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What is tramadol and what is it used for?

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Medically reviewed by Drugs. Last updated on June 15, Adults 17 years or older : 50 to mg orally every 4 to 6 hours as needed for pain -For patients Tramadol tablets dosage requiring rapid onset of analgesic effect: Initial dose: 25 mg orally once a day; titrate in 25 mg increments every 3 days to reach a dose of 25 mg four times a day; thereafter increase by 50 mg as tolerated every 3 days Maximum dose: mg per day Comments: -Doses should be individualized; for patients not requiring rapid analgesia, tolerability may be increased by a slow dose titration. Use: For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Use: For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Dose selection should be cautious generally starting at the low end of the dose range Over 75 years: Maximum dose of Immediate-release: mg per day Comments : -Respiratory depression is the chief risk for elderly patients treated with opioids; titrate dose slowly and Tramadol tablets dosage closely for s of central nervous system and respiratory depression.

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The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient.

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The lowest effective dose for analgesia should generally be selected. Acute pain: An initial dose is mg depending on the intensity of pain. This can be followed by doses of 50 or mg hours later, and duration of therapy should be matched to clinical need see section 5. A total daily dose of mg should not be exceeded except in special clinical circumstances. Pain associated with chronic conditions: Use an initial dose of 50 mg and then titrate dose according to pain severity. The initial dose may be followed if necessary by Tramadol tablets dosage every hours.

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The recommended doses are intended as a guideline. Patients should always receive the lowest dose that provides effective pain control. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported see section 4.

The capsules are to be taken whole, not divided or chewed, with sufficient liquid, independent of meals. Tramadol should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with tramadol is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out if necessary with Tramadol tablets dosage in treatment to Tramadol tablets dosage whether and to what extent further treatment is necessary. 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 intervals should be carefully considered according to the patient's requirements. 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 treating patients with respiratory depression, or if concomitant CNS depressant drugs are being administered see section 4.

Convulsions 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 patients taking other medicinal products that lowers the seizure threshold see section 4. Patients with epilepsy or those susceptible to 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 Tramadol tablets dosage only be carried out for short periods under strict medical supervision. When a patient no 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 suppress morphine withdrawal symptoms. Tramadol should be used with caution in patients with impaired hepatic and renal function see section 4. Tramadol is metabolised by the liver enzyme CYP2D6. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect may not be obtained. 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 Tramadol tablets dosage, 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 for symptoms of opioid toxicity including respiratory depression.

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Tramadol is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper Tramadol tablets dosage or lung infections, multiple trauma or extensive surgical procedures. Concomitant use of Tramadol and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.

Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible.

If a decision is made to prescribe Tramadol concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible. The patients should be followed closely for s and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms see section 4.

Opioids can cause sleep-related breathing disorders including central sleep apnoea CSA and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Opioid analgesics may occasionally cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy. Symptoms of acute or chronic adrenal insufficiency may include e.

Tramadol Aurobindo capsules contains Sodium. This medicine contains less than 1 mmol sodium 23 mg per capsule, that is to say essentially 'sodium-free'. In patients treated with MAO inhibitors in the 14 days prior to the use of the opioid pethidine, life threatening interactions on the central nervous system, respiratory and Tramadol tablets dosage function have been observed.

The same interactions with MAO inhibitors cannot be ruled out during treatment with tramadol.

Dosing & uses

Concomitant administration of tramadol with other centrally depressant medicinal products including alcohol may potentiate the CNS effects see section 4. The of pharmacokinetic studies have so far shown that on the concomitant or administration of cimetidine enzyme inhibitor clinically relevant interactions are unlikely to occur. Simultaneous or administration of carbamazepine enzyme inducer may reduce the analgesic effect and shorten the duration of action.

Tramadol can induce convulsions and increase the potential for selective serotonin re-uptake inhibitors SSRIsserotonin-norepinephrine reuptake inhibitors SNRIstricyclic anti-depressants, anti-psychotics and other seizure threshold lowering medicinal products such as bupropion, mirtazapine, tetrahydrocannabinol to cause convulsions.

Serotonin syndrome is likely when one of the following is observed:Spontaneous clonus.

Withdrawal of the serotonergic drugs usually brings about a rapid improvement. Treatment depends on the type and severity of the symptoms. Caution should be exercised during concomitant treatment with tramadol and coumarin derivatives e.

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Other medicinal products known to inhibit CYP3A4, such as ketoconazole, ritonavir and erythromycin, might inhibit the metabolism of tramadol N-demethylation and 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 of studies the pre- or postoperative application of the antiemetic 5-HT3 antagonist ondansetron increased the requirement of tramadol in patients with postoperative pain. The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect.

The dose and duration of concomitant use should be limited see section 4. Animal studies with tramadol revealed at very high doses effects on organ development, ossification and neonatal mortality. Teratogenic effects Tramadol tablets dosage not observed. Tramadol crosses the placenta. There is inadequate evidence available Tramadol tablets dosage the safety of tramadol in human pregnancy.

Therefore tramadol should not be used in pregnant women. Tramadol - administered before or during birth - does not affect uterine contractility. In new-born infants it may induce changes in the respiratory rate which are usually not clinically relevant. Chronic use during pregnancy may lead to neonatal withdrawal symptoms. Approximately 0. 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.

Even when taken according to 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 alcohol and other psychotropic substances. Rare : Hallucinations, confusion, sleep disturbance, anxiety and nightmares. Psychic side-effects may occur following administration of tramadol, which vary individually in intensity and nature depending on personality and duration of medication. These include changes in mood usually elation, occasionally dysphoriachanges in activity mostly reduced, occasionally increased and changes Tramadol tablets dosage cognitive and sensorial ability e.

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Dependence may occur. Rare: Changes in appetite, paraesthesia, tremor, respiratory depression, epileptiform convulsions, abnormal coordination, involuntary muscle contractions, syncope.

If the recommended doses are considerably exceeded and other centrally depressant substances are administered concomitantly see section 4. Epileptiform convulsions occurred mainly after administration of high doses of tramadol or after concomitant treatment with medicinal products which can lower the seizure threshold see sections 4. Uncommon: Cardiovascular regulation palpitations, tachycardia, postural hypotension or cardiovascular collapse.

These adverse effects may occur especially in connection with intravenous administration and if the patient is experiencing physical stress. Frequency not known : Worsening of asthma has been reported, though Tramadol tablets dosage causal relationship has not been established, Hiccups.

Usual adult dose for pain

Uncommon: Retching; Tramadol tablets dosage irritation a feeling of pressure in the stomach, bloatingdiarrhoea. Frequency not known: In a few isolated cases an increase in liver enzyme values has been reported in a temporal connection with the therapeutic use of tramadol. Rare: Allergic reactions e. Other symptoms that have very rarely been seen with tramadol discontinuation include: panic attacks, severe anxiety, hallucinations, paraesthesias, tinnitus and unusual CNS symptoms i. 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, Website: www. In principle, on intoxication with tramadol symptoms similar to those of other centrally acting Tramadol tablets dosage opioids are to be expected. These include in particular miosis, vomiting, cardiovascular collapse, consciousness disorders up to coma, convulsions and respiratory depression up to respiratory arrest. The general emergency measures apply. Keep open the respiratory tract aspirationmaintain respiration and circulation depending on the symptoms.

The stomach is to be emptied by vomiting conscious patient or gastric irrigation. The antidote for respiratory depression is naloxone.