| GLUCOZID
Gliclazide
Composition:
Each Glucozid
tablet contains Gliclazide BP 80 mg.
Indications:
Glucozid (Gliclazide)
is indicated for control of blood glucose in patients with non-insulin
dependent diabetes mellitus (Type-II, maturity onset diabetes
mellitus) whose hyperglycemia cannot be controlled by diet alone.
Glucozid
(Gliclazide) is a second-generation oral hypoglycemic sulfonylurea,
which stimulates the release of insulin from pancreatic beta
cells by facilitating Ca++ transport across the beta-cell
membranes and decreases hepatic glucose output.
Dosage &
administration:
Initially, 40-80
mg daily adjusted according to response, up to 160 mg as a single
dose. If necessary, upto 320 mg daily can be taken. Doses more
than 160 mg daily should be given in 2 divided doses.
Contraindications:
1. Hypersensitivity
to sulfonylurea.
2. Diabetes complicated
by ketoacidosis.
3. With coma.
4. Sole therapy
of insulin-dependent (Type-1) diabetes mellitus.
5. Diabetes when
complicated by pregnancy.
6. Breast-feeding.
7. Porphyria.
Side effects:
Hypoglycemia may
occur in concurrent conditions such as hepatic & renal diseases,
alcohol intoxication and adrenal & pituitary insufficiency.
Gastro-intestinal
disturbances including nausea, epigastric fullness, heartburn
are most common, but dose related and may disappear when dose
is reduced.
Allergic skin reactions
including rash, pruritus, and erythema, urticarias have been
reported. These may be transient and may disappear despite continued
use of the drug. If skin reactions persist, discontinue the
drug.
Several hematological
adverse reactions such as leukopenia, thrombocytopenia, agranulocytosis,
aplastic anemia, hemolytic anemia, pancytopenia, hepatic porphyria
have reported with other sulfonylureas, but have not been reproted
with Glucozid.
Use in pregnancy
and lactation:
Pregnancy:
Gliclazide should not be used in pregnancy.
Nursing Mothers:
gliclazide should not be used during breast-feeding.
Drug Interactions:
Androgens, anticoagulants,
chloramphenicol, fluconazole, miconazole, histamine H2
antagonists, MAO inhibitors, phenylbutazone, probenecid, salicylates,
sulfonamides, and tricyclic antidepressants may enhance the
hypoglycemic effect of Glucozid.
Beta-blockers,
rifampicin and thiazide diuretics, thyroid hormones, laxatives
and oral contraceptives may decrease the hypoglycemic effect
of Glucozid.
Precautions:
Care should be
exercised in patients with hepatic and/or renal impairment and
a small starting dose should be used with careful patient monitoring.
In long term clinical trials patients with renal insufficiency
have been treated satisfactory using Glucozid (Gliclazide)
at reduced doses.
Overdose and
treatment:
Overdosage can
produce hypoglycemia. Treat mild hypoglycemia without loss of
consciousness or neurologic findings aggressively with oral
glucose and adjustments in drug dosage or meal patterns. Severe
hypoglycemic reaction occurs infrequently, but require immediate
hospitalization. If hypoglycemic coma is suspected, rapidly
inject concentrated (50%) dextrose IV. Follow by a continuous
infusion of more dilute (10%) dextrose at a rate that will maintain
the blood glucose at a level of about 100 mg/dl.
Storage:
Store below 30º
C temperature.
Packing:
Box containing
5x10's tablets in blister/strip pack. |
