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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: Management (treatment and prevention) of moderate to severe pain.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Treatment should be short and intermittent as dependence can occur with tramadol. The benefits of continued use should be reviewed in order to ensure that they outweigh the risks of dependence (see Special warnings & Special precautions for use and Undesirable effects section).
As with all analgesic drugs, the dose of Tramadol 50mg Capsules should be adjusted according to the severity of the pain and the clinical response of the individual patient. The lowest effective dose for analgesia should generally be selected.
Geriatric patients:
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.
Renal insufficiency/dialysis and hepatic impairment:
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.
Adults and children aged 12 years and over:
Oral administration.
Acute Pain:
An initial dose of 100mg is usually necessary. This can then be followed by doses of 50mg or 100mg not more frequently than 4 hourly, and duration of therapy should be matched to clinical need.
Pain associated with chronic conditions:
Use an initial dose of 50mg and then titrate dose accordingly to pain severity. 4). The lowest analgesically effective dose should generally be selected. Daily doses of 400mg active substance should not be exceeded, except in special clinical circumstances.
The capsules should be swallowed whole, not divided or chewed, with sufficient liquid and independently 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 breaks in treatment) to establish whether and to what extent further treatment is necessary.
The most commonly reported adverse reactions are nausea and dizziness, both occurring in more than 10 % of patients.
The frequencies are defined as follows:
Very common: ≥1/10 Common: ≥1/100, <1/10 Uncommon: ≥1/1000, <1/100 Rare: ≥1/10 000, <1/1000 Very rare: <1/10 000 Not known: cannot be estimated from the available data.
Cardiac disorders:
Uncommon: cardiovascular regulation (palpitation, tachycardia). These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed.
Rare: bradycardia Vascular disorders:
Uncommon: cardiovascular regulation (postural hypotension or cardiovascular collapse). These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed.
Investigations:
Rare: increase in blood pressure Nervous system disorders: Very common: dizziness Common: headache, somnolence Rare: paraesthesia, tremor, epileptiform convulsions, involuntary muscle contractions, abnormal coordination, syncope, speech disorders.
5). 5), respiratory depression may occur. Worsening of asthma has been reported, though a causal relationship has not been established.
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). g. g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis. Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal, may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms.
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. 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 signs and symptoms of respiratory depression and sedation. 5). 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 (400 mg).
5). Patients with epilepsy or those susceptible to seizures should be only treated with tramadol if there are compelling circumstances. 9) as the possibility of respiratory depression cannot be excluded in these situations. Sleep-related breathing disorders 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. 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.
1. 5), • in 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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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Elderly No adjustment of dosage is necessary in elderly patients up to 75 years, as there is no significant difference in tramadol pharmacokinetics with increasing age. However, it should be noted that in volunteers aged over 75 years, the elimination half-life of tramadol was increased by 17% following oral administration.
Therefore, if necessary, the dosage interval is to be extended according to the patients requirements.
Renal Impairment / renal dialysis:
The elimination of tramadol may be prolonged, hence in these patients prolongation of dosage intervals should be carefully considered according to the patients requirements. It is recommended that the usual initial dosage be used and when repeated dosing is required the interval between doses is extended.
For patients with creatinine clearance < 30ml/min, the dosage interval should be increased to 12 hours. Tramadol is not recommended for patients with severe renal impairment (creatinine clearance < 10ml/min). As tramadol is only removed very slowly by haemodialysis or haemofiltration, post dialysis administration to maintain analgesia is not usually necessary.
Hepatic impairment:
The elimination of tramadol may be prolonged. The usual initial dosage should be used but in severe hepatic impairment the dosage interval should be increased to 12 hours.
Children aged 12 years and under:
On account of their high dosage strength, Tramadol 50mg Capsules are not recommended for use in children under 12 years of age.
e. confusion, delusions, depersonalisation, derealisation, paranoia).
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.
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Symptoms of serotonin syndrome may include mental status changes, autonomic instability, neuromuscular abnormalities and/or gastrointestinal symptoms.
Serotonin syndrome is likely when one of the following is observed:
Spontaneous clonus Inducible or ocular clonus with agitation or diaphoresis Tremor and hyperreflexia Hypertonia and body temperature > 38 °C and inducible or ocular clonus If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
Withdrawal of the serotonergic drugs usually brings about a rapid improvement. 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). Before initiating treatment with Tramadol and during the treatment, treatment goals and a discontinuation plan should be agreed with the patient. 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 psychoactive drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
Drug withdrawal syndrome 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. Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction.
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. Tramadol is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms.
Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain. This might be qualitatively and […]