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TRAMADOL is a brand name for Tramadol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of moderate to severe pain.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology 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 400 mg tramadol should not be exceeded, except in special clinical circumstances (for example, in case of cancer pain or postoperative severe pain).
Unless otherwise prescribed, Tramadol should be administered as follows:
Adults and adolescents above the age of 12 years Depending on the intensity of pain, 50–100 mg of tramadol (corresponds to 1-2 ml of Tramadol) is administered every 4–6 hours. The total daily dose of 400 mg should not be exceeded. Elderly patients A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency.
In patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to individual requirements. Renal insufficiency/dialysis and hepatic insufficiency In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed.
In these patients prolongation of the dosage intervals should be carefully considered according to the patient's requirements. Paediatric population Tramadol should not be used in children under 1 year of age. For children up to the age of 12, the single dose of tramadol is 1-2 mg per kg body weight.
The lowest effective dose for analgesia should generally be selected. The total daily dose must not exceed the lowest of these doses – 8 mg/kg body weight or 400 mg of the active substance. Method of administration Intravenous (solution is to be injected slowly (1 ml (50 mg of tramadol hydrochloride) per minute)), intramuscular or subcutaneous injection.
9% sodium chloride or 5% glucose solution) and infused. 6. Treatment goals and discontinuation Before initiating treatment with Tramadol, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.
During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with tramadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
The side effects mentioned below are listed according to MedDRA system organ classification. The frequencies are ranked according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
The most commonly reported adverse reactions are nausea and dizziness. These occur in more than 10% of patients. g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis. Cardiac disorders Uncommon: effect on cardiovascular regulation (palpitations, tachycardia).
These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed. Rare: bradycardia. Investigations Rare: increase in blood pressure. Vascular disorders Uncommon: effect on cardiovascular regulation (postural hypotension or cardiovascular collapse).
These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed. Nervous system disorders Very common: dizziness. Common: headache, somnolence. Rare: paraesthesia, tremor, epileptiform convulsions, involuntary muscle contractions, abnormal coordination, syncope, speech disorders.
5). Not known: serotonin syndrome. Metabolism and nutrition disorders Rare: changes in appetite. Not known: hypoglycaemia. Psychiatric disorders Rare: hallucinations, confusion, sleep disturbance, delirium, anxiety and nightmares. Psychic adverse reactions may occur following administration of tramadol which vary individually in intensity and nature (depending on personality and duration of treatment).
g. decision behaviour, perception disorders). Drug dependence may occur. Symptoms of drug withdrawal syndrome, similar to those occurring during opiate withdrawal, may occur. These include: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms.
CYP2D6 metabolism 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. Estimates indicate that up to 7% of the Caucasian population may have this deficiency.
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. 9% Northern European 1% to 2% Post-operative use in children There have been reports in the published literature that tramadol given post-operatively in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, led to rare, but life threatening adverse events.
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. Children with compromised respiratory function 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. 9). If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose escalations.
Symptoms of serotonin syndrome may include mental status changes, autonomic instability, neuromuscular abnormalities and/or gastrointestinal symptoms. If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
5) - Patients with epilepsy not adequately controlled by treatment - For use in narcotic withdrawal treatment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tramadol in United Kingdom.
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4). Duration of administration 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 breaks in treatment) to establish whether and to what extent further treatment is necessary.
e. confusion, delusions, depersonalisation, derealisation, paranoia). Eye disorders Rare: miosis, mydriasis, blurred vision. Respiratory, thoracic and mediastinal disorders Rare: respiratory depression, dyspnoea. 5), respiratory depression may occur.
Worsening of asthma has been reported, though a causal relationship has not been established. Not known: hiccups. Gastrointestinal disorders Very common: nausea. Common: constipation, dry mouth, vomiting. Uncommon: retching, gastrointestinal discomfort (a feeling of pressure in the stomach, bloating), diarrhoea.
Hepatobiliary disorders Very rare: in a few isolated cases an increase in liver enzyme values has been reported in a temporal connection with the therapeutic use of tramadol. Skin and subcutaneous tissue disorders Common: hyperhidrosis.
g. pruritus, rash, urticaria). Musculoskeletal and connective tissue disorders Rare: muscular weakness. Renal and urinary disorders Rare: micturition disorders (dysuria and urinary retention). General disorders and administration site conditions Common: fatigue.
Drug dependence Repeated use of Tramadol can lead to drug dependence, even at therapeutic doses. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Withdrawal of the serotonergic drugs usually brings about a rapid improvement. Sleep-related breathing disorders 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. Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Tramadol.
Repeated use of Tramadol can lead to opioid use disorder (OUD). A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Tramadol may result in overdose and/or death.
g. major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician.
g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
Adrenal insufficiency Opioid analgesics may occasionally cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy. g. severe abdominal pain, nausea and vomiting, low blood pressure, extreme fatigue, decreased appetite, and weight loss.
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.
In patients sensitive to opiates the product should only be used with caution. 9) as the possibility of respiratory depression cannot be excluded in these situations. Convulsions have been reported in patients receiving tramadol at the recommended dose levels.
The risk may be increased when a dose of tramadol exceeds the recommended daily dose (400 mg). 5). In patients with epilepsy or those susceptible to seizures, tramadol may only be used when absolutely necessary. When a patient no longer requires therapy with tramadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
This medicinal product is not suitable as a substitute in opioid-dependent patients. Although […]