Demadex

Yes, it's available as a generic drug.

• Torsimide (Demadex) comes in tablets of 5, 10, 20, and 100 mg. The 10 mg/ml injectable solution has been discontinued.
• Patients can take the tablets at any time without regard to meals. (You can take it on an empty stomach.)
• For the treatment for patients with heart failure the initial dose is 10 to 20 mg by mouth or injection once daily. The dose may be doubled until the desired diuretic effect is achieved. The maximum dose is 200 mg daily.
• Chronic kidney failure is treated with 20 to 200 mg orally or by injection once daily.
• The dose for treating high blood pressure is 2.5 to 10 mg orally once daily.
• Liver cirrhosis is treated with 5 to 40 mg orally or by injection once daily. It is combined with aldosterone antagonists or potassium-sparing diuretics.

DEMADEX® (torsemide) is a diuretic of the pyridine-sulfonylurea class. Its chemical name is 1-isopropyl-3 [(4-m-toluidino-3-pyridyl) sulfonyl] urea and its structural formula is:

Its empirical formula is C16H20N4O3S, its pKa is 7.1, and its molecular weight is 348.43.

Torsemide is a white to off-white crystalline powder. The tablets for oral administration also contain lactose NF, crospovidone NF, povidone USP, microcrystalline cellulose NF, and magnesium stearate NF.

Demadex can cause serious side effects including:

• electrolyte imbalance. This medication may affect electrolytes including sodium, potassium, calcium, magnesium, and chloride. Your doctor will check these levels using a blood test. Warning signs of electrolyte imbalance include:
  • dry mouth
  • thirst
  • weakness
  • lack of energy
  • drowsiness
  • restlessness
  • muscle pains or cramps
  • muscle fatigue
  • low blood pressure
  • decreased urination
  • fast heart rate
  • nausea and vomiting
• worsening of kidney disease
• worsening of gout
• hearing loss. Risk of hearing loss is higher when Demadex is combined with other medications known to cause hearing loss. Tell your doctor right away if you experience hearing loss or ringing in the ears.
• high blood glucose "sugar" concentrations in people with diabetes

This medication may cause drowsiness or dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Do not take Demadex if you:

• are allergic to Demadex or any other ingredient of Demadex 
• are allergic to "sulfa" drugs
• are unable to produce urine

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Demadex, there are no specific foods that you must exclude from your diet when receiving this medication.

You should not use this medication if you are allergic to torsemide or if you are unable to urinate

To make sure torsemide is safe for you, tell your doctor if you have any of these other conditions:

• kidney disease;
• cirrhosis or other liver disease; or
• an allergy to sulfa drugs.

FDA pregnancy category B. Torsemide is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether torsemide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The following risks are discussed in more detail in others sections:

• Hypotension and Worsening Renal Function [see WARNINGS AND PRECAUTIONS]
• Electrolyte and Metabolic Abnormalities [see WARNINGS AND PRECAUTIONS]
• Ototoxicity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In pre-approval studies, DEMADEX has been evaluated for safety in approximately 4000 subjects; over 800 of these subjects received DEMADEX for at least 6 months, and over 380 were treated for more than 1 year. Among these subjects were 564 who received DEMADEX during United States-based trials in which 274 other subjects received placebo.

Discontinuation of therapy due to adverse reactions occurred in 3.5% of United States patients treated with DEMADEX and in 4.4% of patients treated with placebo.

In United States placebo-controlled trials excessive urination occurred in 6.7% of patients compared with 2.2% of patients receiving placebo. The daily doses of DEMADEX used in these trials ranged from 1.25 mg to 20 mg, with most patients receiving 5 mg to 10 mg; the duration of treatment ranged from 1 to 52 days, with a median of 41 days.

In the placebo-controlled hypertension studies excessive urination was dose related; 1% of patients receiving placebo, 4% of those treated with 5 mg of daily DEMADEX, and 15% of those treated with 10 mg. Excessive urination was generally not reported as an adverse event among patients who received DEMADEX for cardiac, renal, or hepatic failure.

There was no effect of age or sex on the incidence of adverse reactions.

Laboratory Parameters

In controlled studies in the United States, DEMADEX was administered to hypertensive patients at doses of 5 mg or 10 mg daily. After 6 weeks at these doses, the mean decrease in serum potassium was approximately 0.1 mEq/L. The percentage of patients who had a serum potassium level below 3.5 mEq/L at any time during the studies was 1.5% on DEMADEX and 3% on placebo. In patients followed for 1 year, there was no progressive change in mean serum potassium levels. In patients with congestive heart failure, hepatic cirrhosis, or renal disease treated with DEMADEX at doses higher than those studied in United States antihypertensive trials, hypokalemia was observed with greater frequency, in a dose-related manner.

