Carvedilol (Page 6 of 7)

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 studies, the starting dose did not exceed 12.5 mg. At 50 mg/day, Carvedilol reduced sitting through (12-hour) blood pressure by about 9/5.5 mm Hg; at 25 mg/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/minute at 50 mg/day. In general, as is true for other β-blockers, responses were smaller in black than non-black patients. 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 study (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

Carvedilol Tablets USP, 3.125 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘01’ on the other side.
Bottles of 30 NDC 10544-184-30

Carvedilol Tablets USP, 6.25 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘02’ on the other side.
Bottles of 30 NDC 10544-187-30
Bottles of 90 NDC 10544-187-90
Carvedilol Tablets USP, 12.5 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘03’ on the other side.
Bottles of 30 NDC 10544-190-30
Bottles of 90 NDC 10544-190-90
Bottles of 181 NDC 10544-190-81
Carvedilol Tablets USP, 25 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘04’ on the other side.
Bottles of 30 NDC 10544-191-30
Bottles of 90 NDC 10544-191-30

Storage and Handling

Store at 20° to 25°C (68° to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container [see USP].

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 072, India

Marketed/ Packaged by:
Blenheim Pharmacal, Inc.
North Blenheim, NY 12131, (USA)
Revised: 10/2011

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (17.2).

17.1 Patient Advice

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 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.

17.2 FDA-Approved Patient Labeling

Patient labeling is provided as a tear-off leaflet at the end of this full prescribing information.

PATIENT INFORMATION

CARVEDILOL 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 high blood pressure (hypertension)
to treat patients who had a heart attack that worsened how well the heart pumps

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

Who should not take carvedilol tablets?

Do not take carvedilol tablet 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 tablets are 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. You should not breastfeed while using carvedilol tablets.
Are scheduled for surgery and will be given anesthetic agents.
Are taking prescription or non-prescription medicines, vitamins, and herbal supplements. Carvedilol tablets and certain other medicines can affect each other and cause serious side effects. Carvedilol tablets may affect the way other medicines work. Also, other medicines may affect how well carvedilol tablets 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 much 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 heart beat
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.

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.

How should I store carvedilol tablets?

Store carvedilol tablets at 20 to 25°C (68 to 77°F). Keep the tablets dry.
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 1-866-850-2876. This call is free.

What are the ingredients in carvedilol tablets?

Active Ingredient: carvedilol

Inactive Ingredients: lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose.
Carvedilol tablets come in the following strengths: 3.125 mg, 6.25 mg, 12.5 mg, or 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 for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 072, India

Marketed/ Packaged by:
Blenheim Pharmacal, Inc.
North Blenheim, NY 12131, (USA) Revised: 10/2011

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