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Gliclazide (United States: Not available): Drug information

Gliclazide (United States: Not available): Drug information
(For additional information see "Gliclazide (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • APO-Gliclazide;
  • APO-Gliclazide MR;
  • Diamicron MR;
  • Diamicron [DSC];
  • Gliclazide-80 [DSC];
  • MINT-Gliclazide MR;
  • MYLAN-Gliclazide MR;
  • SANDOZ Gliclazide MR;
  • TARO-Gliclazide MR;
  • TEVA-Gliclazide
Pharmacologic Category
  • Antidiabetic Agent, Sulfonylurea
Dosing: Adult

Note: The 30 mg modified-release tablet is equivalent to the 80 mg immediate-release tablet.

Diabetes mellitus, type 2, treatment

Diabetes mellitus, type 2, treatment:

Note: May be used as an adjunctive agent or alternative monotherapy for patients in whom initial therapy with lifestyle modification and metformin failed or who cannot take metformin. Sulfonylureas are associated with a greater risk of hypoglycemia than other noninsulin antidiabetic agents; if one is chosen, a sulfonylurea with a lower relative risk of hypoglycemia (eg, gliclazide, glipizide, glimepiride) is preferred (Ref).

Immediate-release tablet:

Oral: Initial: 40 to 80 mg once daily with the first main meal (Ref).

Dosage adjustment: May increase dose in 40 to 80 mg increments every 1 to 4 weeks if needed to achieve glycemic goals; usual maintenance dose: 40 to 160 mg/day (maximum: 320 mg/day) (Ref). Note: Administer doses ≥160 mg/day in 2 divided doses.

Note: Dosing in the prescribing information may not reflect current clinical practice and is not routinely recommended.

Modified-release tablet:

Oral: Initial: 30 mg once daily with the first main meal.

Dosage adjustment: May increase dose in 30 mg increments every 1 to 4 weeks if needed to achieve glycemic goals; usual maintenance dose: 30 to 60 mg/day (maximum: 120 mg/day) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Note: Gliclazide is primarily metabolized in the liver to several inactive metabolites, with <1 % excreted unchanged in the urine (Ref); however, conservative initial and maintenance dosing is recommended to avoid hypoglycemic events (Ref).

Altered kidney function:

eGFR >60 mL/minute/1.73 m2: No dosage adjustment necessary (Ref).

eGFR 15 to 60 mL/minute/1.73 m2:

Note: Use with caution. Initiate at low doses, and titrate gradually with close monitoring. Consider further dose reductions for hypoglycemia or with worsening kidney function.

IR tablet: Oral: Initial: 40 once daily; may gradually increase dose in 40 mg increments every 2 to 4 weeks if needed to achieve glycemic goals (Ref).

Modified-release tablet: Oral: Initial: 30 once daily; may increase dose in 30 mg increments every 2 to 4 weeks if needed to achieve glycemic goals (Ref). Note: Gliclazide MR 30 mg is considered bioequivalent to gliclazide IR 80 mg; initiation with immediate release product may be preferred in some patients (Ref).

eGFR <15 mL/minute/1.73 m2:

Note: Avoid use if possible (Ref); use is contraindicated in the manufacturer's labeling; agents other than sulfonylureas are preferred due to risk of hypoglycemia (Ref); if hypoglycemia should occur, it may be prolonged (Ref). If necessary, the following doses may be considered:

IR tablet: Oral: Initial: 20 to 40 mg once daily; may increase dose in 20 to 40 mg increments every 2 to 4 weeks if needed to achieve glycemic goals (expert opinion).

Modified-release tablet: Immediate-release is preferred for initiation of therapy. If patient is already on a stable dose of modified release product, may consider continuing therapy at a reduced dose with close monitoring for hypoglycemia (Ref). Note: Gliclazide MR 30 mg is considered bioequivalent to gliclazide IR 80 mg.

Hemodialysis, intermittent (thrice weekly): Not likely to be substantially dialyzable (highly protein bound) (Ref):

Oral: Dose as for eGFR <15 mL/minute/1.73 m2 (Ref).

Peritoneal dialysis: Not likely dialyzable (highly protein bound) (Ref):

Oral: Dose as for eGFR <15 mL/minute/1.73 m2 (Ref).

CRRT: Avoid use (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Avoid use (Ref).

Dosing: Hepatic Impairment: Adult

Mild to moderate impairment

Immediate-release tablet: There are no specific dosage adjustments provided in the manufacturer’s labeling; however, a dosage reduction may be required.

Modified-release tablet: Refer to adult dosing.

Severe impairment: Use is contraindicated.

Dosing: Older Adult

Note: Use of sulfonylureas (eg, gliclazide) is associated with increased risk of hypoglycemia. Diabetes Canada guidelines suggest using sulfonylureas with caution, and note preference for gliclazide due to lower relative risk of hypoglycemia compared to other sulfonylureas (Ref).

Immediate-release tablet: Initial: 40 mg once daily (Ref).

