Digicap Overdose

How do you administer this medicine?
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What happens if I overdose Digicap?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; fast, slow, or irregular heartbeat; loss of appetite; severe nausea, vomiting, or stomach pain; unusual tiredness; vision changes (eg, blurred vision, seeing halos, yellow-green vision); weight loss, drowsiness, or mental or mood problems in children.

Proper storage of Digicap tablets:

Store Digicap tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Digicap tablets out of the reach of children and away from pets.

Overdose of Digicap in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Signs and Symptoms in Adults and Children

The signs and symptoms of toxicity are generally similar to those described in the Adverse Reactions (6.1) but may be more frequent and can be more severe. Signs and symptoms of Digicap toxicity become more frequent with levels above 2 ng/mL. However, in deciding whether a patient's symptoms are due to Digicap, the clinical state together with serum electrolyte levels and thyroid function are important factors.

Adults: The most common signs and symptoms of Digicap toxicity are nausea, vomiting, anorexia, and fatigue that occur in 30 to 70% of patients who are overdosed. Extremely high serum concentrations produce hyperkalemia especially in patients with impaired renal function. Almost every type of cardiac arrhythmia has been associated with Digicap overdose and multiple rhythm disturbances in the same patient are common. Peak cardiac effects occur 3 to 6 hours following ingestion and may persist for 24 hours or longer. Arrhythmias that are considered more characteristic of Digicap toxicity are new-onset Mobitz type 1 A-V block, accelerated junctional rhythms, non-paroxysmal atrial tachycardia with A-V block, and bi-directional ventricular tachycardia. Cardiac arrest from asystole or ventricular fibrillation is usually fatal.

Digicap toxicity is related to serum concentration. As Digicap serum levels increase above 1.2 ng/mL, there is a potential for increase in adverse reactions. Furthermore, lower potassium levels increase the risk for adverse reactions. In adults with heart disease, clinical observations suggest that an overdose of Digicap of 10 to 15 mg results in death of half of patients. A dose above 25 mg ingested by an adult without heart disease appeared to be uniformly fatal if no Digicap Immune Fab (DIGIBIND®, DIGIFAB®) was administered.

Among the extra-cardiac manifestations, gastrointestinal symptoms (e.g., nausea, vomiting, anorexia) are very common (up to 80% incidence) and precede cardiac manifestations in approximately half of the patients in most literature reports. Neurologic manifestations (e.g., dizziness, various CNS disturbances), fatigue, and malaise are very common. Visual manifestations may also occur with aberration in color vision (predominance of yellow green) the most frequent. Neurological and visual symptoms may persist after other signs of toxicity have resolved. In chronic toxicity, non-specific extra-cardiac symptoms, such as malaise and weakness, may predominate.

Children: In pediatric patients, signs and symptoms of toxicity can occur during or shortly after the dose of Digicap. Frequent non-cardiac effects are similar to those observed in adults although nausea and vomiting are not seen frequently in infants and small pediatric patients. Other reported manifestations of overdose are weight loss in older age groups, failure to thrive in infants, abdominal pain caused by mesenteric artery ischemia, drowsiness, and behavioral disturbances including psychotic episodes. Arrhythmias and combinations of arrhythmias that occur in adult patients can also occur in pediatric patients although sinus tachycardia, supraventricular tachycardia, and rapid atrial fibrillation are seen less frequently in pediatric patients. Pediatric patients are more likely to develop A-V conduction disturbances, or sinus bradycardia. Any arrhythmia in a child treated with Digicap should be considered related to Digicap until otherwise ruled out. In pediatric patients aged 1 to 3 years without heart disease, clinical observations suggest that an overdose of Digicap of 6 to 10 mg would result in death of half of the patients. In the same population, a dose above 10 mg resulted in death if no Digicap Immune Fab were administered.

Treatment

Chronic Overdose

If there is suspicion of toxicity, discontinue Digicap Tablets and place the patient on a cardiac monitor. Correct factors such as electrolyte abnormalities, thyroid dysfunction, and concomitant medications. Correct hypokalemia by administering potassium so that serum potassium is maintained between 4.0 and 5.5 mmol/L. Potassium is usually administered orally, but when correction of the arrhythmia is urgent and serum potassium concentration is low, potassium may be administered by the intravenous route. Monitor electrocardiogram for any evidence of potassium toxicity (e.g., peaking of T waves) and to observe the effect on the arrhythmia. Avoid potassium salts in patients with bradycardia or heart block. Symptomatic arrhythmias may be treated with Digicap Immune Fab.

