CORE PSEUDOEPHEDRINE PRODUCT INFORMATION

Product description

This section should include:

•	a description of the dosage form;
•	a list of the active ingredients expressed quantitatively; and
•	a list of the excipients expressed qualitatively

Pharmacology

Pharmacokinetics:
Pseudoephedrine is readily absorbed from the gastrointestinal tract. It is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite. It has a half-life of about 5-8 hours; elimination is enhanced and half-life reduced accordingly in acid urine. Small amounts are distributed into breast milk.

Pharmacodynamics/Mechanism of action:
Pseudoephedrine has direct- and indirect- sympathomimetic activity and is an effective decongestant in the upper respiratory tract. It is a stereoisomer of ephedrine and has a similar action, but has been found to have less pressor activity and fewer central nervous system (CNS) effects.

Sympathomimetic agents are used as nasal decongestants to provide symptomatic relief. They act by causing vasoconstriction resulting in redistribution of local blood flow to reduce oedema of the nasal mucosa, thus improving ventilation, drainage and nasal stuffiness.

Indications

This section must contain the indications of the product as specified in the ARTG. If the indications are not specified in the ARTG (e.g. for a non-validated grandfathered product), the indications must be as specified on the product label. 

Contraindications

Pseudoephedrine is contraindicated for use in patients:
•	with known hypersensitivity or idiosyncratic reaction to pseudoephedrine (or any of the other ingredients in the product);
•	with severe hypertension or coronary artery disease;
•	taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the previous 14 days.

Refer to ‘Interactions with other medicines’ for additional information

Precautions

Pseudoephedrine should be used with caution in patients with:
•	hypertension
•	hyperthyroidism
•	diabetes mellitus
•	coronary heart disease
•	ischaemic heart disease
•	glaucoma
•	prostatic hypertrophy
•	severe hepatic or renal dysfunction.

Refer to ‘Interactions with other medicines’ for additional information

Use in pregnancy
Category B2: Pseudoephedrine has been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals are inadequate or may be lacking, but available data shows no evidence of an increased occurrence of foetal damage. 

Pseudoephedrine should be used in pregnancy only if the potential benefits to the patient are weighed against the possible risk to the foetus.

Lactation
Pseudoephedrine is secreted in breast milk in small amounts. It has been estimated that 0.5% to 0.7% of a single dose of pseudoephedrine ingested by the mother will be excreted in the breast milk over 24 hours. Therefore it is not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant.

Interaction with other medicines
The following interactions with pseudoephedrine have been noted:
•	Antidepressant medication eg tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs) – may cause a serious increase in blood pressure or hypertensive crisis
•	other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants – may cause an increase in blood pressure and additive effects
•	methyldopa and β-blockers – may cause an increase in blood pressure 
•	urinary acidifiers enhance elimination of pseudoephedrine
•	urinary alkalinisers decrease elimination of pseudoephedrine

Adverse reactions

Adverse effects include:
•	cardiovascular stimulation – elevated blood pressure, tachycardia or arrhythmias
•	central nervous system (CNS) stimulation – restlessness, insomnia, anxiety, tremors and (rarely) hallucinations
•	skin rashes and urinary retention 

Children and the elderly are more likely to experience adverse effects than other age groups.

Dosage

This section must contain the current dosage instructions of the registered product, as specified on the product label. 

Overdosage

In case of overdose, immediately contact the Poisons Information Centre (in Australia, call 13 11 26; in New Zealand call 0800 764 766) for advice.

Presentation

Information should be included on:

•	the presentation, including dosage form and pack sizes;
•	identifying details (eg. colour, shape, identifying markings);
•	poisons schedule details; and
•	name and address of the sponsor.

Include the date of approval as the date on which the notification application is lodged