1. Name Of The Medicinal Product
Meltus Decongestant.
2. Qualitative And Quantitative Composition
Pseudoephedrine Hydrochloride BP 30.00mg/5ml.
3. Pharmaceutical Form
Oral Solution.
4. Clinical Particulars
4.1 Therapeutic Indications
Meltus Decongestant is a decongestant of the mucous membranes of the upper respiratory tract, especially the nasal mucosa and sinuses. It is indicated for the symptomatic relief of conditions such as the common cold, influenza, hay fever, allergic and vasomotor rhinitis. It is intended for the relief of such symptoms as blocked sinuses, stuffed up noses and catarrh.
4.2 Posology And Method Of Administration
Route of administration: Oral. To be taken three times a day. Adults and children over 12 years: Two 5ml spoonfuls. Children 6 - 12 years: One 5ml spoonful. Children 2 - 5 years: One 2.5ml spoonful.
4.3 Contraindications
Contraindicated in patients who have previously shown intolerance to pseudoephedrine. It is contraindicated in persons under treatment with MAOIs, and within two weeks of stopping such treatment. It is also contraindicated in patients with severe hypertension or severe coronary artery disease.
4.4 Special Warnings And Precautions For Use
Although pseudoephedrine has virtually no pressor effects in patients with normal blood pressure, Meltus Decongestant should be used with caution in patients taking antihypertensive agents, tricyclic antidepressants, other sympathomimetic agents, such as decongestants, appetite suppressants, and amphetamine-like psycho-stimulants. The effects of a single dose on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment. As with other sympathomimetic agents, caution should be exercised in patients with uncontrolled diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The effect of antihypertensive agents which modify sympathetic activity may be partially reversed by Meltus Decongestant. Concomitant use with other sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine like psycho-stimulants or with MAIOs which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in high blood pressure.
The antibacterial agent furazolidine is known to cause a dose related inhibition of monoamine oxidase inhibitors and although there are no reports of hypertensive crises having occurred, it should not be administrated at the same time as Meltus Decongestant.
4.6 Pregnancy And Lactation
Pseudoephedrine has been in widespread use for many years without apparent ill consequences. Caution should, therefore, be exercised by balancing the potential benefit of treatment against any possible hazards. Systemic administration of pseudoephedrine up to 50 times the human dose in rats and up to 35 times the human dose in rabbits did not produce teratogenic effects. It has been estimated that approximately 0.5-0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours.
4.7 Effects On Ability To Drive And Use Machines
None reported.
4.8 Undesirable Effects
Side effects are uncommon. In some patients pseudoephedrine may occasionally cause insomnia. Rarely, sleep disturbances and hallucinations have been reported. A fixed drug eruption to pseudoephedrine, taking the form of erythmatous nummular patches has been reported, but is rare occurrence. Urinary retention has been reported in male patients in whom prostatic enlargement could have been an important predisposing factor.
4.9 Overdose
Irritability, restlessness, tremor, convulsions, palpitations, hypertension and difficulty in micturation.
Treatment: Gastric lavage and supportive measures for respiration and circulation should be performed if indicated. Convulsions should be controlled with an anti-convulsant. Catheterisation of the bladder may be necessary. If desired the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pseudoephedrine has direct and indirect sympathomimetic activity and is an orally effective upper respiratory tract decongestant.
5.2 Pharmacokinetic Properties
Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract following oral administration, with no pre-systemic metabolism. It achieves peak plasma concentration between one and three hours after oral dosing. It is eliminated, largely unchanged, in the urine (55-90%) in 24 hours, although there is some metabolism in the liver (<1%) by N-demethylation. It has a plasma half life of 5-8 hours following oral dosing, but its urinary elimination and hence its half life, is pH dependant such that elimination will be increased in subjects with acidic urine and decreased in patients with alkaline urine.
Pseudoephedrine is rapidly distributed throughout the body. Its volume of distribution is 2-3 L/Kg body weight but there are no reports of the extent of plasma binding and similarly, although CNS effects are observed, there is no specific information concerning its penetration into the CNS.
It is excreted in the breast milk at concentrations consistently higher than those in maternal plasma. The fraction of dose excreted in the milk has been estimated at approximately 0.5% of a single oral dose over 24 hours. Pseudoephedrine is likely to cross the placenta. The elimination of pseudoephedrine is reduced in renal impairment and with deteriorating renal function in the elderly.
Oral absorption: >95%
Presystemic metabolism: negligible
Plasma half-life: 5.4 - 8 hours
Volume of distribution: 2 - 3 L/Kg
Plasma protein binding: -
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sorbitol Solution Non Crystallising BP; Menthol BP; Loganberry Flavour 500195E; Methylhydroxybenzoate BP; Propylhydroxybenzoate BP; Alcohol 96% BP; Glycerin BP;
Sodium Saccharin BP; Sodium Cyclamate 1968 BP; Carmellose Sodium BP; Water.
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months unopened.
6.4 Special Precautions For Storage
Store at or below 25oC. Protect from light.
6.5 Nature And Contents Of Container
Amber glass sirop bottle with tamper evident cap with fitted polycone liner packed into an outer carton containing a 5ml CE marked polystyrene measuring spoon with a 2.5ml graduation – bottle contains 100ml of product.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Cupal Limited, Tubiton House, Oldham, OL1 3HS.
8. Marketing Authorisation Number(S)
PL 0338/0082.
9. Date Of First Authorisation/Renewal Of The Authorisation
3rd September 1992 /29th January 2004.
10. Date Of Revision Of The Text
January 2004
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