GlipiZIDE (Lexi-Drugs)

Pronunciation

(GLIP i zide)

Brand Names: US

glipiZIDE XL; Glucotrol; Glucotrol XL

Brand Names: Canada

Glucotrol XL

Pharmacologic Category

Antidiabetic Agent, Sulfonylurea

Dosing: Adult

Diabetes mellitus, type 2, treatment: Oral:

Note: Adjunctive or alternative monotherapy for patients who have suboptimal response to or cannot take metformin. Selection of a pharmacologic agent for the treatment of type 2 diabetes mellitus should follow a patient-centered approach, including consideration of hypoglycemia risk, comorbid conditions (eg, atherosclerotic cardiovascular disease, heart failure, renal impairment), impact on weight, efficacy, potential adverse effects, route of administration, cost, and patient preferences (ADA 2019). Sulfonylureas are known to have a relatively high risk of hypoglycemia as compared to other noninsulin antidiabetic agents due to their mechanism of action (AACE [Garber 2019]; ADA 2019). In general, if a sulfonylurea is chosen, a shorter-duration sulfonylurea (eg, glipizide) is preferred (ADA 2019).

Immediate release:

Initial: 2.5 mg once daily (McCulloch 2019) administered 30 minutes before a meal (preferably before breakfast)

Titration: If adequate glycemic control is not obtained, may increase the dose in 2.5 to 5 mg increments no more frequently than every few days (manufacturer’s labeling); however, titration strategies are often more conservative in clinical practice. Most clinicians increase the dose more slowly at a frequency of every 1 to 2 weeks (DeFronzo 1999; Del Prato 2014) and some experts use a 2- to 4-week titration interval (McCulloch 2019). If a once-daily dose does not provide adequate glycemic control, dividing the daily dose into 2 doses, given 30 minutes before breakfast and 30 minutes before the evening meal, may improve efficacy; doses >15 mg/day should generally be administered in 2 divided doses.

Maximum effective dose: 20 mg/day (Abraira 1998; DeFronzo 1999; Wåhlin-Boll 1982). Note: Although a higher maximum total daily dose (40 mg/day) is listed in the manufacturer’s labeling, escalating the dose beyond 20 mg/day has not been shown to improve glycemic control (Abraira 1998; Hurren 2013; Stenman 1993; Wåhlin-Boll 1982).

Extended release:

Initial: 2.5 mg (McCulloch 2019) to 5 mg administered once daily with breakfast or the first meal of the day

Titration: Adjust dose based on glycemic control; one study allowed dosage increases in 5 to 10 mg increments once weekly (Berelowitz 1994)

Maximum dose: 20 mg/day

Patients already maintained on glipizide who require hospitalization: In patients who require hospitalization, consider temporary discontinuation of noninsulin antidiabetic agents (Bogun 2013; Inzucchi 2006) and initiation and/or continuation of insulin therapy (ADA 2019; Bogun 2013; Inzucchi 2006). Use of noninsulin antidiabetic agents may be considered in noncritically ill hospitalized patients if there are no contraindications, nutrition is consistent, and blood glucose is well controlled; close monitoring and subsequent dosage adjustments are recommended (Bogun 2013; Inzucchi 2006).

Glipizide conversion recommendations:

When converting from immediate-release glipizide to extended-release glipizide: May switch the immediate-release total daily dose to the nearest equivalent daily dose of the extended-release tablet and administer once daily.

When converting from insulin to immediate-release glipizide: Note: When determining the timing of the transition from insulin to glipizide, clinicians should consider the known onset and duration of the insulin product being discontinued; closely monitor blood glucose.

Current insulin requirement ≤20 units: Discontinue insulin and initiate glipizide at usual dose.

Current insulin requirement >20 units: Decrease insulin by 50% and initiate glipizide at usual dose; gradually decrease insulin dose based on patient response.

Dosing: Geriatric

Diabetes mellitus, type 2, treatment (alternative agent): Oral:

Note: For the treatment of type 2 diabetes in older adults, medication classes with low risk of hypoglycemia are preferred (ADA 2019); sulfonylureas are known to have a relatively high risk of hypoglycemia as compared to other noninsulin antidiabetic agents due to their mechanism of action (AACE [Garber 2019]; ADA 2019). In general, if a sulfonylurea is chosen, a shorter-duration sulfonylurea (eg, glipizide) is preferred (ADA 2019).

