Dapagliflozin

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Assess renal function prior to initiation and then as clinically indicated.
• Assess volume status and correct volume depletion before initiating.
• ( 2.1 ) To improve glycemic control, the recommended starting dosage is 5 mg orally once daily.
• Dosage can be increased to 10 mg orally once daily for additional glycemic control.
• ( 2.2 ) For all other indications, the recommended dosage is 10 mg orally once daily.
• (2.3) See full prescribing information for dosage recommendations in patients with renal impairment.
• ( 2.2 , 2.3) Withhold dapagliflozin tablets for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting.
• ( 2.4 )
• 2.1 Testing Prior to Initiation of Dapagliflozin Tablets Assess renal function prior to initiation of dapagliflozin tablets and then as clinically indicated [see Warnings and Precautions (5.2) ] .
• Assess volume status.
• In patients with volume depletion, correct this condition before initiating dapagliflozin tablets [see Warnings and Precautions (5.2) and Use in Specific Populations (8.5 , 8.6) ] .
• Recommended Dosage for Glycemic Control in
• Adults with Type 2 Diabetes Mellitus In
• adults with type 2 diabetes mellitus, the recommended starting dosage of dapagliflozin tablets is 5 mg orally once daily to improve glycemic control.
• For additional glycemic control, the dosage can be increased to 10 mg orally once daily.
• For Adult Patients with Type 2 Diabetes Mellitus and Renal Impairment:
• The recommended dosage for dapagliflozin tablets in patients with an eGFR greater than or equal to 45 mL/min/1.73 m 2 is the same as the recommended dosage in patients with normal renal function.
• Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 .
• Dapagliflozin tablets are likely to be ineffective to improve glycemic control in this setting based upon its mechanism of action.
• Pediatric use information is approved for AstraZeneca AB’s Farxiga ® (dapagliflozin) Tablets.
• However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.
• Recommended Dosage for Other Indications in
• Adults The recommended dosage of dapagliflozin tablets is 10 mg orally once daily in
• adults for the following indications:
• To reduce the risk of hHF in patients with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors.
• For
• Adults with Renal Impairment Receiving Dapagliflozin Tablets for Indications Other than Glycemic Control:
• The recommended dosage of dapagliflozin tablets in patients with an eGFR greater than or equal to 25 mL/min/1.73 m 2 is the same as the recommended dosage in patients with normal renal function.
• Initiation with dapagliflozin tablets is not recommended in patients with an eGFR less than 25 mL/min/1.73 m 2 .
• 2.4 Temporary Interruption for Surgery Withhold dapagliflozin tablets for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting.
• Resume dapagliflozin tablets when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2) ].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and effectiveness of dapagliflozin tablets for glycemic control in type 2 diabetes mellitus have not been established in pediatric patients less than 10 years of age.
• The safety and effectiveness of dapagliflozin tablets have not been established in pediatric patients to reduce the risk of [see Indications and Usage (1) ]:
• hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
• Pediatric use information is approved for AstraZeneca AB’s Farxiga ® (dapagliflozin) Tablets.
• However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• No dapagliflozin tablets dosage change is recommended based on age.
• A total of 1424 (24%) of the 5936 dapagliflozin tablets-treated patients were 65 years and older and 207 (3.5%) patients were 75 years and older in a pool of 21 double-blind, controlled, clinical trials assessing the efficacy of dapagliflozin tablets in improving glycemic control in type 2 diabetes mellitus.
• After controlling for level of renal function (eGFR), efficacy was similar for patients under age 65 years and those 65 years and older.
• In patients ≥65 years of age, a higher proportion of patients treated with dapagliflozin tablets for glycemic control had adverse reactions of hypotension [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] .

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following important adverse reactions are described below and elsewhere in the labeling:
• Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.1) ] Volume Depletion [see Warnings and Precautions (5.2) ] Urosepsis and Pyelonephritis [see Warnings and Precautions (5.3) ] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.4) ] Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) [see Warnings and Precautions (5.5) ] Genital Mycotic Infections [see Warnings and Precautions (5.6) ] Most common adverse reactions (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 o r www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
• Dapagliflozin has been evaluated in clinical trials in adult patients with type 2 diabetes mellitus.
