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Qualitative and quantitative composition This product contains - Pseudoephedrine Pharmaceutical form Liquid for oral administration. 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: Children under 6 years. This product is contraindicated in children under the age of 6 years see section 4. 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. Caution should be exercised when administering this product to patients with severe hepatic impairment. 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. Concomitant use of other sympathomimetic decongestants, beta-blockers see section 4. Should not be given to patients taking MAOIs or within 14 days of stopping treatment: Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus.
Systemic administration of pseudoephedrine, up to 50 times the human daily dose in rats and up to 35 times the human daily dosage in rabbits did not produce teratogenic effects. Pseudoephedrine is excreted in breast milk in small amounts, but the effect of this on breast-fed infants is not known.
It has been estimated that 0. 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. 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. The plasma half life was about 5. The only metabolism was n-demethylation which occurred to a small extent.
Active ingredient pseudoephedrine hydrochloride. Last updated on eMC: Show table of contents Hide table of contents 1. Name of the medicinal product 2. Qualitative and quantitative composition 3. Marketing authorisation holder 8. Marketing authorisation number s 9. Date of revision of the text. This information is intended for use by health professionals. This product contains - Pseudoephedrine For the relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract associated with the common cold.
Oral Adults and Children aged 12 years and over: Children 6 - 12 years 5 ml elixir every hours up to 4 times a day. Children under 6 years This product is contraindicated in children under the age of 6 years see section 4. 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. This product is contraindicated in individuals with known hypersensitivity to the product or any of its components.
Although pseudoephedrine has been in widespread use for many years without apparent ill consequence, there are no specific data on its use during pregnancy. As with other sympathomimetic agents, symptoms of overdose include irritability, restlessness, tremor, convulsions, palpitations, hypertension and difficulty in micturition. Psuedoephedrine has direct and indirect sympathlomimetic activity and is an orally effective upper respiratory tract decongestant. Pseudoephedrine is rapidly and completely absorbed after oral administration.
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