- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Tablet containing glimepiride 1mg
Tablet containing glimepiride 2mg
Tablet containing glimepiride 3mg
Tablet containing glimepiride 4mg
Treatment of non-insulin dependent (type 2) diabetes mellitus when diet, physical exercise and weight reduction alone are not adequate.
Dosage is determined by the results of blood and urinary glucose measurements.
The initial dose is 1mg daily.
If a patient has a hypoglycaemic reaction on 1mg daily, this indicates that they can be controlled by diet alone.
If good control is achieved then this dose may be maintained.
If control is unsatisfactory the dose should be increased, in line with glucose measurements, by 1mg every one to two weeks, until a satisfactory response is achieved with a dose of 2mg, 3mg or 4mg daily.
Increasing the dose beyond 4mg, improves control only in exceptional cases. The maximum recommended dose is 6mg glimepiride daily.
Change in dosage, or cessation of therapy may need to be considered in the course of treatment when: improved control of diabetes results in higher insulin sensitivity, if there are changes in the patient's weight or lifestyle, or if other factors increase the risk of hypoglycaemia or hyperglycaemia.
Combination with metformin:
In patients not adequately controlled with the maximum daily dose of metformin, concomitant glimepiride therapy may be started. While maintaining the metformin dose, glimepiride therapy is started at a low dose and titrated up. Combination therapy should be initiated under close medical supervision.
Combination with insulin:
In patients not adequately controlled on the maximum dose of glimepiride, concomitant insulin therapy may be started at a low dose and titrated up. Combination therapy should be initiated under close medical supervision.
Changing from other oral hypoglycaemic agents
The strength and half life of the previous medication should be considered. In some cases, notably those agents with a long half life (e.g. chlorpropamide) a wash out period of a few days is advised to avoid additive hypoglycaemic episodes.
The initial dose is 1mg daily. Based on the response the dose may be increased stepwise, as above.
Changing from insulin to glimepiride
In exceptional cases, where type II diabetic patients are regulated on insulin, a changeover to glimepiride may be indicated. The changeover should be initiated under close medical supervision.
The available data on safety and efficacy are sufficient in children under 18 years and therefore its use is not recommended.
Patients with Renal Impairment
Glimepiride is contraindicated in patients with severe renal impairment.
Use with caution in patients with mild to moderate renal impairment.
Patients with Hepatic Impairment
Glimepiride is contraindicated in severe hepatic impairment.
Oral once daily dosing is usually sufficient.
The dose should be taken shortly before or during the first main meal of the day.
Tablets should be swallowed whole with liquid.
If a dose is omitted, advise the patient that the next dose must not be increased.
Severe renal impairment
Severe hepatic impairment
Pregnancy (see Pregnancy section)
Lactation (see Lactation section)
Children under 18 years
Precautions and Warnings
Glimepiride must be taken shortly before or with a meal.
When meals are taken at irregular hours or skipped altogether, treatment may lead to hypoglycaemia (signs of adrenergic counter-regulation may also be present). The clinical picture of hypoglycaemia may resemble that of a stroke.
Symptoms can almost always be promptly controlled by immediate intake of carbohydrates/sugar. Despite initial successful treatment, hypoglycaemia may recur. Hypoglycaemia that is severe or prolonged and only temporarily controlled by the usual amounts of sugar requires immediate medical treatment. Hospitalisation may be needed in some instances.
Factors that may favour the development of hypoglycaemia include:
Poor patient compliance (particularly in the elderly)
Undernutrition, irregular mealtimes, missed meals, fasting
Alterations in diet
Imbalance between exercise and dietary intake
Alcohol consumption (notably in combination with missed meals)
Impaired renal function
Serious hepatic impairment
Certain uncompensated endocrine disorders affecting carbohydrate metabolism ( e.g. thyroid disorders, anterior pituitary disorders, adrenocortical insufficiency)
Overdose with glimepiride
Monitor hepatic function
Monitor haematological parameters (especially leucocytes and thrombocytes)
Monitor blood or urinary glucose
Monitoring of glycosylated haemoglobin is recommended
Cross sensitivity to sulfonamides or derivatives may occur.
Blood glucose control may be affected by fever, trauma, infection or surgical intervention. In some cases transfer to insulin may be necessary. Glimepiride dosage should be omitted on the morning of surgery; insulin is required because of the ensuing hyperglycaemia in these circumstances. Patients should be advised to maintain a healthy diet for optimum blood glucose control.
Glimepiride should be used with caution in elderly and debilitated patients as these groups are more susceptible to hypoglycaemia.
This medication contains lactose and should therefore be avoided in patients with rare hereditary problems of lactose intolerance or glucose-galactose malabsorption syndrome.
Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia and therefore this medication should not be used in such patients.
The patient's ability to drive/operate machinery may be impaired as a result of hypoglycaemia, hyperglycaemia or visual impairment. Patients should be advised to take precautions to avoid hypoglycaemia, especially if they have reduced or absent awareness of hypoglycaemia developing or have frequent hypoglycaemic episodes. The advisability of driving in these circumstance should be considered.
Inform the patient that they may need to inform the Driving and Vehicle Licensing Agency (DVLA) about the medication they are receiving. The Drivers Medical Group at the DVLA will be able to advise the patient on the legal issues surrounding the treatment of diabetes mellitus and driving.