• The overall safety profile of dapagliflozin was consistent across the studied indications.
• Severe hypoglycemia and diabetic ketoacidosis (DKA) were observed only in patients with diabetes mellitus.
• Clinical Trials for Glycemic Control in Adult Patients with Type 2 Diabetes Mellitus Pool of 12 Placebo-Controlled Adult Trials for Dapagliflozin Tablets 5 and 10 mg for Glycemic Control The data in Table 1 is derived from 12 glycemic control placebo-controlled trials in adult patients with type 2 diabetes mellitus ranging from 12 to 24 weeks.
• In 4 trials dapagliflozin tablets were used as monotherapy, and in 8 trials dapagliflozin tablets were used as add-on to background antidiabetic therapy or as combination therapy with metformin [see Clinical Studies (14.1 )].
• These data reflect exposure of 2338 adult patients to dapagliflozin tablets with a mean exposure duration of 21 weeks.
• Patients received placebo (N=1393), dapagliflozin tablets 5 mg (N=1145), or dapagliflozin tablets 10 mg (N=1193) once daily.
• The mean age of the population was 55 years and 2% were older than 75 years of age.
• Fifty percent (50%) of the population were male; 81% were White, 14% were Asian, and 3% were Black or African American.
• At baseline, the population had diabetes for an average of 6 years, had a mean hemoglobin A1c (HbA1c) of 8.3%, and 21% had established microvascular complications of diabetes.
• Baseline renal function was normal or mildly impaired in 92% of patients and moderately impaired in 8% of patients (mean eGFR 86 mL/min/1.73 m 2 ).
• Table 1 shows common adverse reactions in
• adults associated with the use of dapagliflozin tablets.
• These adverse reactions were not present at baseline, occurred more commonly on dapagliflozin tablets than on placebo, and occurred in at least 2% of patients treated with either dapagliflozin tablets 5 mg or dapagliflozin tablets 10 mg.
• Table 1:
• Adverse Reactions in Placebo-Controlled Trials of Glycemic Control Reported in ≥2% of
• Adults Treated with Dapagliflozin Tablets Adverse Reaction % of Patients Pool of 12 Placebo-Controlled Trials Placebo N=1393 Dapagliflozin Tablet 5 mg N=1145 Dapagliflozin Tablet 10 mg N=1193 Female genital mycotic infections Genital mycotic infections include the following adverse reactions, listed in order of frequency reported for females:
• vulvovaginal mycotic infection, vaginal infection, vulvovaginal candidiasis, vulvovaginitis, genital infection, genital candidiasis, fungal genital infection, vulvitis, genitourinary tract infection, vulval abscess, and vaginitis bacterial.
• (N for females:
• Placebo=677, dapagliflozin tablets 5 mg=581, dapagliflozin tablets 10 mg=598). 1.5 8.4
• 6.9 Nasopharyngitis 6.2 6.6
• 6.3 Urinary tract infections Urinary tract infections include the following adverse reactions, listed in order of frequency reported:
• urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection, and prostatitis. 3.7 5.7
• 4.3 Back pain 3.2 3.1
• 4.2 Increased urination Increased urination includes the following adverse reactions, listed in order of frequency reported:
• pollakiuria, polyuria, and urine output increased. 1.7 2.9
• 3.8 Male genital mycotic infections Genital mycotic infections include the following adverse reactions, listed in order of frequency reported for males:
• balanitis, fungal genital infection, balanitis candida, genital candidiasis, genital infection male, penile infection, balanoposthitis, balanoposthitis infective, genital infection, and posthitis.
• (N for males:
• Placebo=716, dapagliflozin tablets 5 mg=564, dapagliflozin tablets 10 mg=595). 0.3 2.8
• 2.7 Nausea 2.4 2.8
• 2.5 Influenza 2.3 2.7
• 2.3 Dyslipidemia 1.5 2.1
• 2.5 Constipation 1.5 2.2
• 1.9 Discomfort with urination 0.7 1.6
• 2.1 Pain in extremity 1.4 2.0
• 1.7 Pool of 13 Placebo-Controlled Adult Trials for Dapagliflozin Tablets 10 mg for Glycemic Control Dapagliflozin tablets 10 mg was also evaluated in a larger glycemic control placebo-controlled trial pool in adult patients with type 2 diabetes mellitus.
