Xigduoxr

Quick links to important sections

Xigduoxr

Selected form

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Xigduoxr


Quick Facts

Property Description
Active ingredients Dapagliflozin, Metformin Hydrochloride
Form Extended-Release (XR) tablets
Pharmacological class Antihyperglycaemic combination (SGLT2 inhibitor + Biguanide)
General purpose Improved glycaemic control in Type 2 Diabetes Mellitus
Origin Synthetic

What is Xigduoxr and What Type of Drug is It?

Xigduoxr is a synthetic oral antihyperglycaemic agent classified as a fixed-dose combination medicine utilized for the management of Type 2 Diabetes Mellitus. The drug combines two distinct pharmacological classes: the SGLT2 inhibitor, Dapagliflozin, and the Biguanide, Metformin Hydrochloride. Its status as a combination of two established agents is clinically recognized for providing a comprehensive approach to blood sugar management. This combination product is designed for oral administration and provides a dual-mechanistic strategy, serving as an adjunct to diet and exercise when single-agent treatments have not been sufficient.


Composition of Xigduoxr and its Extended-Release Form

The medicine is composed of the two active ingredients: Dapagliflozin (as propanediol monohydrate) and Metformin Hydrochloride. Dapagliflozin acts primarily on the kidneys, while Metformin works primarily on the liver and helps improve the body's response to insulin. The medication is formulated as an extended-release (XR) tablet, a specialized pharmaceutical preparation. This modified release design ensures the slow, controlled delivery of the compounds over a longer period, a key differentiating factor that can help simplify a patient's daily regimen compared to multiple immediate-release doses.


What is the General Purpose of Taking Xigduoxr?

The primary purpose of Xigduoxr is to achieve robust and comprehensive glycaemic control in adults with Type 2 Diabetes Mellitus. For example, it is typically used in patients who need to lower their high blood sugar levels after their initial therapy with Metformin or another agent has not been fully effective. By utilizing the complementary mechanisms of action of its two components, the medicine systematically lowers both fasting plasma glucose (FPG) and postprandial plasma glucose (PPG). This two-pronged approach is intended to help individuals maintain more stable, healthier blood sugar levels.

What side effects are possible with Xigduoxr?

Possible Side Effects and Safety Information

Adverse reactions to Xigduoxr are officially classified based on the body system affected and their expected frequency, derived from regulatory documents. The most frequently reported adverse reactions fall into the Very Common (ge1/10) and Common (ge1/100 to <1/10) categories.


Adverse Reaction Scope

Classification Examples of Adverse Reactions (by System-Organ Class)
Very Common Gastrointestinal disturbances, including diarrhoea and nausea/vomiting (Metformin component). Hypoglycemia (low blood sugar), specifically when used with insulin or a sulfonylurea.
Common Genital mycotic infections (e.g., vulvovaginitis), Urinary Tract Infection (UTI), and Nasopharyngitis.

Serious Adverse Reactions

The official safety profile highlights rare but clinically significant adverse reactions, which are classified as serious in regulatory documents. These include Lactic Acidosis (Metformin-associated, a rare but life-threatening metabolic event), Diabetic Ketoacidosis (DKA, associated with the Dapagliflozin component), and Necrotizing Fasciitis of the Perineum (Fournier's Gangrene).

Population-Specific Safety Notes

The medicine is formally contraindicated in patients with severe renal impairment ( eGFR below 30 mL/min/1.73 m^2) and in cases of metabolic acidosis. Older adults may have a higher risk of adverse reactions related to volume depletion. Due to the Metformin component, the use of Xigduoxr is generally advised to be avoided in patients with hepatic impairment. Additionally, the official label notes that gastrointestinal side effects are often reported at the beginning of treatment and may subside.


Regulatory Safety Summary

  • The adverse reaction profile is dictated by the combined pharmacology of the two components, resulting in distinct categories of risks, such as metabolic and infectious.
  • Temporary discontinuation of the medicine is officially required prior to or at the time of iodinated contrast imaging procedures or major surgery.
  • The official documents specify that the risk of Lactic Acidosis increases with factors such as excessive alcohol intake and impaired renal function.

