What is Digitek?
Digitek is derived from the leaves of a digitalis plant. Digitek helps make the heart beat stronger and with a more regular rhythm.
Digitek is used to treat heart failure.
Digitek is also used to treat atrial fibrillation, a heart rhythm disorder of the atria (the upper chambers of the heart that allow blood to flow into the heart).
Digitek may also be used for purposes not listed in this medication guide.
Digitek indications
Heart Failure in Adults
Digitek® (Digitek tablets) is indicated for the treatment of mild to moderate heart failure in adults. Digitek® (Digitek 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® (Digitek tablets) should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor.
Heart Failure in Pediatric Patients
Digitek® (Digitek tablets) increases myocardial contractility in pediatric patients with heart failure.
Atrial Fibrillation in Adults
Digitek® (Digitek tablets) is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.
How should I use Digitek?
Use Digitek solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Digitek solution by mouth. Do not take it within 30 to 60 minutes of food high in fiber.
- If you take an antacid, cholestyramine, or colestipol, ask your doctor or pharmacist how to take it with Digitek solution.
- Use the dropper that comes with Digitek solution to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
- If you miss a dose of Digitek solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Digitek solution.
Uses of Digitek in details
Digitek is used to treat heart failure, usually along with other medications. It is also used to treat a certain type of irregular heartbeat (chronic atrial fibrillation). Treating heart failure may help maintain your ability to walk and exercise and may improve the strength of your heart. Treating an irregular heartbeat can decrease the risk for blood clots, an effect that may reduce your risk for a heart attack or stroke.
Digitek belongs to a class of medications called cardiac glycosides. It works by affecting certain minerals (sodium and potassium) inside heart cells. This reduces strain on the heart and helps it maintain a normal, steady, and strong heartbeat.
How to use Digitek
Take this medication by mouth with or without food, usually once daily or as directed by your doctor. If you are using the liquid form of this medication, carefully measure the dose using the dropper provided by the manufacturer. Do not use a household spoon because you may not get the correct dose.
Your body may not absorb this drug as well if you also eat foods that are high in fiber or if you take certain medications. Therefore, take this medication at least 2 hours before or after eating food products that are high in fiber (such as bran). If you are also taking cholestyramine, colestipol, or psyllium, wait at least 2 hours after taking your Digitek dose before taking any of these products. If you are taking antacids, kaolin-pectin, milk of magnesia, metoclopramide, sulfasalazine, or aminosalicylic acid, take them as far apart from your Digitek dose as possible. Ask your pharmacist if you are not sure when to take any of your medications.
The dosage of this medication is based on your medical condition, age, body weight, laboratory tests, and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped.
Tell your doctor if your condition does not improve or if it worsens.
Digitek description
A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone digoxigenin. Digitek Pediatric has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in atrial fibrillation and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)
Digitek dosage
Important Dosing and Administration Information
In selecting a Digitek dosing regimen, it is important to consider factors that affect Digitek blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of Digitek 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 or initiated with maintenance dosing without a loading dose.
Parenteral administration of Digitek should be used only when the need for rapid digitalization is urgent or when the drug cannot be taken orally.
Intramuscular injection can lead to severe pain at the injection site, thus intravenous administration is preferred. If the drug must be administered by the intramuscular route, it should be injected deep into the muscle followed by massage. For adults, no more than 500 mcg of Digitek Injection should be injected into a single site. For pediatric patients, no more than 200 mcg of Digitek Injection Pediatric should be injected into a single site.
Administer the dose over a period of 5 minutes or longer and avoid bolus administration to prevent systemic and coronary vasoconstriction. Mixing of Digitek Injection and Injection Pediatric with other drugs in the same container or simultaneous administration in the same intravenous line is not recommended.
Digitek Injection and Injection Pediatric can be administered undiluted or diluted with a 4-fold or greater volume of Sterile Water for Injection, 0.9% Sodium Chloride Injection, or 5% Dextrose Injection. The use of less than a 4-fold volume of diluent could lead to precipitation of the Digitek. Immediate use of the diluted product is recommended.
If tuberculin syringes are used to measure very small doses do not flush with the parenteral solution after its contents are expelled into an indwelling vascular catheter to avoid overadministration of Digitek.
Consider interruption or reduction in Digitek dose prior to electrical cardioversion.
