Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Macleods Pharmaceuticals SA (Pty) Ltd, Office block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock, Ext. 12, Alberton, South Africa
Management of moderate to moderately severe pain.
The dosage should be adjusted to the intensity of pain and the sensitivity of the individual patient. In principle, the lowest pain-relieving dose should be selected. In general, a total oral daily dose of 400 mg of Tramadol (equivalent to 8 DOLTREX 50 MG tablets) should not be exceeded.
The recommended dosages are guidelines.
DOLTREX 50 MG tablets should be taken as follows:
Initial dose of 50 mg of Tramadol (1 DOLTREX 50 MG tablets), followed by 50 mg or 100 mg 4-6 hourly.
Initial dose of 100 mg followed by 50 mg or 100 mg 4-6 hourly. Tablets are to be taken whole, not divided or chewed, with sufficient liquid, with or without food.
On account of the high dosage strength, DOLTREX 50 MG tablets are not intended for children below the age of 12 years.
A downward adjustment of the dose and/or prolongation of the interval between doses are recommended in the elderly over 75 years.
In patients with renal insufficiency, the elimination of tramadol hydrochloride is delayed. In these patients prolongation of the dosage intervals should be carefully considered according to the patient’s requirements. In cases of severe renal insufficiency DOLTREX 50 MG tablets are not recommended.
In patients with hepatic insufficiency the elimination of tramadol hydrochloride is delayed. In these patients prolongation of the dosage intervals should be carefully considered according to the patient’s requirements. In cases of severe hepatic insufficiency DOLTREX 50 MG tablets are not recommended.
Under no circumstances should DOLTREX 50 MG tablets be given for longer than absolutely necessary. If the nature and severity of the disease require long-term pain treatment, careful checks should be carried out initially and at regular intervals to assess efficacy and adverse events and to what extent further treatment with DOLTREX 50 MG tablets is necessary.
Oral.
Tablets are to be taken whole, not divided or chewed, with sufficient liquid, with or without food.
Following an overdose with DOLTREX 50 MG tablets, symptoms similar to those of other centrally acting analgesics (opioids) are to be expected. These include in particular constriction of the pupil of the eye, vomiting, cardiovascular collapse, consciousness disorders, coma, convulsions, respiratory depression and respiratory arrest.
The general emergency measures apply. Keep open the respiratory tract, maintain respiration and circulation depending on the symptoms. Suitable measures should be taken to avoid aspiration dangers.
Respiratory depression can be antagonised with a pure opiate antagonist (naloxone).
Convulsions should be treated with intravenous diazepam.
In cases of intoxication with oral formulations, gastrointestinal decontamination with activated charcoal is only recommended within 2 hours after DOLTREX 50 MG tablets intake.
Gastrointestinal decontamination at a later time point may be useful in case of intoxication with exceptionally large quantities.
Tramadol is minimally eliminated from the serum by haemodialysis or haemofiltration. Treatment of acute intoxication with DOLTREX 50 MG tablets with haemodialysis or haemofiltration alone is therefore not suitable for detoxification.
24 months from the manufacturing date.
Store at or below 25°C.
Keep the HDPE containers closed.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN
Container Pack: Tablets are packed in a round white opaque plastic container (HDPE) and are closed with a white child resistant closure, packed in an outer carton. Pack sizes include 100 tablets
Blister Pack: Clear, transparent PVC 250 µm as the forming material and silver coloured, plain 25 µm aluminium foil/ 6-8 gsm HSL in a pre-printed outer carton.
Not all packs and pack sizes are necessarily marketed.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
