Tramadol Stada/Tramadol Stada 50

Tramadol Stada/Tramadol Stada 50

tramadol

Manufacturer:

Stada

Distributor:

HK Medical Supplies
/
Health Express
Full Prescribing Info
Contents
Tramadol hydrochloride.
Description
Tramadol Stada: Oral drops: 1 ml solution (equivalent to 40 drops) contains: Tramadol hydrochloride 100 mg, Potassium sorbate 1.64 mg, sucrose 0.2 g, anise oil, peppermint oil, polysorbate 20, saccharin sodium 2H2O, purified water.
Injection: 1 ampoule of 2 ml injectable solution contains: Tramadol hydrochloride 100 mg, Sodium acetate, Water for injection.
Tramadol Stada 50: 1 capsule contains: Tramadol hydrochloride 50 mg, calcium hydrogen phosphate 2H2O, gelatins, magnesium stearate, colloidal anhydrous silica, coloring agent E171.
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 re-uptake 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 75%; 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
Moderately severe to severe pain.
Dosage/Direction for 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. For moderately severe pain, tramadol should be given at the following dosages to adults and juveniles over the age of 16 (single doses): Tramadol Stada: Oral dops: 0.5 ml solution, equivalent to 20-40 drops (50-100 mg). If a dose of 0.5 ml solution (equivalent to 20 drops or 50 mg tramadol hydrochloride) is not followed by adequate pain relief within 30-60 minutes, a second single dose of 0.5 ml (20 drops, 50 mg 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 1 ml solution (equivalent to 40 drops or 100 mg tramadol hydrochloride).
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 0.5 ml 8 times daily, equivalent to 20 drops 8 times daily (400 mg tramadol hydrochloride) are generally adequate. In the treatment of tumour-induced pain, however, much higher daily doses have been used.
Injection: I.V.: 1 ampule Tramadol Stada equivalent to 100 mg tramadol hydrochloride - inject slowly or infuse diluted in an infusion solution.
I.M.: 1 ampule Tramadol Stada equivalent to 100 mg tramadol hydrochloride.
S.C.: 1 ampule Tramadol Stada equivalent to 100 mg 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. For the treatment of severe post-operative pain, tramadol doses of up to 500 mg/4 h may be used in an on-demand analgesia system. This however requires monitoring facilities and special apparatus.
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 (400 mg tramadol hydrochloride) are generally adequate. When tramadol infusions are used intraoperatively, or in the treatment of tumor-induced pain, however, much higher daily doses have been used.
Tramadol Stada 50: 1-2 capsules of Tramadol 50 Stada, equivalent to 50-100 mg tramadol hydrochloride.
If a dose of 1 capsule (50 mg tramadol hydrochloride) is not followed by adequate pain relief within 30-60 minutes, a second single dose of 1 capsule of Tramadol 50 Stada (50 mg 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 (100 mg tramadol hydrochloride).
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 (400 mg tramadol hydrochloride) are generally adequate. In the treatment of tumour-induced pain, however, much higher daily doses may be used.
Elderly patients < 75 years with normal renal and hepatic function can be given the adult dose. The elimination half-life of Tramadol may be prolonged in patients over 75 years of age. In these cases dosing intervals should be prolonged individually. For elderly patients > 75 years old, administer < 300 mg/day in divided doses.
Approximately 30% of Tramadol dose is excreted unchanged in the urine. The duration of action of tramadol may be prolonged in patients with disorders of renal or hepatic function. Tramadol is contraindicated for patients with severe renal impairment (creatinine clearance < 10 ml/min) and or severe hepatic impairment. Patients with hepatic or renal insufficiency (creatinine clearance < 30 ml/min) may require longer dosing interval of about 12 hours. The maximum recommended daily dose is 200 mg. 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.
The oral drops solution should be taken with a little fluid or with a lump of sugar, without relation to mealtimes.
Tramadol solution is intended for oral use and must not on any account be injected.
The capsules should be taken with little fluid, without relation to mealtimes.
Notes: The recommended dosages are guidelines only. In principle, the lowest effective analgesic dose should be chosen. In the treatment of chronic pain, time-tabling of doses is preferred.
Overdosage
The following typical symptoms of overdosage have been observed, disturbances of consciousness extending to coma; generalized epileptic fit, hypertension, tachycardia, constricted or dilated pupils, respiratory depression.
These effects can be abolished by administration of an opiate antagonist (e.g. naloxone).
In addition, intensive care measures particularly intubation and ventilation should also be introduced. If fits occur, the use of benzodiazepines should be considered.
Contraindications
This medicine must not be used in patients with known hypersensitivity to tramadol; acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids 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.
Special Precautions
Misuse and dependence are possible with tramadol. Tramadol is not suitable for drug substitution.
If the recommended parenteral dose is exceeded, as occasionally occurs particularly during general anesthesia, respiratory depression should be expected. Similarly if the recommended dosage is exceeded, or other central nervous depressant drugs are simultaneously used, respiratory suppression should 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.
Intravenous injections should be given slowly.
Caution should be taken in patients with 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.
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.
Use In Pregnancy & Lactation
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 the concentration of approximately 0.1% of the maternal plasma concentration. With a single dose of tramadol, interruption of breast-feeding is usually unnecessary.
Side Effects
Tramadol Stada/Tramadol Stada 50 produces dose-dependent respiratory depression and sedation of varying degrees (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 partially 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.
Skin diaphoresis has been reported in up to 20% of patients treated with oral/parenteral tramadol.
Drug Interactions
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.
Increased incidence of seizures may occur with concomitant administration of tricyclic antidepressants, e.g. cyclobenzaprine MAOI, selective serotonin re-uptake inhibitors, neuroleptic agents and other drugs that lower the seizure threshold.
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.
Patient Counseling Information
Oral drops: The bottle has a child-proof screw cap. To open, press the cap downwards and simultaneously turn in the direction of the arrow. The dropper bottle should be held vertically upside down, and the base of the bottle gently tapped with a finger until the first drops appear. The cap should be screwed tight again after use.
ATC Classification
N02AX02 - tramadol ; Belongs to the class of other opioids. Used to relieve pain.
Presentation/Packing
Tramadol Stada: Oral drops 100 mg/mL x 50 mL. Inj 100 mg/2 mL x 5's.
Tramadol Stada 50: Cap 50 mg x 50's.
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