Tramadol Capsules BP 50 mg.
DOSAGE FORM AND STRENGTH
Dosage Form Capsule
Strength – 50mg
HISTORY OF ACT WE INGREDIENTS
Tramadol Hydrochloride is a non-steroidal anti-inflammatory agent which has analgesic properties.
Each Hard Gelatin Capsule contains:
Tramadol Hydrochloride BP 50mg
Approved colours used in empty capsule shells.
ATC CODE: NO2AX02
Tramadol is a centrally acting analgesic. It is a non-selective pure agonist at mu, delta and kappa opioid receptors with a higher affinity for the mu receptor. Other mechanisms, which may contribute to its analgesic effect, are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release.
Tramadol has an antitussive effect, in contrast to morphine, analgesic doses of tramadol over a wide range have no respiratory depressant effect. Also gastrointestinal motility is less affected. Effects on the cardiovascular system tend to be slight. The potency of tramadol as reported to be 1/10 (one tenth) to 1/6 (one sixth) that of morphine.
The inhibition of one or both types of the isoenzymes CYP3A4 and CYP2D6 involved in the metabolism of tramadol hydrochloride, may affect the plasma concentration of tramadol hydrochloride or its active metabolite.
Tramadol hydrochloride crosses both the blood-brain barrier and the placental barrier. Tramadol hydrochloride and its metabolite O-demethyltramadol are excreted in breast milk in very small amounts (0.1% and 0.02% of the administered dose, respectively).
In humans tramadol hydrochloride is mainly metaboilsed by means of N- and O-demethylation and conjugation of the O-demethylation products with glucuronic acid. Only O-desmethyl-tramadol is pharmacologically active. There are considerable Interindividual quantitative differences between the other metabolites.
INDICATION AND USAGE
Treatment of moderate to severe pain.
Hypersensitivity to tramadol hydrochloride or to any of the excipients.
Buprenorphine, Nalbuphine, Pentazocine, Tramadol can induce convulsions and increase the potential for selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, antipsychotics and other seizure threshold-lowering medicinal products (such as bupropion, mirtazapine, tetrahydrocannabinol) to cause convulsions.
Concomitant use of Tramadol Hydrochloride increases the seizure risk in patients taking Tricyclic antidepressants, MAO inhibitors, selective serotonin re-uptake inhibitors and other Opioids.
Animal studies have not revealed teratogenic effects although minimal embryotoxicity (delayed ossification) was noted. Fertility, reproductive performance and development of offsprings were unaffected. There is inadequate evidence available on the safety of tramadol in human pregnancy; therefore tramadol should not be used in pregnant women. Tramadol administered before or during birth-does not affect uterine contractility. In neonates it may induce changes in the respiratory rate which are usually not clinically relevant. Chronic use during pregnancy may lead to neonatal withdrawal symptoms.
Tramadol and its metabolites are found in small amounts in human breast milk. An infant could ingest 0.1 % of the dose given to the mother. Tramadol should not be administered during breast-feeding.
Keep all medicines out of reach of children.
Tramadol should be used with caution in patients with head injury, increased intracranial pressure, severe impairment of hepatic and renal function and in patients prone to convulsive disorders or in shock. Care should be taken when treating patients with respiratory depression, or if concomitant CNS depressant drugs are being administered, as the possibility of respiratory depression cannot be excluded in these situations. At therapeutic doses respiratory depression has infrequently been reported.
Nausae, dizziness, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, headache, vertigo, bradycardia, tachycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood, hallucinations, respiratory depression.
DRUG ABUSE AND DEPENDENCE
SYMPTOMS OF OVERDOSE AND ANTIDOTE
Symptoms of overdosage are typical of other opioid analgesics, and include miosis, vomiting, cardiovascular collapse, sedation and coma, seizures and respiratory depression in case of intoxication orally, gastrointestinal decontamination with activated Charcoal or by gastric lavage as only recommended within 2 hours after tramadol intake. Gastrointestinal decontamination at a later point may be useful in case of intoxication with exceptionally large quantities.
Supportive measures such as maintaining the patency of the airway and maintaining cardiovascular function should be instituted, nalozone should be used to reverse respiratory depression: fits can be controlled with diazepam. Tramadol is minimally eliminated from the serum by haemodiadysis or haemofiltration.
The general emergency measures apply. Keep open the respiratory tract (aspiration) maintain respiration and circulation depending on the symptoms. The antidote for respiratory depression is naloxone. In animal experiments naloxone had no effect on convulsions. In such cases diazepem should be given intravenously.
In case of intoxication orally, gastrointestinal decontamination with activated charcoal or by gastric lavage is only recommended within 2 hours after tramadol intake.
Gastrointestinal decontamination at a later time point may be useful in case of intoxication with exceptionally large quantities. Tramadol as minimally eliminated from the serum by haemodialysis or haemo-filtration. Therefore treatment of acute tramadol intoxication with haemodialysis or heamofiltration alone is not suitable for detoxification.
DOSAGE AND ADMINISTRATION
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.
Or as directed by the physician.
THE PREPARATION FOR USE
1 x 10 Capsules packed in a unit carton along with patient information leaflet.
Store in a cool and dry place. Protect from light.
NAFDAC Reg. No.: 04.7444
Manufactured in India by
Laborate Pharmaceutical (India)
E-11 Ind. Area, Panipat – 132 103
Embassy Pharmaceutical and Chemicals Ltd.
Lagos – Nigeria.