Mabron

Mabron

tramadol

Manufacturer:

Medochemie

Distributor:

Medochemie
Full Prescribing Info
Contents
Tramadol HCl.
Description
Tramadol HCl is (+)-trans-2-(dimethylaminomethyl)-1-(m-methoxyphenyl)-cyclohexanol-hydrochloride.
Action
Opioid analgesic.
Indications/Uses
Severe acute and chronic pain.
Injection: Diagnostic measures and surgical pain.
Potent drug for the relief of pain eg, wound pain, fractures, severe nerve pain, tumour pain, heart attack. It should not be used for minor pain. The effect sets in quickly and lasts for some hours.
Dosage/Direction for Use
The dosage should be adjusted to the intensity of the pain. Unless otherwise prescribed, Mabron should be taken as follows: Adults and Adolescents >14 years: Single Dose: Capsule: Independent of Meals: 1 capsule to be taken with a little liquid.
This is usually sufficient to relieve the pain. If however, pain relief is unsatisfactory, a further Mabron capsule may be taken after about 30-60 min.
In general, the daily dose should not exceed 400 mg.
Injection: 1 ampoule injected via slow IV or diluted in solution for infusion; or 1 ampoule via IM or SC. Maximum Daily Dose: 4 ampoule (400 mg).
Renal or Hepatic Impairment: In impaired renal or hepatic function, it may be necessary to adjust the dose.
Duration of Treatment: During long-term treatment with Mabron, 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 Therefore, the physician is to decide on the duration of treatment and whether the preparation is to be withdrawn temporarily.
Mabron should not be given for longer than therapeutically necessary.
Contraindications
Acute intoxication with alcohol, hypnotics, analgesics or other central nervous system-acting drugs.
Injection: Respiratory depression; excessive bronchial secretion; presence of acute alcoholism; head injuries and conditions in which intracranial pressure is raised; during bronchial asthma attack or heart failure secondary to chronic lung disease.
Special Precautions
Mabron should be used with care in patients with increased reactivity to opioids.
Injection: It should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, kidney or liver impairment, prostatic hypertrophy or shock; obstructive bowel disorders and myasthenia gravis.
Respiratory depression has so far not been observed during treatment with Mabron. However, it cannot definitely be ruled out if the recommended dosage is considerably exceeded or on the concomitant administration of other centrally depressant drugs.
Effects on the Ability to Drive or Operate Machinery: Even when taken according to instructions, Mabron may affect the reaction ability of the patient to such an extent that his capacity to drive or operate machines may be impaired. This applies particularly in conjunction with alcohol.
Use in pregnancy & lactation: In accordance with currently prevailing recommendations, medication with Mabron should only be resorted to during pregnancy after careful consideration of the risks. So far, no reports are available on its use during lactation.
Use In Pregnancy & Lactation
Use in pregnancy & lactation: In accordance with currently prevailing recommendations, medication with Mabron should only be resorted to during pregnancy after careful consideration of the risks. So far, no reports are available on its use during lactation.
Adverse Reactions
Sweating, dizziness, nausea, vomiting, dry mouth and fatigue may occur after Mabron administration. It is also possible that the preparation may affect the cardiovascular system in rare cases. Adverse reactions occur particularly when the patient is under physical strain.
Injection: Constipation, drowsiness, contusion, facial flushing, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood, miosis, raised intracranial pressure.
Drug Interactions
On the concomitant administration of Mabron with substances which also act on the central nervous system (eg, tranquilizers, hypnotics) the sedative effects (fatigue) may be intensified. At the same time, however, combining Mabron with a tranquilizer, for example, will probably have a favourable effect on pain sensation. Mabron should not be used in patients receiving MAOIs.
Storage
Store below 25°C.
Injection (Ampoule): Do not refrigerate. Keep in the original packaging.
MIMS Class
ATC Classification
N02AX02 - tramadol ; Belongs to the class of other opioids. Used to relieve pain.
Presentation/Packing
Cap 50 mg x 2 x 10's, 50 x 10's. Inj (amp) 100 mg/2 mL x 5's.
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