COREG CR (Page 10 of 11)

14.3 Hypertension

A double-blind, randomized, placebo-controlled, 8-week trial evaluated the blood pressure-lowering effects of COREG CR 20 mg, 40 mg, and 80 mg once daily in 338 subjects with essential hypertension (sitting diastolic blood pressure [DBP] greater than or equal to 90 and less than or equal to 109 mm Hg). Of 337 evaluable subjects, a total of 273 subjects (81%) completed the trial. Of the 64 (19%) subjects withdrawn from the trial, 10 (3%) were due to adverse events, 10 (3%) were due to lack of efficacy; the remaining 44 (13%) withdrew for other reasons. The mean age of the subjects was approximately 53 years, 66% were male, and the mean sitting systolic blood pressure (SBP) and DBP at baseline were 150 mm Hg and 99 mm Hg, respectively. Dose titration occurred at 2‑week intervals.

Statistically significant reductions in blood pressure as measured by 24‑hour ambulatory blood pressure monitoring (ABPM) were observed with each dose of COREG CR compared with placebo. Placebo-subtracted mean changes from baseline in mean SBP/DBP were ‑6.1/‑4.0 mm Hg, ‑9.4/‑7.6 mm Hg, and ‑11.8/‑9.2 mm Hg for COREG CR 20 mg, 40 mg, and 80 mg, respectively. Placebo-subtracted mean changes from baseline in mean trough (average of hours 20 to 24) SBP/DBP were ‑3.3/‑2.8 mm Hg, ‑4.9/‑5.2 mm Hg, and ‑8.4/‑7.4 mm Hg for COREG CR 20 mg, 40 mg, and 80 mg, respectively. The placebo-corrected trough to peak (3 to 7 h) ratio was approximately 0.6 for COREG CR 80 mg. In this trial, assessments of 24‑hour ABPM monitoring demonstrated statistically significant blood pressure reductions with COREG CR throughout the dosing period (Figure 5).

Figure 5. Changes from Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Measured by 24-Hour ABPM

Figure 5. Changes from Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Measured by 24-Hour ABPM
(click image for full-size original)

Immediate‑release carvedilol was studied in 2 placebo‑controlled trials that utilized twice‑daily dosing, at total daily doses of 12.5 to 50 mg. In these and other trials, the starting dose did not exceed 12.5 mg. At 50 mg per day, COREG reduced sitting trough (12‑hour) blood pressure by about 9/5.5 mm Hg; at 25 mg per day the effect was about 7.5/3.5 mm Hg. Comparisons of trough‑to‑peak blood pressure showed a trough‑to‑peak ratio for blood pressure response of about 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 evaluated 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)].

HOW SUPPLIED

Product: 68151-5049

NDC: 68151-5049-1 1 CAPSULE, EXTENDED RELEASE in a PACKAGE

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:
Patients should not interrupt or discontinue using COREG CR without a physician’s advice.
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.
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.
If experiencing dizziness or fatigue, patients should avoid driving or hazardous tasks.
Patients should consult a physician if they experience dizziness or faintness, in case the dosage should be adjusted.
Patients should not crush or chew COREG CR capsules.
Patients should take COREG CR with food.
Diabetic patients should report any changes in blood sugar levels to their physician.
Contact lens wearers may experience decreased lacrimation.

COREG CR and COREG are registered trademarks of the GSK group of companies.

TOPROL-XL is a trademark of its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2015 the GSK group of companies. All rights reserved.

CCR:18PI

PHARMACIST─DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

PATIENT INFORMATION
COREG CR® (Co-REG)

(carvedilol phosphate)

Extended-release Capsules

Read the Patient Information that comes with COREG CR before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about COREG CR, ask your doctor or pharmacist.

What is the most important information I should know about COREG CR?

It is important for you to take your medicine every day as directed by your doctor. If you stop taking COREG CR suddenly, you could have chest pain and a heart attack. If your doctor decides that you should stop taking COREG CR, your doctor may slowly lower your dose over time before stopping it completely.
What is COREG CR?

COREG CR is a prescription medicine that belongs to a group of medicines called “beta-blockers”. COREG CR is used, often with other medicines, for the following conditions:

to treat patients with certain types of heart failure
to treat patients who had a heart attack that worsened how well the heart pumps
to treat patients with high blood pressure (hypertension)

COREG CR is not approved for use in children under 18 years of age.

Who should not take COREG CR?

Do not take COREG CR if you:

have severe heart failure and require certain intravenous medicines that help support circulation.
have asthma or other breathing problems.
have a slow heartbeat or certain conditions that cause your heart to skip a beat (irregular heartbeat).
have liver problems.
are allergic to any of the ingredients in COREG CR. See “What are the ingredients in COREG CR?”

