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TRAMADOL HYDROCHLORIDE KRKA 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. Tramadol hydrochloride Krka is indicated in adults and adolescents aged 12 years and older.
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 active substance should not be exceeded, except in special circumstances.
Unless otherwise prescribed, Tramadol hydrochloride Krka should be administered as follows: Adults and adolescents above the age of 12 years: The usual initial dose is 50-100 mg tramadol hydrochloride twice daily, morning and evening.
If an initial dose lower than 100 mg is required, alternative tramadol hydrochloride containing product should be used. 1). Children Tramadol hydrochloride Krka is not suitable for children below the age of 12 years. 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 insufficiency In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed.
In these patients prolongation of the dosage interval should be carefully considered according to the patients requirements. In cases of severe renal and/or severe hepatic insufficiency Tramadol hydrochloride Krka prolonged-release tablets are not recommended.
Method of administration Oral use. The tablets are to be taken whole, not divided or chewed, with sufficient liquid, independent of meals. 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.
Treatment goals and discontinuation Before initiating treatment with Tramadol hydrochloride Krka, 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.
In evaluating undesirable effects, the frequencies are defined as follows: - 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, both occurring in more than 10 % of patients.
g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis. Metabolism and nutrition disorders Changes in appetite. Hypoglycaemia Psychiatric disorders 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). 1 Symptoms of drug withdrawal syndrome, similar to those occurring during opiate withdrawal, may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms.
e. confusion, delusions, depersonalisation, derealisation, paranoia). Nervous system Dizziness. Headache, Speech disorders, Serotonin disorders somnolence. paraesthesia, tremor, epileptiform convulsions, involuntary muscle contractions, abnormal coordination, syncope.
5). syndrome Eye disorders Miosis, mydriasis, blurred vision. Cardiac disorders Cardiovascular regulation (palpitation, tachycardia). These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed.
Bradycardia. Vascular disorders Cardiovascular regulation (postural hypotension or cardiovascular collapse). These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed. Respiratory, thoracic and mediastinal disorders Respiratory depression, dyspnoea.
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 tramadol should only be used with caution. 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. 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.
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 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. Opioid-induced ventilatory impairment and persistent post-operative opioid use Do not use for acute post-operative pain owing to the increased risk of persistent post- operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI) Adrenal insufficiency Opioid analgesics may occasionally cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy.
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.
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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.
4).
5), respiratory depression may occur. Worsening of asthma has been reported, though a causal relationship has not been established. Hiccups. Gastrointestinal disorders Nausea. Constipation, dry mouth, vomiting. Retching; gastrointestinal discomfort (a feeling of pressure in the stomach, bloating), diarrhoea.
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. Skin and subcutaneous tissue disorders Hyperhidrosis. g. pruritus, rash, urticaria).
Musculoskeletal and connective tissue disorders Motorial weakness. Renal and urinary disorders Micturition disorders (dysuria and urinary retention). General disorders and administration site conditions Fatigue. Investigations Increase in blood pressure.
1Repeated use of Tramadol hydrochloride Krka 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 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.
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.
Tramadol is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms. 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 signs and symptoms of respiratory depression and sedation. 5). When a patient no longer requires therapy with tramadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
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. Estimates of […]