RSS | Login | Register

RYBIX ODT

Last Updated: July 15, 2010

Manufacturer:

Victory Pharma

Pharmacological Class:

Opioid

Active Ingredient(s):

Tramadol HCl 50mg; orally-disintegrating tabs; mint flavor; contains phenylalanine.

Indication(s):

Moderate to moderately severe pain in adults.

Pharmacology:

Rybix ODT is an orally disintegrating tablet formulation of the centrally acting synthetic opioid, tramadol HCl. Tramadol and its O-demethylated metabolite M1 bind to the mu-opioid receptors in the CNS and also exert weak inhibition of norepinephrine and serotonin reuptake to produce an analgesic effect.

Clinical Trials:

The efficacy of Rybix ODT was derived from three double-blind, controlled trials of 1–3 months duration that evaluated orally swallowed immediate-release tramadol tablets. The studies enrolled a total of 820 patients with a variety of chronic painful conditions. Average tramadol doses of approximately 250mg/day in divided doses were shown to be comparable to five doses of acetaminophen 300mg with codeine phosphate 30mg daily, five doses of aspirin 325mg with codeine phosphate 30mg daily, or 2–3 doses of acetaminophen 500mg with oxycodone HCl 5mg daily.

There have been no studies indicating that Rybix ODT has a faster onset of action than orally swallowed immediate-release tramadol tablets.

Legal Classification:

Adults:

≥17years: Dissolve on tongue; swallow with or without water. Titration regimen: increase total daily dose by 50mg as tolerated every 3 days up to 200mg/day (eg, 50mg four times daily), then may increase to 50–100mg every 4–6 hours; max 400mg/day. For rapid onset of analgesic effect: 50–100mg every 4–6 hours as needed; max 400mg/day. >75 years: max 300mg/day. Renal dysfunction (CrCl <30mL/min): increase dosing intervals to 12 hours; max 200mg/day. Cirrhosis: 50mg every 12 hours.

Children:

<17years: not recommended.

Contraindication(s):

Acute intoxication with alcohol, hypnotics, narcotics, centrally acting analgesics, other opioids, or psychotropic drugs.

Warnings/Precautions:

Do not give to opioid-dependent patients. Respiratory depression. Increased intracranial pressure. Head injury. Seizure disorders. Acute abdomen. Renal or hepatic impairment. Suicidal ideation. Drug abusers. Avoid abrupt cessation. Elderly (esp. >75 years). Labor & delivery, pregnancy (Cat.C), nursing mothers: not recommended.

Interaction(s):

Concomitant MAOIs, carbamazepine, alcohol, or other forms of tramadol: 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).