Alogliptin oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Tablets containing alogliptin.
Drugs List
Therapeutic Indications
Uses
Type 2 diabetes (NIDDM) not controlled by diet,weight loss & exercise alone
Treatment of type 2 diabetes mellitus in combination with other glucose lowering medicinal products including insulin, when these together with diet and exercise, do not provide adequate glycaemic control.
Dosage
Adults
25mg once daily as add-on therapy to metformin, a thiazolidinedione, a sulfonylurea, or insulin or as triple therapy with metformin and a thiazolidinedione or insulin.
Patients with Renal Impairment
Creatinine clearance 30 to 50ml/minute
12.5mg once daily.
Creatinine clearance below 30ml/minute or end-stage renal disease requiring dialysis
6.25mg once daily.
Alogliptin may be administered without regard to the timing of dialysis. However, experience in such patients is limited.
Additional Dosage Information
When alogliptin is used in combination with a sulfonylurea or insulin, a lower dose of the sulfonylurea or insulin may be considered to reduce the risk of hypoglycaemia.
When alogliptin is used in combination with metformin and/or a thiazolidinedione, the dose of metformin and/or the thiazolidinedione should be maintained. However, in case of hypoglycaemia while the patient is treated with triple therapy, a lower dose of metformin or thiazolidinedione may be considered.
Contraindications
Children under 18 years
Breastfeeding
Pregnancy
Severe hepatic impairment
Precautions and Warnings
History of pancreatitis
New York Heart Association class III failure
New York Heart Association class IV failure
Renal impairment - creatinine clearance below 51ml/minute
Advise ability to drive/operate machinery may be affected by side effects
Monitor renal function before treatment and regularly during treatment
If hepatic impairment symptoms occur monitor LFT & consider discontinuation
Monitor hepatic function
Reduce dose in patients with creatinine clearance below 51ml/min
Advise patients to report symptoms of acute pancreatitis immediately
Discontinue if pemphigus-type reactions develop
Discontinue permanently if acute pancreatitis occurs
Discontinue if pancreatitis is suspected
Patient to inform DVLA if fitness to drive impaired or hypoglycaemic risk
Pregnancy and Lactation
Pregnancy
Alogliptin is contraindicated in pregnancy.
Manufacturers advise to avoid the use of alogliptin during pregnancy as precautionary measure.
At the time of writing there are no data from the use of alogliptin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Detailed guidance on the treatment of diabetes during pregnancy is available from the National Institute for Health and Clinical Excellence (NICE) at https://www.nice.org.uk/guidance/ng3.
Lactation
Alogliptin is contraindicated in breastfeeding.
Manufacturers advise either to stop breastfeeding or to discontinue alogliptin therapy.
At the time of writing, there is no published experience concerning the use of alogliptin during breastfeeding. Animal studies have shown excretion of alogliptin in breast milk. It is unknown whether alogliptin is excreted in human breast milk.
Side Effects
Abdominal pain
Acute pancreatitis
Anaphylactic reaction
Angioedema
Bullous pemphigoid
Diarrhoea
Erythema multiforme
Exfoliative dermatitis
Gastroesophageal reflux disease
Headache
Hepatic failure
Hepatic impairment
Hypersensitivity reactions
Hypoglycaemia
Nasopharyngitis
Pruritus
Rash
Stevens-Johnson syndrome
Upper respiratory tract infection
Urticaria
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: March 2019
Reference Sources
Summary of Product Characteristics: Vipidia 6.25mg, 12.5mg, 25mg film coated tablets. Takeda UK Ltd. Revised March 2021.
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