Alogliptin and metformin

Name: Alogliptin and metformin

What is alogliptin and metformin?

Alogliptin and metformin are oral diabetes medicines that help control blood sugar levels.

Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Alogliptin works by regulating the levels of insulin your body produces after eating.

Alogliptin and metformin is a combination medicine used with diet and exercise to improve blood sugar control in adults with type 2 diabetes.

This medication is not for treating type 1 diabetes.

Alogliptin and metformin may also be used for purposes not listed in this medication guide.

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.

Dosing

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, 1 tablet (either alogliptin 12.5 milligrams [mg] plus metformin 500 mg or alogliptin 12.5 mg plus metformin 1000 mg) 2 times a day with food. 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.

Missed Dose

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.

Storage

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.

What are some things I need to know or do while I take Alogliptin and Metformin?

  • Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
  • Check your blood sugar as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Follow the diet and workout plan that your doctor told you about.
  • It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • If you have been taking alogliptin and metformin for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine stops working well. Do not take more than ordered.
  • Heart failure has happened in people taking alogliptin and metformin. Tell your doctor if you have ever had heart failure or kidney problems. Call your doctor right away if you feel very tired or you have shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Low blood sugar can happen. The chance of low blood sugar may be raised when this medicine is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do if you get low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.
  • A skin reaction called bullous pemphigoid has happened with drugs like this one. Sometimes, people have had to go to the hospital. Call your doctor right away if you have blisters or if your skin starts to break down.
  • If you are 65 or older, use alogliptin and metformin with care. You could have more side effects.
  • There is a chance of pregnancy in women of childbearing age who have not been ovulating. If you want to avoid pregnancy, use birth control that you can trust while taking this medicine.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using alogliptin and metformin while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Kazano: Alogliptin 12.5 mg and metformin hydrochloride 500 mg, Alogliptin 12.5 mg and metformin hydrochloride 1000 mg

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture.

ALERT U.S. Boxed Warning

Lactic acidosis:

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms, such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors such as topiramate), age 65 years or older, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information.

If metformin-associated lactic acidosis is suspected, immediately discontinue alogliptin and metformin and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

Monitoring Parameters

HbA1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2017a]), serum glucose, hematologic parameters (eg, hemoglobin/hematocrit, red blood cell indices); hepatic function (prior to initiation of therapy and as clinically indicated thereafter), renal function (prior to initiation of therapy then annually or more frequent if necessary); vitamin B12 (periodically with long-term treatment) and folate (if megaloblastic anemia is suspected)

Alogliptin / metformin Breastfeeding Warnings

AU and UK: Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. US: Use Caution Excreted into human milk: Unknown (alogliptin); Yes (metformin) Excreted into animal milk: Yes (alogliptin); Yes (metformin) The effects in the nursing infant are unknown.

There are no adequate and well-controlled studies in nursing mothers with this combination drug or with alogliptin. Metformin levels are expected to be 0.5% of their mother's weight-adjusted dosage and are expected to be relatively constant, so timing of breastfeeding with drug administration is expected to be of little benefit. In one large study, no adverse effects were observed in breastfed infants with the mother's use of metformin, although low detectable serum levels were found in some breastfed infants. As there is no information available on the use of alogliptin, an alternate drug may be preferred, especially while nursing a newborn or preterm infant and metformin should be used with caution while nursing a newborn or premature infant, especially those with renal impairment.

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