Analab Dosage/Direction for Use

Paediatric population: The safety and efficacy of ANALAB CAPSULE/INJECTION has not been studied in the paediatric population.
Therefore, use of ANALAB CAPSULE/INJECTION is not recommended in patients under 12 years of age.
Capsule: Oral, 50 mg.
The dosage should be adjusted to the intensity of the pain, unless otherwise prescribed, ANALAB CAPSULE should be taken as follows independent of meals: Single dose: For adults and adolescents (12 years and older): ANALAB CAPSULE is not approved for use in patients below 12 years old.
One 50 mg capsule to be taken with a little liquid. This is usually sufficient to relieve the pain. If, however, pain relief is unsatisfactory, a further 50 mg capsule may be taken after about 30-60 minutes.
In general the daily dose: Should not exceed 400 mg ANALAB CAPSULE.
In impaired renal or hepatic function it may be necessary to adjust the dose.
Duration of treatment: During long-term treatment with ANALAB CAPSULE, the possibility of dependence cannot be entirely excluded. Therefore the physician is to decide on the duration of treatment and whether the preparation is to be withdrawn temporarily, ANALAB CAPSULE should not be given for longer than therapeutically necessary.
Injection: The dosage depends on the intensity of the pain and the sensitivity of the individual patient. ANALAB INJECTION should be administered as follows: Single dose: For adults and adolescents (12 years and older): ANALAB INJECTION is not approved for use in patients below 12 years old.
I.V. 1-2 ampoules-injected slowly or diluted in solution for injection and infused.
I.M. 1-2 ampoules.
S.C. 1-2 ampoules.
If satisfactory pain relief is not obtained within 30-60 minutes of the administration of 50 mg Tramadol hydrochloride, a 2^nd dose of 50 mg may be given. If clinical experience has shown that a higher dose (2 ampoules) is probably necessary in cases of severe pain, the higher dose may be used for the initial dose.
In general, a daily dosage of 400 mg should not be exceeded.
For the treatment of severe post-operative pain, the higher doses in the first few hours may be given.
Generally, over 24 hours more than the normal doses are not necessary.
Geriatric patients: In acute pain a dosage adjustment is not necessary. In chronic pain the dosage intervals may have to be extended because elimination may be prolonged in old patients (usually >75 years) with no clinically manifest hepatic or renal insufficiency.
Hepatic and Renal Insufficiency/Dialysis: In acute pain a dosage adjustment is not necessary. In patients with severe renal and/or hepatic insufficiency ANALAB INJECTION should not be administered.
In less severe cases the dosage interval should be prolonged according to the patient's requirements.
Duration of Treatment: ANALAB INJECTION should not be given for longer than necessary. Patients with a tendency of drug abuse or dependence should only be given ANALAB INJECTION for short periods and under strict medical supervision.