Naloxegol acts in an opposite way to opioid and is used for the treatment of constipation due to opioids in adult patients
Naloxegol tablets are used for treating constipation caused by opioids in adults with pain which is not related to cancer.
Naloxegol should not be used in patients:
• An allergy to naloxegol.
• With a high risk of gastrointestinal obstruction (block in the intestine).
• With any stomach or bowel (intestines) problems, including stomach ulcer, Crohn’s disease, diverticulitis, cancer of the stomach or bowel, or Ogilvie’s syndrome.
• Using medicines like clarithromycin, ketoconazole because they can significantly increase the effect to naloxegol which may increase the opioid withdrawal symptoms such as excess sweating, chills, diarrhoea, abdominal pain, anxiety, irritability, and yawning.
• With kidney problems
• With liver problems
Naloxegol is available as 12.5mg and 25mg tablets for in adults.
They should be taken on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal.
Discontinue laxative (drug which stimulates bowel) therapy before starting naloxegol.
Alteration in analgesic (painkiller) dosing regimen before starting naloxegol is not required
Naloxegol effect can be seen in patients who have taken opioids for at least 4 weeks
Naloxegol Tablets must be swallowed as whole.
Tablets should not be crushed or chewed.
Discontinue if treatment with the opioid pain medicine is also stopped.
The recommended dose is 1 tablet of 25 mg daily; if not tolerated, reduce to 12.5 mg 1 tablet daily.
In case of severe kidney damage (Creatinine cr. < 60 mL/min), 12.5 mg 1 tablet should be given daily. Slowly the dose can be increased to 25 mg a tablet if tolerated well.
• Cases of gastrointestinal perforation were reported with use of another opioid antagonist in patients with conditions like peptic ulcer disease (ulcer in the duodenum), gastrointestinal tract cancer or cancer that has spread to the peritoneum.
• The overall risk-benefit ratio should be assessed when using naloxegol in patients with Crohn’s disease where there is an impaired integrity of intestine.
• Patients should be monitored for severe, persistent or increasing abdominal pain. In this case, discontinue naloxegol.
• Patients should be monitored for various opioid withdrawal symptoms like hyperhidrosis (excess sweating), chills, diarrhea, abdominal pain, anxiety, irritability, and yawning.
• Patients taking treatment with methadone (an opioid) for their pain were having a higher frequency of gastrointestinal side effects.
• Gastrointestinal: Abdominal pain, nausea, vomiting, flatulence, diarrhea, gastrointestinal perforation
• Nervous system: Headache
• Others: Hyperhidrosis (excess sweating), opioid withdrawal symptoms
Caution is exercised in case of pregnancy in which opioid withdrawal in developing baby may be increased.
Discontinue drug for nursing women taking into consideration, the importance of the drug to mother.
As the risk of side effects increases with systemic exposure, a starting dose of 12.5 mg single tablet is recommended.
In case of overdosage, no antidote is known for naloxegol.
Dialysis may be ineffective to eliminate naloxegol from the body.
Naloxegol effect may be increased by taking along with antifungal drugs like ketoconazole, itraconazole and antibiotics like erythromycin, clarithromycin and other drugs like diltiazem, verapamil, quinidine.
Intake of grapefruit juice can also increase the effect of naloxegol.
Naloxegol effect can be decreased by drugs like rifampicin, carbamazepine, St John’s wort
Store naloxegol tablets at 20-25°C.
Subscribe to our Free Newsletters!