Immediate release: Initial: 2.5 mg once daily; consider titrating by 2.5 to 5 mg/day at 1- to 2-week intervals. Maintenance dosing should be conservative to avoid hypoglycemia.

Extended release: Initial: 2.5 mg once daily; maintenance dosing should be conservative to avoid hypoglycemia.

Dosing: Renal Impairment: Adult

Immediate release: Oral: Glipizide is a preferred sulfonylurea in patients with CKD (due to inactive metabolites) (ADA [Tuttle 2014]; KDOQI 2012); however, conservative initial dosing (eg, 2.5 mg once daily) is recommended. An initial dose of 2.5 mg once daily, followed by elective titration (up to 20 mg/day) has been studied in patients with eGFR <50 mL/minute/1.73 m2 (Arjona Ferreira 2013).

ESRD: An initial dose of 2.5 mg once daily with titration as needed has been recommended (Gianchandani 2017)

Extended release: Oral: Initial: 2.5 mg once daily; use caution.

Dosing: Hepatic Impairment: Adult

Immediate release: Oral: Initial: 2.5 mg once daily; maintenance dosing should be conservative to avoid hypoglycemia

Extended release: Oral: Initial: 2.5 mg once daily; maintenance dosing should be conservative to avoid hypoglycemia

Use: Labeled Indications

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

Clinical Practice Guidelines

American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE), “Consensus Statement on the Comprehensive Type 2 Diabetes Management Algorithm – 2019 Executive Summary,” January 2019

American Diabetes Association, “Standards of Medical Care in Diabetes – 2019,” January 2019

American Diabetes Association/European Association for the Study of Diabetes, “Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD),” December 2018

Administration: Oral

Patients that are NPO or require decreased caloric intake may need doses held to avoid hypoglycemia.

Immediate release: Administer 30 minutes before a meal (preferably before breakfast if once-daily dosing) to achieve greatest reduction in postprandial hyperglycemia.

Extended release: Administer with breakfast or the first meal of the day; swallow tablets whole, do not chew, divide or crush.

Dietary Considerations

Take immediate release tablets 30 minutes before meals (preferably before breakfast if once-daily dosing); extended release tablets should be taken with breakfast or the first meal of the day. Individualized medical nutrition therapy (MNT) based on ADA recommendations is an integral part of therapy.

Storage/Stability

Extended release: Store at 68°F to 77°F (20°C to 25°C); excursions permitted between 59°F to 86°F (15°C to 30°C). Protect from moisture and humidity.

Immediate release: Store below 30°C (86°F).

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dizziness, diarrhea, flatulence, anxiety, or tablet shell in stool. Have patient report immediately to prescriber signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), vision changes, slurred speech, tingling, or severe loss of strength and energy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  High alert medication:
Contraindications

Hypersensitivity to glipizide, sulfonamide derivatives, or any component of the formulation; type 1 diabetes mellitus; diabetic ketoacidosis (with or without coma).

Note: Although glipizide extended-release (XL) FDA-approved product labeling states this medication is contraindicated with other sulfonamide-containing drug classes, the scientific basis of this statement has been challenged. See Warnings/Precautions for more detail.

Documentation of allergenic cross-reactivity for sulfonylureas is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular mortality: Product labeling 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. In patients with established atherosclerotic cardiovascular disease (ASCVD), other agents are preferred (ADA 2019).

• Hypoglycemia: All sulfonylurea drugs are capable of producing severe hypoglycemia. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when ethanol is ingested, or when more than one glucose-lowering drug is used. It is also more likely in elderly or debilitated patients, malnourished patients and in patients with impaired renal or hepatic function, adrenal and/or pituitary insufficiency; use with caution. Autonomic neuropathy, advanced age, 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, two 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 well understood and it is not possible to completely exclude this potential based on current insights. In cases where prior reactions were severe (Stevens-Johnson syndrome/TEN), some clinicians choose to avoid exposure to these classes.

Disease-related concerns:

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency: Patients with 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 patients with hepatic impairment; hypoglycemia may be prolonged.

• Renal impairment: Use with caution in patients with renal impairment.

