Digitaline Nativelle

Generic Name: digoxin (Oral route)

di-JOX-in

Commonly used brand name(s)

In the U.S.

• Digitek


• Lanoxicaps


• Lanoxin


• Lanoxin Pediatric

In Canada

• Digitaline Nativelle

Available Dosage Forms:

• Tablet


• Capsule, Liquid Filled


• Solution


• Elixir

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Cardiac Glycoside

Chemical Class: Digitalis Glycoside

Uses For Digitaline Nativelle

Digoxin is used in combination with a diuretic ("water pill") and an angiotensin-converting enzyme (ACE) inhibitor to treat congestive heart failure and a heart rhythm problem called atrial fibrillation.

Digoxin belongs to the class of medicines called digitalis glycosides. It is 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 the hands and ankles in patients with heart problems.

This medicine is available only with your doctor's prescription.

Before Using Digitaline Nativelle

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of digoxin in children. However, infants are more likely to be very sensitive to the effects of digoxin which may require an individual dose for infants receiving digoxin.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of digoxin in the elderly. However, elderly patients are more likely to have age-related kidney or heart problems which may require an adjustment in the dose for patients receiving digoxin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with 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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam


• Amiodarone


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Boceprevir


• Buthiazide


• Calcium


• Chan Su


• Chlorothiazide


• Chlorthalidone


• Clarithromycin


• Clopamide


• Conivaptan


• Cyclopenthiazide


• Cyclothiazide


• Demeclocycline


• Diphenoxylate


• Doxycycline


• Dronedarone


• Erythromycin


• Ezogabine


• Hydrochlorothiazide


• Hydroflumethiazide


• Indapamide


• Indomethacin


• Itraconazole


• Kyushin


• Lapatinib


• Lily of the Valley


• Methyclothiazide


• Metolazone


• Minocycline


• Oleander


• Oxytetracycline


• Pheasant's Eye


• Polythiazide


• Propafenone


• Propantheline


• Quercetin


• Quinethazone


• Quinidine


• Ritonavir


• Saquinavir


• Spironolactone


• Squill


• St John's Wort


• Succinylcholine


• Telaprevir


• Tetracycline


• Trichlormethiazide


• Verapamil


• Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose


• Acebutolol


• Alprenolol


• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Aminosalicylic Acid


• Arbutamine


• Atenolol


• Atorvastatin


• Azithromycin


• Azosemide


• Bepridil


• Betaxolol


• Bevantolol


• Bisoprolol


• Bucindolol


• Canrenoate


• Carteolol


• Carvedilol


• Cascara Sagrada


• Celiprolol


• Cholestyramine


• Colchicine


• Colestipol


• Cyclosporine


• Darunavir


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Dilevalol


• Diltiazem


• Disopyramide


• Epoprostenol


• Esmolol


• Etravirine


• Flecainide


• Fluoxetine


• Furosemide


• Gatifloxacin


• Hydroxychloroquine


• Indecainide


• Labetalol


• Lenalidomide


• Lornoxicam


• Lurasidone


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Mepindolol


• Metipranolol


• Metoclopramide


• Metoprolol


• Mibefradil


• Nadolol


• Nebivolol


• Nefazodone


• Neomycin


• Nilvadipine


• Nisoldipine


• Nitrendipine


• Omeprazole


• Oxprenolol


• Pancuronium


• Paromomycin


• Penbutolol


• Pindolol


• Piretanide


• Posaconazole


• Propranolol


• Quinine


• Rabeprazole


• Ranolazine


• Rifampin


• Rifapentine


• Roxithromycin


• Simvastatin


• Sotalol


• Sucralfate


• Sulfasalazine


• Talinolol


• Telithromycin


• Telmisartan


• Tertatolol


• Ticagrelor


• Timolol


• Torsemide


• Tramadol


• Trazodone


• Trimethoprim


• Valspodar

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood vessel disease (e.g., arteriovenous shunt) or


• Hypocalcemia (low calcium in the blood) or


• Hypoxia (low oxygen in the blood) or


• Thyroid disease—Use with caution. Patients with these conditions may be less sensitive or resistant to the effects of digoxin.

