Carvedilol (Page 6 of 7)

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

The tablets 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
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
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
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
500’s: NDC 68462-165-05
1000’s: NDC 68462-165-10

Store below 30°C (86°F). Protect from moisture. Dispense in a tight, light-resistant container.

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 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.

17.2 FDA-Approved Patient Labeling

PATIENT INFORMATION

Carvedilol Tablets USP

(kar’ ve dil ol)

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

What is Carvedilol?

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

Carvedilol is used, often with other medicines, for the following conditions:

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

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

Who should not take Carvedilol?

Do not take carvedilol 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?

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 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. You should not breastfeed while using carvedilol.
Are scheduled for surgery and will be given anesthetic agents
Are scheduled for cataract surgery and have taken or are currently taking carvedilol.
Are taking prescription or non-prescription 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?

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

Take carvedilol 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 and do not change the amount of carvedilol you take without talking to your doctor.
Tell your doctor if you gain weight or have trouble breathing while taking carvedilol.
Take carvedilol with food.
If you miss a dose of carvedilol, 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, call your doctor or poison control center right away.

What should I avoid while taking Carvedilol?

Carvedilol 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?

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 may hide some of the symptoms of low blood sugar, especially a fast heartbeat.
Carvedilol 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. These reactions can be life-threatening.

Other side effects of carvedilol 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.

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