Carvedilol (Coreg)

Trade Name : COREG

GlaxoSmithKline LLC

TABLET, FILM COATED

Strength 3.125 mg/1

CARVEDILOL Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]

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Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Carvedilol (Coreg) which is also known as COREG and Manufactured by GlaxoSmithKline LLC. It is available in strength of 3.125 mg/1 per ml. Read more

Carvedilol (Coreg) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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No data

COREG is an alpha-/beta-adrenergic blocking agent indicated for the treatment of:

COREG should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.
Take with food. Individualize dosage and monitor during up-titration. ()

The white, oval, filmu2011coated tablets are available in the following strengths:
Tablets: 3.125 mg, 6.25 mg, 12.5 mg, 25u00a0mg ()

COREG is contraindicated in the following conditions:

2.4n- 4

No data

5.2n- 5.3n- 5.4
4n- 5.5

Most common adverse events ():

Heart failure and left ventricular dysfunction following myocardial infarction (u226510%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase.
Hypertension (u22655%): Dizziness.
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

7.1n- 7.5
7.3n- 7.4

No data

Overdosage may cause severe hypotension, bradycardia, cardiac insufficiency, cardiogenic shock, and cardiac arrest. Respiratory problems, bronchospasms, vomiting, lapses of consciousness, and generalized seizures may also occur.
The patient should be placed in a supine position and, where necessary, kept under observation and treated under intensive-care conditions. The following agents may be administered:
For excessive bradycardia:
To support cardiovascular function:
If peripheral vasodilation dominates, it may be necessary to administer adrenaline or noradrenaline with continuous monitoring of circulatory conditions. For therapy-resistant bradycardia, pacemaker therapy should be performed. For bronchospasm, u03b2-sympathomimetics (as aerosol or IV) or aminophylline IV should be given. In the event of seizures, slow IV injection of diazepam or clonazepam is recommended.
NOTE: In the event of severe intoxication where there are symptoms of shock, treatment with antidotes must be continued for a sufficiently long period of time consistent with the 7- to 10-hour half-life of carvedilol.
Cases of overdosage with COREG alone or in combination with other drugs have been reported. Quantities ingested in some cases exceeded 1,000u00a0milligrams. Symptoms experienced included low blood pressure and heart rate. Standard supportive treatment was provided and individuals recovered.

Carvedilol is a nonselective u03b2-adrenergic blocking agent with u03b1-blocking activity. It is (u00b1)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure:
COREG is a white, oval, film-coated tablet containing 3.125u00a0mg, 6.25u00a0mg, 12.5u00a0mg, or 25u00a0mg of carvedilol. The 6.25-mg, 12.5-mg, and 25-mg tablets are TILTAB tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sucrose, and titanium dioxide.
Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of CHNO. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5).

No data

In 2-year studies conducted in rats given carvedilol at doses up to 75u00a0mg per kg per day (12u00a0times the MRHD as mg per m) or in mice given up to 200u00a0mg per kg per day (16u00a0times the MRHD as mg per m), carvedilol had no carcinogenic effect.
Carvedilol was negative when tested in a battery of genotoxicity assays, including the Ames and the CHO/HGPRT assays for mutagenicity and the in vitro hamster micronucleus and in vivo human lymphocyte cell tests for clastogenicity.
In a combined fertility/developmental/post-natal toxicity study, rats were given carvedilol (12, 60, 300 mg per kg per day) orally by gavage for 2 weeks before mating and through mating, gestation, and weaning for females and for 62 days prior to and through mating for males. At a dosage of 300u00a0mg per kg per day (greater than or equal to 50u00a0times the MRHD as mg per m) carvedilol was toxic to adult rats (sedation, reduced weight gain) and was associated with a reduced number of successful matings, prolonged mating time, fewer corpora lutea and implants per dam, fewer live pups per litter, and delays in physical growth/development. The no-effect level for overt toxicity and impairment of fertility was 60u00a0mg per kg per day (10u00a0times the MRHD as mg per m).

No data

The white, oval, filmu2011coated tablets are available in the following strengths:
The 6.25-mg, 12.5-mg, and 25-mg tablets are TILTAB tablets.
Store below 30u00b0C (86u00b0F). Protect from moisture. Dispense in a tight, lightu2011resistant container.

