Sinu-C

Paracetamol, pseudoephedrine hydrochloride, chlorpheniramine maleate.

Active Ingredients: Each 5 ml contains Paracetamol 250 mg, Pseudoephedrine HCl 15 mg, Chlorpheniramine Maleate 1 mg.
Excipients/Inactive Ingredients: Preservatives: Methyl Hydroxybenzoate 0.1% w/v, Propyl Hydroxybenzoate 0.01% w/v, Sodium Benzoate 0.1% w/v.

Pharmacology: Paracetamol: The 2 major actions of Paracetamol are: Relieve pain by inhibiting prostaglandin synthesis in the central nervous system and blocking peripheral pain impulse generation; Reduce fever by acting on the hypothalamic heat-regulating centre to produce increased blood flow through skin, sweating and thus help in heat dissipation.
Paracetamol is rapidly and completely absorbed following oral administration and will exert its effect between 30 minutes to 2 hours later. This effect could last for 3 to 4 hours. 85% to 90% of the administered dose is eliminated in the urine within 24 hours of ingestion.
Pseudoephedrine HCl: Pseudoephedrine HCl is a sympathomimetic used for the relief of nasal and bronchial congestion. It acts directly on α-adrenergic receptors in the respiratory tract mucosa producing vasoconstriction resulting in the shrinkage of swollen nasal mucous membrane, reduction of tissue hyperaemia, oedema, and nasal congestion thus an increase in nasal airway patency. Drainage of sinus secretions is increased and obstructed Eustachian ostia may be opened. Relaxation of bronchial smooth muscle by stimulation of b-adrenergic receptors may also occur.
Pseudoephedrine is readily absorbed from the gastrointestinal tract. It is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite. Elimination is enhanced and half-life accordingly shorter in acidic urine.
Chlorpheniramine Maleate: Chlorpheniramine Maleate is a member of the alkyl amine group of antihistamines (H1 receptor antagonist). It does not block the release of histamine but acts by competitively antagonising the effects of histamine at H1 receptor sites. If the histamine concentration at the receptor sites exceeds the drug concentration, histamine release causes allergic reactions; therefore it is used for the symptomatic relief of allergic conditions.
Chlorpheniramine is absorbed relatively slowly from the gastrointestinal tract, peak plasma concentrations occurring about 2.5 to 6 hours after administration by mouth. Chlorpheniramine appears to undergo considerable first-pass metabolism. It is extensively metabolised. Metabolites include desmethyl- and didesmethylchlorpheniramine. Unchanged drug and metabolites are excreted primarily in urine; excretion is dependent on urinary pH and flow rate. Only trace amounts have been found in the faeces. A duration of action of 4 to 6 hours has been reported.

Sinu-C relieves common cold and flu symptoms including fever and pain, headache, body aches, nasal congestion and runny nose. It also relieves allergy symptoms such as sneezing, itching and watery eyes.

For oral administration only.
Adults and children above 12 years: Take 15 ml 3 to 4 times daily (maximum daily dose of 60 ml).
Children 6 to 12 years: Give 10 ml 3 to 4 times daily (maximum daily dose of 40 ml).
Children 2 to 5 years: Give 5 ml 3 to 4 times daily (maximum daily dose of 20 ml).
Do not give more than the recommended dose unless advised by a doctor.
Do not exceed 4 doses in 24 hours.
Shake well before use.

In case of overdose call the National Poison Centre at 1800-888-099.
Paracetamol: Symptoms: Symptoms of Paracetamol overdosage in the first 24 hours are diarrhoea, sweating, loss of appetite, nausea or vomiting, stomach cramps or pain. Persistence beyond this time, pain, swelling or tenderness in the upper abdomen or stomach area, usually indicates development of hepatic necrosis. Liver damage may be apparent within 12 to 48 hours after overdosage.
Treatment: Despite a lack of significant early symptoms, patients who have taken an overdose of Paracetamol should be admitted to hospital immediately.
1. Induction of vomiting may reduce absorption if 100 to 150 mg/kg or greater of Paracetamol is ingested.
2. Administration of activated charcoal should be considered if Paracetamol in excess of 150 mg/kg or 12 g whichever is smaller, is thought to have been ingested within the previous hour.
3. Gastric lavage is indicated if the patient is unwilling or unable to take the activated charcoal.
4. Dextrose and blood infusion.
5. Antidotes such as acetylcysteine and methionine protect the liver if given within 10 to 12 hours of ingestion and other supportive treatments may be provided in the hospital.
6. Haemoperfusion may be worthwhile if too much time has elapsed since the poisoning to allow the use of antidote.
Pseudoephedrine HCl: Symptoms: Overdosage of Pseudoephedrine closely resembles those resulting from overdosage of any sympathomimetics. These symptoms include nausea, vomiting, irritability, nervousness, convulsion, tachycardia, spasms and respiratory failure. Hypertension may develop initially, followed later by hypotension accompanied by anuria.
Treatment: For acute overdosage, the drug should be discontinued and supportive and symptomatic treatment instituted. If respirations are shallow or cyanosis is present, assisted respiration is recommended. Convulsion may be controlled with Diazepam. In the presence of cardiovascular collapse, blood pressure should be maintained. Hypertension may be managed with α-adrenergic blocker and tachycardia may be controlled with b-adrenergic blocker. Catheterisation of the bladder may be necessary.
Chlorpheniramine Maleate: Symptoms: Overdosage of antihistamine include extreme sleepiness, confusion, weakness, blurred vision, large pupils, dry mouth, flushing, shaking, insomnia, hallucinations and possibly seizures.
Treatment: Treatment of acute antihistamine overdosage consists of symptomatic and supportive therapy including artificial respiration, if necessary. If the patient is conscious, has not lost the gag reflex, and is not having seizures, emesis should be induced. If emesis cannot be induced, gastric lavage and administration of activated charcoal are indicated.

