Clit80 mg/5 ml

Clit is indicated for the following uses:

Established / Approved Uses

• Treatment of uncomplicated malaria caused by chloroquine-sensitive strains of Plasmodium vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum, in geographic areas without known chloroquine resistance.
• Prophylaxis (prevention) of malaria in travelers to regions where chloroquine-resistant P. falciparum has not been reported.

Adjunct / Combination Use

• Extraintestinal amebiasis (amebic liver abscess) — Clit is used only as an adjunct together with an effective intestinal amebicide; it is not effective against intestinal (luminal) amebiasis alone.

Off-Label Use

• Clit has been used off-label for certain autoimmune/rheumatic conditions such as discoid and systemic lupus erythematosus and rheumatoid arthritis, although hydroxychloroquine is generally preferred for these indications due to a more favorable safety/toxicity profile.

Clit is not effective against chloroquine-resistant strains of malaria and should not be relied upon in regions where resistance is documented; a physician should confirm local resistance patterns before prescribing.

Each tablet of Chloroquine Phosphate typically contains chloroquine phosphate equivalent to a specific amount of chloroquine base (e.g., 250 mg chloroquine phosphate is approximately equal to 150 mg base; 500 mg chloroquine phosphate is approximately equal to 300 mg base). Oral liquid/syrup formulations of Chloroquine Phosphate are also available in some markets, typically expressed as base-equivalent strength per 5 mL. Exact strength and excipients vary by manufacturer and formulation; refer to the specific product label for details.

Clit is the phosphate salt of chloroquine, a synthetic 4-aminoquinoline compound with antimalarial and amebicidal activity. It has been used clinically since the mid-20th century and remains an option for malaria caused by chloroquine-sensitive parasite strains, as well as an adjunct treatment for extraintestinal amebiasis. It is administered orally and is available as tablets and, in some markets, oral suspension/syrup.

Clit belongs to the antimalarial drug class, specifically the 4-aminoquinoline group of agents. It also possesses amebicidal properties and has been used, off-label, in the management of certain autoimmune conditions.

Chloroquine Phosphate acts against the erythrocytic (blood) stages of susceptible Plasmodium species. Within the parasite's digestive vacuole, Chloroquine Phosphate concentrates and interferes with the parasite's ability to detoxify heme released during hemoglobin digestion, allowing toxic heme complexes to accumulate and damage the parasite. It does not eliminate hepatic (liver-stage) forms of P. vivax or P. ovale (hypnozoites), so a separate agent such as primaquine is needed to prevent relapse. Against Entamoeba histolytica, Chloroquine Phosphate concentrates in the liver and is amebicidal against the trophozoite form, which explains its usefulness in extraintestinal (hepatic) amebiasis. Following oral administration, Chloroquine Phosphate is rapidly and almost completely absorbed from the gastrointestinal tract, is extensively distributed into tissues, is partly metabolized in the liver, and is slowly eliminated (elimination half-life may extend to several weeks), largely via renal excretion.

Clit is for oral use only. Tablets should be swallowed with food or a full glass of water/milk to minimize stomach upset; the oral liquid formulation, where available, should be measured with an accurate dosing device. Do not take antacids at the same time as Clit; separate dosing by at least 4 hours.

Clit has several clinically significant drug interactions:

• QT-prolonging drugs (e.g., certain antiarrhythmics, some antipsychotics, some antibiotics such as macrolides/fluoroquinolones): concomitant use with Clit increases the risk of additive QT prolongation and serious ventricular arrhythmias; avoid combination where possible and monitor ECG if unavoidable.
• Digoxin: Clit can increase serum digoxin levels, raising the risk of digoxin toxicity; monitor digoxin levels and clinical status.
• Antacids and kaolin: reduce the absorption of Clit; separate administration by at least 4 hours.
• Cimetidine: inhibits the metabolism of Clit, increasing its plasma levels and risk of toxicity; an alternative acid-reducing agent may be preferred.
• Monoamine oxidase inhibitors (MAOIs): may increase toxicity of Clit; use with caution.
• Mefloquine: increases the risk of seizures when combined with Clit; concurrent use should be avoided.

Always inform your physician or pharmacist of all medicines, supplements, and herbal products being taken before starting Clit.

Common side effects of Clit include:

• Nausea, vomiting, diarrhea, abdominal pain, and loss of appetite
• Headache and dizziness
• Pruritus (itching), which can be pronounced in dark-skinned individuals
• Skin and mucous membrane pigmentation changes, hair loss or bleaching
• Blurred vision (usually reversible with short-term use)

Serious but less common effects include:

• Retinopathy with long-term use or high cumulative doses, which can be irreversible (see Precautions and Warnings)
• Cardiomyopathy and QT-interval prolongation, which can lead to serious arrhythmias (see Precautions and Warnings)
• Hemolytic anemia in individuals with G6PD deficiency
• Rare blood dyscrasias (e.g., agranulocytosis, aplastic anemia)
• Neuropsychiatric effects and neuromuscular weakness with prolonged use

Seek medical attention promptly for visual changes, palpitations, fainting, unusual bleeding/bruising, or signs of infection while taking Clit.