Modified-release tablet: Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Endocrine & metabolic: Hypoglycemia (11% to 12%)

1% to 10%:

Cardiovascular: Hypertension (3% to 4%), angina pectoris (2%), peripheral edema (1%)

Central nervous system: Headache (4% to 5%), dizziness (2%), depression (1% to 2%), insomnia (1% to 2%), neuralgia (≤1%)

Dermatologic: Dermatological disorders (2%), dermatitis (1% to 2%), skin rash (1%; includes maculopapular rash, morbilliform rash), pruritus (≤1%)

Endocrine & metabolic: Hyperglycemia (2%), hyperlipidemia (≤1%), lipid metabolism disorder (≤1%)

Gastrointestinal: Diarrhea (2% to 3%), constipation (1% to 2%), gastroenteritis (1% to 2%), abdominal pain (1%), gastritis (1%), nausea (≤1%)

Genitourinary: Urinary tract infection (3%)

Infection: Viral infection (6% to 8%)

Neuromuscular & skeletal: Back pain (4% to 5%), arthralgia (3% to 4%), asthenia (2% to 3%), arthropathy (2%), myalgia (2%), arthritis (1% to 2%), tendinopathy (1%)

Ophthalmic: Conjunctivitis (1%)

Otic: Otitis media (≤1%)

Respiratory: Bronchitis (4% to 5%), rhinitis (4% to 5%), pharyngitis (4%), upper respiratory tract infection (3% to 4%), cough (2%), pneumonia (1% to 2%), sinusitis (1% to 2%)

Frequency not defined:

Endocrine & metabolic: Increased lactate dehydrogenase

Renal: Increased serum creatinine

<1%, postmarketing, and/or case reports: Abnormal lacrimation, acute myocardial infarction, acute pancreatitis, agranulocytosis, albuminuria, anal fissure, anemia, angioedema, anxiety, arteritis, asthma, auditory disturbance, balanitis, bone disease (spine malformation), breast neoplasm (female; benign), bullous rash, bursitis, cardiac failure, carpal tunnel syndrome, cataract, cerebrovascular disease, chest pain, cholestatic jaundice, colitis, confusion, conjunctival hemorrhage, coronary artery disease, cystitis, dermal ulcer, diplopia, disulfiram-like reaction, drug reaction with eosinophilia and systemic symptoms, duodenal ulcer, dyspepsia, dyspnea, eczema, epigastric fullness, epistaxis, erythema of skin, erythrocytopenia, esophagitis, fecal incontinence, fever, flatulence, fungal dermatitis, fungal infection, gastroesophageal reflux disease, gastrointestinal neoplasm (benign), glaucoma, glycosuria, gout, hemolytic anemia, hemorrhoids, hepatitis, hepatomegaly, hypercholesterolemia, hyperkeratosis, hypersensitivity angiitis, hypersensitivity reaction, hypertriglyceridemia, hypoglycemic coma, hyponatremia, hypotension, hypothyroidism, impotence, increased appetite, increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, increased serum transaminases, increased thirst, infection, leukopenia, lower extremity pain, malaise, mastitis, melena, menstrual disease, nail disease, nephrolithiasis, nervousness, neuropathy, nocturia, onychomycosis, pain, palpitations, pancytopenia, polyuria, prostatic disease, renal cyst, retinopathy, sialorrhea, skeletal pain, Stevens-Johnson syndrome, tachycardia, thrombocytopenia, thrombophlebitis, tinnitus, toothache, toxic epidermal necrolysis, tracheitis, urticaria, vaginitis, vascular disease (vein disorder), visual disturbance, vitreous disorder, vomiting, weight gain, xeroderma, xerophthalmia, xerostomia

Contraindications

Hypersensitivity to gliclazide, other sulfonylureas or sulfonamides, or any component of the formulation; unstable and/or type 1 diabetes mellitus; diabetic ketoacidosis (with or without coma); severe renal or hepatic impairment; stress conditions (eg, serious infection, trauma, surgery); concurrent use with miconazole (systemic or oromucosal gel); pregnancy; breastfeeding.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Note: Although the FDA-approved product labeling states this medication is contraindicated in patients with hypersensitivity to sulfonamide-containing drugs, the scientific basis of this cross-sensitivity has been challenged. See “Warnings/Precautions” for more detail.

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular mortality: US product labeling of sulfonylureas states oral hypoglycemic drugs may be associated with an increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. Data to support this association are limited, and several studies, including a large prospective trial (UKPDS 1998), have not supported an association. The American Diabetes Association (ADA) and Canadian guidelines suggest second generation sulfonylureas (including gliclazide) have a neutral cardiovascular risk profile; however, in patients with established atherosclerotic cardiovascular disease, other agents (eg, with demonstrated cardiovascular risk reduction) are preferred (ADA 2022; Diabetes Canada 2018).

• Hypersensitivity: Serious skin and hypersensitivity reactions including rash, pruritus, urticaria, angioedema, erythema, maculopapular rashes, bullous reactions (such as Stevens-Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN]) and drug rash with eosinophilia and systemic symptoms have been reported.

• Hypoglycemia: All sulfonylurea drugs are capable of producing severe hypoglycemia; the incidence of hypoglycemia is least with gliclazide compared to other sulfonylureas (eg, glimepiride, glyburide) (Diabetes Canada 2018). Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when ethanol is ingested, or when >1 glucose-lowering drug is used. It is also more likely in older adults, malnourished patients, and in patients with impaired renal or hepatic function; use with caution. Autonomic neuropathy and concomitant use of beta-blockers or other sympatholytic agents may impair the patient's ability to recognize the signs and symptoms of hypoglycemia; use with caution.

