Carvedilol description, usages, side effects, indications, overdosage, supplying and lots more!

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Carvedilol

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

CARVEDILOL DESCRIPTION


Carvedilol





CLINICAL PHARMACOLOGY

Mechanism of Action


PHARMACODYNAMICS





















PHARMACOKINETICS









USE IN SPECIFIC POPULATIONS

























































INDICATIONS & USAGE








CARVEDILOL CONTRAINDICATIONS


  • ●Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of COREG.
  • ●Second- or third-degree AV block
  • ●Sick sinus syndrome
  • ●Severe bradycardia (unless a permanent pacemaker is in place)
  • ●Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. Such patients should first be weaned from intravenous therapy before initiating COREG.
  • ●Patients with severe hepatic impairment
  • ●Patients with a history of a serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to any component of this medication or other medications containing carvedilol.

WARNINGS AND PRECAUTIONS


































DRUG INTERACTIONS



















PREGNANCY



NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE







CARVEDILOL ADVERSE REACTIONS






















































OVERDOSAGE








DOSAGE & ADMINISTRATION

















DOSAGE FORMS & STRENGTHS



HOW SUPPLIED





INFORMATION FOR PATIENTS










  • ●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





  • ●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 COREG. The active ingredient is carvedilol. See the end of this leaflet for a list of all the ingredients in COREG.



  • ●Have problems with blood flow in your feet and legs (peripheral vascular disease) COREG 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 COREG 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 passes into your breast milk. You should not breastfeed while using COREG.
  • ●Are scheduled for surgery and will be given anesthetic agents
  • ●Are taking prescription or non-prescription medicines, vitamins, and herbal supplements. COREG and certain other medicines can affect each other and cause serious side effects. COREG may affect the way other medicines work. Also, other medicines may affect how well COREG works.





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




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






  • ●Safely, throw away COREG that is out of date or no longer needed.
  • ●Keep COREG and all medicines out of the reach of children.




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Carvedilol





Carvedilol



Carvedilol

Carvedilol TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-032(NDC:55111-252)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Carvedilol CARVEDILOL 3.125 mg

Inactive Ingredients

Ingredient Name Strength
HYDRATED SILICA
CROSPOVIDONE
HYPROMELLOSES
.BETA.-D-GALACTOSE
MAGNESIUM STEARATE
AMMONIUM LAURETH-5 SULFATE
polysorbate 80
COPOVIDONE

Product Characteristics

Color Size Imprint Code Shape
yellow 5 mm R;252 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-032-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076649 2011-08-02


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Be sure to consult your doctor before taking any medication!
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