• Stress-related states: It may be necessary to discontinue therapy and administer insulin if the patient is exposed to stress (fever, trauma, infection, surgery).

Dosage form specific issues:

• GI tract stricture/narrowing: The extended release formulation consists of drug within a nondeformable matrix; following drug release/absorption, the matrix/shell is expelled in the stool. The use of nondeformable products in patients with known stricture/narrowing of the GI tract has been associated with symptoms of obstruction. Avoid use of extended release tablets (Glucotrol XL) in patients with severe gastrointestinal narrowing or esophageal dysmotility.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Debilitated or malnourished patients: Use with caution; dosing should be conservative and monitor closely for hypoglycemia.

• Elderly: Use with caution; dosing should be conservative and monitor closely for hypoglycemia. Sulfonylureas of shorter duration (eg, glipizide) are preferred in elderly patients (ADA 2019).

Other warnings/precautions:

• Appropriate use: Not for use in patients with diabetic ketoacidosis (DKA) or patients with type 1 diabetes mellitus.

Geriatric Considerations

Glipizide is a useful agent since there are few drug-to-drug interactions and elimination of the active drug is not dependent upon renal function. However, like other sulfonylureas, glipizide is associated with hypoglycemia, especially when used concomitantly with insulin, and should be used with caution. Intensive glucose control (HbA1c <6.5%) has been linked to increased all-cause and cardiovascular mortality, hypoglycemia requiring assistance, and weight gain in adult type 2 diabetes. How “tightly” to control a geriatric patient’s blood glucose needs to be individualized. Such a decision should be based on several factors, including the patient’s functional and cognitive status, how well he/she recognizes hypoglycemic or hyperglycemic symptoms, and how to respond to them and other disease states. An HbA1c <7.5% is an acceptable endpoint for a healthy older adult, while <8% to 8.5% is acceptable for elderly patients depending on the level of comorbidities, functional and cognitive status, and living situation (eg, caregiver present to assist, long-term care facility). For elderly patients with diabetes who are relatively healthy, attaining target goals for aspirin use, blood pressure, lipids, smoking cessation, and diet and exercise may be more important than normalized glycemic control (ADA 2018b).

Pregnancy Considerations

Glipizide was found to cross the placenta in vitro (Elliott 1994). Severe hypoglycemia lasting 4 to 10 days has been noted in infants born to mothers taking a sulfonylurea at the time of delivery.

In women with diabetes, maternal hyperglycemia can be associated with congenital malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 201 2018; ADA 2019; Metzger 2007). 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 2019; Blumer 2013). Agents other than glipizide are currently recommended to treat diabetes in pregnant women (ADA 2019).

The manufacturer recommends if glipizide is used during pregnancy, it should be discontinued at least 1 month before the expected delivery date.

Breast-Feeding Considerations

Data from two mother-infant pairs note that glipizide was not detected in breast milk (Feig 2005). According to the manufacturer, due to the potential for hypoglycemia in the breastfeeding infant, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of treatment to the mother. Current guidelines note that breastfeeding is encouraged for all women, including those with diabetes (ACOG 201 2018; ADA 2019; Blumer 2013; Metzger 2007). A small snack before breastfeeding may help decrease the risk of hypoglycemia in women with pregestational diabetes (ACOG 201 2018; Reader 2004). All types of insulin may be used while breastfeeding and some oral agents, including glipizide, may be acceptable for use as well (Metzger 2007).

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Frequency not always defined.

Cardiovascular: Syncope (<3%)

Central nervous system: Dizziness (2% to 7%), nervousness (4%), anxiety (<3%), depression (<3%), hypoesthesia (<3%), insomnia (<3%), pain (<3%), paresthesia (<3%), drowsiness (2%), headache (2%)

Dermatologic: Diaphoresis (<3%), pruritus (1% to <3%), eczema (1%), erythema (1%), maculopapular rash (1%), morbilliform rash (1%), skin rash (1%), urticaria (1%)

Endocrine & metabolic: Hypoglycemia (<3%), increased lactate dehydrogenase

Gastrointestinal: Diarrhea (1% to 5%), flatulence (3%), dyspepsia (<3%), vomiting (<3%), constipation (1% to <3%), nausea (1% to <3%), abdominal pain (1%)

