Description
By HF – Hemofarm /STADA GRUP/
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Lorazepam Hemofarm 2.5 mg 20 tablets in Box
$34.90
- 1. Name of the medicinal product
- Lorazepam 2.5mg Tablets
Pharmacodynamic propertiesLorazepam is a benzodiazepine with anxiolytic, sedative and hypnotic properties.
5.2 Pharmacokinetic propertiesLorazepam is almost completely absorbed from the gastrointestinal tract and peak serum levels are reached in 2 hours. It is metabolised by a simple one-step process to a pharmacologically inert glucuronide. There are no major active metabolites. The elimination half-life is about 12 hours and there is minimal risk of excessive accumulation.
- 2. Qualitative and quantitative composition
- Lorazepam 2.5mg Tablets contain 2.5mg of the active ingredient lorazepam.Lorazepam (INN, BAN) is chemically defined as 7-chloro-5-(0-chlorphenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one.
- 3. Pharmaceutical form
- Lorazepam 2.5mg Tablets are yellow, capsule-shaped tablets, measuring approximately 4 x 8mm, plain on one face and ‘gp’ breakbar ’20’ on the other.
- 4. Clinical particulars
- 4.1 Therapeutic indications
- FOR SHORT TERM (2-4 weeks only) USE (adults only)• Symptomatic relief of anxiety that is severe, disabling or subjecting the individual to unacceptable distress occurring alone or in association with insomnia or short-term psychometric, organic or psychotic illness.AS PREMEDICATION (adults and children 5 years and above)Before operative dentistry and general surgery
NOT FOR USE
• Long term (i.e. longer than 4 weeks)
• For mild/moderate anxiety
• For insomnia or anxiety in children
- 4.2 Posology and method of administration
-
Route of administration: oral
Treatment to be given:
• Under close medical supervision
• At the lowest effective dose
• For the shortest possible duration (not exceeding 4 weeks)
Doses should be individualised
Extension of use should not take place without further clinical evaluation
Chronic use not recommended (little is known of the long term safety and efficacy; potential for dependence–see section 4.4
When treatment is started the patient should be informed that
• treatment will be of limited duration
• the dosage will be progressively decreased
• there is a possibility of rebound phenomena
Dosage:
Adults:
Anxiety: 1-4mg daily in divided doses.
Insomnia: 1-2mg before retiring
Premedication before operative dentistry or general surgery:
2-3mg the night before operation 2-4mg one to two hours before the procedure
Elderly:
The elderly may respond to lower doses (half normal adult dose or less)
Children (aged 5-13 years):
Premedication: 0.5-2.5mg at 0.05mg/kg to the nearest 0.5mg according to weight, not less than one hour before operation.
Patients with Renal or Hepatic impairment:
Lower doses may be sufficient in these patients (See section 4.4). Use in patients with severe hepatic insufficiency is contraindicated. (See section 4.6).
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