What is tramadol hydrochloride

Added: Isidoro Gray - Date: 29.03.2022 12:58 - Views: 16163 - Clicks: 3713

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with Tramadol hydrochloride in order to minimise the risk of addiction and drug withdrawal syndrome see section 4. 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. Acute pain: An initial dose of mg is usually necessary. This can be followed by doses of 50 mg or mg at 4- 6 hourly intervals, and duration of therapy should be matched to clinical need. Use an initial dose of 50mg and then titrate dose according to pain severity.

The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported, although rarely See section 4. 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. The capsules are to be taken whole, not divided or chewed, with sufficient liquid, independent of meals. Tramadol Capsules should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with Tramadol Capsules is necessary in view of the nature and severity of the illness, 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 should not be administered to patients who have ly demonstrated hypersensitivity to it, or to any of the ingredients, or in cases of acute intoxication with alcohol, hypnotics, analgesics, opioids or other psychotroic medicinal drugs. In common with other opioid analgesics it should not be administered to patients who are receiving monoamine oxidase MAO inhibitors or within two weeks of their withdrawal see section 4.

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.

Concomitant use of Tramadol and sedating medicinal products such as benzodiazepines or related substances, may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedating medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Tramadol concomitantly with sedating medicinal products, the lowest effective dose of Tramadol should be used, and the duration of the concomitant 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. 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. Care should be taken when treating patients with respiratory depression, or if concomitant CNS depressant drugs are being administered see section 4. Opioids can cause sleep-related breathing disorders including central sleep apnea 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. For all patients, prolonged use of this product may lead to drug dependence addictioneven at therapeutic doses. The risks are increased in individuals with current or past history of substance misuse disorder including alcohol misuse or mental health disorder e.

Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions. Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers. These could be s that the patient is developing tolerance.

It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with Tramadol Hydrochloride. Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction.

What is tramadol hydrochloride

When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months. The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain. This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality.

Symptoms of hyperalgesia may resolve with a reduction of opioid dose. 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.

What is tramadol hydrochloride

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 for symptoms of opioid toxicity including respiratory depression.

What is tramadol hydrochloride

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.

When a patient no longer requires therapy with tramadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. Tramadol capsule contains lactose and therefore should not be used by patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. 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 cardiovascular function have been observed.

The same interactions with MAO inhibitors cannot be ruled out during treatment with Tramadol. Concomitant administration of Tramadol with other centrally depressant medicinal products including alcohol may potentiate the CNS effects see section 4.

The concomitant use of opioids with sedating medicinal products such as benzodiazepines or related substances increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose of Tramadol and the duration of the concomitant use should be limited 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 reuptake inhibitors SSRIsserotonin-norepinephrine reuptake inhibitors SNRIstricyclic antidepressants, antipsychotics and other seizure threshold-lowering medicinal product such as bupropion, mirtazapine, tehrahydrocannabinol to cause 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 exercised 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 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 tramadol should not be used in pregnant women. Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate.

What is tramadol hydrochloride

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Tramadol Hydrochloride 50 mg Capsules