RYZOLT Rx

Indications for RYZOLT:

Moderate to moderately severe chronic pain when around-the-clock treatment for an extended time is needed.

Adult Dose for RYZOLT:

Swallow whole. Take once daily (allow 24 hours in between doses). Not currently on tramadol: 100mg once daily; may increase every 2–3 days by 100mg/day. Usual range: 200–300mg/day. Currently on immediate-release tramadol: Switch to ext-rel at same daily dose or rounded down to nearest 100mg increment. Max 300mg/day. Withdraw gradually.

Children's Dose for RYZOLT:

<16yrs: not recommended.

Pharmacological Class:

Opioid.

Contraindications:

Significant respiratory depression, acute or severe bronchial asthma, or hypercapnia in unmonitored settings or without resuscitative equipment.

Warnings/Precautions:

Do not give to opioid- dependent patients. Respiratory depression. Increased intracranial pressure. Head injury. Seizure disorders. Suicidal ideation. Acute abdomen. Hepatic or severe renal impairment (CrCl<30mL/min): not recommended. Drug abusers. Avoid abrupt cessation. Elderly (esp. >75yrs). Labor & delivery, pregnancy (Cat.C), nursing mothers: not recommended.

Interactions:

Concomitant other forms of tramadol. Do not take with MAOIs, alcohol, carbamazepine. Potentiated by alcohol, other CNS depressants (reduce dose). 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. May be affected by CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine, amitriptyline) or CYP3A4 inhibitors (eg, ketoconazole, erythromycin) or inducers (eg, rifampin, St. John's wort). Monitor digoxin, warfarin.

Adverse Reactions:

GI upset, constipation, dizziness, drowsiness, anorexia, sweating, dry mouth, vertigo, insomnia; anaphylaxis.

How Supplied:

Tabs—30, 90