GLIMEPIRIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

GLIMEPIRIDE (UNII: 6KY687524K) (GLIMEPIRIDE - UNII:6KY687524K)

Mevcut itibaren:

DirectRX

INN (International Adı):

GLIMEPIRIDE

Kompozisyon:

GLIMEPIRIDE 4 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

- Glimepiride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)]. 1.1 Important Limitations of Use Glimepiride tablets USP should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. Glimepiride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)]. Glimepiride tablets USP should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. - Glimepiride is contraindicated in patients with a history of a hypersensitivity reaction to: Glimepiride or any of the product’s ingredients [see Warnings and Precautions (5.2)]. Sulfonamide derivatives: Patients who have developed an allergic reaction to sulfonamide derivatives may develop an allergic reaction

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

GLIMEPIRIDE- GLIMEPIRIDE TABLET
DIRECTRX
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GLIMEPIRIDE
INDICATIONS & USAGE SECTION
Glimepiride tablets USP are indicated as an adjunct to diet and
exercise to improve glycemic control
in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)].
1.1 Important Limitations of Use
Glimepiride tablets USP should not be used for the treatment of type 1
diabetes mellitus or diabetic
ketoacidosis, as it would not be effective in these settings.
DOSAGE & ADMINISTRATION SECTION
2.1 Recommended Dosing
Glimepiride tablets should be administered with breakfast or the first
main meal of the day.
The recommended starting dose of glimepiride tablets is 1 mg or 2 mg
once daily. Patients at
increased risk for hypoglycemia (e.g., the elderly or patients with
renal impairment) should be
started on 1 mg once daily [see Warnings and Precautions (5.1) and Use
in Specific Populations
(8.5,8.6)].
After reaching a daily dose of 2 mg, further dose increases can be
made in increments of 1 mg or 2
mg based upon the patient’s glycemic response. Uptitration should
not occur more frequently than
every 1 to 2 weeks. A conservative titration scheme is recommended for
patients at increased risk
for hypoglycemia [see Warnings and Precautions (5.1) and Use in
Specific Populations (8.5, 8.6)].
The maximum recommended dose is 8 mg once daily.
Patients being transferred to glimepiride tablets from longer
half-life sulfonylureas (e.g.,
chlorpropamide) may have overlapping drug effect for 1 to 2 weeks and
should be appropriately
monitored for hypoglycemia.
When colesevelam is coadministered with glimepiride, maximum plasma
concentration and total
exposure to glimepiride is reduced. Therefore, glimepiride should be
administered at least 4 hours
prior to colesevelam.
DOSAGE FORMS & STRENGTHS SECTION
Glimepiride tablets are formulated as:
1 mg - speckled pink, rectangular shaped, flat-faced, beveled edge
tablets debossed “37” bisect “44” on
one side and debossed “V” bisect “V” on the reverse side
2 mg - green, rectangula