Digoxin injection is contraindicated in patients with: Ventricular fibrillation [see Warnings and Precautions ( 5.1 )] Known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.
Digoxin injection is contraindicated in patients with: Ventricular fibrillation [see Warnings and Precautions ( 5.1 )] Known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.
Digoxin injection, USP: Ampules of 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per 1 mL).
Digoxin Injection, USP 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per mL) is available as follows: NDC 0781-3059-95 ampules of 2 mL in boxes of 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Discard unused portion.
NDC 71872-7325-1 Digoxin Injection, USP 500 mcg (0.5 mg)/2 mL [250 mcg (0.25 mg)/mL] Rx Only For Intravenous or Intramuscular Injection. Dilution not required. Protect from light. Discard unused portion. Sterile 1 x 2 mL Ampule
| Class | Version | Type | Effective |
|---|---|---|---|
| DIGOXIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 20d84de3-cb46-44c4-9211-63e833fa2688 | Product name | 2 | 20221214 |
| 4d74103a-bb9b-9034-fbc8-dac635e6e729 | Product name | 3 | 20221117 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 5c3aa978-6f46-c7ca-2a83-b57385976bee | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71872-7325-1 | Digoxin | 1 in 1 BAG | INJECTION, SOLUTION | 1 | 1 | |
| 71872-7325-1 | Digoxin | 2 mL in 1 AMPULE | INJECTION, SOLUTION | 2 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71872-7325 | DIGOXIN INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC] | 1 | Current NDC, 2 package rows | 20241212_28f2c2cd-e58c-aea2-e063-6394a90a73e7.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-3059-72 | ML - Milliliter | 0781-3059 | cd3c38ad-f9b0-4abc-af83-1bbde869cb1e | 1 | 2015-04-03 |
| 0781-3059-95 | ML - Milliliter | 0781-3059 | fa7386a2-12d0-4b52-a1d2-97cbe88223c1 | 1 | 2012-07-24 |
| Product NDC | Package NDC |
|---|---|
| 71872-7325 | 71872-7325-1 |
| 0781-3059 |
| Name | UNII | Kind |
|---|---|---|
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM | GR686LBA74 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| DIGOXIN | 73K4184T59 | ACTIB |
Digoxin injection, USP: Ampules of 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per 1 mL).
Digoxin injection is contraindicated in patients with: Ventricular fibrillation [see Warnings and Precautions ( 5.1 )] Known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.
The following adverse reactions are included in more detail in the Warnings and Precautions section of the label: Cardiac arrhythmias [see Warnings and Precautions ( 5.1 , 5.2 )] Digoxin Toxicity [see Warnings and Precautions ( 5.3 )]
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.
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 Digitalis lanata . The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 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-ribo -hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C 41 H 64 O 14 , its molecular weight is 780.95, and its structural formula is: Digoxin exists as clear to white odorless crystals or white, odorless crystalline powder that melts 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. Digoxin injection, USP is a sterile solution of digoxin for intravenous or intramuscular injection. Each mL contains: digoxin 0.25 mg, propylene glycol 40% (v/v), anhydrous ethanol 10% (v/v), dibasic sodium phosphate 0.3% (w/v) and anhydrous citric acid 0.08% (w/v) to adjust pH between 6.8 and 7.2, and water for injection. Dilution is not required.
Digoxin Injection, USP 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per mL) is available as follows: NDC 0781-3059-95 ampules of 2 mL in boxes of 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Discard unused portion.
Advise patients to contact their doctor or a health care professional if they experience nausea, vomiting, persistent diarrhea, confusion, weakness, or visual disturbances (including blurred vision, green-yellow color disturbances, halo effect) as these could be signs that the dose of digoxin may be too high. Advise parents or caregivers that the symptoms of having too high digoxin doses may be difficult to recognize in infants and pediatric patients. Symptoms such as weight loss, failure to thrive in infants, abdominal pain, and behavioral disturbances may be indications of digoxin toxicity. Instruct the patient to monitor and record their heart rate and blood pressure daily. Distributed by Sandoz Inc., Princeton, NJ 08540
NDC 71872-7325-1 Digoxin Injection, USP 500 mcg (0.5 mg)/2 mL [250 mcg (0.25 mg)/mL] Rx Only For Intravenous or Intramuscular Injection. Dilution not required. Protect from light. Discard unused portion. Sterile 1 x 2 mL Ampule