Hepatic: Increased serum alkaline phosphatase, increased serum AST

Neuromuscular & skeletal: Tremor (4%), arthralgia (<3%), leg cramps (<3%), myalgia (<3%)

Ophthalmic: Blurred vision (<3%)

Renal: Increased blood urea nitrogen, increased serum creatinine

Respiratory: Rhinitis (<3%)

1%, postmarketing, and/or case reports: Agranulocytosis, anorexia, aplastic anemia, bloody stools, cardiac arrhythmia, chills, cholestatic jaundice, confusion, conjunctivitis, decreased libido, disulfiram-like reaction, dyspnea, dysuria, edema, eye pain, flushing, hemolytic anemia, hepatic injury, hypertension, hypertonia, hyponatremia, jaundice, leukopenia, migraine, pancytopenia, pharyngitis, porphyria, retinal hemorrhage, SIADH (syndrome of inappropriate antidiuretic hormone secretion), skin photosensitivity, thrombocytopenia, unsteady gait, vertigo

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

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

Drug Interactions 

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

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

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

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

Beta-Blockers: May enhance the hypoglycemic effect of Sulfonylureas. Cardioselective beta-blockers (eg, acebutolol, atenolol, metoprolol, and penbutolol) may be safer than nonselective beta-blockers. All beta-blockers appear to mask tachycardia as an initial symptom of hypoglycemia. Ophthalmic beta-blockers are probably associated with lower risk than systemic agents. Exceptions: Levobunolol; Metipranolol. 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 decrease the metabolism of Sulfonylureas. Risk C: Monitor therapy

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

Clarithromycin: May increase the serum concentration of GlipiZIDE. Risk C: Monitor therapy

Colesevelam: May decrease the serum concentration of GlipiZIDE. Management: Administer glipizide at least 4 hours prior to colesevelam. Risk D: Consider therapy modification

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

Dabrafenib: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP2C9 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

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

Enzalutamide: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP2C9 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP2C9 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

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

Fluconazole: May increase the serum concentration of Sulfonylureas. Management: Seek alternatives when possible. If used together, monitor closely for increased effects of sulfonylureas if fluconazole is initiated/dose increased, or decreased effects if fluconazole is discontinued/dose decreased. Risk D: Consider therapy modification

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

Herbs (Hypoglycemic Properties): 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

Indobufen: May increase the serum concentration of GlipiZIDE. Risk C: Monitor therapy

Lumacaftor: May decrease the serum concentration of CYP2C9 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor 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 Blood Glucose Lowering Agents. Risk C: Monitor therapy

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

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. 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

MiFEPRIStone: May increase the serum concentration of CYP2C9 Substrates (High risk with Inhibitors). Management: Use CYP2C9 substrates at the lowest recommended dose, and monitor closely for adverse effects, during and in the 2 weeks following mifepristone treatment. Risk D: Consider therapy modification

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

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

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

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

Posaconazole: May enhance the hypoglycemic effect of GlipiZIDE. Posaconazole may increase the serum concentration of GlipiZIDE. Risk C: Monitor therapy

Probenecid: May decrease the protein binding of Sulfonylureas. Probenecid may increase the serum concentration of Sulfonylureas. Risk C: Monitor therapy

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

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

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

RifAMPin: May decrease the serum concentration of Sulfonylureas. Management: Seek alternatives to these combinations when possible. Monitor closely for diminished therapeutic effects of sulfonylureas if rifampin is initiated/dose increased, or enhanced effects if rifampin is discontinued/dose decreased. Risk D: Consider therapy modification

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 Blood Glucose Lowering Agents. Risk C: Monitor therapy

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

Sodium-Glucose Cotransporter 2 (SLGT2) Inhibitors: May enhance the hypoglycemic effect of Sulfonylureas. Management: Consider a decrease in sulfonylurea dose when initiating therapy with a sodium-glucose cotransporter 2 inhibitor and monitor patients for hypoglycemia. Risk D: Consider therapy modification

Sulfonamide Antibiotics: 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.

Food: A delayed release of insulin may occur if glipizide is taken with food. Management: Immediate release tablets should be administered 30 minutes before meals to avoid erratic absorption.

