Maxtra Syrup

Phenylephrine Hydrochloride and Chlorpheniramine Maleate Syrup [5 mg + 2 mg]

Each 5 ml contains :

Phenylephrine Hydrochloride USP 5 mg

Chlorpheniramine Maleate USP 2 mg

Excipients q.s.

In a mentholated flavoured syrup base.

Syrup

5 mg / 2 mg

4.1 Therapeutic indication

Treatment of cough and cold with nasal congestion.

4.2 Posology and method of administration

Adults and children > 12 years

• 10 ml every 4 to 6 hours.

In children > 6 to 12 years

• 5 ml every 4 to 6 hours.

In children 4 to 6 years

• 2.5 ml every 4 to 6 hours or as directed by the Physician.

Maxtra syrup should not be used in children below 4 years of age.

Do not give continuously for more than 5 days without medical advice.

4.3 Contraindications

• Patients who are hypersensitive to antihistamines or to any of the syrup ingredients.
• Acute asthma.
• Premature infants or neonates because of their increased susceptibility to the antimuscarinic effects.
• Concomitant use of other sympathomimetic decongestants.
• Phaeochromocytoma.
• Closed angle glaucoma.
• Hepatic or severe renal impairment, hypertension, diabetes or heart disease.

4.4 Special warnings and precautions for use

This medicine should be given with caution to patients with epilepsy, severe cardiovascular disorders, liver disorders, glaucoma, urinary retention, pyloroduodenal obstruction, asthma, bronchitis, bronchiectasis, thyrotoxicosis, and severe hypertension.

Special care should be taken when using Chlorpheniramine Maleate in children, as they are more prone to developing neurological anticholinergic effects.

This product should not be used in patients taking other sympathomimetics (such as decongestants).

Patients suffering from chronic cough or asthma should consult a physician before taking this product.

Patients should stop using the product and consult a health care professional if cough lasts for more than 5 days or comes back or is accompanied by a fever, rash or persistent headache.

Warning

May cause drowsiness.

Keep all medicines out of the reach of children.

Although most antihistamines should be avoided by patients with porphyria, Chlorpheniramine Maleate has been used and is thought to be safe.

Special label warnings

Do not take with other flu, cold or decongestant products.

Do not take with a cough suppressant.

Do not exceed the recommended dose.

4.5 Drugs interactions

Chlorpheniramine Maleate

This medicine may enhance the sedative effects of hypnotics, anxiolytics, sedatives, opioid analgesics and neuroleptics.

The antimuscarinic effects of Chlorpheniramine are enhanced by other antimuscarinic drugs and both antimuscarinic and sedative effects are enhanced by MAOIs and tricyclic antidepressants.

Metabolism of phenytoin may be inhibited by Chlorpheniramine with the possible development of phenytoin toxicity.

Phenylephrine Hydrochloride

Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported :

If urine is collected within 24 hours of a dose of this product, a metabolite may cause a colour interference with laboratory determinations of 5 Hydroxy-indole-acetic acid (5-HIAA) and Vanilly-mandelic acid (VMA).

4.6 Use in special populations

Pregnancy

Information regarding the use of Maxtra syrup during pregnancy is not available. Please consult your doctor.

Lactation

Information regarding the use of Maxtra syrup during breastfeeding is not available. Please consult your doctor.

4.7 Effects on ability to drive and use machines

It is not known whether Maxtra syrup alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.

4.8 Undesirable effects

Chlorpheniramine Maleate

The product may cause drowsiness, which may progress to deep sleep, headache, dizziness, psychomotor impairment, inability to concentrate, lassitude, irritability and antimuscarinic effects such as urinary retention, dry mouth and blurred vision.

Gastrointestinal disturbances may occur including abdominal pain, dyspepsia and anorexia.

Paradoxical CNS stimulation may occur especially in children or after high doses.

Skin rashes including exfoliative dermatitis and photosensitivity reactions and hypersensitivity reactions including urticaria may occur.

Other side effects include convulsions, sweating, myalgia, paraesthesia, tinnitus, palpitations, tachycardia, arrhythmias, chest pain, haemolytic anaemia and other blood dyscrasias, extrapyramidal effects, tremor, liver dysfunction, including hepatitis and jaundice, sleep disturbances, including nightmares, depression, hypotension, hair loss, thickening of bronchial secretions and confusional psychosis in the elderly.