• Sulfonamide ("sulfa") allergy: The FDA-approved product labeling for many medications containing a sulfonamide chemical group includes a broad contraindication in patients with a prior allergic reaction to sulfonamides. There is a potential for cross-reactivity between members of a specific class (eg, 2 antibiotic sulfonamides). However, concerns for cross-reactivity have previously extended to all compounds containing the sulfonamide structure (SO2NH2). An expanded understanding of allergic mechanisms indicates cross-reactivity between antibiotic sulfonamides and nonantibiotic sulfonamides may not occur or, at the very least, this potential is extremely low (Brackett 2004; Johnson 2005; Slatore 2004; Tornero 2004). In particular, mechanisms of cross-reaction due to antibody production (anaphylaxis) are unlikely to occur with nonantibiotic sulfonamides. T-cell-mediated (type IV) reactions (eg, maculopapular rash) are less understood and it is not possible to completely exclude this potential based on current insights. In cases where prior reactions were severe (SJS/TEN), some clinicians choose to avoid exposure to these classes.

Disease-related concerns:

• Bariatric surgery:

– Altered absorption: Use IR formulations after surgery to minimize the potential effects of bypassing stomach and proximal small bowel with gastric bypass or more rapid gastric emptying and proximal small bowel transit with sleeve gastrectomy (Apovian 2015). ER formulations may have altered release and absorption patterns after gastric bypass or sleeve gastrectomy (but not gastric band). Compared to control, Tmax in a gastric bypass cohort administered tolbutamide was significantly shorter (1.4 ± 1.8 vs 5.1 ± 1.7 hours; P <0.001), while Cmax and AUC0- ∞ were not altered (Tandra 2013).

– Hypoglycemia: Use an antidiabetic agent without the potential for hypoglycemia if possible; hypoglycemia may occur after gastric bypass, sleeve gastrectomy, and gastric band (Mechanick 2020). Insulin secretion and sensitivity may be partially or completely restored after these procedures (gastric bypass is most effective, followed by sleeve and finally band) (Korner 2009; Peterli 2012). First-phase insulin secretion and hepatic insulin sensitivity have been shown to be significantly improved in the immediate days after gastric bypass and sleeve gastrectomy. The restorative effects of these procedures on peripheral insulin sensitivity may occur later in the 3- to 12-month period postsurgery (Mingrone 2016).

– Weight gain: Evaluate risk vs benefit and consider alternative therapy after gastric bypass, sleeve gastrectomy, and gastric banding; weight gain may occur (Apovian 2015).

• Glucose-6-phosphate dehydrogenase deficiency: Patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency may be at an increased risk of sulfonylurea-induced hemolytic anemia; however, cases have also been described in patients without G6PD deficiency during postmarketing surveillance. Use with caution and consider a nonsulfonylurea alternative in patients with G6PD deficiency.

• Hepatic impairment: Use with caution in hepatic impairment (undergoes hepatic metabolism); adjust dose cautiously. Cholestasis, jaundice, and hepatitis have been reported rarely; discontinue use if cholestatic jaundice occurs.

• Renal impairment: Use with caution in renal impairment (primarily excreted in urine); adjust dose cautiously.

• Stress-related states: Use during periods of stress (eg, trauma, infection, surgery) is contraindicated. It may be necessary to discontinue therapy and administer insulin if the patient is exposed to stress conditions.

Dosage forms specific issues:

• Lactose: Some formulations may contain lactose; avoid use in patients with galactose intolerance, glucose-galactose malabsorption, or congenital lactose deficiency.

Product Availability

Not available in the United States.

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Diamicron: 80 mg [DSC] [contains corn starch]

Generic: 80 mg

Tablet Extended Release 24 Hour, Oral:

Diamicron MR: 30 mg, 60 mg

Generic: 30 mg, 60 mg

Administration: Adult

Oral: Patients that are NPO or require decreased caloric intake may need doses held to avoid hypoglycemia. Administer with meals (modified-release tablet should be administered with breakfast). May split the 60 mg modified-release tablets in half; however, the 30 mg modified-release tablets must be swallowed whole. Modified-release tablets should not be crushed or chewed.

Bariatric surgery: Tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Consider switching to immediate-release tablets.

Use: Labeled Indications

Note: Not approved in the United States.

Diabetes mellitus, type 2, treatment: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Medication Safety Issues
High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drugs which have a heightened risk of causing significant patient harm when used in error.

Older Adult: High-Risk Medication:

Avoid routine use of sulfonylureas due to increased risk of hypoglycemia; however, if a sulfonylurea is needed, one with a lower relative risk of hypoglycemia (eg, gliclazide, glipizide, glimepiride) is preferred (ADA 2023; Beers Criteria [AGS 2023]; Diabetes Canada 2018).

