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Digitek

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Digitek

Digitek

Digitek Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Digitek (digoxin) is used to treat congestive heart failure. It 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). It is a cardiac (or digitalis) glycoside. This medication is available in generic form. Common side effects include nausea, vomiting, headache, loss of appetite, and diarrhea.

Dose of Digitek depends on the patient's body weight, renal function, age, other conditions, and other medications. Digitek may interact with antacids, alprazolam, cancer medications, clonidine, supplements or medications containing calcium, diuretics (water pills), amphotericin B, cholestyramine, epinephrine, guanabenz or guanfacine, indomethacin, isoproterenol, itraconazole, levothyroxine, methyldopa, metoclopramide, neomycin, rifampin, sulfasalazine, antibiotics, beta-blockers, calcium channel blockers, decongestant cold or allergy medicine, nasal sprays, heart rhythm medications, or steroids. Other drugs can interact with Digitek. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant before using Digitek. This drug passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Our Digitek (digoxin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Digitek in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fast, slow, or uneven heart rate;
  • bloody or black, tarry stools;
  • blurred vision, yellowed vision; or
  • confusion, hallucinations, unusual thoughts or behavior.

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea;
  • feeling weak or dizzy;
  • headache;
  • enlarged breasts in men; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Digitek (Digoxin Tablets) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Digitek FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In general, the adverse reactions of digoxin are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect. Hence, adverse reactions are less common when digoxin 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 par ticularly susceptible to side effects with digoxin, the dosage of the drug should always be selected carefully and adjust- ed as the clinical condition of the patient warrants. In the past, when high doses of digoxin were used and little attention was paid to clinical status or concurrent medications, adverse reactions to digoxin 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-four th of these adverse reactions. However, available evidence suggests that the incidence and severity of digoxin toxicit y 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 digoxin and in those taking placebo. In a large mortality trial, the incidence of hospitalization for suspected digoxin toxicity was 2% in patients taking digoxin compared to 0.9% in patients taking placebo. In this trial, the most common manifestations of digoxin toxicity included gastrointestinal and cardiac disturbances; CNS manifestations were less common.

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

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

CNS: Digoxin 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 digoxin. Thrombocytopenia and maculopapular rash and other skin reactions have been rarely observed.

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

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

  Digoxin Patients Placebo Patients
Adverse Experience (n=123) (n=125)
Cardiac
  Palpitation 1 4
  Ventricular extrasystole 1 1
  Tachycardia 2 1
  Heart arrest 1 1
Gastrointestinal
  Anorexia 1 4
  Nausea 4 2
  Vomiting 2 1
  Diarrhea 4 1
  Abdominal pain 0 6
CNS
  Headache 4 4
  Dizziness 6 5
  Mental disturbances 5 1
Other
  Rash 2 1
  Death 4 3

Infants and Children: The side effects of digoxin in infants and children differ from those seen in adults in several respects. Although digoxin 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 digoxin in infants and children is the appearance of cardiac arrhy thmias, including sinus bradycardia. In children, the use of digoxin 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 digoxin intoxication, especially in infants, even in the absence of first degree heart block. Any arrhy thmia or alteration in cardiac conduction that develops in a child taking digoxin should be assumed to be caused by digoxin, until fur ther evaluation proves other wise.

Read the entire FDA prescribing information for Digitek (Digoxin Tablets) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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