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saxagliptin and metformin (Oral route)

sax-a-GLIP-tin hye-droe-KLOR-ide, met-FOR-min hye-droe-KLOR-ide

Oral route(Tablet, Extended Release)

Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk of lactic acidosis increases with conditions such as sepsis, dehydration, excessive alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure. Discontinue therapy and hospitalize the patient immediately for suspected lactic acidosis .

Commonly used brand name(s)

In the U.S.

  • Kombiglyze XR

Available Dosage Forms:

  • Tablet, Extended Release

Therapeutic Class: Antidiabetic

Pharmacologic Class: Saxagliptin

Chemical Class: Metformin

Uses For saxagliptin and metformin

Saxagliptin and metformin combination is used with diet and exercise to treat high blood sugar (glucose) levels in patients with type 2 diabetes. Saxagliptin helps to control blood sugar levels by making the pancreas gland release more insulin. It also signals the liver to stop producing sugar 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. saxagliptin and metformin does not help patients who have insulin-dependent or type 1 diabetes.

saxagliptin and metformin is available only with your doctor's prescription.

Before Using saxagliptin 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 saxagliptin and metformin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to saxagliptin 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of saxagliptin and metformin combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of saxagliptin 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 saxagliptin and metformin. saxagliptin and metformin is not recommended in patients 80 years of age and older who have kidney problems.

Pregnancy

Pregnancy Category Explanation
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.

Breast Feeding

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 saxagliptin 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 saxagliptin 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
  • Diatrizoate
  • Ethiodized Oil
  • Iobenzamic Acid
  • Iobitridol
  • Iocarmic Acid
  • Iocetamic Acid
  • Iodamide
  • Iodipamide
  • Iodixanol
  • Iodohippuric Acid
  • Iodopyracet
  • Iodoxamic Acid
  • Ioglicic Acid
  • Ioglycamic Acid
  • Iohexol
  • Iomeprol
  • Iopamidol
  • Iopanoic Acid
  • Iopentol
  • Iophendylate
  • Iopromide
  • Iopronic Acid
  • Ioseric Acid
  • Iosimide
  • Iotasul
  • Iothalamate
  • Iotrolan
  • Iotroxic Acid
  • Ioversol
  • Ioxaglate
  • Ioxitalamic Acid
  • Ipodate
  • Metrizamide
  • Metrizoic Acid
  • Tyropanoate Sodium

Using saxagliptin 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.

  • Aspirin
  • Balofloxacin
  • Besifloxacin
  • Bupropion
  • Ceritinib
  • Ciprofloxacin
  • Cobicistat
  • Dasabuvir
  • Dofetilide
  • Dolutegravir
  • Eliglustat
  • Enoxacin
  • Fleroxacin
  • Flumequine
  • Gatifloxacin
  • Gemifloxacin
  • Idelalisib
  • Lanreotide
  • Levofloxacin
  • Lomefloxacin
  • Moxifloxacin
  • Nadifloxacin
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Ombitasvir
  • Paritaprevir
  • Pasireotide
  • Pazufloxacin
  • Pefloxacin
  • Prulifloxacin
  • Ritonavir
  • Rufloxacin
  • Simeprevir
  • Sparfloxacin
  • Thioctic Acid
  • Tosufloxacin
  • Vandetanib

Using saxagliptin 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.

  • Acebutolol
  • Atenolol
  • Betaxolol
  • Bisoprolol
  • Bitter Melon
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Esmolol
  • Fenugreek
  • Furazolidone
  • Glucomannan
  • Guar Gum
  • Iproniazid
  • Isocarboxazid
  • Labetalol
  • Levobunolol
  • Linezolid
  • Methylene Blue
  • Metipranolol
  • Metoprolol
  • Moclobemide
  • Nadolol
  • Nebivolol
  • Nialamide
  • Oxprenolol
  • Penbutolol
  • Phenelzine
  • Pindolol
  • Practolol
  • Procarbazine
  • Propranolol
  • Psyllium
  • Ranolazine
  • Rasagiline
  • Rifampin
  • Safinamide
  • Selegiline
  • Sotalol
  • Timolol
  • Tranylcypromine

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 saxagliptin and metformin. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol, excessive use or
  • Congestive heart failure or
  • Dehydration or
  • Gallstones, history of or
  • Hypertriglyceridemia (high triglycerides or fats in the blood) or
  • Kidney disease or
  • Liver disease or
  • Pancreas problems, history of or
  • Sepsis (severe infection) or
  • Weakened physical condition—Use with caution. May cause side effects to become worse.
  • 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.
  • Heart failure, history of or
  • Kidney disease—May increase risk for heart failure.

