| Composition |
Fedron: Each F.C.Tablet contains:
Paracetamol 325 mg.
Phenylephrine HCl 5 mg.
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| EXCIPIENTS |
Corn starch, Magnesium stearate, Microcrystalline cellulose, Povidon , Stearic acid, Hypromellose, Propylene glycol, Polysorbate, Titanium dioxide.
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| PROPERTIES |
PROPERTIES:
Paracetamol has analgesic and antipyretic activity, which is believed to be mediated through its inhibition of prostaglandin synthesis within the central nervous system.
Phenylephrine is an alpha-receptor agonist with low cardioselective beta-receptor affinity and minimal central stimulant activity. It is a decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.
PHARMACOKINETIC PROPERTIES:
Paracetamol: Paracetamol is absorbed readily after taking this drug and is detected in the plasma within 5 minutes. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a T½ of approximately 2 hours. The major metabolites are excreted in urine.
Phenylephrine: Phenylephrine is absorbed from the gastro-intestinal tract, but has reduced bioavailability by the oral route due to first-pass metabolism.
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| INDICATIONS |
| For relief of symptoms of colds and influenza, including the relief of aches and pains, sore throat, headache, nasal congestion and lowering of temperature. |
| Dosage & Administration |
Children older than 12 years of age and Adult: Take 2 tablets every 4 hours. It should not be taken more than 10 tablets in 24 hours
It should not be taken For more than 48 hours in children 12-17 years or more than a few days in adults, except on medical advice
If symptoms get worse or persist the doctor should be consulted.
Children under 12 years of age: it is not recommended for use. Safety and effectiveness of this drug have not been established.
Renal Dose Adjustments: Data not available.
Liver Dose Adjustments: Use with caution in patients with liver disease. Chronic use of paracetamol is not recommended in patients with liver disease.
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| Contraindications |
Hypersensitivity to any of the active substances or any ingredient.
Severe coronary heart disease and cardiovascular disorders.
Hypertension.
diabetes
enlargement of the prostate gland (Patients with prostatic hypertrophy may have increased difficulty with micturition).
Hyperthyroidism.
Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors
In patie
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| Warnings and precautions |
- Use with caution in patients with Raynaud's phenomenon.
- Phenylephrine should be used with care in patients with closed angle glaucoma.
- Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
- If the patient needs a surgery or medical tests, the surgeon or the doctor should be told that the patient has taken this medicine within the past few days.
- The doctor should be told if the patient has a severe infection as this may increase the risk of metabolic acidosis.
- The patient should consult the doctor or pharmacist if it is safe to take this medicine if there is other medical conditions, especially: liver disease, cirrhosis, a history of alcoholism, or if the patient drinks more than 3 alcoholic beverages per day (Chronic, heavy alcohol users may be at increased risk of liver damage)
- Although rare, there is the possibility of paracetamol intoxication on chronic use of the drug
- The medicine should be stopped and the doctor should be called at once if the patient has: Changes in heart rate, confusion, hallucinations, tremor, seizure (convulsions), little or no urinating, nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice, dangerously high blood pressure.
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| DRUG INTERACTION |
• It must not be taken with any other paracetamol-containing products. The physician or pharmacist should check that sympathomimetic containing preparations are not simultaneously administered by several routes, orally and topically.
• Paracetamol:
o The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
o The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
o Medicinal products which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxity of paracetamol.
• Phenylephrine hydrochloride:
o Monoamine oxidase inhibitors (including moclobemide): hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors.
o Sympathomimetic amines: concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.
o Beta-blockers and other anti-hypertensives (including debrisoquine, guanethidine, reserpine, and methyldopa): phenylephrine may reduce the efficacy of beta-blockers and antihypertensives. The risk of hypertension and other cardiovascular side effects may be increased.
o Tricyclic antidepressants (e.g. amitriptyline): may increase the risk of cardiovascular side effects with phenylephrine.
o Digoxin and cardiac glycosides: concomitant use of phenylephrine may increase the risk of irregular heartbeat or heart attack.
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| Pregnancy and lactation |
Epidemiological studies in human pregnancy have shown no ill-effects due to paracetamol used in the recommended dosage. Paracetamol is excreted in breastmilk, but not in a clinically significant amount.
Due to the vasoconstrictive properties of phenylephrine the product should not be used in patients with a history of pre-eclampsia. Phenylephrine may reduce placental perfusion. There is no information on use in lactation.
The safety of this medicine during pregnancy and lactation has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to phenylephrine, the use of the product during pregnancy should be avoided.
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| Undesirable effects |
Paracetamol: Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis, but these were not causally related to paracetamol. Acute pancreatitis after ingestion of above normal amounts.
Phenylephrine hydrochloride: High blood pressure with headache, vomiting, probably only in overdosage. Rarely, palpitations. Also, rare reports of allergic reactions and occasionally urinary retention in males.
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| OVERDOSE |
Paracetamol:
Risk factors: If the patient: Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primadone, rifampicin, St. John's Wort or other drugs that induce liver enzymes, or Regularly consumes ethanol in excess of recommended amounts, or Is likely to be glutathione depleted.
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure may develop even in the absence of severe liver damage.
Management: Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol. The effectiveness of the antidote declines sharply after this time. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.
Phenylephrine hydrochloride:
Features of severe overdosage of phenylephrine include haemodynamic changes and cardiovascular collapse with respiratory depression. Treatment includes early gastric lavage and symptomatic and supportive measures.
Phenylephrine overdose is likely to result in: nervousness, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, mydriasis, acute angle closure glaucoma, tachycardia, palpitations, allergic reactions, dysuria, urinary retention in severe cases confusion, hallucinations, seizures and arrhythmias may occur.
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| STORAGE |
| Store at temperature between (15-30) ºC, Protect from light and moisture. |
| PACKAGING |
Fedron: Carton box contains 20 F.C.Tablets blister packed with a leaflet.
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