Quimal Chloroquine Phosphate Tablets and Syrup

QUIMAL
(CHLOROQUINE PHOSPHATE TABLETS / SYRUP)

 

Composition

Each Tablet contains:

Chloroquine Phosphate BP 250mg equivalent to Chloroquine base 155mg.

Each 5 ml syrup contains:

Chloroquine Phosphate BP 80mg equivalent to Chloroquine base 50mg.

 

Action

Chloroquine Phosphate inhibits protein synthesis in susceptible organisms by inhibiting DNA and RNA polymerase resulting in;

– Death of amoeba responsible for causing amebiasis.

– Improvement in inflammation in rheumatoid arthritis and systemic lupus erythematosus.

 

Pharmacokinetics

Absorption and distribution: Chloroquine Phosphate is well absorbed following oral administration and widely distributed, with high tissue concentrations achieved. It crosses the placenta and enters breast milk.

Metabolism and Excretion: 30% metabolizes by the liver. 70% excreted unchanged by the Kidneys. Half-life: 3 – 5 days.

 

Indications and Administration

Chloroquine Phosphate is used in the following conditions:

Extraintestinal Amebiasis

Rheumatoid Arthritis.

Lupus Erythematosus.

 

Unlabelled Use

This drug is not listed in the approved professional labeling for the drug but may be prescribed by health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. These conditions include:

Amebic Liver Abscess Arthritis, Rheumatoid Chronic Cutaneous Vasculitis Discoid Lupus Erythematosus Juvenile Arthritis, Lupus Erythematosus, Systemic Polymorp,  Light Erupt., Solar Uticaria Porphyria Cutanea Tarda Sarcoid Associated Hypercalcemia.

 

Extraintestinal Amebiasis

For the treatment of extraintestinal amebiasis, including amebic liver abscess, caused by E. histolytica, chloroquine is administered in conjunction with an intestinal amebicide.

The usual adult oral dosage of chloroquine recommended by the manufacturer for the treatment of extraintestinal amebiasis is 600 mg of chloroquine (1 g of chloroquine phosphate) once daily for 2 days, followed by 300 mg (500 mg of chloroquine phosphate) once daily for at least 2 – 3weeks.

The usual oral dosage of chloroquine for the treatment of extraintestinal amebiasis in children is 10 mg/kg (16.7 mg/kg of chloroquine phosphate) once daily for 2 – 3 weeks.
The maximum oral dosage of chloroquine for children is usually 300mg (500mg of chloroquine phosphate) daily.

 

Rheumatoid Arthritis

The usual adult oral dosage of chloroquine used in the treatment of rheumatoid arthritis is 150 mg (250 mg of chloroquine phosphate) daily. A response to chloroquine may not occur until after 4 – 6 weeks of therapy with the drug, and some clinicians recommend that chloroquine be continued for 4 months before the drug is considered ineffective in the treatment of rheumatoid arthritis. After remission or maximum improvement of rheumatoid arthritis occurs, dosage should be reduced.

 

Lupus Erythematosus

The usual adult oral dosage of chloroquine for the treatment of lupus erythematosus is 150 mg (250 mg of chloroquine phosphate) daily. When chloroquine is used in conjunction with topical corticosteroids in the treatment of discoid lupus erythematosus, skin lesions may regress within 3 – 4 weeks and new lesions may not appear. When systemic and cutaneous manifestations of lupus erythematosus subside, dosage of chloroquine is reduced gradually over several months, and the drug discontinued as soon as possible.

 

Side effects

Blurred vision, nausea, vomiting, abdominal cramps, headache, and diarrhea may occur.

If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Tell your doctor immediately if any of these unlikely but serious side effects occur: bleaching of hair color, hair loss, mental/mood changes (such as confusion, personality changes, unusual thoughts/behavior, depression), ringing in the ears, darkening of skin/tissue inside the mouth, worsening of skin conditions (such as dermatitis, psoriasis), sun sensitivity.

Some side effects only occur rarely with daily, long-term use (over weeks to years).

Seek immediate medical attention if any of these very serious side effects occur: sign of poorly pumping heart (such as tiredness, shortness of breath, swelling legs/ankles), muscle weakness, severe vision changes (such as light flashes/streaks, difficulty reading, complete blindness), hearing loss.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/slow/irregular heartbeat, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

 

Precautions

Before taking chloroquine, tell your doctor or pharmacist if you are allergic to it; or to hydroxychloroquine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

 

Seizures

This drug may cause blurred vision or rarely make you dizzy. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Chloroquine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. During pregnancy, this medication should be used only where clearly needed, it may harm an unborn baby. This drug passes into breast milk and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.

 

Interactions

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. Some products that may interact with this drug include: agalsidase, mefloquine, penicillamine, sulfadoxine/ pyrimethamine, products that may harm the liver (such as acetaminophen, isoniazid, alcohol). This medication can speed up or slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include cyclosporine and praziquantel among others. Many drugs besides chloroquine may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, mefloquine, pimozide, procainamide, quinidine, sotliol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using chloroquine, report all medications you are currently using to your doctor or pharmacist. Cimetidine is a nonprescription drug that is commonly used to treat extra stomach acid. Because cimetidine and other antacids may interact with chloroquine, ask your pharmacist about other products to treat extra stomach acid. Take chloroquine at least 2 hours before or after taking ampiclllin. Chloroquine may decrease the amount of ampicillin in your body and the ampicillin may not work as well.

 

Overdosage

If overdose is suspected, contact a poison control center or emergency room immediately. Symptoms of overdose may include: fast/irregular heartbeat, fainting, slow/shallow breathing, seizures, inability to wake up (coma).

 

Notes

Do not share this medication with others. Laboratory and/or medical tests (such as eye exams, reflex tests, liver tests, EKG, complete blood counts) should be performed periodically to monitor your progress or check for side effects if you are taking chloroquine for long periods. Consult your doctor for more details.

 

Missed dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Presentation

1000 tablets per jar / 1 blister of 10 tablets in monocarton / 60ml syrup.

 

Manufactured by

DANA PHARMACEUTICALS LIMITED

Shiroro Dam Road, Maitumbi, Minna,

Niger State, Nigeria.

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