Demadex (Oral)

Torsemide is used to treat fluid retention (edema) and swelling caused by congestive heart failure, liver disease, and kidney disease. It is part of a group of medicines called loop diuretics (water pills). This medicine works by acting on the kidneys to increase urine flow.

Torsemide is also used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure makes the heart and arteries work harder. If it lasts a long time, it can cause the heart and arteries to not work properly. This can damage the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. High blood pressure may also raise the risk of heart attacks. Controlling blood pressure may help reduce these problems.

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

It is very important that your doctor check your progress at regular visits to make sure Demadex (Oral) is working properly. Blood and urine tests may be needed to check for unwanted effects.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

Demadex (Oral) may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how Demadex (Oral) affects you. Sit or lie down if you feel dizzy. Stand up carefully.

Demadex (Oral) may cause you to lose more potassium from your body than normal (hypokalemia). This is more likely to occur if you have liver disease (e.g., cirrhosis), or if you are using Demadex (Oral) together with steroids (cortisone-like medicines), adrenocorticotropic hormone (ACTH), large amounts of licorice, or laxatives for a long time. Tell your doctor if you become sick with severe or continuing nausea, vomiting, or diarrhea, and drink fluids to prevent getting dehydrated. Check with your doctor right away if you have dry mouth, increased thirst, muscle cramps, or nausea or vomiting.

Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing. You may also have dizziness or ringing in the ears. Tell your doctor if you have a feeling of constant movement of self or surroundings or a sensation of spinning.

Demadex (Oral) may cause an increase in blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

Make sure any doctor or dentist who treats you knows that you are using Demadex (Oral). Demadex (Oral) may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

In deciding to use a medicine, you and your doctor need to weigh the risks of taking the medicine against the benefits. Here are some things to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on the effects of torsemide in children. Its safety and effectiveness in this age group have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the effectiveness of torsemide. However, older patients are more likely to have age-related liver, kidney, or heart issues, which may need caution and dose adjustments for those taking torsemide.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. If this medicine is prescribed, it is very important that your healthcare professional knows if you are taking any of the following medicines. The following interactions have been chosen based on their potential importance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

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

• Aceclofenac
• Acemetacin
• Albuterol
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Bromfenac
• Bufexamac
• Buprenorphine
• Capecitabine
• Celecoxib
• Ceritinib
• Choline Salicylate
• Clonixin
• Codeine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Digitoxin
• Dipyrone
• Dofetilide
• Droperidol
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flurbiprofen
• Formoterol
• Foscarnet
• Ibuprofen
• Indomethacin
• Ketanserin
• Ketoprofen
• Ketorolac
• Levomethadyl
• Lithium
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Methotrexate
• Metolazone
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenobarbital
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pixantrone
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sotalol
• Sparsentan
• Sulindac
• Tapentadol
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib
• Warfarin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both medicines are prescribed, your doctor may change the dose or how often you take one or both of the medicines.

• Benazepril
• Captopril
• Cilazapril
• Enalapril
• Enalaprilat
• Fosinopril
• Germanium
• Ginseng
• Gossypol
• Licorice
• Lisinopril
• Moexipril
• Perindopril
• Quinapril
• Ramipril
• Spirapril
• Trandolapril
• Zofenopril

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Anuria (not able to pass urine) or
• Hepatic coma—Should not be used in patients with these conditions.

• Dehydration or
• Electrolyte imbalance (e.g., low calcium, chlorine, magnesium, potassium, or sodium in the blood) or
• Gout or
• Hearing problems (e.g., tinnitus) or
• Hyperuricemia (high uric acid in the blood) or
• Hypotension (low blood pressure) or
• Hypovolemia (low blood volume) or
• Kidney failure or
• Severe liver disease (e.g., cirrhosis)—Use with caution. May worsen these conditions.

• Hypoproteinemia (low protein in the blood) due to a kidney problem or
• Radiocontrast nephropathy (kidney problem)—May worsen 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:

Less common

• Chest pain
• decreased urination
• diarrhea
• dry mouth
• increased thirst
• irregular heartbeat
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• seizures
• swelling of the hands, ankles, feet, or lower legs
• trouble breathing
• unusual tiredness or weakness

Rare

• Black, tarry stools
• dizziness, faintness, or lightheadedness when getting up from a suddenly sitting or lying position
• ringing or buzzing in the ears or any hearing loss
• skin rash

Incidence not known

• Blistering, peeling, or loosening of the skin
• bloating
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• constipation
• darkened urine
• decrease in frequency of urination
• decrease in urine volume
• difficulty in passing urine (dribbling)
• fever
• indigestion
• itching
• joint or muscle pain
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• red irritated eyes
• red skin lesions, often with a purple center
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising
• yellow eyes or skin

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

Symptoms of overdose

• Blurred vision
• coma
• confusion
• decreased urine output
• dizziness
• drowsiness
• fainting
• fast heartbeat
• headache
• increase in heart rate
• irritability
• lightheadedness
• rapid breathing
• sunken eyes
• sweating
• unusual tiredness or weakness
• weak pulse
• wrinkled skin

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:

More common

• Increase in urination

Less common

• Acid or sour stomach
• belching
• difficulty having a bowel movement (stool)
• difficulty in moving
• heartburn
• increased cough
• lack or loss of strength
• muscle pain or stiffness
• nervousness
• pain in the joints
• sneezing
• sore throat
• stomach discomfort, upset, or pain
• stuffy or runny nose
• swollen joints
• trouble sleeping

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.

• Demadex
• Soaanz

Available Dosage Forms:

• Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Diuretic, Loop

Take this medicine exactly as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, most patients feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

This medicine will not cure your high blood pressure but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems, such as heart failure, blood vessel disease, stroke, or kidney disease.

If you are taking cholestyramine (Questran®), take it at least 1 hour after or 4 to 6 hours before taking torsemide. It may keep torsemide from working properly.

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 oral dosage form (Demadex® tablets): For edema caused by heart failure: Adults—At first, 10 or 20 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 200 mg per day. Children—Use and dose must be determined by your doctor. For edema caused by kidney failure: Adults—At first, 20 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 200 mg per day. Children—Use and dose must be determined by your doctor. For edema caused by liver cirrhosis: Adults—At first, 5 or 10 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day. Children—Use and dose must be determined by your doctor. For high blood pressure: Adults—At first, 5 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 mg per day. Children—Use and dose must be determined by your doctor.
• For oral dosage form (Soaanz® tablets): For edema caused by heart failure or kidney failure: Adults—At first, 20 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 200 mg per day. Children—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.

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.

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