• Electrical cardioversion (a medical procedure)—Dose of digoxin may be reduced 1 to 2 days prior to electrical cardioversion of atrial fibrillation to avoid worsening of the condition.

• Heart disease (e.g., amyloid heart disease, AV block, constrictive pericarditis, cor pulmonale, heart attack, hypertrophic cardiomyopathy, restrictive cardiomyopathy, sick sinus syndrome, Wolff-parkinson-white syndrome) or


• Hypercalcemia (high calcium in the blood) or


• Hypokalemia (low potassium in the blood) or


• Hypomagnesemia (low magnesium in the blood)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal from the body.

• Ventricular fibrillation (heart rhythm problem)—Should not be used in patients with this condition.

Proper Use of digoxin

This section provides information on the proper use of a number of products that contain digoxin. It may not be specific to Digitaline Nativelle. Please read with care.

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.

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

Measure the oral solution correctly using the marked measuring dropper or Patients cups™ that comes with the package. Rinse the dosing dropper or cup with water after each use.

Your doctor may want you to check your pulse before you take each dose of this medicine. A nurse or other caregiver can teach you how to check your pulse. Your doctor will tell you how fast your pulse should be (for adults, the usual range is 60 to 100 heartbeats per minute). If your pulse is too high or too low, call your doctor before you take the medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For heart failure or atrial fibrillation:
  
  • For oral dosage form (solution):
    
    • Adults—Dose is based on age, body weight, and medical condition and must be determined by your doctor. Your doctor may increase your dose as needed. However, the dose is usually 3 microgram per kilogram per day (mcg/kg/day).
    
    
    • Teenagers and children above 2 years of age—Dose is based on age, body weight, and medical condition and must be determined by your doctor. Your doctor may increase your dose as needed. However, the dose is usually 10 microgram per kilogram per day (mcg/kg/day).
    
    
    • Children below 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—Your doctor will give your first few doses intravenously (rapid digitalization) and then, you'll be switched to oral tablets for maintenance therapy. A maintenance dose of 0.125 to 0.5 milligram (mg) once a day will be given depending on your body weight and medical condition.
    
    
    • Teenagers and children above 10 years of age—Dose is based on body weight and must be determined by your doctor.
    
    
    • Children below 10 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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, skip the missed dose and 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Digitaline Nativelle

It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.

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

Watch for signs and symptoms of overdose while you are taking this 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), 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 receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Before having any tests, tell your doctor that you are using this medicine. This medicine may affect the results of certain medical tests.

Digitaline Nativelle Side Effects

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 immediately if any of the following side effects occur:

More common

• Dizziness


• fainting


• fast, pounding, or irregular heartbeat or pulse


• slow heartbeat

Rare

• Black, tarry stools


• bleeding gums


• blood in the urine or stools


• bloody vomit


• pinpoint red spots on the skin


• rash with flat lesions or small raised lesions on the skin


• severe stomach pain


• unusual bleeding or bruising

Incidence not known

• Chest pain or discomfort


• nausea


• shortness of breath


• sweating


• swelling of the feet and lower legs


• troubled breathing


• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Agitation or combativeness


• anxiety


• confusion


• depression


• diarrhea


• expressed fear of impending death


• hallucinations


• rash


• vomiting

Rare

• Abdominal or stomach pain

Incidence not known

• Blurred or loss of vision


• disturbed color perception


• double vision


• halos around lights


• headache


• lack of feeling or emotion


• loss of appetite


• night blindness


• overbright appearance of lights


• swelling of the breasts or breast soreness in both females and males


• tunnel vision


• uncaring


• weakness


• weight loss

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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More Digitaline Nativelle resources

• Digitaline Nativelle Use in Pregnancy & Breastfeeding
• Drug Images
• Digitaline Nativelle Drug Interactions
• Digitaline Nativelle Support Group
• 6 Reviews for Digitaline Nativelle - Add your own review/rating

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