Details for: DIGOXIN INJECTION C.S.D.
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02048264 | DIGOXIN INJECTION C.S.D. | DIGOXIN | 0.5 MG / 2 ML | LIQUID | INTRAMUSCULAR |
| 02048264 | DIGOXIN INJECTION C.S.D. | DIGOXIN | 0.5 MG / 2 ML | LIQUID | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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 non-medicinal ingredients are
Citric acid 0.08%, ethyl alcohol 10 %, propylene glycol 40 %, sodium phosphate 0.3 %, and water for injection.
What dosage form 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, nonprescription 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.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); | ✔ | ||
| a severe headache, fainting, extreme drowsiness or dizziness | ✔ | ||
| irregular heartbeats | ✔ | ||
| slow heartbeats (fewer than 60 beats per minute) | ✔ | ||
| abnormally fast heartbeats | ✔ | ||
| vision changes (e.g., yellow-green or blurred vision) | ✔ | ||
| hallucinations | ✔ | ||
| abnormal or psychotic behaviour | ✔ | ||
| decreased appetite and diarrhea | ✔ | ||
| unusual tiredness or weakness | ✔ | ||
| nausea or vomiting | ✔ |
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
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 side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Sandoz Canada Inc., at: 1-800-361-3062
Or by written request at:
145, Jules-Léger
Boucherville, (QC), Canada
J4B 7K8
Or by e-mail at :
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc.
Last revised: October 21, 2016