Digicap Uses

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What is Digicap?

Digicap is derived from the leaves of a digitalis plant. Digicap helps make the heart beat stronger and with a more regular rhythm.

Digicap is used to treat heart failure.

Digicap 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).

Digicap may also be used for purposes not listed in this medication guide.

Digicap indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Heart Failure in Adults

Digicap® (Digicap tablets) is indicated for the treatment of mild to moderate heart failure in adults. Digicap® (Digicap 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, Digicap® (Digicap tablets) should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor.

Heart Failure in Pediatric Patients

Digicap® (Digicap tablets) increases myocardial contractility in pediatric patients with heart failure.

Atrial Fibrillation in Adults

Digicap® (Digicap tablets) is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.

How should I use Digicap?

Use Digicap solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Digicap solution.

Uses of Digicap in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Digicap 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.

Digicap 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 Digicap

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 Digicap 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 Digicap 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.

Digicap description

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A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone digoxigenin. Digicap 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)

Digicap dosage

Important Dosing and Administration Information

In selecting a Digicap dosing regimen, it is important to consider factors that affect Digicap blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of Digicap 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 Digicap 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 Digicap Injection should be injected into a single site. For pediatric patients, no more than 200 mcg of Digicap 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 Digicap Injection and Injection Pediatric with other drugs in the same container or simultaneous administration in the same intravenous line is not recommended.

Digicap 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 Digicap. 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 Digicap.

Consider interruption or reduction in Digicap dose prior to electrical cardioversion.

Loading Dosing Regimen in Adults and Pediatric Patients

Table 1: Recommended Digicap 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 Digicap Injection Maintenance Dosage in Adults and Pediatric Patients Over 10 Years Old

Age Total

Intravenous 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 Digicap 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 Digicap 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 Digicap toxicity and clinical response. Adjust dose based on toxicity, efficacy, and blood levels.

Serum Digicap 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 Digicap concentration in the overall clinical context, and do not use an isolated measurement of serum Digicap concentration as the basis for increasing or decreasing the Digicap dose. Serum Digicap concentrations may be falsely elevated by endogenous Digicap-like substances. If the assay is sensitive to these substances, consider obtaining a baseline Digicap level before starting Digicap and correct post-treatment values by the reported baseline level.

Obtain serum Digicap concentrations just before the next scheduled Digicap dose or at least 6 hours after the last dose. The Digicap 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 Digicap concentrations using twice daily dosing whether sampling is done at 8 or 12 hours after a dose.

Switching from

Intravenous Digicap to

Oral Digicap

When switching from intravenous to oral Digicap 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 Digicap

Absolute Bioavailability Equivalent Doses (mcg)
Digicap Tablets 60-80% 62.5 125 250 500
Digicap

Intravenous Injection

100% 50 100 200 400

How supplied

Dosage Forms And Strengths

Digicap Injection: Ampules of 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per 1 mL).

Digicap Injection Pediatric: Ampules of 100 mcg (0.1 mg) in 1 mL.

Storage And Handling

Digicap (Digicap) Injection, 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per mL); box of 10 ampules (NDC 24987 260 10)

Digicap (Digicap) 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.

Digicap Injection manufactured by Jubilant Hollister. Kirkland, Canada H9H 4J4. Digicap Injection Pediatric manufactured by DSM Pharmaceuticals, Inc. Greenville, NC 27834. Distributed by Covis Pharmaceuticals, Inc. Cary, NC 27511

Digicap interactions

See also:
What other drugs will affect Digicap?

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Potassium-depleting diuretics are a major contributing factor to digitalis toxicity. Calcium, particularly if administered rapidly by the intravenous route, may produce serious arrhythmias in digitalized patients. Quinidine, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, and spironolactone raise the serum Digicap concentration due to a reduction in clearance and/or in volume of distribution of the drug, with the implication that digitalis intoxication may result. Erythromycin and clarithromycin (and possibly other macrolide antibiotics) and tetracycline may increase Digicap absorption in patients who inactivate Digicap by bacterial metabolism in the lower intestine, so that digitalis intoxication may result. The risk of this interaction may be reduced if Digicap is given as capsules. Propantheline and diphenoxylate, by decreasing gut motility, may increase Digicap absorption. Antacids, kaolin-pectin, sulfasalazine, neomycin, cholestyramine, certain anticancer drugs, and metoclopramide may interfere with intestinal Digicap absorption, resulting in unexpectedly low serum concentrations. Rifampin may decrease serum Digicap concentration, especially in patients with renal dysfunction, by increasing the non-renal clearance of Digicap. There have been inconsistent reports regarding the effects of other drugs (e.g., quinine, penicillamine) on serum Digicap concentration. Thyroid administration to a digitalized, hypothyroid patient may increase the dose requirement of Digicap. Concomitant use of Digicap and sympathomimetics increases the risk of cardiac arrhythmias. Succinylcholine may cause a sudden extrusion of potassium from muscle cells, and may thereby cause arrhythmias in digitalized patients. Although beta-adrenergic blockers or calcium channel blockers and Digicap may be useful in combination to control atrial fibrillation, their additive effects on AV node conduction can result in advanced or complete heart block.

