alogliptin and metformin (Oral route)
al-oh-GLIP-tin BEN-zoe-ate, met-FOR-min hye-droe-KLOR-ide
Lactic acidosis is a rare but serious complication of metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure. Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, elevated blood lactate, and increased anion gap. Discontinue therapy and hospitalize patient immediately for suspected lactic acidosis .
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antidiabetic
Pharmacologic Class: Alogliptin
Chemical Class: Metformin
Uses For alogliptin and metformin
Alogliptin and metformin combination may be used alone or together with other medicines and with a proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. Alogliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) when there is too much sugar in the blood. Metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and helps your body use sugar better. alogliptin and metformin does not help patients who have insulin-dependent or type 1 diabetes.
alogliptin and metformin is available only with your doctor's prescription.
Before Using alogliptin and metformin
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For alogliptin and metformin, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to alogliptin and metformin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of alogliptin and metformin combination in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alogliptin and metformin combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution for patients receiving alogliptin and metformin.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking alogliptin and metformin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using alogliptin and metformin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Acetrizoic Acid
- Ethiodized Oil
- Iobenzamic Acid
- Iocarmic Acid
- Iocetamic Acid
- Iodohippuric Acid
- Iodoxamic Acid
- Ioglicic Acid
- Ioglycamic Acid
- Iopanoic Acid
- Iopronic Acid
- Ioseric Acid
- Iotroxic Acid
- Ioxitalamic Acid
- Metrizoic Acid
- Tyropanoate Sodium
Using alogliptin and metformin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Thioctic Acid
Using alogliptin and metformin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Bitter Melon
- Guar Gum
- Methylene Blue
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of alogliptin and metformin. Make sure you tell your doctor if you have any other medical problems, especially:
- Adrenal gland problem (underactive) or
- Congestive heart failure, acute or unstable or
- Dehydration, severe or
- Heart attack, acute or
- Heart or blood vessel problems or
- Heart failure, history of or
- Hypoxemia (decreased oxygen in the blood) or
- Kidney disease, history of or
- Liver disease or
- Poorly nourished condition or
- Sepsis (severe infection) or
- Shock (low blood pressure, blood circulation is poor) or
- Weakened physical condition—Use with caution. May increase the risk of serious side effects.
- Alcohol, excessive use of or
- Diabetic ketoacidosis or metabolic acidosis (high ketones and acid in the blood) or
- Kidney disease or
- Type 1 diabetes—Should not be used in patients with these conditions.
- Anemia or
- Vitamin B12 deficiency—Use with caution. May make these conditions worse.
- Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history with other dipeptidyl peptidase-4 (DPP-4) inhibitors—Use with caution. May increase the risk of this condition occurring again.
- Gallbladder stones or
- Pancreas problems, history of—Use with caution. May increase risk for getting pancreatitis (swelling and inflammation of the pancreas).
- Radiologic procedures (eg, X-rays, CT scans, and MRIs) that require dyes to be injected in your vein—alogliptin and metformin should be stopped before you have one of these procedures.
Proper Use of alogliptin and metformin
Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to work properly. Exercise regularly and test for sugar in your blood or urine as directed.
alogliptin and metformin should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Swallow the tablet whole. Do not crush, break, or chew it. Take alogliptin and metformin with food.
The dose of alogliptin and metformin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of alogliptin and metformin. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For type 2 diabetes:
- Adults—At first, one tablet (either alogliptin 12.5 milligrams [mg] plus metformin 500 mg or alogliptin 12.5 mg plus metformin 1000 mg) two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than alogliptin 25 mg plus metformin 2000 mg per day.
- Children—Use and dose must be determined by your doctor.
- For type 2 diabetes:
If you miss a dose of alogliptin and metformin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using alogliptin and metformin
It is very important that your doctor check your progress at regular visits to make sure that alogliptin and metformin is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
Under certain conditions, too much metformin can cause lactic acidosis. The symptoms of lactic acidosis are severe and quick to appear, and usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Symptoms of lactic acidosis include abdominal or stomach discomfort, decreased appetite, diarrhea, fast, shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness.
If symptoms of lactic acidosis occur, you should get immediate emergency medical help.
Pancreatitis (swelling and inflammation of the pancreas) may occur while you are using alogliptin and metformin. Check with your doctor right away if you have a sudden and severe stomach pain, chills, constipation, nausea, vomiting, loss of appetite, fever, or lightheadedness.
If you are rapidly gaining weight, having shortness of breath, chest pain, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of a heart problem.
alogliptin and metformin may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (eg, Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using alogliptin and metformin.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
alogliptin and metformin may cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, cannot eat because of nausea or vomiting, take certain medicines, or take alogliptin and metformin combination with another type of diabetes medicine (eg, glimepiride, glipizide, glyburide, pioglitazone). Symptoms of low blood sugar must be treated before they cause you to pass out (unconsciousness). People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly.
Symptoms of low blood sugar include anxiety, behavior changes similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headaches that continue, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
If symptoms of low blood sugar occur, check your blood sugar level. If you have low blood sugar, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drinks, or sugar dissolved in water. Glucagon is a medicine that is used in emergency situations when severe symptoms, such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. The members of your family should also know how to use glucagon.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual.
Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), loss of appetite, sleepiness, stomachache, nausea, or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness (passed out), or unusual thirst.
If symptoms of high blood sugar occur, check your blood sugar level and call your doctor for instructions.
There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes with a list of all your medicines.
It is important to tell the doctor in charge that you are taking alogliptin and metformin if you are going to have any medical or surgical procedures.
alogliptin and metformin may cause severe and disabling joint pain. Call your doctor right away if you have severe joint pain while using alogliptin and metformin.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
alogliptin and metformin Side Effects
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:More common
- Blurred vision
- pounding in the ears
- slow or fast heartbeat
- bladder pain
- bloody or cloudy urine
- chest pain
- cold sweats
- cool, pale skin
- decreased urine output
- 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
- 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
- darkened urine
- difficulty with swallowing
- hives or itching
- 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
- yellow eyes or skin
- Dark-colored urine
- general feeling of tiredness or weakness
- light-colored stools
- redness of the skin
- severe joint pain
- stomach pain, continuing
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:More common
- Body aches or pain
- ear congestion
- loss of voice
- muscle aches
- 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.
See also: Side effects (in more detail)
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