Metabolism/Transport Effects

Substrate of CYP2C9 (major), OATP1B1/1B3 (SLCO1B1/1B3); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Ajmaline: Sulfonamides may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Risk C: Monitor therapy

Alcohol (Ethyl): Sulfonylureas may enhance the adverse/toxic effect of Alcohol (Ethyl). A flushing reaction may occur. Risk C: Monitor therapy

Alpelisib: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Risk C: Monitor therapy

Alpha-Glucosidase Inhibitors: May enhance the hypoglycemic effect of Sulfonylureas. Management: Consider a decrease in sulfonylurea dose when initiating therapy with an alpha-glucosidase inhibitor and monitor patients for hypoglycemia. Risk D: Consider therapy modification

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Amiodarone: May enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Androgens: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Beta-Blockers (Beta1 Selective): May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Beta-Blockers (Nonselective): May enhance the hypoglycemic effect of Sulfonylureas. Beta-Blockers (Nonselective) may diminish the therapeutic effect of Sulfonylureas. Risk C: Monitor therapy

Bortezomib: May enhance the therapeutic effect of Antidiabetic Agents. Bortezomib may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Carbocisteine: Sulfonylureas may enhance the adverse/toxic effect of Carbocisteine. Specifically, sulfonylureas may enhance adverse effects of alcohol that is present in liquid formulations of carbocisteine-containing products. Risk C: Monitor therapy

Chloramphenicol (Systemic): May increase the serum concentration of Sulfonylureas. Risk C: Monitor therapy

Clarithromycin: May enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

CYP2C9 Inducers (Moderate): May decrease the serum concentration of Sulfonylureas. Risk C: Monitor therapy

CYP2C9 Inhibitors (Moderate): May increase the serum concentration of Sulfonylureas. Risk C: Monitor therapy

Dexketoprofen: May enhance the adverse/toxic effect of Sulfonamides. Risk C: Monitor therapy

Dipeptidyl Peptidase-IV Inhibitors: May enhance the hypoglycemic effect of Sulfonylureas. Management: Consider a decrease in sulfonylurea dose when initiating therapy with a dipeptidyl peptidase-IV inhibitor and monitor patients for hypoglycemia. Risk D: Consider therapy modification

Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Etilefrine: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Fibric Acid Derivatives: May enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Glucagon-Like Peptide-1 Agonists: May enhance the hypoglycemic effect of Sulfonylureas. Management: Consider sulfonylurea dose reductions when used in combination with glucagon-like peptide-1 agonists. Risk D: Consider therapy modification

Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Herbal Products with Glucose Lowering Effects: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Hypoglycemia-Associated Agents: May enhance the hypoglycemic effect of other Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Lumacaftor and Ivacaftor: May decrease the serum concentration of CYP2C9 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may increase the serum concentration of CYP2C9 Substrates (High Risk with Inhibitors or Inducers). Risk C: Monitor therapy

Maitake: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Mecamylamine: Sulfonamides may enhance the adverse/toxic effect of Mecamylamine. Risk X: Avoid combination

Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy

Metreleptin: May enhance the hypoglycemic effect of Sulfonylureas. Management: Sulfonylurea dosage adjustments (including potentially large decreases) may be required to minimize the risk for hypoglycemia with concurrent use of metreleptin. Monitor closely for signs or symptoms of hypoglycemia. Risk D: Consider therapy modification

Miconazole (Oral): May enhance the hypoglycemic effect of Sulfonylureas. Miconazole (Oral) may increase the serum concentration of Sulfonylureas. Risk C: Monitor therapy

Mitiglinide: May enhance the adverse/toxic effect of Sulfonylureas. Risk X: Avoid combination

Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Omeprazole: May increase the serum concentration of Gliclazide. Risk C: Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Sulfonylureas. Risk C: Monitor therapy

Prothionamide: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Quinolones: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy

Rifapentine: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Risk C: Monitor therapy

Ritodrine: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors: May enhance the hypoglycemic effect of Sulfonylureas. Management: Consider a decrease in sulfonylurea dose when initiating therapy with a sodium-glucose cotransporter 2 (SGLT2) inhibitor and monitor patients for hypoglycemia. Risk D: Consider therapy modification

St John's Wort: May decrease the serum concentration of Gliclazide. Risk C: Monitor therapy

Sulfonamide Antibiotics: May enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Tetracyclines: May enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Thiazolidinediones: May enhance the hypoglycemic effect of Sulfonylureas. Management: Consider sulfonylurea dose adjustments in patients taking thiazolidinediones and monitor for hypoglycemia. Risk D: Consider therapy modification

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Sulfonylureas may enhance the anticoagulant effect of Vitamin K Antagonists. Vitamin K Antagonists may enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Voriconazole: May increase the serum concentration of Sulfonylureas. Risk C: Monitor therapy

Food Interactions

Ethanol may cause rare disulfiram reactions. Management: Monitor patients.

Reproductive Considerations

Sulfonylureas are not recommended for patients with type 2 diabetes mellitus planning to become pregnant. Patients who could become pregnant should use effective contraception during therapy. Transition to a preferred therapy should be initiated prior to conception and contraception should be continued until glycemic control is achieved (ADA 2022; Alexopoulos 2019; Egan 2020)

Pregnancy Considerations

Gliclazide is contraindicated for use during pregnancy.

