Description

LABEL DILAUDID is a highly potent opioid analgesic formulated with hydromorphone hydrochloride, designed for managing severe pain in patients who have not found relief with other treatments. Its primary mechanism involves binding to mu-opioid receptors, offering significant pain relief while also potentially causing respiratory depression and cough suppression.

Indications

• Acute and Chronic Pain Management: Particularly suited for opioid-tolerant patients.
• Short-term Use: Recommended when other pain management strategies are ineffective or inappropriate.

Formulations

LABEL DILAUDID is available in various formulations to suit different medical needs:

• Immediate-release Oral Tablets: 2 mg, 4 mg, 8 mg
• Extended-release Oral Tablets: 4 mg, 8 mg, 12 mg, 16 mg, 32 mg, 64 mg
• Oral Solution: 1 mg/mL
• Injectable Solutions: Ranging from 1 mg/mL to 10 mg/mL
• Intravenous Solutions: Including high concentrations for specific clinical settings
• Suppositories: 3 mg

Administration Routes

• Oral
• Intramuscular
• Intravenous
• Subcutaneous
• Rectal

Physical Description

The tablets are distinctively marked for easy identification:

• 2 mg Tablets: Light orange, round
• 4 mg Tablets: Light yellow, round
• 8 mg Tablets: White, triangular

Pharmacology

Hydromorphone is approximately 5–8 times more potent than morphine by weight. It is rapidly absorbed with an oral bioavailability of around 25%, metabolized in the liver, and primarily excreted through urine. The plasma half-life varies slightly between oral and intravenous administration.

Dosage and Administration

• Initial Dosing: Typically 2–4 mg every 4 hours for non-opioid-tolerant adults, with adjustments needed for those with hepatic or renal impairments.
• Tablet Integrity: Slow-release tablets should not be cut, crushed, or chewed.
• Discontinuation: Gradual tapering is recommended to mitigate withdrawal symptoms.

Contraindications

Use of LABEL DILAUDID is contraindicated in individuals with:

• Severe respiratory conditions
• Certain gastrointestinal obstructions
• Recent MAOI therapy
• Specific conditions during pregnancy and labor

Warnings and Precautions

• Risk of Abuse and Addiction: Requires careful monitoring and patient education.
• Respiratory Depression: Particularly during initial dosing or dose adjustments.
• Use in Special Populations: Caution advised in elderly patients and those with certain medical conditions.

Adverse Effects

Common side effects include constipation, nausea, dizziness, and drowsiness. Serious effects may involve respiratory issues, hypotension, and potential for dependence.

Drug Interactions

Interactions may occur with CNS depressants, opioid antagonists, and certain antidepressants, necessitating careful management.

Storage and Handling

• Storage Conditions: Below 25°C, away from light and moisture.
• Safe Disposal: Essential to prevent accidental exposure or misuse.

Special Precautions

High-concentration forms are intended for opioid-tolerant patients only, requiring stringent administration protocols and comprehensive patient education to ensure safe use.