Tramadol 50 Stada/Tramadol Stada

Tramadol 50 Stada/Tramadol Stada

tramadol

Manufacturer:

Stada

Distributor:

DCH Auriga
Full Prescribing Info
Contents
Tramadol hydrochloride.
Description
Tramadol 50 Stada: 1 capsule contains: Tramadol hydrochloride 50 mg.
Tramadol Stada: Each ampoule of 2 ml of injectable solution contains: tramadol hydrochloride, 100 mg.
Excipients/Inactive Ingredients: Tramadol 50 Stada: Calcium hydrogen phosphate 2H2O, gelatins, magnesium stearate, colloidal anhydrous silica, colouring agent E 171.
Tramadol Stada: Sodium acetate, water for injection.
Action
Pharmacology: Tramadol Hydrochloride is a cyclohexanol derivative with central analgesic and antitussive activities. The drug (and its active M1 metabolite) acts as an opiate agonist, apparently by selective activity at the μ-receptor. In addition to opiate agonist activity, tramadol inhibits reuptake of certain monoamine (norepinephrine, serotonin) which appears to contribute to the drug's analgesic effect. Unlike morphine tramadol has no respiratory depressant effect over a wide range of analgesic doses. It also does not affect gastrointestinal motility. Its effects on the cardiovascular system are relatively slight.
Pharmacokinetics: Following oral administration (100 mg), tramadol is rapidly and almost completely absorbed. The mean absolute bioavailability of Tramadol after oral administration, irrespective of simultaneous food intake, is 68%; following rectal administration it is 79%; and following i.m. administration 100%. The maximum first-pass effect after oral administration is 30% and after rectal administration 20%.
Tramadol crosses the blood-brain barrier and the placental barrier. It is found in breast milk, together with its 0-demethyl derivative, in very low concentration (0.1% and 0.02% respectively of the administered dose). The elimination half-life t1/2 irrespective of the route of administration, is 5-7 hours. This is slightly prolonged in patients over 65 years of age. Tramadol and its metabolites are almost entirely excreted by the kidney. In the presence of disorders of hepatic and renal function, the half-lives are likely to be somewhat prolonged.
Indications/Uses
For moderate to severe pain.
Dosage/Direction for Use
Dosage guide, route and duration of use: Unless otherwise prescribed, the following dosage guidelines apply: Tramadol should not in any circumstances be used longer than therapeutically absolutely necessary.
If the nature and severity of the disease makes more prolonged analgesic treatment with Tramadol necessary, a regular, careful and frequent check should be carried out (possibly by the use of treatment-free intervals) to determine whether and to what extent a medical requirement still exists.
Tramadol dosage should be adjusted to the severity of pain and the patient's individual sensitivity.
The duration of action of tramadol may be prolonged in patients with disorders of renal or hepatic function. The need for dosage alterations in elderly patients is under discussion.
There is some evidence that elderly patients require lower doses of Tramadol than younger patients. Creatinine clearance should be monitored and used as a determining factor for dosage adjustment. Age alone is not sufficient criteria for dosage adjustment.
Notes: The recommended dosages are guidelines only. In principle, the lowest effective analgesic dose should be chosen. In the treatment of chronic pain, strict time-tabling of doses is preferred.
Tramadol 50 Stada:
For moderately severe pain, tramadol should be given at the following dosages to adults and juveniles over the age of 14 (single doses): 1-2 capsules Tramadol 50 Stada, equivalent to 50-100mg tramadol hydrochloride. Single oral dose of tramadol hydrochloride ranging from 50-200mg have provided relief of postoperative pain in patients who have undergone various type of surgery.
If a dose of 1 capsule (50mg tramadol hydrochloride) is not followed by adequate pain relief within 30-60 minutes, a second single dose of 1 capsule of Tramadol 50 Stada (50mg tramadol hydrochloride) may be given.
In severe pain, if clinical experience suggests that a higher analgesic dose is likely to be required, the initial dose may be 2 capsules Tramadol 50 Stada (100mg tramadol hydrochloride).
Not suitable for children weighing less than 25kg and cannot usually dosed individually for children under 14 years. An oral solution and an injectable solution are available for this purpose.
The duration of action of tramadol hydrochloride is on average 4-8 hours, depending on the severity of pain, when therapeutic doses are given. Daily doses of up to 8 capsules of Tramadol 50 Stada (400mg tramadol hydrochloride) are generally adequate. In the treatment of tumour-induced pain, however, much higher daily doses have been used (150 to 400mg daily in divided doses).
