Exalgo
Exalgo is an extended-release formulation of hydromorphone hydrochloride, a potent Schedule II prescription opioid agonist. It utilizes an osmotic drug delivery system (OROS) to provide controlled release of hydromorphone over a 24-hour period. Because of the risk of addiction, abuse, misuse, and life-threatening respiratory depression, Exalgo is strictly reserved for patients who are already opioid-tolerant and require continuous long-term pain management.
Dosage by Body Weight
Exalgo must be taken once daily, around the same time each day. Tablets must be swallowed whole with enough water to ensure complete swallowing; do not crush, chew, split, or dissolve, as this can cause rapid release and absorption of a potentially fatal dose of hydromorphone. Initial dosage is customized based on prior daily opioid exposure and converted using established conversion ratios. It is intended only for patients who are already receiving opioid therapy at stable doses equivalent to at least 8 mg of oral hydromorphone daily.
- Body Weight
- Below 5 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- Safety and effectiveness in pediatric patients have not been established. Highly potent long-acting opioid posing fatal overdose risk to infants.
- Body Weight
- 5-7 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- Risk of severe, life-threatening respiratory depression. Not indicated for pediatric use.
- Body Weight
- 8-10 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- Not recommended. Exalgo is strictly indicated for adult, opioid-tolerant patients.
- Body Weight
- 11-15 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- Potent extended-release formulation is not suitable for pediatric weight ranges.
- Body Weight
- 16-20 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- This medication is reserved exclusively for opioid-tolerant adults requiring continuous around-the-clock analgesia.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Contraindicated | Do not use | Safety and effectiveness in pediatric patients have not been established. Highly potent long-acting opioid posing fatal overdose risk to infants. |
| 5-7 kg | Contraindicated | Do not use | Risk of severe, life-threatening respiratory depression. Not indicated for pediatric use. |
| 8-10 kg | Contraindicated | Do not use | Not recommended. Exalgo is strictly indicated for adult, opioid-tolerant patients. |
| 11-15 kg | Contraindicated | Do not use | Potent extended-release formulation is not suitable for pediatric weight ranges. |
| 16-20 kg | Contraindicated | Do not use | This medication is reserved exclusively for opioid-tolerant adults requiring continuous around-the-clock analgesia. |
Formulation
Purpose
Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, specifically in opioid-tolerant patients.
Generic Name
Hydromorphone hydrochlorideScheduled Drug
Yes. This medicine should be supplied or used only according to applicable prescription and regulatory requirements.