Veracold VT

Sky-blue, round, flattened, beveled-edge tablet with score on one side and engraved with "VERACOLD" on the other.
Each tablet contains Paracetamol 50 mg, Phenylephrine hydrochloride 10 mg, Chlorpheniramine maleate 2 mg.

Pharmacology: Pharmacodynamics: Paracetamol: ATC code: N02BE01.
Analgesic: The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent, through a peripheral action by blocking pain-impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.
Antipyretic: Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.
Chlorpheniramine maleate: ATC code: R06AB02.
Chlorpheniramine is a potent antihistamine (H1-antagonist). Antihistamines diminish or abolish the actions of histamine in the body by competitive reversible blockade of histamine H1-receptor sites on tissues. Chlorpheniramine also has anticholinergic activity. Antihistamines act to prevent the release of histamine, prostaglandins and leukotrienes and have been shown to prevent the migration of inflammatory mediators. The actions of chlorpheniramine include inhibition of histamine on smooth muscle, capillary permeability and hence reduction of edema and wheal in hypersensitivity reactions such as allergy and anaphylaxis.
Phenylephrine hydrochloride: ATC code: C01CA06.
Phenylephrine hydrochloride is a sympathomimetic agent with mainly direct effects on adrenergic receptors (predominantly alpha-adrenergic activity) producing nasal decongestion.
Pharmacokinetics: Paracetamol: Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral doses. The absorption of paracetamol was slow and incomplete in vegetarian subjects compared with non-vegetarian subjects. 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 metabolised mainly in the liver and excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged paracetamol. A minor hydroxylated metabolite (N-acetyl-p-benzoquinone imine), is usually produced in very small amounts by cytochrome P450 isoenzymes (mainly CYP2E1 and CYP3A4) in the liver and kidney. It is usually detoxified by conjugation with glutathione but may accumulate after paracetamol overdosage and cause tissue damage.
Chlorpheniramine maleate: Chlorphenamine maleate is absorbed relatively slowly from the gastrointestinal tract, peak plasma concentrations occurring about 2.5 to 6 hours after oral doses. Bioavailability is low, values of 25 to 50% having been reported. Chlorphenamine appears to undergo considerable first-pass metabolism. About 70% of chlorphenamine in the circulation is bound to plasma proteins. There is wide interindividual variation in the pharmacokinetics of chlorphenamine; values ranging from 2 to 43 hours have been reported for the half-life. Chlorphenamine is widely distributed in the body, and enters the CNS.
Chlorphenamine maleate is extensively metabolised. Metabolites include desmethyl- and didesmethyl chlorphenamine. 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.
A duration of action of 4 to 6 hours has been reported this is shorter than may be predicted from pharmacokinetic parameters.
More rapid and extensive absorption, faster clearance, and a shorter half-life have been reported in children.
Phenylephrine hydrochloride: Phenylephrine has low oral bioavailability owing to irregular absorption and first-pass metabolism by monoamine oxidase in the gut and liver.

For the symptomatic relief of nasal congestion, sneezing, runny nose, fever and headache due to colds, sinusitis, hay fever or other upper respiratory tract allergies.

Adults: 1 tablet every 4 hours.
Children 6 to 12 years: ½ tablet every 4 hours.
Children under 6 years: Consult a physician.

Sign: Acetaminophen Overdose: Typical Toxidrome: Significant overdoses of acetaminophen may result in potentially fatal hepatotoxicity. The physician should be mindful that there is no early presentation that is pathoneumonic for the overdose. A high degree of clinical suspicion must always be maintained.
Due to the wide availability of acetaminophen, it is commonly involved in single and mixed drug overdose situations, and the practitioner should have a low threshold for screening for its presence in a patient's serum. Acute toxicity after single dose overdoses of acetaminophen can be anticipated when the overdose exceeds 150 mg/kg. Chronic alcohol abusers, cachectic individuals, and persons taking pharmacologic inducers of the hepatic P450 microsomal enzyme system may be at risk with lower exposures.
There have been rare reports of chronic intoxication in persons consuming in excess of 150 mg/kg of acetaminophen daily for several days.
Treatment: Specific Antidote: NAC (N-acetylcysteine) administered by either the i.v. or the oral route is known to be a highly effective antidote for acetaminophen poisoning. It is most effective when administered within 8 hours of a significant overdose but reports have indicated benefits to treatment initiated well beyond this time period. It is imperative to administer the antidote as early as possible in the time course of acute intoxication to reap the full benefits of the antidote's protective effects.
General Management: When the possibility of acetaminophen overdose exists, treatment should begin immediately and include appropriate decontamination of the gastrointestinal tract, proper supportive care, careful assessment of appropriately timed serum acetaminophen estimations evaluated against the Rumack-Matthew nomogram, timely administration of NAC as required and appropriate follow-up care. Delays in initiation of appropriate therapy may jeopardize the patient's chances for full recovery.

Hypersensitivity to any of the components.
Patients receiving MAO inhibitors.

