Lanoxin Pediatric (Intramuscular, Intravenous)

Digoxin injection is used along with a diuretic (water pill) and an angiotensin-converting enzyme (ACE) inhibitor to treat heart failure in adults and children. It is also used to treat adults with atrial fibrillation (a heart rhythm problem).

Digoxin is part of a group of medicines known as cardiac glycosides. It helps make the heart stronger and work better, or it helps control how fast and regularly the heart beats. This results in improved blood flow and less swelling in the hands and ankles for patients with heart issues.

This medicine should only be given by a doctor or under a doctor's direct supervision.

It is very important for your doctor to check your progress closely while you are taking 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. Your doctor may also want you to monitor and record your blood pressure and heart rate daily.

Watch for signs and symptoms of overdose while you are taking this medicine. 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 vision problems. Other signs of overdose include 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 quickly as adults.

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

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

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 (e.g., St. John's wort) or vitamin supplements.

In deciding to use a drug, the risks of taking the medicine must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medication, the following should be considered:

Allergies

Tell your clinician if you have ever had any unusual or allergic reaction to this drug or any other medicines. Also inform 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 have not been performed on the relationship of age to the effects of digoxin injection to treat atrial fibrillation in the pediatric population. Safety and efficacy have not been established.

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

Geriatric

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

Breast Feeding

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

Interactions with Medications

Although certain medications should not be used together at all, in other cases two different drugs 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 receiving this medicine, it is especially essential that your healthcare professional know if you are using 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 drug with any of the following medications is not advised. Your doctor may decide not to treat you with this medicine or change some of the other drugs you take.

• Levoketoconazole

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

• Abrocitinib
• Aceclofenac
• Acemetacin
• Adagrasib
• Albuterol
• Alprazolam
• Amiodarone
• Amlodipine
• Amtolmetin Guacil
• Aspirin
• Atorvastatin
• Azithromycin
• Bemetizide
• Bendroflumethiazide
• Benzthiazide
• Berotralstat
• Boceprevir
• Bromfenac
• Bufexamac
• Buthiazide
• Calcium
• Canagliflozin
• Cannabidiol
• Capmatinib
• Captopril
• Carvedilol
• Celecoxib
• Ceritinib
• Chan Su
• Chlorothiazide
• Chlorthalidone
• Choline Salicylate
• Cinnarizine
• Clarithromycin
• Clevidipine
• Clonixin
• Clopamide
• Cobicistat
• Colchicine
• Conivaptan
• Crizotinib
• Cyclopenthiazide
• Cyclothiazide
• Daclatasvir
• Daridorexant
• Darunavir
• Demeclocycline
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Diltiazem
• Dipyrone
• Dofetilide
• Dopamine
• Doxercalciferol
• Dronedarone
• Droxicam
• Elacestrant
• Elagolix
• Eliglustat
• Enasidenib
• Ephedrine
• Epinephrine
• Erythromycin
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Felodipine
• Fenoprofen
• Fepradinol
• Feprazone
• Fingolimod
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Gentamicin
• Gilteritinib
• Hydrochlorothiazide
• Hydroflumethiazide
• Ibuprofen
• Indapamide
• Indomethacin
• Isavuconazonium Sulfate
• Isradipine
• Itraconazole
• Ivacaftor
• Ketoprofen
• Ketorolac
• Kyushin
• Lapatinib
• Lasmiditan
• Ledipasvir
• Lenacapavir
• Lily of the Valley
• Lorlatinib
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Magnesium Sulfate
• Manidipine
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Methyclothiazide
• Metoclopramide
• Metolazone
• Mifepristone
• Milnacipran
• Minocycline
• Mitapivat
• Moricizine
• Morniflumate
• Nabumetone
• Naproxen
• Nefazodone
• Nepafenac
• Neratinib
• Nicardipine
• Nifedipine
• Niflumic Acid
• Nilvadipine
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nimodipine
• Nirmatrelvir
• Nisoldipine
• Nitrendipine
• Norepinephrine
• Octreotide
• Oleander
• Omeprazole
• Oxaprozin
• Oxyphenbutazone
• Oxytetracycline
• Parecoxib
• Paroxetine
• Pheasant's Eye
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piroxicam
• Pirtobrutinib
• Polythiazide
• Ponesimod
• Potassium Phosphate
• Pranoprofen
• Proglumetacin
• Propafenone
• Propantheline
• Propyphenazone
• Proquazone
• Quinethazone
• Quinidine
• Quinine
• Rabeprazole
• Ranolazine
• Rifampin
• Ritonavir
• Rofecoxib
• Rolapitant
• Salicylic Acid
• Salsalate
• Saquinavir
• Selpercatinib
• Simeprevir
• Simvastatin
• Siponimod
• Sodium Salicylate
• Sotagliflozin
• Sotalol
• Sotorasib
• Sparsentan
• Spironolactone
• Squill
• Succinylcholine
• Sulindac
• Taurursodiol
• Telaprevir
• Telmisartan
• Tenoxicam
• Tepotinib
• Teriparatide
• Tetracycline
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Tolvaptan
• Trichlormethiazide
• Trimethoprim
• Tucatinib
• Valbenazine
• Valdecoxib
• Vandetanib
• Vemurafenib
• Venetoclax
• Verapamil
• Vibegron
• Vilazodone
• Voclosporin
• Xipamide

