Decolgen FX

Decolgen FX is three-layered (yellow-orange-yellow) caplet/capsule-shaped tablet, debosed with the word "DECOLGEN" on one side and scored on the other side.
Each caplet contains: Paracetamol 650 mg, Pseudoephedrine HCl 30 mg, Chlorpheniramine Maleate 2 mg.

Pharmacology: DECOLGEN FX acts as an analgesic-antipyretic, antihistamine and nasal decongestant. Paracetamol produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat regulating center. Pseudoephedrine HCl is a sympathomimetic amine which provides relief of nasal and sinus congestion. Chlorpheniramine Maleate is an antihistamine which helps provide relief of runny nose, sneezing, watery and itchy eyes.
Pharmacokinetics: Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentration occurring about 10 to 60 minutes after oral administration. Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma protein-binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. The elimination half-life of Paracetamol varies from about 1 to 3 hours. Paracetamol is metabolized predominantly in the liver and excreted in the urine mainly as the glucuronic acid and sulphate conjugates. Less than 5% is excreted as unchanged Paracetamol.
Pseudoephedrine HCl is readily absorbed from the gastrointestinal tract. It is excreted largely unchanged in the urine with small amounts of its hepatic metabolite. It has a half-life of about 5 to 8 hours; elimination is enhanced and half-life accordingly shorter in acidic urine. Small amounts are distributed into breast milk. Concentration of pseudoephedrine in milk were consistently higher than in plasma; the half-life in both fluids was between 4.2 and 7 hours. Assuming a generous milk secretion of 500 mL over 12 hours, it was calculated that the excreted dose was the equivalent of 250 to 330 mcg of pseudoephedrine base, or 0.5 to 0.7% of the dose ingested by the mothers.
Chlorpheniramine Maleate is absorbed from the gastrointestinal tract, peak plasma concentrations occurring about 2.5 to 6 hours after administration by mouth. Bioavailability values of 25% to 50% have been reported. Chlorpheniramine appears to undergo considerable first-pass metabolism. About 70% of Chlorpheniramine in the circulation is bound to plasma proteins. There is wide interindividual variation in the pharmacokinetics of Chlorpheniramine; values ranging from 2 to 43 hours have been reported for the half-life. Chlorpheniramine is widely distributed in the body, including passage into the CNS. Chlorpheniramine Maleate is extensively metabolized. Metabolites include desmethyl and didesmethylchlorpheniramine. Unchanged drug and metabolites are excreted primarily in the urine; excretion is dependent on urinary pH and flow rate. Only trace amounts have been found in the faeces. More rapid and extensive absorption, faster clearance, and a shorter half-life have been reported in children.

For the symptomatic relief of mild to moderate pain, headache, fever, nasal congestion, and allergic conditions including sneezing, itching, and allergic rhinitis.

Adults: 1 caplet to be taken 3-4 times daily or as prescribed by the physician.
Route of Administration: Oral.

Symptoms: Toxic symptoms include vomiting, abdominal pain, hypotension, and sweating. The most serious adverse effect of acute overdosage of paracetamol is a dose-dependent, potentially fatal hepatic necrosis in adults, hepatotoxicity may occur after ingestion of a single dose 10 to 15 g of paracetamol; a dose of 25 g or more is potentially fatal. Symptoms during the first 2 days of acute poisoning by paracetamol do not reflect the potential seriousness of the intoxication. Major manifestations of liver failure such as jaundice, hypoglycemia, and metabolic acidosis may take at least 3 days to develop.
Treatment: Treatment in case of overdosage and methods of reducing the absorption of ingested drug are important. Gastric lavage is essential even if several hours have elapsed. Prompt administration of 50 g activated charcoal and 500 mL iced mannitol 25% by mouth, may reduce absorption. If the history suggest that 15 g paracetamol or more has been ingested, administer one of the following antidotes: Acetylcysteine 20% IV: administer intravenously, 20% acetylcysteine immediately without waiting for positive urine test or plasma level results, initial dose of 150 mg/kg over 15 minutes, followed by continuous infusion of 50 mg/kg in 500m mL 5% glucose over 4 hours and 100 mg/kg in 1 L 5% glucose over 16 hours.
Oral Methionine: 2.5 g immediately followed by three further doses of 2.5 g at four-hourly intervals. For 3 years old child, 1 g oral methionine every four hours for four doses has been used.
Oral Acetylcysteine 5%: 140 mg/kg as a loading dose, then 70 mg/kg every 4 hours for a total 17 maintenance doses. If patients vomit within one hour of administration of any dose, repeat dose. If more than one hour have elapsed since the overdosage was taken, the antidote may be ineffective.

Do not use in patients with liver dysfunction and hypersensitivity to any component in this medication or sympathomimetics.
In patients under the treatment with monoamine oxidase inhibitors (MAOIs) and within 2 weeks of stopping such treatment.
In patients with severe hypertension or severe coronary disease.

This preparation contains PARACETAMOL. Do not take any other Paracetamol containing medicine at the same time.
May cause drowsiness.
If affected do not drive or operate machinery.
Do not exceed the stated dose.
If the symptoms persist, consult a doctor.

Avoid doing activities requiring alertness such as driving vehicles or operating machineries.
Patients with hypertension, glaucoma, diabetes, or hyperthyroidism should not be allowed to take the drug.
Stop using the drug when sleeplessness, palpitation and dizziness occurs.
Paracetamol should be given with care to patients with impaired kidney or liver function and alcohol dependence.
Use in Children, Pregnancy & Lactation: Children under 6 years and pregnant/nursing women should strictly follow the dosage as prescribed by the physician.

This product should be used in pregnancy only if the potential benefits to the patient outweigh the possible risk to the foetus.
It is not recommended for breastfeeding mother unless the potential benefits to the patient outweigh the possible risk to the infant.

Drowsiness/sedation, gastrointestinal disturbance, insomnia, tremor, tachycardia, arrhythmia, dry mouth, palpitation and urinary retention.
Long term overdosage may cause liver damage.
Overdosage with paracetamol if left untreated can result in severe, sometimes fatal liver damage and rarely, acute renal tubular necrosis. Skin rashes and hypersensitivity reactions may occur occasionally. CNS depressive effects include sedation and impaired performance (impaired driving performance, poor work performance, incoordination, reduced motor skills, and impaired information processing). Performance may be impaired in the absence of sedation and may persist till the morning after a night-time dose. CNS stimulatory effects of may include anxiety, hallucinations, appetite stimulation, muscle dyskinesis and activation of epilepthogenic factor.

Caution to be exercised in patients who are using drugs with CNS depressant effect simultaneously with DECOLGEN FX.
Avoid alcohol while on this medication to reduce liver damage risk.
Concomitant use of DECOLGEN FX with other sympathomimetic such as decongestant, tricyclic antidepressants, appetite suppressant and amphetamine like psychostimulants or with monoamine oxidase inhibitors, which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure. Due to the pseudoephedrine content, DECOLGEN FX may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including boetylium, bethanidine, guanethidine, deprisoquine, methyldopa, alpha and beta adrenergic blocking agent.

Store at temperature below 30°C.
Shelf Life: 3 years.

Cough & Cold Preparations

N02BE51 - paracetamol, combinations excl. psycholeptics ; Belongs to the class of anilide preparations. Used to relieve pain and fever.

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