While the usual oral tramadol hydrochloride dosage of 50-100mg every 4-6 hours as needed can be used in geriatric patients 65 years of age and older with normal renal and hepatic function, it is recommended that dosage not exceed 300mg daily in those than 75 years of age. Dosage of tramadol hydrochloride should be reduced in certain patients with renal or hepatic impairment by decreasing the frequency of administration. Adults and children 16 years of age and older with creatinine less than 30 ml/min) may receive an oral tramadol hydrochloride dosage of 50-100mg every 12 hours, not to exceed 200 mg daily. Since less than 10% of a dose of tramadol hydrochloride is removed by hemodialysis, patients undergoing dialysis may receive their usual dosage on the day of dialysis. Adults and children 16 years of age and older with hepatic cirrhosis may receive a tramadol hydrochloride dosage of 50mg every 12 hours.
The capsules should be taken with a little fluid, without relation to mealtimes.
Tramadol Stada: For moderately severe pain, tramadol should be given at the following dosages to adults and juveniles over the age of 14 (single dose): i.v.: 1 ampoule Tramadol Stada equivalent to 100mg tramadol hydrochloride - inject slowly or infuse diluted in an infusion solution.
i.m.: 1 ampoule Tramadol Stada equivalent to 100mg tramadol hydrochloride.
s.c.: 1 ampoule Tramadol Stada equivalent to 100mg tramadol hydrochloride.
If the analgesic effect is inadequate, a second single dose may be administered after 30-60 minutes. In severe pain, if clinical experience suggests that a higher analgesic requirement can be expected, the higher dose of tramadol may be used initially. The recommended dose for postoperative pain is 100mg initially then 50 mg every 10-20 minutes if necessary during first hour to the total max of 250mg (including initial dose in first hour, then 50-100mg every 4-6 hours max. 600mg daily.) For the treatment of severe postoperative pain, tramadol doses of up to 500mg/4h may be used in an on-demand analgesia system. This, however, requires monitoring facilities and special apparatus. In children aged from 1 year upwards, experience to date suggests that tramadol hydrochloride may be used at doses of 1-2mg/kg body weight.
The duration of action of tramadol hydrochloride is on average 4-8 hours, depending on the severity of pain, when therapeutic doses are given. Daily doses of up to 4 ampoules of Tramadol Stada (400mg tramadol hydrochloride) are generally adequate. The recommended dose for cancer pain is i.m. 300 mg daily in divided doses. When tramadol infusion is used intraoperatively, or in the treatment of tumour-induced pain, however, much higher daily doses have been used.
Approximately 30% of Tramadol dose is excreted unchanged in the urine. In patients with creatinine clearance less than 30 ml/min, the dosing interval of tramadol should be increased to 12 hours. The maximum recommended daily dose is 200mg. Since less than 10% of a dose of tramadol hydrochloride is removed by hemodialysis, patients undergoing dialysis may receive their usual dosage on the day of dialysis. Adults and children 14 years of age and older with hepatic cirrhosis may receive a tramadol hydrochloride dosage of 50mg every 12 hours.
Overdosage
The following typical symptoms of overdosage have been observed: disturbances of consciousness, extending to coma; generalised epileptic fits, hypertension, tachycardia, constricted or dilated pupils, respiratory depression extending to respiratory arrest.
These effects can be abolished by administration of an opiate antagonist (e.g. naloxone), which should be administered cautiously in repeated small doses, since its duration of action is shorter than that of tramadol. In addition, intensive-care measures (particularly incubation and ventilation) should also be introduced. If fits occur, the use of benzodiazepines should be considered. In addition, measures to prevent heat loss, and volume replacement therapy, may be required. In oral intoxication with tramadol, gastric lavage may be useful. Some manifestations of overdosage, eg seizures, may not be reversible with an opiate antagonist eg Naloxone.
Contraindications
Tramadol 50 Stada: This medicine must not be used in patients with: known hypersensitivity to tramadol; acute intoxication with alcohol, analgesics, sedatives, or psychotropic drugs; receiving MAOI.
This medicine must only be used with great caution in: opiate dependence; disturbance of consciousness of unknown cause; disorders of the respiratory center or respiratory function; conditions with raised intracranial pressure, unless artificial ventilation is being given; children below the age of one year.
Tramadol Stada: Tramadol Stada must not be used in patients with: known hypersensitivity to tramadol; acute alcohol, analgesic (pain-killer), soporific (sleeping drug), or psychoactive drug intoxication; receiving MAOI.
