bout 65%. Heart rate fell by about 7.5 beats per minute at 50 mg per day. In general, as is true for other β‑blockers, responses were smaller in black than non‑black subjects. There were no age‑ or gender‑related differences in response. The dose‑related blood pressure response was accompanied by a dose‑related increase in adverse effects [see Adverse Reactions (6)].
14.4 Hypertension with Type 2 Diabetes Mellitus
In a double-blind trial (GEMINI), carvedilol, added to an ACE inhibitor or angiotensin receptor blocker, was eva luated in a population with mild‑to‑moderate hypertension and well-controlled type 2 diabetes mellitus. The mean HbA1c at baseline was 7.2%. COREG was titrated to a mean dose of 17.5 mg twice daily and maintained for 5 months. COREG had no adverse effect on glycemic control, based on HbA1c measurements (mean change from baseline of 0.02%, 95% CI: ‑0.06 to 0.10, P = NS) [see Warnings and Precautions (5.6)].
16 HOW SUPPLIED/STORAGE AND HANDLING
The hard gelatin capsules are available in the following strengths:
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10 mg – white and green capsule shell printed with “GSK COREG CR” and “10 mg”
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20 mg – white and yellow capsule shell printed with “GSK COREG CR” and “20 mg”
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40 mg – yellow and green capsule shell printed with “GSK COREG CR” and “40 mg”
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80 mg – white capsule shell printed with “GSK COREG CR” and “80 mg”
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10 mg bottles of 30: NDC 0007-3370-13
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20 mg bottles of 30: NDC 0007-3371-13
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40 mg bottles of 30: NDC 0007-3372-13
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80 mg bottles of 30: NDC 0007-3373-13
Store at 25°C (77°F); excursions 15° to 30°C (59° to 86°F). Dispense in a tight, light-resistant container.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Patients taking COREG CR should be advised of the following:
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Patients should not interrupt or discontinue using COREG CR without a physician’s advice.
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Patients with heart failure should consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.
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Patients may experience a drop in blood pressure when standing, resulting in dizziness and, rarely, fainting. Patients should sit or lie down when these symptoms of lowered blood pressure occur.
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If experiencing dizziness or fatigue, patients should avoid driving or hazardous tasks.
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Patients should consult a physician if they experience dizziness or faintness, in case the dosage should be adjusted.
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Patients should not crush or chew COREG CR capsules.
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Patients should take COREG CR with food.
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Diabetic patients should report any changes in blood sugar levels to their physician.
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Contact lens wearers may experience decreased lacrimation.
COREG CR and COREG are trademarks owned by or licensed to the GSK group of companies.
The other brand listed is a trademark owned by or licensed to its owner and is not owned by or licensed to the GSK group of companies. The maker of this brand is not affliated with and does not endorse the GSK group of companies or its products.
GlaxoSmithKline
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