Torsid5 mg

Torsid is a loop diuretic (water tablet) used in the following settings:

Established / FDA-approved uses

• Edema associated with congestive heart failure, chronic renal (kidney) disease, and hepatic (liver) cirrhosis.
• Hypertension - to lower blood pressure, alone or in combination with other antihypertensive agents, to reduce the risk of fatal and non-fatal cardiovascular events such as stroke and myocardial infarction.

Notes on use

• In hepatic cirrhosis, Torsid is generally used together with an aldosterone antagonist or a potassium-sparing diuretic, as monotherapy in this setting can precipitate serious electrolyte disturbances.
• Use for indications other than the above is not established and should not be undertaken without specialist guidance.

Each tablet contains Torsemide as the active ingredient, commonly available in strengths of 5 mg, 10 mg, 20 mg, and 100 mg. An intravenous injectable formulation is also available in some markets. Exact available strengths and dosage forms vary by manufacturer and market.

Torsid is a pyridine-sulfonylurea-type loop diuretic that acts primarily on the ascending limb of the loop of Henle in the kidney. It is used to reduce fluid overload (edema) in patients with heart failure, chronic kidney disease, or liver cirrhosis, and to treat hypertension. Compared with some other loop diuretics, Torsid has a longer duration of action and higher, more consistent oral bioavailability. It is available as oral tablets and, in some markets, as an intravenous injection for use when oral therapy is not feasible.

Loop diuretic (high-ceiling diuretic)

Mechanism of action

Torsemide inhibits the Na+/K+/2Cl- co-transporter in the thick ascending limb of the loop of Henle, blocking reabsorption of sodium and chloride and promoting excretion of sodium, chloride, and water, along with increased excretion of potassium, magnesium, and calcium. This produces a dose-dependent diuretic and antihypertensive effect.

Pharmacokinetics

• Absorption: Rapidly and almost completely absorbed after oral administration (bioavailability greater than 80%), with peak plasma concentration reached within about 1 hour; food may slightly delay absorption without reducing overall extent.
• Distribution: Highly bound to plasma proteins (greater than 99%); relatively small volume of distribution.
• Metabolism: Extensively metabolized in the liver, mainly via the CYP2C9 enzyme, to metabolites with little or no diuretic activity.
• Excretion: Approximately 80% is eliminated via hepatic metabolism and biliary/fecal excretion of metabolites, with the remainder excreted unchanged in urine; elimination half-life is approximately 3.5 hours in healthy individuals.
• Onset/Duration: Diuresis begins within about 1 hour of an oral dose and lasts approximately 6-8 hours.

Torsid tablets are taken orally, once daily, with or without food, generally in the morning to avoid nocturnal diuresis disturbing sleep. Where an injectable form is used, it is administered intravenously by a healthcare professional, typically when oral administration is not practical.

The most common adverse effect of Torsid is excessive or increased urination.

Common

• Increased urination, dizziness, headache
• Electrolyte disturbances (see Precautions and Warnings)

Less common / postmarketing

• Gastrointestinal: nausea, diarrhea, constipation, abdominal pain, rarely pancreatitis
• Nervous system: paresthesia, confusion, blurred vision
• Ototoxicity: tinnitus and hearing loss, usually reversible (see Precautions)
• Hematologic (rare): leukopenia, thrombocytopenia, anemia
• Dermatologic (rare): photosensitivity, and very rare serious skin reactions such as Stevens-Johnson syndrome/toxic epidermal necrolysis
• Urogenital: acute urinary retention (particularly in patients with bladder outlet obstruction)

Pregnancy: There are no adequate, well-controlled human studies of Torsid in pregnancy. Animal reproduction studies have not shown teratogenicity at therapeutic doses, though fetal toxicity was observed at higher doses. Torsid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and only under close medical supervision.

Lactation: It is not known whether Torsid is excreted in human breast milk. Diuretics in general may suppress lactation. A decision on breastfeeding while using Torsid should be made only after consulting a physician, weighing the benefits of breastfeeding against the mother's clinical need for the drug.

Fluid, electrolyte, and renal monitoring

Excessive diuresis with Torsid can cause dehydration, reduction in blood volume, hypotension, and worsening renal function, particularly in elderly patients or with aggressive dosing. Periodic monitoring of serum electrolytes (sodium, potassium, magnesium, chloride), renal function, and blood glucose/uric acid is recommended, especially at higher doses or with concurrent diuretic combinations.

Electrolyte disturbances

Risk of hypokalemia, hyponatremia, hypomagnesemia, and hypochloremic metabolic alkalosis. Hyperuricemia and, rarely, precipitation of acute gout may occur; hyperglycemia has also been reported.

Ototoxicity

Tinnitus and hearing loss (usually reversible) have been reported, especially with rapid intravenous administration, very high doses, severe renal impairment, or when given with other ototoxic drugs; caution is advised in these situations.

Hepatic cirrhosis

Sudden alterations in fluid and electrolyte balance in patients with cirrhosis and ascites may precipitate hepatic coma; diuresis should generally be initiated in a hospital setting under close monitoring, with concurrent use of an aldosterone antagonist or potassium-sparing diuretic.

Sulfonamide hypersensitivity

Torsid is chemically related to sulfonamide-derived drugs; patients with known sulfonamide allergy may have cross-sensitivity and should be monitored closely if the drug is used.

Lithium therapy

Concurrent lithium use increases the risk of lithium toxicity due to reduced renal lithium clearance; monitor lithium levels closely.

Overdosage with Torsid may cause dehydration, hypovolemia, hypotension, hyponatremia, hypokalemia, and hypochloremic alkalosis. There is no specific antidote. If overdose is suspected, seek immediate medical attention or contact a poison control center; treatment is supportive, consisting of fluid and electrolyte replacement under medical supervision. Torsid is not significantly removed by dialysis.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Pediatric use

Safety and efficacy of Torsid in pediatric patients have not been established.

Geriatric use

No overall differences in effectiveness or safety have been observed between elderly and younger patients in clinical studies, but elderly patients may be more sensitive to excessive diuresis, dehydration, and electrolyte disturbances; use with caution and monitor closely.

Renal impairment

Total body clearance of Torsid is not markedly altered in renal impairment, though higher doses may be required to achieve an adequate diuretic response; monitor renal function and electrolytes.

Hepatic impairment

Use with caution; risk of precipitating hepatic coma from fluid/electrolyte shifts (see Precautions and Warnings). Initiate in hospital with concomitant aldosterone antagonist or potassium-sparing diuretic.

Duration of treatment with Torsid depends on the underlying condition: hypertension and chronic edematous states (heart failure, chronic kidney disease, cirrhosis) typically require long-term, often indefinite, therapy with periodic reassessment of dose and clinical/laboratory monitoring by a physician; the lowest effective dose should be used and treatment reviewed regularly.

Loop diuretics; High-ceiling diuretics; Antihypertensive agents

Torsemide inhibits the Na+/K+/2Cl- co-transport system in the thick ascending limb of the loop of Henle, reducing reabsorption of sodium and chloride and increasing urinary excretion of sodium, chloride, water, potassium, magnesium, and calcium, producing diuresis and a reduction in blood pressure.

B

The safety and efficacy of Torsid in pediatric patients have not been established, and it is not generally recommended for use in children outside specialist supervision. Loop diuretics, including Torsid, used in premature infants have been associated with nephrocalcinosis/nephrolithiasis; renal ultrasound monitoring may be warranted if used in this population under specialist care.