QDOLO Dosage & Rx Info | Uses, Side Effects

Qdolo Generic Name & Formulations

Legal Class

CIV

General Description

Tramadol HCl 5mg/mL; oral soln; grape flavor.

Pharmacological Class

Opioid agonist.

How Supplied

Soln—473mL

Storage

Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].

Manufacturer

Athena Bioscience

Generic Availability

Mechanism of Action

The analgesic effect of tramadol is believed to be due to both binding to µ-opioid receptors and weak inhibition of re-uptake of norepinephrine and serotonin.

Qdolo Indications

Indications

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Due to risks of addiction, abuse, and misuse with opioids (can occur at any dosage or duration), reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics) are not tolerated or inadequate to provide analgesia. Should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Qdolo Dosage and Administration

Adult

Use calibrated measuring device. Use lowest effective dose for shortest duration. Individualize. ≥18yrs: initially 25mg/day; increase by 25mg increments every 3 days up to 100mg/day (25mg four times daily). Total daily dose may then be increased, as tolerated, by 50mg every 3 days up to 200mg/day (50mg four times daily). Usual dose: 50–100mg every 4–6 hours as needed; max 400mg/day (80mL). Elderly (>75yrs): max 300mg/day. Renal impairment (CrCl <30mL/min): max 100mg every 12 hours. Severe hepatic impairment: max 50mg every 12 hours. Concomitant use or discontinuation of CYP2D6 inhibitors, CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.

Children

<18yrs: not recommended.

Qdolo Contraindications

Contraindications

Children <12yrs. Post-op management in children <18yrs following tonsillectomy and/or adenoidectomy. 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.

Qdolo Boxed Warnings

Boxed Warning

Serious and life-threatening risks from use of Qdolo: Risk of medication errors; Addiction, abuse, and misuse; Life-threatening respiratory depression; Accidental ingestion; Risks from concomitant use with benzodiazepines or other CNS depressants; Neonatal opioid withdrawal syndrome; Opioid analgesic risk evaluation and mitigation strategy (REMS); Ultra-rapid metabolism of tramadol and other risk factors for life-threatening respiratory depression in children; Interactions with drugs affecting CYP450 isoenzymes.

Qdolo Warnings/Precautions

Warnings/Precautions

Risk of medication errors; ensure accurate dosing. Abuse potential (monitor). Life-threatening respiratory depression esp. during initiation or 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. Risk of life-threatening respiratory depression and death related to ultra-rapid metabolizers of tramadol (esp. in children for post-tonsillectomy and/or adenoidectomy pain). Avoid in adolescents 12–18yrs with conditions associated with hypoventilation (eg, post-op status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, concomitant drugs that cause respiratory depression). Opioid-induced hyperalgesia (OIH) and allodynia; consider decreasing dose of current opioid or opioid rotation if OIH is suspected. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. Monitor for signs of hypotension when initiating or titrating dose. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. Avoid in depressed, suicidal, or addiction-prone patients; consider non-narcotic analgesics. Emotional disturbance. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Hyponatremia. Hypoglycemia. Diabetes. Drug abusers. Severe hepatic (Child-Pugh Class C) or renal impairment (CrCl<30mL/min): reduce dose (see Adult). Ultra-rapid metabolizers (due to CYP2D6 polymorphism): avoid. Reevaluate periodically. Avoid abrupt cessation. Elderly (esp. >75yrs). Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.

Qdolo Pharmacokinetics

Absorption

Mean absolute bioavailability: ~75%. Mean peak plasma concentration occurs at 2 hours.

Distribution

Volume of distribution: 2.6 L/kg (male); 2.9 L/kg (female). Plasma protein bound: ~20%.

Metabolism

Hepatic (CYP2D6, CYP3A4).

Elimination

Renal. Half-life: 6.3 ± 1.4 hours. Total clearance: 8.50 mL/min/kg.

Qdolo Interactions

Interactions

Concomitant other forms of tramadol or carbamazepine: not recommended. Increased risk of profound sedation, respiratory depression, coma, and death 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, cyclobenzaprine, metaxalone, 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 seizure threshold. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or 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). May potentiate serum amylase. Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. Monitor digoxin, warfarin.

Qdolo Adverse Reactions

Adverse Reactions

Dizziness, nausea, constipation, headache, somnolence, pruritus, vomiting; respiratory depression, orthostatic hypotension, syncope, OIH and allodynia; rare: serious skin reactions or other hypersensitivity (discontinue if occur).

Qdolo Clinical Trials

See Literature

Qdolo Note

Not Applicable

Qdolo Patient Counseling

Cost Savings Program

Qdolo Savings & Support

Qdolo

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