Saxagliptin-Metformin

By Medically reviewed by hellodoktor

Generic Name: Saxagliptin-Metformin Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: B

Uses

What is Saxagliptin-Metformin used for?

Saxagliptin-Metformin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

This product contains 2 medications: saxagliptin and metformin. Saxagliptin works by increasing levels of natural substances called incretins. Incretins help to control blood sugar by increasing insulin release, especially after a meal. They also decrease the amount of sugar your liver makes. Metformin lowers blood sugar by helping to restore your body’s proper response to the insulin. It also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb.

How should I take Saxagliptin-Metformin?

Take this medication by mouth as directed by your doctor, usually once a day with the evening meal.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

Drink plenty of fluids while taking this medication unless otherwise directed by your doctor.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of side effects (such as upset stomach), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Carefully follow the medication treatment plan, meal plan, and exercise program your doctor has recommended.

How do I store Saxagliptin-Metformin?

Saxagliptin-Metformin is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Saxagliptin-Metformin in the bathroom or the freezer. There may be different brands of Saxagliptin-Metformin that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Saxagliptin-Metformin down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Saxagliptin-Metformin?

Before taking milnacipran, tell your doctor or pharmacist if you are allergic to it; or to levomilnacipran; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, alcohol use, personal or family history of glaucoma (angle-closure type), personal or family history of psychiatric disorders (such as bipolar/manic-depressive disorder), personal or family history of suicide attempts, high blood pressure, heart problems (such as chest pain, heart attack, fast/irregular heartbeat), seizure disorder, severe loss of body water (dehydration), stomach/intestinal ulcers, mineral imbalance (low level of sodium in the blood), painful/difficult urination (for example, due to enlarged prostate).

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Drinking alcohol can also increase your risk of liver problems.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be at greater risk for mineral imbalance (low level of sodium in the blood) while using this drug, especially if they are also taking “water pills” (diuretics) with this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Saxagliptin-Metformin during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Saxagliptin-Metformin. Saxagliptin-Metformin is pregnancy risk category B according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Saxagliptin-Metformin?

Nausea, vomiting, stomach upset, diarrhea, headache, or a metallic taste in the mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after taking the same dose for several days or weeks), tell your doctor right away. Stomach symptoms that occur after the first days of your treatment may be signs of lactic acidosis.

An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: joint pain, unusual skin blisters, signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).

Although this medication by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if this drug is prescribed with other diabetes medications. Talk with your doctor or pharmacist about all your diabetes medication(s).

Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don’t have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Talk with your doctor or pharmacist about what to do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.

Get medical help right away if you have any very serious side effects, including: signs of disease of the pancreas (such as severe stomach/abdominal pain which may spread to the back, nausea/vomiting that doesn’t stop).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Saxagliptin-Metformin?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: “water pills” (diuretics such as furosemide), drugs that can cause bleeding/bruising (such as “blood thinners” including warfarin/heparin, anti-platelet drugs including clopidogrel).

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and at least 5 days after treatment with this medication. Ask your doctor when to start or stop taking this medication.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (nonsteroidal anti-inflammatory drugs-NSAIDs such as aspirin, ibuprofen, naproxen) that may increase your risk for bleeding if taken together with this drug. Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day). Consult your doctor or pharmacist for more details.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/”ecstasy,” St. John’s wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, other SNRIs such as duloxetine/venlafaxine), tryptophan, among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

Milnacipran is very similar to levomilnacipran. Do not use medications containing levomilnacipran while using milnacipran.

Saxagliptin-Metformin may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Saxagliptin-Metformin?

Saxagliptin-Metformin may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Saxagliptin-Metformin?

Saxagliptin-Metformin may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Saxagliptin-Metformin.

What is the dose of Saxagliptin-Metformin for an adult?

Usual Adult Dose for Diabetes Type 2

Individualize dose based patient’s current regimen, effectiveness, and tolerability; gradual dose titration of metformin is advised to reduce gastrointestinal side effects.

Saxagliptin-Metformin XR:

Usual dose: 1 tablet orally once a day with the evening meal

Maximum dose: saxagliptin 5 mg-metformin 2000 mg orally once a day

Maximum dose with concomitant strong CYP450 3A4/5 inhibitors: saxagliptin 2.5-metformin 1000 mg orally once a day

-Patients not currently treated with metformin: Initial dose saxagliptin 5 mg-metformin 500 mg orally once daily

-Patients currently treated with metformin: Initial dose: saxagliptin 5 mg plus the dose of metformin that is already being taken, or the nearest therapeutically appropriate dose.

Comments:

-Patients requiring saxagliptin 2.5 mg per day AND are either metformin-naive or require a dose of metformin greater than 1000 mg per day should use the individual components.

-Following a switch from metformin immediate-release to metformin extended release, glycemic control should be closely monitored and dosage adjustments made according.

-When used in combination with a sulfonylurea or insulin, a lower dose of the sulfonylurea or insulin may be considered to reduce the risk of hypoglycemia.

-Note: There are saxagliptin-metformin combination products available internationally that contain immediate-release metformin; saxagliptin-metformin products containing immediate-release metformin should be dosed twice a day.

Use: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both saxagliptin and metformin is appropriate.

Renal Dose Adjustments

Renal impairment: Contraindicated (e.g. serum creatinine levels 1.5 mg/dL or greater in men; 1.4 mg/dL or greater in women, or abnormal CrCl)

New Metformin Renal Dosing: Obtain eGFR prior to initiating therapy:

-eGFR less than 30 mL/min/1.73 m2: Use is contraindicated

-eGFR 30 to 45 mL/min/1.73 m2: Initiating therapy is not recommended

-eGFR that falls below 30 mL/min/1.73 m2 during therapy: Discontinue therapy

-eGFR that falls below 45 mL/min/1.73 m2 during therapy: Assess risks versus benefit of continued therapy

-eGFR greater than 45 mL/min/1.73 m2: No dose adjustments recommended

Saxagliptin:

Mild renal dysfunction (CrCl more than 50 mL/min): No adjustment recommended.

Moderate or severe renal dysfunction (CrCl 50 mL/min or less): 2.5 mg orally once a day, regardless of meals

IODINATED CONTRAST PROCEDURE:

-For patients with eGFR between 30 and 60 mL/min/1.73 m2: Stop this drug at the time of, or before imaging procedure; re-evaluate eGFR 48 hours after procedure; restart therapy only if renal function is stable.

-Use is contraindicated in conditions that may result in renal impairment such as cardiovascular collapse (shock), acute myocardial infarction, and septicamia; regular renal function monitoring is recommended to reduce the risk of developing lactic acidosis

-Treatment should not be initiated in patients 80 years or older unless measurement of CrCl demonstrates that renal function is not reduced.

Liver Dose Adjustments

Not recommended

Dose Adjustments

-When used in combination with a sulfonylurea or insulin, a lower dose of the sulfonylurea or insulin may be considered to reduce the risk of hypoglycemia.

Saxagliptin-metformin should be temporarily discontinued at the time of or prior to radiologic studies utilizing intravascular administration of iodinated contrast materials, withheld for 48 hours post procedure, and restarted once renal function has been confirmed as normal.

What is the dose of Saxagliptin-Metformin for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Saxagliptin-Metformin available?

Saxagliptin-Metformin is available in the following dosage forms and strengths:

  • Oral tablet, extended release.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Saxagliptin-Metformin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: August 10, 2018 | Last Modified: September 11, 2019

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