Ultracet

Ultracet

tramadol + paracetamol

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Tramadol HCl 37.5 mg, acetaminophen 325 mg
Indications/Uses
Management of moderate to severe pain.
Dosage/Direction for Use
Adult & childn >16 yr 1-2 tab 4-6 hrly when necessary. Max: 8 tab/day. Patient w/ CrCl <30 mL/min Max: 2 tab 12 hrly.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to tramadol, acetaminophen or opioids. Acute intoxication w/ alcohol, hypnotics, narcotics, centrally-acting analgesics, opioids or psychotropic drugs.
Special Precautions
Patients at risk for seizure when used concomitantly w/ SSRIs, TCAs, other tricyclic compounds eg promethazine, opioids, MAOIs, neuroleptics or drugs that reduce the seizure threshold. Risk of convulsions increased in patients w/ epilepsy, history of seizures or patients w/ recognized risk of seizure. History of anaphylactoid reactions to codeine & other opioids, opioid dependence & hepatic impairment. Resp depression, increased intracranial pressure or head injury, renal disease, patients receiving CNS depressants or MAOI/SSRI & heavy alcohol abusers. Discontinue treatment gradually. May impair ability to drive or operate machinery. Pregnancy & lactation.
Adverse Reactions
Nausea, dizziness, somnolence. Asthenia, fatigue, hot flushes. Headache, tremor. Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, dry mouth, vomiting. Anorexia, anxiety, confusion, euphoria, insomnia, nervousness. Pruritus, rash, increased sweating.
Drug Interactions
MAOIs, SSRIs, carbamazepine, quinidine, warfarin-like compd, CYP2D6 inhibitors eg fluoxetine, paroxetine, amitriptyline.
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 film-coated tab
Packing/Price
30's
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