Gene Testing May Be Considered
Monitoring Parameters

Signs and symptoms of hypoglycemia (fatigue, excessive hunger, profuse sweating, numbness of extremities), blood glucose, hemoglobin A1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2019]), renal function, liver function, weight (due to potential to cause weight gain)

Reference Range

Recommendations for glycemic control in patients with diabetes:

Nonpregnant adults (ADA 2019):

HbA1c: <7% (a more aggressive [<6.5%] or less aggressive [<8%] HbA1c goal may be targeted based on patient-specific characteristics)

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

Peak postprandial capillary blood glucose: <180 mg/dL (more or less stringent goals may be appropriate based on patient-specific characteristics)

Older adults (≥65 years) (ADA 2019):

HbA1c: <7.5% (healthy); <8% (complex/intermediate health); <8.5% (very complex/poor health) (individualization may be appropriate based on patient and caregiver preferences)

Preprandial capillary blood glucose: 90 to 130 mg/dL (healthy); 90 to 150 mg/dL (complex/intermediate health); 100 to 180 mg/dL (very complex/poor health)

Bedtime capillary blood glucose: 90 to 150 mg/dL (healthy); 100 to 180 mg/dL (complex/intermediate health); 110 to 200 mg/dL (very complex/poor health)

Classification of hypoglycemia (ADA 2019):

Level 1: ≥54 to ≤70 mg/dL; hypoglycemia alert value; initiate fast-acting carbohydrate (eg, glucose) treatment

Level 2: <54 mg/dL; 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

Advanced Practitioners Physical Assessment/Monitoring

Monitor for hypoglycemia during therapy.

Nursing Physical Assessment/Monitoring

Monitor for hypoglycemia during therapy.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Glucotrol: 5 mg, 10 mg [scored]

Generic: 5 mg, 10 mg

Tablet Extended Release 24 Hour, Oral:

glipiZIDE XL: 2.5 mg, 5 mg, 10 mg

Glucotrol XL: 2.5 mg, 5 mg, 10 mg

Generic: 2.5 mg, 5 mg, 10 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet Extended Release 24 Hour, Oral:

Glucotrol XL: 5 mg, 10 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • A10BB07
Generic Available (US)

Yes

Pricing: US

Tablet, 24-hour (glipiZIDE ER Oral)

2.5 mg (per each): $0.41

5 mg (per each): $0.41

10 mg (per each): $0.81

Tablet, 24-hour (Glucotrol XL Oral)

2.5 mg (per each): $1.97

5 mg (per each): $1.97

10 mg (per each): $3.82

Tablets (glipiZIDE Oral)

5 mg (per each): $0.34 – $0.40

10 mg (per each): $0.59 – $0.76

Tablets (Glucotrol Oral)

5 mg (per each): $1.98

10 mg (per each): $3.70

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

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

Pharmacodynamics/Kinetics

Duration: 12 to 24 hours

Absorption: Immediate release: Rapid and complete; delayed with food

Distribution: 10 to 11 L

Protein binding: 98% to 99%; primarily to albumin

Bioavailability: 90% to 100%

Metabolism: Hepatic via CYP2C9; forms metabolites (inactive)

Half-life elimination: 2 to 5 hours

Time to peak: 1 to 3 hours; extended release tablets: 6 to 12 hours

Excretion: Urine (<10% as unchanged drug; 80% as metabolites); feces (10%)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Patients with diabetes should be questioned by the dental professional at each dental visit to assess their risk for stress-induced hypoglycemia. The dental professional should inquire about the patient’s routine (ie, work, sleep schedule, eating patterns), history of hypoglycemia, time of last medication dose, last meal, and most recent blood sugar assessment. Keep a supply of glucose tablets and other carbohydrates in the office to prepare for a hypoglycemic event. Seek medical attention when necessary (American Diabetes Association, 2018).

Effects on Bleeding

No information available to require special precautions

Index Terms

Glydiazinamide

FDA Approval Date
May 08, 1984
References

Abraira C, Henderson WG, Colwell JA, et al. Response to intensive therapy steps and to glipizide dose in combination with insulin in type 2 diabetes. VA feasibility study on glycemic control and complications (VA CSDM). Diabetes Care. 1998;21(4):574-579.[PubMed 9571345]

American College of Obstetricians and Gynecologists ACOG Practice Bulletin No. 201: Pregestational Diabetes Mellitus. Obstet Gynecol. 2018;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960.[PubMed 15738045]

American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins—Obstetrics. ACOG Practice Bulletin No. 190: Gestational diabetes mellitus. Obstet Gynecol. 2018;131(2):e49-e64.[PubMed 30461693]

American Diabetes Association (ADA). Diabetes Care. 2019;42(suppl 1):S1-S193. http://care.diabetesjournals.org/content/42/Supplement_1. Accessed February 11, 2019.

