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DIGITEK

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Overview

What is DIGITEK?

DIGITEK (digoxin) is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of . The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”).

Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribohexopyranosyl) oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is CHO, its molecular weight is 780.95, and its structural formula is:

Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine.

DIGITEK (digoxin tablets, USP) is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin, USP and the following inactive ingredients: corn starch, croscarmellose sodium, lactose anhydrous, lactose hydrous impalpable, microcrystalline cellulose, pregelatinized starch (corn), silicon dioxide and stearic acid. In addition, the 125 mcg (0.125 mg) tablet contains D&C Yellow No. 10 Aluminum Lake.



What does DIGITEK look like?



What are the available doses of DIGITEK?

Tablets:

3

What should I talk to my health care provider before I take DIGITEK?

How should I use DIGITEK?

DIGITEK (digoxin tablets) is indicated for the treatment of mild to moderate heart failure in adults. DIGITEK (digoxin tablets) increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, DIGITEK (digoxin tablets) should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor.

In selecting a DIGITEK (digoxin tablets) dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only slightly higher than therapeutic levels. Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired initiated with maintenance dosing without a loading dose.

Consider interruption or reduction in digoxin dose prior to electrical cardioversion

Use digoxin solution to obtain the appropriate dose in infants, young pediatric patients, or patients with very low body weight.


What interacts with DIGITEK?

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What are the warnings of DIGITEK?

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What are the precautions of DIGITEK?

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What are the side effects of DIGITEK?

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What should I look out for while using DIGITEK?

DIGITEK (digoxin tablets) is contraindicated in patients with:


What might happen if I take too much DIGITEK?


How should I store and handle DIGITEK?

Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.DIGITEK (digoxin tablets, USP) is available containing 125 mcg (0.125 mg) or 250 mcg (0.25 mg) of digoxin, USP.The 125 mcg (0.125 mg) tablets are yellow, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6155-01bottles of 100 tabletsNDC 0378-6155-10bottles of 1000 tabletsThe 250 mcg (0.25 mg) tablets are white, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6156-01bottles of 100 tabletsNDC 0378-6156-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Store in a dry place. Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.DIGITEK (digoxin tablets, USP) is available containing 125 mcg (0.125 mg) or 250 mcg (0.25 mg) of digoxin, USP.The 125 mcg (0.125 mg) tablets are yellow, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6155-01bottles of 100 tabletsNDC 0378-6155-10bottles of 1000 tabletsThe 250 mcg (0.25 mg) tablets are white, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6156-01bottles of 100 tabletsNDC 0378-6156-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Store in a dry place. Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.DIGITEK (digoxin tablets, USP) is available containing 125 mcg (0.125 mg) or 250 mcg (0.25 mg) of digoxin, USP.The 125 mcg (0.125 mg) tablets are yellow, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6155-01bottles of 100 tabletsNDC 0378-6155-10bottles of 1000 tabletsThe 250 mcg (0.25 mg) tablets are white, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6156-01bottles of 100 tabletsNDC 0378-6156-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Store in a dry place. Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.DIGITEK (digoxin tablets, USP) is available containing 125 mcg (0.125 mg) or 250 mcg (0.25 mg) of digoxin, USP.The 125 mcg (0.125 mg) tablets are yellow, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6155-01bottles of 100 tabletsNDC 0378-6155-10bottles of 1000 tabletsThe 250 mcg (0.25 mg) tablets are white, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6156-01bottles of 100 tabletsNDC 0378-6156-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Store in a dry place. Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.DIGITEK (digoxin tablets, USP) is available containing 125 mcg (0.125 mg) or 250 mcg (0.25 mg) of digoxin, USP.The 125 mcg (0.125 mg) tablets are yellow, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6155-01bottles of 100 tabletsNDC 0378-6155-10bottles of 1000 tabletsThe 250 mcg (0.25 mg) tablets are white, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6156-01bottles of 100 tabletsNDC 0378-6156-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Store in a dry place. Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.DIGITEK (digoxin tablets, USP) is available containing 125 mcg (0.125 mg) or 250 mcg (0.25 mg) of digoxin, USP.The 125 mcg (0.125 mg) tablets are yellow, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6155-01bottles of 100 tabletsNDC 0378-6155-10bottles of 1000 tabletsThe 250 mcg (0.25 mg) tablets are white, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6156-01bottles of 100 tabletsNDC 0378-6156-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Store in a dry place. Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.DIGITEK (digoxin tablets, USP) is available containing 125 mcg (0.125 mg) or 250 mcg (0.25 mg) of digoxin, USP.The 125 mcg (0.125 mg) tablets are yellow, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6155-01bottles of 100 tabletsNDC 0378-6155-10bottles of 1000 tabletsThe 250 mcg (0.25 mg) tablets are white, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6156-01bottles of 100 tabletsNDC 0378-6156-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Store in a dry place. Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.DIGITEK (digoxin tablets, USP) is available containing 125 mcg (0.125 mg) or 250 mcg (0.25 mg) of digoxin, USP.The 125 mcg (0.125 mg) tablets are yellow, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6155-01bottles of 100 tabletsNDC 0378-6155-10bottles of 1000 tabletsThe 250 mcg (0.25 mg) tablets are white, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6156-01bottles of 100 tabletsNDC 0378-6156-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Store in a dry place. Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.DIGITEK (digoxin tablets, USP) is available containing 125 mcg (0.125 mg) or 250 mcg (0.25 mg) of digoxin, USP.The 125 mcg (0.125 mg) tablets are yellow, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6155-01bottles of 100 tabletsNDC 0378-6155-10bottles of 1000 tabletsThe 250 mcg (0.25 mg) tablets are white, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6156-01bottles of 100 tabletsNDC 0378-6156-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Store in a dry place. Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.DIGITEK (digoxin tablets, USP) is available containing 125 mcg (0.125 mg) or 250 mcg (0.25 mg) of digoxin, USP.The 125 mcg (0.125 mg) tablets are yellow, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6155-01bottles of 100 tabletsNDC 0378-6155-10bottles of 1000 tabletsThe 250 mcg (0.25 mg) tablets are white, round, scored, slope-faced tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6156-01bottles of 100 tabletsNDC 0378-6156-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Store in a dry place. Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

All of digoxin’s actions are mediated through its effects on Na-K ATPase. This enzyme, the “sodium pump,” is responsible for maintaining the intracellular milieu throughout the body by moving sodium ions out of and potassium ions into cells. By inhibiting Na-K ATPase, digoxin

The cardiologic consequences of these direct and indirect effects are an increase in the force and velocity of myocardial systolic contraction (positive inotropic action), a slowing of the heart rate (negative chronotropic effect), decreased conduction velocity through the AV node, and a decrease in the degree of activation of the sympathetic nervous system and renin-angiotensin system (neurohormonal deactivating effect).

Non-Clinical Toxicology
DIGITEK (digoxin tablets) is contraindicated in patients with:

Drug Interactions:









Ranitidine may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability. This can result in either an increase in absorption (e.g., triazolam, midazolam, glipizide) or a decrease in absorption (e.g., ketoconazole, atazanavir, delavirdine, gefitinib). Appropriate clinical monitoring is recommended.





























Patients with Wolff-Parkinson-White syndrome who develop atrial fibrillation are at high risk of ventricular fibrillation. Treatment of these patients with digoxin leads to greater slowing of conduction in the atrioventricular node than in accessory pathways, and the risks of rapid ventricular response leading to ventricular fibrillation are thereby increased.

The following adverse reactions are included in more detail in the Warnings and Precautions section of the label:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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