Description
Glipizide and Metformin combination is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store the excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future. Proper diet is the first step in managing type 2 diabetes but often medicines are needed to help your body. With two actions, the combination of glipizide and metformin helps your body cope with high blood sugar. Glipizide stimulates the release of insulin from the pancreas, directing your body to store blood sugar. Metformin has three different actions: it slows the absorption of sugar in your small intestine; it also stops your liver from converting stored sugar into blood sugar; and it helps your body use your natural insulin more efficiently.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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
Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of glipizide and metformin in children with use in other age groups.
Geriatric
Some older adults may be more sensitive than younger adults to the effects of these medicines. The first signs of low or high blood sugar are not easily seen or do not occur at all in older adults. This may increase the chance of low blood sugar developing during treatment. Older adults are more likely to have age-related problems and glipizide and metformin should be used carefully as age increases. This medicine should not be started in adults over 80 years of age unless kidney function is not reduced.
Breastfeeding
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.
Drug Interactions
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 this medicine, 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 this medicine 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.
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acarbose
- Acetazolamide
- Alogliptin
- Asciminib
- Aspirin
- Bexagliflozin
- Bictegravir
- Brinzolamide
- Bupropion
- Capmatinib
- Carbamazepine
- Ceritinib
- Chloroquine
- Chlorothiazide
- Chlorpropamide
- Chlorthalidone
- Cimetidine
- Ciprofloxacin
- Dabrafenib
- Dasabuvir
- Delafloxacin
- Desmopressin
- Diatrizoate
- Dichlorphenamide
- Disopyramide
- Dofetilide
- Dolutegravir
- Dorzolamide
- Dulaglutide
- Enoxacin
- Entacapone
- Ethiodized Oil
- Fedratinib
- Fexinidazole
- Fluconazole
- Furosemide
- Gatifloxacin
- Gemifloxacin
Using this medicine 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
- Aminolevulinic Acid
- Atenolol
- Betaxolol
- Bisoprolol
- Bitter Melon
- Carteolol
- Carvedilol
- Celiprolol
- Cimetidine
- Clarithromycin
- Colesevelam
- Cyclosporine
- Esmolol
- Fenugreek
- Gemfibrozil
- Glecaprevir
- Glucomannan
- Goldenseal
- Guar Gum
- Hydrastis
- Isocarboxazid
- Labetalol
- Levobunolol
- Linezolid
- Methylene Blue
- Metipranolol
- Metoprolol
- Nadolol
- Nebivolol
- Oxprenolol
- Ozanimod
- Patiromer
- Penbutolol
- Phenelzine
- Pibrentasvir
- Pindolol
- Practolol
- Procarbazine
- Propranolol
Other Interactions
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.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Acid in the blood (acidosis or ketoacidosis) or
- Surgery (major)—Use of insulin is best to help control diabetes in patients with these conditions.
- Blood poisoning or
- Dehydration (severe) or
- Heart or blood vessel disorders or
- Kidney disease or
- Liver disease—Lactic acidosis can occur in these conditions and chances of it occurring are even greater with a medicine that contains metformin.
- Congestive Heart Failure—Glipizide and metformin should not be used in patients who have this medical condition.
- Kidney, heart, or other problems that require medical tests or examinations that use certain medicines called contrast agents, with x-ray exams—Because this medicine contains metformin, your doctor should advise you to stop taking it before you have any medical exams or diagnostic tests that might cause less urine output than usual; you may be advised to start taking the medicine again 48 hours after the exams or tests if your kidney function is tested and found to be normal.
- Alcohol intoxication or
- Strenuous exercise not accompanied by adequate intake of food or
- Underactive adrenal gland, not properly controlled or
- Underactive pituitary gland, not properly controlled or
- Undernourished condition or
- Weakened physical condition or
- Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking a medication that contains glipizide and metformin.
- Vitamin B12 deficiency—This condition may be made worse by this medication.
Proper Use
Follow carefully the special meal plan your doctor gave you. This is the most 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.
Glipizide and metformin combination should be taken with meals to help reduce the gastrointestinal side effects that may occur during treatment.
Dosing
The dose of this medicine 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 this medicine. 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:
- For first-time treatment:
- Adults: At first, 2.5 milligrams (mg) of glipizide and 250 milligrams (mg) of metformin once a day with a meal. Then, your doctor may increase your dose a little at a time every two weeks until your blood sugar is controlled.
- Children: Use and dose must be determined by your doctor.
- As second-line therapy:
- Oral, 2.5 milligrams (mg) of glipizide and 500 milligrams (mg) of metformin or 5 milligrams (mg) of glipizide and 500 milligrams (mg) of metformin two times a day, with the morning and evening meals. Then, your doctor may increase your dose a little at a time until your blood sugar is controlled. The starting dose should not exceed the daily dose of glipizide or metformin already being taken.
- Children: Use and dose must be determined by your doctor.
- For patients previously treated with a sulfonylurea antidiabetic agent and/or metformin:
- Adults: When switching patients from a sulfonylurea plus metformin to the glipizide and metformin combination, the initial dose should not exceed the daily dose of glipizide (or equivalent dose of another sulfonylurea) and metformin that was being taken.
- Children: Use and dose must be determined by your doctor.
- For first-time treatment:
- For type 2 diabetes:
Missed Dose
If you miss a dose of this medicine, 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
Your doctor will want to check your progress at regular visits , especially during the first few weeks that you take this medicine.
Under certain conditions, too much glipizide and metformin can cause lactic acidosis. 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; 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.
It is very important to follow carefully any instructions from your health care team about:
- Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
- Other medicines—Do not take other medicines unless they have been discussed with your doctor.
- Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
- Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
In case of emergency—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 that you have diabetes and a list of all your medicines.
Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.
Glipizide and metformin combination can cause low blood sugar. However, it also can occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take glipizide and metformin with another type of diabetes medicine. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.
If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it.
Symptoms of hyperglycemia (high blood sugar) include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and volume); ketones in urine; loss of appetite; sleepiness; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.
High blood sugar may occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan.
If symptoms of high blood sugar occur, check your blood sugar level and then call your health care professional for instructions.
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
- blurred vision
- chills
- cold sweats
- coma
- confusion
- cool pale skin
- cough
- depression
- dizziness
- fast heartbeat
- fever
- headache
- increased hunger
- nausea
- nervousness
- nightmares
- seizures
- shakiness
- slurred speech
- sneezing
- sore throat
- unusual tiredness or weakness
Less common
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- frequent urge to urinate
- lower back or side pain
- pounding in the ears
- slow heartbeat
Rare
- Abdominal discomfort
- decreased appetite
- diarrhea
- fainting spells
- fast, shallow breathing
- general feeling of discomfort
- muscle pain or cramping
- shortness of breath
- sleepiness
Symptoms of Overdose
Get emergency help immediately if any of the following symptoms of overdose occur:
- Abdominal discomfort
- anxiety
- behavior change, similar to drunkenness
- blurred vision
- cold sweats
- coma
- confusion
- cool, pale skin
- decreased appetite
- diarrhea
- difficulty in concentrating
- drowsiness
- excessive hunger
- fast heartbeat
- fast, shallow breathing
- general feeling of discomfort
- headache
- muscle pain or cramping
- nausea
- nervousness
- nightmares
- restless sleep
- seizures
- shakiness
- slurred speech
- unusual sleepiness
- unusual tiredness or weakness
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
- Muscle or bone pain
- stomach pain
- vomiting
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.
CON-XXXXXXXX