Ultracet

Tramadol HCl 37.5 mg, paracetamol 325 mg

Management of moderate to moderately severe pain.

Adult 1 or 2 tab every 4-6 hr as needed. Max: 8 tab daily. Acute pain Use for max of 7 days at the lowest dose that provides adequate pain relief.

May be taken with or without food.

Hypersensitivity to tramadol, paracetamol or other opioid analgesics. Patients w/ known or suspected mechanical GI obstruction (eg, bowel obstruction or strictures) or any diseases/conditions that affect bowel transit (eg, ileus of any type); suspected surgical abdomen (eg, acute appendicitis or pancreatitis); mild pain that can be managed w/ other pain medications; acute or severe bronchial asthma, chronic obstructive airway, or status asthmaticus; acute resp depression, elevated CO₂ blood levels, & cor pulmonale; acute alcoholism, delirium tremens, & convulsive disorders; severe CNS depression, increased cerebrospinal or intracranial pressure, & head injury. Patients taking MAOIs (or w/in 14 days following discontinuation). Any situation where opioids are contraindicated, including acute intoxication w/ alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs. Patients w/ severe hepatic or renal impairment (Child-Pugh Class C &/or CrCl <30 mL/min). Pregnancy & lactation. During labour & delivery. Post-op management in childn <18 yr following tonsillectomy &/or adenoidectomy. Childn <12 yr.

Discontinue immediately in case of hypersensitivity. No approved use in the management of addictive disorders. W/drawal symptoms may occur following abrupt discontinuation. Not indicated for pre-emptive analgesia. Do not co-administer w/ other paracetamol- or tramadol-containing products. Risk of resp depression; seizures; opioid addiction, abuse, misuse; dependence/tolerance; severe hypotension in patients whose ability maintain adequate BP is compromised by reduced blood vol, or concurrent administration of drugs eg, phenothiazine, other tranquilizers, sedatives/hypnotics, TCAs or general anaesth; QTc interval prolongation. Monitor patients for resp depression, especially during treatment initiation or following a dose increase. Caution in patients w/ head injury or elevated intracranial pressure produced by trauma. Reports of adrenal insufficiency & hyponatremia. Decreased bowel motility. Risk of serotonin syndrome w/ serotonergic drugs. Risks of resp depression & sedation w/ benzodiazepines or other CNS depressants. Do not consume w/ alcohol. Can cause sleep-related breathing disorders eg, sleep apnea syndromes (including central sleep apnea) & hypoxia (including sleep-related hypoxia). Increased risk of acute liver failure in individuals w/ underlying liver disease & in individuals who ingest alcohol while taking paracetamol. Long-term use of opioids may be associated w/ decreased sex hormone levels & symptoms eg, slow libido, erectile dysfunction, or infertility. Patients w/ hepatic or renal impairment. May impair ability to drive or operate machinery. Prolonged maternal use during pregnancy can result in neonatal opioid w/drawal syndrome. Elderly >75 yr. Not recommended in patients <18 yr.

Headache, dizziness, nausea, constipation, somnolence. Fatigue, hot flushes, flu-like symptoms; HTN; hypoesthesia; dry mouth, vomiting, abdominal pain, diarrhea; insomnia, anorexia, nervousness; pruritus, increased sweating, rash.

Decreased rate of tramadol metabolism w/ CYP2D6 inhibitors eg, quinidine, fluoxetine, paroxetine, amitriptyline & bupropion; CYP3A4 inhibitors eg, macrolide antibiotics (eg, erythromycin), azole-antifungal agents (eg, ketoconazole), PIs (eg, ritonavir). Increased rate of tramadol metabolism w/ CYP3A4 inducers eg, rifampin, carbamazepine, phenytoin. Additive or synergistic pharmacodynamic effect w/ benzodiazepines & other sedatives/hypnotics, antidepressants, anxiolytics, tranquilizers, muscle relaxants, general anesth, other opioids, antipsychotics, phenothiazines, neuroleptics, antihistamines, antiemetics, alcohol, SSRIs, SNRIs, TCAs, triptans, 5-HT₃ receptor antagonists, drugs that affect the serotonin neurotransmitter system (eg, mirtazapine & trazodone), some muscle relaxants (eg, cyclobenzaprine), MAOIs (eg, phenelzine, tranylcypromine, linezolid & methylene blue, lithium or St. John's Wort), serotonin-precursors (eg, L-tryptophan), drugs which impair serotonin metabolism, & drugs which may impair tramadol metabolism (CYP2D6 & CYP3A4 inhibitors). Reports of increased INR in some patients taking warfarin. Post-marketing surveillance of tramadol has revealed rare reports of digoxin toxicity. Avoid concomitant use w/ QTc interval-prolonging drugs; drugs that can decrease electrolyte levels.

Analgesics (Opioid)

N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.

P₁S₁S₃