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Composition Each Tablet Contains: Tramadol & Paracetamol Product Description Tramadol is an atypical opioid which is a centrally acting analgesic, used for treating moderate to severe pain. Paracetamol is the active metabolite of phenacetin, a so called coal tar analgesic. Mechanism of Action Tramadol it is believed to work through modulation of the GABAergic, noradrenergic and serotonergic systems. The contribution of non-opioid activity is demonstrated by the analgesic effects of tramadol not being fully antagonised by the µ-opioid receptor antagonist naloxone. Paracetamol Paracetamol has long been suspected of having a similar mechanism of action to aspirin because of the similarity in structure. That is, it has been assumed that paracetamol acts by reducing production of prostaglandins, which are involved in the pain and fever processes, by inhibiting the cyclooxygenase (COX) enzyme as aspirin does. 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. Paracetamol Bioavailability - almost 100% ; Metabolism - 90 to 95% Hepatic ; Half life - 1–4 hours ; Excretion - Renal |
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 A strip of 10 Tablets |
© 2007 SHREE RAJ PHARMACEUTICALS, PANCHKULA, HARYANA, INDIA