1. Name of the medicinal product
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Dexamfetamine Sulfate 5 mg Tablets
2. Qualitative and quantitative composition
Each Tablet contains 5mg Dexamfetamine Sulfate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets
Plain white uncoated flat bevelled edged tablet, one side plain and one side score and embossed with “D5”.
The tablet can be divided into equal doses.
4. Clinical particulars
Dexamfetamine Sulfate is a sympathomimetic amine with central stimulant and anorectic activity. It is indicated in narcolepsy. It is also indicated for children with refractory hyperkinetic states under the supervision of a physician specialising in child psychiatry.
4.2 Posology and method of administration
For oral administration.
Adults: In narcolepsy, the usual starting dose is 10mg dexamfetamine sulfate a day, given in divided doses. Dosage may be increased if necessary by 10mg a day at weekly intervals to a suggested maximum of 60mg a day.
Elderly: Start with 5mg a day, and increase by increments of 5mg at weekly intervals.
Children: In hyperkinetic states, the usual starting dosage for children aged 3-5 years is 2.5mg a day, increased if necessary by 2.5mg a day at weekly intervals; for children aged 6 years and over, the usual starting dose is 5-10mg a day increasing if necessary by 5mg at weekly intervals. Buy aspen dexamfetamine dexedrine for sale online Australia
The usual upper limit is 20mg a day though some older children have needed 40mg or more for optimal response.
4.3 Contraindications
• Hypersensitivity to dexamfetamine or other amfetamine derivatives or any of the excipients.
• Patients with symptomatic cardiovascular disease, structural cardiac abnormalities and/or moderate or severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels)
Cerebrovascular disorders (cerebral aneurysm, vascular abnormalities including vasculitis or stroke)
Patients with advanced arteriosclerosis. Buy aspen dexamfetamine dexedrine for sale online Australia
Pregnancy and lactation.
4.4 Special warnings and precautions for use
Precautions to be taken before handling or administering the medicinal product
Pre-treatment screening:
Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient’s cardiovascular status including blood pressure and heart rate. A comprehensive history should document concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death and accurate recording of pre-treatment height and weight on a growth chart (see sections 4.3 and 4.4). Buy aspen dexamfetamine dexedrine for sale online Australia
Ongoing monitoring
Growth, psychiatric and cardiovascular status should be continuously monitored (see also Section 4.4).
• Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months;
• Development of de novo or worsening of pre-existing psychiatric disorders, including depression and aggressive behaviour, should be monitored at every adjustment of dose and then at least every 6 months and at every visit. Patients should be monitored for the risk of diversion, misuse, and abuse of dexamfetamine. Buy aspen dexamfetamine dexedrine for sale online Australia
Long-term use (more than 12 months) in children and adolescents
Cardiomyopathy has been reported with chronic amfetamine use.
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