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Glucotrol XL

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Glucotrol XL

SIDE EFFECTS

In U.S. controlled studies the frequency of serious adverse experiences reported was very low and causal relationship has not been established.

The 580 patients from 31 to 87 years of age who received GLUCOTROL XL (glipizide extended release) Extended Release Tablets in doses from 5 mg to 60 mg in both controlled and open trials were included in the evaluation of adverse experiences. All adverse experiences reported were tabulated independently of their possible causal relation to medication.

Hypoglycemia

See PRECAUTIONS and OVERDOSAGE sections.

Only 3.4% of patients receiving GLUCOTROL XL (glipizide extended release) Extended Release Tablets had hypoglycemia documented by a blood-glucose measurement < 60 mg/dL and/or symptoms believed to be associated with hypoglycemia. In a comparative efficacy study of GLUCOTROL XL and Glucotrol, hypoglycemia occurred rarely with an incidence of less than 1% with both drugs.

In double-blind, placebo-controlled studies the adverse experiences reported with an incidence of 3% or more in GLUCOTROL XL (glipizide extended release) - treated patients include:

Adverse Effect GLUCOTROL XL (%)
(N=278)
Placebo (%)
(N=69)
Asthenia 10.1 13.0
Headache 8.6 8.7
Dizziness 6.8 5.8
Nervousness 3.6 2.9
Tremor 3.6 0.0
Diarrhea 5.4 0.0
Flatulence 3.2 1.4

The following adverse experiences occurred with an incidence of less than 3% in GLUCOTROL XL (glipizide extended release) -treated patients:

Body as a whole - pain
Nervous system - insomnia, paresthesia, anxiety, depression and hypesthesia
Gastrointestinal - nausea, dyspepsia, constipation and vomiting
Metabolic - hypoglycemia
Musculoskeletal - arthralgia, leg cramps and myalgia
Cardiovascular - syncope
Skin - sweating and pruritus
Respiratory - rhinitis
Special senses - blurred vision
Urogenital - polyuria

Other adverse experiences occurred with an incidence of less than 1% in GLUCOTROL XL-treated patients:

Body as a whole - chills
Nervous system - hypertonia, confusion, vertigo, somnolence, gait abnormality and decreased libido
Gastrointestinal - anorexia and trace blood in stool
Metabolic - thirst and edema
Cardiovascular - arrhythmia, migraine, flushing and hypertension
Skin - rash and urticaria
Respiratory - pharyngitis and dyspnea
Special senses - pain in the eye, conjunctivitis and retinal hemorrhage
Urogenital - dysuria

Although these adverse experiences occurred in patients treated with GLUCOTROL XL, a causal relationship to the medication has not been established in all cases.

There have been rare reports of gastrointestinal irritation and gastrointestinal bleeding with use of another drug in this non-deformable sustained release formulation, although causal relationship to the drug is uncertain.

In post-marketing experience of GLUCOTROL XL (glipizide extended release) , the additional adverse reaction of abdominal pain has been reported.

The following are adverse experiences reported with immediate release glipizide and other sulfonylureas, but have not been observed with GLUCOTROL XL (glipizide extended release) :

Hematologic

Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas.

Metabolic

Hepatic porphyria and disulfiram-like reactions have been reported with sulfonylureas. In the mouse, glipizide pretreatment did not cause an accumulation of acetaldehyde after ethanol administration. Clinical experience to date has shown that glipizide has an extremely low incidence of disulfiram-like alcohol reactions.

Endocrine Reactions

Cases of hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with glipizide and other sulfonylureas.

Laboratory Tests

The pattern of laboratory test abnormalities observed with glipizide was similar to that for other sulfonylureas. Occasional mild to moderate elevations of SGOT, LDH, alkaline phosphatase, BUN and creatinine were noted. One case of jaundice was reported. The relationship of these abnormalities to glipizide is uncertain, and they have rarely been associated with clinical symptoms.

Read the Glucotrol XL (glipizide extended release) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta-adrenergic blocking agents. When such drugs are administered to a patient receiving glipizide, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving glipizide, the patient should be observed closely for loss of control. In vitro binding studies with human serum proteins indicate that glipizide binds differently than tolbutamide and does not interact with salicylate or dicumarol. However, caution must be exercised in extrapolating these findings to the clinical situation and in the use of glipizide with these drugs.

Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving glipizide, the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving glipizide, the patient should be observed closely for hypoglycemia.

A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, topical, or vaginal preparations of miconazole is not known. The effect of concomitant administration of Diflucan® (fluconazole) and Glucotrol has been demonstrated in a placebo-controlled crossover study in normal volunteers. All subjects received Glucotrol alone and following treatment with 100 mg of Diflucan® as a single daily oral dose for 7 days. The mean percentage increase in the Glucotrol AUC after fluconazole administration was 56.9% (range: 35 to 81%).

Read the Glucotrol XL Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 1/8/2009
This monograph has been modified to include the generic and brand name in many instances.

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