DIGITALISMEDICINES (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

Category

• Antiarrhythmic
• cardiotonic

Description

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

Although digitalis has been prescribed to help some patients lose weight,it should never be used in this way. When usedimproperly, 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 willdo. 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 orallergic reaction to digitalis medicines. Also tell your health care professionalif 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 humansor animals. Make sure your doctor knows if you are pregnant or if you maybecome pregnant before taking digitalis medicines.

Breast-feeding?Digoxin passes into breast milk; it is notknown if digitoxin passes into breast milk. Although most medicines pass intobreast 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 discussthis with their doctor.

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

Older adults?Signs and symptoms of overdose may be especiallylikely to occur in elderly patients, who are usually more sensitive than youngeradults to the effects of digitalis medicines.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingor receiving digitalis medicines it is especially important that your healthcare professional know if you are taking any other medicines because theymay affect the levels of digitalis in the body and cause side effects. Thefollowing 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 rhythmproblems

• 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 medicinesin 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 heartbeatmay be increased

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

Other medical problems?The presence of other medical problems may affectthe use of digitalis medicines. Make sure you tell your doctor if you haveany other medical problems, especially:

• Electrolyte disorders or
• Heart disease or
• Lung disease (severe)?The heart may be more sensitive to theeffects of digitalis medicines

• Heart rhythm problems?Digitalis medicines may make certainheart rhythm problems worse

• Kidney disease or
• Liver disease?Effects may be increased because of slower removalof digitalis medicines from the body

• Thyroid disease?Patients with low or high thyroid gland activitymay be more or less sensitive to the effects of digitalis medicines

Proper Use of This Medicine

To keep your heart workingproperly, take this medicine exactly as directed eventhough you may feel well. Do not take more of it than your doctor orderedand do not miss any doses. Take the medicine at the same time each day. Thismedicine 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 dropperbottle. The amount you should take is to be measured only with the speciallymarked dropper.

Dosing?When you are taking digitalis medicines, itis very important that you get the exact amount of medicine that you need.The dose of digitalis medicine will be different for different patients. Yourdoctor 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 checkyour blood level of digitalis medicine to find out if your dose needs to bechanged. 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 thatyou take depends on the strength of the medicine.

Missed dose?If you miss a dose of this medicine, and you rememberit within 12 hours, take it as soon as you remember. However, if you do notremember until later, do not take the missed dose at all and do not doublethe next one. Instead, go back to your regular dosing schedule. If you haveany 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 otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It isimportant that your doctor check your progress at regular visits to make surethe medicine is working properly. This will allow your doctor to make anychanges in directions for taking it, if necessary.

Do not stop taking this medicine without first checkingwith your doctor. Stopping suddenly may cause a serious change in heartfunction.

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 whileyou are taking digitalis medicine. Follow your doctor's directions carefully.The amount of this medicine needed to help most people is very close to theamount that could cause serious problems from overdose. Some early warningsigns of overdose are loss of appetite, nausea, vomiting, diarrhea, or problemsin seeing. Other signs of overdose are changes in the rate or rhythm of theheartbeat (becoming irregular or slow), palpitations (feeling of poundingin the chest), and/or fainting. In infants and small children, the earliestsigns of overdose are changes in the rate and rhythm of the heartbeat. Childrenmay not show the other symptoms as soon as adults.

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

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

For patients taking the tablet or capsule formof 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 thismay have serious results. Ask your pharmacist for ways to avoid mix-ups withmedicines 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 sideeffects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following sideeffects 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 occurin infants and children, but heartbeat rate or rhythm side effects are morecommon initially than stomach upset, loss of appetite, changes in vision,or other side effects.

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.