Use in Porphyria
The Norwegian porphyria centre (NAPOS) classes glimepiride as being 'possibly porphyrinogenic'. Therefore this medication should not be used in patients with porphyria.
Pregnancy and Lactation
Glimepiride is contraindicated in pregnancy.
At the time of writing, there is no published experience concerning exposed human pregnancies and their outcomes. Animal studies have shown no teratogenic effects although there are reports of skeletal deformities developing during the postnatal period in rats and also foetotoxicity (intrauterine death) in rats and rabbits. Foetotoxicity has been seen with other sulfonylureas at doses sufficient to produce maternal hypoglycaemia and it is thought that it may be due to that effect. It is unknown whether glimepiride crosses the placenta although foetal exposure can be expected due to the molecular weight. Hypoglycaemia in the newborn is therefore a potential risk if glimepiride were to be taken close to delivery.
Insulin is considered to be the drug of choice in diabetic patients during pregnancy as it provides superior glycaemic control to oral antidiabetic agents and also does not cross the placenta. Insulin is the treatment of choice for both Type 1 and Type 2 diabetes during pregnancy as it provides better control of maternal blood glucose compared to oral hypoglycaemics. It is believed that human insulin and insulin analogues do not cross the placenta, however there may be endogenous carrier proteins allowing passage of insulin to the embryo during early gestation; animal insulin is believed to cross the human placenta. The foetus produces its own insulin once insulin-secreting cells in the foetal pancreas become differentiated at the end of the first trimester.
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/CG63/NiceGuidance/pdf/English .
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
At the time of writing there is no published experience concerning the use of glimepiride during breastfeeding. Due to its relatively low molecular weight, it is likely to appear in breast milk and animal studies have demonstrated this. Neonatal hypoglycaemia is therefore a potential risk. It is recommended that insulin should be used in women wishing to breast-feed.
Insulin is a natural component of breast milk and insulin treatment of breastfeeding mothers should represent no risk to the infant. Insulin in breast milk is digested by the infant's gut (Briggs, 2011) and is thought to contribute to intestinal maturation and decrease the risk of contracting type 1 diabetes in breastfed infants (Lactmed, via Toxnet). Proper insulin levels are required for lactation. Good glycaemic control decreases the delay in establishment of lactation that is observed in diabetic mothers as well as enhancing maternal serum and milk prolactin concentrations. No adverse effects have been reported relating the use of insulin to breastfeeding, therefore it is considered safe to for diabetic mothers receiving insulin to continue breastfeeding.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Effects on Ability to Drive and Operate Machinery
The patients ability to drive/operate machinery may be impaired as a result of hypoglycaemia, hyperglycaemia or visual impairment.
Patients should be advised to take precautions to avoid hypoglycaemia, especially if they have reduced or absent awareness of hypoglycaemia developing or have frequent hypoglycaemic episodes. The advisability of driving in these circumstance should be considered.
Advise patients the dose should be taken shortly before or during the first main meal of the day.
Advise patients tablets should be swallowed whole with liquid.
Advise patients that if a dose is omitted, this should not be corrected by increasing the next dose.
Advise patients alcohol consumption (notably in combination with missed meals) may alter the hypoglycaemic action of glimepiride in an unpredictable manner.
Advise patients the patients ability to drive/operate machinery may be impaired as a result of hypoglycaemia, hyperglycaemia or visual impairment. Patients should be advised to take precautions to avoid hypoglycaemia, especially if they have reduced or absent awareness of hypoglycaemia developing or have frequent hypoglycaemic episodes. The advisability of driving in these circumstance should be considered.
Inform the patient that he/she needs to inform the Driving and Vehicle Licensing Agency (DVLA) about the medication they are receiving. The Drivers Medical Group at the DVLA will be able to advise the patient on the legal issues surrounding the treatment of diabetes mellitus and driving.
The DVLA can be contacted by post at the following address:
Drivers Medical Group, DVLA, Swansea, SA99 1TU
By phone on 0870 600 0301; or by fax on 0845 850 0095
Detailed guidance on eligibility to drive, and precautions required, is available from the DVLA.
Further information concerning diabetes and driving may be obtained from the DVLA website at:
Liver function disturbances
Increases in hepatic enzymes
Allergic skin reactions
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 ).
Shelf Life and Storage
Storage conditions vary between brands. Consult product literature.
Last Full Review Date: September 2012
British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Amaryl 1mg tablets. Sanofi-Aventis. Revised September 2012.
Summary of Product Characteristics: Amaryl 2mg tablets. Sanofi-Aventis. Revised September 2012.
Summary of Product Characteristics: Amaryl 3mg tablets. Sanofi-Aventis. Revised September 2012.
Summary of Product Characteristics: Amaryl 4mg tablets. Sanofi-Aventis. Revised September 2012.
Summary of Product Characteristics: Glimepiride 1mg tablets. Teva UK Ltd. Revised May 2011.
Summary of Product Characteristics: Glimepiride 2mg tablets. Teva UK Ltd. Revised May 2011.
Summary of Product Characteristics: Glimepiride 3mg tablets. Teva UK Ltd. Revised May 2011.
Summary of Product Characteristics: Glimepiride 4mg tablets. Teva UK Ltd. Revised May 2011.
The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.
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