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Presentation

\nWinpain 50: Each capsule contains Tramadol Hydrochloride BP 50 mg. \nWinpain ER 100: Each extended release capsule contains Tramadol Hydrochloride BP 100 mg. \nWinpain 2 ml IM/IV injection: Each 2 ml contains a concentrated solution of Tramadol hydrochloride BP 100 mg. \n \n

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Description

\nTramadol hydrochloride is a centrally acting analgesic. The chemical name of Tramadol hydrochloride is (+-) cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a Pka of 9.41. \n \n

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Indications

\nModerate to moderately severe pain. \n \n

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Dosage & Administration

\nCapsule \nThe dosage should be adjusted to the intensity of pain and the individuals response to the analgesic action of Winpain. \nAdults and children over the age of 14 years: \nModerate pain: Initial dose of 50 mg, followed by 50 mg or 100 mg 4-6 hourly. \nModerately severe pain: Initial dose of 50 mg or 100 mg followed by 50 mg or 100 mg 4-6 \nhourly. A total oral daily dose of 400 mg must not be exceeded. \nElderly: \nThe usual dosages may be used except in patients 75 years of age and over, a downward adjustment of the dose and/or prolongation of the interval between doses are recommended. \n \nWinpain ER 100 capsule: \n100 mg twice daily increased if necessary up to 200 mg twice daily. A total oral daily dose of 400 mg must not be exceeded. \nInjection \nIM/IV: 50-100 mg every 4-6 hours (Over 2-3 minutes). \nThe dosage should be adjusted to the intensity of the pain and the sensitivity of the individual patients. \n* In moderate pain, adults and adolescents above 14 years of age should receive 1 ml Tramadol hydrochloride (50 mg Tramadol hydrochloride) injection as a single dose. \n* In case of severe pain a higher dose is necessary, 2 ml Tramadol hydrochloride (100 mg Tramadol hydrochloride) should be administered as a single dose. \n* For the treatment of severe pain after operations, on-demand pain relief may require even higher doses in the first few hours. In general, over 24 hours more than the normal daily doses are not necessary. \nIn general, 16 ml Tramadol hydrochloride injection (800 mg Tramadol hydrochloride) per day should not be exceeded. However, for the treatment of cancer pain and severe pain after operations much higher doses may be necessary. \nDosage for Children \nChildren aged 1 to 13 years should receive 1-2 mg Tramadol hydrochloride per kg body weight as a single dose. \n \nIn this case Tramadol hydrochloride 1 ml injection is diluted in water for injection. \nGeriatric patients \nIn acute pain Tramadol hydrochloride 1 ml injection is given once or a few times, and therefore a dose adjustment is not necessary. In chronic pain a dose adjustment is not usually necessary in elderly patients ( up to 75 years ) with no clinically manifested liver or kidney insufficiency. In old patients ( above 75 years) elimination may be prolonged. Consequently the dose interval may have to be prolonged, depending on the individual patients. \n \nLiver and kidney insufficiency \nIn acute pain Tramadol hydrochloride 1 ml injection is only given once or a few times, and therefore a dose adjustment is not necessary. In patients with severe liver and/or kidney insufficiency Tramadol hydrochloride injection should not be given. In less severe cases extending the dosage interval should be considered. \n \n

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Side Effects

\nThe following side effects have been reported. Gastrointestinal system: Nausea, vomiting, dry mouth, heartburn, constipation. Central nervous system and psychiatric: Fatigue, sedation, drowsiness, dizziness, confusion, hallucination and seizures. \n \n

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Precautions

\nThe administration of Tramadol Hydrochloride concurrently with central nervous system depressant medicines is likely to intensify and prolong CNS effects. Patients should be warned not to operate machinery or drive a car while taking Tramadol Hydrochloride. \n \n

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Use in Pregnancy & Lactation

\nSafety during pregnancy and lactation has not been established. \n \n

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Drug Interaction

\nTramadol Hydrochloride must not be combined with a MAO-inhibitor or within 14 days of discontinuation of it, as potentiation of serotonergic and noradrenergic effects may result. \n \n

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Commercial Pack

\nWinpain 50: Box containing 4 blister strips of 10 capsules. \nWinpain ER 100: Box containing 2 blister strips of 10 capsules. \nWinpain 2 ml IM/IV injection: Each box contains 5 Ampoules of 2 ml solution of Tramadol hydrochloride. \n \n