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TRAMADOL HYDROCHLORIDE is a brand name for Tramadol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Therapeutic indications Treatment of moderate to severe pain.
Verbatim from this product's MHRA label. Tap a section to expand.
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 400 mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances.
Unless otherwise prescribed, Tramadol hydrochloride 50 mg/ml solution for injection or infusion should be administered as follows: Adults and adolescents above the age of 12 years: The usual dose is 50 or 100mg 4-6 hourly by the intravenous or intramuscular route.
Dosage should be adjusted according to pain severity and response. Intravenous injections must be given slowly over 2-3 minutes. For post-operative pain administer an initial bolus of 100mg. During the 60 minutes following the initial bolus, further doses of 50mg may be given every 10- 20 minutes, up to a total dose of 250mg including the initial bolus.
Subsequent doses should be 50mg or 100mg 4-6 hourly up to a total daily dose of 400mg. Children Tramadol hydrochloride 50 mg/ml solution for injection or infusion is not suitable for children below the age of 12 years. Geriatric patients A dose adjustment is not usually necessary in elderly 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 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. 6) for administration by infusion or patient controlled analgesia. Treatment goals and discontinuation Before initiating treatment with Tramadol hydrochloride 50 mg/ml solution for injection or infusion, 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.
Rapid intravenous administration may be associated with a higher incidence of adverse effects and therefore should be avoided. 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 Investigations: Rare: increase in blood pressure 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. 5), respiratory depression may occur. Worsening of asthma has been reported, though a causal relationship has not been established.
Nervous system disorders: very common : dizziness common : headache, somnolence rare : changes in appetite, paraesthesia, tremor, respiratory depression, epileptiform convulsions, involuntary muscle contractions, abnormal coordination, syncope.
not known: serotonin syndrome. 5). Psychiatric disorders: rare : hallucinations, confusion, sleep disturbance, delirium, anxiety and nightmares. Psychological adverse reactions may occur following administration of Tramadol hydrochloride 50 mg/ml solution for injection or infusion which vary individually in intensity and nature (depending on personality and duration of treatment).
g. decision behaviour, perception disorders). Dependence may occur. Symptoms of drug withdrawal reactions, similar to those occurring during opiate withdrawal, may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms.
Tramadol hydrochloride 50 mg/ml solution for injection or infusion 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 doses of tramadol exceed the recommended upper daily dose limit (400 mg). 5). Patients with epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling circumstances.
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Tramadol hydrochloride 50 mg/ml solution for injection or infusion 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 hydrochloride 50 mg/ml solution for injection or infusion 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 signs and symptoms of respiratory depression and sedation. 5). 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. Adrenal insufficiency Opioid analgesics may occasionally cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy.
1. - in patients suffering from acute intoxication with alcohol, hypnotics, analgesics, opioids, or psychotropic medicinal products. 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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4). Duration of administration Tramadol hydrochloride 50 mg/ml solution for injection or infusion should under no circumstances be administered for longer than absolutely necessary. If long- term pain treatment with Tramadol hydrochloride 50 mg/ml solution for injection or infusion is necessary in view of the nature and severity of the illness, then careful 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). g. pruritus, rash, urticaria) Musculoskeletal and connective tissue disorders: rare : motorial weakness Hepatobiliary disorders: In a few isolated cases an increase in liver enzyme values has been reported in a temporal connection with the therapeutic use of tramadol.
g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis General disorders and administration site conditions: common : fatigue Uncommon: drug withdrawal syndrome Drug dependence Repeated use of Tramadol hydrochloride 50 mg/ml solution for injection or infusion 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.
g. severe abdominal pain, nausea and vomiting, low blood pressure, extreme fatigue, decreased appetite, and weight loss. 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 hydrochloride 50 mg/ml solution for injection or infusion.
Repeated use of Tramadol hydrochloride 50 mg/ml solution for injection or infusion 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 hydrochloride 50 mg/ml solution for injection or infusion 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.
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 hydrochloride 50 mg/ml solution for injection or infusion.
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.
Tramadol hydrochloride 50 mg/ml solution for injection or infusion is not a suitable substitute in opioid dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms. If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.
Hyperalgesia 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.
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