Carvedilol (Page 8 of 9)

14.2 Left Ventricular Dysfunction following Myocardial Infarction

CAPRICORN was a double-blind trial comparing carvedilol and placebo in 1,959 subjects with a recent myocardial infarction (within 21 days) and left ventricular ejection fraction of less than or equal to 40%, with (47%) or without symptoms of heart failure. Subjects given carvedilol received 6.25 mg twice daily, titrated as tolerated to 25 mg twice daily. Subjects had to have a systolic blood pressure greater than 90 mm Hg, a sitting heart rate greater than 60 beats per minute, and no contraindication to β-blocker use. Treatment of the index infarction included aspirin (85%), IV or oral β-blockers (37%), nitrates (73%), heparin (64%), thrombolytics (40%), and acute angioplasty (12%). Background treatment included ACE inhibitors or angiotensin receptor blockers (97%), anticoagulants (20%), lipid-lowering agents (23%), and diuretics (34%). Baseline population characteristics included an average age of 63 years, 74% male, 95% Caucasian, mean blood pressure 121/74 mm Hg, 22% with diabetes, and 54% with a history of hypertension. Mean dosage achieved of carvedilol was 20 mg twice daily; mean duration of follow-up was 15 months.

All-cause mortality was 15% in the placebo group and 12% in the carvedilol group, indicating a 23% risk reduction in subjects treated with carvedilol (95% CI 2% to 40%, P = 0.03), as shown in Figure 3. The effects on mortality in various subgroups are shown in Figure 4. Nearly all deaths were cardiovascular (which were reduced by 25% by carvedilol), and most of these deaths were sudden or related to pump failure (both types of death were reduced by carvedilol). Another trial end point, total mortality and all-cause hospitalization, did not show a significant improvement.

There was also a significant 40% reduction in fatal or non-fatal myocardial infarction observed in the group treated with carvedilol (95% CI 11% to 60%, P = 0.01). A similar reduction in the risk of myocardial infarction was also observed in a meta-analysis of placebo-controlled trials of carvedilol in heart failure.

Figure 3. Survival Analysis for CAPRICORN (Intent-to-Treat)

figure-3
(click image for full-size original)

Figure 4. Effects on Mortality for Subgroups in CAPRICORN

figure-4
(click image for full-size original)

14.3 Hypertension

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, carvedilol 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 peak antihypertensive effect occurred 1 to 2 hours after a dose. 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%. Carvedilol was titrated to a mean dose of 17.5 mg twice daily and maintained for 5 months. Carvedilol 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 carvedilol tablets, USP are available in the following strengths:

3.125 mg – White, film-coated circular shaped tablets with ‘G’ engraved on one side and plain on the other side,

6.25 mg – White, film-coated circular shaped tablets with ‘G’ engraved on one side and ‘41’ engraved on the other side,

12.5 mg – White, film-coated capsule shaped tablets with ‘G’ engraved on one side and ‘164’ engraved on the other side,

25 mg – White, film-coated circular shaped tablets with ‘G41’ engraved on one side and ‘25’ engraved on the other side.

3.125 mg
60’s: NDC 68462-162-60
100’s: NDC 68462-162-01
180’s: NDC 68462-162-18
500’s: NDC 68462-162-05
1000’s: NDC 68462-162-10
6.25 mg
60’s: NDC 68462-163-60
100’s: NDC 68462-163-01
180’s: NDC 68462-163-18
500’s: NDC 68462-163-05
1000’s: NDC 68462-163-10
12.5 mg
60’s: NDC 68462-164-60
100’s: NDC 68462-164-01
180’s: NDC 68462-164-18
500’s: NDC 68462-164-05
1000’s: NDC 68462-164-10
25 mg
60’s: NDC 68462-165-60
100’s: NDC 68462-165-01
180’s: NDC 68462-165-18
500’s: NDC 68462-165-05
1000’s: NDC 68462-165-10

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Patients taking carvedilol should be advised of the following:

Patients should take carvedilol with food.
Patients should not interrupt or discontinue using carvedilol 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.
Diabetic patients should report any changes in blood sugar levels to their physician.
Contact lens wearers may experience decreased lacrimation.

