ULTRACET Rx

Indications for ULTRACET:

Short-term (≤5 days) management of acute pain.

Adult Dose for ULTRACET:

2 tabs every 4–6 hours; max 8 tabs/day. Renal dysfunction (CrCl <30 mL/min): max 2 tabs every 12 hours.

Children's Dose for ULTRACET:

Not recommended.

Pharmacological Class:

Opioid + non-opioid analgesic.

Contraindications:

Acute intoxication with alcohol, hypnotics, narcotics, centrally-acting analgesics, other opioids, or psychotropics.

Warnings/Precautions:

Do not give to opioid-dependent patients. Hepatic impairment: not recommended. Respiratory depression. Increased intracranial pressure. Head injury. Seizure disorders. Acute abdomen. Suicidal ideation. Renal impairment. Avoid abrupt cessation. Elderly. Drug abusers. Labor & delivery, pregnancy (Cat.C), nursing mothers: not recommended.

Interactions:

Concomitant MAOIs, carbamazepine, alcohol, other tramadol- or acetaminophen-containing products: not recommended. Increased risk of seizures and/or serotonin syndrome with SSRIs, SNRIs, tricyclics, cyclobenzaprine, promethazine, opioids, MAOIs, naloxone, triptans, linezolid, lithium, neuroleptics, others that lower seizure threshold. Potentiation with alcohol, other CNS depressants; reduce dose. May be potentiated by CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine, amitriptyline). May potentiate digoxin, warfarin. May be affected by CYP3A4 inhibitors (eg, ketoconazole, erythromycin) or CYP3A4 inducers (eg, rifampin, St. John's Wort).

Adverse Reactions:

Somnolence, constipation, dizziness, sweating, GI upset, anorexia, dry mouth, pruritus, insomnia, prostate disorders, seizures, anaphylaxis, hepatotoxicity (overdosage).

How Supplied:

Tabs—100