Glucotrol XL

Glucotrol XL is a prescription medication used to treat type 2 diabetes. Glucotrol XL belongs to a group of drugs called sulfonylureas, which help lower blood sugar levels by causing the pancreas to secrete insulin.

This medication comes in an extended release tablet form and is taken once a day with breakfast.

Common side effects of Glucotrol XL include nausea, diarrhea, and gas. Glucotrol XL can cause dizziness. Do not drive or operate machinery until you know how Glucotrol XL affects you.

 

The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:

• Hypoglycemia [see WARNINGS AND PRECAUTIONS]
• Hemolytic anemia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, 580 patients from 31 to 87 years of age received GLUCOTROL XL in doses from 5 mg to 60 mg in both controlled and open trials. The dosages above 20 mg are not recommended dosages. In these trials, approximately 180 patients were treated with GLUCOTROL XL for at least 6 months.

Table 1 summarizes the incidence of adverse reactions, other than hypoglycemia, that were reported in pooled double-blind, placebo-controlled trials in ≥3% of GLUCOTROL XL-treated patients and more commonly than in patients who received placebo.

Table 1: Incidence (%) of Adverse Reactions Reported in ≥3% of Patients Treated in Placebo-Controlled Clinical Trials and More Commonly in Patients Treated with GLUCOTROL XL (Excluding Hypoglycemia)

Of the 580 patients that received GLUCOTROL XL in clinical trials, 3.4% had hypoglycemia documented by a blood-glucose measurement <60 mg/dL and/or symptoms believed to be associated with hypoglycemia and 2.6% of patients discontinued for this reason. Hypoglycemia was not reported for any placebo patients.

In clinical trials, the incidence of gastrointestinal (GI) side effects (nausea, vomiting, constipation, dyspepsia), occurred in less than 3% of GLUCOTROL XL-treated patients and were more common in GLUCOTROL XL-treated patients than those receiving placebo.

In clinical trials, allergic skin reactions, i.e., urticaria occurred in less than 1.5% of treated patients and were more common in GLUCOTROL XL treated patients than those receiving placebo. These may be transient and may disappear despite continued use of glipizide XL; if skin reactions persist, the drug should be discontinued.

Laboratory Tests

Mild to moderate elevations of ALT, LDH, alkaline phosphatase, BUN and creatinine have been noted. The relationship of these abnormalities to glipizide is uncertain.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of GLUCOTROL XL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Abdominal pain
• Cholestatic and hepatocellular forms of liver injury accompanied by jaundice
• Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia [see WARNINGS AND PRECAUTIONS], aplastic anemia, pancytopenia
• Hepatic porphyria and disulfiram-like reactions
• Hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion
• Rash
• There have been reports of gastrointestinal irritation and gastrointestinal bleeding with use of another drug with this non dissolvable extended release formulation.

Read the entire FDA prescribing information for Glucotrol XL (Glipizide Extended Release)

This section provides information on the proper use of a number of products that contain glipizide. It may not be specific to Glucotrol XL. Please read with care.

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.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

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

If you are taking the extended release tablet, part of the tablet may pass into your stool after your body has absorbed the medicine. This is normal and nothing to worry about.

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 type 2 diabetes:
  • For oral dosage form (extended-release tablets):
    • Adults—At first, 5 milligrams (mg) once a day taken with breakfast. Your doctor may adjust your dose if needed. The dose is usually not more than 20 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—At first, 5 milligrams (mg) once a day taken at least 30 minutes before breakfast. Your doctor may adjust your dose if needed. The dose is usually not more than 40 mg per day.
    • Children—Use and dose must be determined by your doctor.

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.

