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Chlorpropamide: Drug information

Copyright 1978-2019 Lexicomp, Inc. All rights reserved.

(For additional information see "Chlorpropamide: Patient drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)

Brand Names: Canada

APO-ChlorproPAMIDE

Pharmacologic Category
Antidiabetic Agent, Sulfonylurea

Dosing: Adult

Diabetes mellitus, type 2: Oral:

Initial: 250 mg once daily or in divided doses if GI intolerance occurs; consider

conservative doses for malnourished or debilitated patients

Titration: After 5 to 7 days of initiation, subsequent daily dosages may be increased or

decreased by 50 to 125 mg at 3- to 5-day intervals

Maintenance: 100 to 250 mg once daily or in divided doses if GI intolerance occurs;

doses ≤100 mg/day may be adequate in some mildly diabetic patients; severely
diabetic patients may require 500 mg/day; avoid doses >750 mg/day

Central (neurogenic) diabetes insipidus (off-label) : Note: Very limited data: Oral: 125
to 250 mg once or twice daily; higher dosages may produce additional antidiuretic effect
but may also be associated with increased hypoglycemia (Cushard 1971; Wales 1971;
Webster 1970)

Dosing: Renal Impairment: Adult

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No specific dosage adjustment provided in manufacturer’s labeling; conservative initial and

maintenance doses are recommended.

Alternate recommendations (Aronoff, 2007):

CrCl >50 mL/minute: Reduce dose by 50%.

CrCl <50 mL/minute: Avoid use.

Hemodialysis: Avoid use.

Peritoneal dialysis: Avoid use.

Continuous renal replacement therapy (CRRT): Avoid use.

Dosing: Hepatic Impairment: Adult

No specific dosage adjustment provided in manufacturer’s labeling; conservative initial and
maintenance doses are recommended in patients with liver impairment since chlorpropamide
undergoes extensive hepatic metabolism.

Dosing: Geriatric
Initial: 100 to 125 mg once daily or in divided doses if GI intolerance occurs; after 5 to 7 days of
initiation, subsequent daily dosages may be increased or decreased by 50 to 125 mg at 3- to
5-day intervals (slower upward titration may be appropriate in older patients)

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

Tablet, Oral:

Generic: 100 mg, 250 mg

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

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

Tablet, Oral:

Generic: 100 mg, 250 mg

Administration: Adult

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Oral: Administer once daily with breakfast. Daily dose may be divided to reduce GI upset.
Patients that are NPO or require decreased caloric intake may need doses held to avoid
hypoglycemia.

Use: Labeled Indications

Diabetes mellitus, type 2: As an adjunct to diet and exercise to improve glycemic control in
adults with type 2 diabetes mellitus

Use: Off-Label: Adult

Central (neurogenic) diabetes insipidus

Medication Safety Issues

Sound-alike/look-alike issues:

ChlorproPAMIDE may be confused with chlorproMAZINE

Diabinese may be confused with DiaBeta

High alert medication:

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

Geriatric Patients: High-Risk Medication:

Beers Criteria: Chlorpropamide is identified in the Beers Criteria as a potentially

inappropriate medication to be avoided in patients 65 years and older (independent of
diagnosis or condition) because of its prolonged half-life in older adults, which may
cause prolonged hypoglycemia. In addition, chlorpropamide may cause syndrome of
inappropriate antidiuretic hormone secretion (SIADH) (Beers Criteria [AGS 2015]).
Note: Updates for the American Geriatrics Society 2019 Updated AGS Criteria for
Potentially Inappropriate Medication Use in Older Adults are in process.

Pharmacy Quality Alliance (PQA): Chlorpropamide is identified as a high-risk

medication in patients 65 years and older on the PQA's Use of High-Risk Medications
in the Elderly (HRM) performance measure, a safety measure used by the Centers for
Medicare and Medicaid Services (CMS) Star Rating System for Medicare plans.

International issues:

Diabinese [Multiple international markets] may be confused with Diamox brand name
for acetazolamide [Canadan, multiple international markets]

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Adverse Reactions
Frequency not always defined.

Central nervous system: Disulfiram-like reaction, dizziness, headache

Dermatologic: Pruritus (<3%), maculopapular rash (≤1%), urticaria (≤1%), erythema

multiforme, exfoliative dermatitis, skin photosensitivity

Endocrine & metabolic: Hepatic porphyria, hypoglycemia, porphyria cutanea tarda, SIADH
(syndrome of inappropriate antidiuretic hormone secretion), weight gain

Gastrointestinal: Nausea (<5%), anorexia (<2%), diarrhea (<2%), hunger (<2%), vomiting
(<2%)

Hematologic & oncologic: Agranulocytosis, aplastic anemia, eosinophilia, hemolytic

anemia, leukopenia, pancytopenia, thrombocytopenia

Hepatic: Cholestatic jaundice, hepatic failure, hepatitis

<1%, postmarketing, and/or case reports: Proctocolitis

Contraindications
Hypersensitivity to chlorpropamide or any component of the formulation; type 1 diabetes
mellitus; diabetic ketoacidosis (with or without coma)

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 patients, malnourished patients
and in patients with impaired renal or hepatic function; 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

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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 issues:

• 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.

