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Drug Details

Larapam 200mg SR Tablets

• Presentation
  Prolonged-release tablet. Larapam 200mg SR Tablets are capsule shaped, off white tablets
• Description
  Each prolonged-release tablet contains 200 mg tramadol hydrochloride.
• Indications
  Treatment of moderate to severe pain.
• Adult Dosage
  

  The dose should be adjusted to the severity of the pain and the individual clinical response of the patient.

  Unless otherwise prescribed, Larapam SR Tablets should be given as follows:

  Adults and adolescents older than 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 be swallowed whole without breaking or chewing, with a sufficient amount of liquid. The tablets can be taken with or without food.

  The recommended doses are intended as a guideline.

  The dose used should be the lowest dose that provides pain relief. A daily dose of 400 mg active substance is usually sufficient, except in special clinical circumstances.

  Under no circumstances should Larapam SR Tablets be used 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.

  Children

  Larapam SR Tablets are not suitable for children under the age of 12 years.

  Elderly

  As a rule adjustment of the dose, in elderly patients (up to 75 years) without any clinical manifestations of hepatic or renal impairment , is not necessary.

  In older patients (above 75 years) the elimination may be delayed. In which case the dose interval should be prolonged.

  Renal impairment, dialysis and hepatic impairment

  In patients with serious renal or hepatic impairment the use of Larapam SR Tablets are not recommended. In moderate cases, an adjustment of the dosage interval may be considered.

• Contra Indications
  

   Larapam SR Tablets must not be used in:

  - hypersensitivity to tramadol, or any excipients in the tablet.

  - in acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic medicinal products.

  - in patients receiving MAO-inhibitors, or within 2 weeks of their withdrawal.

  - in patients who are suffering from uncontrolled epilepsy

  Larapam SR Tablets must not be used for narcotic withdrawal treatment.

• Special Precautions
  

  Larapam SR Tablets must be used with caution in patients dependent on opioids, patients suffering head injuries, shock, decreased level of consciousness of unknown origin, disturbances of the respiratory centre or function, or increased intracranial pressure.

  In patients sensitive for opiods the medicinal product should be used cautiously.

  Convulsions have been reported at therapeutic doses and the risk may be increased at doses exceeding the usual upper daily dose limit (400 mg).

  The risk on convulsions may increase in patients taking tramadol and concomitant medicinal products that can lower the seizure threshold. Patients with a history of epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling reasons.

  Tramadol has a low dependence potential. On long-term use tolerance, psychic and physical dependence may develop. At therapeutic doses withdrawal symptoms have been reported at a frequency of 1 in 8,000. Reports of dependence and abuse have been less frequent. Because of this potential the clinical need for continued analgesic treatment should be reviewed regularly. In patients with a tendency to drug abuse or dependence, treatment should be for short periods under strict medical supervision

  Tramadol is not a suitable substitute in opioid dependent patients. The medicinal product does not suppress morphine withdrawal symptoms although it is an opioid agonist.

• Interactions
  

  Larapam SR Tablets must not be combined with mono amino oxidase (MAO) inhibitors. In concomitant use of Larapam SR Tablets and other centrally acting active substances, including alcohol, a potentiation of central nervous system (CNS) effects has to be taken into consideration. The results of pharmacokinetic research, so far, showed that no interactions need to be expected in concomitant or prior use of cimetidine (enzyme inhibitor). The concomitant or prior use of carbamazepine (enzyme inductor) may reduce the analgesic effectiveness and shorten the duration of the action. The combination of mixed agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) and tramadol is not recommended because it is theoretically possible that the analgesic effect of a pure agonist is attenuated under these circumstances.

  Tramadol may induce convulsions and may increase the potential for selective serotonin re-uptake inhibitors, tricyclic antidepressants, anti-psychotics and other seizure threshold lowering active substances to cause convulsions. Isolated cases of serotonergic syndrome have been reported with the therapeutic use of tramadol in combination with other serotonergic agents such as selective serotonin re-uptake inhibitors (SSRIs). Serotonergic syndrome can be manifested by symptoms such as confusion, restlessness, fever, sweating, ataxia, hyperreflexia, myoclonia and diarrhoea. Withdrawal of the serotonergic agent produces a rapid improvement.

  It depends on the nature and severity of symptoms whether medicinal treatment is to be considered. Caution must be exercised during concomitant treatment with tramadol and coumarin derivatives (e.g. warfarin) due to reports of increased international normalisation ratio (INR) and ecchymoses in some patients. Other medicinal products with a known inhibiting effect on CYP3A4, such as ketoconazole and erythromycine, could inhibit the metabolism of tramadol (N-demethylation) and probably also the metabolism of the active O-demethyl-metabolite. The clinical relevancy of this interaction has not been investigated.

• Adverse Drug Reactions
  

  The most commonly reported adverse drug reactions are nausea and dizziness, both occurring in more than 10% of patients.

  Cardiac disorders:

  Uncommon (>1/1000, <1/100 ): effects on cardiovascular regulation (palpitation, tachycardia, postural hypotension or cardiovascular collapse). These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed.

  Rare (>1/10000, <1/1,000): bradycardia, increase in blood pressure.

  Very rare (<0.01%): flushing

  Nervous system disorders:

  Very common (> 1/10): dizziness

  Common (>1/100, <1/10): headache, drowsiness

  Rare (>1/10000, < 1/1000): changes in appetite, paraesthesia, tremor, respiratory depression, epileptiform convulsions.

  If the recommended doses are considerably exceeded and other centrally depressant active substances are administered concomitantly respiratory depression may occur.

  Epileptiform convulsions occurred mainly after administration of high doses of tramadol or after concomitant treatment with active substances which can lower the seizure threshold or themselves induce cerebral convulsions.

  Very rare (< 1/10000): vertigo

  Psychiatric disorders:

  Rare (>1/10000, <1/1000): hallucinations, confusion, sleep distubances and nightmares. Psychic undesirable effects may vary individually in intensity and nature (depending on personality and duration of medication). These include changes in mood (usually elation, occasionally dysphoria), changes in activity (usually suppression, occasionally increase) and changes in cognitive and sensorial capacity (e.g. decision behaviour, perception disorders). Tramadol can cause dependence. Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal, may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesias, tremor and gastrointestinal symptoms.

  Eye disorders:

  Rare (>1/10000, <1/1000): blurred vision

  Respiratory , thoracic and mediastinal disorders:

  Worsening of asthma has also been reported, though a causal relationship has not been established.

  Gastrointestinal disorders:

  Very common (>1/10): vomiting, nausea

  Common (>1/100, <1/10): vomiting, constipation, dry mouth.

  Uncommon (>1/1000, <1/100): Retching, gastrointestinal irritation (a feeling of pressure in the stomach, bloating).

  Skin and subcutaneous tissue disorders:

  Common (>1/100, <1/10): sweating

  Uncommon (>1/1,000, <1/100): dermal reactions (e.g. pruritus, rash, urticaria)

  Musculoskeletal, connective tissue and bone disorders:

  Rare (>1/10000, <1/1000): motorial weakness

  Hepato-biliary disorders:

  Very rare (<1/10000), including isolated reports of an increase in liver enzyme values has been reported after use of tamadol.

  Renal and urinary disorders:

  Rare (>1/10000, <1/1000): micturition disorders (difficulty in passing urine and urinary retention).

  Immune system disorders:

  Rare (>1,10000, <1/1000): Allergic reactions (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis;

  General disorders:

  Common (>1/100, <1/10): fatigue