Phenylephrine Hydrochloride

The following adverse events have been observed in clinical trials with Phenylephrine and may therefore represent the most commonly occurring adverse events.

Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to : medico@zuventus.com

Website : http://www.zuventus.co.in/safety.aspx

By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

Treatment with activated charcoal should be considered or gastric lavage and aspiration should be performed. Treatment is most effective if given within an hour of ingestion. Hypotension and arrhythmias should be treated vigorously. Symptomatic and supportive measures should be undertaken, particularly with regard to cardiovascular and respiratory systems.

5.1 Mechanism of action / pharmacodynamic properties

Chlorpheniramine Maleate

Chlorpheniramine antagonises competitively the effects of histamine on H1-receptors and also has weak antimuscarinic and moderate anti-serotonin and local anaesthetic actions. It penetrates the brain and causes stimulation or sedation in animals.

Phenylephrine Hydrochloride

Phenylephrine is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It has predominantly alpha adrenergic activity and is without stimulating effects on the central nervous system. The sympathomimetic effect of Phenylephrine produces vasoconstriction which in turn relieves nasal congestion.

5.2 Pharmacokinetic properties

Chlorpheniramine Maleate

Chlorpheniramine Maleate is almost completely absorbed after administration by mouth, peak plasma concentrations occurring at about 2.5 to 6 hours. The drug is widely distributed including passage into the CNS, with a volume of distribution of between 1 and 10 L/kg. About 70% of Chlorpheniramine in the circulation is protein-bound. Chlorpheniramine undergoes some fi rst pass metabolism and enterohepatic recycling. Chlorpheniramine is extensively metabolised, principally to inactive desmethylated metabolites which are excreted primarily in the urine, together with about 35% unchanged drug. Only trace amounts are excreted in the faeces. The mean elimination half-life has been reported to be about 30 hours, with mean values ranging from 2 to 43 hours.

Phenylephrine Hydrochloride

Phenylephrine Hydrochloride is irregularly absorbed from the gastrointestinal tract and undergoes first-pass metabolism by monoamine oxidase in the gut and liver; orally administered Phenylephrine thus has reduced bioavailability. It is excreted in the urine almost entirely as the sulphate conjugate.

6.1 Animal toxicology or pharmacology

The antihistaminic potency of Chlorpheniramine is confined mainly to its (+)-isomer. The racemate is similarly or slightly more toxic because of the contribution of (-)-isomer. The toxicity may therefore be non-specific, perhaps attributable to local anaesthetic action and the toxic effects (excitation / sedation, coma, convulsions and death) resemble those of other classic H1 antihistamines. Toxic doses may cause hypotension attributable to myocardial depression, an effect which is clearer with the (-)-isomer.

The experimental data on the carcinogenicity and mutagenicity of Chlorpheniramine indicate lack of these adverse effects, but the racemate and the (+)-isomer have shown some embryotoxicity in fertility tests.

Effective antihistaminic concentrations of Chlorpheniramine in vitro are about 1 - 10 µg/L and oral doses of 0.2 - 1 mg/kg antagonise histamine-induced bronchospasm in guinea pigs.

Maxtra syrup contains Phenylephrine Hydrochloride (a nasal decongestant) and Chlorpheniramine Maleate (an antihistamine). Each 5 ml syrup contains : Phenylephrine Hydrochloride USP 5 mg, Chlorpheniramine Maleate USP 2 mg, and Excipients (q.s.).

8.1 Incompatibilities

Not applicable

8.2 Shelf-life

24 Months

8.3 Packaging information

1 x 60 ml

1 x 100 ml

8.4 Storage and handing instructions

Store below 30°C. Protect from light.

KEEP AWAY FROM THE REACH OF CHILDREN.

Maxtra syrup should not be used in children below 4 years of age.

• Maxtra syrup helps relieve symptoms of cold and flu such as watery eyes, runny nose, sneezing, and itching of the nose or throat.
• Take it as per the dose and duration prescribed by your doctor.
• It may cause dizziness and sleepiness. Don't drive or do anything that requires mental focus until you know how it affects you.
• Avoid consuming alcohol when taking Maxtra syrup as it may cause excessive drowsiness.
• Inform your doctor if you are pregnant or planning to conceive or breastfeeding.

26 March 2024