Particular caution must be exercised when using tramadol in any of the following situations: opioid dependence; clouding of consciousness of unclear aetiology; respiratory centre/respiratory function disturbances; conditions associated with elevated intracranial pressure, unless mechanical ventilation is provided; children under one year of age.
Warnings
Tramadol Stada: Tramadol has a dependence potential. Prolonged use results in the development of tolerance, mental and physical dependence. Tramadol and other opioids show cross-tolerance.
Special Precautions
Caution should be taken in patients with previous hypersensitivity to morphine - like analgesic, patients with head injury and history of seizures. In patients with myxedema, hypothyroidism or hypoadrenalism, dose reduction may be required.
Tramadol 50 Stada:
Misuse and dependence are possible with tramadol. Tramadol is not suitable for drug substitution.
If the recommended dose is exceeded, or other central nervous depressant drugs are used simultaneously, a respiratory depressant effect must be allowed for. The duration of action is prolonged in patients with disorders of hepatic or renal function. The dosage interval should therefore be prolonged in such cases, if necessary allowing for recurrence of pain.
Effects on drivers and operators of machinery: Even when tramadol is used appropriately, the capacity to drive in traffic or operate machinery may be abolished.
Tramadol Stada: Tramadol has a potential for both abuse and dependence. Tramadol is not suitable for use as a substitution drug.
There is a risk of respiratory depression when the recommended parenteral dosage is exceeded, which may occasionally be the case in general anaesthesia. Also, if the recommended dosage is exceeded and or another CNS-depressant drug is being used at the same time, breathing may become depressed.
As the duration of action of the drug is prolonged in patients with impaired liver or kidney function, the dosing interval should be increased, taking account of the pain recurrence pattern as appropriate.
Intravenous tramadol should be administered by slow intravenous injection.
Effects on ability to drive and use machines: Even when used as directed, tramadol may have such a significant effect on mental alertness that patients should not drive a car or other vehicle nor operate machinery while using Tramadol Stada.
Use In Pregnancy & Lactation
Tramadol 50 Stada: Tramadol crosses the placenta. No teratogenic effects of Tramadol have been observed in animals. However, adequate systematic studies have not yet been carried out. Chronic treatment should be avoided throughout pregnancy.
In neonates, tramadol may lead to changes in respiratory rate, which are usually of no importance. When given to breast-feeding mothers, tramadol is excreted in the breast milk at a concentration of approximately 0.1% of the maternal plasma concentration. With a single dose of tramadol, interruption of breast feeding is usually unnecessary.
Tramadol Stada: Tramadol crosses the placental barrier. Animal studies have revealed no teratogenic effects. However, as there is a lack of systematic studies, chronic use of tramadol should be avoided during all three trimesters of pregnancy.
In newborn babies, tramadol may produce changes in respiratory rate typically with no clinical significance. Tramadol is excreted in breast milk in a proportion of about 0.1% of maternal plasma concentrations while breast-feeding. However, single dosing with tramadol does not usually necessitate interruption of breast-feeding.
Side Effects
Skin-Diaphoresis has been reported in up to 20% of patients treated with oral/parental Tramadol.
Cases of hypoglycemia have been reported very rarely in patients taking tramadol. Most reports were in patients with predisposing risk factors, including diabetes or renal insufficiency, or in elderly patients.
Tramadol 50 Stada:
Tramadol produces dose-dependent respiratory depression and sedation of varying degree from mild fatigue to dizziness, but these symptoms do not generally manifest themselves when moderately severe pain is treated with the recommended oral or rectal doses.
Nausea, sweating, dry mouth, dizziness and giddiness may occasionally occur. Effects on the circulation (palpitations, tachycardia, faintness or circulatory collapse) are possible in rare cases. These adverse effects are particularly liable to occur when in the upright posture, when the drug is given intravenously, or in patients undergoing physical stress.
In addition, headaches, nausea, vomiting, constipation, gastrointestinal irritation (abdominal pressure, feeling of fullness) and skin reactions (e.g. pruritus, rashes) may rarely occur. Very rare effects include muscular weakness, alterations in appetite, and disturbances of micturition.