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Patients taking COREG should be advised of the following:
COREG, COREG CR, and TILTAB are trademarks owned by or licensed to the GSK group of companies.
The other brand listed is a trademark owned by or licensed to its owner and is not owned by or licensed to the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.
Manufactured for
GlaxoSmithKline
Research Triangle Park, NC 27709
u00a92017 the GSK group of companies or its licensor.n
CRG:25PIn
PHARMACISTu2011DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
-------------------------------------------------------------------------------------------------------------

PATIENT INFORMATIONn- COREG (Co-REG)
(carvedilol)
tablets
Read the Patient Information that comes with COREG 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 COREG, ask your doctor or pharmacist.n n n
COREG is a prescription medicine that belongs to a group of medicines called u201cbeta-blockersu201d. COREG is used, often with other medicines, for the following conditions:
Who should not take COREG?
Do not take COREG if you:
What should I tell my doctor before taking COREG?
Tell your doctor about all of your medical conditions, including if you:
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 COREG?
It is important for you to take your medicine every day as directed by your doctor. If you stop taking COREG suddenly, you could have chest pain and/or a heart attack. If your doctor decides that you should stop taking COREG, your doctor may slowly lower your dose over a period of time before stopping it completely.
What should I avoid while taking COREG?
What are possible side effects of COREG?
Other side effects of COREG 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 donu2019t 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 COREG?
General Information about COREG
Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use COREG for a condition for which it was not prescribed. Do not give COREG to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about COREG. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about COREG that is written for healthcare professionals.
What are the ingredients in COREG?
Active Ingredient: carvedilol.
Inactive Ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sucrose, and titanium dioxide.
Carvedilol tablets come in the following strengths: 3.125u00a0mg, 6.25u00a0mg, 12.5u00a0mg, 25u00a0mg.
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. COREG 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.
COREG is a trademark owned by or licensed to the GSK group of companies.
Manufactured for
GlaxoSmithKline
Research Triangle Park, NC 27709
u00a92017 the GSK group of companies or its licensor.n
September 2017
CRG:7PIL

PRINCIPAL DISPLAY PANEL
NDC 0007-4139-20
Arrayn- COREG
Arrayn- (carvedilol) Tablets
Arrayn- 3.125 mg
R only
Arrayn- 100 Tablets
Store below 30C (86F).
Do not accept if membrane seal under cap is missing or broken.
Dispense in a tight, light-resistant container.
Protect from moisture. Each tablet contains carvedilol, 3.125 mg.
Dosage:
Important:
Trademark is owned by or licensed to the GSK group of companies.
Manufactured for GlaxoSmithKline
Research Triangle Park, NC 27709
Made in India
u00a92017 GSK or licensor.

PRINCIPAL DISPLAY PANEL
NDC 0007-4140-20
Arrayn- COREG
Arrayn- (carvedilol) Tablets
Arrayn- 6.25 mg
R only
Arrayn- 100 TILTAB Tablets
Store below 30C (86F).
Do not accept if membrane seal under cap is missing or broken.
Dispense in a tight, light-resistant container.
Protect from moisture. Each TILTABtablet contains carvedilol, 6.25 mg.
Dosage:
Important:
Trademarks are owned by or licensed to the GSK group of companies.
Manufactured for GlaxoSmithKline
Research Triangle Park, NC 27709
Made in India
u00a92017 GSK or licensor.

PRINCIPAL DISPLAY PANEL
NDC 0007-4141-20
Arrayn- COREG
Arrayn- (carvedilol) Tablets
Arrayn- 12.5 mg
R only
Arrayn- 100 TILTAB Tablets
Store below 30C (86F).
Do not accept if membrane seal under cap is missing or broken.
Dispense in a tight, light-resistant container.
Protect from moisture. Each TILTABtablet contains carvedilol, 12.5 mg.
Dosage:
Important:
Trademarks are owned by or licensed to the GSK group of companies.
Manufactured for GlaxoSmithKline
Research Triangle Park, NC 27709
Made in India
u00a92017 GSK or licensor.

PRINCIPAL DISPLAY PANEL
NDC 0007-4142-20
Arrayn- COREG
Arrayn- (carvedilol) Tablets
Arrayn- 25 mg
R only
Arrayn- 100 TILTAB Tablets
Store below 30C (86F).
Do not accept if membrane seal under cap is missing or broken.
Dispense in a tight, light-resistant container.
Protect from moisture. Each TILTABtablet contains carvedilol, 25 mg.
Dosage:
Important:
Trademarks are owned by or licensed to the GSK group of companies.
Manufactured for GlaxoSmithKline
Research Triangle Park, NC 27709
Made in India
u00a92017 GSK or licensor.

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Carvedilol (Coreg)

Trade Name : COREG

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Carvedilol (Coreg)

Trade Name : COREG

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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CONTACT US

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