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Carvedilol Phosphate - Cr (Coreg)

Trade Name : COREG

GlaxoSmithKline LLC

CAPSULE, EXTENDED RELEASE

Strength 10 mg/1

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

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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 Phosphate - Cr (Coreg) which is also known as COREG and Manufactured by GlaxoSmithKline LLC. It is available in strength of 10 mg/1 per ml. Read more

Carvedilol Phosphate - Cr (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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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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About GNH

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.

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
  • COREGu00a0CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of:
  • COREGu00a0CR is an extended-release capsule intended for onceu2011daily administration. Patients controlled with immediateu2011release carvedilol tablets alone or in combination with other medications may be switched to COREGu00a0CR extendedu2011release capsules based on the total daily doses shown in .
  • COREGu00a0CR should be taken once daily in the morning with food. COREGu00a0CR should be swallowed as a whole capsule. COREGu00a0CR and/or its contents should not be crushed, chewed, or taken in divided doses.
  • Alternative Administration
  • The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified-release properties of this formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use. Absorption of the beads sprinkled on other foods has not been tested.
  • Take with food. Do not crush or chew capsules. Individualize dosage and monitor during up-titration. ()
  • The hard gelatin capsules are filled with white to off-white microparticles and are available in the following strengths:
  • Capsules: 10 mg, 20 mg, 40 mg, 80u00a0mg ()
  • COREG CR is contraindicated in the following conditions:
  • 2.4n- 4
  • In clinical trials of COREGu00a0CR in subjects with hypertension (338 subjects) and in subjects with left ventricular dysfunction following a myocardial infarction or heart failure (187u00a0subjects), the profile of adverse events observed with carvedilol phosphate was generally similar to that observed with the administration of immediateu2011release carvedilol. Therefore, the information included within this section is based on data from controlled clinical trials with COREGu00a0CR as well as immediateu2011release carvedilol.
  • 5.2n- 5.3n- 5.4
  • 4n- 5.5
  • The safety profile of COREG CR was similar to that observed for immediate-release carvedilol. Most common adverse events seen with immediate-release carvedilol ():
  • 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, u03b2u2011sympathomimetics (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.
  • There is no experience of overdosage with COREGu00a0CR. Cases of overdosage with carvedilol 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 phosphate is a nonselective u03b2u2011adrenergic blocking agent with u03b1-blocking activity. It is (2)-1-(9-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure:
  • Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of CHNOu2022HPOu20221/2 HO.
  • COREGu00a0CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80u00a0mg carvedilol phosphate. COREGu00a0CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone.
  • No data
  • In 2u2011year 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).
  • Support for the use of COREGu00a0CR extended-release capsules for the treatment of mild-to-severe heart failure and for patients with left ventricular dysfunction following myocardial infarction is based on the equivalence of pharmacokinetic and pharmacodynamic (u03b2u2011blockade) parameters between COREGu00a0CR and immediate-release carvedilol .
  • The clinical trials performed with immediate-release carvedilol in heart failure and left ventricular dysfunction following myocardial infarction are presented below.
  • The hard gelatin capsules are available in the following strengths:
  • Store at 25u00b0C (77u00b0F); excursions 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). Dispense in a tight, light-resistant container.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • COREGu00a0CR and COREG 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.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92017 GSK group of companies or its licensor.
  • CCR:19PI
  • PATIENT INFORMATION n- COREGu00a0CR (Co-REG)
  • (carvedilol phosphate)
  • Extended-release Capsules
  • Read the Patient Information that comes with COREGu00a0CR 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 COREGu00a0CR, ask your doctor or pharmacist.
  • What is the most important information I should know about COREGu00a0CR?
  • It is important for you to take your medicine every day as directed by your doctor. If you stop taking COREGu00a0CR suddenly, you could have chest pain and a heart attack. If your doctor decides that you should stop taking COREGu00a0CR, your doctor may slowly lower your dose over time before stopping it completely.n- What is COREGu00a0CR?
  • COREGu00a0CR is a prescription medicine that belongs to a group of medicines called u201cbeta-blockersu201d. COREGu00a0CR is used, often with other medicines, for the following conditions:
  • COREGu00a0CR is not approved for use in children under 18 years of age.n
  • Who should not take COREGu00a0CR?
  • Do not take COREGu00a0CR if you:
  • What should I tell my doctor before taking COREGu00a0CR?
  • Tell your doctor about all of your medical conditions, including if you:
  • Tell your doctor about all of the medicines you take
  • Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist before you start a new medicine.
  • How should I take COREGu00a0CR?
  • What should I avoid while taking COREGu00a0CR?
  • COREGu00a0CR 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.n n n
  • Serious side effects of COREG CR include:
  • Call your doctor if you have any side effects that bother you or donu2019t go away.n 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 COREGu00a0CR?
  • Store COREGu00a0CR at less than 86u00b0F (30u00b0C).
  • Safely throw away COREGu00a0CR that is out of date or no longer needed.
  • Keep COREGu00a0CR and all medicines out of the reach of children.n- General information about COREGu00a0CR
  • Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use COREGu00a0CR for a condition for which it was not prescribed. Do not give COREGu00a0CR to other people, even if they have the same symptoms you have. It may harm them.
  • This leaflet summarizes the most important information about COREGu00a0CR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about COREGu00a0CR that is written for healthcare professionals.n n n
  • Active ingredient: carvedilol phosphate
  • Inactive ingredients: crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone
  • COREGu00a0CR capsules come in the following strengths: 10u00a0mg, 20u00a0mg, 40u00a0mg, 80u00a0mg.n n n
  • 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 CR 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.
  • COREGu00a0CR and COREG are trademarks owned by or licensed to the GSK group of companies.n GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92017 the GSK group of companies or its licensorn September 2017
  • CCR:8PIL
  • PRINICIPAL DISPLAY PANEL
  • NDC 0007-3370-13
  • COREG CRn
  • (carvedilol phosphate)
  • Extended-release Capsules
  • 10 mg
  • ONCE-A-DAY DOSING
  • 30 Capsules
  • R only
  • www.CoregCR.com
  • Call 1-888-825-5249
  • Each extended-release capsule contains 10 mg of carvedilol phosphate. Store at 25C (77F) [see USP].
  • Do not accept if membrane seal under cap is missing or broken.
  • Dosage
  • Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional help or contact a poison control center immediately.
  • GlaxoSmithKline, RTP, NC 27709
  • Made in Canada
  • 10000000143784
  • PRINICIPAL DISPLAY PANEL
  • NDC 0007-3371-13
  • COREG CRn
  • (carvedilol phosphate)
  • Extended-release Capsules
  • 20 mg
  • ONCE-A-DAY DOSING
  • 30 Capsules
  • R only
  • www.CoregCR.com
  • Call 1-888-825-5249
  • Each extended-release capsule contains 20 mg of carvedilol phosphate. Store at 25C (77F) [see USP].
  • Do not accept if membrane seal under cap is missing or broken.
  • Dosage
  • Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional help or contact a poison control center immediately.
  • GlaxoSmithKline, RTP, NC 27709
  • Made in Canada
  • 10000000144411
  • PRINICIPAL DISPLAY PANEL
  • NDC 0007-3372-13
  • COREG CRn
  • (carvedilol phosphate)
  • Extended-release Capsules
  • 40 mg
  • ONCE-A-DAY DOSING
  • 30 Capsules
  • R only
  • www.CoregCR.com
  • Call 1-888-825-5249
  • Each extended-release capsule contains 40 mg of carvedilol phosphate. Store at 25C (77F) [see USP].
  • Do not accept if membrane seal under cap is missing or broken.
  • Dosage
  • Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional help or contact a poison control center immediately.
  • GlaxoSmithKline, RTP, NC 27709
  • Made in Canada
  • 10000000143783
  • PRINICIPAL DISPLAY PANEL
  • NDC 0007-3373-13
  • COREG CRn
  • (carvedilol phosphate)
  • Extended-release Capsules
  • 80 mg
  • ONCE-A-DAY DOSING
  • 30 Capsules
  • R only
  • www.CoregCR.com
  • Call 1-888-825-5249
  • Each extended-release capsule contains 80 mg of carvedilol phosphate. Store at 25C (77F) [see USP].
  • Do not accept if membrane seal under cap is missing or broken.
  • Dosage
  • Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional help or contact a poison control center immediately.
  • GlaxoSmithKline, RTP, NC 27709
  • Made in Canada
  • 10000000143785
  • PRINICIPAL DISPLAY PANEL
  • NDC 0007-3383-13
  • COREG CR
  • (carvedilol phosphate)
  • Extended-release Capsules
  • 10 mg
  • ONCE-A-DAY DOSING
  • 30 Capsules
  • R only
  • www.CoregCR.com
  • Call 1-888-825-5249
  • Each extended-release capsule contains 10 mg of carvedilol phosphate. Store at 25C (77F) [see USP].
  • Do not accept if membrane seal under cap is missing or broken.
  • Dosage
  • Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional help or contact a poison control center immediately.
  • GlaxoSmithKline, RTP, NC 27709
  • Made in Canada
  • 62000000042454
  • PRINICIPAL DISPLAY PANEL
  • NDC 0007-3385-13
  • COREG CR
  • (carvedilol phosphate)
  • Extended-release Capsules
  • 20 mg
  • ONCE-A-DAY DOSING
  • 30 Capsules
  • R only
  • www.CoregCR.com
  • Call 1-888-825-5249
  • Each extended-release capsule contains 20 mg of carvedilol phosphate. Store at 25C (77F) [see USP].
  • Do not accept if membrane seal under cap is missing or broken.
  • Dosage
  • Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional help or contact a poison control center immediately.
  • GlaxoSmithKline, RTP, NC 27709
  • Made in Canada
  • 62000000042455
  • PRINICIPAL DISPLAY PANEL
  • NDC 0007-3387-13
  • COREG CR
  • (carvedilol phosphate)
  • Extended-release Capsules
  • 40 mg
  • ONCE-A-DAY DOSING
  • 30 Capsules
  • R only
  • www.CoregCR.com
  • Call 1-888-825-5249
  • Each extended-release capsule contains 40 mg of carvedilol phosphate. Store at 25C (77F) [see USP].
  • Do not accept if membrane seal under cap is missing or broken.
  • Dosage
  • Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional help or contact a poison control center immediately.
  • GlaxoSmithKline, RTP, NC 27709
  • Made in Canada
  • 62000000042456
  • PRINICIPAL DISPLAY PANEL
  • NDC 0007-3388-13
  • COREG CR
  • (carvedilol phosphate)
  • Extended-release Capsules
  • 80 mg
  • ONCE-A-DAY DOSING
  • 30 Capsules
  • R only
  • www.CoregCR.com
  • Call 1-888-825-5249
  • Each extended-release capsule contains 80 mg of carvedilol phosphate. Store at 25C (77F) [see USP].
  • Do not accept if membrane seal under cap is missing or broken.
  • Dosage
  • Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional help or contact a poison control center immediately.
  • GlaxoSmithKline, RTP, NC 27709
  • Made in Canada
  • 62000000042458

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