Connection to the Overall Safety Profile

The totality of the official safety information structures the drug's risk profile by clearly defining two distinct tiers: frequent, usually non-serious adverse events and rare, serious metabolic and infectious complications. This regulatory framework distinguishes between expected side effects and high-severity risks, and formally restricts use based on renal status and the presence of acute conditions.

Overdose and Emergency Response

Overdose and when to seek help

The information regarding overdose is strictly based on the officially documented descriptions and mandated emergency actions found in government regulatory labeling.

Overdose with Xigduoxr (Dapagliflozin/Metformin Hydrochloride Extended-Release) is primarily a metabolic and systemic emergency due to its two components, and official labeling outlines specific, potentially life-threatening risks.


Documented Overdose Manifestations and Risks

Classification Official Regulatory Statement
Life-Threatening Risk Metformin-associated Lactic Acidosis (MALA), a severe metabolic emergency associated with non-specific symptoms such as malaise, somnolence, and respiratory distress and associated with death.
Metabolic Risk Potential for Diabetic Ketoacidosis (DKA), which can occur with or without high blood sugar, and systemic effects of hypoglycemia and volume depletion (hypotension).
Monitoring Note Overdose with the extended-release formulation requires extended observation and continuous monitoring due to sustained drug absorption.

Required Emergency Actions

Immediate medical attention is required in the event of a suspected overdose or if symptoms of lactic acidosis or diabetic ketoacidosis are observed. The medicine must be immediately discontinued.

For Metformin-associated Lactic Acidosis, the management procedure described in the labeling includes prompt hemodialysis due to the dialyzability of Metformin, along with general symptomatic and supportive treatment. No specific antidote is known for the Dapagliflozin component. Patients with impaired renal or hepatic function have a documented increased risk of severe overdose outcomes.

Therapeutic Uses of Xigduoxr

Xigduo XR is commonly used to help manage multiple complex conditions associated with Type 2 Diabetes. The medication is approved for use across specific therapeutic domains. This treatment may be part of symptomatic management in patients with conditions presenting with systemic or localized discomfort.


The medication is applied across therapeutic domains involving blood sugar management, support for heart health in patients with cardiovascular risk factors, and assistance in contexts where renal functional stability may be affected. It is relevant in contexts involving heightened systemic burden and helps address symptoms related to systemic imbalance.

This support may provide support that helps ease the overall symptom burden, and helps patients cope more steadily with the day-to-day fluctuations of their condition, which supports general well-being during symptomatic phases.


Quick Fact: Support for Systemic Imbalance

Eligibility and Restrictions for Use

Who can and cannot use Xigduoxr? — Official Regulatory Information

The eligibility for Xigduoxr is strictly governed by a patient’s organ function, metabolic stability, and specific physiological states, as defined in regulatory labeling.

Eligibility Status Key Restriction or Exclusion
Contraindicated Severe renal impairment (eGFR <30 mL/min/1.73 m^2) or End-Stage Renal Disease (ESRD).
Contraindicated Metabolic acidosis (including Diabetic Ketoacidosis or lactic acidosis).
Contraindicated Severe hepatic impairment or acute conditions causing tissue hypoxia (e.g., shock, severe infection).
Not Recommended Pregnancy (specifically 2nd and 3rd trimesters) or Lactation (breastfeeding).
Restricted Use Moderate renal impairment (eGFR 30 to <45 mL/min/1.73 m^2). Initiation is not recommended, and use requires dose limitation.

Age-Related Eligibility: The medicine is approved for adults and pediatric patients aged 10 years and older with Type 2 Diabetes Mellitus. Use in children younger than 10 is not established. Older adults (ge 65) require more frequent monitoring of renal function.

Condition-Based Exclusions: Xigduoxr is not indicated for Type 1 Diabetes Mellitus or in patients with a history of a serious hypersensitivity reaction to its components. Temporary discontinuation is required prior to major surgery or certain imaging procedures using iodinated contrast agents.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation structures the interaction profile of Xigduoxr (Dapagliflozin/Metformin) around pharmacokinetic clearance, pharmacodynamic effects, and procedural restrictions.

