Naldemedine tablets
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Drugs List
Therapeutic Indications
Uses
Treatment of opioid-induced constipation
Treatment of opioid-induced constipation (OIC) in patients who have been previously been treated with a laxative.
Dosage
Adults
200 micrograms daily.
Take at the same time each day. Naldemedine must be discontinued if treatment with the opioid pain medicinal product is discontinued.
Contraindications
Children under 18 years
Predisposition to gastrointestinal perforation
Suspected gastrointestinal obstruction
Breastfeeding
Gastrointestinal obstruction
Gastrointestinal perforation
Severe hepatic impairment
Precautions and Warnings
Patients over 75 years
Advanced Alzheimer's disease
Brain neoplasm
Central nervous system metastasis
Crohn's disease
Gastrointestinal malignancy
Multiple sclerosis
Ogilvie's syndrome
Peptic ulcer
Pregnancy
Severe renal impairment
Within 3 months of a cerebrovascular accident
Within 3 months of a myocardial infarction
Advise patient to stop and contact Dr if severe/persistent abdominal pain
Discontinue if severe abdominal symptoms develop
If opioid withdrawal occurs, discontinue treatment and contact physician
Advise patient not to take St John's wort concurrently
Advise patient to avoid grapefruit products
Patients that experience blood-brain barrier disruptions may be at increased risk of opioid withdrawal or reduced analgesia. A risk assessment prior to treatment and close monitoring should be considered in these patients.
Pregnancy and Lactation
Pregnancy
Use naldemedine with caution during pregnancy.
The manufacturer does not recommend using naldemedine during pregnancy unless the clinical condition of the woman requires treatment. At the time of writing there is limited published information regarding the use of naldemedine during pregnancy. The use of naldemedine during pregnancy may cause opiod withdrawal in the foetus due to the immature foetal blood brain barrier. Potential risks are unknown.
Lactation
Naldemedine is contraindicated during breastfeeding.
Use of naldemedine when breastfeeding is contraindicated by the manufacturer. It is unknown whether naldemedine or its metabolites are excreted in human milk. Animal data reports significant levels of naldemedine in the breast milk. The effects on exposed infants are unknown.
Side Effects
Abdominal discomfort
Abdominal pain
Arthralgia
Chills
Diarrhoea
Gastro-intestinal perforation
Hot flushes
Hyperhidrosis
Hypersensitivity reactions
Increased lacrimation
Myalgia
Nausea
Opioid withdrawal syndrome
Pyrexia
Sensation of cold
Sneezing
Tachycardia
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: June 2021
Reference Sources
Summary of Product Characteristics: Rizmoic 200micrograms film-coated tablets. Shionogi. Revised January 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 June 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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