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:

• Anxiety
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• depression
• difficulty with moving
• dizziness
• fainting
• fast heartbeat
• headache
• increased hunger
• joint pain
• leg cramps
• muscle aching or cramping
• muscle pain or stiffness
• nausea
• nervousness
• nightmares
• pain in the joints
• problems in urination or increase in the amount of urine
• seizures
• shakiness
• slurred speech
• sweating
• swollen joints
• unusual tiredness or weakness

• Abdominal or stomach pain
• bloating
• bloody or black, tarry stools
• body aches or pain
• burning, dry, or itching eyes
• clay-colored stools
• congestion
• constipation
• cough
• dark urine
• decreased vision or other changes in vision
• diarrhea
• difficult or labored breathing
• difficult or painful urination
• dryness or soreness of the throat
• excessive tearing
• fainting
• fast, slow, or irregular heartbeat
• feeling of warmth
• fever
• heartburn
• hoarseness
• indigestion
• itching
• loss of appetite
• pain in the eye
• pounding in the ears
• rash
• redness of the face, neck, arms and occasionally, upper chest
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• runny nose
• severe stomach pain
• shortness of breath
• tender, swollen glands in the neck
• tightness in the chest
• trouble in swallowing
• unpleasant breath odor
• voice changes
• vomiting of blood or material that looks like coffee grounds
• wheezing
• yellow eyes or skin

• Agitation
• back or leg pains
• bleeding gums
• blood in the urine or stools
• chest pain
• convulsions
• decreased urine output
• fluid-filled skin blisters
• general body swelling
• general feeling of tiredness or weakness
• high fever
• hostility
• increased thirst
• irritability
• lethargy
• light-colored stools
• lower back or side pain
• muscle twitching
• nosebleeds
• pinpoint red pots on the skin
• rapid weight gain
• sensitivity to the sun
• skin thinness
• sores, ulcers, or white spots on the lips or in the mouth
• stupor
• swelling of the face, ankles, or hands
• unusual bleeding or bruising

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:

• Indigestion
• passing of gas

• Acid or sour stomach
• belching
• excess air or gas in the stomach or intestines
• full feeling
• pain
• sleeplessness
• sneezing
• stuffy nose
• trouble sleeping
• unable to sleep

• Decreased interest in sexual intercourse
• dizziness or lightheadedness
• excessive muscle tone
• feeling of constant movement of self or surroundings
• flushing or redness of the skin
• headache, severe and throbbing
• hives or welts
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• mood or mental changes
• muscle stiffness
• muscle tension or tightness
• sensation of spinning
• skin rash, encrusted, scaly, and oozing
• sleepiness or unusual drowsiness
• unusually warm skin
• walking in unusual manner
• weight loss

• Increased sensitivity of the skin to sunlight
• severe sunburn

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.

• If you have an allergy to glipizide or any other part of Glucotrol XL (glipizide extended-release tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Acidic blood problem or type 1 diabetes.
• If you have G6PD deficiency.
• If you have a narrowing of the GI (gastrointestinal) tract or a bowel block.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Glucotrol XL with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

. Pregnancy

Pregnancy Category C: Glipizide was found to be mildly fetotoxic in rat reproductive studies at all dose levels (5–50 mg/kg). This fetotoxicity has been similarly noted with other sulfonylureas, such as tolbutamide and tolazamide. The effect is perinatal and believed to be directly related to the pharmacologic (hypoglycemic) action of glipizide. There are no adequate and well controlled studies in pregnant women. Glucotrol XL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects: Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates born to mothers who were receiving a sulfonylurea drug at the time of delivery. This has been reported more frequently with the use of agents with prolonged half-lives. If glipizide is used during pregnancy, it should be discontinued at least one month before the expected delivery date.

. Nursing Mothers

It is not known whether Glucotrol XL is excreted in human milk. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

. Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

There were no overall differences in effectiveness or safety between younger and older patients, but greater sensitivity of some individuals cannot be ruled out. Elderly patients are particularly susceptible to the hypoglycemic action of anti-diabetic agents. Hypoglycemia may be difficult to recognize in these patients. Therefore, dosing should be conservative to avoid hypoglycemia. [see Dosage and Administration (2.1), Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)]

Hepatic Impairment

There is no information regarding the effects of hepatic impairment on the disposition of glipizide. However, since glipizide is highly protein bound and hepatic biotransformation is the predominant route of elimination, the pharmacokinetics and/or pharmacodynamics of glipizide may be altered in patients with hepatic impairment. If hypoglycemia occurs in such patients, it may be prolonged and appropriate management should be instituted. [see Dosage and Administration (2.1), Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)]

Overdosage of sulfonylureas including Glucotrol XL can produce severe hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated with oral glucose. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment are medical emergencies requiring immediate treatment. The patient should be treated with glucagon or intravenous glucose. Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycemia may recur after apparent clinical recovery. Clearance of glipizide from plasma may be prolonged in persons with liver disease. Because of the extensive protein binding of glipizide, dialysis is unlikely to be of benefit.

