Alogliptin & Metformin

Alogliptin/metformin is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. It is a combination of two prescription medications, alogliptin and metformin.

Alogliptin belongs to a group of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by stopping the DPP-4 enzyme from removing a hormone that is responsible for telling your body to release insulin after you eat. This allows insulin to be released, which lowers blood sugar. Metformin belongs to a group of drugs called biguanides. It decreases blood sugar levels by decreasing the amount of glucose made by the liver, decreasing the amount of glucose absorbed in the intestines from the food that is eaten, and helping the body to respond to insulin.

Alogliptin/metformin comes in tablet form and is usually taken twice daily, with food.  Do not break or cut alogliptin/metformin tablets before swallowing.

Some of the common side effects of alogliptin/metformin include stuffy or runny nose and sore throat, headache, and cold-like symptoms, and diarrhea.

Alogliptin/metformin is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

The dose your doctor recommends will depend on several factors including:

• the medications you are currently taking
• other medical conditions you have
• how well alogliptin/metformin works for you
• how well you tolerate the medication (side effects)

The maximum recommended daily dose is 25 mg alogliptin and 2000 mg metformin.

WARNING: LACTIC ACIDOSIS

• Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.
• The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. 
• If acidosis is suspected, alogliptin/metformin should be discontinued and the patient hospitalized immediately.

Alogliptin/metformin can cause serious side effects, including:

• feel very weak or tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have unusual sleepiness or sleep longer than usual
• have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a slow or irregular heartbeat

You have a higher chance for getting lactic acidosis with alogliptin/metformin if you:

• have kidney problems. People whose kidneys are not working properly should not take alogliptin/metformin.
• have liver problems
• have congestive heart failure that requires treatment with medicines
• drink a lot of alcohol (very often or short-term “binge” drinking)
• get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
• have certain x-ray tests with injectable dyes or contrast agents
• have surgery
• have a heart attack, severe infection, or stroke

Inflammation of the pancreas (pancreatitis). Alogliptin, one of the medicines in alogliptin/metformin, may cause pancreatitis which may be severe. Certain medical conditions make you more likely to get pancreatitis.

• pancreatitis
• stones in your gallbladder (gallstones)
• a history of alcoholism
• kidney problems
• liver problems

Stop taking alogliptin/metformin and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

2. Liver problems. Call your doctor right away if you have symptoms, such as:

• nausea or vomiting
• stomach pain
• unusual or unexplained tiredness
• loss of appetite
• dark urine
• yellowing of your skin or the whites of your eyes

3. 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

4. Severe and persistent joint pain. If you experience severe and persistent joint pain, contact your doctor right away. Do not stop taking your medication. Your doctor will decide if your medication is the possible cause of severe  joint pain and will discontinue the drug if appropriate.

Do not take alogliptin/metformin if you:

• have kidney problems
• have a condition called metabolic acidosis or have had diabetic ketoacidosis (increased ketones in your blood or urine)
• are going to get an injection of dye or contrast agents for an x-ray procedure, alogliptin/metformin will need to be stopped for a short time. Talk to your doctor about when you should stop alogliptin/metformin and when you should start alogliptin/metformin again.
• are allergic to alogliptin (Nesina) or metformin or any of the ingredients in alogliptin/metformin or have had a serious allergic (hypersensitivity) reaction to alogliptin or metformin. 

• swelling of your face, lips, throat, and other areas on your skin
• difficulty with swallowing or breathing
• raised, red areas on your skin (hives)
• skin rash, itching, flaking, or peeling

If you have any of these symptoms, stop taking alogliptin/metformin and contact your doctor right away or go to the nearest hospital emergency room.

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

• 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 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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy. This medication falls into category B. It is not known if alogliptin/metformin will harm your unborn baby. Talk with your doctor about the best way to control your blood sugar while you are pregnant or if you plan to become pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether alogliptin/metformin passes into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking alogliptin/metformin.

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.

Do not break or cut alogliptin/metformin tablets before swallowing.

Stay on your diet and exercise programs and check your blood sugar as your doctor tells you to.