Arjona Ferreira JC, Marre M, Barzilai N, et al. Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes and moderate-to-severe chronic renal insufficiency. Diabetes Care. 2013;36(5):1067-1073.[PubMed 23248197]

Berelowitz M, Fischette C, Cefalu W, Schade DS, Sutfin T, Kourides IA. Comparative efficacy of a once-daily controlled-release formulation of glipizide and immediate-release glipizide in patients with NIDDM. Diabetes Care. 1994;17(12):1460-1464.[PubMed 7882817]

Blumer I, Hadar E, Hadden DR, et al. Diabetes and pregnancy: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2013;98(11):4227-4249.[PubMed 24194617 ]

Bogun M, Inzucchi SE. Inpatient management of diabetes and hyperglycemia. Clin Ther. 2013;35(5):724-733. doi: 10.1016/j.clinthera.2013.04.008.[PubMed 23688537]

Brackett CC, Singh H, Block JH. Likelihood and mechanisms of cross-allergenicity between sulfonamide antibiotics and other drugs containing a sulfonamide functional group. Pharmacotherapy. 2004;24(7):856-870.[PubMed 15303450]

DeFronzo RA. Pharmacologic therapy for type 2 diabetes mellitus. Ann Intern Med. 1999;131(4):281-303.[PubMed 10454950]

Del Prato S, Camisasca R, Wilson C, Fleck P. Durability of the efficacy and safety of alogliptin compared with glipizide in type 2 diabetes mellitus: a 2-year study. Diabetes Obes Metab. 2014;16(12):1239-1246. doi: 10.1111/dom.12377.[PubMed 25132212]

Elliott BD, Schenker S, Langer O, et al. Comparative placental transport of oral hypoglycemic agents in humans: a model of human placental drug transfer. Am J Obstet Gynecol.1994;171(3):653-660.[PubMed 8092211]

Feig DS, Briggs GG, Kraemer JM, et al. Transfer of glyburide and glipizide into breast milk. Diabetes Care. 2005;28(8):1851-1855.[PubMed 16043722]

Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2019 executive summary. Endocr Pract. 2019;25(1):69-100. doi: 10.4158/CS-2018-0535.[PubMed 30742570]

Gianchandani RY, Neupane S, Iyengar JJ, Heung M. Pathophysiology and management of hypoglycemia in end-stage renal disease patients: a review. Endocr Pract. 2017;23(3):353-362.[PubMed 27967230]

Glucotrol (glipizide) tablets [prescribing information]. New York, NY: Pfizer; October 2016.

Glucotrol XL (glipizide) [prescribing information]. New York, NY: Pfizer; August 2018.

Hurren KM, Bartley EP, O’Neill JL, Ronis DL. Effect of sulfonylurea dose escalation on hemoglobin A1c in Veterans Affairs patients with type 2 diabetes. Acta Diabetol. 2013;50(2):261-265. doi: 10.1007/s00592-010-0197-1.[PubMed 20512383]

Inzucchi SE. Clinical practice. Management of hyperglycemia in the hospital setting. N Engl J Med. 2006;355(18):1903-1911. doi: 10.1056/NEJMcp060094.[PubMed 17079764]

Johnson KK, Green DL, Rife JP, Limon L. Sulfonamide cross-reactivity: fact or fiction? [published correction appears in Ann Pharmacother. 2005;39(7-8):1373]. Ann Pharmacother. 2005;39(2):290-301.[PubMed 15644481]

McCulloch DK. Sulfonylureas and meglitinides in the treatment of diabetes mellitus. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed March 4, 2019.

