Description
FORMULA:
Paracetamol 500 mg
Eragel, wheat starch, magnesium stearate, PVP q.s for 1 tablet.
INDICATIONS:
– Frantamol is used widely to Reduce mild to moderate pain such as: headache, myalgia, backache, pain in arthritis, toothache, menstrual crampsrelieve fever due to rheumatism, cold, flu and other respiratory infections.
CONTRAINDICATIONS:
– Patients with repeated anemia or heart disease, lung, or liver.
– Hypersensitivity to paracetamol.
– Patients with a deficiency of glucose -6 – phosphate dehydrogenase.
Adverse drug reaction ( ADR):
– Rash and other allergic reactions sometimes occur. Often rash or hives, but sometimes more serious and may include drug fever and mucosal lesions.
– In a few cases Paracetamol has caused a decrease of neutrophils, thrombocytopenia, and blood cells.
– Can cause kidney toxicity if the drug is abused for a long time. Inform your doctor of unwanted effects related to drug use.
TREATMENT FOR ADR
If there are severe unwanted effects, stop taking Paracetamol. About treatment refer to “Overdose”
DOSAGE AND ADMINISTRATION:
For adults and children> 12 years: 1 tablet / time x 2 -3 times / day, no more than 8 tablets / day unless ordered by a physician. Keep the doses at least 4 hours apart.
In the case of patients with severe renal impairment (creatinine clearance <10 ml / min) interval between doses of 8 hours
INTERACTIONS:
– Concurrent use with phenothiazines and therapeutic hypothermia can cause severe hypothermia.
– Drinking too much alcohol for too long can increase the risk of liver toxicity of paracetamol.
– Anticonvulsants (including phenytoin, barbiturates, carbamazepine), isoniazid may increase the hepatotoxicity of paracetamol. Often there is no need to reduce the dosage in patients using paracetamol and anticonvulsants concomitantly but patients must limit themselves while taking Paracetamol and using anticonvulsants or isoniazid
Use in Pregnancy or lactating women
– The safety of paracetamol during pregnancy with related to undesirable effects on developing fetus is not established. Paracetamol therefore should only be used in pregnant women if clearly needed.
– Lactation period: studies showed no adverse effects on infants.
Effects on ability to drive and use machines:
None recorded
OVERDOSAGE:
– Paracetamol poisoning can be caused by using a single poisoning dose, or by repeated large doses of paracetamol. Dose-dependent hepatic necrosis and acute toxicity effects due to overdose can be fatal.
– Nausea, vomiting and abdominal pain usually occurs within 2-3 hours after ingestion of toxic doses of the drug. Quickly bring the patient to a medical center. Remove drugs from the stomach by gastric lavage as soon as possible. The specific anti – poisoning drugs are acetylcysteine or methionine.
PHARMACODYNAMICS:
Paracetamol is an effective painkiller and hypothermia which can replace aspirin; however in contrast to aspirin, paracetamol is not effective in treating arthritis. With an equal dose per gram of paracetamol has similar antipyretic and analgesic effect to aspirin.
Paracetamol reduces the body temperature of patients with fever, but rarely for a normal person. It acts on the hypothalamus for hypothermia, increase heat dissipation due to vasodilation and increase peripheral blood flow.
PHARMACOKINETICS:
-Paracetamol Is absorbed rapidly and almost completely through the gastrointestinal tract. Food can extend the releasing period of it, causing paracetamol to be absorbed slower and food rich in carbohydrate can reduce the rate of absorption of paracetamol. Peak plasma concentrations are reached within 30-60 minutes after ingestion of therapeutic doses.
-Paracetamol distributes quickly and evenly in most tissues of the body. Approximately 25% of paracetamol in blood combines with serum protein. Paracetamol’s half-life is 1.25 to 3 hours.
-Paracetamol is metabolized primarily in the liver and partly in the kidneys, forming derivatives conjugated glucuronic and sulfonic. The excretion of paracetamol in urine under conjugated glucuronic form is about 50-80%, as conjugated sulfonic is about 20- 30%, unchanged <5%. A small fraction (<4%) is metabolized by cytochrome P450 under the action of N-acetyl metabolite parabenzoquinonimin, which is then detoxified by glutathione of liver quickly. However, with high doses of paracetamol, the metabolites are formed with enough concentration to deplete hepatic glutathione, and in that condition, its reaction with sulfhydryl hepatic protein increases and can lead to gangrene liver
SHELF LIFE: 36 months from date of manufacture.
Do not use past expiry date on the packaging.
STORAGE: Store in dry place, the temperature not above 30 ° C, protected from light.
STANDARD: Vietnamese pharmacopeia edition 4th