Proper Use of saxagliptin and metformin

Take saxagliptin and metformin exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of unwanted effects.

saxagliptin and metformin usually comes with a Medication Guide. Read the information carefully and make sure you understand it before taking saxagliptin and metformin. If you have any questions, ask your doctor.

Carefully follow the special meal plan your doctor gave you. This is a very important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Take the medicine with the evening meal to help reduce unwanted stomach effects that may occur during the first few weeks of treatment.

Swallow the extended-release tablet whole. Do not crush, break, or chew it.

While taking the extended-release tablet, part of the tablet may pass into your stools. This is normal and is nothing to worry about.

Dosing

The dose of saxagliptin 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 saxagliptin 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 (extended-release tablets):
    • For type 2 diabetes:
      • For patients taking metformin alone:
        • Adults—The metformin dose is the same as the dose you are already taking. Your doctor may adjust your dose until your blood sugar is controlled. However, the dose is usually not more than 5 milligrams (mg) of saxagliptin and 2000 mg of metformin once a day.
        • Children—Use and dose must be determined by your doctor.
      • For patients taking saxagliptin alone:
        • Adults—At first, one tablet containing 5 milligrams (mg) of saxagliptin and 500 mg of metformin once a day. Your doctor may adjust your dose until your blood sugar is controlled. However, the dose is usually not more than 5 mg of saxagliptin and 2000 mg of metformin once a day.
        • Children—Use and dose must be determined by your doctor.
      • For patients using 2.5 milligrams (mg) of saxagliptin and extended-release metformin together:
        • Adults—One tablet containing 2.5 mg of saxagliptin and 1000 mg of metformin once a day.
        • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of saxagliptin 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.

Precautions While Using saxagliptin and metformin

Your doctor will want to check your progress at regular visits, especially during the first few weeks that you take saxagliptin and metformin. Blood and urine tests may be needed to check for unwanted effects.

Let your doctor or dentist know you are taking saxagliptin and metformin. Your doctor may advise you to temporarily stop taking saxagliptin and metformin before you have major surgery or diagnostic tests, including procedures that use contrast dye.

Under certain conditions, too much metformin can cause a condition called lactic acidosis. The symptoms of lactic acidosis are severe, appear quickly, and usually occur when other health problems are present, such as a heart attack or kidney failure. Symptoms of lactic acidosis include abdominal or stomach discomfort, decreased appetite, diarrhea, fast or 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 saxagliptin and metformin. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, 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.

saxagliptin and metformin may cause serious types of allergic reactions, including anaphylaxis and angioedema. These conditions may be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, or chest tightness.

Saxagliptin and metformin combination may cause hypoglycemia (low blood sugar). This can also occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, take certain medicines, or take saxagliptin together with other types of diabetes medicines. People feel different symptoms with low blood sugar. It is very important that you learn which symptoms you usually have so you can treat it quickly.

Symptoms of hypoglycemia (low blood sugar) include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness. Low blood sugar must be treated before it causes you to pass out (unconsciousness). Talk to your doctor about ways to treat low blood sugar.

saxagliptin and metformin may cause severe joint pain. Call your doctor right away if you have severe joint pain with saxagliptin 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.

saxagliptin 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
  • Anxiety
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • body aches or pain
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • cough
  • depression
  • difficult, burning, or painful urination
  • difficulty with breathing
  • dizziness
  • ear congestion
  • fast heartbeat
  • fever
  • frequent urge to urinate
  • headache
  • increased hunger
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • nausea
  • nightmares
  • runny nose
  • seizures
  • shakiness
  • slurred speech
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Rare
  • Cough or hoarseness
Incidence not known
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • constipation
  • darkened urine
  • difficulty with swallowing
  • hives or skin rash
  • indigestion
  • 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
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest
  • unusual bleeding or bruising
  • vomiting
  • yellow eyes or skin

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
  • Diarrhea
  • muscle aches
Less common
  • Abdominal or stomach pain
  • itching
  • pain or tenderness around the eyes and cheekbones
  • redness of the skin
  • weakness
  • welts

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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