"The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.
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In U.S. and foreign controlled studies, the frequency of serious adverse reactions reported was very low. Of 702 patients, 11.8% reported adverse reactions and in only 1.5% was GLUCOTROL (glipizide) discontinued.
Gastrointestinal: Gastrointestinal disturbances are the most common reactions. Gastrointestinal complaints were reported with the following approximate incidence: nausea and diarrhea, one in seventy; constipation and gastralgia, one in one hundred. They appear to be dose-related and may disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with sulfonylureas: GLUCOTROL (glipizide) should be discontinued if this occurs.
Dermatologic: Allergic skin reactions including erythema, morbilliform or maculopapular eruptions, urticaria, pruritus, and eczema have been reported in about one in seventy patients. These may be transient and may disappear despite continued use of GLUCOTROL (glipizide) ; if skin reactions persist, the drug should be discontinued. Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas.
Metabolic: Hepatic porphyria and disulfiram-like reactions have been reported with sulfonylureas. In the mouse, GLUCOTROL (glipizide) pretreatment did not cause an accumulation of acetaldehyde after ethanol administration. Clinical experience to date has shown that GLUCOTROL (glipizide) has an extremely low incidence of disulfiram-like alcohol reactions.
Miscellaneous: Dizziness, drowsiness, and headache have each been reported in about one in fifty patients treated with GLUCOTROL (glipizide) . They are usually transient and seldom require discontinuance of therapy.
The pattern of laboratory test abnormalities observed with GLUCOTROL (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 GLUCOTROL (glipizide) is uncertain, and they have rarely been associated with clinical symptoms.
The following adverse events have been reported in post-marketing surveillance:
Hepatobiliary: Cholestatic and hepatocellular forms of liver injury accompanied by jaundice have been reported rarely in association with glipizide; GLUCOTROL (glipizide) should be discontinued if this occurs.
Read the Glucotrol (glipizide) Side Effects Center for a complete guide to possible side effects
The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents, some azoles, 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 GLUCOTROL (glipizide) , the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving GLUCOTROL (glipizide) , the patient should be observed closely for loss of control. In vitro binding studies with human serum proteins indicate that GLUCOTROL (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 GLUCOTROL (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 GLUCOTROL (glipizide) , the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving GLUCOTROL (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 (glipizide) has been demonstrated in a placebo-controlled crossover study in normal volunteers. All subjects received GLUCOTROL (glipizide) 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 (glipizide) AUC after fluconazole administration was 56.9% (range: 35 to 81).
Read the Glucotrol Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 4/4/2011
This monograph has been modified to include the generic and brand name in many instances.
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