Loading Dosing Regimen in Adults and Pediatric Patients
Table 1: Recommended Digitek Injection Loading Dose
| Age | Total IV Loading Dose (mcg/kg) Administer half the total loading dose initially, then 1/4 the loading dose every 6-8 hours twice |
| Premature | 15-25 |
| Full-Term | 20-30 |
| 1-24 Months | 30-50 |
| 2-5 Years | 25-35 |
| 5-10 Years | 15-30 |
| Adults and pediatric patients over 10 years | 8-12 |
| mcg = microgram |
Maintenance Dosing in Adults and Pediatric Patients Over 10 Years Old
The maintenance dose is based on lean body weight, renal function, age, and concomitant products.
The recommended starting maintenance doses in adults and pediatric patients over 10 years old with normal renal function are given in Table 2. Doses may be increased every 2 weeks according to clinical response, serum drug levels, and toxicity.
Table 2: Recommended Starting Digitek Injection Maintenance Dosage in Adults and Pediatric Patients Over 10 Years Old
| Age | TotalIntravenous Maintenance Dose, mcg/kg/day (given once daily) |
| Adults and pediatric patients over 10 years | 2.4-3.6 |
| mcg = microgram |
Table 3 provides the recommended (once daily) maintenance dose for adults and pediatric patients over 10 years old (to be given once daily) according to lean body weight and renal function. The doses are based on studies in adult patients with heart failure. Alternatively, the maintenance dose may be estimated by the following formula (peak body stores lost each day through elimination):
Total Maintenance Dose = Loading Dose (i.e., Peak Body Stores) x % Daily Loss/100 (% Daily Loss = 14 + Creatinine clearance/5)
Reduce the dose of Digitek in patients whose lean weight is an abnormally small fraction of their total body mass because of obesity or edema.
Table 3: Recommended Maintenance Dose (in micrograms given once daily) of Digitek Injection in Pediatric Patients Over 10 Years Old and Adults by Lean Body Weight and by Renal Function
| Corrected Creatinine Clearance If no loading dose administered. |
Monitoring to Assess Safety, Efficacy, and Therapeutic Blood Levels
Monitor for signs and symptoms of Digitek toxicity and clinical response. Adjust dose based on toxicity, efficacy, and blood levels.
Serum Digitek levels less than 0.5 ng/mL have been associated with diminished efficacy, while levels above 2 ng/mL have been associated with increased toxicity without increased benefit.
Interpret the serum Digitek concentration in the overall clinical context, and do not use an isolated measurement of serum Digitek concentration as the basis for increasing or decreasing the Digitek dose. Serum Digitek concentrations may be falsely elevated by endogenous Digitek-like substances. If the assay is sensitive to these substances, consider obtaining a baseline Digitek level before starting Digitek and correct post-treatment values by the reported baseline level.
Obtain serum Digitek concentrations just before the next scheduled Digitek dose or at least 6 hours after the last dose. The Digitek concentration is likely to be 10-25% lower when sampled right before the next dose (24 hours after dosing) compared to sampling 8 hours after dosing (using once-daily dosing). However, there will be only minor differences in Digitek concentrations using twice daily dosing whether sampling is done at 8 or 12 hours after a dose.
Switching from
Intravenous Digitek to
Oral Digitek
When switching from intravenous to oral Digitek formulations, make allowances for differences in bioavailability when calculating maintenance dosages.
Table 6: Comparison of the Systemic Availability and Equivalent Doses of
Oral and
Intravenous Digitek
| Absolute Bioavailability | Equivalent Doses (mcg) | ||||
| Digitek Tablets | 60-80% | 62.5 | 125 | 250 | 500 |
DigitekIntravenous Injection | 100% | 50 | 100 | 200 | 400 |
How supplied
Dosage Forms And Strengths
Digitek Injection: Ampules of 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per 1 mL).
Digitek Injection Pediatric: Ampules of 100 mcg (0.1 mg) in 1 mL.
Storage And Handling
Digitek (Digitek) Injection, 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per mL); box of 10 ampules (NDC 24987 260 10)
Digitek (Digitek) Injection Pediatric, 100 mcg (0.1 mg) in 1 mL; box of 10 ampules (NDC 24987 262 10)
Store at 25 °C (77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) and protect from light.
Digitek Injection manufactured by Jubilant Hollister. Kirkland, Canada H9H 4J4. Digitek Injection Pediatric manufactured by DSM Pharmaceuticals, Inc. Greenville, NC 27834. Distributed by Covis Pharmaceuticals, Inc. Cary, NC 27511
Digitek interactions
See also:
What other drugs will affect Digitek?
