Usual Adult Dose for Constipation - Drug Induced

Opioid-Induced Constipation - Chronic:

Initial dose: 25 mg orally once a day
Maintenance dose: 25 mg orally once a day; dose may be reduced to 12.5 mg orally once a day for patients unable to tolerate higher dose

Comments: Prior to initiation, discontinue all maintenance laxative therapy; laxatives can be used as needed for suboptimal response after 3 days.

Use: For the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain.

Renal Dose Adjustments

• CrCl less than 60 mL/min: Reduce starting dose to 12.5 mg orally once a day; may increase to 25 mg orally once a day as needed for symptoms, if tolerated.
• Use caution in patients with renal impairment as there is a potential for markedly increased exposures in some patients with renal impairment.

Liver Dose Adjustments

Mild or moderate hepatic impairment: No adjustment recommended
Severe hepatic impairment: Avoid use

Dose Adjustments

Dose Adjustments due to Drug Interactions:

• Concomitant use with strong CYP450 3A4 inhibitors is contraindicated.
• Concomitant use with moderate CYP450 3A4 inhibitors should be avoided; if unavoidable, reduce dose of naloxegol to 12.5 mg orally once a day and monitor for adverse reactions.

• Discontinue use of this drug if treatment with the opioid pain medication is discontinued.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take on an empty stomach, 1 hour before the first meal of the day or 2 hours after the meal
• Swallow tablets whole, do not crush or chew
• If unable to swallow tablets whole, may crush to a powder and mix with 4 ounces of water; drink immediately, then rinse glass with an additional 4 ounces of water and drink again.
• Avoid grapefruit (juice and fruit) during treatment

• Flush NG tube with 30 mL of water using a 60 mL syringe
• Crush tablet and mix with 60 mL of water; draw mixture into 60 mL syringe and administer contents through NG tube
• Rinse container used to mix crushed tablet with water with an additional 60 mL of water; use all the water to flush the NG tube.

• If treatment with opioid pain medication is discontinued, this drug should be discontinued.
• In patients with chronic non-cancer pain, all maintenance laxative therapy should be discontinued prior to initiating therapy; laxatives can be used as needed after 3 days.
• This drug has been shown to be efficacious in patients who have taken opioids for at least 4 weeks; sustained exposure to opioids prior to starting this drug may increase the patient's sensitivity.

• Monitor for the development of severe, persistent, or worsening abdominal pain

• If unusually severe, persistent, or worsening abdominal pain develops, promptly seek medical attention.
• If severe or persistent diarrhea occurs, patients should be advised to stop therapy and consult their healthcare provider.
• If symptoms of opioid withdrawal such as sweating, chills, anxiety, irritability, and yawning occur, patients should be instructed to let their healthcare provider know.
• Speak to your physician or health care professional if you become pregnant, intend to become pregnant, or are breastfeeding.

Frequently asked questions

• Which drugs cause opioid-induced constipation?