Tramadin Plus

Tramadin Plus

tramadol + paracetamol

Manufacturer:

Korea Pharma

Distributor:

JustRight Healthcare
Concise Prescribing Info
Contents
Tramadol HCl 37.5 mg, paracetamol 325 mg
Indications/Uses
Symptomatic treatment of moderate to severe pain.
Dosage/Direction for Use
Individualized dose. Initially 2 tab. Max: 8 tab daily. Dose interval not <6 hr.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Acute intoxication w/ alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs. MAOIs or w/in 2 wk of w/drawal. Severe hepatic impairment; epilepsy not controlled by treatment.
Special Precautions
Convulsions. Patients w/ non-cirrhotic alcoholic liver disease; opioid dependent patients or w/ cranial trauma, patients prone to convulsive disorder, biliary tract disorders, in a state of shock & altered state of consciousness for unknown reasons, w/ problems affecting resp center/function, or increased intracranial pressure. Repeated use or long-term use. Not recommended in severe renal insufficiency (CrCl <10 mL/min). Concomitant use of opioid agonists-antagonists (nalbuphine, buprenorphine, pentazocine) is not recommended. Elderly >75 yr. Not recommended for childn <12 yr.
Adverse Reactions
Dizziness, somnolence; nausea. Headache, trembling; confusion, mood changes (anxiety, nervousness, euphoria), sleep disorders; vomiting, constipation, dry mouth, diarrhea, abdominal pain, dyspepsia, flatulence; sweating, pruritus.
Drug Interactions
Risk of non-serotoninergic syndrome w/ MAOIs. Increased sedative effect w/ alcohol. Increased risk of convulsions w/ medicinal products reducing seizure threshold eg, bupropion, serotonin reuptake inhibitor antidepressants, TCAs & neuroleptics. Decreased analgesic effect by competitive blocking effect at the receptors & risk of occurrence of w/drawal syndrome w/ opioid agonists-antagonists (buprenorphine, nalbuphine, pentazocine). Increased risk of resp depression w/ other opioid derivatives (including antitussive drugs & substitutive treatments), benzodiazepines & barbiturates. Increased central depression w/ other central nervous system depressants eg, other opioid derivatives (including antitussive drugs & substitutive treatments), barbiturates, benzodiazepines, other anxiolytics, hypnotics, sedative antidepressants & antihistamines, neuroleptics, centrally-acting antihypertensives, thalidomide & baclofen. Increased INR w/ warfarin-like compds. Tramadol: Decreased plasma conc w/ carbamazepine & other enzyme inducers. Serotonin syndrome w/ other serotoninergic medicines eg, SSRIs & triptans. Inhibit metabolism w/ other drugs known to inhibit CYP3A4 eg, ketoconazole & erythromycin. Pre- or postop application of antiemetic 5-HT3 antagonist ondansetron increased requirement of tramadol in patients w/ postop pain. Paracetamol: Absorption of paracetamol increased by metoclopramide or domperidone & reduced by cholestyramine.
MIMS Class
Analgesics (Non-Opioid) & Antipyretics
ATC Classification
N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.
Presentation/Packing
Form
Tramadin Plus FC tab
Packing/Price
100's
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