Lanoxicaps

Digoxin is also used to treat heart pain (angina) and may be used after a heart attack. Talk to your doctor about the possible risks of using this drug for your condition.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Your doctor may recommend a low-sodium (low-salt) diet and a potassium supplement. Ask your pharmacist or doctor for a list of foods that are low in sodium and high in potassium. Follow all diet directions carefully.

Digoxin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness or lightheadedness
• drowsiness
• vision changes (blurred or yellow)
• rash
• irregular heartbeat

Some side effects may be serious. If you experience any of the following symptoms, call your doctor immediately:

• upset stomach
• vomiting
• diarrhea
• loss of appetite
• swelling of the feet or hands
• unusual weight gain
• difficulty breathing

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of digoxin, there are no specific foods that you must exclude from your diet when receiving digoxin.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Digoxin falls into category C. This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

It is not known if digoxin will harm your unborn baby.

In the U.S.

• Digitek
• Digox
• Lanoxicaps
• Lanoxin
• Lanoxin Pediatric

In Canada

• Digitaline Nativelle

Available Dosage Forms:

• Tablet
• Capsule, Liquid Filled
• Solution
• Elixir

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Cardiac Glycoside

Chemical Class: Digitalis Glycoside

This section provides information on the proper use of a number of products that contain digoxin. It may not be specific to Lanoxicaps. Please read with care.

To keep your heart working properly, take this medicine exactly as directed even though you may feel well. Do not take more of it than your doctor ordered and do not miss any doses. Take the medicine at the same time each day. This medicine works best when there is a constant amount in the blood.

When you are taking this medicine, it is very important that you get the exact amount of medicine that you need. The dose of digoxin will be different for different patients. Your doctor will determine the proper dose of digoxin for you. Follow your doctor's orders or the directions on the label.

Measure the oral solution correctly using the marked measuring dropper that comes with the package or an oral syringe. Do not use teaspoons and tablespoons that are used for serving and eating food. They do not measure exact amounts.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For heart failure or atrial fibrillation:
  • For oral dosage form (solution):
    • Adults, teenagers, and children 10 years of age and older—Dose is based on age, body weight, and medical condition and must be determined by your doctor. At first, the dose is usually 10 to 15 micrograms (mcg) per kilogram (kg) of body weight. Your doctor may adjust your dose as needed. However, the maintenance dose is usually 3 to 4.5 mcg per kg of body weight per day.
    • Children 5 to 10 years of age—Dose is based on age, body weight, and medical condition and must be determined by your doctor. At first, the dose is usually 20 to 35 micrograms (mcg) per kilogram (kg) of body weight. Your doctor may adjust your dose as needed. However, the maintenance dose is usually 5.6 to 11.3 mcg per kg of body weight per day.
    • Children 2 to 5 years of age—Dose is based on age, body weight, and medical condition and must be determined by your doctor. At first, the dose is usually 30 to 45 micrograms (mcg) per kilogram (kg) of body weight. Your doctor may adjust your dose as needed. However, the maintenance dose is usually 9.4 to 13.1 mcg per kg of body weight per day.
    • Infants 1 month to 24 months of age—Dose is based on age, body weight, and medical condition and must be determined by your doctor. At first, the dose is usually 35 to 60 micrograms (mcg) per kilogram (kg) of body weight. Your doctor may adjust your dose as needed. However, the maintenance dose is usually 11.3 to 18.8 mcg per kg of body weight per day.
    • Full-term babies—Dose is based on age, body weight, and medical condition and must be determined by your doctor. At first, the dose is usually 25 to 35 micrograms (mcg) per kilogram (kg) of body weight. Your doctor may adjust your dose as needed. However, the maintenance dose is usually 7.5 to 11.3 mcg per kg of body weight per day.
    • Premature babies—Dose is based on age, body weight, and medical condition and must be determined by your doctor. At first, the dose is usually 20 to 30 micrograms (mcg) per kilogram (kg) of body weight. Your doctor may adjust your dose as needed. However, the maintenance dose is usually 4.7 to 7.8 mcg per kg of body weight per day.
  • For oral dosage form (tablets):
    • Adults—Your doctor will give your first few doses intravenously (rapid digitalization) and then, you'll be switched to oral tablets for maintenance therapy. A maintenance dose of 0.125 to 0.5 milligram (mg) once a day will be given depending on your body weight and medical condition.
    • Teenagers and children older than 10 years of age—Dose is based on body weight and must be determined by your doctor.
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine, and you remember it within 12 hours, take it as soon as you remember. However, if you do not remember until later, skip the missed dose and go back to your regular dosing schedule. If you have any questions about this or if you miss doses for 2 or more days in a row, check with your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

LANOXIN (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 two 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 C41H64O14, its molecular weight is 780.95, and its structural formula is:

Digoxin exists as odorless white crystals that melt 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.

Lanoxicaps is a stable solution of digoxin enclosed within a soft gelatin capsule for oral use. Each capsule contains the labeled amount of digoxin USP dissolved in a solvent comprised of polyethylene glycol 400 USP, 8 percent ethyl alcohol, propylene glycol USP, and purified water USP. Inactive ingredients in the capsule shell include D&C Yellow No. 10 (0.1-mg and 0.2-mg Capsules), FD&C Blue No. 1 (0.2-mg Capsule), gelatin, glycerin, methylparaben and propylparaben (added as preservatives), purified water, and sorbitol. Capsules are printed with edible ink.

Heart Failure

LANOXIN is indicated for the treatment of mild to moderate heart failure. LANOXIN increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, LANOXIN should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these 3 drugs cannot be specified.

Atrial Fibrillation

LANOXIN is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation.

Sinus Node Disease and AV Block

Because digoxin slows sinoatrial and AV conduction, the drug commonly prolongs the PR interval. The drug may cause severe sinus bradycardia or sinoatrial block in patients with pre-existing sinus node disease and may cause advanced or complete heart block in patients with pre-existing incomplete AV block. In such patients consideration should be given to the insertion of a pacemaker before treatment with digoxin.

Accessory AV Pathway (Wolff-Parkinson-White Syndrome)

After intravenous digoxin therapy, some patients with paroxysmal atrial fibrillation or flutter and a coexisting accessory AV pathway have developed increased antegrade conduction across the accessory pathway bypassing the AV node, leading to a very rapid ventricular response or ventricular fibrillation. Unless conduction down the accessory pathway has been blocked (either pharmacologically or by surgery), digoxin should not be used in such patients. The treatment of paroxysmal supraventricular tachycardia in such patients is usually direct-current cardioversion.

Use in Patients with Preserved Left Ventricular Systolic Function

Patients with certain disorders involving heart failure associated with preserved left ventricular ejection fraction may be particularly susceptible to toxicity of the drug. 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 digoxin.