Metzger BE, Buchanan TA, Coustan DR, et al. Summary and recommendations of the Fifth International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care.2007;30(suppl 2):S251-S260.[PubMed 17596481]

National Kidney Foundation. KDOQI clinical practice guidelines for diabetes and CKD: 2012 update. Am J Kidney Dis. 2012;60(5):850-886. doi: 10.1053/j.ajkd.2012.07.005.[PubMed 23067652]

Reader D, Franz MJ. Lactation, diabetes, and nutrition recommendations. Curr Diab Rep. 2004;4(5):370-376.[PubMed 15461903 ]

Slatore CG, Tilles SA. Sulfonamide hypersensitivity. Immunol Allergy Clin North Am. 2004;24(3):477-490.[PubMed 15242722]

Stenman S, Melander A, Groop PH, Groop LC. What is the benefit of increasing the sulfonylurea dose? Ann Intern Med. 1993;118(3):169-172.[PubMed 8417634]

Tornero P, De Barrio M, Baeza ML, Herrero T. Cross-reactivity among p-amino group compounds in sulfonamide fixed drug eruption: diagnostic value of patch testing. Contact Dermatitis. 2004;51(2):57-62.[PubMed 15373844]

Tuttle KR, Bakris GL, Bilous RW, et al. Diabetic kidney disease: a report from an ADA consensus conference. Diabetes Care. 2014;37(10):2864-2883. doi: 10.2337/dc14-1296.[PubMed 25249672]

UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33) [published correction appears in: Lancet. 1999;354(9178):602]. Lancet. 1998;352(9131):837-853.[PubMed 9742976]

Wåhlin-Boll E, Sartor G, Melander A, Scherstén B. Impaired effect of sulfonylurea following increased dosage. Eur J Clin Pharmacol. 1982;22(1):21-25.[PubMed 7047168]

Brand Names: International

Actine (BD); Antidiab (HR, PL); Apamid (SE); Brilizid (PH); Diabes (TW); Diacon (LK); Diactin (BD, SG); Diasef (SG); Dibizide (MY); Digrin (KR); Dipazide (TH); Flumedil (MX); Gabaz (MX); Gipix (BD); Gipzide (TH); Glibenese (AE, AT, BE, BF, BH, BJ, CH, CI, CY, DE, DK, EG, ET, FI, FR, GH, GM, GN, GR, IL, IQ, IR, JO, KE, KW, LR, LU, LY, MA, ML, MR, MU, MW, NE, NG, NL, OM, PL, RU, SA, SC, SD, SE, SL, SN, SY, TN, TZ, UG, YE, ZA, ZM, ZW); Glibenese GITS (PL); Glibetin (TW); Glican (SV); Glidiab (TW); Glipid (NZ); Glipimed (TH); Glipizide (PL); Glipizide BP (PL); Glipom (AE, BH, QA, SA); Glix (MY); Glizide (TH); Gluco-Rite (IL); Glucodiab (TH); Glucolip (IN, PH); Gluconil (PH); Glucotrol XL (BB, BM, BS, BZ, CN, GY, HK, ID, JM, LV, RO, SR, TT); Glucozide (TW); Glupizide (TW); Gluzide (LK); Glygen (TH); Glynase (IN, LK, SG, VN); Glyzip (IN); Luditec (MX); Meibida (CN); Melizid (FI); Melizide (AU, SG); Mindiab (DK, EE, FI, NO, PK, RU, SE); Minibit (TH); Minidiab (AE, AT, AU, BE, BF, BG, BH, BJ, BR, CI, CL, CY, CZ, EG, ET, FR, GH, GM, GN, HN, HU, IL, IQ, IR, IS, IT, JO, KE, KW, LK, LR, LU, LY, MA, ML, MR, MU, MW, MY, NE, NG, OM, PH, PL, PT, SA, SC, SD, SI, SK, SL, SN, SY, TH, TN, TR, TW, TZ, UG, VE, VN, YE, ZA, ZM, ZW); Minodiab (AR, CR, ES, GB, GR, GT, IE, MX, NI, PA); Napizide (TW); Ozidia (FR); Pezide (TH); Singloben (MX); Sucrazide (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Sunglucon (HK); Topizide (TH); Xeltic (TH)

Glipizide (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(GLIP i zide)