DEMADEX produces small dose-related increases in each of these laboratory values. In hypertensive patients who received 10 mg of DEMADEX daily for 6 weeks, the mean increase in blood urea nitrogen was 1.8 mg/dL (0.6 mmol/L), the mean increase in serum creatinine was 0.05 mg/dL (4 mmol/L), and the mean increase in serum uric acid was 1.2 mg/dL (70 mmol/L). Little further change occurred with long-term treatment, and all changes reversed when treatment was discontinued.

Hypertensive patients who received 10 mg of daily DEMADEX experienced a mean increase in serum glucose concentration of 5.5 mg/dL (0.3 mmol/L) after 6 weeks of therapy, with a further increase of 1.8 mg/dL (0.1 mmol/L) during the subsequent year. In long-term studies in diabetics, mean fasting glucose values were not significantly changed from baseline.

DEMADEX 20 mg caused small increases in total cholesterol and triglycerides in short term hypertension studies. The changes subsided with chronic therapy.

Postmarketing Experience

The following adverse reactions have been identified during the post-approval use of DEMADEX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure.

Gastrointestinal system: Pancreatitis, abdominal pain

Nervous System: Paresthesia, confusion, visual impairment, loss of appetite

Hematologic: Leucopenia, thrombocytopenia, anemia

Hepatobiliary: Increase in liver transaminases, gamma-glutamyltransferase

Metabolism: Thiamine (vitamin B1) deficiency

Skin/hypersensitivity: Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity reaction, pruritus

Urogenital: Acute urinary retention

Read the entire FDA prescribing information for Demadex (Torsemide)

Many drugs can interact with torsemide. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• cholestyramine, lithium, phenytoin, probenecid, warfarin (Coumadin, Jantoven);

• an intravenous (IV) antibiotic medicine;

• any other diuretic medicine;

• antifungal medicine--fluconazole, voriconazole;

• heart or blood pressure medicine--amiodarone, candesartan, digoxin, enalapril, lisinopril, olmesartan, valsartan, and others;

• NSAIDs (nonsteroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;

• salicylates--aspirin, Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others or

• steroid medicine--oxandrolone, prednisone, and others.

This list is not complete and many other drugs can interact with torsemide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Contraindications

• Anuria.1 12 13 14

• Known hypersensitivity to torsemide or to sulfonylureas.1 12 13 14

Warnings/Precautions

Warnings

Sudden alterations of electrolyte balance in patients with cirrhosis may precipitate hepatic coma; use with caution in patients with hepatic cirrhosis and ascites.1 12 13 14

Therapy in such patients is best initiated in the hospital.1 14 Use an aldosterone antagonist or potassium-sparing agent concomitantly with torsemide to prevent hypokalemia and metabolic alkalosis in such patients.1 12 13 14

Tinnitus and hearing loss, usually reversible, have been observed following rapid IV injection of other loop diuretics and following oral torsemide administration.1 12 13 14 Administer IV slowly (over 2 minutes); do not exceed 200 mg as a single dose.1 12 14

Observe carefully for manifestations of fluid and electrolyte depletion (e.g., dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, nausea, vomiting).1 12 13 14

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in geriatric patients.1 12 13 14

Laboratory changes may include altered serum concentrations of sodium, chloride, and potassium; acid-base abnormalities; and increased BUN.1 12 If electrolyte imbalance, hypovolemia, or prerenal azotemia develops, torsemide should be discontinued until the abnormality is corrected; treatment then may be restarted at a reduced dosage.1 12 13 14

Risk of hypokalemia, especially with brisk diuresis, with inadequate oral electrolyte intake, in those with cirrhosis, or during concomitant use of corticosteroids or ACTH.1 12 Risk of arrhythmias secondary to hypokalemia in patients with cardiovascular disease, especially those receiving concomitant therapy with a cardiac glycoside.1 12 13

Periodically monitor serum potassium and other electrolyte concentrations.1 12 13 14

General Precautions

Possible increased blood glucose concentrations; hyperglycemia occurred rarely. 1 12 13 14

Small, dose-related, reversible increases in BUN, Scr, and uric acid concentrations reported.1 14 12 Symptomatic gout reported at an incidence similar to placebo.1 12 13 14

Slight alterations in calcium and magnesium concentrations.1 12 13

Increases in total plasma cholesterol concentrations may occur; usually subside during chronic therapy.1 12 13 14