• Stress-related states: It may be necessary to discontinue therapy and administer

insulin if the patient is exposed to stress (fever, trauma, infection, surgery).

Other warnings/precautions:

• Long half-life: Patients should be properly instructed in the early detection and
treatment of hypoglycemia; long half-life may complicate recovery from excess effects.

• Secondary failure: Loss of efficacy may be observed following prolonged use as a

result of the progression of type 2 diabetes mellitus which results in continued beta cell
destruction. In patients who were previously responding to sulfonylurea therapy,
consider additional factors which may be contributing to decreased efficacy (eg,
inappropriate dose, nonadherence to diet and exercise regimen). If no contributing
factors can be identified, consider discontinuing use of the sulfonylurea due to
secondary failure of treatment. Additional antidiabetic therapy (eg, insulin) will be
required.

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

Drug Interactions
(For additional information: Launch drug interactions program)

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

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

Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of ChlorproPAMIDE.

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-

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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: 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

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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

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for hypoglycemia. Risk D: Consider therapy modification

Urinary Acidifying Agents: May increase the serum concentration of ChlorproPAMIDE. Risk
C: Monitor therapy

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
Possible disulfiram-like reaction may occur with concurrent ethanol use. Management: Monitor
patients.

Pregnancy Risk Factor

C (show table)

Pregnancy Implications
Chlorpropamide crosses the placenta and measurable serum concentrations can be found in
infants exposed in utero. Severe hypoglycemia lasting 4 to 10 days has been noted in infants
born to mothers taking a sulfonylurea (including chlorpropamide) at the time of delivery;
additional adverse events have also been reported and may be influenced by maternal
glycemic control (Jackson 1962; Kemball 1970; Uhrig 1983; Zucker 1968).

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 2005;
ADA 2018c; 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 2018c; Blumer 2013). Agents other
than chlorpropamide are currently recommended to treat diabetes in pregnant women (ADA
2018c). The manufacturer recommends if chlorpropamide is used during pregnancy, it should
be discontinued at least 1 month before the expected delivery date.

Breast-Feeding Considerations
Chlorpropamide is present in breast milk. Breastfeeding is not recommended by the
manufacturer.

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Dietary Considerations
May cause GI upset; take with food.

Monitoring Parameters
Blood glucose, HbA1c (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 2018a]); monitor for signs and symptoms of hypoglycemia (fatigue, sweating,
blurred vision)

Reference Range

Recommendations for glycemic control in nonpregnant adults with diabetes (ADA 2018a):

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

Preprandial capillary plasma 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)

Recommendations for glycemic control in older adults (≥65 years) with diabetes (ADA
2018b):

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 plasma 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)

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 and Pharmacokinetics

Onset of action: 1 hour

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Peak effect: 3-6 hours

Duration: 24 hours

Absorption: Rapid

Distribution: Vd: 0.13-0.23 L/kg (Arrigoni 1987)

Protein binding: 90%

Metabolism: Extensively hepatic (~80%), primarily via CYP2C9; forms metabolites

Half-life elimination: ~36 hours; prolonged in elderly or with renal impairment

End-stage renal disease: 50-200 hours

Time to peak, serum: 2-4 hours

Excretion: Urine (unchanged drug and as hydroxylated or hydrolyzed metabolites)

Pricing: US

Tablets (chlorproPAMIDE Oral)

100 mg (per each): $1.20

250 mg (per each): $2.54

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.

Brand Names: International

Abemide (JP, TW); Adiaben (HR); Anti-D (SG); Arodoc C (JP); Biodiabes (UY); BPros (KR);
Chlormide (JP); Chlorpropamid (PL); Copamide (IN); Dabinese (VE); Diabemide (BF, BJ, CI,
ET, GH, GM, GN, IT, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG,
ZM, ZW); Diabenese (AE, BB, BF, BH, BJ, BM, BS, BZ, CI, CO, CR, CY, DO, ET, GB, GH, GM,
GN, GR, GT, GY, HN, IL, IQ, IR, IT, JM, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, MX, NE,

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NG, NI, NL, OM, PA, PR, PT, QA, SC, SD, SL, SN, SR, SV, SY, TN, TT, TZ, UG, YE, ZA, ZM,
ZW); Diabezin (TW); Diabines (SE); Diabinese (AR, AU, BE, BR, CH, CL, EC, HK, HR, IE, KR,
LU, PE, PH, PK, PL, SA, TH, UY); Diabitex (BB, BM, BS, BZ, GY, JM, NL, SR, TT, ZA); Dibecon
(TH); Glicorp (BR); Hypomide (ZA); Insogen (MX); Litangen (TW); Meldian (HR); Mellitos C
(JP); Pamidin (EG); Propamide (MY, SG); Trane (AR)

For country abbreviations used in Lexicomp (show table)

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