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carvedilol- Carvedilol tablet, coated for oral use


  1. Patient Information
  2. What Is Carvedilol?
  3. Who Should Not Take Carvedilol?
  4. How Should I Take Carvedilol?
  5. What Should I Avoid While Taking Carvedilol?
  6. What Are Possible Side Effects Of Carvedilol?
  7. How Should I Store Carvedilol?
  8. What Are The Ingredients In Carvedilol?
  9. Revised: 10/2007document Id:

Patient Information 

17.1Patient 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.

PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

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17.2FDA-Approved Patient Labeling

PATIENT INFORMATION

Rx Only

Carvedilol Tablets

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

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.

The active ingredient is 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 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 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 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.

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.

How Should I Store Carvedilol? 

  • Store carvedilol at less than 86 F (30 C). Keep the tablets dry.
  • Safely, throw away carvedilol that is out of date or no longer needed.
  • Keep carvedilol and all medicines out of the reach of children.

GENERAL INFORMATION ABOUT CARVEDILOL

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use carvedilol for a condition for which it was not prescribed. Do not give carvedilol 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. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about carvedilol that is written for healthcare professionals. You can also find out more about carvedilol by visiting the websitewww.ranbaxyusa.comor calling 1-888-RANBAXY- (726-2299). This call is free.

What Are The Ingredients In Carvedilol? 

Active Ingredient: Carvedilol

Inactive Ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polysorbate 80, povidone, propylene glycol, sucrose, talc and titanium dioxide

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

Manufatured for:

Ranbaxy Pharmaceuticals Inc.

Jacksonville, FL 32257 USA

by: Ohm Laboratories Inc.

North Brunswick, NJ 08902 USA

September 2007

CARVEDILOL
carvedilol tablet, coated
Product Information
Product TypeItem Code (Source)NDC:63304-823
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
carvedilol(UNII: 0K47UL67F2) (carvedilol - UNII:0K47UL67F2)3.125 mg
Inactive Ingredients
Ingredient NameStrength
colloidal silicon dioxide()
crospovidone()
titanium dioxide(UNII: 15FIX9V2JP)
polysorbate 80()
hydroxypropyl cellulose()
hypromellose()
lactose monohydrate()
magnesium stearate(UNII: 70097M6I30)
povidone(UNII: LI81FMI713)
propylene glycol(UNII: 6DC9Q167V3)
sucrose(UNII: C151H8M554)
talc(UNII: 7SEV7J4R1U)
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize6mm
FlavorImprint CodeRX4
Contains
CoatingtrueSymbolfalse
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63304-823-101000 in 1 BOTTLE
2NDC:63304-823-3030 in 1 BOTTLE
CARVEDILOL
carvedilol tablet, coated
Product Information
Product TypeItem Code (Source)NDC:63304-824
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
carvedilol(UNII: 0K47UL67F2) (carvedilol - UNII:0K47UL67F2)6.25 mg
Inactive Ingredients
Ingredient NameStrength
colloidal silicon dioxide()
crospovidone()
talc(UNII: 7SEV7J4R1U)
hydroxypropyl cellulose()
hypromellose()
lactose monohydrate()
magnesium stearate(UNII: 70097M6I30)
polyethylene glycol()
polysorbate 80()
povidone()
sucrose(UNII: C151H8M554)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize8mm
FlavorImprint CodeRX;824
Contains
CoatingtrueSymbolfalse
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63304-824-101000 in 1 BOTTLE
2NDC:63304-824-3030 in 1 BOTTLE
CARVEDILOL
carvedilol tablet, coated
Product Information
Product TypeItem Code (Source)NDC:63304-825
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
carvedilol(UNII: 0K47UL67F2) (carvedilol - UNII:0K47UL67F2)12.5 mg
Inactive Ingredients
Ingredient NameStrength
colloidal silicon dioxide()
crospovidone()
hydroxypropyl cellulose()
talc(UNII: 7SEV7J4R1U)
hypromellose()
lactose monohydrate()
magnesium stearate(UNII: 70097M6I30)
propylene glycol(UNII: 6DC9Q167V3)
polysorbate 80()
povidone()
sucrose(UNII: C151H8M554)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize12mm
FlavorImprint CodeRX825
Contains
CoatingtrueSymbolfalse
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63304-825-101000 in 1 BOTTLE
2NDC:63304-825-3030 in 1 BOTTLE
CARVEDILOL
carvedilol tablet, coated
Product Information
Product TypeItem Code (Source)NDC:63304-826
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
carvedilol(UNII: 0K47UL67F2) (carvedilol - UNII:0K47UL67F2)25 mg
Inactive Ingredients
Ingredient NameStrength
colloidal silicon dioxide()
crospovidone()
hydroxypropyl cellulose()
talc(UNII: 7SEV7J4R1U)
hypromellose()
lactose monohydrate()
magnesium stearate(UNII: 70097M6I30)
propylene glycol(UNII: 6DC9Q167V3)
polysorbate 80()
povidone()
sucrose(UNII: C151H8M554)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize15mm
FlavorImprint CodeRX826
Contains
CoatingtrueSymbolfalse
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63304-826-101000 in 1 BOTTLE
2NDC:63304-826-3030 in 1 BOTTLE
Labeler -Ranbaxy Pharmaceuticals Inc.

Revised: 10/2007document Id: 

3FD99144-3C4D-9DBB-E6D6-C75688CA8B1CSet id: 7d485d38-5d43-4a54-bc63-82734035c66aVersion: 1Effective Time: 20071006Ranbaxy Pharmaceuticals Inc.



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