Increases in plasma triglyceride concentrations reported.1 12 13

In long-term studies, no clinically important differences in lipid profiles compared to baseline.1 12 14

No clinically important effects on hemoglobin; hematocrit; WBC, erythrocyte, or platelet counts; or serum alkaline phosphatase concentrations.1 12 13 14

Specific Populations

Category B.1 12 13

Not known whether torsemide is distributed into milk.1 12 13 14 Caution if used in nursing women.1 12 13 14

Safety and efficacy not established.1 12 13 14

Renal calcifications reported in severely premature infants with edema secondary to patent ductus arteriosus and hyaline membrane disease receiving another loop diuretic.1 12 14 Increased risk of persistent patent ductus arteriosus in premature neonates with hyaline membrane disease receiving another loop diuretic also has been reported.1 12 13 14

No substantial differences in safety and efficacy relative to younger adults.1 12 13 14

Seizures reported in patients with acute renal failure receiving higher than recommended dosages of torsemide.1 12 13

Common Adverse Effects

Headache, excessive urination, dizziness, rhinitis, asthenia, diarrhea, ECG abnormality, increased cough.1 12 13 14

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

Torsemide is also used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

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

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:

• Chest pain
• convulsions
• 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
• shortness of breath
• swelling of the hands, ankles, feet, or lower legs
• unusual tiredness or weakness

• 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

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

• 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:

• Increase in urination

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

• If you have an allergy to torsemide or any other part of Demadex (torsemide tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are not able to pass urine.
• If you have very bad liver disease.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Demadex with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

The signs and symptoms of overdosage can be anticipated to include those of excessive pharmacologic effect: dehydration, hypovolemia, hypotension, hyponatremia, hypokalemia, hypochloremic alkalosis, and hemoconcentration. Treatment of overdosage should consist of fluid and electrolyte replacement.

Laboratory determinations of serum levels of torsemide and its metabolites are not widely available.

No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of torsemide and its metabolites. Torsemide is not dialyzable, so hemodialysis will not accelerate elimination.

NDC 0037-3505-01           100 Tablets

Demadex®

(torsemide)

5 mg

MEDA          Rx only

Applies to torsemide: injectable solution, oral tablet

General

The most common adverse reactions were headache and excessive urination.[Ref]

Metabolic

Common (1% to 10%): Edema
Frequency not reported: Hyperglycemia, hyperuricemia, hypokalemia, hypovolemia, excessive thirst, gout, calcium excretion increased, serum calcium increased, serum calcium decreased, magnesium excretion increased, serum magnesium increased, serum magnesium decreased, BUN increased, creatinine increased, uric acid increased, serum glucose increased, total plasma cholesterol increased, plasma triglycerides increased[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, constipation, nausea, dyspepsia, sore throat
Frequency not reported: Vomiting, esophageal hemorrhage, gastrointestinal hemorrhage, rectal bleeding, dry mouth
Postmarketing reports: Pancreatitis[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Frequency not reported: Syncope, tinnitus, hearing loss, limb paresthesia[Ref]

Other

Common (1% to 10%): Asthenia, chest pain
Frequency not reported: Weakness, digitalis intoxication[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia
Frequency not reported: Arthritis[Ref]

Psychiatric

Common (1% to 10%): Insomnia, nervousness[Ref]

Respiratory

Common (1% to 10%): Rhinitis, cough increased[Ref]

Cardiovascular

Common (1% to 10%): ECG abnormality
Frequency not reported: Atrial fibrillation, hypotension, shunt thrombosis, ventricular tachycardia[Ref]

Genitourinary

Common (1% to 10%): Excessive urination
Frequency not reported: Impotence[Ref]

Hematologic

Frequency not reported: Red blood cells decreased, white blood cells decreased, platelets decreased, hemoglobin decreased, hematocrit decreased, erythrocyte count decreased, white blood cell count increased, platelet count increased, serum alkaline phosphatase increased
Postmarketing reports: Leukopenia, thrombocytopenia[Ref]

Dermatologic

Frequency not reported: Rash, angioedema
Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis[Ref]

Ocular

Frequency not reported: Visual disturbance[Ref]

Some side effects of Demadex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Animal studies revealed evidence of fetotoxicity at doses that produced maternal toxicity. There are no controlled data in human pregnancy. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is considered contraindicated and should be used during pregnancy only if clearly needed. US FDA pregnancy category: B

UK: Use is contraindicated. US: Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown Comments: The effects in the nursing infant are unknown.

LactMed Record Number

264

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.