Interaction Scope

Category Officially Documented Interaction Restriction/Effect
Interacting Drug Categories Carbonic Anhydrase Inhibitors, Loop Diuretics, Insulin and Insulin Secretagogues (e.g., Sulfonylureas)
Specific Interacting Medicines Ranolazine, Vandetanib, Dolutegravir, and Cimetidine (drugs that reduce Metformin clearance)
Mechanistic Basis Pharmacokinetic (reduced renal tubular clearance of Metformin); Pharmacodynamic (additive glucose-lowering or volume depletion effects)
Timing-based Rules Temporary discontinuation of the Metformin component is required at the time of or prior to procedures using Iodinated Contrast Media
Procedural Restriction The Dapagliflozin component requires temporary discontinuation prior to scheduled surgery

to mitigate documented risks | | Population Notes | Renal impairment increases the risk of Metformin accumulation. Elderly patients have a higher incidence of volume depletion risk with diuretics |


Interaction Classifications (High-Level)

Classification Official Regulatory Documentation Statement
Interaction Severity Clinically Significant (with Insulin/Sulfonylureas and Transporter Inhibitors)
Substance Interaction Excessive Alcohol Intake officially potentiates the risk of lactic acidosis

Resulting Interaction Structure

Official regulatory statements indicate co-administration with Insulin or Insulin Secretagogues formally increases the risk of hypoglycemia. Drugs like Ranolazine and Cimetidine are documented to increase the systemic exposure of the Metformin component by inhibiting its clearance. This profile mandates specific temporary withholding rules for the medicine before procedures using iodinated contrast and scheduled surgery.

Mechanism of Action

Xigduoxr is a fixed-dose combination product containing dapagliflozin and metformin hydrochloride, each modulating glucose homeostasis through distinct molecular targets. Dapagliflozin acts as a reversible inhibitor of the sodium-glucose cotransporter 2 (SGLT2), primarily located in the proximal renal tubules of the kidney. SGLT2 is the main mediator of glucose reabsorption from the glomerular filtrate. By blocking this transporter, dapagliflozin reduces glucose reabsorption, leading to increased urinary glucose excretion and an associated osmotic diuresis. This systemic consequence includes mild volume reduction.

Metformin's primary mechanism involves the activation of AMP-activated protein kinase (AMPK) in hepatocytes. AMPK activation downstream reduces hepatic gluconeogenesis and glycogenolysis, thereby decreasing the liver's glucose output. Metformin also acts on muscle and adipose tissue to increase insulin sensitivity via enhanced glucose uptake and utilization. This biguanide further modifies intestinal glucose metabolism by promoting intestinal glucose uptake and non-systemic metabolism.

Dosage and Administration Information

How to Use Xigduoxr: Official Administration Guidelines

This section details the official administration instructions for Xigduoxr (dapagliflozin and metformin hydrochloride extended-release).


Administration Scope

Feature Instruction
Route of administration Oral administration only.
Dosing schedule The total daily dose must not exceed 10 mg of dapagliflozin and 2,000 mg of metformin HCl. The starting dose of the dapagliflozin component is generally 5 mg once daily for glycemic control.
Timing in relation to meals Must be taken with food to minimize gastrointestinal effects associated with the metformin component.
Preparation requirements None; the extended-release tablet must be used as provided.
Age-group rules Approved for use in pediatric patients aged 10 years and older. Dosing in older adults should be guided by renal function.
Missed-dose rules If a dose is missed, it should be taken when remembered, unless it is almost time for the next scheduled dose, in which case the missed dose should be skipped.
Special procedural conditions The tablet must be swallowed whole and not crushed, cut, or chewed, which is essential for preserving its extended-release properties. Temporary discontinuation is required before major surgery or specific iodinated contrast imaging procedures.

Resulting Procedural Structure

Official step sequence:

  • The appropriate strength is determined based on the patient's existing therapy and needs, ensuring the maximum daily doses are not exceeded.
  • The extended-release tablet is taken once daily in the morning.
  • The tablet must be swallowed whole and with food.

