Alogliptin-metFORMIN

Alogliptin & Metformin may be found in some form under the following brand names:

• Kazano

Alogliptin/metformin can cause serious side effects. See Precautions.

The most common side effects of alogliptin/metformin include:

• cold-like symptoms (upper respiratory tract infection)
• stuffy or runny nose and sore throat
• diarrhea
• increase in blood pressure
• headache
• back pain
• urinary tract infection

 Alogliptin/metformin may cause low blood sugar (hypoglycemia). If you take alogliptin/metformin with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take alogliptin/metformin. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, and then call your doctor. Signs and symptoms of low blood sugar may include:

• shaking or feeling jittery
• sweating
• fast heartbeat
• change in vision
• hunger
• headache
• change in mood
• confusion
• dizziness

Taking alogliptin/metformin with food can help lessen the common stomach side effects of metformin that usually happen at the beginning of treatment. If you have unexplained stomach problems, tell your doctor. Stomach problems that start later, during treatment may be a sign of something more serious.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of alogliptin/metformin. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• beta-blockers
• cough and cold products containing decongestants
• calcium channel blockers
• cimetidine (Tagamet)
• corticosteroids
• digoxin (Lanoxin)
• diuretics such as furosemide (Lasix)
• estrogens
• insulins or other medicines for diabetes
• isoniazid (INH, Nydrazid)
• morpine
• niacin (nicotinic acid, Niaspan)
• nifedipine
• oral contraceptives
• oral steroids
• phenothiazines such as promethazine (Phenergan)
• phenytoin (Dilantin)
• procainamide
• quinidine
• quinine
• ranitidine
• thyroid medicines such as levothyroxine (Levothroid, Levoxyl, Synthroid, Tirosint)
• triamterene
• trimethoprim
• vancomycin

This is not a complete list of alogliptin/metformin drug interactions. Ask your doctor or pharmacist for more information.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of alogliptin/metformin there are no specific foods that you must exclude from your diet when receiving alogliptin/metformin.

Take alogliptin/metformin exactly as your doctor tells you to take it.

• Take alogliptin/metformin 2 times each day.
• Take alogliptin/metformin with food to lower your chances of having an upset stomach.
• Do not break or cut alogliptin/metformin tablets before swallowing.
• Your doctor may need to change your dose of alogliptin/metformin to control your blood glucose. Do not change your dose unless told to do so by your doctor.
• If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose, and take the next dose at your regular schedule. Do not take 2 doses of alogliptin/metformin at the same time.
• If you take too much alogliptin/metformin, call your doctor or go to the nearest hospital emergency room right away.
• If your body is under stress, such as from fever, infection, accident, or surgery, the dose of your diabetes medicines may need to be changed. Call your doctor right away.
• Stay on your diet and exercise programs and check your blood sugar as your doctor tells you to.

Your doctor may do certain blood tests before you start alogliptin/metformin and during treatment as needed. Your doctor may ask you to stop taking alogliptin/metformin based on the results of your blood tests due to how well your kidneys are working. 

Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.

• Store alogliptin/metformin at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the container of alogliptin/metformin tightly closed.
• Keep alogliptin/metformin and all medicines out of the reach of children.

Dosage Forms & Strengths

alogliptin/metformin

tablet

• 12.5mg/500mg
• 12.5mg/1000mg

Diabetes Mellitus Type 2

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Starting dose based on patient’s current regimen

Take PO BID with food; gradually escalation dose to reduce GI side effects caused by metformin

Not to exceed 25 mg/2000 mg per day

Dosage Modifications

Renal impairment

• Obtain eGFR before starting metformin
• eGFR <30 mL/min/1.73 m²: Contraindicated
• eGFR 30-45 mL/min/1.73 m²: Not recommended to initiate treatment
• Monitor eGFR at least annually or more often for those at risk for renal impairment (eg, elderly)
• If eGFR falls below 45mL/min/1.73 m² while taking metformin, risks and benefits of continuing therapy should be evaluated
• If eGFR falls below 30 mL/min/1.73 m²: while taking metformin, discontinue the drug

Safety and efficacy not established

1-10%

Upper respiratory tract infection (8%)

Nasopharyngitis (6.8%)

Hypoglycemia (1.8-6.3%)

Diarrhea (5.5%)

Hypertension (5.5%)

Headache (5.3%)

Back pain (4.3%)

Urinary tract infection (4.2%)

<1%

Hypersensitivity (0.6%)

Pancreatitis (0.2%)

Postmarketing reports

Severe and disabling arthralgia