Alogliptin-Metformin

Alogliptin-Metformin is a combination medication used to treat the symptoms of Type 2 Diabetes Mellitus.

• Alogliptin-Metformin is available under the following different brand names: Kazano

Common side effects of Alogliptin-Metformin include:

• Diarrhea,
• Upset stomach,
• Severe headache,
• Blurred vision,
• Pounding in the neck or ears,
• Back pain,
• Headache,
• Stuffy nose,
• Sinus pain, and
• Sore throat

Serious side effects of Alogliptin-Metformin include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Fever,
• Sore throat,
• Burning eyes,
• Skin pain,
• Red or purple skin rash with blistering and peeling,
• Severe pain in the upper stomach spreading to the back,
• Nausea,
• Vomiting,
• Loss of appetite,
• Fast heartbeats,
• Unusual muscle pain,
• Feeling cold,
• Trouble breathing,
• Dizziness,
• Lightheadedness,
• Tiredness,
• Weakness,
• Stomach pain,
• Slow or irregular heart rate,
• Severe ongoing pain in the joints,
• Pain or burning while urinating,
• Dark urine,
• Yellow of the skin or eyes (jaundice),
• Shortness of breath,
• Swelling in the legs or feet, and
• Rapid weight gain

Rare side effects of Alogliptin-Metformin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 12.5 mg/500 mg
• 12.5 mg/1000 mg

Diabetes mellitus type 2

Adult dosage

• Take orally twice daily with food; gradually escalate the dose to reduce GI side effects caused by metformin
• Not to exceed 25 mg/2000 mg per day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Alogliptin-Metformin has severe interactions with no other drugs.
• Alogliptin-Metformin has serious interactions with the following drugs:
  • contrast media (iodinated)
  • ethanol
  • ioversol
  • methylene blue
  • pacritinib
  • ranolazine
  • risdiplam
  • selegiline
  • selegiline transdermal
  • tafenoquine
  • tedizolid
  • tranylcypromine
  • trilaciclib
• Alogliptin-Metformin has moderate interactions with at least 190 other drugs.
• Alogliptin-Metformin has minor interactions with at least 82 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Renal impairment (i.e, eGFR below 30 ml/min/1.73 m²); renal impairment may also result from medical conditions (.g, shock, acute MI, septicemia)
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis; diabetic ketoacidosis should be treated with insulin
• Hypersensitivity to alogliptin or metformin, including anaphylaxis, angioedema, or severe cutaneous adverse reactions including Stevens-Johnson syndrome

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Alogliptin-Metformin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Alogliptin-Metformin?”

Cautions

• Lactic acidosis (see Black Box Warnings)
• Pancreatitis reported
• Caution with sensitivity to another DPP-4 inhibitor or metformin; discontinue if serious hypersensitivity reaction is suspected (see Contraindications)
• Fatal and nonfatal hepatic failure reported; type 2 DM is also known to cause fatty liver disease and liver enzyme elevation; monitor carefully and interrupt alogliptin treatment if LFTs are elevated, do not restart alogliptin without another explanation for the liver test abnormalities
• Insulin and insulin secretagogues (. g, sulfonylureas) are known to cause hypoglycemia; therefore, a lower dose of insulin secretagogue may be needed to minimize hypoglycemia risk
• Coadministration with drugs that may affect renal function or metformin elimination
• Temporarily withhold metformin for any surgical procedures that restrict fluid/food intake
• Hypoxic conditions (. g, shock, acute CHF, acute MI) associated with lactic acidosis (see Black Box Warnings)
• Alcohol potentiates metformin’s effect on lactate metabolism; avoid excessive alcohol intake
• Metformin may decrease vitamin B12 levels
• Hypoglycemia may occur with metformin if calorie intake is deficient
• Severe and disabling arthralgia reported in patients taking DPP-4 inhibitors; considered as a possible cause for severe joint pain and discontinue drug if appropriate
• Iodinated contrast imaging procedures
  • Discontinue metformin at the time of or before an iodinated contrast imaging procedure in patients with an eGFR between 30-60 mL/minute/1.73 m²; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast
  • Reevaluate eGFR 48 hours after the imaging procedure; restart metformin if renal function is stable
• Congestive heart failure (CHF) risk
  • The EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial enrolled 5,380 patients with type 2 diabetes and recent acute coronary syndrome
  • Hospitalization for CHF was observed in 106 (3.9%) patients treated with alogliptin and 89 (3.3%) patients treated with placebo; although the difference was not statistically significant (hazard ratio, 1.19), heart failure was not an endpoint of the study
  • Healthcare professionals should consider discontinuing medications containing alogliptin in patients who develop heart failure and monitor their diabetes control
  • Lancet. 2015 May 23;385(9982):2067-76

Pregnancy and Lactation

• Limited available data on pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage; published studies with metformin use during pregnancy have not reported a clear association between metformin and major birth defect or miscarriage risk; there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy
• Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications. Poorly controlled diabetes increases the fetal risk for major malformations, stillbirth, and macrosomia-related morbidity
• Lactation
  • There is no information regarding the presence of metformin or alogliptin in human milk, its effects on breastfed infants, or its effects on milk production; limited published studies report that metformin is present in human milk; however, there is insufficient information to determine the effects of metformin on the breastfed infant and no available information on effects of metformin on milk production; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from therapy or the underlying maternal condition