• This pool combined 13 placebo-controlled trials, including 3 monotherapy trials, 9 add-on to background antidiabetic therapy trials, and an initial combination with metformin trial.
• Across these 13 trials, 2360 patients were treated once daily with dapagliflozin tablets 10 mg for a mean duration of exposure of 22 weeks.
• The mean age of the population was 59 years and 4% were older than 75 years.
• Fifty-eight percent (58%) of the population were male; 84% were White, 9% were Asian, and 3% were Black or African American.
• At baseline, the population had diabetes for an average of 9 years, had a mean HbA1c of 8.2%, and 30% had established microvascular disease.
• Baseline renal function was normal or mildly impaired in 88% of patients and moderately impaired in 11% of patients (mean eGFR 82 mL/min/1.73 m 2 ).
• Other Adverse Reactions in Adult Patients with Type 2 Diabetes Mellitus Volume Depletion Dapagliflozin tablets cause an osmotic diuresis, which may lead to a reduction in intravascular volume.
• Adverse reactions related to volume depletion (including reports of dehydration, hypovolemia, orthostatic hypotension, or hypotension) in adult patients with type 2 diabetes mellitus for the 12-trial and 13-trial, short-term, placebo-controlled pools and for the DECLARE trial are shown in Table 2 [see Warnings and Precautions (5.2) ] .
• Table 2:
• Adverse Reactions Related to Volume Depletion Volume depletion includes reports of dehydration, hypovolemia, orthostatic hypotension, or hypotension. in Clinical Trials in
• Adults with Type 2 Diabetes Mellitus with Dapagliflozin Tablets Pool of 12 Placebo-Controlled Trials Pool of 13 Placebo-Controlled Trials DECLARE Tria l Placebo Dapagliflozin Tablet 5 mg Dapagliflozin Tablet 10 mg Placebo Dapagliflozin Tablet 10 mg Placebo Dapagliflozin Tablet 10 mg Overall population N (%) N=1393 5 (0.4%) N=1145 7 (0.6%) N=1193 9 (0.8%) N=2295 17 (0.7%) N=2360 27 (1.1%) N=8569 207 (2.4%) N=8574 213 (2.5%) Patient Subgroup n (%) Patients on loop diuretics n=55 1 (1.8%) n=40 0 n=31 3 (9.7%) n=267 4 (1.5%) n=236 6 (2.5%) n=934 57 (6.1%) n=866 57 (6.6%) Patients with moderate renal impairment with eGFR ≥30 and <60 mL/min/1.73 m 2 n=107 2 (1.9%) n=107 1 (0.9%) n=89 1 (1.1%) n=268 4 (1.5%) n=265 5 (1.9%) n=658 30 (4.6%) n=604 3 5 (5.8%) Patients ≥65 years of age n=276 1 (0.4%) n=216 1 (0.5%) n=204 3 (1.5%) n=711 6 (0.8%) n=665 11 (1.7%) n=3950 121 (3.1%) n=3948 117 (3.0%) Hypoglycemia The frequency of hypoglycemia by trial in adult patients with type 2 diabetes mellitus [see Clinical Studies (14.1) ] is shown in Table 3.
• Hypoglycemia was more frequent when dapagliflozin tablets were added to sulfonylurea or insulin [see Warnings and Precautions (5.4) ].