What should I tell my doctor before taking COREG CR?

Tell your doctor about all of your medical conditions, including if you:

have asthma or other lung problems (such as bronchitis or emphysema).
have problems with blood flow in your feet and legs (peripheral vascular disease). COREG CR can make some of your symptoms worse.
have diabetes.
have thyroid problems.
have a condition called pheochromocytoma.
have had severe allergic reactions.
are scheduled for surgery and will be given anesthetic agents.
are scheduled for cataract surgery and have taken or are currently taking COREG CR.
are pregnant or trying to become pregnant. It is not known if COREG CR is safe for your unborn baby. You and your doctor should talk about the best way to control your high blood pressure during pregnancy.
are breastfeeding. It is not known if COREG CR passes into your breast milk. You should not breastfeed while using COREG CR.


Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. COREG CR and certain other medicines can affect each other and cause serious side effects. COREG CR may affect the way other medicines work. Also, other medicines may affect how well COREG CR works.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist before you start a new medicine.

How should I take COREG CR?

Take COREG CR exactly as prescribed. Take COREG CR one time each day with food. It is important that you take COREG CR only one time each day. To lessen possible side effects, your doctor might begin with a low dose and then slowly increase the dose.
Swallow COREG CR capsules whole. Do not chew or crush COREG CR capsules.
If you have trouble swallowing COREG CR whole:
The capsule may be carefully opened and the beads sprinkled over a spoonful of applesauce which should be eaten right away. The applesauce should not be warm.
Do not sprinkle beads on foods other than applesauce.
Do not stop taking COREG CR and do not change the amount of COREG CR you take without talking to your doctor.
If you miss a dose of COREG CR, take your dose as soon as you remember, unless it is time to take your next dose. Take your next dose at the usual time. Do not take 2 doses at the same time.
If you take too much COREG CR, call your doctor or poison control center right away.


What should I avoid while taking COREG CR?

COREG CR can cause you to feel dizzy, tired, or faint. Do not drive a car, use machinery, or do anything that needs you to be alert if you have these symptoms.
What are possible side effects of COREG CR?

Serious side effects of COREG CR include:

chest pain and heart attack if you suddenly stop taking COREG CR. See “What is the most important information I should know about COREG CR?”
slow heart beat.
low blood pressure (which may cause dizziness or fainting when you stand up). If these happen, sit or lie down, and tell your doctor right away.
worsening heart failure. Tell your doctor right away if you have signs and symptoms that your heart failure may be worse, such as weight gain or increased shortness of breath.
changes in your blood sugar. If you have diabetes, tell your doctor if you have any changes in your blood sugar levels.
masking (hiding) the symptoms of low blood sugar, especially a fast heartbeat.
new or worsening symptoms of peripheral vascular disease.
leg pain that happens when you walk, but goes away when you rest
no feeling (numbness) in your legs or feet while you are resting
cold legs or feet
masking the symptoms of hyperthyroidism (overactive thyroid), such as a fast heartbeat.
worsening of severe allergic reactions. Medicines to treat a severe allergic reaction may not work as well while you are taking COREG CR.
rare but serious allergic reactions (including hives or swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing) have happened in patients who were on COREG or COREG CR. These reactions can be life-threatening. In some cases, these reactions happened in patients who had been on COREG before taking COREG CR.


Common side effects of COREG CR include shortness of breath, weight gain, diarrhea, and tiredness. If you wear contact lenses, you may have fewer tears or dry eyes that can become bothersome.

Call your doctor if you have any side effects that bother you or don’t go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store COREG CR?

Store COREG CR at less than 86°F (30°C).

Safely throw away COREG CR that is out of date or no longer needed.

Keep COREG CR and all medicines out of the reach of children.
General information about COREG CR

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use COREG CR for a condition for which it was not prescribed. Do not give COREG CR to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about COREG CR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about COREG CR that is written for healthcare professionals. You can also find out more about COREG CR by visiting the website www.COREGCR.com or calling 1-888-825-5249. This call is free.
What are the ingredients in COREG CR?

Active ingredient: carvedilol phosphate

Inactive ingredients: crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone

COREG CR capsules come in the following strengths: 10 mg, 20 mg, 40 mg, 80 mg.
What is high blood pressure (hypertension)? Blood pressure is the force of blood in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. High blood pressure makes the heart work harder to pump blood through the body and causes damage to blood vessels. COREG CR can help your blood vessels relax so your blood pressure is lower. Medicines that lower blood pressure may lower your chance of having a stroke or heart attack.

COREG CR and COREG are registered trademarks of the GSK group of companies.
GlaxoSmithKline

Research Triangle Park, NC 27709

©2015 the GSK group of companies. All rights reserved.
October 2015

CCR:7PIL

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