These may arise from effects on the renal excretion, tissue-binding, plasma protein-binding, distribution within the body, gut absorptive capacity and sensitivity to Digitek. Consideration of the possibility of an interaction whenever concomitant therapy is contemplated is the best precaution and a check on serum Digitek concentration is recommended when any doubt exists.
Digitek, in association with β-adrenergic blocking drugs, may increase AV conduction time.
Agents causing hypokalemia or intracellular potassium deficiency may cause increased sensitivity to Digitek; they include some diuretics, lithium salts, corticosteroids and carbenoxolone.
Patients receiving Digitek are more susceptible to the effects of suxamethonium-exacerbated hyperkalemia.
Calcium, particularly if administered rapidly by the IV route, may produce severe arrhythmias in digitalized patients.
Serum levels of Digitek may be increased by concomitant administration of amiodarone, flecainide, prazosin, propafenone, quinidine, spironolactone, macrolide antibiotics eg, erythromycin and clarithromycin, tetracycline (and possibly other antibiotics), gentamicin, itraconazole, quinine, trimethoprim, alprazolam, indomethacin, propantheline, nefazodone, atorvastatin, cyclosporine, epoprostenol (transient) and carvedilol.
Serum levels of Digitek may be reduced by concomitant administration of antacids, some bulk laxatives, kaolin-pectin, acarbose, neomycin, penicillamine, rifampicin, some cytostatics, metoclopramide, sulfasalazine, adrenaline, salbutamol, cholestyramine, phenytoin, St. John's wort (Hypericum perforatum).
Calcium channel blocking agents may either increase or cause no change in serum Digitek levels. Verapamil, felodipine and tiapamil increase serum Digitek levels. Nifedipine and diltiazem may increase or have no effect on serum Digitek levels while isradipine causes no change. Angiotensin-converting enzyme inhibitors may also increase or cause no change in serum Digitek levels.
Milrinone does not alter steady-state serum Digitek levels.
Digitek is a substrate of P-gp. Thus, inhibitors of P-gp may increase blood concentrations of Digitek by enhancing its absorption and/or by reducing its renal clearance.
Digitek side effects
See also:
What are the possible side effects of Digitek?
The following adverse reactions are included in more detail in the Warnings and Precautions section of the label:
- Cardiac arrhythmias
- Digitek Toxicity
Clinical Trials Experience
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 Digitek Tablets are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect. Hence, adverse reactions are less common when Digitek Tablets are used within the recommended dose range, are 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 Digitek on mortality and morbidity in patients with heart failure), the incidence of hospitalization for suspected Digitek toxicity was 2% in patients taking Digitek Tablets compared to 0.9% in patients taking placebo.
The overall incidence of adverse reactions with Digitek has been reported as 5 to 20%, with 15 to 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: In addition to nausea and vomiting, the use of Digitek has been associated with abdominal pain, intestinal ischemia, and hemorrhagic necrosis of the intestines.
CNS: Digitek can cause headache, weakness, dizziness, apathy, confusion, and mental disturbances (such as anxiety, depression, delirium, and hallucination).
Other: Gynecomastia has been occasionally observed following the prolonged use of Digitek. Thrombocytopenia and maculopapular rash and other skin reactions have been rarely observed.
Digitek contraindications
See also:
What is the most important information I should know about Digitek?
You should not use this medication if you are allergic to Digitek, or if you have ventricular fibrillation (a heart rhythm disorder of the ventricles, or lower chambers of the heart that allow blood to flow out of the heart).
Before using Digitek, tell your doctor if you have certain heart conditions, especially "AV block" (unless you have a pacemaker), or a recent history of heart attack. Also tell your doctor if you have kidney disease, a thyroid disorder, an electrolyte imbalance (such as low levels of calcium, potassium, or magnesium in your blood), or if you are malnourished or have recently been sick with vomiting or diarrhea.
Keep taking Digitek as directed, even if you feel well. Get your prescription refilled before you run out of medicine completely.
Do not stop taking Digitek without first talking to your doctor. Stopping suddenly may make your condition worse.
Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Digitek overdose can occur more easily if you are dehydrated.
