Torsemide Tablets USP 20mg Taj Pharma

Torsemide Tablets USP 5mg, 10mg, 20mg, 100mg  

Torsemide Tablets USP 5mg Taj Pharma
Torsemide Tablets USP 10mg Taj Pharma
Torsemide Tablets USP 20mg Taj Pharma
Torsemide Tablets USP 100mg Taj Pharma

WHAT IS TORSEMIDE AND HOW DOES IT WORK?

Torsemide is a diuretic used to reduce oedema (swelling) from multiple causes such as heart failure, renal disease, or liver disease. Use of torsemide has been found to be effective for the treatment of oedema associated with chronic renal failure.

Torsemide tablets are also indicated for the treatment of high blood pressure (hypertension) alone or in combination with other antihypertensive agents.

Torsemide is available under the following different brand names: Demadex.

Dosages of Torsemide:

Dosage Forms and Strengths

Tablet

  • 5 mg
  • 10 mg
  • 20 mg
  • 100 mg

Injectable solution

  • 10 mg/mL

Dosage Considerations – Should be Given as Follows:

Congestive Heart Failure

  • 10-20 mg orally/intravenously once daily initially; doubled until the desired diuretic effect is achieved; individual dose not to exceed 200 mg

Chronic Renal Failure

  • 20 mg orally/intravenously once daily initially; doubled until the desired diuretic effect is achieved; individual dose not to exceed 200 mg

Hepatic Cirrhosis

  • 5-10 mg orally/intravenously once daily initially with aldosterone antagonist or potassium-sparing diuretic; individual dose not to exceed 40 mg

Hypertension

  • 5-5 mg/day orally initially; increased to 10 mg/day orally in 4-6 weeks as needed

Dosing Considerations

Use for fluid retention refractory to thiazides or with impaired renal function

Overdose management

  • Normal saline may be used for volume replacement
  • Dopamine or norepinephrine may be used to treat hypotension
  • If dysrhythmia due to decreased potassium or magnesium is suspected, replace aggressively
  • Discontinue treatment if no symptoms are apparent after 6 hours

Pediatric: Safety and efficacy not established

WHAT ARE SIDE EFFECTS ASSOCIATED WITH USING TORSEMIDE?

Common side effects of Torsemide include:

  • Constipation
  • Cough
  • Decreased sex drive
  • Diarrhoea
  • Difficulty having an orgasm
  • Dizziness
  • Electrolyte imbalance
  • Excessive or increased urination
  • Headache
  • Impotence
  • Indigestion/heartburn
  • Insomnia
  • Joint pain
  • Nausea
  • Nervousness
  • Runny or stuffy nose
  • Stomach upset

Less common side effects of torsemide include:

  • Dizziness on standing
  • Ear damage (ringing in the ears [tinnitus] and hearing loss, usually reversible; avoid doses greater than 200 mg)
  • Fatigue
  • Hyperuricemia
  • Itching
  • Low back pain
  • Muscle cramps
  • Rash

Serious side effects of torsemide include:

  • Atrial fibrillation
  • Electrolyte disorders
  • Lightheadedness and fainting
  • Liver disease
  • Low blood potassium (hypokalemia)
  • Low blood pressure(hypotension)
  • Skin swelling due to an allergic reaction
  • Ventricular fibrillation

Postmarketing side effects of torsemide reported include:

  • Gastrointestinal system: Pancreatitis, abdominal pain
  • Nervous System: Numbness and tingling, confusion, visual impairment, loss of appetite
  • Hematologic: Low white blood cell count(leucopenia), low platelets(thrombocytopenia), anemia
  • Hepatobiliary: Increase in liver transaminases, gamma-glutamyltransferase
  • Metabolism: Thiamine(vitamin B1) deficiency
  • Skin/hypersensitivity: Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity reaction, itching
  • Urogenital: Acute urinary retention

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

WHAT OTHER DRUGS INTERACT WITH TORSEMIDE?

 

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Torsemide has no known severe interactions with other drugs.

Serious interactions of torsemide include:

  • amikacin
  • amisulpride
  • cisapride
  • gentamicin
  • kanamycin
  • neomycin PO
  • netilmicin
  • paromomycin
  • squill
  • streptomycin
  • tobramycin

Torsemide has moderate interactions with at least 150 different drugs.

Torsemide has mild interactions with at least 76 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

WHAT ARE WARNINGS AND PRECAUTIONS FOR TORSEMIDE?

Warnings

This medication contains torsemide. Do not take Demadex if you are allergic to torsemide or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

  • Known hypersensitivity to torsemide or to povidone
  • Anuria
  • Hepatic coma

Effects of Drug Abuse

  • No information available

Short-Term Effects

  • See “What Are Side Effects Associated with Using Torsemide?”

Long-Term Effects

  • See “What Are Side Effects Associated with Using Torsemide?”

Cautions

  • Use with caution in diabetes mellitus, fluid or electrolyte imbalance (hypokalemia, hyponatremia), hyperglycemia, hyperlipidemia, hyperuricemia or gout, severe liver disease with cirrhosis and ascites
  • Use with caution in cirrhosis; avoid changes in fluid and electrolyte balance and acid-base status, which may lead to hepatic encephalopathy
  • Monitor fluid status and renal function to prevent azotemia, oliguria, and reversible increases in blood urea nitrogen(BUN) and creatinine
  • Excessive diuresis may cause potentially symptomatic dehydration, blood volume reduction and hypotension and worsening renal function, including acute renal failure particularly in salt-depleted patients or those taking renin-angiotensin-aldosterone inhibitors; worsening of renal function can also occur with concomitant use of nephrotoxic drugs (e.g., aminoglycosides, cisplatin, and nonsteroidal anti-inflammatory drugs [NSAIDs]); monitor volume status and renal function periodically
  • Can cause potentially symptomatic hypokalemia, hyponatremia, hypomagnesemia, hypocalcemia, and hypochloremic alkalosis; therapy can cause an increase in blood glucose levels and hyperglycemia; asymptomatic hyperuricemia can occur and gout may rarely be precipitated; monitor serum electrolytes and blood glucose periodically
  • Tinnitus and hearing loss (ototoxicity; usually reversible) have been observed with loop diuretics; higher than recommended doses, severe renal impairment, and hypoproteinemia, appears to increase the risk of ototoxicity

Pregnancy and Lactation

  • There are no available data on use of torsemide in pregnant women and the risk of major birth defects or miscarriage. However, in pregnant rats and rabbits administered 50 and 6.8 times the human dose, respectively, decreases in body weight, decreased fetal resorption and delayed fetal ossification were observed
  • There are no data regarding the presence of torsemide in human milk or effects on the breastfed child
  • Diuretics can suppress lactation
  • Consult your doctor before breastfeeding
  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

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Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.