Pregnancy: Clit should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus. For the treatment and prevention of malaria specifically, the benefit of Clit generally outweighs the risk, because malaria itself poses substantial risk to both mother and fetus; however, use should always be guided by a physician. Data on use for other (e.g., autoimmune) indications in pregnancy are more limited, and such use should be individualized.

Lactation: Clit passes into breast milk in small amounts. It is generally considered acceptable for malaria prophylaxis/treatment in breastfeeding women under medical supervision, but a nursing infant should still be monitored, and a physician should be consulted before use.

Clit carries several important warnings:

• Retinopathy: Long-term or high cumulative-dose use of Clit is associated with irreversible retinal toxicity that can cause visual impairment. Baseline and periodic ophthalmologic examinations are recommended, especially with prolonged therapy.
• Cardiotoxicity: Clit can prolong the QT interval and, with prolonged use, has been associated with cardiomyopathy that may lead to cardiac failure, sometimes with fatal outcome. Use with caution in patients with cardiac disease, electrolyte disturbances, or concomitant QT-prolonging drugs; cardiac monitoring is recommended for extended therapy.
• Narrow therapeutic index / overdose risk: The margin between a therapeutic and a fatal dose of Clit is small; overdose can be rapidly fatal (see Overdose Effects).
• G6PD deficiency: Use with caution; Clit can cause hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency.
• Neuromuscular effects: Prolonged use may cause skeletal muscle weakness; periodic assessment is advised for long-term therapy.
• Psoriasis and porphyria: Clit can exacerbate psoriasis (see Contraindications) and porphyria.
• Hypoglycemia: Clit may cause severe hypoglycemia, including in non-diabetic patients; monitor blood glucose, particularly in patients on concurrent antidiabetic therapy.

Clit overdose is a recognized medical emergency and a well-documented cause of serious and potentially fatal poisoning — a single tablet can be fatal to a young child. Symptoms of overdose can develop rapidly (within 1–3 hours) and may include headache, drowsiness, visual disturbances, nausea and vomiting, cardiovascular collapse (hypotension, life-threatening arrhythmias), seizures, and respiratory/cardiac arrest.

If overdose of Clit is suspected, seek emergency medical attention or contact a poison control center immediately — do not wait for symptoms to appear. There is no specific antidote widely available; treatment is supportive and requires close monitoring in a hospital/emergency setting, potentially including gastric decontamination, cardiac monitoring, and management of arrhythmias and seizures, all under direct medical supervision. Do not attempt home treatment.

Store Clit at room temperature (below 30°C), away from light and moisture. Keep Clit strictly out of the reach and sight of children — accidental ingestion of even a small number of tablets can be fatal to a child.

Renal impairment: Use Clit with caution; dose adjustment or closer monitoring may be needed as elimination can be reduced.

Hepatic impairment: Use Clit with caution in patients with significant liver disease or in combination with other hepatotoxic drugs.

Elderly: Older adults may be more susceptible to the cardiac and neuromuscular effects of Clit; use with caution and monitor closely.

G6PD deficiency: Risk of hemolysis; use with caution and monitor (see Precautions and Warnings).

Children: Weight-based (mg/kg) dosing is required; children are especially vulnerable to fatal overdose with Clit, so dosing and storage require extreme care (see Dosage and Administration, Overdose Effects, and Storage Conditions).

Duration of Clit therapy depends on the indication: malaria treatment courses typically last 3 days; malaria prophylaxis continues weekly throughout exposure and for 4 weeks after leaving an endemic area; extraintestinal amebiasis treatment typically continues for at least 2–3 weeks in combination with an intestinal amebicide. For off-label autoimmune indications, duration is determined by the prescribing physician based on response and tolerability. Do not extend or shorten the prescribed course of Clit without medical advice.

Chloroquine Phosphate is classified as an antimalarial agent of the 4-aminoquinoline chemical class, with additional amebicidal activity.

Chloroquine Phosphate concentrates within the acidic digestive vacuole of intraerythrocytic malaria parasites, where it interferes with the parasite's ability to detoxify heme generated from hemoglobin breakdown. Accumulation of toxic heme complexes damages parasite membranes and metabolism, leading to parasite death. Against Entamoeba histolytica, Chloroquine Phosphate concentrates in hepatic tissue and exerts amebicidal activity against trophozoites, which underlies its use in extraintestinal (hepatic) amebiasis.

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Clit is used in children for the treatment and prevention of malaria caused by susceptible Plasmodium species, with dosing calculated on a milligrams-per-kilogram (base-equivalent) basis and never exceeding the adult dose. Safety and efficacy of Clit for indications other than malaria and extraintestinal amebiasis have not been established in children. Because children are especially susceptible to fatal overdose from even small amounts of Clit, doses must be measured precisely by a caregiver or healthcare professional, and the medicine must be stored strictly out of children's reach.