Reconil200 mg

Reconil is a 4-aminoquinoline antimalarial and disease-modifying antirheumatic drug (DMARD) with the following indications:

Established / FDA-approved uses

• Malaria: Treatment of uncomplicated malaria due to susceptible strains of Plasmodium falciparum, P. malariae, P. ovale, and P. vivax, and chemoprophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
• Chronic discoid lupus erythematosus (DLE) and systemic lupus erythematosus (SLE): Treatment of skin, joint and systemic manifestations.
• Rheumatoid arthritis (RA): Treatment of active RA, usually as part of combination DMARD therapy rather than as monotherapy in moderate-to-severe disease.

Guideline-supported / adjunct uses

• As a background or adjunct DMARD alongside methotrexate or other agents in combination regimens for rheumatoid arthritis, per rheumatology treatment guidelines.
• Maintenance therapy to reduce lupus flare frequency and long-term organ damage in SLE, as recommended in lupus management guidelines.

Off-label uses (not FDA-approved; use only under physician supervision)

• Other connective tissue and autoimmune conditions such as Sjogren's syndrome and certain forms of juvenile idiopathic arthritis, based on limited evidence and specialist judgment.

Note: Reconil does not have proven efficacy for the treatment or prevention of COVID-19; use for this purpose is not supported by current evidence and is not recommended.

Each tablet of Hydroxychloroquine Sulphate commonly contains 200 mg of hydroxychloroquine sulfate (equivalent to approximately 155 mg of hydroxychloroquine base). Strengths and available formulations may vary by manufacturer; refer to the product label for the exact composition of the specific brand dispensed.

Reconil is a synthetic 4-aminoquinoline compound structurally related to chloroquine. It possesses antimalarial, anti-inflammatory, and immunomodulatory properties, and has been used for decades in the treatment of malaria and chronic autoimmune rheumatic diseases such as lupus and rheumatoid arthritis. Compared with chloroquine, Reconil is generally considered to have a somewhat more favorable long-term tolerability profile, though it carries similar classes of risk, including retinal toxicity with prolonged use.

Reconil belongs to the therapeutic class of antimalarials (4-aminoquinoline derivatives) and is also classified as a disease-modifying antirheumatic drug (DMARD) used in rheumatology and connective tissue disease management.

The precise mechanism by which Hydroxychloroquine Sulphate exerts its antirheumatic and antimalarial effects is not completely understood.

Antimalarial action

Hydroxychloroquine Sulphate concentrates within the acidic food vacuole of intraerythrocytic malaria parasites, raising the vacuolar pH and interfering with the parasite's ability to detoxify heme released during hemoglobin digestion, leading to accumulation of toxic heme and parasite death.

Immunomodulatory/anti-inflammatory action

In autoimmune disease, Hydroxychloroquine Sulphate is thought to accumulate in lysosomes of antigen-presenting cells, raising intralysosomal pH, which interferes with antigen processing/presentation, toll-like receptor signaling (particularly TLR-9), and reduces the release of pro-inflammatory cytokines. It also has mild antiplatelet and lipid-lowering effects.

Reconil tablets should be taken by mouth, swallowed whole with a full glass of water, and preferably taken with food or a meal (e.g., with milk) to reduce gastrointestinal upset. Doses should be taken at the same time(s) each day to maintain consistent blood levels, particularly for chronic rheumatic/lupus therapy where effect may take weeks to become apparent.

Reconil has the following clinically significant drug interactions:

• QT-prolonging drugs (e.g., amiodarone, certain antipsychotics, macrolide/fluoroquinolone antibiotics): additive risk of QT prolongation and serious ventricular arrhythmia; avoid combination where possible and monitor ECG if co-administration is unavoidable.
• Digoxin: Reconil can increase serum digoxin concentrations; monitor digoxin levels and for signs of toxicity.
• Antidiabetic drugs (insulin, sulfonylureas): Reconil can enhance the hypoglycemic effect; monitor blood glucose closely and adjust antidiabetic dose as needed.
• Antacids and kaolin: may reduce absorption of Reconil; separate dosing by at least 4 hours.
• Mefloquine: increased risk of convulsions when used with Reconil.
• MAO inhibitors: may interact and increase toxicity risk; use with caution.
• Drugs affecting CYP2D6 metabolism: Reconil can inhibit CYP2D6 and raise levels of drugs metabolized by this pathway.