Patients with known hypersensitivity to Paracetamol, Pseudoephedrine or Chlorpheniramine.
Patients with severe hypertension and coronary heart diseases.
Not recommended for children under 2 years of age.

Patients with impaired liver or kidney functions should take the medication with caution.
Patients should seek medical consultation if the symptoms persist for longer than 7 days, or tend to recur, or is accompanied by a fever lasting more than 3 days, rash or persistent headache or if there is any allergic reaction to the medication.
As with all sympathomimetic decongestants, Pseudoephedrine should be used with caution in patients with hypertension, heart disease, thyroid disease, diabetes, glaucoma, asthma, prostatic hyperplasia or bladder dysfunction.
Chlorpheniramine should be used with caution in patients with stenotic peptic ulcer, pyloroduodenal obstruction, urinary bladder obstruction and prostatic hyperplasia.
This preparation contains Paracetamol. Do not take any other Paracetamol-containing medicines at the same time.
Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters or rash. These could be signs of a serious condition. If these reactions occur, stop use and seek medical assistance right away.
This medicine may cause drowsiness and may increase the effects of alcohol. If affected, do not drive a motor vehicle or operate machinery. Avoid alcoholic drinks.
Not to be used in children less than 2 years of age.
To be used with caution and doctor's advice in children 2 to 6 years of age.

Pregnancy: Category C: A retrospective study found that foetus exposed to Pseudoephedrine during gestation may have increased risk of gastroschisis, a congenital defect of the anterior abdominal wall. However, it is cautioned that underlying maternal illness may have confounded the results of this study. Therefore, Pseudoephedrine should be given only if the potential benefit justified the potential risk to the foetus.
Lactation: Paracetamol is excreted in breast milk in less than 1% of the dose ingested by lactating women. Therefore, maternal ingestion of therapeutic doses does not present a risk to the baby. Only small amounts of Pseudoephedrine are distributed into breast milk and too small to be harmful. Chlorpheniramine may inhibit lactation and should be avoided if possible. Therefore, it is not recommended for lactating women unless the expected benefits outweigh any potential risk.

Cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis have been reported.
Pseudoephedrine is generally well tolerated. Some common side effects include tachycardia, anxiety, restlessness and insomnia; skin rashes and urinary retention may occasionally occur.
Moderate drowsiness is the most common side effect of Chlorpheniramine. In some patients, side effects such as dizziness, ataxia, headache, nausea, urinary retention, blurred vision, dry mouth and skin rashes may occur.

Cautions should be taken when Paracetamol, Pseudoephedrine and Chlorpheniramine are administered concurrently with these medications: Paracetamol may increase Chloramphenicol concentrations.
Prolonged use or high doses of Paracetamol may increase the effects of oral anticoagulants (e.g. Warfarin).
Paracetamol absorption is increased by drugs that increase gastric emptying (e.g. Metoclopramide).
Paracetamol absorption is decreased by drugs which decrease gastric emptying (e.g. Propantheline or narcotic analgesics, Pethidine).
Paracetamol toxicity may be increased by the concomitant use of enzyme-inducing agents (e.g. alcohol or Phenytoin).
The absorption of Pseudoephedrine is increased by concomitant use of Aluminium Hydroxide mixture (e.g. antacids) and decreased by the administration of Kaolin.
The concurrent use of Pseudoephedrine may reduce the hypotensive effect of certain adrenergic neurone blockers (e.g. Bretylium).
The sedative effect of Chlorpheniramine may be potentiated when used with alcohol, barbiturates, anxiolytics, tricyclic antidepressants (TCAs), hypnotics or other CNS depressants.
The antimuscarinic effects of Chlorpheniramine may be increased by the concomitant use with other antimuscarinic drugs.

Store below 30°C. Protect from light. Keep cap tightly closed.
Shelf Life: 3 years from the date of manufacture.

Cough & Cold Preparations

R01BA52 - pseudoephedrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.

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