Applies to the following strength(s): 12.5 mg ; 25 mg
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Usual Adult Dose for:
Additional dosage information:
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: Data not available
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.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-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 whole, tablet may be crushed and mixed 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
NASOGASTRIC (NG) Administration:
-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; discontinue therapy if this occurs.
-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.
More about naloxegol
- Other brands: Movantik