This drug may cause drowsiness, dizziness and psychomotor impairment in some patients which may seriously affect ability to perform hazardous activities requiring mental or physical alertness. Patients should not drive, use machinery and perform any hazardous activities during administration of the drug.
Should not be used concomitantly with alcohol or alcohol containing beverages.
It has been used only under the direction of a clinician in children under one year of age; patients with narrow angle glaucoma, prostatic hypertrophy or urinary retention.
It should be used with caution in pregnancy especially first trimester and lactation.
Do not exceed the recommended dose, overdosage may cause hepatotoxicity and do not continue use more than 5 days.
Avoid using this medicine with any other drug containing paracetamol. It may cause overdosage.
Patients with liver disease or renal disease or drinking alcoholic, should ask a physician or pharmacist before using this medicine.
If the symptom of swelling of the face; eyelid; lips; urticaria, faint, skin rash usually erythematous; maculopapular and toxic epidermal necrolysis have developed, the drug should be discontinued and consult a physician.
It has adverse effects include dryness of mouth, urinary retention, thickening of bronchial secretions, blurred vision, dizziness, nervousness and blood dyscrasia.
Pediatric and geriatric patients may be particularly susceptible to dizziness, sedation, delirium, dryness of mouth, urinary retention, hypotension, restlessness, insomnia and some patient may experience paradoxical reactions characterized by even seizures.
If it is used concomitantly with other depressant drugs such as benzodiazepines, anticholinergic drugs and antidepressants, caution should be exercised.
It should be used with caution in patients with hypertension, cardiovascular diseases, hyperthyroidism, experience of asthma and bronchiectasis.

Use with caution on elderly patients or patients with allergies to the drug, chronic alcoholism, serious liver or kidney disease, diabetes, heart or thyroid disease, high blood pressure, chronic lung disease, glaucoma, difficulty in urination due to enlarged prostate, or pregnant or nursing, or taking antidepressants, other antihistamines, tranquilizers, or sedating drugs.
Occupational Hazards: Effects on Ability to Drive and Use Machines: Patients should be cautioned not to operate vehicles or hazardous machinery until their response to the drug has been determined. Since the depressant effects of antihistamines are additive to those of other drugs affecting the CNS, patients should be cautioned against drinking alcoholic beverages or taking hypnotics, sedatives, psychotherapeutic agents or other drugs with CNS depressant effects during antihistamine therapy.

Use in Pregnancy: Pregnancy Category C.
There are no adequate and controlled studies to date using chlorpheniramine in pregnant women, and the drug should be used during the first 2 trimesters only when clearly needed.
Nursing Mothers: It is not known whether chlorpheniramine is distributed into milk, but other antihistamines (e.g., diphenhydramine) have been detected in milk. Because of the potential for serious adverse reactions to antihistamines in nursing infants, a decision should be made whether to discontinue nursing or chlorpheniramine, taking into account the importance of the drug to the woman.

Drowsiness may occur. Other possible adverse reactions may include restlessness, dry mouth, nervousness, visual disturbances, dermatitis, weakness and nausea.
Chronic use of large doses of acetaminophen may produce more significant toxicity.
Renal: Nephropathy, including papillary renal failure, has been reported following consumption of large amounts of acetaminophen. Renal tubular necrosis has been associated occasionally with hepatic injury produced by acetaminophen overdose.
Hematologic: Neutropenia and thrombocytopenia purpura have been reported and rarely agranulocytosis.
Hypersensitivity: Laryngeal edema, angioedema and anaphylactoid reactions may occur rarely.
Hepatic: Hepatic toxicity has been associated with acetaminophen in overdose. Chronic use of high doses, e.g., 5 g daily for several weeks in adults or 150 mg/kg/day for 2 to 4 days in children, has also been associated with hepatotoxicity. Alcoholics, patients with liver disease, the malnourished and patients taking drugs that induce hepatic microsomal enzymes, may be at increased risk for hepatic toxicity.
Respiratory: May aggravate bronchospasm in patients sensitive to ASA or other analgesics.

Paracetamol: Barbiturates (eg, phenobarbital): The potential hepatotoxicity of paracetamol may be increased when large or chronic doses of barbiturates are coadministered. The therapeutic effects of paracetamol may be reduced with barbiturate therapy.
Ethanol: Chronic consumption of ethanol may increase the risk of paracetamol-induced liver damage.
Chlorpheniramine maleate: Alcohol, CNS depressants, tricyclic antidepressants: Concurrent use may potentiate the effects of either these medications or antihistamines.
MAO inhibitors: Concurrent use may prolong and intensify the antimuscarinic effects of antihistamines and is generally not recommended.
Ototoxic medications, in particular the ototoxic antibiotics: Concurrent use with antihistamines may mask the symptoms of ototoxicity.
Alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if the patient is taking sedatives or tranquilizers, without first consulting the physician.
Phenylephrine hydrochloride: Monoamine oxidase (MAO) inhibitors: Do not use this product with prescription MAO inhibitors (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease) or for 2 weeks after stopping the MAO inhibitor drug. If the patient is uncertain whether prescription drugs contain an MAO inhibitor, consult a health professional before giving this product.

Keep in tight containers, protected from light. Store below 30°C.

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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