Metolazone 5mg Tablet

Metolazone 5mg Tablet is an oral thiazide-like diuretic containing 5mg of metolazone. In the UK, Xaqua 5mg Tablets is a licensed prescription-only metolazone product indicated for oedema associated with kidney disease, including nephrotic syndrome and impaired renal function, oedema associated with congestive heart failure, and mild to moderate hypertension.

Metolazone promotes the excretion of sodium and chloride and is used in clinical situations where reduction of excess fluid or blood pressure is required. The current UK product information identifies metolazone under ATC code C03BA08.

Product Information

Generic Name

Metolazone

Strength

5mg

Dosage Form

Tablet

Route

Oral

Drug Class

Thiazide-like diuretic / diuretic

Pharmacotherapeutic Group

Sulfonamides, plain

ATC Code

C03BA08

UK Reference Product

Xaqua 5mg Tablets

UK Marketing Authorisation Holder

Renascience Pharma Limited

UK Legal Category

Prescription Only Medicine (POM)

UK Marketing Authorisation

PL 44696/0010

UK Pack Sizes

20, 60 or 100 tablets, although not all pack sizes may be marketed

Metolazone 5mg and Xaqua 5mg

Metolazone is the active pharmaceutical ingredient.

Xaqua 5mg Tablets is a specific UK-licensed medicinal product containing 5mg metolazone and marketed by Renascience Pharma Ltd.

Therefore, a page for an independently manufactured Metolazone 5mg Tablet should not automatically be described as “generic Xaqua” unless the particular product has the relevant regulatory/equivalence basis.

Metolazone and Zaroxolyn

Zaroxolyn® is a historical/reference brand name associated with metolazone, particularly in the United States.

However, metolazone formulations are not necessarily interchangeable at the same milligram dose. Current U.S. labeling explicitly warns that formulations equivalent to Zaroxolyn and formulations equivalent to Mykrox should not be interchanged because their bioavailability characteristics can differ.

This is particularly important for SEO content: “Metolazone 5mg” and “Zaroxolyn 5mg” are related search entities, but they should not be treated as automatically therapeutically interchangeable products.

Metolazone 5mg Tablet Formulation

The current UK Xaqua tablet is described as a round, biplanar, white to off-white tablet with bevelled edges and a single score-line. Each tablet contains 5mg metolazone and 53mg lactose monohydrate. The tablet can be divided into equal halves.

The listed excipients include microcrystalline cellulose, lactose monohydrate, croscarmellose sodium and sodium stearyl fumarate.

Renal and Electrolyte Monitoring

Metolazone can produce clinically important changes in sodium, potassium, magnesium and other electrolytes. The UK SmPC recommends regular monitoring of serum electrolytes and careful observation for signs of fluid or electrolyte imbalance.

Particular caution is required where metolazone is used alongside other medicines that alter electrolyte balance, especially other diuretics, corticosteroids, ACE inhibitors, angiotensin-II antagonists and aldosterone antagonists.

Metolazone 5mg and Kidney Function

Metolazone is commonly associated with treatment of fluid retention in patients with kidney disease, but severe renal impairment requires careful clinical assessment.

The UK SmPC advises regular monitoring of renal function and states that metolazone should be discontinued if azotaemia and oliguria deteriorate during treatment in severe renal disease.

Metolazone 5mg and Heart Failure

Metolazone is indicated in the UK for oedema associated with congestive heart failure. Its diuretic action promotes sodium and fluid excretion, which is the basis for its role in managing fluid retention.

The medicine may also be combined clinically with other diuretics, but this requires professional supervision because combined diuretic treatment can substantially increase the risk of electrolyte abnormalities.

Metolazone 5mg and Hypertension

The UK Xaqua product is indicated for mild and moderate hypertension, either alone or with other antihypertensive medicines of a different class.

Because metolazone can contribute to hypotension and electrolyte abnormalities, blood pressure and relevant laboratory parameters may require monitoring during treatment.

UK Availability

The electronic Medicines Compendium currently lists Xaqua 5mg Tablets as a prescription-only UK medicine containing 5mg metolazone. The active ingredient search on eMC currently identifies Xaqua as the listed UK metolazone product.

For a separately manufactured Metolazone 5mg product, UK marketing authorisation, manufacturer, pack size and dispensing status should be verified for that specific product rather than assumed from the active ingredient alone.

International Market Information

Metolazone 5mg is documented in multiple international markets, although the product name, manufacturer, formulation and regulatory status vary.

In Australia, the TGA maintains ARTG records for DIULO metolazone 5mg tablets, including bottle and blister presentations.

In the United States, current DailyMed records include prescription metolazone 5mg tablets from multiple manufacturers. U.S. labeling also distinguishes different metolazone formulations because they may have different bioavailability characteristics.

South Korean pharmaceutical databases also list multiple 5mg metolazone tablet products, including products containing metolazone as the active ingredient.

International availability and dispensing requirements should always be checked against the specific country and product registration.

How it works

Metolazone reduces the reabsorption of sodium in parts of the nephron, including the ascending branch of the loop of Henle and proximal tubules. This increases urinary excretion of sodium and chloride and promotes diuresis.

The UK SmPC describes metolazone as having thiazide-type diuretic activity while retaining diuretic activity in patients with low glomerular filtration rates.

According to the current UK Xaqua SmPC, metolazone is indicated for:

Oedema associated with kidney disease:
This includes oedema related to nephrotic syndrome and states of impaired renal function.

Oedema associated with congestive heart failure:
Metolazone can be used to promote fluid removal where excess fluid is associated with heart failure.

Mild to moderate hypertension:
The UK product is also indicated for mild and moderate hypertension, either alone or with an antihypertensive medicine from another class.

Storage

The UK Xaqua SmPC states that no special temperature storage conditions are required and that the product should be stored in its original package to protect it from light. The listed shelf life is three years.

Metolazone can affect fluid balance, electrolytes and renal function, so appropriate clinical monitoring is important. The UK SmPC highlights hypokalaemia, hyponatraemia, hypomagnesaemia, hypochloraemia, hyperuricaemia, hyperglycaemia, increased urea and increased creatinine among reported metabolic effects.

Patients with severe renal impairment, severe hepatic impairment or pre-existing electrolyte disturbances require particular caution. Metolazone is contraindicated in anuria, hepatic coma or precoma, severe electrolyte disturbances, and hypersensitivity to metolazone, sulfonamides, thiazides or relevant excipients.

Commonly reported adverse effects include headache, dizziness, fatigue, hypotension, orthostatic hypotension, nausea, vomiting, constipation, diarrhoea and muscle cramps. Electrolyte abnormalities are clinically important and may become serious.

Rare reactions include renal insufficiency, oliguria, tachycardia, chest pain, pancreatitis, hepatitis, photosensitivity, severe skin reactions and other serious effects.

Metolazone 5mg Interactions

Important interactions listed in the UK SmPC include:

• Loop diuretics such as furosemide, which may considerably increase diuretic effects and the risk of electrolyte disturbances.
• Corticosteroids and ACTH, which may increase hypokalaemia risk.
• Cardiac glycosides, where hypokalaemia can increase the risk of digitalis toxicity.
• NSAIDs, which may reduce diuretic and antihypertensive effects and increase renal risk.
• Lithium, because thiazides can reduce lithium clearance and increase toxicity risk.
• Other antihypertensive medicines, which may increase hypotension.
• Calcium-containing products, where monitoring may be required.
• Cyclosporine, which may increase serum creatinine.