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Cerebraplex

Cerebraplex Recall

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

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 should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

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History

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Other Information

Glimepiride is an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride, USP is a white, crystalline, odorless to practically odorless powder and is practically insoluble in water.

The structural formula is:

Glimepiride Structural Formula

Glimepiride tablets, USP contain the active ingredient glimepiride, USP and the following inactive ingredients:lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate. In addition, the 2 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake and the 4 mg also contains D&C Red No. 27 Aluminum Lake.

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Cerebraplex Manufacturers

  • Apotheca Company
    Cerebraplex | Mylan Institutional Inc.
    No Recall

    Cerebraplex | Mylan Institutional Inc.

    Cerebraplex | Mylan Institutional Inc.
    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 tablets should be administered at least 4 hours prior to colesevelam.

  • Bioactive Nutritional, Inc.
    Cerebraplex | Bioactive Nutritional, Inc.
    No Recall

    Cerebraplex | Bioactive Nutritional, Inc.

    Cerebraplex | Bioactive Nutritional, Inc.

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

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