Acute Overdose

Patients who have intentionally or accidently ingested massive doses of Digicap should receive activated charcoal orally or by nasogastric tube regardless of the time since ingestion since Digicap recirculates to the intestine by enterohepatic circulation. In addition to cardiac monitoring, temporarily discontinue Digicap Tablets until the adverse reaction resolves. Correct factors that may be contributing to the adverse reactions. In particular, correct hypokalemia and hypomagnesemia. Digicap is not effectively removed from the body by dialysis because of its large extravascular volume of distribution. Life-threatening arrhythmias (ventricular tachycardia, ventricular fibrillation, high degree A-V block, bradyarrhythmia, sinus arrest) or hyperkalemia requires administration of Digicap Immune Fab. Digicap Immune Fab has been shown to be 80 to 90% effective in reversing signs and symptoms of Digicap toxicity. Bradycardia and heart block caused by Digicap are parasympathetically mediated and respond to atropine. A temporary cardiac pacemaker may also be used. Ventricular arrhythmias may respond to lidocaine or phenytoin. When a large amount of Digicap has been ingested, especially in patients with impaired renal function, hyperkalemia may be present due to release of potassium from skeletal muscle. In this case, treatment with Digicap Immune Fab is indicated; an initial treatment with glucose and insulin may be needed if the hyperkalemia is life-threatening. Once the adverse reaction has resolved, therapy with Digicap Tablets may be reinstituted following a careful reassessment of dose.

What should I avoid while taking Digicap?

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.

Digicap warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Ventricular Fibrillation in Patients With Accessory AV Pathway (Wolff- Parkinson-White Syndrome)

Patients with Wolff-Parkinson-White syndrome who develop atrial fibrillation are at high risk of ventricular fibrillation. Treatment of these patients with Digicap 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.

Sinus Bradycardia and Sino-atrial Block

Digicap Tablets may cause severe sinus bradycardia or sinoatrial block particularly in patients with pre-existing sinus node disease and may cause advanced or complete heart block in patients with pre-existing incomplete AV block. Consider insertion of a pacemaker before treatment with Digicap.

Digicap Toxicity

Signs and symptoms of Digicap toxicity include anorexia, nausea, vomiting, visual changes and cardiac arrhythmias [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]. Toxicity is usually associated with Digicap levels greater than 2 ng/ml although symptoms may also occur at lower levels. Low body weight, advanced age or impaired renal function, hypokalemia, hypercalcemia, or hypomagnesemia may predispose to Digicap toxicity. Obtain serum Digicap levels in patients with signs or symptoms of Digicap therapy and interrupt or adjust dose if necessary. Assess serum electrolytes and renal function periodically.

The earliest and most frequent manifestation of Digicap toxicity 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 arrhythmias or alteration in cardiac conduction that develops in a child taking Digicap should initially be assumed to be a consequence of Digicap intoxication.

Given that adult patients with heart failure have some symptoms in common with Digicap toxicity, it may be difficult to distinguish Digicap toxicity from heart failure. Misidentification of their etiology might lead the clinician to continue or increase Digicap Tablets dosing, when dosing should actually be suspended. When the etiology of these signs and symptoms is not clear, measure serum Digicap levels.

Risk of Ventricular Arrhythmias During Electrical Cardioversion

It may be desirable to reduce the dose of or discontinue Digicap Tablets for 1 to 2 days prior to electrical cardioversion of atrial fibrillation to avoid the induction of ventricular arrhythmias, but physicians must consider the consequences of increasing the ventricular response if Digicap is decreased or withdrawn. If digitalis toxicity is suspected, elective cardioversion should be delayed. If it is not prudent to delay cardioversion, the lowest possible energy level should be selected to avoid provoking ventricular arrhythmias.

Risk of Ischemia in Patients With Acute Myocardial Infarction

Digicap Tablets are not recommended in patients with acute myocardial infarction because Digicap may increase myocardial oxygen demand and lead to ischemia.

Vasoconstriction in Patients With Myocarditis

Digicap Tablets can precipitate vasoconstriction and may promote production of pro-inflammatory cytokines; therefore, avoid use in patients with myocarditis.

Decreased Cardiac Output in Patients With Preserved Left Ventricular Systolic Function

Patients with heart failure associated with preserved left ventricular ejection fraction may experience decreased cardiac output with use of Digicap Tablets. Such disorders include restrictive cardiomyopathy, constrictive pericarditis, amyloid heart disease, and acute cor pulmonale. Patients with idiopathic hypertrophic subaortic stenosis may have worsening of the outflow obstruction due to the inotropic effects of Digicap. Patients with amyloid heart disease may be more susceptible to Digicap toxicity at therapeutic levels because of an increased binding of Digicap to extracellular amyloid fibrils.

Digicap Tablets should generally be avoided in these patients, although it has been used for ventricular rate control in the subgroup of patients with atrial fibrillation.

Reduced Efficacy in Patients With Hypocalcemia

Hypocalcemia can nullify the effects of Digicap in humans; thus, Digicap may be ineffective until serum calcium is restored to normal. These interactions are related to the fact that Digicap affects contractility and excitability of the heart in a manner similar to that of calcium.

Altered Response in Thyroid Disorders and Hypermetabolic States

Hypothyroidism may reduce the requirements for Digicap.

