Pediatric Digoxin Injection C.S.D.: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

This medicine is used for patients who have mild to moderate congestive heart failure. Heart failure, results when the heart cannot pump blood well enough to supply the body's needs. As a result, circulation becomes poor, and fluid can build up in the lungs and legs. This medicine can also be used in patients with fast heart rate or irregular heart rhythm. If you have a rapid or irregular heart beat, such as atrial fibrillation (sometimes called "a-fib"), digoxin can slow down and control your heart rate.

What it does:

If you have heart failure, digoxin can improve your heart's ability to pump blood. Better pumping of the heart will often improve symptoms such as shortness of breath. As a result, you may find it easier to go about your daily activities.

When it should not be used:

• If you have ever had any unusual or allergic reaction to digoxin

  or any nonmedicinal ingredients (see below).

• If you suffer from ventricular fibrillation (a heart condition).

What the medicinal ingredient is:

Digoxin

What the important nonmedicinal ingredients are:

Citric acid 0.08%, ethyl alcohol 10 %, propylene glycol 40 %, sodium phosphate 0.3 %, and water for injection.

What dosage forms it comes in:

Digoxin Injection, C.S.D. 0.25 mg/mL is available as 2 mL ampoules, boxes of 10.

Pediatric Digoxin Injection, C.S.D. 0.05 mg/mL is available as 1 mL ampoules, boxes of 3.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

! Do not take other prescription, non-prescription and herbal medications without advice from your doctor.

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

BEFORE you use ^Pr Digoxin Injection talk to your doctor or pharmacist if:

• You are pregnant or could become pregnant during treatment. Digoxin crosses the placenta and should not be used in pregnant women unless absolutely needed;

• You are breast-feeding-Digoxin is distributed into breast milk; caution should be used
• You are taking any other prescription, non-prescription and herbal medication.
• you are over 65 years of age, you may be more likely to experience side effects from digoxin. You may require a dosage adjustment or special monitoring.
• you have ever had any unusual or allergic reaction to digitalis medicines
• If you have been diagnosed with unusual calcium or low magnesium blood levels.

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 (Imbalance in bodily salts)
• Heart disease
• Lung disease (severe)
• Heart rhythm problems
• Kidney disease
• Liver disease
• Thyroid disease

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with Digoxin Injection include:

• another medication for irregular heartbeats, such as quinidine, amiodarone, or propafenone;
• an antacid or laxative that contains aluminum, magnesium, or kaolin-pectin such as Maalox, Rolaids, Mylanta, Milk of Magnesia, and others;
• a beta-blocker such as atenolol, propranolol, acebutolol, metoprolol, labetalol or nadolol;
• a calcium channel blocker such as diltiazem, bepridil, amlodipine, felodipine, nifedipine, verapamil and others;
• a cancer chemotherapy drug;
• a diuretic (water pill) such as hydrochlorothiazide, chlorothiazide, chlorthalidone, furosemide, triamterene, amiloride, spironolactone and others;

• a steroid medicine such as prednisone, methylprednisolone,

  prednisolone, dexamethasone, and others;

• a thyroid medication;
• albuterol
• alprazolam
• amphotericin B
• atrovastatin
• barbiturates (e.g. Phenobarbital)
• calcium (particularly if given intravenously)
• cholestyramine or colestipol
• diphenoxylate
• erythromycin or clarithromycin
• flecainide
• indomethacin
• itraconazole
• metoclopramide (Reglan)
• neomycin
• omeprazole
• phenytoin
• propantheline
• rifampin
• succinylcholine
• sucralfate
• sulfasalazine or
• tetracycline

Herbal products that may interact with DIGOXIN (e.g. St. John’s Wort)

You may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with digoxin or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

PROPER USE OF THIS MEDICATION

Usual dose:

• Digoxin Injection C.S.D. and Pediatric Digoxin Injection

  C.S.D are given as an intravenous injection by your doctor or nurse. Your doctor will discuss the most appropriate dose for you or your child.

• The medication should be given at the same time every day.

  Your doctor may want to perform blood tests during your digoxin treatment to monitor the amount of medication in your blood.

• Ask your doctor to teach you how to monitor your heart rate

  and at what heart rate you should notify them.

• Do not suddenly stop taking Digoxin without talking to your

  doctor. Stopping suddenly, even if you feel better, could make your condition worse.

• Make sure you always have enough digoxin on hand for

  vacations and holidays.

• This medicine has been tested in children. Dosages should be

  individualized as directed by your doctor.

• Digoxin is usually given in injectable form to stabilize your

  condition. It may take several weeks to several months for

  digoxin to improve your heart function. Don't be surprised if your symptoms don't get better right away. Digoxin is used to treat heart conditions that last for a long time, so you may take digoxin the rest of your life, so you may take digoxin for the rest of your life. Call your doctor if you have any problems with the drug.

  • A lower dose may be required in the elderly, in children, or if you have kidney problems.

Overdose:

• Seek emergency medical attention.
• Symptoms of a digoxin overdose include nausea, vomiting, decreased appetite, diarrhea, confusion, seizures, hallucinations, light "halos" around objects, green or yellow vision, fatigue, irregular heartbeats, and abnormally fast or slow heartbeats.

Missed Dose:

Take the missed dose up to 12 hours late. If more than 12 hours have passed, skip the missed dose and take only the next regularly scheduled dose. Do Not take a double dose of this medication. Tell your doctor if you have missed 2 or more days of DIGOXIN.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

• If you experience any of the following side effects, talk to your doctor if you experience:

  • depression;
  • decreased sex drive; or
  • enlarged breasts in males.

This is not a complete list of side effects. For any unexpected effects while taking DIGOXIN Injection contact your doctor or pharmacist.

HOW TO STORE IT

Store at 15-30°C in a dry place and protect from light. Protect from freezing. Avoid exposure to excessive heat. Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax: 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.sandoz.ca

or by contacting the sponsor, Sandoz Canada Inc, at: 1-800-361-3062

or at mailing address:

145 rue Jules Léger

Boucherville, (QC), Canada

J4B 7K8

Last revised: June 28, 2006