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

• Acebutolol
• Arbutamine
• Arotinolol
• Atenolol
• Azosemide
• Befunolol
• Bepridil
• Betaxolol
• Bevantolol
• Bisoprolol
• Bopindolol
• Bucindolol
• Bupranolol
• Bupropion
• Canrenoate
• Carteolol
• Cascara Sagrada
• Celiprolol
• Chloroquine
• Cyclosporine
• Dilevalol
• Disopyramide
• Epoprostenol
• Esmolol
• Etravirine
• Exenatide
• Flecainide
• Flibanserin
• Gatifloxacin
• Glecaprevir
• Hydroxychloroquine
• Indecainide
• Labetalol
• Landiolol
• Lenalidomide
• Levobunolol
• Mepindolol
• Metipranolol
• Metoprolol
• Mibefradil
• Miglitol
• Mirabegron
• Nadolol
• Nebivolol
• Oxprenolol
• Pancuronium
• Penbutolol
• Pibrentasvir
• Pindolol
• Practolol
• Propranolol
• Rifapentine
• Roxithromycin
• Sulfasalazine
• Talinolol
• Telithromycin
• Tertatolol
• Ticagrelor
• Timolol
• Tramadol
• Trazodone
• Velpatasvir

Interactions with Food/Tobacco/Alcohol

Certain medications 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. Discuss with your healthcare professional the use of your medication with food, alcohol, or tobacco.

Other Medical Problems

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

• AV block (type of abnormal heart rhythm), with no pacemaker or
• Heart disease (eg, amyloid heart disease, constrictive pericarditis, cor pulmonale, hypertrophic or restrictive cardiomyopathy) or
• Hypercalcemia (high calcium in the blood) or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Sick sinus syndrome (type of abnormal heart rhythm), with no pacemaker or
• Wolff-Parkinson-white syndrome (heart rhythm issue)—Use with caution. May make these conditions worse.

• Blood vessel disease (eg, arteriovenous shunt) or
• Diarrhea, chronic 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 injection.

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

• Heart attack—Use of digoxin is not advised in patients with this condition.

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

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

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they might need medical attention.

Check with your doctor or nurse 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

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Abdominal or stomach pain
• confusion
• drowsiness
• general feeling of discomfort or illness
• green-yellow color disturbances
• halos around lights
• loss of appetite
• nervousness
• numbness or tingling in the hands, feet, or lips
• vomiting
• weakness or heaviness of the legs
• weight loss

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
• depression
• diarrhea
• expressed fear of impending death
• hallucinations
• rash

Incidence not known

• Blurred or loss of vision
• double vision
• 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

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.

In the U.S.

• Lanoxin
• Lanoxin Pediatric

Pharmacologic Class: Cardiac Glycoside

Chemical Class: Digitalis Glycoside

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is usually given as a shot into a muscle or into a vein.

Your doctor may give you a few doses of this medicine until your condition improves, and then you may be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.