrhythmias (QT prolongation, Torsades de Pointes, ventricular fibrillation)
- Seizures
- Hypokalemia
- Respiratory depression
- Coma
- Death
What to Do:
Seek immediate emergency medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment may include gastric lavage, activated charcoal, supportive care, and management of arrhythmias and seizures. Close cardiac monitoring is essential.
Drug Interactions
Major Interactions
- Amiodarone (increased risk of cardiac arrhythmias, QT prolongation)
- Digoxin (increased serum digoxin levels)
- Insulin and oral hypoglycemics (enhanced hypoglycemic effect)
- Mefloquine (increased risk of seizures and arrhythmias)
- QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, antipsychotics, tricyclic antidepressants, macrolide antibiotics, fluoroquinolones) - increased risk of torsades de pointes
- Tamoxifen (increased risk of retinopathy)
Moderate Interactions
- Antacids/Kaolin (decreased hydroxychloroquine absorption; separate administration by at least 4 hours)
- Cyclosporine (increased cyclosporine levels)
- Cimetidine (may inhibit metabolism, increasing hydroxychloroquine levels)
- Praziquantel (decreased praziquantel levels)
- Vaccines (live attenuated vaccines: theoretical reduced immune response, though generally considered safe for most patients on stable doses)
- Drugs metabolized by CYP2D6 (e.g., metoprolol, desipramine) - potential for increased levels of these drugs
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Ophthalmologic examination (visual acuity, fundoscopy, automated visual fields, OCT, multifocal ERG)
Rationale: To detect pre-existing maculopathy and establish a baseline for potential retinopathy.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential
Rationale: To assess for baseline hematologic abnormalities (e.g., anemia, leukopenia, thrombocytopenia) as hydroxychloroquine can cause bone marrow suppression.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function, as hydroxychloroquine is metabolized by the liver and can cause hepatotoxicity.
Timing: Prior to initiation of therapy.
Renal Function Tests (Creatinine, eGFR)
Rationale: To assess baseline renal function, as hydroxychloroquine is primarily renally excreted and dose adjustments may be needed in renal impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Ophthalmologic examination (visual acuity, fundoscopy, automated visual fields, OCT, multifocal ERG)
Frequency: Annually after 5 years of therapy, or sooner if risk factors (e.g., high dose, renal/hepatic impairment, concomitant tamoxifen, pre-existing retinal disease) are present.
Target: Normal findings; no evidence of retinopathy.
Action Threshold: Any new visual changes or objective findings of retinopathy warrant immediate discontinuation and referral to ophthalmologist.
Complete Blood Count (CBC) with differential
Frequency: Every 3-6 months, or as clinically indicated.
Target: Within normal limits.
Action Threshold: Significant or persistent cytopenias (e.g., leukopenia, thrombocytopenia) may require dose reduction or discontinuation.
Liver Function Tests (LFTs)
Frequency: Every 3-6 months, or as clinically indicated.
Target: Within normal limits.
Action Threshold: Significant or persistent elevation of liver enzymes may require dose reduction or discontinuation.
Symptom Monitoring
- Visual changes (blurred vision, difficulty reading, light sensitivity, halos, blind spots, color vision changes)
- Muscle weakness or atrophy
- Unexplained fatigue
- Skin rash or itching
- Nausea, vomiting, diarrhea, abdominal pain
- Dizziness, headache
- Hair loss
- Changes in mood or behavior (rare)
- Signs of hypoglycemia (sweating, tremor, confusion, hunger)
Special Patient Groups
Pregnancy
Hydroxychloroquine is generally considered compatible with pregnancy for the treatment of lupus and rheumatoid arthritis, as the benefits of controlling maternal disease often outweigh potential risks. It is classified as Pregnancy Category C. Studies have not shown a consistent increase in birth defects.
Trimester-Specific Risks:
First Trimester:
No clear evidence of increased risk of major birth defects.
Second Trimester:
Generally considered safe and continued for disease control.
Third Trimester:
Generally considered safe and continued for disease control.
Lactation
Hydroxychloroquine is excreted into breast milk in small amounts. The American Academy of Pediatrics considers it compatible with breastfeeding. Monitor the infant for adverse effects, though serious effects are rare. Lactation Risk L3 (Moderately Safe).
Infant Risk:
Low risk of adverse effects in breastfed infants. Monitor for gastrointestinal upset (diarrhea, vomiting) or rash.
Pediatric Use
Used in pediatric patients for juvenile idiopathic arthritis, systemic lupus erythematosus, and malaria. Dosing is weight-based. Close monitoring for retinopathy is crucial, especially with long-term use.
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, particularly visual changes and cardiac effects.
Clinical Information
Clinical Pearls
- Hydroxychloroquine has a very long half-life, meaning it takes weeks to months to reach steady-state and for its full therapeutic effect to be observed. Patients should be counseled on this delayed onset of action.
- The most critical long-term adverse effect is retinopathy, which is dose-dependent and cumulative. Regular, comprehensive ophthalmologic exams are essential, especially after 5 years of use or if risk factors are present.
- Take with food or milk to minimize gastrointestinal side effects.
- Hydroxychloroquine can cause hypoglycemia, even in patients without diabetes. Monitor for symptoms, especially if on other hypoglycemic agents.
- While generally well-tolerated, patients should be educated on the importance of reporting any new or worsening symptoms, particularly visual disturbances, muscle weakness, or skin changes.
- It is a foundational DMARD for lupus and RA due to its favorable safety profile compared to other immunosuppressants, especially regarding myelosuppression and infection risk.
Alternative Therapies
- For Rheumatoid Arthritis: Methotrexate, Sulfasalazine, Leflunomide, Biologic DMARDs (e.g., TNF inhibitors, IL-6 inhibitors, T-cell costimulation modulators), JAK inhibitors.
- For Systemic Lupus Erythematosus: Belimumab, Anifrolumab, Mycophenolate Mofetil, Azathioprine, Methotrexate, Corticosteroids.
- For Malaria: Chloroquine (if susceptible), Atovaquone/Proguanil, Mefloquine, Doxycycline, Artemisinin-based combination therapies (ACTs).
Cost & Coverage
Average Cost:
Varies, typically $20-$100 per 30 tablets (200mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.