• Table 3:
• Incidence of Severe Hypoglycemia Severe episodes of hypoglycemia were defined as episodes of severe impairment in consciousness or behavior, requiring external (third party) assistance, and with prompt recovery after intervention regardless of glucose level. and Hypoglycemia with Glucose <54 mg/dL Episodes of hypoglycemia with glucose <54 mg/dL (3 mmol/L) were defined as reported episodes of hypoglycemia meeting the glucose criteria that did not also qualify as a severe episode. in Controlled Glycemic Control Clinical Trials in
• Adults with Type 2 Diabetes Mellitus Placebo/Act ive Control Dapagliflozi n Tablet 5 mg Dapagliflozi n Tablet 10 mg Monotherapy (24 weeks) N=75 N=64 N=70 Severe [n (%)] 0 0 0 Glucose <54 mg/dL [n (%)] 0 0 0 Add-on to Metformin (24 weeks) N=137 N=137 N=135 Severe [n (%)] 0 0 0 Glucose <54 mg/dL [n (%)] 0 0 0 Add-on to Glimepiride (24 weeks) N=146 N=145 N=151 Severe [n (%)] 0 0 0 Glucose <54 mg/dL [n (%)] 1 (0.7) 3 (2.1) 5 (3.3) Add-on to Metformin and a Sulfonylurea (24 Weeks) N=109 - N=109 Severe [n (%)] 0 - 0 Glucose <54 mg/dL [n (%)] 3 (2.8) - 7 (6.4) Add-on to Pioglitazone (24 weeks) N=139 N=141 N=140 Severe [n (%)] 0 0 0 Glucose <54 mg/dL [n (%)] 0 1 (0.7) 0 Add-on to DPP4 inhibitor (24 weeks) N=226 - N=225 Severe [n (%)] 0 - 1 (0.4) Glucose <54 mg/dL [n (%)] 1 (0.4) - 1 (0.4) Add-on to Insulin with or without other OADs OAD = oral antidiabetic therapy.
• (24 weeks) N=197 N=212 N=196 Severe [n (%)] 1 (0.5) 2 (0.9) 2 (1.0) Glucose <54 mg/dL [n (%)] 43 (21.8) 55 (25.9) 45 (23.0) In the DECLARE trial [see Clinical Studies (14.3)] , severe events of hypoglycemia were reported in 58 (0.7%) out of 8574 adult patients treated with dapagliflozin tablets and 83 (1.0%) out of 8569 adult patients treated with placebo.
• Genital Mycotic Infections In the glycemic control trials in
• adults, genital mycotic infections were more frequent with dapagliflozin tablets treatment.
• Genital mycotic infections were reported in 0.9% of patients on placebo, 5.7% on dapagliflozin tablets 5 mg, and 4.8% on dapagliflozin tablets 10 mg, in the 12-trial placebo-controlled pool.
• Discontinuation from trial due to genital infection occurred in 0% of placebo-treated patients and 0.2% of patients treated with dapagliflozin tablets 10 mg.
• Infections were more frequently reported in females than in males (see Table 1).
• The most frequently reported genital mycotic infections were vulvovaginal mycotic infections in females and balanitis in males.
• Patients with a history of genital mycotic infections were more likely to have a genital mycotic infection during the trial than those with no prior history (10.0%, 23.1%, and 25.0% versus 0.8%, 5.9%, and 5.0% on placebo, dapagliflozin tablets 5 mg, and dapagliflozin tablets 10 mg, respectively).
• In the DECLARE trial [see Clinical Studies (14.3 )] , serious genital mycotic infections were reported in <0.1% of patients treated with dapagliflozin tablets and <0.1% of patients treated with placebo.
• Genital mycotic infections that caused trial drug discontinuation were reported in 0.9% of patients treated with dapagliflozin tablets and <0.1% of patients treated with placebo.
• Hypersensitivity Reactions Hypersensitivity reactions (e.g., angioedema, urticaria, hypersensitivity) were reported with dapagliflozin tablets treatment.
• In glycemic control trials in
• adults, serious anaphylactic reactions and severe cutaneous adverse reactions and angioedema were reported in 0.2% of comparator-treated patients and 0.3% of dapagliflozin tablets-treated patients.
• If hypersensitivity reactions occur, discontinue use of dapagliflozin tablets; treat per standard of care and monitor until signs and symptoms resolve.
• Ketoacidosis in Patients with Diabetes Mellitus In the DECLARE trial [see Clinical Studies (14.3)] , events of diabetic ketoacidosis (DKA) were reported in 27 out of 8574 adult patients in the dapagliflozin tablets-treated group and 12 out of 8569 adult patients in the placebo group.
• The events were evenly distributed over the trial period.
• Laboratory Tests in Adult Patients with Type 2 Diabetes Mellitus Increases in Serum Creatinine and Decreases in eGFR Initiation of SGLT2 inhibitors, including dapagliflozin tablets causes a small increase in serum creatinine and decrease in eGFR.
