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|Lanoxin Elixir Pediatric

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DIGITALIS MEDICINES (Systemic)

Some commonly used brand names are:

In the U.S.—

Lanoxicaps ²
Lanoxin ²
Lanoxin Elixir Pediatric ²
Lanoxin Injection ²
Lanoxin Injection Pediatric ²

In Canada—

Digitaline ¹
Lanoxin ²
Lanoxin Pediatric Elixir ²
Lanoxin Injection ²
Lanoxin Pediatric Injection ²
Novo-Digoxin ²

Note:

For quick reference, the following digitalis medicines are numbered to match the corresponding brand names.

This information applies to the following medicines:
1.	Digitoxin (di-ji-TOX-in)*
2.	Digoxin (di-JOX-in)‡§
* Not commercially available in the U.S.
‡ Generic name product may be available in the U.S.
§ Generic name product may be available in Canada

Description

Digitalis medicines are used to improve the strength and efficiency of the heart, or to control the rate and rhythm of the heartbeat. This leads to better blood circulation and reduced swelling of hands and ankles in patients with heart problems.

Although digitalis has been prescribed to help some patients lose weight, it should never be used in this way. When used improperly, digitalis can cause serious problems.

Digitalis medicines are available only with your doctor"s prescription, in the following dosage forms:

Oral
Digitoxin
- Tablets (Canada)
Digoxin
- Capsules (U.S.)
- Elixir (U.S. and Canada)
- Tablets (U.S. and Canada)

Parenteral
Digoxin
- Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For digitalis medicines, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to digitalis medicines. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Digitalis medicines pass from the mother to the fetus. However, studies on effects in pregnancy have not been done in either humans or animals. Make sure your doctor knows if you are pregnant or if you may become pregnant before taking digitalis medicines.

Breast-feeding—Digoxin passes into breast milk; it is not known if digitoxin passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. However, the dose is very different for babies and children, and it is important to follow your doctor"s instructions exactly.

Older adults—Signs and symptoms of overdose may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of digitalis medicines.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking or receiving digitalis medicines it is especially important that your health care professional know if you are taking any other medicines because they may affect the levels of digitalis in the body and cause side effects. The following medicines are especially important:

Amphetamines or
Appetite suppressants (diet pills) or
Medicine for asthma or other breathing problems or
Medicine for colds, sinus problems, or hay fever or other allergies (including nose drops or sprays)—May increase the risk of heart rhythm problems

Antiarrhythmic or other heart medicine, such as amiodarone (e.g., Cordarone) taken within the last 3 months or
Calcium channel blocking agents (bepridil [e.g., Bepadin, Vascor], diltiazem [e.g., Cardizem, Cardizem CD, Cardizem SR], felodipine [e.g., Plendil], flunarizine [e.g., Sibelium], isradipine [e.g., DynaCirc], nicardipine [e.g., Cardene], nifedipine [e.g., Adalat, Procardia, Procardia XL], nimodipine [e.g., Nimotop], nisoldipine [e.g., Sular], verapamil [e.g., Calan, Calan SR, Isoptin, Isoptin SR, Verelan]) or
Propafenone (e.g., Rythmol) or
Quinidine (e.g., Quinidex)—May cause levels of digitalis medicines in the body to be higher than usual, which could lead to overdose

Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], bisoprolol [e.g., Zebeta], carteolol [e.g., Cartrol], carvedilol [e.g., Coreg], labetalol [e.g., Normodyne], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Sotacor], timolol [e.g., Blocadren])—Effects on slowing the heartbeat may be increased

Diuretics (water pills)—These medicines can cause hypokalemia (low levels of potassium in the body), which can increase the unwanted effects of digitalis medicines

Other medical problems—The presence of other medical problems may affect the use of digitalis medicines. Make sure you tell your doctor if you have any other medical problems, especially:

Electrolyte disorders or
Heart disease or
Lung disease (severe)—The heart may be more sensitive to the effects of digitalis medicines

Heart rhythm problems—Digitalis medicines may make certain heart rhythm problems worse

Kidney disease or
Liver disease—Effects may be increased because of slower removal of digitalis medicines from the body

Thyroid disease—Patients with low or high thyroid gland activity may be more or less sensitive to the effects of digitalis medicines

Proper Use of This Medicine

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.

For patients taking the liquid form of digoxin :

This medicine is to be taken by mouth even if it comes in a dropper bottle. The amount you should take is to be measured only with the specially marked dropper.

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

After you begin taking digitalis medicines, your doctor may sometimes check your blood level of digitalis medicine to find out if your dose needs to be changed. Do not change your dose of digitalis medicine unless your doctor tells you to do so.

The number of capsules, tablets, drops, or dropperfuls of solution that you take depends on the strength of the medicine.

Missed dose—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, do not take the missed dose at all and do not double the next one. Instead, 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—To store this medicine:

Keep out of the reach of children.
Store away from heat and direct light.
Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits to make sure the medicine is working properly. This will allow your doctor to make any changes in directions for taking it, if necessary.

Do not stop taking this medicine without first checking with your doctor . Stopping suddenly may cause a serious change in heart function.

Keep this medicine out of the reach of children . Digitalis medicines are a major cause of poisoning in children.

Watch for signs and symptoms of overdose while you are taking digitalis medicine. Follow your doctor"s directions carefully. The amount of this medicine needed to help most people is very close to the amount that could cause serious problems from overdose. Some early warning signs of overdose are loss of appetite, nausea, vomiting, diarrhea, or problems in seeing. Other signs of overdose are changes in the rate or rhythm of the heartbeat (becoming irregular or slow), palpitations (feeling of pounding in the chest), and/or fainting. In infants and small children, the earliest signs of overdose are changes in the rate and rhythm of the heartbeat. Children may not show the other symptoms as soon as adults.

Your doctor may want you to carry a medical identification card or bracelet stating that you are taking this medicine.

Do not take any other medicine without consulting your doctor . Many over-the-counter (OTC) or nonprescription medicines contain ingredients that interfere with digitalis medicines or that may make your condition worse. These medicines include antacids; laxatives; asthma remedies; cold, cough, or sinus preparations; medicine for diarrhea; and weight reducing or diet medicines.

For patients taking the tablet or capsule form of this medicine:

This medicine may look like other tablets or capsules you now take. It is very important that you do not get the medicines mixed up since this may have serious results. Ask your pharmacist for ways to avoid mix-ups with medicines that look alike.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects or symptoms occur:

In adults

Anxiety, blurred or yellow vision, confusion, dizziness, mental depression, feeling of not caring, headache, loss of appetite, seeing or hearing things that are not there, and/or weakness; diarrhea, loss of appetite, lower stomach pain, nausea, and/or vomiting; irregular or slow heartbeat, palpitations (feeling of pounding in the chest), and/or fainting

Rare

Skin rash; nosebleeds or bleeding gums

With long-term use

Breast enlargement in males

In infants and children

The above signs and symptoms also can occur in infants and children, but heartbeat rate or rhythm side effects are more common initially than stomach upset, loss of appetite, changes in vision, or other side effects.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 03/02/99

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