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Metformin and saxagliptin

Generic name: metformin and saxagliptin [met-FOR-min-and-SAX-a-GLIP-tin]
Brand name: Kombiglyze XR
Oral tablet: 1000 mg–2.5 mg; 1,000 mg–5 mg; 500 mg–5 mg
Drug class: Combinations of anti-diabetics

What is Metformin and saxagliptin ?

Metformin and saxagliptin help control blood sugar levels. Metformin reduces glucose production (sugar) and decreases glucose absorption by the intestines. Saxagliptin regulates the insulin levels your body makes after you eat. Metformin and saxagliptin are a combination of medicines that can be used in conjunction with diet and physical activity to control blood sugar levels among adults who have type 2 diabetes mellitus. Metformin and saxagliptin are not used to treat type 1 diabetes. This medication guide does not list all possible uses of metformin or saxagliptin.

Side effects of Metformin and saxagliptin

If you experience any of the following symptoms of an allergy: itching, hives, or peeling of the skin; difficulty breathing; swelling in your lips, face, throat, tongue, or mouth; call 911 immediately.If you experience any of the following symptoms, stop taking this medication and contact your doctor immediately: nausea, vomiting, rapid heartbeat, and severe abdominal pain that spreads to your lower back.Metformin can cause lactic acidosis. This condition is fatal. Seek emergency medical attention if even minor symptoms, such as:

  • Unusual muscle pain;
  • Feeling cold
  • Trouble breathing
  • Feeling dizzy, fatigued, or weak?
  • Stomach pain, vomiting;
  • Heart rate irregularity

If you experience any of the following serious side effects, call your doctor immediately.

  • Severe autoimmune reactions—itching and blisters; breakdown of the outer skin layer
  • Are you suffering from severe joint pain?
  • Pain or burning after urinating;
  • Symptoms of heart failure include shortness of breath (even when lying down) and swelling in the legs and feet.

Some of the common side effects associated with metformin or saxagliptin include:

  • Diarrhea, nausea;
  • Headache;
  • Cold symptoms like a runny, stuffy, or stuffy nasal passage, sneezing, and sore throat.

There may be other side effects.If you experience side effects, seek medical advice by consulting your physician or calling 1-800-FDA-1088 to report it.

Warnings

If you suffer from severe kidney problems or diabetes ketoacidosis, then it is best to consult your doctor.You could develop lactic acidosis. Buildup of harmful lactic acids in your blood. If you experience unusual pain in your muscles, difficulty breathing, nausea, stomach pain, or dizziness, or feel cold or very tired, call your doctor.

Before you take this drug

This medicine should not be used if you have an allergic reaction to saxagliptin, metformin (Onglyza), or severe kidney problems (call your physician for insulin treatment).

If you've ever:

  • Kidney disease: Before taking this medication, you may have to get your kidney function checked.
  • Liver Disease
  • Heart Disease
  • Pancreatitis;
  • High triglycerides
  • Gallstones;

You can develop lactic acidosis. This is a buildup of dangerous lactic acids in your blood. You may have a higher risk if there are other conditions, such as chronic alcoholism or severe infections. Consult a healthcare provider in order to assess your level of risk.You may have to stop using metformin or saxagliptin temporarily if you are going to undergo surgery or any x-rays or CT scans that use a dye injected directly into your veins. Make sure you let your healthcare providers know that this drug is being used.If you're pregnant, or if you get pregnant in the future, follow your doctor’s advice about this medication.Metformin can stimulate ovulation and increase unintended pregnancies in women who are not yet menopausal. Speak to your doctor if you are concerned.Breastfeeding may be unsafe while taking this medication. You should consult your physician about the risks.The use of this medicine by those under 18 is prohibited.

How to take Metformin and saxagliptin?

Read all of the instructions or guides included with your medication and follow all directions as outlined on your prescription label. Metformin and saxagliptin should both be taken with meals for best results. Avoid chewing or crushing the tablet. You might feel hungry or dizzy. In order to quickly treat hyperglycemia, consume or drink sugary food or beverages (fruit juices, candy bars, crackers or raisins).If you suffer from severe hypoglycemia, your physician might provide an injection kit. Make sure your family or close friends understand how to administer this injection. Watch for symptoms of hyperglycemia, such as increased thirst or urine production. Stress, illness, surgeries, alcohol and skipping meals may all have an effect on blood sugar levels; before making changes or dose modifications to any medication or dosage schedule. Always seek advice from your physician first before altering anything about them or your daily dose schedule. Metformin or saxagliptin are only one part of an overall treatment plan that could also include diet and exercise, weight management, testing for blood sugar, and other medical attention. You should follow your doctor’s advice. Keep away from heat and moisture at room temperature.

Details on dosage

Adult dosage for diabetes type 2:
To reduce side effects, it is recommended to gradually increase the dose of metformin based on the patient’s existing regimen, its effectiveness, and tolerance.
Saxagliptin-Metformin XR:
Normal dose: Take 1 tablet with your evening meal.
Maximum dosage: saxagliptin 5000 mg and metformin 8000 mg, orally taken once daily.
Saxagliptin, 2.5-metformin orally, 1000 mg once a week.
Patients not receiving metformin currently: initial dose of saxagliptin (5 mg)-metformin (500 mg), orally, once daily
Patients currently taking metformin should receive a dose that includes saxagliptin plus their current dose or the closest therapeutically appropriate dose.
Comments:
Patients who require 2.5mg of saxagliptin per day, are metformin-naive, or need a daily dose greater than 1,000mg should take the components separately.
After switching from metformin instant-release to extended-release metformin, the glycemic level should be closely monitored and dose adjustments made accordingly.
When used with a combination of sulfonylureas or insulins, it may be possible to use a smaller dose of the insulin or sulfonylurea. This will reduce the risk of hypoglycemia.
Note: Note that there are currently available international products combining saxagliptin with immediate-release metformin; when taken twice daily.
Use: As an adjunct to diet, exercise, and metformin to improve the glycemic level in adults who have type II diabetes.

What happens if I miss the dose?

If you are close to your next dose, skip the missed dosage. Never take more than one dose at a time.

What happens if I overdose?

Call the Poison Help Line at 1-800-222-1222 or seek emergency medical care. If you have a severe low blood sugar level (extreme fatigue, nausea, tremors or trembling, confusion, difficulty speaking, rapid heartbeats, seizures, etc.), then seek emergency medical attention.

What should be avoided?

Alcohol lowers blood sugar and may increase your risk of lactic acidosis. Alcohol lowers your blood sugar levels and can increase the risk of developing lactic acidosis.

Interaction with other drug

Metformin, or saxagliptin, can be affected by many drugs, making them less effective and increasing the risk of lactic acidosis.

Inform your physician of any other medications taken, such as:

  • Antibiotics or antifungal medicines;
  • Insulin or diabetes oral medicine
  • Medicine to treat HIV/AIDS.

The list below is not exhaustive. Metformin or saxagliptin may be affected by other drugs, such as prescription, over-the-counter, herbal, and other products. This list does not include all interactions with other drugs.