Presentation

Winpain 50: Each capsule contains Tramadol Hydrochloride BP 50 mg.

Winpain ER 100: Each extended release capsule contains Tramadol Hydrochloride BP 100 mg.

Winpain 2 ml IM/IV injection: Each 2 ml contains a concentrated solution of Tramadol hydrochloride BP 100 mg.

Description

Tramadol 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.

Indications

Moderate to moderately severe pain.

Dosage & Administration

Capsule

The dosage should be adjusted to the intensity of pain and the individuals response to the analgesic action of Winpain.

Adults and children over the age of 14 years:

Moderate pain: Initial dose of 50 mg, followed by 50 mg or 100 mg 4-6 hourly.

Moderately severe pain: Initial dose of 50 mg or 100 mg followed by 50 mg or 100 mg 4-6

hourly. A total oral daily dose of 400 mg must not be exceeded.

Elderly:

The 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.

Winpain ER 100 capsule:

100 mg twice daily increased if necessary up to 200 mg twice daily. A total oral daily dose of 400 mg must not be exceeded.

Injection

IM/IV: 50-100 mg every 4-6 hours (Over 2-3 minutes).

The dosage should be adjusted to the intensity of the pain and the sensitivity of the individual patients.

* 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.

* 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.

* 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.

In 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.

Dosage for Children

Children aged 1 to 13 years should receive 1-2 mg Tramadol hydrochloride per kg body weight as a single dose.

In this case Tramadol hydrochloride 1 ml injection is diluted in water for injection.

Geriatric patients

In 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.

Liver and kidney insufficiency

In 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.

Side Effects

The 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.

Precautions

The 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.

Use in Pregnancy & Lactation

Safety during pregnancy and lactation has not been established.

Drug Interaction

Tramadol 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.

Commercial Pack

Winpain 50: Box containing 4 blister strips of 10 capsules.

Winpain ER 100: Box containing 2 blister strips of 10 capsules.

Winpain 2 ml IM/IV injection: Each box contains 5 Ampoules of 2 ml solution of Tramadol hydrochloride.