Poorly controlled diabetes during pregnancy can be associated with an increased risk of adverse maternal and fetal outcomes, including diabetic ketoacidosis, preeclampsia, spontaneous abortion, preterm delivery, delivery complications, major malformations, stillbirth, and macrosomia (ACOG 201 2018). To prevent adverse outcomes, prior to conception and throughout pregnancy, maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ADA 2022; Blumer 2013).

Agents other than gliclazide are currently recommended to treat diabetes mellitus in pregnancy (ADA 2022).

Breastfeeding Considerations

It is not known if gliclazide is present in breast milk.

Use is contraindicated in breastfeeding mothers.

Dietary Considerations

Should be taken with meals. Individualized medical nutrition therapy (MNT) based on CDA recommendations is an integral part of therapy.

Monitoring Parameters

Monitor for signs and symptoms of hypoglycemia; plasma glucose (individualize frequency based on treatment regimen, hypoglycemia risk, and other patient-specific factors) (ADA 2022); renal and hepatic function (baseline [all patients] then periodically thereafter in patients with mild-moderate dysfunction).

HbA1c: Monitor at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; monitor quarterly in patients in whom treatment goals have not been met, or with therapy change. Note: In patients prone to glycemic variability (eg, patients with insulin deficiency), or in patients whose HbA1c is discordant with serum glucose levels or symptoms, consider evaluating HbA1c in combination with blood glucose levels and/or a glucose management indicator (ADA 2022; KDIGO 2020).

Reference Range

Recommendations for glycemic control in patients with diabetes:

Nonpregnant adults (ADA 2022):

HbA1c: <7% (a more aggressive [<6.5%] or less aggressive [<8%] HbA1c goal may be targeted based on patient-specific characteristics). Note : In patients using a continuous glucose monitoring system, a goal of time in range >70% with time below range <4% is recommended and is similar to a goal HbA1c <7%.

Preprandial capillary blood glucose: 80 to 130 mg/dL (SI: 4.4 to 7.2 mmol/L) (more or less stringent goals may be appropriate based on patient-specific characteristics).

Peak postprandial capillary blood glucose (~1 to 2 hours after a meal): <180 mg/dL (SI: <10 mmol/L) (more or less stringent goals may be appropriate based on patient-specific characteristics).

Older adults (≥65 years of age) (ADA 2022):

Note: May consider less strict targets in patients who are using insulin and/or insulin secretagogues (eg, sulfonylureas, meglitinides) (ES [LeRoith 2019]).

HbA1c: <7% to 7.5% (healthy); <8% to 8.5% (complex/intermediate health). Note: Individualization may be appropriate based on patient and caregiver preferences and/or presence of cognitive impairment. In patients with very complex or poor health (ie, limited remaining life expectancy), consider making therapy decisions based on avoidance of hypoglycemia and symptomatic hyperglycemia rather than HbA1c level.

Preprandial capillary blood glucose: 80 to 130 mg/dL (SI: 4.4 to 7.2 mmol/L) (healthy); 90 to 150 mg/dL (SI: 5 to 8.3 mmol/L) (complex/intermediate health); 100 to 180 mg/dL (SI: 5.6 to 10 mmol/L) (very complex/poor health).

Bedtime capillary blood glucose: 80 to 180 mg/dL (SI: 4.4 to 10 mmol/L) (healthy); 100 to 180 mg/dL (SI: 5.6 to 10 mmol/L) (complex/intermediate health); 110 to 200 mg/dL (SI: 6.1 to 11.1 mmol/L) (very complex/poor health).

Classification of hypoglycemia (ADA 2022):

Level 1: 54 to 70 mg/dL (SI: 3 to 3.9 mmol/L); hypoglycemia alert value; initiate fast-acting carbohydrate (eg, glucose) treatment.

Level 2: <54 mg/dL (SI: <3 mmol/L); threshold for neuroglycopenic symptoms; requires immediate action.

Level 3: Hypoglycemia associated with a severe event characterized by altered mental and/or physical status requiring assistance.

Mechanism of Action

Stimulates insulin release from the pancreatic beta cells; reduces glucose output from the liver; insulin sensitivity is increased at peripheral target sites.

Pharmacokinetics (Adult Data Unless Noted)

Duration of action: Modified-release tablet: 24 hours

Absorption: Immediate-release formulation: Rapid; Modified-release formulation: Slow and complete

Bioavailability: Modified release: 97%

Distribution: Vd: 20% to 40% of body weight

Protein binding: ~94% to 95%

Metabolism: Hepatic (via CYP2C9 and CYP2C19; Elliot 2007) to inactive metabolites

Half-life elimination: Immediate-release tablet: 10.4 hours; Modified-release tablet: 16 hours (range: 12 to 20 hours)

Time to peak: Immediate-release tablet: 4 to 6 hours; Modified-release tablet: ~6 hours

Excretion: Urine (60% to 70%; <1% as unchanged drug); feces (10% to 20%) as metabolites

