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Fepril

 

DESCRIPTION
Fepril Tablets: Round and biconvex tablets with one side scored and blue in colour.
Each tablet contains: Paracetamol BP 500mg
Fepril Syrup 120mg/5mL: Clear syrup, free from visible particles, light pink in colour and odour fruity of pineapple.

Each 5ml contains: Paracetamol BP 120mg

Preservative used: Methyl Paraben 6mg, Propyl Paraben 1mg.

Fepril Syrup 250mg/5mL: Clear syrup, free from visible particles, red in colour, odour fruity of raspberry and pineapple.

Each 5ml contains: Paracetamol BP 250mg

Preservative used: Methyl Paraben 6mg, Propyl Paraben 1mg.

Fepril Suspension 250mg/5mL: Viscous, opaque liquid, free from visible impurities, light orange in colour, sweet in taste and of fruity odour.

Each 5ml contains: Paracetamol BP 250mg

Preservative used: Methyl Paraben 10mg, Propyl Paraben, 2.5mg

 

PHARMACOLOGY / PHARMACOKINETICS
Absorption: Rapid and almost complete following oral administration.
Protein Binding: Not significant with doses producing plasma concentration below 60 mcg/ml; may reach moderate levels with high or toxic dose.
Metabolism: 90-95% metabolized in liver, primarily by conjugation with glucuronic, sulphuric acid and cysteine. An intermediate metabolite, which may accumulate in overdosage after the primary metabolic pathways become saturated, is hepatotoxic and possibly nephrotoxic.

Half-Life: 1-4 hours, does not change with renal failure but may be prolonged in acute overdosage, in some forms of hepatic disease, in the elderly and in the neonate and may be somewhat shortened in children.

Time To Peak Concentration: 0.5 to 2 hours.

Peak Plasma Concentration: 5 to 20mcg/ml (with doses up to 650mg).

Time To Peak Effect: 1-3 hours.

Duration of Action: 3 to 4 hours.

Excretion: Mainly in urine as conjugates (glucuronide and sulphate conjugates).

INDICATIONS
Paracetamol is indicated for relief of mild to moderate pain and to reduce fever. It provides symptomatic relief only; additional therapy to treat the cause of the pain or fever should be instituted when necessary.

Paracetamol has minimal anti-inflammatory activity and does not relieve redness, swelling, or stiffness due to arthritis; it cannot be used in place of aspirin or other salicylates or other non-steroidal anti-inflammatory agents in the treatment of rheumatoid arthritis. However, it may be used to relieve pain due to mild osteoarthritis. Paracetamol may be used when aspirin therapy is contraindicated or inadvisable, i.e, in patients receiving anticoagulants or uricosuric agents, those with hemophilia or other bleeding problems, and those with upper gastrointestinal disease or intolerance or hypersensitivity to aspirin. However, chronic, high-dose Paracetamol therapy may require adjustment of anticoagulant dosage based on increased monitoring of prothrombin time in patients receiving a coumarin or indandione-derivative anticoagulant.

CONTRAINDICATIONS
In patients hypersensitive to Paracetamol.

SIDE EFFECTS I ADVERSE EFFECTS
Side effects of Paracetamol are usually mild. though haematological reactions have been reported. Skin rashes and other allergic reactions occur occasionally.

Symptoms of Paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia, and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion by increases in serum concentrations of aminotransferases and bilirubin and in prothrombin time. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma, and death.

Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported. Liver damage is likely in adults who have taken 10 gm or more of Paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of Paracetamol are employed), become irreversibly bound to liver tissue.

PRECAUTIONS / WARNINGS
Cross-Sensitivity : Patients intolerant of aspirin may not be intolerant of Paracetamol; however, mild bronchospastic reactions with Paracetamol have been reported in some aspirin-sensitive asthmatics.
Pregnancy : Problems in humans have not been documented, Risk-benefit must be considered because Paracetamol crosses the placenta.
Breast-Feeding : Problems in humans have not been documented; however risk - benefit must be considered.

DRUG INTERACTIONS
Be alert of the possible drug interactions leading to their related problems when Paracetamol is used in combinations with the following:

i) Alcohol, Hepatic Enzyme Inducers Or Hepatotoxic Medications. (Risk of hepatotoxicity with single toxic doses or prolonged use of high doses of Paracetamol may be increased in chronic alcoholics or patients regularly taking other hepatotoxic medications or hepatic enzyme inducers))

ii) Anticoagulants, Coumarin - Or Indandione - Or indandione-Derivative. (Concurrent chronic, high dose administration of Paracetamol may increase the anticoagulant effect, possibly by decreasing hepatic synthesis of procoagulant factors; anticoagulant dosage adjustment based on increased monitoring of prothrombin time may be necessary when chronic, high-dose Paracetamol therapy is initiated or discontinued; however this does not apply to occasional use or to chronic use of doses below 2 grams per day of Paracetamol).

iii) Nonsteroidal Anti-inflammatory Analgesics, Aspirin Or Other Salicytates. (Prolonged concurrent use of Paracetamol with a salicylate is not recommended because recent evidence suggests that chronic, high-dose administration of the combined analgesics {1.35 grams daily or cumulative ingestion of 1 kg annually, for 3 years or longer}significantly increases the risk of analgesic nephropathy, renal papillary necrosis, end stage renal disease, and cancer of the kidney or urinary bladder; Also it is recommended that for short-term use, the combined dose of Paracetamol plus salicylate not exceed that recommended for Paracetamol or a salicylate given alone).

(Prolonged concurrent use of Paracetamol with other nonsteroidal anti-inflammatory analgesics may also increase the risk of adverse renal effects; it is recommended that patients be under close medical supervision while receiving such combined therapy).

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