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LANOXIN PEDIATRIC ELIXIR

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• Do not keep outdated medicine or medicine no longer needed.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.

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

• 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