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Digoxin (Digoxin)

Trade Name : DIGOXIN

NuCare Pharmaceuticals, Inc.

TABLET

Strength 0.25 mg/1

DIGOXIN Cardiac Glycoside [EPC],Cardiac Glycosides [CS]

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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 Digoxin (Digoxin) which is also known as DIGOXIN and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 0.25 mg/1 per ml. Read more

Digoxin (Digoxin) 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

Validated Cold Chain Shipment

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
  • DIGOXIN is a cardiac glycoside indicated for:
  • n Treatment of mild to moderate heart failure in adults. (n n n )n n n
  • n Increasing myocardial contractility in pediatric patients with heart failure. (n n n )n n n
  • n Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (n n n )n n n
  • DIGOXIN dose is based on patient-specific factors (age, lean body weight, renal function, etc.). See full prescribing information. Monitor for toxicity and therapeutic effect. (n n n ) n nn
  • Scored Tablets: 125 mcg are yellow, round, scored tablets with u201cY3Bu201d imprinted on one side.n n n Scored Tablets: 250 mcg are white, round, scored tablets with u201cX3Au201d imprinted on one side.n nn
  • Scored Tablets 125 and 250 mcg (n n n )n nn
  • DIGOXIN is contraindicated in patients with:
  • n Ventricular fibrillation. (n n n )n n n
  • n Known hypersensitivity to digoxin or other forms of digitalis. (n n n )n n n
  • No data
  • n Risk of rapid ventricular response leading to ventricular fibrillation in patients with AV accessory pathway. (n n n )n n n
  • n Risk of advanced or complete heart block in patients with sinus node disease and AV block. (n n n )n n n
  • n Digoxin toxicity: Indicated by nausea, vomiting, visual disturbances, and cardiac arrhythmias. Advanced age, low body weight, impaired renal function and electrolyte abnormalities predispose to toxicity. (n n n )n n n
  • n Risk of ventricular arrhythmias during electrical cardioversion. (n n n )n n n
  • n Not recommended in patients with acute myocardial infarction. (n n n )n n n
  • n Avoid DIGOXIN in patients with myocarditis. (n n n )n n n
  • The following adverse reactions are included in more detail in the Warnings and Precautions section of the label:
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
  • In general, the adverse reactions of DIGOXIN are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect. Hence, adverse reactions are less common when DIGOXIN is used within the recommended dose range, is maintained within the therapeutic serum concentration range, and when there is careful attention to concurrent medications and conditions.
  • In the DIG trial (a trial investigating the effect of digoxin on mortality and morbidity in patients with heart failure), the incidence of hospitalization for suspected digoxin toxicity was 2% in patients taking DIGOXIN compared to 0.9% in patients taking placebo n n n . n nn
  • The overall incidence of adverse reactions with digoxin has been reported as 5-20%, with 15-20% of adverse events considered serious. Cardiac toxicity accounts for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse events.
  • Gastrointestinal:
  • CNS:
  • Other:
  • The overall incidence of adverse reactions with digoxin has been reported as 5-20%, with 15-20% of adverse events considered serious. Cardiac toxicity accounts for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse events. (n n n ) n n n n
  • To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or n n n .n n n
  • Digoxin has a narrow therapeutic index, increased monitoring of serum digoxin concentrations and for potential signs and symptoms of clinical toxicity is necessary when initiating, adjusting, or discontinuing drugs that may interact with digoxin. Prescribers should consult the prescribing information of any drug which is co-prescribed with digoxin for potential drug interaction information.
  • ntttttttttttttttttttttPGP Inducers/Inhibitors: Drugs that induce or inhibit PGP have the potential to alter digoxin pharmacokinetics. (n n n )n n n
  • The potential for drug-drug interactions must be considered prior to and during drug therapy. See full prescribing information. (n n n , n n n , n n n )n n n
  • No data
  • n Pregnant patients: It is unknown whether use during pregnancy can cause fetal harm. (n n n )n n n
  • n Pediatric patients: Newborn infants display variability in tolerance to DIGOXIN. (n n n )n n n
  • n Geriatric patients: Consider renal function in dosage selection, and carefully monitor for side effects. (n n n )n n n
  • n Renal impairment: DIGOXIN is excreted by the kidneys. Consider renal function during dosage selection. (n n n )n n n
  • No data
  • DIGOXIN (digoxin) is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium.u00a0 These drugs are found in a number of plants. Digoxin is extracted from the leaves of n n n . The term u201cdigitalisu201d is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence u201cglycosidesu201d).n nn
  • Digoxin is described chemically as (3u03b2,5u03b2,12u03b2)-3-[(n n n -2,6-dideoxy-u03b2-n n n -hexopyranosyl-(1u21924)-n n n -2,6-dideoxy-u03b2-n n n hexopyranosyl-(1u21924)-2,6-dideoxy-u03b2-n n n -n n n -hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is Cn n n Hn n n On n n , its molecular weight is 780.95, and its structural formula is:n nn
  • Digoxin exists as odorless white crystals that melt with decomposition above 230u00b0C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine.
  • DIGOXIN is supplied as 125 mcg (scored) and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn and potato starches, lactose and magnesium stearate. The 125 mcg tablets contain D&C Yellow No. 10 and FD&C Yellow No.u00a06.
  • No data
  • Digoxin showed no genotoxic potential in n n n studies (Ames test and mouse lymphoma). No data are available on the carcinogenic potential of digoxin, nor have studies been conducted to assess its potential to affect fertility.n nn
  • No data
  • DIGOXIN Tablets have u201cLANOXINu201d on one side and are supplied as follows:
  • Round white scored tablet Imprint X3A on the scored side,
  • Bottles of 30: NDC 66267-078-30
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15 to 30u00b0C (59 to 86u00b0F) [See USP controlled Room Temperature] in a dry place and protect from light. Keep out of reach of children. Dispense in tight, light-resistant container.
  • No data
  • Distributed Byn n n Par Pharmaceuticaln n n Chestnut Ridge, NY 10977n nn
  • Manufactured by Patheon Manufacturing Services LLC.n n n Greenville, NC 27834n nn
  • 0S514-01-89-02n n n 015978n nn
  • No data

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Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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