Common and serious side effects of Reconil include:

Common

• Nausea, vomiting, diarrhea, abdominal pain, loss of appetite
• Headache, dizziness
• Skin rash, itching, and reversible skin/mucosal pigmentation changes; hair lightening or hair loss

Serious (less common but clinically important)

• Retinopathy: dose- and duration-dependent risk of irreversible retinal damage with long-term use (see Precautions & Warnings).
• Cardiac effects: QT interval prolongation, and rare cases of cardiomyopathy with long-term high-dose use.
• Hematologic: hemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency; rarely, blood dyscrasias (aplastic anemia, agranulocytosis, thrombocytopenia).
• Hypoglycemia
• Neuromuscular/muscular weakness (myopathy) with prolonged use
• Central nervous system effects: irritability, nightmares, rarely psychosis

Seek prompt medical attention for visual changes, palpitations, unusual bruising/bleeding, or profound muscle weakness while taking Reconil.

Reconil is generally considered to have a relatively more favorable safety profile among antimalarial/DMARD agents used during pregnancy, and is commonly continued through pregnancy in women with lupus when the benefit of preventing disease flare outweighs potential risk, based on physician assessment. Nonetheless, it should be used in pregnancy only if clearly needed, and only after the treating physician has weighed the potential benefit against potential risk to the fetus for the individual patient. Reconil passes into breast milk in small amounts; breastfeeding decisions should be made in consultation with a physician, weighing the low reported infant exposure against the benefits of continued maternal therapy and breastfeeding.

Important precautions with Reconil:

• Retinopathy: Long-term use of Reconil (particularly for rheumatologic/lupus indications) carries a well-established risk of irreversible retinal toxicity that increases with cumulative dose and duration of therapy. A baseline comprehensive ophthalmologic examination is recommended within the first year of starting therapy, with periodic (generally annual, after five years of use, sooner if risk factors are present) ophthalmologic monitoring thereafter.
• Cardiac risk: Reconil can prolong the QT interval and, rarely, cause cardiomyopathy with long-term use; use with caution in patients with cardiac disease, electrolyte abnormalities, or when co-administered with other QT-prolonging drugs.
• Hypoglycemia: Reconil can cause severe hypoglycemia, including in non-diabetic patients; monitor blood glucose, especially when combined with antidiabetic drugs.
• G6PD deficiency: use with caution due to risk of hemolysis.
• Neuromuscular disease: long-term use may cause skeletal muscle myopathy or neuropathy; periodic assessment of muscle strength and deep tendon reflexes is advised during prolonged therapy.
• May exacerbate psoriasis and porphyria; use with caution in these conditions.
• Use with caution in patients with a history of epilepsy, as Reconil may lower the seizure threshold.

Overdose of Reconil can be serious and potentially fatal, particularly in children, and toxic effects can develop rapidly (sometimes within 30 minutes to a few hours). Symptoms may include headache, visual disturbance, drowsiness, convulsions, cardiac arrhythmia, hypotension, and sudden respiratory and cardiac arrest. Overdose of Reconil is a medical emergency: seek immediate emergency medical attention or contact a poison control center. Keep Reconil out of reach of children, as even a small number of tablets can be fatal to a child.

Store Reconil at room temperature (below 30 degrees C), away from light and moisture. Keep out of reach of children.

Renal impairment: Use Reconil with caution in patients with significant renal impairment; consider using the lowest effective dose with clinical monitoring, as the drug is partly renally eliminated.

Hepatic impairment: Use Reconil with caution in patients with hepatic disease or in combination with other hepatotoxic drugs; monitor liver function periodically during prolonged therapy.

Elderly: No specific dose adjustment is established for elderly patients, but they should be monitored closely for cardiac, renal, hepatic, and ophthalmologic adverse effects given a higher likelihood of comorbidities and concomitant medications.

G6PD deficiency: Use with caution due to risk of hemolytic anemia (see Precautions & Warnings).

Duration of Reconil therapy depends on indication: malaria treatment is a short 3-day course, malaria prophylaxis continues throughout exposure and for 4 weeks after leaving the endemic area, while treatment of lupus or rheumatoid arthritis is typically long-term (months to years), with periodic reassessment of benefit versus cumulative retinal-toxicity risk. Do not stop, extend, or change the duration of Reconil therapy without consulting the prescribing physician.

Antimalarial (4-aminoquinoline derivative); Disease-Modifying Antirheumatic Drug (DMARD); Immunomodulatory agent.

Hydroxychloroquine Sulphate raises the pH within intracellular acidic vesicles (parasite food vacuoles and host-cell lysosomes), which interferes with heme detoxification in malaria parasites and with antigen processing/toll-like receptor signaling in immune cells, producing both antimalarial and immunomodulatory/anti-inflammatory effects.

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Reconil is used in children for the treatment and prevention of malaria at weight-based doses under direct physician supervision. Long-term use of Reconil in children (e.g., for juvenile arthritis or lupus) is not recommended due to greater sensitivity to retinal toxicity and other cumulative adverse effects in this age group, and safety and efficacy of long-term pediatric use have not been well established. Accidental ingestion of even a few Reconil tablets by a young child can be fatal; the medicine must be stored safely out of children's reach.