Alogliptin and metformin

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Other drugs may increase or decrease the effects of alogliptin and metformin on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In the U.S.

• Kazano

Available Dosage Forms:

• Tablet

Therapeutic Class: Antidiabetic

Pharmacologic Class: Alogliptin

Chemical Class: Metformin

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat

• Anxiety
• bladder pain
• bloody or cloudy urine
• chest pain
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• decreased urine output
• depression
• difficult, burning, or painful urination
• dilated neck veins
• extreme fatigue
• frequent urge to urinate
• increased hunger
• irregular breathing
• irregular heartbeat
• lower back or side pain
• nausea
• nightmares
• seizures
• shakiness
• slurred speech
• swelling of the face, fingers, feet, or lower legs
• tightness in chest
• troubled breathing
• unusual tiredness or weakness
• weight gain

• Blistering, peeling, or loosening of the skin
• bloating
• constipation
• cough
• darkened urine
• diarrhea
• difficulty with swallowing
• fever
• hives or itching
• indigestion
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• vomiting
• yellow eyes or skin

• Dark-colored urine
• general feeling of tiredness or weakness
• large, hard skin blisters
• light-colored stools
• redness of the skin
• severe joint pain
• stomach pain, continuing
• welts

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• ear congestion
• loss of voice
• muscle aches
• sneezing
• stuffy or runny nose

• Back pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to lower blood sugar in patients with high blood sugar (diabetes).

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Loose stools (diarrhea).
• Back pain.
• Headache.
• Signs of a common cold.
• Sore throat.
• Stuffy nose.
• Runny nose.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Alogliptin and Metformin Hydrochloride
• Alogliptin Benz/Metformin HCl
• Metformin and Alogliptin
• Metformin Hydrochloride and Alogliptin

Diabetes mellitus, type 2: Oral: Initial doses should be based on current daily dose of alogliptin and metformin; Range: Alogliptin 12.5 mg/metformin 500 to 1000 mg twice daily. Maximum: Alogliptin 12.5 mg/metformin 1,000 mg twice daily

Concomitant use with insulin or insulin secretagogues: Reduced dose of insulin or insulin secretagogues (eg, sulfonylureas) may be needed.

The manufacturer recommends to avoid metformin because liver disease is considered a risk factor for the development of lactic acidosis during metformin therapy. However, continued use of metformin in patients with diabetes with liver dysfunction, including cirrhosis, has been used successfully and may be associated with a survival benefit in carefully selected patients; use cautiously in patients at risk for lactic acidosis (eg, renal impairment, alcohol use) (Brackett, 2010; Zhang, 2014). Alogliptin has not been studied in patients with severe impairment.

-eGFR less than 30 mL/min/1.73 m2:: Contraindicated
-eGFR 30 to 60 mL/min/1.73 m2: Not recommended because dose of alogliptin required is not available in the fixed combination product
-eGFR greater than 60 mL/min/1.73 m2: No dose adjustments recommended

IODINATED CONTRAST PROCEDURE:
-For patients with eGFR between 30 and 60 mL/min/1.73 m2: Stop therapy at the time of, or before iodinated contrast imaging procedure; re-evaluate eGFR 48 hours after procedure; restart therapy only if renal function is stable.
-For patients receiving intra-arterial iodinated contrast, this drug should be stopped and restarted only if renal function is stable.

Hepatic impairment: Use not recommended

-If liver injury is detected, promptly interrupt therapy and assess for probable cause.
-If liver injury is confirmed and no alternative etiology is found, do not restart this drug.