1. Diabetes, 19, SUPP. 2: 747–830, 1970

NDC 0049-1620-30

30 Tablets

Glucotrol XL®
(glipizide)
extended release

2.5 mg    GITS

Pfizer
Distributed by
Roerig
Division of Pfizer Inc, NY, NY 10017

NDC 0049-1560-66

100 Tablets Tablets
Rx only

Glucotrol XL®
(glipizide) extended release

10 mg    GITS

Pfizer
Distributed by
Roerig
Division of Pfizer Inc, NY, NY 10017

Applies to glipizide: oral tablet, oral tablet extended release

Along with its needed effects, glipizide (the active ingredient contained in Glucotrol XL) 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 while taking glipizide:

• Anxiety
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• depression
• difficulty with moving
• dizziness
• fainting
• fast heartbeat
• headache
• increased hunger
• joint pain
• leg cramps
• muscle aching or cramping
• muscle pain or stiffness
• nausea
• nervousness
• nightmares
• pain in the joints
• problems in urination or increase in the amount of urine
• seizures
• shakiness
• slurred speech
• sweating
• swollen joints
• unusual tiredness or weakness

• Abdominal or stomach pain
• bloating
• bloody or black, tarry stools
• body aches or pain
• burning, dry, or itching eyes
• clay-colored stools
• congestion
• constipation
• cough
• dark urine
• decreased vision or other changes in vision
• diarrhea
• difficult or labored breathing
• difficult or painful urination
• dryness or soreness of the throat
• excessive tearing
• fainting
• fast, slow, or irregular heartbeat
• feeling of warmth
• fever
• heartburn
• hoarseness
• indigestion
• itching
• loss of appetite
• pain in the eye
• pounding in the ears
• rash
• redness of the face, neck, arms and occasionally, upper chest
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• runny nose
• severe stomach pain
• shortness of breath
• tender, swollen glands in the neck
• tightness in the chest
• trouble in swallowing
• unpleasant breath odor
• voice changes
• vomiting of blood or material that looks like coffee grounds
• wheezing
• yellow eyes or skin

• Agitation
• back or leg pains
• bleeding gums
• blood in the urine or stools
• chest pain
• convulsions
• decreased urine output
• fluid-filled skin blisters
• general body swelling
• general feeling of tiredness or weakness
• high fever
• hostility
• increased thirst
• irritability
• lethargy
• light-colored stools
• lower back or side pain
• muscle twitching
• nosebleeds
• pinpoint red pots on the skin
• rapid weight gain
• sensitivity to the sun
• skin thinness
• sores, ulcers, or white spots on the lips or in the mouth
• stupor
• swelling of the face, ankles, or hands
• unusual bleeding or bruising

Some side effects of glipizide 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:

• Indigestion
• passing of gas

• Acid or sour stomach
• belching
• excess air or gas in the stomach or intestines
• full feeling
• pain
• sleeplessness
• sneezing
• stuffy nose
• trouble sleeping
• unable to sleep

• Decreased interest in sexual intercourse
• dizziness or lightheadedness
• excessive muscle tone
• feeling of constant movement of self or surroundings
• flushing or redness of the skin
• headache, severe and throbbing
• hives or welts
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• mood or mental changes
• muscle stiffness
• muscle tension or tightness
• sensation of spinning
• skin rash, encrusted, scaly, and oozing
• sleepiness or unusual drowsiness
• unusually warm skin
• walking in unusual manner
• weight loss

• Increased sensitivity of the skin to sunlight
• severe sunburn