Tramadol Hydrochloride

TRAMADOL HYDROCHLORIDE

Manufacturer: RPK Pharmaceuticals, Inc.

Score: 148.0

Quick Summary

Tramadol hydrochloride extended-release tablets are 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 contraindicated in children younger than 12 years of age, and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Tramadol hydrochloride extended-release tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. The dosage of tramadol hydrochloride extended-release tablets should be individualized according to patient need, and the tablets should be taken whole and not crushed, chewed, split, or dissolved.

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 and inhibitor of reuptake of norepinephrine and serotonin
Extended-release formulation for oral use

Important Safety Information

Warning

Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; ultra-rapid metabolism of tramadol and other risk factors for life-threatening respiratory depression in children; neonatal opioid withdrawal syndrome; interactions with drugs affecting cytochrome P450 isoenzymes; and risks from concomitant use with benzodiazepines or other CNS depressants

Contraindications

Children younger than 12 years of age
Children younger than 18 years of age 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 gastrointestinal obstruction, including paralytic ileus
Hypersensitivity to tramadol
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days

Adverse Reactions

Dizziness
Constipation
Nausea
Headache
Somnolence
Flushing
Pruritus
Vomiting
Insomnia
Dry mouth

Dosing Recommendations

General Guidance

Do not exceed a daily dose of 300 mg tramadol; do not use with other tramadol products

Chronic pain

Adult Dose

100 mg once daily, titrated up by 100 mg increments every 5 days as needed and tolerated

Pediatric Dose

Not recommended for use in pediatric patients younger than 18 years of age

Special Population Considerations

Pregnancy

Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome
Use with caution in pregnant women, and advise them of the potential risk to a fetus

Nursing Mothers

Tramadol is known to be excreted in human milk
Use with caution in nursing mothers, and monitor the infant for signs of sedation and respiratory depression

Pediatric Use

Not recommended for use in pediatric patients younger than 18 years of age
Life-threatening respiratory depression and death have occurred in children who received tramadol

Geriatric Use

Use with caution in geriatric patients, and monitor them closely for signs of central nervous system and respiratory depression
Titrate the dosage slowly in geriatric patients, and consider their decreased renal function when selecting a dose