Hapacol 150 - Analgesic – Antipyretic - DHG PHARMA

Description

HAPACOL 150

COMPOSITION:

Paracetamol ............................ 150 mg

Excipients q.s ........................ 1 sachet

(Anhydrous citric acid, mannitol, sucrose, aspartame, sodium hydrogen carbonate, PVP K30, sunset yellow, orange-flavored powder).

DOSAGE FORM: Effervescent powder.

PRESENTATIONS: Box of 24 sachets x 1.5 g.

ACTIONS: Paracetamol produces analgesia, antipyresis. The drug acts on the hypothalamus to produce antipyresis; heat dissipation is increased as a result of vasodilation and increased peripheral blood flow. Paracetamol lowers body temperature in patients with fever but rarely lowers normal body temperature. Paracetamol produces analgesia by elevation of the pain threshold.

With therapeutic doses, the analgesic, antipyretic effects of paracetamol are similar to those of aspirin. Paracetamol appears to have little effect on cardiovascular and respiratory system, causes no acid - base balance, no gastric irritation, scratch, bleeding.

Paracetamol is rapidly and almost completely absorbed by the gastrointestinal tract. The elimination half-life of paracetamol varies from about 1.25 to 3 hours. Paracetamol is metabolized predominantly by the liver and excreted by the kidney.

Hapacol 150 contains 150 mg of paracetamol that is suitable for children aged 1 to 3 years. It is prepared in the dosage form of effervescent powder and is dissolved in water before oral administration.

INDICATIONS:

Analgesic and antipyretic actions on children in cases of: cold, flu, petechial fever, bacterial infections, viral infections, teething, post-vaccination, post-surgery.

CONTRAINDICATIONS: Hypersensitivity to any components of the drug. Patients with glucose - 6 - phosphate dehydrogenase deficiency.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE:

Individuals with phenylketonuria and other individuals who must restrict their intake of phenylalanine should be advised no concurrent administration of paracetamol and aspartame-containing food or drugs.

Patients with hypersensitivity (asthma) should not use concurrently paracetamol and sulfite-containing food or drugs.

Cautions should be taken in patients with previous anemia, hepatic and renal failure.

Because chronic, excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity, it is advised to avoid chronic ingestion of alcohol.

The physician should warn patients of serious signs of skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).

PREGNANCY AND LACTATION: Safety of paracetamol on foetus has not determined when administered to pregnant women. Therefore, the drug should be only used in pregnant women if clearly needed.

Studies in breast-feeding mothers showed that use of paracetamol causes no adverse effects at nursing infants

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: The drug does not affect the possibility of driving vehicles and operating machinery.

INTERACTIONS: Chronic ingestion of large doses of paracetamol has been reported to potentiate the effects of coumarin- and indandione-derivative anticoagulants.

The possibility of severe hypothermia should be considered in patients receiving concomitant phenothiazine and antipyretic therapy.

Anticonvulsants (including phenytoin, barbiturates, carbamazepine), isoniazid and other antituberculosis drugs may increase paracetamol-induced liver toxicity.

Chronic, excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity.

ADVERSE EFFECTS: Uncommonly: rash; nausea, vomiting; rephropathy, renal toxicity due to chronic ingestion; neutropenia, pancytopenia, anemia.

Rarely: hypersensitive reactions

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

OVERDOSAGE: Paracetamol toxicity may result from a single toxic dose, from repeated ingestion of large doses of paracetamol (e.g. 7.5 - 10 g daily for 1 - 2 days), or from chronic ingestion of the drug. Dose-dependent, hepatic necrosis is the most serious acute toxic effect associated with overdosage and potentially fatal.

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

In severe poisoning, mild stimulation, excitement, and delirium may occur initially. This may be followed by CNS depression; stupor; hypothermia; marked prostration; rapid, shallow breathing; rapid, weak, irregular pulses; low blood pressure; and circulatory failure.

Treatment: Early diagnosis is very important in treatment of paracetamol overdosage.

In the event of severe paracetamol intoxication, 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.

Methionine, activated charcoal and/or saline cathartic are also advised to treat overdose.

DOSAGE & ADMINISTRATION: Hapacol 150 is dissolved in water (suitable for children) until ending of effervescence.

It is orally taken every 6 hrs, not more than 5 times daily.

Average recommended doses are 10 - 15 mg/kg body-weight/time.

Maximum recommended doses are not more than 60 mg/kg body-weight/24 hours.

Or the doses are as follows:

Children aged from 1 to 3 years take 1 sachet/time.

Or as prescribed by the physician.

Notes: Prolonged self-administration is not recommended. Ask a physician if:

- any new symptoms occur.

- fever gets high (39.50C) and lasts more than 3 days or recurs.

- pain gets worse or lasts more than 5 days.

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 30oC, protect from light.

Specifications: Manufacturer's.