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Comprid | Diamicron | Emicron | Glicomel mr | Glyka MR | Glyzide | Hyponorm mr | Stramicron mr;
  • (AR) Argentina: Aglucide | Aglucide mr | Diamicron mr | Glicaglucid mr | Gliclazida Vannier | Tradon | Tradon mr | Unava;
  • (AT) Austria: Diabrezide | Diamicron | Gliclada | Gliclazid +pharma | Gliclazid genericon | Gliclazid Sandoz | Gliclazid Stada | Gliclazid-ratiopharm | Glydium;
  • (AU) Australia: Apo gliclazide | Apx gliclazide | Ardix gliclazide mr | Cm gliclazide | Diamicron | Diamicron mr | Glyade | Mellihexal | Nidem | Oziclide | PHARMACOR GLICLAZIDE | Pharmacor gliclazide mr | Tw gliclazide;
  • (BD) Bangladesh: Admira | Comprid | Consucon | Dela | Diacon | Diamicron | Diaprid | Diapro | Diatrol | Diazid | Digreen | Dimerol | Eucron | Glad | Glicasil | Gliclid | Glicron | Glikazid | Glimicron | Glisil | Glitab | Glitz | Glix | Glix mr | Glizid | Glucostat | Glucozid | Gored | Kezid | Life | Lozide | Oclazid | Orazid | SB Glic | Sinazid | Sucleer | Sucotab | Sugred | Zide;
  • (BE) Belgium: Diamicron | Gliclazide Apotex | Gliclazide merck-generics | Gliclazide Mylan | Gliclazide Ratiopharm | Gliclazide sandoz | Uni diamicron;
  • (BG) Bulgaria: Diab | Diabrezide | Diaprel | Diglical | Ecozid | Ecozid mr | Gliazid | Glica mr | Gliclacon sr | Gliclada | Gliclazide gamma | Gliclazide zentiva | Mellizide | Normodiab | Normodiab mr | Zodediab mr;
  • (BR) Brazil: Azukon mr | Beteglid | Clazi xr | Diamicron | Dicazid mr | Glicaron | Gliclazida | Gliclazida pharlab;
  • (CH) Switzerland: Diamicron | Gliclazid actavis | Gliclazid mr sandoz | Gliclazid retard zentiva | Gliclazid spirig hc retard | Gliclazid Teva | Gliclazide helvepharm;
  • (CI) Côte d'Ivoire: Glide | Glycinorm 80;
  • (CL) Chile: Diamicron mr | Dianormax | Glikem;
  • (CN) China: Da er de | Da mei kang | Diamicron | Gliclazide tablets (II) | Hai wang | Jia jian tang di | Jia tao | Kang jin | Lie ke | Medoclazide | Sheng ji da | Tai rui xin | Tang heng | Tang qing | Zheng tang ning;
  • (CO) Colombia: Diamicron | Diamicron mr | Glicazida | Gliclazida | Glidiab | Glycinorm | Glycinorm mr;
  • (CZ) Czech Republic: Apo Gliclazid | Diaprel | Glicirex | Gliclazid Mylan | Gliclazide Teva | Gliklazid actavis | Predian;
  • (DE) Germany: Diamicron | Gliclazid axcount;
  • (DK) Denmark: Gliclazid "Krka";
  • (DO) Dominican Republic: Diamicron mr | Gliclazida calox;
  • (EC) Ecuador: Diamicron mr | Gliclazida | Glyzide;
  • (EE) Estonia: Diabrezide | Diaprel | Gliclazide Actavis | Gliclazide krka | Gliclazide Teva;
  • (EG) Egypt: Diabel | Diabetron | Diabyl | Diamac | Diamedizen | Diamicron | Dianormal | Gli | Glicla | Glicla mr | Glipicrone | Serviclazide | Unocron;
  • (ES) Spain: Diamicron | Gliclazida Actavis | Gliclazida bluefish | Gliclazida cinfa | Gliclazida combix | Gliclazida Kern | Gliclazida Krka | Gliclazida Normon | Gliclazida ranbaxy | Gliclazida ratiopharm | Gliclazida sandoz | Gliclazida Stada | Gliclazida Teva | Gliclazida uxa | Gliclazida zentiva | Uni diamicron;
  • (ET) Ethiopia: Diamicron | Oziclide;
  • (FR) France: Diamicron | Gliclazide arrow | Gliclazide Biogaran | Gliclazide cristers | Gliclazide evolugen | Gliclazide g gam | Gliclazide gnr | Gliclazide irex | Gliclazide Isomed | Gliclazide ivax | Gliclazide krka | Gliclazide merck | Gliclazide Qualimed | Gliclazide ranbaxy | Gliclazide Ratiopharm | Gliclazide rpg | Gliclazide sandoz | Gliclazide servier | Gliclazide Teva | Gliclazide Winthrop | Gliclazide Zydus | Glycemirex | Glydium | Sulfam;
  • (GB) United Kingdom: Bilxona | Dacadis mr | Diaglyk | Diamicron | Duclazide | Gliclazide almus | Gliclazide alpharma | Gliclazide arrow | Gliclazide cox | Gliclazide dom | Gliclazide kent | Gliclazide sandoz | Glydex | Laaglyda | Lamzarin | Vamju | Vivazide | Ziclaseg | Zicron | Zicron pr;
