Tablets tramadol 150 mg
Excipient with known effect: Each prolonged-release tablet contains 2. Round, biconvex, pale orange coloured film-coated tablets, marked with the manufacturer's logo on one side, marked T2 on the other side. The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected.
The total daily dose of mg active substance should not be exceeded, except in special circumstances. The usual initial dose is mg tablets hydrochloride twice daily, morning and evening. If pain relief is insufficient, the dose may be titrated upwards to mg or mg tramadol hydrochloride twice daily tablets section 5.
A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient's requirements. In these patients prolongation of the dosage interval should be carefully considered according tablets the patients requirements. The tablets are to be taken whole, not divided or chewed, with sufficient liquid, independent of meals.
Tramadol tablets under no circumstances be administered xanax and drug tests longer than absolutely necessary. If long-term pain treatment with tramadol is necessary in view of the tablets and severity of the tablets, then careful and regular monitoring should be carried out if necessary with breaks in treatment to establish whether and to what extent further treatment is necessary.
Tramadol may only be used with particular caution in opioid-dependent patients, patients with head injury, shock, a reduced level of consciousness of uncertain origin, disorders of the respiratory centre or function, increased intracranial pressure. Care should be taken when tramadol withdrawal depression how long patients with respiratory depression, or if concomitant CNS depressant drugs are being administered see section 4.
Tablets have been reported in patients receiving tramadol at the recommended dose levels. The risk may be increased when doses of tramadol exceed the recommended upper daily dose limit mg. In addition, tramadol may increase the seizure risk in tramadol side effects atrial fibrillation taking other medicinal products that lowers the seizure threshold tablets section 4.
Patients tablets epilepsy or those susceptible tramadol 150 seizures should be only treated with tramadol if there are compelling circumstances. Tolerance, psychic and physical dependence may develop, especially after long-term use. In patients with a tendency to drug abuse or dependence, treatment with tramadol should only be carried out for short periods under strict medical supervision.
When what lorazepam does to the brain patient tablets longer requires therapy with tramadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. Tramadol is not suitable as a substitute in opioid-dependent patients.
Although it is an opioid agonist, tramadol cannot tablets morphine withdrawal symptoms. Tramadol is metabolised by the liver enzyme CYP2D6. If tablets patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect may not be obtained. However, if the patient is an ultra-rapid metaboliser there is a risk of developing side effects of opioid toxicity even at commonly prescribed doses. General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite.
In severe cases this may include symptoms of circulatory and respiratory depression, which may be life threatening and very rarely fatal. Estimates of prevalence of ultra-rapid metabolisers in different populations are summarised below:. Extreme caution should be exercised when tramadol is administered to children for post-operative pain relief and should be accompanied by close monitoring tablets symptoms of opioid toxicity including respiratory depression.
Tramadol is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. These factors may worsen symptoms of opioid toxicity.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. In patients treated with MAO inhibitors in the 14 days prior to the use of the opioid pethidine, life-threatening interactions is tramadol and percocet the same thing the central nervous system, respiratory and cardiovascular function have been observed.
Concomitant tablets of tramadol with other centrally depressant medicinal products including alcohol may potentiate the CNS effects see section 4. The results of pharmacokinetic studies have so far shown that on tablets concomitant or previous administration of cimetidine enzyme inhibitor clinically relevant interactions are unlikely to occur.
Simultaneous or previous tramadol 50 and methocarbamol 500mg tablets of carbamazepine enzyme inducer may reduce the analgesic effect and shorten the duration of action. Tramadol can induce convulsions and increase the tramadol 150 for selective serotonin reuptake inhibitors SSRIsserotonin-norepinephrine reuptake inhibitors SNRIstricyclic antidepressants, antipsychotics and other tablets threshold-lowering medicinal product such as bupropion, mirtazapine, tetrahydrocannabinol to tramadol 150 convulsions.
Concomitant therapeutic use of tramadol and serotonergic drugs, such as selective serotonin reuptake inhibitors SSRIsserotonin-norepinephrine reuptake inhibitors SNRIsMAO inhibitors see section 4. Serotonin syndrome is likely when one of the following is observed:. Withdrawal of the serotonergic drugs usually brings about a rapid improvement. Treatment depends on the type and severity of the symptoms. Caution should be 150 tramadol during concomitant treatment with tramadol and coumarin derivatives e.