On very rare occasions, tramadol shows a variety of psychological side-effects, varying in nature and intensity from individual to individual, depending on personality and duration of treatment. They include alterations in mood (usually elevated, but sometimes a gloomy mood, known as dysphoria), alterations in activity (usually suppression, sometimes intensification) and alterations in memory (e.g. decision-taking, disturbances of perception). There have been few cases of cerebral convulsions. These, however, almost always occurred following intravenous administration of high doses of tramadol with concomitant treatment with neuroleptic agents. Allergic reactions, extending to shock, cannot be reliably ruled out.
Tramadol Stada: Tramadol Stada injectable solution produces dose-related respiratory depression and sedation of variable intensity ranging from mild drowsiness to reduced awareness.
There have been occasional reports of nausea, sweating, dry mouth, dizziness, and lightheadedness. Dysregulation symptoms on postural change (palpitations, tachycardia, tendency to collapse to the point of circulatory failure) have been observed on rare occasions. Upright posture, administration of intravenous tramadol and physical exertion tend to be predisposing factors for these adverse reactions.
There have been rare reports of headaches, feeling and being sick, constipation, gastro-intestinal complaints (eg epigastric distress, sensation of fullness) or skin reactions (e.g itching, rash).
Muscle weakness, appetite changes or difficulty passing urine have very rarely been observed.
Tramadol has very rarely been associated with various psychiatric adverse effects whose manifestations showed great between-patient variability in intensity and nature and were dependent on personality and duration of therapy. These mental effects include mood changes (usually euphoria but occasionally dysphoria as well), changes in activity level (usually depression but occasionally elevation as well) and changes in cognitive and sensory performance (eg alterations in decision-making ability, impaired perception). There have been isolated reports of epileptic seizures, but these nearly always occurred following intravenous administration of high doses of tramadol in patients on concurrent treatment with antipsychotic drugs (also called neuroleptics or major tranquilizers). Allergic reactions to the point of shock cannot be ruled out altogether.
Drug Interactions
Increased incidence of seizures may occur with concomitant administration of Tricyclic Antidepressants, e.g. Cyclobenzaprine, MAOI, Selective Serotonin Reuptake Inhibitors (SSRIs), neuroleptic agents and other drugs that lower the seizure threshold. Tramadol may potentiate the effects of other CNS depressants (alcohol, sedatives, hypnotic, other centrally acting analgesics, opiate agonists). The drug should be used with caution, and dosage of Tramadol may need to be reduced in patients receiving such drugs.
Tramadol 50 Stada:
Simultaneous use of Tramadol and other drugs with a central nervous inhibitory effect or alcohol can lead to potentiation of the central nervous side-effects of tramadol, particularly respiratory depression. When concomitant medication with neuroleptic drugs is given, convulsions have been observed in a few cases.
The effect of treatment with cimetidine (a drug for the treatment of gastric ulcers and gastric mucosal irritation) on the excretion of tramadol is so slight that the alterations in analgesic effect attributable to this effect are insignificant.
When patients have been treated with MAO inhibitors (drugs for the treatment of psychiatric disorders) within the last fourteen days before opioid administration, life-threatening interactions affecting the central nervous system, respiratory and circulatory function have been observed with pethidine (another analgesic agent in the same group), and such effects cannot be excluded in the case of tramadol.
Note: Tramadol possesses a potential for dependency. With long-term usage, tolerance, psychological and physical dependence may develop. There is cross-tolerance with other opioids.
Tramadol Stada: Concurrent use of tramadol and other CNS-depressant drugs and/or alcohol may enhance the central adverse effects of tramadol, respiratory depression in particular.
Concomitant treatment with tramadol and antipsychotic drugs (also called neuroleptics or major tranquilizers) has, on isolated occasions, been associated with epileptic seizures.
The effect of cimetidine (a drug used for treatment of gastric ulcers and gastritis) on the excretion of tramadol is so small that the resultant changes in analgesic (pain-killing) activity are irrelevant in clinical practice.
Patients treated with MAO inhibitors (drugs for the treatment of mental disorders) within the last 14 days prior to opioid administration have experienced life-threatening interactions with pethidine (another pain killer that belongs to the same group of drugs) on the central nervous system, respiratory and circulatory centres. Similar interactions cannot be ruled out for tramadol.
Storage
Do not store above 25°C.
Tramadol Stada: Shelf life: Shelf life is 5 years in normal storage condition.
MIMS Class
ATC Classification
N02AX02 - tramadol ; Belongs to the class of other opioids. Used to relieve pain.
Presentation/Packing
Tramadol 50 Stada: Cap (white) 50 mg x 50's.
Tramadol Stada: Inj (clear, colourless soln) 100 mg/2 mL x 5's.
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in