Coldacmin

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Barcode: 8935206012514
Description

COMPOSITION:

Paracetamol ................................ 325 mg

Chlorpheniramine maleate ................4 mg

Excipients q.s.............................1 capsule

(Wheat starch, PVA, refined sugar, erythrosine red, tartrazine yellow)

DOSAGE FORM: Capsules.

PRESENTATION: Bottle of 100 capsules.Bottle of 200 capsules.Bottle of 500 capsules. Box of 10 blisters x 10 capsules.

 

ACTIONS: Paracetamol is effectively analgesic, antipyretic. Paracetamol has action on the hypothalamic heat-regulating center causing hypothermia, increase in thermolysis due to vasodilation and peripheral hypervolemia; this relieves body temperature in fever patients, but rarely in a normal body. Paracetamol produces analgesia by elevation of the pain threshold. Paracetamol is rapidly and completely absorbed by the gastrointestinal tract. At therapeutic dosage, Peak plasma concentration occurs about 30 to 60 mins after administration by mouth.  Paracetamol is rapidly and equally diffused in most body tissues. The elimination half-life of Paracetamol varies from about 1.25 to 3 hours. Chlorpheniramine maleate is an antihistamine, which blockades histamine H1 - receptors competitively,  leading to inability to release histamine and inhibition of histamine activities on smooth muscle and capillary absorptivity. As a result, it reduces or relieves the allergic or inflammatory symptoms, particularly in upper respiratory tract.

Chlorpheniramine is well absorbed following oral administration, and appears in plasma within 30 to 60 mins. Peak plasma concentration occurs about 2.5 to 6 hours after administration by mouth. The elimination half-life of Chlorpheniramine varies from 12 to 15 hours.

INDICATIONS: For symptomatic treatment of flu, aches and pains e.g. headache, myalgia, and osteoarticular pains associated with stuffiness, coryza, rhinitis, catarrhal mucitis, sinusitis due to flu or weather allergy.

For treatment of allergy, urticaria, rashes, contact dermatitis, vasomotor rhinitis due to histamine.

For treatment of upper respiratory tract infections with some manifestations e.g. fever, headache, coryza, chill...

 

CONTRAINDICATIONS: Hypersensitivity to any components of the drug. Patients with acute course of asthma, prostatauxe, risk of retention, narrow-angle glaucoma. People receiving MAO inhibitors Patients with anemia, cardiopathy, pneumopathy, renopathy. In cases of glucose-6-phosphate dehydrogenase deficiency; impaired hepatic function. Pregnant women and breast-feeding mothers. Newborn babies.

PRECAUTIONS: Avoid alcoholic drinks when using the drug. Renal function should be monitored in case of prolonged use of drug or renal impairment. Patients with duodenal and pyloric obstruction, myasthenia gravis. Patients with chronic pneumopathy, short breath or dyspnea. The elderly over 60 years. Drivers and machinery operators.

INTERACTIONS: In concern with chlorpheniramine: avoid concurrent use with alcoholic drinks, sedative drugs, phenytoin.

In concern with paracetamol: prolonged use of paracetamol may increase the effects of anticoagulants.

ADVERSE EFFECTS: In concern with chlorpheniramine: dryness of mouth, dysaptation, urinary retention, sweating, drowsiness.

In concern with paracetamol:

Uncommonly: skin rash, nausea, vomiting, neutrophilopenia, hypoleukemia, anemia, renopathy, rephrotoxicity due to prolonged abuse.

Rarely: hypersensitive reactions.

Prolonged or high-dose use of Coldacmin shows to cause hepatic impairment (due to hepatolysis).

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE: Paracetamol overdosage is due to a single-dose or repeated large doses ingestion (7.5 - 10 g daily for 1 - 2 days), or long-time ingestion. In acute Paracetamol overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect.

Symptoms of overdosage include nausea, vomiting, abdominal pains, cyanosis on skin, mucosa, and nails.

Treatment of overdosage:

In case of severe Paracetamol overdose, full supportive measures should also be instituted. Gastric lavage should be carried out especially if the overdose was taken within the previous 4 hours.

The main detoxication therapy is use of sulfhydryl compound. N-acetylcysteine gives its effect followed by oral route or an intravenous infusion. N-acetylcysteine should be administered as soon as possible, preferably within 36 hours of overdosage. N-acetylcysteine is more effective if administered within 10 hours of overdosage. It can be diluted with water or alcohol-free drinks to a 5% solution and orally taken within 1 hour. Oral N-acetylcysteine is given as a 140 mg/kg body-weight initial dose followed by 70 mg/kg body-weight every four hours for 17 more doses.

Methionin, activated charcoal and/or salt cleaners are also advised to treat overdose.

Symptoms of Chlorpheniramine overdosage include sedation, psychosis, epilepsy, apnoea, convulsion, antiacetylcholine action …

Treatment: Gastric lavage or vomitive with Ipecacuanha syrup; then, using activated carbon or cathartic to limit absorption. Full supportive measures should also be instituted in case of hypotension and arrhythmia. Convulsions may be treated by intravenous injection of Diazepam or phenytoin.

 

DOSAGE & ADMINISTRATION: Adults: oral dose of 1 - 2 capsules, 2 - 3 times daily (initial dose: 1 capsule/time)

Children > 6 years of age: half the dose of adult.

Or as directed by the physician.

Read the directions carefully before use.

Consult the physician for more information.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 300C.

Specifications: Manufacturer's.

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