• These changes in serum creatinine and eGFR generally occur within two weeks of starting therapy and then stabilize regardless of baseline kidney function.
• Changes that do not fit this pattern should prompt further evaluation to exclude the possibility of acute kidney injury [see Warnings and Precautions (5.2) ] .
• In two trials that included adult patients with type 2 diabetes mellitus with moderate renal impairment, the acute effect on eGFR reversed after treatment discontinuation, suggesting acute hemodynamic changes may play a role in the renal function changes observed with dapagliflozin tablets.
• Increase in Hematocrit In the pool of 13 placebo-controlled trials of glycemic control, increases from baseline in mean hematocrit values were observed in dapagliflozin tablets-treated adult patients starting at Week 1 and continuing up to Week 16, when the maximum mean difference from baseline was observed.
• At Week 24, the mean changes from baseline in hematocrit were −0.33% in the placebo group and 2.30% in the dapagliflozin tablets 10 mg group.
• By Week 24, hematocrit values >55% were reported in 0.4% of placebo-treated patients and 1.3% of dapagliflozin tablets 10 mg-treated patients.
• Increase in Low-Density Lipoprotein Cholesterol In the pool of 13 placebo-controlled trials of glycemic control, changes from baseline in mean lipid values were reported in dapagliflozin tablets-treated adult patients compared to placebo-treated patients.
• Mean percent changes from baseline at Week 24 were 0.0% versus 2.5% for total cholesterol,and −1.0% versus 2.9% for LDL cholesterol in the placebo and dapagliflozin tablets 10 mg groups, respectively.
• In the DECLARE trial [see Clinical Studies (14.3)] , mean changes from baseline after 4 years were 0.4 mg/dL versus -4.1 mg/dL for total cholesterol, and -2.5 mg/dL versus -4.4 mg/dL for LDL cholesterol, in dapagliflozin tablets-treated and the placebo groups, respectively.
• Decrease in Serum Bicarbonate In a trial of concomitant therapy of dapagliflozin tablets 10 mg with exenatide extended-release (on a background of metformin) in
• adults, four patients (1.7%) on concomitant therapy had a serum bicarbonate value of less than or equal to 13 mEq/L compared to one each (0.4%) in the dapagliflozin tablets and exenatide-extended release treatment groups [see Warnings and Precautions (5.1) ].
• Pediatric use information is approved for AstraZeneca AB’s Farxiga ® (dapagliflozin) Tablets.
• However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.
• 6.2 Postmarketing Experience Additional adverse reactions have been identified during post-approval use of dapagliflozin tablets in patients with diabetes mellitus.
• Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Infections:
• Necrotizing fasciitis of the perineum (Fournier’s Gangrene), urosepsis and pyelonephritis Metabolism and Nutrition Disorders:
• Ketoacidosis Renal and Urinary Disorders:
• Acute kidney injury Skin and Subcutaneous Tissue Disorders:
• Rash

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Medication Guide).
• Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis In patients with type 1 diabetes mellitus, inform them that using dapagliflozin tablets can increase their risk of life-threatening diabetic ketoacidosis.
• For all other patients, inform them that dapagliflozin tablets can cause potentially fatal ketoacidosis and that type 2 diabetes mellitus and pancreatic disorders (e.g., history of pancreatitis or pancreatic surgery) are risk factors.
• Educate all patients on precipitating factors (such as insulin dose reduction or missed insulin doses, infection, reduced caloric intake, ketogenic diet, surgery, dehydration, and alcohol abuse) and symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, and labored breathing).
• Inform patients that blood glucose may be normal even in the presence of ketoacidosis.
• Advise patients that they may be asked to monitor ketones.
• If symptoms of ketoacidosis occur, instruct patients to discontinue dapagliflozin tablets and seek medical attention immediately [see Warnings and Precautions (5.1) ] .
• Volume Depletion Inform patients that symptomatic hypotension may occur with dapagliflozin tablets and advise them to contact their healthcare provider if they experience such symptoms [see Warnings and Precautions (5.2) ] .
• Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake.
• Serious Urinary Tract Infections Inform patients of the potential for urinary tract infections, which may be serious.
• Provide them with information on the symptoms of urinary tract infections.