Heart failure and/or atrial arrhythmias resulting from hypermetabolic or hyperdynamic states (e.g., hyperthyroidism, hypoxia, or arteriovenous shunt) are best treated by addressing the underlying condition. Atrial arrhythmias associated with hypermetabolic states are particularly resistant to Digicap treatment. Patients with beri beri heart disease may fail to respond adequately to Digicap if the underlying thiamine deficiency is not treated concomitantly.

What should I discuss with my healthcare provider before taking Digicap?

Some medical conditions may interact with Digicap solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Digicap solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Digicap solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Digicap precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Ventricular Fibrillation in Patients With Accessory AV Pathway (Wolff- Parkinson-White Syndrome)

Patients with Wolff-Parkinson-White syndrome who develop atrial fibrillation are at high risk of ventricular fibrillation. Treatment of these patients with Digicap 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.

Sinus Bradycardia and Sino-atrial Block

Digicap Tablets may cause severe sinus bradycardia or sinoatrial block particularly in patients with pre-existing sinus node disease and may cause advanced or complete heart block in patients with pre-existing incomplete AV block. Consider insertion of a pacemaker before treatment with Digicap.

Digicap Toxicity

Signs and symptoms of Digicap toxicity include anorexia, nausea, vomiting, visual changes and cardiac arrhythmias [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]. Toxicity is usually associated with Digicap levels greater than 2 ng/ml although symptoms may also occur at lower levels. Low body weight, advanced age or impaired renal function, hypokalemia, hypercalcemia, or hypomagnesemia may predispose to Digicap toxicity. Obtain serum Digicap levels in patients with signs or symptoms of Digicap therapy and interrupt or adjust dose if necessary. Assess serum electrolytes and renal function periodically.

The earliest and most frequent manifestation of Digicap toxicity 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 arrhythmias or alteration in cardiac conduction that develops in a child taking Digicap should initially be assumed to be a consequence of Digicap intoxication.

Given that adult patients with heart failure have some symptoms in common with Digicap toxicity, it may be difficult to distinguish Digicap toxicity from heart failure. Misidentification of their etiology might lead the clinician to continue or increase Digicap Tablets dosing, when dosing should actually be suspended. When the etiology of these signs and symptoms is not clear, measure serum Digicap levels.

Risk of Ventricular Arrhythmias During Electrical Cardioversion

It may be desirable to reduce the dose of or discontinue Digicap Tablets for 1 to 2 days prior to electrical cardioversion of atrial fibrillation to avoid the induction of ventricular arrhythmias, but physicians must consider the consequences of increasing the ventricular response if Digicap is decreased or withdrawn. If digitalis toxicity is suspected, elective cardioversion should be delayed. If it is not prudent to delay cardioversion, the lowest possible energy level should be selected to avoid provoking ventricular arrhythmias.

Risk of Ischemia in Patients With Acute Myocardial Infarction

Digicap Tablets are not recommended in patients with acute myocardial infarction because Digicap may increase myocardial oxygen demand and lead to ischemia.

Vasoconstriction in Patients With Myocarditis

Digicap Tablets can precipitate vasoconstriction and may promote production of pro-inflammatory cytokines; therefore, avoid use in patients with myocarditis.

Decreased Cardiac Output in Patients With Preserved Left Ventricular Systolic Function

Patients with heart failure associated with preserved left ventricular ejection fraction may experience decreased cardiac output with use of Digicap Tablets. Such disorders include restrictive cardiomyopathy, constrictive pericarditis, amyloid heart disease, and acute cor pulmonale. Patients with idiopathic hypertrophic subaortic stenosis may have worsening of the outflow obstruction due to the inotropic effects of Digicap. Patients with amyloid heart disease may be more susceptible to Digicap toxicity at therapeutic levels because of an increased binding of Digicap to extracellular amyloid fibrils.

Digicap Tablets should generally be avoided in these patients, although it has been used for ventricular rate control in the subgroup of patients with atrial fibrillation.

Reduced Efficacy in Patients With Hypocalcemia

Hypocalcemia can nullify the effects of Digicap in humans; thus, Digicap may be ineffective until serum calcium is restored to normal. These interactions are related to the fact that Digicap affects contractility and excitability of the heart in a manner similar to that of calcium.

Altered Response in Thyroid Disorders and Hypermetabolic States

Hypothyroidism may reduce the requirements for Digicap.

Heart failure and/or atrial arrhythmias resulting from hypermetabolic or hyperdynamic states (e.g., hyperthyroidism, hypoxia, or arteriovenous shunt) are best treated by addressing the underlying condition. Atrial arrhythmias associated with hypermetabolic states are particularly resistant to Digicap treatment. Patients with beri beri heart disease may fail to respond adequately to Digicap if the underlying thiamine deficiency is not treated concomitantly.

What happens if I miss a dose of Digicap?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Take the missed dose as soon as you remember. If your next dose is less than 12 hours away, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.



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. DrugBank. "digoxin". http://www.drugbank.ca/drugs/DB00390 (accessed September 17, 2018).
  3. MeSH. "Enzyme Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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