1. Name Of The Medicinal Product
Decongestant Tablets
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Tablets
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of nasal and sinus congestion without causing drowsiness.
For oral administration.
4.2 Posology And Method Of Administration
Adults and children over 12 years: One tablet if necessary, up to four times daily at intervals of not less than 4 hours.
Children under 12 years: Not recommended.
Elderly: There is no need for dosage reduction in the elderly.
4.3 Contraindications
Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease, hypertension, severe renal impairment, diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement and phaeochromocytoma.
4.4 Special Warnings And Precautions For Use
If symptoms are not controlled by Boots Decongestant Tablets, medical advice should be sought.
Keep all medicines out of the reach of children.
Warning: Do not exceed the stated dose.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment. May enhance the effects of anticholinergic drugs such as tricyclic antidepressants. May increase the possibility of arrhythmias in digitalised patients. May increase the vasoconstrictor effects of ergot alkaloids.
4.6 Pregnancy And Lactation
The safety of decongestant tablets during pregnancy and lactation has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to pseudoephedrine, the use of the product during pregnancy should be avoided. The amounts of pseudoephedrine secreted into breast milk are considered to be too small to be harmful.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known.
4.8 Undesirable Effects
Adverse effects may include dry mouth, anxiety, restlessness, tremor, insomnia, tachycardia, cardiac arrhythmias, palpitations, hypertension, nausea, vomiting, headache and occasionally urinary retention in males and skin rashes. Hallucinations have been reported rarely, particularly in children.
4.9 Overdose
Symptoms of overdosage include irritability, restlessness, palpitations, hypertension, difficulty in micturition, nausea, vomiting, thirst and convulsions. In severe overdosage gastric lavage and aspiration should be performed. Symptomatic and supportive measures should be undertaken, particularly with regard to cardiovascular and respiratory systems. Convulsions should be controlled with intravenous diazepam. Chlorpromazine may be used to control marked excitement and hallucinations. Severe hypertension may need to be treated with an alpha-adrenoreceptor blocking drug, such as phentolamine. A beta blocker may be required to control cardiac arrhythmias.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta adrenergic activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which in turn relieves nasal congestion.
5.2 Pharmacokinetic Properties
Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted in the urine unchanged. It has an elimination half-life of 5 to 8 hours but its urinary elimination and hence half-life is pH dependent. Pseudoephedrine is rapidly distributed throughout the body, its volume of distribution being 2 to 3L/KG bodyweight.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium Starch Glycolate
Maize Starch prd
Microcrystalline Cellulose
Pregelled Maize Starch
Purified Water
Stearic Acid
6.2 Incompatibilities
None are known.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
None.
6.5 Nature And Contents Of Container
Blister pack of white or clear 250 microns PVC coated with 40gsm PVdC and 20 micron aluminium foil.
Pack sizes: 6, 7, 10, 12 tablets.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA
8. Marketing Authorisation Number(S)
PL 00014/0375
9. Date Of First Authorisation/Renewal Of The Authorisation
28 January 1988 / 17 December 1997 / 17 December 2002
10. Date Of Revision Of The Text
September 2007
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