Connection to the overall use protocol: The official protocol mandates a standardized, once-daily, oral administration, which is defined by the drug's extended-release formulation. Taking the tablet whole and with food adheres to the proper conditions for the intended delivery of both dapagliflozin and metformin. This structural approach governs the correct, long-term administration of the fixed-dose combination.

Recent Clinical Evidence

Recent Clinical Evidence Overview

Xigduoxr combines two agents—dapagliflozin (an SGLT2 inhibitor) and metformin hydrochloride extended-release (a biguanide)—for the management of Type 2 Diabetes Mellitus. The clinical evidence supporting its use primarily involves studies on the individual components, particularly dapagliflozin, which belongs to a class of medication with demonstrated benefits beyond glycemic control.

Major clinical trials for dapagliflozin have investigated the compound's impact on cardiovascular and renal outcomes in broad patient populations, including those with Type 2 diabetes. These studies have examined key endpoints related to heart and kidney health.

Summary of Key Research Findings

Outcome Category Primary Study Finding (Dapagliflozin Component)
Cardiovascular Risk Clinical data examined the composite risk of cardiovascular death or hospitalization for heart failure, which was observed to be lower in certain patient groups compared to placebo.
Heart Failure Studies indicated a lower rate of hospitalization for heart failure in patients with established cardiovascular disease or multiple risk factors.
Renal Health Research assessed the risk of sustained decline in estimated glomerular filtration rate (eGFR) and progression to end-stage kidney disease. Findings suggested a lower risk for these outcomes in patients with chronic kidney disease (CKD) at risk of progression.

Overall, evidence from clinical programs supports the use of dapagliflozin and metformin in improving glycemic control. Further, the dapagliflozin component has been associated with specific reductions in cardiorenal events, which has influenced its role in current clinical practice guidelines.

Frequently Asked Questions (FAQ)

Common questions about Xigduoxr (FAQ)


Q: Is Xigduoxr the same as taking a separate dapagliflozin and metformin pill?

A: Xigduoxr is a single tablet that is a fixed-dose combination of both dapagliflozin and metformin extended-release. It is a distinct pharmaceutical preparation that delivers both active ingredients at the same time. The extended-release formulation means the timing of drug delivery is different from taking two separate immediate-release tablets.


Q: Does Xigduoxr help with weight loss?

A: The primary official purpose of Xigduoxr is to help manage blood sugar levels. However, official clinical trial data for the dapagliflozin component have noted that a decrease in body weight was observed in some patients.


Q: How quickly can I expect Xigduoxr to start working?

A: Xigduoxr is an extended-release formulation, meaning the medicine is designed to be released and absorbed slowly over several hours. The drug is absorbed into the bloodstream soon after being taken, with components reaching their highest concentration within a few hours.


Q: Can Xigduoxr cause low blood sugar (hypoglycemia) on its own?

A: Official regulatory documents indicate that the risk of hypoglycemia (low blood sugar) is primarily reported when Xigduoxr is used in combination with an insulin or an insulin secretagogue (like a sulfonylurea). When Xigduoxr is used alone, the risk of low blood sugar is described as generally low.


Q: Can older adults safely use Xigduoxr?

A: The medicine is approved for use in older adults. However, official regulatory information advises that individuals in this age group may need more frequent renal function monitoring. This is because older adults have a greater likelihood of experiencing decreased kidney function, and they may also have an increased risk of issues related to volume depletion (dehydration).


Q: Is it safe to drink alcohol in moderation while taking Xigduoxr?

A: Official regulatory information advises that excessive alcohol intake must be avoided while using this medicine. This is a critical precaution because excessive alcohol consumption significantly increases the risk of lactic acidosis, a rare but serious metabolic condition associated with the metformin component.


Q: What should I know about taking Xigduoxr before surgery?

A: The medicine must be temporarily discontinued before any major surgery and procedures involving iodinated contrast media (a dye used in some scans). This is done to mitigate risks related to kidney function and lactic acidosis. Official guidance indicates that re-evaluation of kidney function is advised before restarting the medicine.


Q: Does Xigduoxr need to be taken with food?