Due to the considerable variability of these interactions, the dosage of Digicap should be individualized when patients receive these medications concurrently. Furthermore, caution should be exercised when combining Digicap with any drug that may cause a significant deterioration in renal function, since a decline in glomerular filtration or tubular secretion may impair the excretion of Digicap.

Digicap side effects

See also:
What are the possible side effects of Digicap?

In general, the adverse reactions of Digicap are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect. Hence, adverse reactions are less common when Digicap is used within the recommended dose range or therapeutic serum concentration range and when there is careful attention to concurrent medications and conditions.

Because some patients may be particularly susceptible to side effects with Digicap, the dosage of the drug should always be selected carefully and adjusted as the clinical condition of the patient warrants. In the past, when high doses of Digicap were used and little attention was paid to clinical status or concurrent medications, adverse reactions to Digicap were more frequent and severe. Cardiac adverse reactions accounted for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse reactions. However, available evidence suggests that the incidence and severity of Digicap toxicity has decreased substantially in recent years. In recent controlled clinical trials, in patients with predominantly mild to moderate heart failure, the incidence of adverse experiences was comparable in patients taking Digicap and in those taking placebo. In a large mortality trial, the incidence of hospitalization for suspected Digicap toxicity was 2% in patients taking Digicap compared to 0.9% in patients taking placebo. In this trial, the most common manifestations of Digicap toxicity included gastrointestinal and cardiac disturbances; CNS manifestations were less common.

Adults: Cardiac: Therapeutic doses of Digicap may cause heart block in patients with pre-existing sinoatrial or AV conduction disorders; heart block can be avoided by adjusting the dose of Digicap. Prophylactic use of a cardiac pacemaker may be considered if the risk of heart block is considered unacceptable. High doses of Digicap may produce a variety of rhythm disturbances, such as first-degree, second-degree (Wenckebach), or third-degree heart block (including asystole); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifocal or multiform ventricular premature contractions (especially bigeminy or trigeminy); ventricular tachycardia; and ventricular fibrillation. Digicap produces PR prolongation and ST segment depression which should not by themselves be considered Digicap toxicity. Cardiac toxicity can also occur at therapeutic doses in patients who have conditions which may alter their sensitivity to Digicap.

Gastrointestinal: Digicap may cause anorexia, nausea, vomiting, and diarrhea. Rarely, the use of Digicap has been associated with abdominal pain, intestinal ischemia, and hemorrhagic necrosis of the intestines.

CNS: Digicap can produce visual disturbances (blurred or yellow vision), 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 Digicap. Thrombocytopenia and maculopapular rash

and other skin reactions have been rarely observed.

Table 4 summarizes the incidence of those adverse experiences listed above for patients treated with Digicap tablets or placebo from two randomized, double-blind, placebo-controlled withdrawal trials. Patients in these trials were also receiving diuretics with or without angiotensin-converting enzyme inhibitors. These patients had been stable on Digicap, and were randomized to Digicap or placebo. The results shown in Table 4 reflect the experience in patients following dosage titration with the use of serum Digicap concentrations and careful follow-up. These adverse experiences are consistent with results from a large, placebo-controlled mortality trial (DIG trial) wherein over half the patients were not receiving Digicap prior to enrollment.