  • (GR) Greece: Diamicron | Gliclazide/Generics | Gliclazide/mylan | Gliclazide/sandoz | Glicron;
  • (HK) Hong Kong: Apo gliclazide | Comprid | Diamicron | Diamitex | Dianorm | Efton | Glimicron | Glizid | Glucozide | Glupozide | Glygard | Licla | Marclazide | Qualizide | Staclazide 30 MR | Syncon | Synmicron;
  • (HR) Croatia: Diaprel | Diglical | Glika | Gliklazid PharmaS;
  • (HU) Hungary: Diaprel | Dyaclid | Gliclada | Gliclazide sandoz | Gliclazide Teva | Glucostabil | Gluctam | Normadiab | Zeglidia;
  • (ID) Indonesia: Diamicron | Fonylin mr | Glibet | Glicab | Glidabet | Glikamel | Glikatab | Glucodex | Glumeco | Glyfacor | Gored | Linodiab | Meltika | Nufamicron | Pedab | Vergulon | Xepabet | Zibet | Zumadiac;
  • (IE) Ireland: Diabrezide | Diaclide | Diacronal MR | Diaglyc | Diamicron | Diamicron mr | Lamzarin | Vitile XL | Zicron;
  • (IN) India: Avazide | Azukon | Betazide | Bioglide | Carryl | Comzid | Cyblex | D-clic | Diabeclaz | Diabend | Diamicron | Dianorm | Diasafe | Diatica | Diatrol | Diazide | Diclazid | Eclazide | Euclide | Flisur | G-zide | Gazin | Glic | Glicla | Gliclan | Gliclaz | Glicol | Glicrite | Glidiet | Glik | Gliva 40 | Glix | Gliza | Glizid | Glizid mr | Glizihenz | Glucozid | Gludown sr | Glurib | Glychek | Glycigon | Glycinorm | Glycitrol | Glycor | Glycozide | Glygard | Glykind | Glyloc | Glyneed | Glyred | Glytas | Glz | Liz | Lo-g | Loyzide | Lycazid | Mclazide | Monoglide | Nobegliz | Nuzide | Prizide | Reclide xr | Semi diabend | Semi-glycigon | Signozid | Vidzid | Vitaglic xr | Zeglic | Zicla | Zuker | Zyde;
  • (IT) Italy: Diabrezide | Diamicron | Diamicron mr | Dramion | Galtes | Gleukos | Gliclada | Gliclazide Doc | Gliclazide EG | Gliclazide mylan generics italia | Gliclazide ranbaxy | Gliclazide sandoz | Gliclazide teva italia;
  • (JM) Jamaica: Diamicron mr | Reclide;
  • (JO) Jordan: Debacron | Debaday | Diamicron mr | Diamid | Duclazide | Microzide;
  • (JP) Japan: Benelaxa | Benelaxa sanken | Crawnart | Crawnart choseido | Crawnart maruko | Crawnart taiyo | Diaglico | Gliclazide towa | Gliclazide yd | Glimicron | Glimicron ha | Glimiran | Glutameal | Kyowacron | Pharlinde | Ruimenia;
  • (KE) Kenya: Diagluc | Diamicron mr | Diapro | Getzid mr | Glizid mr | Glizorem | Glycigon | Glycinorm mr | Glycron | Glyzyl | Melanov | Oziclide mr | Remicron mr;
  • (KR) Korea, Republic of: Cladia | Clivit | Clizid | Crabel | Diabeta | Diacla | Diaglu | Diamicron | Diamicron mr | Diamin | Diazide | Diazit | Dicla | Dicrong | Diecla | Diverin mr | Glazid | Glicla | Glicle | Glicol | Gligen | Glizid | Glizide | Glucort | Keizide | Licla | Nodiarex | Samik gliclazide | SCD Glyclazide;
  • (KW) Kuwait: Diamicron | Glyzide;
  • (LB) Lebanon: Diamicron | Glyzide;
  • (LT) Lithuania: Diabeton | Diabrezide | Diaprel | Gliclazide Actavis | Gliclazide ingen pharma | Glydium | Predian;
  • (LU) Luxembourg: Diamicron | Uni gliclazide eg;
  • (LV) Latvia: Diabeton | Diabrezide | Diaprel | Gliclada | Gliclazide zentiva | Predian;
  • (MA) Morocco: Diabalex | Diamicron | Glyazid | Glycemat | Sulfam;
  • (MX) Mexico: Diamicron | Diamicron mr | Zideuno;
  • (MY) Malaysia: Apo gliclazide | Azukon | Diacon | Diacron | Diamicron | Diamitex | Dianid | Diatica | Dimax mr | Gliclada | Gliclazide Pharmaniaga | Glikline | Glimicron | Glizid | Glucozide | Gluvecron | Glyade | Medoclazide | Melicron | Mexan | Oziclide | Plecaz | Reclide | Remicron | Rolazide | Sun Glizide;
  • (NG) Nigeria: Diamicron mr | Remicron mr;
  • (NL) Netherlands: Diamicron;
  • (NZ) New Zealand: Apo gliclazide | Diamicron | Glizide;
  • (OM) Oman: Debacron;
  • (PE) Peru: Diamicron;
