Composition
Each Inj. Contains: Tramadol HCL. 100mg./2 ml.

Product Description
Tramadol HCL. is a centrally acting synthetic opioid analgesic.

Mechanism of Action
Mechanism action of tramadol is believed to work through modulation of the GABAergic, noradrenergic and serotonergic systems. It acts via opioid receptors in CNS to produce analgesia. It has no abuse potential.

Pharmaco Kinetics
Tramadol is well absorbed orally with an absolute bioavailability of 75%. Tramadol is extensively metabolized by a number of pathways, including CYP2D6 and CYP3A4,as well as by conjugation of parent and metabolites. The formation of M1 is dependent upon CYP2D6 and as such is subject to inhibition, which may affect the therapeutic response. Tramadol is eliminated primarily through metabolism by the liver and the metabolites are eliminated primarily by the kidneys. Tramadol and its metabolites are excreted primarily in the urine with observed plasma half-lives of 6.3 and 7.4 hours for tramadol and M1, respectively.

Indications
Moderate to serve acute or chronic pain & in painful diagnostic measures & surgery. Arthralgia, musculoskeletal pain, colics, low back pain, pain associated with fractures, dislocation, contusion and osteoarthritis.

Dosage
50 to 100 mg every 4 to 6 hours.

Contra Indication
Hypersensitivity, acute C.N.S intoxications due to alcohol, analgesics, or psychotropics.

Special Precautions
Alcohol, not to drive or operate machinery.; Paediatrics:Should not be used in children below 16years.; Pregnancy:Safety not established.; Lactation:Not recommended.; Elderly: Reduced dose may be necessary.

Drug Interactions
Concomitantly administered tranquilisers, hypnotics intensifies sedative effects. Fatal interaction with MAOIs. Opioid analgesics like buprenorphine, butorphanol and pentazocine precipitate withdrawal symptoms.

Adverse Effects
Sweating, nausea, vomiting.

Packing
5 vials of 2 ml. each.