Other active substances known to inhibit CYP3A4, such as ketoconazole and erythromycin, might inhibit the metabolism of tramadol N-demethylation probably also the metabolism of the active O-demethylated metabolite. The clinical importance of such an interaction has not been studied see section 4. In a limited number of studies the pre- or postoperative application of the antiemetic 5-HT3 antagonist ondansetron increased the requirement of tramadol in patients with postoperative pain.
Animal studies with tramadol revealed at very high doses effects on organ development, ossification and neonatal mortality. Tramadol crosses the placenta. There is inadequate evidence available on the safety of tramadol in human pregnancy. Therefore tablets should not be used in pregnant women. Tramadol - administered before or during birth - does not affect uterine contractility. In neonates it may induce changes in the respiratory rate which are usually not clinically relevant.
Chronic use during pregnancy may lead to neonatal withdrawal symptoms. For this reason tramadol should not be used during lactation or alternatively, breast-feeding should be discontinued during treatment with tramadol. Discontinuation of breast-feeding is generally not necessary following a single dose of tramadol. Post marketing surveillance does not suggest an effect of tramadol on fertility. Animal tablets did not show an effect of tramadol on fertility. Even when taken according "tramadol 150" instructions, tramadol may cause effects such as somnolence and dizziness and therefore may impair the reactions of drivers and machine operators.
This applies particularly in conjunction with other psychotropic substances, particularly alcohol. This medicine can impair cognitive 150 tramadol and can affect "tablets" patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations tablets 5a of the Road Traffic Act When prescribing this medicine, patients should be told:.
These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed. If the recommended doses are considerably exceeded and other centrally depressant substances are administered concomitantly see section 4. Convulsions occurred mainly after administration of high tablets of tramadol or after concomitant treatment with medicinal products which can lower the seizure threshold see sections 4. Psychic adverse reactions may occur following administration of tramadol which vary individually in intensity and nature depending on personality and duration of treatment.
These include changes in mood usually elation, occasionally dysphoriachanges in activity usually suppression, occasionally increase and changes in cognitive and 150 tramadol capacity e. Drug dependence may occur. Symptoms of drug withdrawal syndrome, similar to those tablets during opiate withdrawal, may occur as follows: Other symptoms that have very rarely been seen with tramadol tablets include: In a few isolated cases an increase in liver enzyme values has been reported in a temporal connection with the therapeutic use of tramadol.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: In principle, on intoxication with tramadol symptoms tablets to those of other centrally acting analgesics opioids are to be expected.
These include in particular miosis, vomiting, cardiovascular collapse, consciousness disorders up tablets coma, convulsions and respiratory depression up to respiratory arrest. The tablets emergency measures apply. Keep open the respiratory tract aspiration! The antidote for respiratory tablets is naloxone. In animal experiments naloxone had no effect on convulsions. In such cases diazepam should be given intravenously. In case of intoxication orally, gastrointestinal decontamination with activated charcoal or by gastric lavage is only recommended within 2 hours after tramadol intake.
Gastrointestinal decontamination at a later time point may be useful in case of intoxication with exceptionally large quantities or prolonged-release formulations. Tramadol is minimally eliminated from the serum by "tablets" or haemo-filtration. Therefore treatment of acute intoxication with ZYDOL SR with haemodialysis or haemofiltration alone is not suitable for detoxification.
150 tramadol is a centrally acting opioid analgesic. Other mechanisms which contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release. Tramadol has an antitussive effect. In contrast to morphine, analgesic doses of tramadol over a wide range have no respiratory depressant effect. Also gastrointestinal motility is less affected.
Effects on the cardiovascular system tend to be slight. Effects of enteral and parenteral administration of tramadol have been investigated in clinical trials involving more than paediatric patients ranging in age from neonate to 17 years of age. The indications for pain treatment studied in those trials included pain after surgery mainly abdominalafter surgical tooth extractions, "tablets" to fractures, burns and traumas as well as other painful conditions likely to require analgesic treatment for at least 7 days.
The conducted trials confirmed the efficacy of tramadol. The safety profile of tramadol was similar in adult and paediatric patients older than 1 year see section 4. The difference between absorbed and non-metabolised available tramadol is probably due to the low first-pass effect.