Manufactured by:

Glenmark Pharmaceuticals Ltd.
India

Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com

September 2019

Patient Information

Carvedilol (kar´ve dil ol) Tablets, USP

Read the Patient Information that comes with carvedilol tablets 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 carvedilol tablets, ask your doctor or pharmacist.

What are Carvedilol Tablets?

Carvedilol tablets are a prescription medicine that belongs to a group of medicines called “beta-blockers”.

Carvedilol tablets are 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)

Carvedilol tablets are not approved for use in children under 18 years of age.

Who should not take Carvedilol Tablets?

Do not take carvedilol tablets if you:

have severe heart failure and are hospitalized in the intensive care unit or require certain intravenous medications that help support circulation (inotropic medications).
are prone to asthma or other breathing problems.
have a slow heartbeat or a heart that skips a beat (irregular heartbeat).
have liver problems.
are allergic to any of the ingredients in carvedilol tablets. The active ingredient is carvedilol. See the end of this leaflet for a list of all the ingredients in carvedilol tablets.

What should I tell my doctor before taking Carvedilol Tablets?

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). Carvedilol tablets can make some of your symptoms worse.
have diabetes.
have thyroid problems.
have a condition called pheochromocytoma.
have had severe allergic reactions.
are pregnant or trying to become pregnant. It is not known if carvedilol 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 carvedilol passes into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking carvedilol tablets.
are scheduled for surgery and will be given anesthetic agents.
are scheduled for cataract surgery and have taken or are currently taking carvedilol tablets.
are taking prescription or over-the-counter medicines, vitamins, and herbal supplements. Carvedilol and certain other medicines can affect each other and cause serious side effects. Carvedilol may affect the way other medicines work. Also, other medicines may affect how well carvedilol works.

Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine.

How should I take Carvedilol Tablets?

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

Take carvedilol tablets exactly as prescribed. Your doctor will tell you how many tablets to take and how often. In order to minimize possible side effects, your doctor might begin with a low dose and then slowly increase the dose.
Do not stop taking carvedilol tablets and do not change the amount of carvedilol tablets you take without talking to your doctor.
Tell your doctor if you gain weight or have trouble breathing while taking carvedilol tablets.
Take carvedilol tablets with food.
If you miss a dose of carvedilol tablets, 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 many carvedilol tablets, call your doctor or poison control center right away.

What should I avoid while taking Carvedilol Tablets?

Carvedilol tablets 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 Carvedilol Tablets?

Low blood pressure (which may cause dizziness or fainting when you stand up). If these happen, sit or lie down right away and tell your doctor.
Tiredness. If you feel tired or dizzy you should not drive, use machinery, or do anything that needs you to be alert.
Slow heartbeat.
Changes in your blood sugar. If you have diabetes, tell your doctor if you have any changes in your blood sugar levels.
Carvedilol tablets may hide some of the symptoms of low blood sugar, especially a fast heartbeat.
Carvedilol tablets may mask the symptoms of hyperthyroidism (overactive thyroid).
Worsening of severe allergic reactions.
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 carvedilol tablets. These reactions can be life-threatening.

Other side effects of carvedilol tablets include shortness of breath, weight gain, diarrhea, and fewer tears or dry eyes that become bothersome if you wear contact lenses.

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 Carvedilol Tablets?

Store carvedilol tablets at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.
Safely, throw away carvedilol tablets that are out of date or no longer needed.
Keep carvedilol tablets and all medicines out of the reach of children.

General Information about Carvedilol Tablets

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

This leaflet summarizes the most important information about carvedilol tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about carvedilol tablets that is written for healthcare professionals. You can also find out more about carvedilol tablets by calling 1 (888) 721-7115. This call is free.

What are the ingredients in Carvedilol Tablets?

Active Ingredient: carvedilol.

Inactive Ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide.

Carvedilol tablets, USP come in the following strengths: 3.125 mg, 6.25 mg, 12.5 mg, 25 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. Carvedilol tablets 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.

Manufactured by:

Glenmark Pharmaceuticals Ltd.
India

Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

September 2019

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