A: Yes, official administration instructions state that the tablets should be taken once daily with food. This practice is recommended to help minimize common gastrointestinal discomfort, such as stomach upset, related to the metformin component of the medicine.


Q: Can I crush or split the Xigduoxr tablet?

A: No, official administration instructions specify that the extended-release tablet must be swallowed whole. It is crucial not to crush, cut, or chew the tablet. Altering the tablet structure prevents the medicine from releasing in the body as intended by its controlled-release properties.


Q: Is it common to feel tired when starting Xigduoxr?

A: Official safety data lists many possible adverse reactions. While tiredness or fatigue itself may not be explicitly listed as a common side effect in all official documents, it is a non-specific symptom that can be associated with low blood sugar (hypoglycemia) or other changes in the body. Patients are advised to review official patient information for the full list of commonly reported effects.


Q: Is there a generic version of Xigduoxr available?

A: Whether a generic version is available depends on the specific country and its regulatory approvals. In some jurisdictions, the medicine may be available as an Authorized Generic version. Official government drug listings or a pharmacist can provide current information regarding availability and generic status.


Q: Are there specific foods or drinks to avoid while on Xigduoxr?

A: Regulatory documents only mandate that excessive alcohol intake must be avoided due to the increased risk of lactic acidosis. Beyond this critical restriction, official product information does not specify any particular foods or drinks that must be avoided while taking this medicine.


Q: Does Xigduoxr interact with common pain relievers like ibuprofen?

A: While regulatory documents do not specifically name ibuprofen, the official label notes caution when using Xigduoxr with drugs that can affect kidney function or the body's acid-base balance. Such combinations may increase the risk of metformin-associated lactic acidosis, which is a serious adverse reaction.


Q: Is Xigduoxr safe to use during pregnancy?

A: Official regulatory information states that the use of Xigduoxr is not recommended during the second and third trimesters of pregnancy. This is due to observations in animal studies showing potential adverse effects on developing kidneys. The medicine should be discontinued when pregnancy is confirmed.


Q: Is Xigduoxr safe to use while breastfeeding?

A: Official labeling advises that the use of Xigduoxr is not recommended while breastfeeding. This is a precaution taken due to the potential for serious adverse reactions in the breastfed infant, as the components of the medicine may pass into breast milk.


Q: Can men experience specific side effects from Xigduoxr?

A: Yes, official documentation lists genital mycotic infections as a common adverse reaction associated with the dapagliflozin component. This includes yeast infections of the penis (balanitis) which can affect men.


Q: Can women experience specific side effects from Xigduoxr?

A: Yes, official documentation lists genital mycotic infections as a common adverse reaction associated with the dapagliflozin component. This includes infections like vulvovaginitis (vaginal yeast infection) which can affect women.


Q: How is Xigduoxr different from single-ingredient metformin or dapagliflozin?

A: Xigduoxr is a single tablet that combines two distinct medicines—dapagliflozin and metformin—each working in a different way to manage blood sugar. Furthermore, it utilizes an extended-release form of metformin, which differentiates it from standard immediate-release metformin tablets.


Q: Are there any known severe allergic reactions associated with Xigduoxr?

A: Yes, official documents advise that the medicine is contraindicated if a patient has a history of a serious hypersensitivity reaction to its components. Severe allergic reactions, including swelling of the face and throat (angioedema) and whole-body reactions (anaphylaxis), have been reported with the dapagliflozin component.


Q: Can Xigduoxr be used by teenagers or children?

A: Official regulatory documents indicate that the medicine is approved for use in pediatric patients aged 10 years and older with Type 2 Diabetes Mellitus. The safety and effectiveness of the drug have not been established in children younger than 10 years old.


Q: Does Xigduoxr affect laboratory test results?

A: Yes, official labeling states that the metformin component may be associated with a decrease in vitamin B12 concentrations in the blood. Because of this potential effect, regulatory documents recommend monitoring B12 levels at least every two to three years.


Q: Is it normal to have more frequent urination when taking Xigduoxr?

A: Yes, this can be a normal effect. The dapagliflozin component works by causing the kidneys to excrete sugar and water into the urine, a process called osmotic diuresis. Regulatory documents list increased urination (polyuria) as a common adverse reaction associated with this mechanism.


