Narcotic analgesics:

Indications for APADAZ:

Short term management (≤14 days) of acute pain severe enough to require opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use:

Reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate.

Adult:

Use lowest effective dose for shortest duration. Individualize. Initially 1–2 tabs every 4–6hrs as needed; max 12 tabs/day. Conversion to/from other opioids: see full labeling. Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.

Children:

<18yrs: not established.

Contraindications:

Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.

Boxed Warning:

Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. CYP3A4 interaction. Hepatotoxicity. Risks from concomitant use with benzodiazepines or other CNS depressants.

Warnings/Precautions:

Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). Increased risk of hepatotoxicity with underlying liver disease, concomitant alcohol, acetaminophen doses >4g/day or involving >1 acetaminophen-containing product. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Discontinue at the 1st sign of rash or any other hypersensitivity. Drug abusers. Renal or hepatic impairment: monitor. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy: potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery: not recommended. Nursing mothers: monitor infants.

Pharmacologic Class:

Opioid + analgesic.

Interactions:

Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs: not recommended. Avoid concomitant other acetaminophen-containing drugs. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. May increase serum amylase.

Adverse Reactions:

Nausea, somnolence, vomiting, constipation, pruritus, dizziness, headache; respiratory depression, severe hypotension, syncope, hepatotoxicity; rare: serious skin or hypersensitivity reactions.

REMS:

YES

How Supplied:

Tabs—100

Pricing for APADAZ

4.08mg/325mg tablet (Qty: 30)
Appx. price $11
GoodRx