There are many other drugs that can interact with Digitek. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
Active ingredient matches for Digitek:
| Unit description / dosage (Manufacturer) | Price, USD |
| Tablet; Oral; Digoxin 0.125 mg | |
| Tablet; Oral; Digoxin 0.25 mg | |
| Digitek tablet .125 mg/1 (Mylan Pharmaceuticals Inc. (US)) | |
| Digitek tablet .25 mg/1 (Mylan Pharmaceuticals Inc. (US)) | |
List of Digitek substitutes (brand and generic names): | |
| Digitax (Brazil) | |
| Digitekt | |
| DIGITRAN (India) | |
| 0.25 mg x 10's (Macleods Pharmaceuticals Pvt Ltd.) | $ 0.07 |
| Digitran 0.25mg TAB / 10 (Macleods Pharmaceuticals Pvt Ltd.) | $ 0.07 |
| Digitran 0.25 mg Tablet (Macleods Pharmaceuticals Pvt Ltd.) | $ 0.01 |
| DIGITRAN TABLET 1 strip / 10 tablets each (Macleods Pharmaceuticals Pvt Ltd.) | $ 0.07 |
| DIGITRAN tab 0.25 mg x 10's (Macleods Pharmaceuticals Pvt Ltd.) | $ 0.07 |
| Digitran 0.25mg TAB / 10 (Macleods Pharmaceuticals Pvt Ltd.) | $ 0.07 |
| Digitran 0.25mg Tablet (Macleods Pharmaceuticals Pvt Ltd.) | $ 0.01 |
| DIGITRAN - 250 | |
| DIGITRAN - 250 Capsule/ Tablet / 0.25mg / 10 units (Macleods Pharmaceuticals) | $ 0.07 |
| Digixina (Brazil) | |
| Digobal (Brazil) | |
| Digocard | |
| Digocard 0.25 mg Injection (Neon Laboratories Ltd) | $ 0.06 |
| Digocard 0.5 mg Injection (Neon Laboratories Ltd) | $ 0.05 |
| Digocard-G (Argentina, Peru) | |
| Digohan (Japan) | |
| Digoksino (Lithuania) | |
| Digoksino 0.25 mg Sanitas (Lithuania) | |
| Digoksino Sanitas (Lithuania) | |
| Digomal (Italy) | |
| Digon (India) | |
| Digon 0.25 mg Tablet (Tas Med (I) Pvt. Ltd.) | $ 0.01 |
| DIGON TABLET 1 strip / 10 tablets each (Tas Med (I) Pvt. Ltd.) | $ 0.17 |
| DIGON tab 0.25 mg x 10's (Tas Med (I) Pvt. Ltd.) | $ 0.16 |
| Digon 0.25mg Tablet (Tas Med (I) Pvt. Ltd.) | $ 0.02 |
| Digonix | |
| Digoregen (Germany) | |
| Tablet; Oral; Digoxin 0.025 mg (Ran) | |
| Digos | |
| Digosin (Japan, South Korea) | |
| Digosin 0.1% (Japan) | |
| Digossina Biologici (Italy) | |
| Digossina Salf (Italy) | |
| DIGOSYP (India) | |
| DIGOSYP Liquid / 0.05mg per ml / 30ml units (Le Sante (Cadila Pharmaceuticals Ltd.)) | $ 0.27 |
| 30ml (Le Sante (Cadila Pharmaceuticals Ltd.)) | $ 0.27 |
| Digosyp Digoxin 0.05 mg, ethanol 95%0.053 mL/1 mL. LIQD / 30ml (Le Sante (Cadila Pharmaceuticals Ltd.)) | $ 0.27 |
| Digosyp 30 ml Syrup (Le Sante (Cadila Pharmaceuticals Ltd.)) | $ 0.01 |
| DIGOSYP oral liqd 30ml (Le Sante (Cadila Pharmaceuticals Ltd.)) | $ 0.27 |
| Digosyp Digoxin 0.05 mg, ethanol 95%0.053 mL/1 mL. LIQD / 30ml (Le Sante (Cadila Pharmaceuticals Ltd.)) | $ 0.27 |
| Digox | |
| Tablet; Oral; Beta-Acetyldigoxin 0.1 mg (Cadila Pharmaceuticals Ltd.) | |
| Tablet; Oral; Beta-Acetyldigoxin 0.2 mg (Cadila Pharmaceuticals Ltd.) | |
| DIGOX Capsule/ Tablet / 0.25mg / 10 units (Cadila Pharmaceuticals Ltd.) | $ 0.02 |
| Digox 0.25mg TAB / 10 (Cadila Pharmaceuticals Ltd.) | $ 0.02 |
| 0.25 mg x 10's (Cadila Pharmaceuticals Ltd.) | $ 0.02 |
See 468 substitutes for Digitek | |
References
- DailyMed. "DIGOXIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "digoxin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "digoxin". http://www.drugbank.ca/drugs/DB00390 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Digitek are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Digitek. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
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Information checked by Dr. Sachin Kumar, MD Pharmacology
