Finished product reference

Antihistamine Decongestant (2)

Capsule, Liquid Filled · Oral · 4 mg/10 mg

List code
52681
Pharmacologic class
Combination antihistamine and nasal decongestant (category)

What it is and how it works

Fixed-dose oral combinations of an H1-antihistamine (e.g. chlorphenamine, loratadine or cetirizine) with a sympathomimetic decongestant (e.g. pseudoephedrine or phenylephrine). The antihistamine reduces sneezing, itching and rhinorrhoea, while the decongestant constricts nasal blood vessels to relieve congestion.

Indications

Symptomatic relief of allergic rhinitis and common cold with nasal congestion, sneezing and rhinorrhoea.

Contraindications

Severe hypertension or coronary artery disease; use with or within 14 days of MAO inhibitors; narrow-angle glaucoma; urinary retention; severe renal impairment (for some components); hyperthyroidism.

Warnings and precautions

Decongestants may raise blood pressure and heart rate and cause insomnia; caution in hypertension, cardiovascular disease, diabetes and prostatic hypertrophy. Sedating antihistamine components impair driving. Pseudoephedrine has rarely been associated with ischaemic colitis and posterior reversible encephalopathy syndrome.

Pregnancy

Generally avoided in pregnancy, particularly in the first trimester.

Storage and supply

Store below 25 °C in a dry place, protected from light.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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