• Advise them to seek medical advice promptly if such symptoms occur [see Warnings and Precautions (5.3) ] .
• Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues Inform patients that the incidence of hypoglycemia may increase when dapagliflozin tablets are added to an insulin secretagogue (e.g., sulfonylurea) and/or insulin.
• Educate patients on the signs and symptoms of hypoglycemia [see Warnings and Precautions (5.4) ] .
• Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) Inform patients that necrotizing infections of the perineum (Fournier’s Gangrene) have occurred with dapagliflozin tablets in patients with diabetes mellitus.
• Counsel patients to promptly seek medical attention if they develop pain or tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, along with a fever above 100.4°F or malaise [see Warnings and Precautions (5.5) ].
• Genital Mycotic Infections in Females (e.g., Vulvovaginitis) Inform female patients that vaginal yeast infections may occur and provide them with information on the signs and symptoms of vaginal yeast infections.
• Advise them of treatment options and when to seek medical advice [see Warnings and Precautions (5.6) ] .
• Genital Mycotic Infections in Males (e.g., Balanitis) Inform male patients that yeast infections of the penis (e.g., balanitis or balanoposthitis) may occur, especially in patients with prior history.
• Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis).
• Advise them of treatment options and when to seek medical advice [see Warnings and Precautions (5.6) ] .
• Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions (e.g., urticaria, anaphylactic reactions, and angioedema) have been reported with dapagliflozin tablets.
• Advise patients to immediately report any signs or symptoms suggesting allergic reaction or angioedema, and to take no more of the drug until they have consulted prescribing physicians.
• Pregnancy Advise pregnant patients of the potential risk to a fetus with treatment with dapagliflozin tablets.
• Instruct patients to immediately inform their healthcare provider if pregnant or planning to become pregnant [see Use in Specific Populations (8.1) ].
• Lactation Advise patients that use of dapagliflozin tablets are not recommended while breastfeeding [see Use in Specific Populations (8.2) ].
• Laboratory Tests Due to its mechanism of action, patients taking dapagliflozin tablets will test positive for glucose in their urine.
• Missed Dose If a dose is missed, advise patients to take it as soon as it is remembered unless it is almost time for the next dose, in which case patients should skip the missed dose and take the medicine at the next regularly scheduled time.
• Advise patients not to take two doses of dapagliflozin tablets at the same time.
• Manufactured by :
• Aizant Drug Research Solutions Pvt Ltd Hyderabad, Telangana 500100, India.
• Manufactured for: Apotex Corp.
• Weston, Florida 33326 USA.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Tablets:
• 5 mg, Light yellow to yellow colored round shaped film-coated tablets debossed with “D” on one side and “5” on the other side.
• Should be free from physical defects. 10 mg, Light yellow to yellow colored diamond shaped film-coated tablets debossed with “D” on one side and “10” on the other side.
• Should be free from physical defects.
• Tablets: 5 mg and 10 mg (3)

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• How Supplied Dapagliflozin tablets have markings on both sides and are available in the strengths and packages listed in Table 18.
• Table 18:
• Dapagliflozin Tablet Presentations Tablet Strength Film-Coated Tablet Color/Shape Tablet Markings Package Size NDC Code 5 mg Light yellow to yellow, round-shaped debossed with "D" on one side and "5" on the other side.
• Bottles of 30 with child-resistant closure 60505-4911-3 10 mg Light yellow to yellow, diamond-shaped debossed with "D" on one side and "10" on the other side.
• Bottles of 30 with child-resistant closure 60505-4912-3 Storage and Handling
• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

What is in it

• Dapagliflozin is described chemically as (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4ethoxyphenyl)methyl]phenyl]-D-glucitol(2S,3R,4R,5S,6R)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol.
• The empirical formula is C 21 H 25 ClO 6 and the molecular weight is 408.88.
• The structural formula is:
• Dapagliflozin tablets are available as film-coated tablets for oral administration containing the equivalent of 5 mg dapagliflozin or the equivalent of 10 mg dapagliflozin, and the following inactive ingredients:
• crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.
• In addition, the film coating contains the following inactive ingredients:
• glycerol esters of fatty acids, iron oxide yellow, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide. structural

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

41 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Dapagliflozin