As with other sympathomimetic agents, symptoms of overdose include irritability, restlessness, tremor, convulsions, palpitations, hypertension and difficulty in micturition.
Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed if indicated. Catheterisation of the bladder may be necessary. If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.
This product is contraindicated in individuals with known hypersensitivity to the product or any of its components.
Concomitant use of other sympathomimetic decongestants, beta-blockers and monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOI treatment
Cardiovascular disease including hypertension
Diabetes mellitus
Phaeochromocytoma
Hyperthyroidism
Closed angle glaucoma
Severe renal impairment
Not to be used in children under the age of 6 years.
None known
Cardiovascular effects
- Tachycardia/palpitations
- Other cardiac dysrhythmias and hypertension
CNS effects
- Irritability
- Anxiety
- Restlessness
- Excitability
- Insomnia
- Hallucinations and paranoid delusion
Skin reactions including rash
Hypersensitivity reactions - cross-sensitivity may occur with other sympathomimetics.
Other reactions
- Nausea and/or vomiting
- Headache
- Urinary retention
None stated.
For the relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract associated with the common cold.
Psuedoephedrine has direct and indirect sympathlomimetic activity and is an orally effective upper respiratory tract decongestant. Psuedoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation in systolic blood pressure and considerably less potent in causing stimulation of the central nervous system.
Pseudoephedrine is rapidly and completely absorbed after oral administration. After an oral dose of 180 mg to man, peak plasma concentrations of 500-900 ng/ml were obtained about 2 hours post dose. The plasma half life was about 5.5 hours and was increased in subjects with alkaline urine and decreased in subjects with acid urine. The only metabolism was n-demethylation which occurred to a small extent. Excretion was mainly via the urine.
Use with caution in occlusive vascular disease
If any of the following occur, this product should be stopped
- Hallucinations
- Restlessness
- Sleep disturbances
Caution in moderate renal impairment
None known.
Oral
Adults and Children aged 12 years and over:
10 ml elixir every 4-6 hours up to 4 times a day.
Children 6 - 12 years
5 ml elixir every 4-6 hours up to 4 times a day. Not to be used for more than five days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.
This product may be diluted 1:1 (1 in 2) or 1:3 (1 in 4) with syrup BP. These dilutions are stable for 4 weeks if stored at 25°C.
Children under 6 years
This product is contraindicated in children under the age of 6 years.
Use in the Elderly
There have been no specific studies of this product in the elderly, experience has indicated that normal adult dosage is appropriate.
Hepatic Dysfunction
Caution should be exercised when administering this product to patients with severe hepatic impairment.
Renal Dysfunction
Caution should be exercised when administering this product to patients with moderate to severe renal impairment.
Do not exceed the stated dose.
Keep out of the reach and sight of children.
Not applicable
Administrative data
