Ultracet

Ultracet

tramadol + paracetamol

Manufacturer:

Johnson & Johnson
Concise Prescribing Info
Contents
Tramadol HCl 37.5 mg, acetaminophen 325 mg
Indications/Uses
Short-term treatment of acute pain.
Dosage/Direction for Use
Adult & childn >16 yr Max single dose: 1-2 tab 4-6 hrly. Max: 8 tab daily. Patient w/ CrCl <30 mL/min ≤2 tab 12 hrly.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to tramadol, acetaminophen, any other component of Ultracet or opioids. Acute alcohol intoxication, hypnotics, narcotics, centrally-acting analgesics, opioids or psychotropic drugs. Concurrent use w/ MAOIs or w/in the last 14 days.
Special Precautions
Seizures have been reported in patients receiving tramadol w/in the recommended dosage range. Seizure risk is increased w/ doses of tramadol above the recommended range. Enhanced seizure risk in patients taking MAOIs, neuroleptics or other drugs that reduce seizure threshold. Risk of convulsions may also increase in patients w/ epilepsy, history of seizures or in patients w/ recognized risk of seizure (eg, head trauma, metabolic disorders, alcohol & drug w/drawal, CNS infections). Patients w/ history of anaphylactoid reaction to codeine & other opioids may be at increased risk. Patients at risk for resp depression; known to be CYP2D6 ultra rapid metabolizers. May impair ability to drive or operate machinery. Hepatic impairment. Pregnancy & lactation. Childn <16 yr.
Adverse Reactions
Drug Interactions
Increased risk of adverse events, including seizures & serotonin syndrome w/ MAOIs & SSRIs. Additive depressant effects w/ benzodiazepines & other sedatives/hypnotics, anesth agents, phenothiazines, tranquilizers, opioids or alcohol. Increased tramadol metabolism w/ carbamazepine. Increased tramadol conc w/ quinidine. Increased INR w/ warfarin-like compd. Inhibition of tramadol metabolism w/ CYP2D6 inhibitors.
MIMS Class
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
Ultracet tab
Packing/Price
3 × 10's (Rp213,515/boks)
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