Table 4: Adverse Experiences in Two Parallel, Double-Blind, Placebo-Controlled Withdrawal Trials (Number of Patients Reporting)
Adverse Experience Digicap Patients

(n = 123)

Placebo Patients

(n = 125)

Cardiac

Palpitation

Ventricular extrasystole

Tachycardia

Heart arrest

1

1

2

1

4

1

1

1

Gastrointestinal

Anorexia

Nausea

Vomiting

Diarrhea

Abdominal pain

1

4

2

4

0

4

2

1

1

6

CNS

Headache

Dizziness

Mental disturbances

4

6

5

4

5

1

Other

Rash

Death

2

4

1

3

Infants and Children: The side effects of Digicap in infants and children differ from those seen in adults in several respects. Although Digicap may produce anorexia, nausea, vomiting, diarrhea, and CNS disturbances in young patients, these are rarely the initial symptoms of overdosage. Rather, the earliest and most frequent manifestation of excessive dosing with Digicap in infants and children is the appearance of cardiac arrhythmias, including sinus bradycardia. In children, the use of Digicap may produce any arrhythmia. The most common are conduction disturbances or supraventricular tachyarrhythmias, such as atrial tachycardia (with or without block) and junctional (nodal) tachycardia. Ventricular arrhythmias are less common. Sinus bradycardia may be a sign of impending Digicap intoxication, especially in infants, even in the absence of first-degree heart block. Any arrhythmia or alteration in cardiac conduction that develops in a child taking Digicap should be assumed to be caused by Digicap, until further evaluation proves otherwise.

Digicap contraindications

See also:
What is the most important information I should know about Digicap?

You should not use this medication if you are allergic to Digicap, 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 Digicap, 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 Digicap as directed, even if you feel well. Get your prescription refilled before you run out of medicine completely.

Do not stop taking Digicap 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. Digicap overdose can occur more easily if you are dehydrated.

There are many other drugs that can interact with Digicap. 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 Digicap:

Digoxin in Egypt.


List of Digicap substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tablet; Oral; Digoxin 0.125 mg (Udl)
Tablet; Oral; Digoxin 0.25 mg (Udl)
Digitek tablet .125 mg/1 (Udl)
Digitek tablet .25 mg/1 (Udl)
0.25 mg x 10's (Macleods Pharmaceuticals Pvt Ltd.)$ 0.09
Digitran 0.25mg TAB / 10 (Macleods Pharmaceuticals Pvt Ltd.)$ 0.09
Digitran 0.25 mg Tablet (Macleods Pharmaceuticals Pvt Ltd.)$ 0.01
DIGITRAN TABLET 1 strip / 10 tablets each (Macleods Pharmaceuticals Pvt Ltd.)$ 0.09
DIGITRAN tab 0.25 mg x 10's (Macleods Pharmaceuticals Pvt Ltd.)$ 0.09
Digitran 0.25mg TAB / 10 (Macleods Pharmaceuticals Pvt Ltd.)$ 0.09
Digitran 0.25mg Tablet (Macleods Pharmaceuticals Pvt Ltd.)$ 0.01
DIGITRAN - 250 Capsule/ Tablet / 0.25mg / 10 units (Macleods Pharmaceuticals)$ 0.09
Digocard 0.25 mg Injection (Neon Laboratories Ltd)$ 0.08
Digocard 0.5 mg Injection (Neon Laboratories Ltd)$ 0.07
Digon 0.25 mg Tablet (Tas Med (I) Pvt. Ltd.)$ 0.01
DIGON TABLET 1 strip / 10 tablets each (Tas Med (I) Pvt. Ltd.)$ 0.22
DIGON tab 0.25 mg x 10's (Tas Med (I) Pvt. Ltd.)$ 0.21
Digon 0.25mg Tablet (Tas Med (I) Pvt. Ltd.)$ 0.02
Tablet; Oral; Digoxin 0.025 mg (Ran)
DIGOSYP Liquid / 0.05mg per ml / 30ml units (Le Sante (Cadila Pharmaceuticals Ltd.))$ 0.35
30ml (Le Sante (Cadila Pharmaceuticals Ltd.))$ 0.35
Digosyp Digoxin 0.05 mg, ethanol 95%0.053 mL/1 mL. LIQD / 30ml (Le Sante (Cadila Pharmaceuticals Ltd.))$ 0.35
Digosyp 30 ml Syrup (Le Sante (Cadila Pharmaceuticals Ltd.))$ 0.01
DIGOSYP oral liqd 30ml (Le Sante (Cadila Pharmaceuticals Ltd.))$ 0.35

References

  1. 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).
  2. PubChem. "digoxin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "digoxin". http://www.drugbank.ca/drugs/DB00390 (accessed September 17, 2018).

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