  • (PH) Philippines: Azukon mr | Clibite | Clizid | Diaclid | Diamicron | Diamicron mr | Diamir | Dianorm | Glazide | Glicla | Glitab | Glubitor | Gluclazide sr | Gluconex mr | Gluconil | Klazid | Melanov MR | Nupava | Zeltine mr;
  • (PK) Pakistan: Azide | Diabetron | Diabo | Diaglic | Diamicron | Diclazide | Diocid | Glicotron | Glimicron | Glinext | Glinext mr | Glynase | Nidonil | Nodibet | Protect | Prozide | Ramicron | Scicon MR | Sugcon | Tagamicron | Zaclazide;
  • (PL) Poland: Clazicon | Diabezidum | Diabrezide | Diagen | Diamicron | Diaprel | Diazidan | Gliclada | Gliclastad | Gliclazide zentiva | Glikuron | Glinormax | Glisan | Normodiab mr | Norsulin | Oziclide | Salson | Symazide;
  • (PT) Portugal: Diamicron | Diamicron lm | Glicazida | Gliclazida | Gliclazida Actavis | Gliclazida bluefish | Gliclazida Krka | Gliclazida labesfal | Gliclazida Mer | Gliclazida ratiopharm | Gliclazida tad | Gliclazida Teva | Gliclazida zentiva;
  • (PY) Paraguay: Diamicron mr | Unava;
  • (QA) Qatar: Claz MR | Debacron | Diamicron MR | Emicron | G-zide MR | Glaze | Glyzide | Microzide;
  • (RO) Romania: Diabrezide | Diaprel | Esquel | Gliclazid lph | Gliclazida ep antibiotice | Gliclazida terapia | Gliclazida zentiva | Glidiet | Glyclada;
  • (RU) Russian Federation: Diabefarm | Diabefarm mv | Diabest | Diabetalong | Diabeton | Diabeton mb | Diabinax | Diabrezide | Diaglizide | Diatics | Diatika | Gliclada | Gliclazide akos | Gliclazide canon | Gliclazide mr | Gliclazide mv-vertex | Glidiab | Glioral | Glizid | Glydiab | Golda mb | Predian | Reclid;
  • (SA) Saudi Arabia: Apo gliclazide | Claz mr | Diamicron | Glaze | Glizide | Glucozide;
  • (SG) Singapore: Apo gliclazide | Diamicron | Dianorm | Diapro | Diverin | Glimicron | Glizide | Glucozide | Glyade | Melicron | Mexan | Sun Glizide;
  • (SI) Slovenia: Diaprel | Gliclada | Gliklazid stada;
  • (SK) Slovakia: Diaprel | Euklazid | Gliclazid Mylan | Gliclazide gamma | Gliclazide mr stada | Gliklazid sandoz | Gluctam | Medoclazide;
  • (TH) Thailand: Cadicon | Clazide | Diabeside | Diabetab | Diaclaron | Diamexon | Diamicron | Dianid | Diglucron | Dimetus | Glibecron | Gliclabit | Glicron | Glucocron | Gluconox | Glucozide | Glucozide mr | Glycon | Medoclazide | Ranclazide | Serviclazide;
  • (TN) Tunisia: Diamezid | Diamicron | Theradiam;
  • (TR) Turkey: Betanorm | Betanorm mr | Diaklazid | Diamicron | Efikas | Glazid | Glikron | Glumikron | Hipoglis | Mellidys | Oramikron;
  • (TW) Taiwan: Anneuton | Antiglucon | Dail | Daycose | Diaglucon | Diamicron mr | Diamin | Diamin MR | Diaronzide | Diclazide | Dicron | Dicron MR | Dimatan | Dimax | Dimicon | Gelid | Glazide | Glian | Glicalin | Glicla | Gliclax | Glicron | Glimed MR | Glimicon | Glizide | Glu-A | Glucolin | Gluzide | Glyade | Glycon | Hanazide MR | Jabisynlon | Kludone mr | Mezide | Syncon | Tadin;
  • (UA) Ukraine: Diabeton | Diabeton MR | Diaglizide mr | Dianorm | Gliclazid Zdorovye | Glidia mv | Glizid | Oziclide;
  • (UG) Uganda: Glimicron | Melanov;
  • (UY) Uruguay: Diamicron mr;
  • (VE) Venezuela, Bolivarian Republic of: Diacor mr | Diamicron | Diatovin | Gliclazida | Glidan | Glinorm | Gliz | Reclide;
  • (VN) Viet Nam: Agilizid | Crondia 30 MR | Diamicron mr | Dorocron MR | Gluzitop mr | Golddicron | Griacron | Pyme Diapro Mr | Staclazide 30 MR | Wonlicla | Zidenol;
  • (ZA) South Africa: Diagen | Diaglucide | Diaglumed | Diamicron mr | Diaran mr | Dyna gliclazide | Dynacaz | Gliclazide mr austell | Glucomed | Gluctam mr | Glycobeta | Glycron | Glygard | Glytab | Merck-gliclazide | Rolab-gliclazide | Sandoz gliclazide | Ziclin;
  • (ZM) Zambia: Diabend | Gliclan | Glucozid | Glycinorm;
  • (ZW) Zimbabwe: Diabend | Glycinorm 80 | Oziclide
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