Brand Names: US

glipiZIDE XL; Glucotrol; Glucotrol XL

What is this drug used for?
  • It is used to lower blood sugar in patients with high blood sugar (diabetes).
What do I need to tell my doctor BEFORE I take this drug?
  • All products:
  • If you have an allergy to glipizide or any other part of this drug.
  • If you have a sulfa allergy.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Acidic blood problem or type 1 diabetes.
  • If you have G6PD deficiency.
  • Extended-release tablets:
  • If you have a narrowing of the GI (gastrointestinal) tract or a bowel block.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • Check your blood sugar as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • Follow the diet and workout plan that your doctor told you about.
  • Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
  • Avoid drinking alcohol while taking this drug.
  • If you also take colesevelam, take it at least 4 hours after you take this drug.
  • It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
  • This drug may raise the chance of death from heart disease. Talk with your doctor.
  • Low blood sugar may happen with this drug. Very low blood sugar can lead to seizures, passing out, long lasting brain damage, and sometimes death. Talk with the doctor.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Low blood sugar has happened in infants born to women who took a drug like this one until the birth date. If this drug is used during pregnancy, you will need to stop taking it some time before your due date. Talk with your doctor.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • Extended-release tablets:
  • You may see the tablet shell in your stool. This is normal and not a cause for concern.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Change in eyesight.
  • Slurred speech.
  • Tingling.
  • Feeling very tired or weak.
  • Low blood sugar can happen. The chance of low blood sugar may be raised when this drug is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do if you get low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Dizziness.
  • Diarrhea.
  • Feeling nervous and excitable.
  • Gas.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Regular-release tablets:
  • Take 30 minutes before meals.
  • Take this drug 30 minutes before the first meal of the day, if taking once a day.
  • Extended-release tablets:
  • Take with the first meal of the day.
  • Swallow whole. Do not chew, break, or crush.
  • All products:
  • Be sure you know what to do if you do not eat as much as normal or if you skip a meal.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Extended-release tablets:
  • Store in original container.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Glipizide (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(GLIP i zide)

Brand Names: US

glipiZIDE XL; Glucotrol; Glucotrol XL

What is this drug used for?
  • It is used to lower blood sugar in patients with high blood sugar (diabetes).
What do I need to tell the doctor BEFORE my child takes this drug?
  • All products:
  • If your child has an allergy to this drug or any part of this drug.
  • If your child has a sulfa allergy.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has any of these health problems: Acidic blood problem or type 1 diabetes.
  • If your child has G6PD deficiency.
  • Extended-release tablets:
  • If your child has a narrowing of the GI (gastrointestinal) tract or a bowel block.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • Have your child’s blood sugar checked as you have been told by your child’s doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • Have your child follow the diet and workout plan your child’s doctor told you about.
  • If your child can drive, do not let your child drive if his/her blood sugar has been low. There is a greater chance of a crash.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • If your child also takes colesevelam, give it at least 4 hours after you give this drug.
  • It may be harder to control your child’s blood sugar during times of stress like when your child has a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your child’s blood sugar. Talk with the doctor.
  • This drug may raise the chance of death from heart disease. Talk with your doctor.
  • Low blood sugar may happen with this drug. Very low blood sugar can lead to seizures, passing out, long lasting brain damage, and sometimes death. Talk with the doctor.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
  • Low blood sugar has happened in infants born to women who took a drug like this one until the birth date. If this drug is used during pregnancy, your child will need to stop taking it some time before her due date. Talk with your child’s doctor.
  • Extended-release tablets:
  • You may see the tablet shell in your child’s stool. This is normal and not a cause for concern.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Change in eyesight.
  • Slurred speech.
  • Tingling.
  • Feeling very tired or weak.
  • Low blood sugar can happen. The chance of low blood sugar may be raised when this drug is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if your child has any of these signs. Follow what you have been told to do if your child gets low blood sugar. This may include giving your child glucose tablets, liquid glucose, or some fruit juices.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Dizziness.
  • Diarrhea.
  • Feeling nervous and excitable.
  • Gas.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Regular-release tablets:
  • Give 30 minutes before meals.
  • Give this drug 30 minutes before the first meal of the day, if your child is taking once a day.
  • Extended-release tablets:
  • Give this drug with the first meal of the day.
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • All products:
  • Be sure you know what to do if your child does not eat as much as normal or if your child skips a meal.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Extended-release tablets:
  • Store in original container.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.