A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Glucotrol Side Effects, and Drug Interactions - Glipizide
Glucotrol Side Effects, and Drug Interactions - Glipizide
SIDE EFFECTS
Immediate Release Tablets
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 glipizide
discontinued.
Hypoglycemia: See PRECAUTIONS
and OVERDOSAGE.
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; 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 glipizide; if skin
reactions persist, the drug should
be discontinued. Porphyria cutanea tarda and photosensitivity reactions
have been reported with sulfonylureas.
Miscellaneous: Dizziness, drowsiness, and headache
have each been reported in about one in fifty patients treated with glipizide.
They are usually transient
and seldom require discontinuance of therapy.
Extended Release Tablets
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 recieved glipizide 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.
Only 3.4% of patients receiving glipizide
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 glipizide
extended-release and glipizide, 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 glipizide extended-release-treated
patients include:
| TABLE 1 |
| Adverse Effect |
Glucotrol XL (%) |
Placebo (%) |
| (N=278) |
(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 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 glipizide
extended-release-treated patients:
- Body as a Whole: Chills.
- Nervous System: Hypertonia, confusion, vertigo, somnolence,
gait abnormality and decreases 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
glipizide extended-release, 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.
Immediate Release Tablets
The following are adverse experiences reported with immediate
release glipizide and other sulfonylureas, but have not been observed
with 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 this 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.
DRUG INTERACTIONS
Immediate and Extended Release Tablets
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 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 fluconazole and glipizide has been demonstrated in a placebo-controlled
crossover study in normal
volunteers. All subjects received glipizide
alone and following treatment with 100 mg of fluconazole as a single daily
oral dose
for seven days. The mean percentage
increase in the glipizide
AUC after fluconazole administration
was 56.9% (range: 35 to 81).
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