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LARAPAM 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. Daily doses of 400 mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances.
Unless otherwise prescribed, Larapam SR Tablets should be given as follows:
Adults and adolescents above the age of 12 years The usual initial dose is one Larapam 100mg SR Tablet, twice daily, in the morning and evening. The dosage interval must not be less than 8 hours. If the pain relief is insufficient, the dose may be increased to: one Larapam 150mg SR Tablet, twice daily or one Larapam 200mg SR Tablet, twice daily.
Larapam SR Tablets should under no circumstances be administered for longer than absolutely necessary. Paediatric population Larapam SR is not suitable for children under the age of 12 years. Elderly A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency.
In elderly people 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. In cases of severe renal and/or severe hepatic insufficiency Larapam SR Tablets are not recommended. The recommended doses are intended as a guideline.
Method of administration Larapam SR Tablets should be swallowed as a whole, without breaking or chewing, with a sufficient amount of liquid. The tablets can be taken with or without food. Treatment goals and discontinuation Before initiating treatment with Larapram SR, 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.
4).
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 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) .
g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis Metabolism and nutrition disorders Rare: changes in appetite Not known: hypoglycaemia Psychiatric disorders Rare: hallucination, confusion, delirium, sleep disturbances, 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). Dependence may occur.
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).
5). Not known: serotonin syndrome. Eye disorders Rare: blurred vision, mydriasis, miosis Cardiac disorders Uncommon: cardiovascular regulation (palpitation, tachycardia) These adverse reactions may occur especially on intravenous administration of Larapam SR Tablets 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 of Larapam SR Tablets and in patients who are physically stressed.
Respiratory, thoracic and mediastinal disorders Rare: respiratory depression, dyspnoea. 5) respiratory depression may occur. Not known: hiccups Worsening of asthma has also been reported, though a causal relationship has not been established.
Larapam SR Tablets 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 Larapam SR Tablets should only be used with caution.
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 medicinal product usually brings about a rapid improvement.
9) as the possibility of respiratory depression cannot be excluded in these situations. Risk from concomitant use of sedative medicinal products such as benzodiazepines or related medicinal products Concomitant use of tramadol and sedative medicinal products such as benzodiazepines or related medicinal products may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative 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 sedative medicinal products, 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.
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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Gastrointestinal disorders Very common: nausea Common: vomiting, constipation, dry mouth Uncommon: retching, gastrointestinal discomfort (a feeling of pressure in the stomach, bloating), diarrhoea Hepatobiliary disorders Very rare: 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 Uncommon: pruritus, rash, urticaria Musculoskeletal and connective tissue disorders Rare: motorial weakness Renal and urinary disorders Rare: micturition disorders (dysuria and urinary retention) General disorders and administration site conditions Common: fatigue Investigations Rare: increase in blood pressure Drug dependence Repeated use of Larapram SR 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).
Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, decreasing the total opioid dose should be considered. 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 adverse reactions 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% 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.
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. The risk may be increased when doses of tramadol hydrochloride exceed the recommended upper daily dose limit (400 mg). 5). Patients with a history of epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling circumstances.
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 Larapram SR. Repeated use of Larapram SR 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 Larapram SR may result in overdose and/or death. The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current […]