Q: Does Xigduoxr affect the absorption of B12?

A: Official regulatory documents note that the metformin component of the medicine may decrease the blood concentration of vitamin B12. If this decrease is prolonged, it may necessitate supplemental treatment. Regulatory documents recommend the monitoring of B12 levels at least every two to three years.


Q: Are there specific instructions for storing Xigduoxr?

A: The medicine must be kept in its original container and the container must be tightly closed. It should be stored at controlled room temperature (e.g., 20 C to 25 C or 68 F to 77 F). As with all medicines, it must be kept out of the reach of children.


Q: Why do official documents state Xigduoxr is not recommended for severe kidney issues?

A: The medicine is contraindicated (officially restricted) for patients with severe renal impairment due to the risk of the metformin component building up in the body. This accumulation significantly increases the risk of a rare but serious metabolic condition called lactic acidosis.


Q: How does Xigduoxr relate to SGLT2 inhibitors and biguanides?

A: Xigduoxr is classified as a fixed-dose combination product that contains one drug from each of these two classes. Dapagliflozin is an SGLT2 inhibitor, and metformin is a biguanide. The medicine works by utilizing the two distinct glucose-lowering mechanisms of these classes simultaneously.


Q: Can Xigduoxr be used for purposes other than blood sugar management?

A: The primary official indication for Xigduoxr is for the management of Type 2 Diabetes Mellitus. However, it is also indicated in some adult patients with Type 2 diabetes who have established heart disease or risk factors to help reduce the risk of hospitalization for heart failure.


Q: What is the maximum strength or dose of Xigduoxr available?

A: Official regulatory documents define the maximum recommended daily dose. This is limited to 10 mg of dapagliflozin and 2,000 mg of metformin extended-release. The tablets are available in various strength combinations that do not exceed these maximums.


Q: Do people typically experience stomach upset when starting Xigduoxr?

A: Yes, official safety information lists gastrointestinal disturbances, such as diarrhea, nausea, or vomiting, as a very common adverse reaction. These effects are often reported at the beginning of treatment and are known to typically subside as the body adjusts to the medicine.


Q: Is Xigduoxr a drug that requires a specific diet to be effective?

A: The drug is officially indicated as an adjunct to diet and exercise to help improve blood sugar control. While a specific rigid diet is not defined in the labeling, consistent adherence to a diet and exercise program is considered a necessary part of the overall management plan to achieve the intended effect.


Q: What is the role of Xigduoxr in long-term diabetes management?

A: Xigduoxr is indicated for the long-term management of Type 2 Diabetes Mellitus when used in addition to diet and exercise. Its role is to help maintain stable blood sugar control over time. In certain patient populations, it also has a formal role in reducing the risk of specific cardiovascular complications.


Q: Is Xigduoxr associated with genital yeast infections?

A: Yes, official safety documents list genital mycotic infections (a type of yeast infection) as a common adverse reaction associated with the dapagliflozin component. This risk is noted for both men and women.


Q: How does Xigduoxr affect the risk of dehydration?

A: Due to its mechanism of action, which involves the increased excretion of sugar and water in the urine, regulatory documents note a risk of volume depletion (dehydration). This risk is particularly noted in patients who are elderly, have existing kidney problems, or are also taking diuretics.

How should Xigduoxr be stored and disposed of?

Storage and Disposal Instructions for Xigduo XR

Official regulatory labeling defines specific conditions for the storage and disposal of Xigduo XR (dapagliflozin and metformin HCl extended-release) tablets to maintain their quality and safety.

Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature, 20 C to 25 C (68 F to 77 F), with excursions permitted up to 30 C (86 F).
Container Keep in the original container and ensure the container is tightly closed.
Safety The medicine must be kept out of the reach of children.

Disposal

Expired or unused tablets must be disposed of properly. Consult a pharmacist or follow local waste disposal regulations and official governmental guidelines, which typically involve preparing the medicine for disposal in household trash rather than flushing.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Xigduoxr found in:

A-Z Index: