Tramadol Extended-Release Tabs CIV

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Tramadol Extended-Release Tabs

Narcotic analgesics
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Generic Name and Formulations:

Tramadol HCl 100mg, 200mg, 300mg.

Select therapeutic use:

Indications for Tramadol Extended-Release Tabs:

Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate.

Adult:

Use lowest effective dose for shortest duration. Swallow whole. Individualize. ≥18yrs: initially 100mg once daily; may increase by 100mg every 5 days; max 300mg/day. Severe renal (CrCl <30mL/min) or hepatic (Child-Pugh Class C) impairment: not recommended. Concomitant use or discontinuation of CYP2D6 inhibitors, CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling. Withdraw gradually by 25–50% every 2–4 days.

Children:

<18yrs: not recommended.

Contraindications:

Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus. During or within 14 days of MAOIs.

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). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. Suicidal ideation. Depression. Emotional disturbance. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Drug abusers. Renal or hepatic impairment. Allergy to codeine or other opioids; avoid. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.

Interactions:

Concomitant carbamazepine, other tramadol-containing products: not recommended. 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. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Increased risk of seizures with SSRIs, SNRIs, anorectics, TCAs, cyclobenzaprine, promethazine, other opioids, MAOIs, naloxone, neuroleptics, and others that lower the seizure threshold. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. May be affected by CYP2D6 inhibitors (eg, amiodarone, quinidine, fluoxetine, paroxetine, bupropion). 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. Monitor digoxin, warfarin.

See Also:

ULTRAM

Pharmacological Class:

Opioid agonist.

Adverse Reactions:

Dizziness, nausea, constipation, headache, somnolence, flushing, pruritus, vomiting, insomnia, dry mouth; respiratory depression, severe hypotension, syncope; rare: serious skin reactions or other hypersensitivity; discontinue if occur.

Note:

Formerly known under the brand name Ultram ER.

How Supplied:

ER tabs—contact supplier; Tabs—100