Hydrocodone Bitartrate

HYDROCODONE BITARTRATE

Manufacturer: Alvogen Inc.

Score: 144.0

Quick Summary

Hydrocodone bitartrate extended-release tablets are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The tablets are available in 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg, and 120 mg film-coated tablets for oral administration. The medication has a boxed warning for addiction, abuse, and misuse, as well as life-threatening respiratory depression, and is not recommended for use in patients who are not opioid-tolerant.

Key Clinical Findings and Indications

Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment
Alternative treatment options are inadequate
Opioid agonist

Important Safety Information

Warning

Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; cytochrome P450 3A4 interaction; and risks from concomitant use with benzodiazepines or other CNS depressants

Contraindications

Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Hypersensitivity to hydrocodone or any component of hydrocodone bitartrate extended-release tablets

Adverse Reactions

Constipation
Nausea
Vomiting
Fatigue
Upper respiratory tract infection
Dizziness
Headache
Somnolence

Dosing Recommendations

General Guidance

Adjust the dose of hydrocodone bitartrate extended-release tablets in increments of 10 mg to 20 mg every 3 to 5 days as needed to achieve adequate analgesia

Opioid-naive patients

Adult Dose

20 mg orally every 24 hours

Pediatric Dose

Not recommended

Opioid-tolerant patients

Adult Dose

Daily doses greater than or equal to 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established

Pediatric Dose

Not recommended

Special Population Considerations

Pregnancy

Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome
Available data with hydrocodone bitartrate extended-release tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage

Nursing Mothers

Chronic use of opioids may cause reduced fertility in females and males of reproductive potential
It is not known whether these effects on fertility are reversible

Pediatric Use

The safety and effectiveness of hydrocodone bitartrate extended-release tablets in pediatric patients have not been established
Pediatric patients may be at increased risk of esophageal obstruction, dysphagia, and choking because of a smaller gastrointestinal lumen if they ingest hydrocodone bitartrate extended-release tablets

Geriatric Use

In a controlled pharmacokinetic study, elderly subjects compared to young adults had similar plasma concentrations of hydrocodone
Use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy