Kazano

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Kazano

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Kazano

Property Description
Active ingredients Alogliptin, Metformin Hydrochloride
Form Oral tablet (Fixed-Dose Combination)
Pharmacological class DPP-4 Inhibitor / Biguanide
General purpose Glycemic control in Type 2 Diabetes Mellitus
Origin Synthetic

Defining Kazano: A Fixed-Dose Antidiabetic Agent

Kazano is a prescription-only (Rx) synthetic antihyperglycemic agent administered as an oral tablet, specifically developed as a fixed-dose combination (FDC) therapy for the management of type 2 diabetes mellitus in adults. The FDC strategy is clinically recognized for improving patient adherence by simplifying the regimen compared to taking two separate tablets. This product contains two distinct active ingredients in a single pill, a design supported by regulatory approval records.

Composition and Pharmacological Classification

The tablet contains the active ingredients Alogliptin and Metformin Hydrochloride, which place it in the dual pharmacological class of Biguanides/Dipeptidyl Peptidase 4 (DPP-4) Inhibitors. Alogliptin is categorized as a DPP-4 inhibitor, which modulates the body's own hormone signals, while Metformin Hydrochloride is the well-established Biguanide component, pharmacologically confirmed as a first-line agent for type 2 diabetes. This combination is typically intended for use when blood sugar control has not been adequately achieved with diet, exercise, and Metformin monotherapy alone, addressing a common step in diabetes care.

General Purpose and Approach to Glycemic Control

The general purpose of Kazano is to achieve more comprehensive and sustained glycemic control by acting on two core issues of type 2 diabetes. The design provides a two-pronged attack: the DPP-4 inhibitor enhances the body's natural signals for insulin secretion only when blood glucose is high, and the Biguanide component reduces the liver's excessive output of sugar (hepatic glucose production) while improving the body's response to insulin (insulin sensitivity). This synergistic effect provides a robust strategy for managing the elevated blood sugar characteristic of type 2 diabetes mellitus.

Regulatory References

  1. MedlinePlus Drug Information on Alogliptin and Metformin

What side effects are possible with Kazano?

Possible side effects and safety information

The safety profile of Kazano, a combination of alogliptin and metformin, is defined by classifications derived from official regulatory documents and clinical data. Adverse reactions are grouped by frequency and the body systems affected.

Frequency-Classified Adverse Reactions

Classification Examples of Reactions (Systems Affected)
Very Common (ge 10%) Diarrhea, Nausea/Vomiting, Flatulence (Gastrointestinal)
Common (1% to le 10%) Upper respiratory tract infection, Headache, Hypoglycemia (Infections, Nervous System, Metabolic)

Serious Adverse Reactions

Official labeling documents certain rare but serious adverse reactions. These include the risk of Lactic Acidosis, a severe metabolic complication, primarily associated with the metformin component. Postmarketing surveillance has reported cases of Acute Pancreatitis and Hepatic Failure (sometimes fatal). Additionally, the label notes serious reactions related to the immune system, such as Severe Hypersensitivity Reactions, including Stevens-Johnson syndrome and Bullous Pemphigoid.


Population-Specific and Safety Constraints

Specific limitations exist based on a patient’s health status. Kazano is contraindicated in individuals with severe renal impairment due to the increased risk of Lactic Acidosis. It is also generally not recommended for use in patients with clinical evidence of hepatic impairment. The gastrointestinal side effects are often noted to be more pronounced at the initiation of treatment. Long-term use of the metformin component is associated with potential Vitamin B12 deficiency.

Overdose and Emergency Response

Overdose and When to Seek Help

The official overdose profile for Kazano is primarily defined by the risk of Metformin-associated Lactic Acidosis (MALA), a rare but serious metabolic complication associated with drug accumulation that can be fatal. In cases of overdose, the onset is often subtle, requiring prompt and specific emergency actions mandated by regulatory authorities.

Documented Overdose Presentations

Symptoms and signs that may accompany overdose or excessive Metformin accumulation are often nonspecific and include malaise, myalgias (muscle pain), respiratory distress, and increasing somnolence (severe drowsiness). More severe manifestations noted in regulatory documents include hypothermia, hypotension, and resistant bradyarrhythmias (slow or irregular heartbeat). Laboratory findings in Lactic Acidosis cases are characterized by elevated blood lactate levels (typically greater than 5 mmol/L) and low plasma pH (anion gap acidosis).

Required Emergency Action

Immediate medical attention is required upon suspicion of Lactic Acidosis. Official regulatory instruction mandates that the medication be discontinued immediately, followed by hospitalization and the institution of general supportive measures. Prompt hemodialysis is recommended for the removal of accumulated Metformin from the bloodstream, as no specific antidote is known for the active components. The risk for severe outcomes, such as MALA, is increased in scenarios involving patients with renal impairment, hepatic impairment, advanced age (65 years or greater), or underlying hypoxic states.

Therapeutic Uses of Kazano

What Kazano Treats: Main Uses and Benefits

Kazano is a fixed-dose combination medication commonly used to support adults managing Type 2 Diabetes Mellitus, and may assist with managing symptoms related to systemic imbalance. It is applied across domains where additional symptomatic support is needed.


Targeting Inadequate Glycemic Control

This medication is generally applied in clinical situations where diet, exercise, and Metformin monotherapy have proven insufficient to achieve target blood sugar goals. It helps address the core symptomatic domains of persistent high blood glucose and high HbA1c (Glycated Hemoglobin). The combination may be part of symptomatic management for patients whose condition requires additional symptomatic support.


Quick Fact: Support for Persistent High Blood Glucose

The medication is relevant in clinical settings where supportive symptom management is appropriate, particularly when patients struggle with the symptoms related to systemic imbalance.

Eligibility and Restrictions for Use

Kazano (alogliptin and metformin hydrochloride) is officially indicated solely for use in adults with type 2 diabetes mellitus as an addition to diet and exercise to improve blood sugar control. Its use is limited to this specific disease and age profile.

Contraindications and Restrictions

Kazano is formally contraindicated in patients who have:

  • Severe Renal Impairment: Specifically, those with an estimated Glomerular Filtration Rate (eGFR) below 30 mL/min/1.73 m^2.
  • Metabolic Acidosis: Including acute or chronic metabolic acidosis, or diabetic ketoacidosis.
  • Hypersensitivity History: A serious history of allergic reaction (such as anaphylaxis or angioedema) to alogliptin or metformin, the components of Kazano.

Specific population restrictions also apply:

Population Category Eligibility Status Basis in Regulatory Documents
Type 1 Diabetes Not authorized for use Drug would not be effective in this setting.
Pediatric Patients Safety and effectiveness not established Limited to adults (age 18 and older).
Hepatic Impairment Use should be avoided Increased risk associated with one drug component.
Radiologic Procedures Must be temporarily withheld Requires discontinuation before or during procedures involving iodinated contrast agents.

Use is also not generally recommended for patients with moderate renal impairment (eGFR between 30 and <60 mL/min/1.73 m^2). The eligibility profile dictates that the drug must be reserved for the adult population with the specified condition while strictly excluding those with severe renal or metabolic compromise.

What should I know about interactions with other medicines?

Kazano, a combination of alogliptin and metformin, has a key interaction profile centered on the risk of lactic acidosis associated with the metformin component, and the risk of low blood sugar from the combination therapy.

Increased Risk of Lactic Acidosis

Certain medicinal product categories and specific drugs are known to increase the concentration of metformin in the bloodstream, raising the risk of lactic acidosis, a rare but serious metabolic complication.

  • Medicines that Reduce Metformin Clearance: Drugs that interfere with the kidney's ability to clear metformin from the body can cause it to accumulate. Examples explicitly noted in regulatory documents include ranolazine, vandetanib, dolutegravir, and cimetidine.
  • Carbonic Anhydrase Inhibitors (CAIs): Concomitant use with CAIs, such as topiramate, acetazolamide, and zonisamide, may increase the risk of lactic acidosis. Frequent patient monitoring is considered necessary with these combinations.
  • Alcohol: Excessive consumption of alcohol should be avoided, as it potentiates the effect of metformin on lactate metabolism.

Procedural and Dose Adjustments

  • Iodinated Contrast Imaging: Kazano must be temporarily discontinued at the time of, or prior to, any radiological study involving the intravenous administration of iodinated contrast materials. Resumption is dependent on stable kidney function checks.
  • Insulin and Insulin Secretagogues: When Kazano is used alongside insulin or medicines that stimulate insulin release (like sulfonylureas), a lower dose of the insulin or secretagogue may be required to minimize the risk of hypoglycemia (low blood sugar).

Mechanism of Action

Enzyme Inhibition and Glucose-Dependent Hormone Modulation

The Alogliptin component acts as a highly selective inhibitor of the Dipeptidyl Peptidase-4 (DPP-4) enzyme. This inhibition protects the natural gut hormones (incretins) from rapid breakdown, thus enhancing the pancreas's ability to release insulin and suppress glucagon only when blood sugar levels are elevated. This mechanism results in a more regulated hormonal response to food intake, which reduces postprandial glucose excursion.

Modulation of Cellular Energy and Hepatic Gluconeogenesis

The Metformin component targets the liver by mildly inhibiting the Mitochondrial Respiratory Chain Complex I. This action leads to the activation of AMP-Activated Protein Kinase (AMPK), a central metabolic sensor. Activation of AMPK suppresses the activity of enzymes responsible for gluconeogenesis, thereby decreasing the amount of glucose the liver produces and releases into the bloodstream, which primarily affects fasting plasma glucose concentration.

Dual-Axis Physiological Synergy

Kazano achieves its comprehensive physiological effect through complementary mechanisms: Alogliptin regulates the pancreatic axis and meal-time hormone response, while Metformin addresses insulin resistance and excessive hepatic glucose output. This dual-axis approach coordinates the correction of two distinct biological dysfunctions, leading to a more regulated state within the pathways governing glucose concentration.

Dosage and Administration Information

How to Use Kazano: Official Administration Guidelines

Kazano (Alogliptin/Metformin HCl) is an oral medication prescribed for the long-term management of Type 2 Diabetes Mellitus. The administration protocol is strictly defined to ensure proper use, focusing on dose limits, frequency, and specific patient contexts.


Core Administration Rules

Instruction Detail
Route and Form Oral administration only, as a film-coated, fixed-dose combination tablet.
Frequency and Timing The medicine is taken twice daily (BID). Each dose must be taken with food (with meals).
Dosing Limit The dose must not exceed a maximum of 25 mg Alogliptin and 2000 mg Metformin HCl per day.
Form Handling Tablets must not be split before swallowing; they should be swallowed whole with water.

Procedural and Population Constraints

Administration begins with an individualized starting dose that is gradually titrated to ensure proper tolerability. Renal function must be assessed prior to initiation and monitored periodically thereafter, as the fixed-dose combination is not recommended for patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m^2) and is contraindicated below that range. Dosing for older adults also requires careful titration due to age-related decline in kidney function.

Furthermore, the medicine may require temporary discontinuation at the time of, or before, iodinated contrast imaging procedures in specific patients. If a dose is missed, it should be taken as soon as remembered, but two doses must never be taken at the same time to compensate for a missed one.

Recent Clinical Evidence

Kazano: Recent Clinical Evidence

Clinical evidence for Kazano (alogliptin and metformin) stems primarily from randomized, controlled trials evaluating its components in adults with type 2 diabetes mellitus. These studies assessed the combination as an adjunct to diet and exercise.

Efficacy in Glycemic Control

Pivotal studies evaluated the combination's association with change in glycated hemoglobin (A1C), a measure of long-term blood glucose control. Key findings demonstrated:

  • Add-on to Metformin: In participants whose type 2 diabetes was inadequately controlled by metformin alone, the addition of alogliptin (one component of Kazano) was associated with significantly greater reductions in A1C compared to adding a placebo.
  • Non-Inferiority vs. Sulfonylureas: In a long-term, active-controlled trial (Study 305), alogliptin combined with metformin was found to be non-inferior (no worse than) to glipizide combined with metformin regarding A1C reduction over 104 weeks.

Comparison of Glycemic Outcomes

Study Population Comparator Regimen Efficacy Endpoint (Change in A1C) Finding Summary
Inadequately controlled on Metformin Metformin + Placebo Reduction from baseline at 26 weeks Associated with statistically greater reduction than placebo.
Inadequately controlled on Metformin Metformin + Glipizide Change from baseline at 52 and 104 weeks Demonstrated non-inferiority to glipizide.

Safety and Tolerability

The safety profile of the combination is generally consistent with the known profiles of its individual components. Common adverse reactions reported in clinical trials include upper respiratory tract infection, nasopharyngitis, and diarrhea (typically linked to the metformin component).

Postmarketing surveillance has included reports of serious events associated with DPP-4 inhibitors (like alogliptin), such as pancreatitis, severe joint pain (arthralgia), and hypersensitivity reactions (e.g., angioedema). As with all metformin-containing products, a Warning regarding the risk of lactic acidosis is included in the prescribing information.

Frequently Asked Questions (FAQ)

Common questions about Kazano (FAQ)

Q: What is Kazano?

Kazano is a prescription medication used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes mellitus. Kazano is a combination of two active ingredients: alogliptin and metformin hydrochloride. Alogliptin belongs to a class of drugs called DPP-4 inhibitors, and metformin is in the biguanide class.

Q: How should I take Kazano?

Kazano is typically taken by mouth twice a day with meals to help reduce stomach upset. Always follow your doctor’s instructions exactly regarding the dose and schedule. Do not stop taking Kazano or change your dose without first talking to your healthcare provider.

Q: What are the common side effects of Kazano?

The most common side effects reported with Kazano include upper respiratory tract infection, headache, and nasopharyngitis (common cold symptoms). Metformin, one of the components, can commonly cause stomach problems like diarrhea, nausea, and stomach upset, especially when first starting treatment.

Q: Can I take Kazano if I have kidney problems?

Kazano is not recommended for use in people with severe kidney problems. Because the drug components are removed from the body by the kidneys, your doctor will likely test your kidney function before and during treatment to ensure the medication is safe for you.

How should Kazano be stored and disposed of?

Kazano tablets must be stored at Controlled Room Temperature, specifically defined as 25 C (77 F). Temporary temperature excursions are permitted between 15 C and 30 C (59 F and 86 F), according to regulatory standards.

The medication must be kept in a closed container, protected from heat, moisture, and direct light, and must not freeze. This temperature control is required to maintain the product’s approved stability and shelf-life.

All tablets must be kept out of the reach of children. For disposal, any unused or outdated medicine should be discarded in accordance with local requirements for pharmaceutical products, often by consulting a healthcare professional.

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

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