Loading…
XAQUA is a brand name for Metolazone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Xaqua is indicated for the treatment of • oedema related to kidney diseases, including the nephrotic syndrome and states of impaired renal function • oedema related to congestive heart failure Xaqua is also indicated for the treatment of mild and moderate hypertension, alone or in combination with other…
Verbatim from this product's MHRA label. Tap a section to expand.
2). Therefore, the recommended doses (expressed in mg) can differ from other metolazone products. A dose adjustment may be necessary and individualised titration based on patient’s response and tolerability is advised if switching from Xaqua tablets to another metolazone product, or vice versa.
Posology Adults Treatment of Oedema Metolazone should generally be administered once daily The tablet should always be taken at the same time in relation to food. 5-5 mg/day. 5 mg/day and the dose must be adjusted according to the individual reaction of the patient.
5 mg/day, and the dose must be adjusted according to the individual reaction of the patient. Once the desired therapeutic effect has been achieved, it may be advisable to reduce the maintenance dose. Renal impairment Metolazone should be used with caution in patients with severe impaired renal function.
If azotemia and oliguria deteriorate during treatment of patients with severe renal disease, metolazone should be discontinued. 4). 4). Patient with electrolyte disturbances Metolazone should be used with caution in patients with preexisting electrolyte disturbances.
4). Elderly Metolazone should be used with caution in elderly patients. Paediatric population The safety and efficacy of Xaqua in children aged under 18 years has not yet been established. No data are available.
Within each System Organ Class, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common ( 1/10); common ( 1/100, < 1/10); uncommon ( 1/1,000, < 1/100); rare ( 1/10,000, < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
System organ class Blood and lymphatic system disorders Uncommon:
Leukopenia Rare: Aplastic or hypoplastic anemia, agranulocytosis, thrombocytopenia Immune system disorders Rare: Allergic reactions, including anaphylactic reactions Metabolism and nutrition disorders Common: Hypokalemia, hyponatremia, hypomagnesemia, hypochloremia, hypochloremic alkalosis, hyperuricemia, hyperglycemia, azotemia, glycosuria, increased serum urea (BUN) and serum creatinine Rare: Hypercalcemia, hypophosphatemia Psychiatric disorders Rare: Psychotic depression, confusion Nervous system disorders Common: Headache, dizziness, fatigue Rare: Neuropathy, vertigo, paresthesia, lethargy, drowsiness, weakness, restlessness (sometimes resulting in insomnia), apathy, seizures, hepatic encephalopathy Eye disorders Rare Transient blurred vision Cardiac disorders Rare Tachycardia, chest pain, palpitation Vascular disorders Common: Hypotension, orthostatic hypotension Rare: Syncope, dehydration, hemoconcentration, venous thrombosis Gastrointestinal disorders Common: Nausea, vomiting, constipation, diarrhoea Rare: Abdominal pain, anorexia, abdominal bloating Hepatobiliary disorders Rare: Hepatitis, intrahepatic cholestasis, pancreatitis Skin and subcutaneous tissue disorders Uncommon: Exanthema incl.
urticaria, vasculitis Rare: Toxic epidermal necrolysis (TEN), Stevens-Johnson Syndrome (SJS), purpura, dermatitis (photosensitivity) Musculoskeletal and connective tissue disorders Common: Muscle pain, muscle cramps Uncommon: Joint pain, gout Renal and urinary disorders Rare: Renal insufficiency , oliguria Reproductive system and breast disorders Rare Erectile disfunction General disorders and administration site conditions Rare: Chills Investigations Rare: Increased LDL cholesterol, increased trigylcerides Description of selected adverse reactions: Cases of choroidal effusion with visual field defect have been reported after the use of thiazide and thiazide-like diuretics.
Renal impairment Metolazone should be used with caution in patients with severe renal impairment. Renal function should be regularly monitored during thiazide therapy. Hepatic impairment In severe hepatic impairment, hypokalaemia caused by diuretics can precipitate encephalopathy.
Electrolyte imbalance Fluid and electrolyte balance should be carefully monitored during treatment with Xaqua, especially if the drug is used concurrently with medicines also affecting electrolyte balance such as other diuretics (risk of hypokalaemia), corticosteroids, ACE-inhibitors, angiotensin-II-antagonists and aldosterone antagonists.
All patients receiving metolazone should have serum electrolytes measured at regular intervals and be observed for clinical signs of fluid and/or electrolyte imbalance; namely, hypokalaemia, hyponatraemia, hypochloraemic alkalosis.
Serum and urine electrolyte measurements are particularly important when the patient is vomiting excessively, has severe diarrhoea, or is receiving parenteral fluids. Warning signs of electrolyte imbalance irrespective of cause are: dryness of mouth; thirst; weakness; lethargy; drowsiness; restlessness; muscle pains or cramps; muscular fatigue; hypotension; oliguria; tachycardia; and gastrointestinal disturbances such as nausea and vomiting.
The risk of hypokalaemia is increased when larger metolazone doses are used, when diuresis is rapid, when severe liver disease is present, when corticosteroids are given concomitantly, when oral intake is inadequate or when excess potassium is being lost extrarenally such as with vomiting or diarrhoea.
Hypokalaemia should be corrected by the addition of potassium-sparing diuretics, potassium supplements or potassium- containing salts substitutes to the regimen. Hyperkalaemia may also occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus.
1. Anuria. Hepatic coma or precomatose conditions. Severe disturbances of the electrolyte balance.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Adequate monitoring of serum potassium in patients at risk is recommended. Hyponatraemia may occur at any time during long term therapy and, on rare occasions, may be life threatening. Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Marked hypercalcemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function. Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesaemia.
Primary adrenal insufficiency Diuretics should be avoided for the treatment of hypertension if the patient has primary adrenal insufficiency, known as Addison’s disease. 5). Orthostatic hypotension associated with diuretics may be enhanced by alcohol, barbiturates and opioids.
Particular caution is also required when metolazone is used in combination with ACE- inhibitors, angiotensin-II-antagonists, aldosterone-antagonists and/or NSAIDs since there have been cases of renal failure, mostly due to enhanced dehydration.
Dose adjustments may be required Concomitant use of metolazone and furosemide may lead to unusually large or prolonged losses of fluid and electrolytes. Gout attacks Azotemia and hyperuricemia may occur during the administration of thiazide therapy.
Infrequently, attacks of gout have been reported in persons with a history of gout Choroidal effusion, acute myopia and secondary angle-closure glaucoma Sulfonamide or sulfonamide derivative drugs can cause an idiosyncratic reaction resulting in choroidal effusion with visual field defect, transient myopia and acute angle-closure glaucoma.
Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue drug intake as rapidly as possible.
Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. Lupus erythematosus Sulfonamide derivatives have been reported to exacerbate or activate systemic lupus erythematosus.
Porphyria Although not reported with Xaqua, thiazides have been associated with acute attacks of porphyria. Caution is required when Xaqua is used in porphyric patients. Glucose metabolism Xaqua has only a slight effect on the glucose metabolism.
Xaqua may increase the blood sugar level, which in patients with diabetes mellitus or latent diabetes mellitus may lead to hyperglycaemia and glycosuria. Therefore, blood sugar levels should be checked on a regular basis. In diabetic patients the antidiabetic treatment may have to be adjusted.
Laboratory values Although not reported with metolazone, thiazides and thiazide-like diuretics have been reported to adversely effect the plasma lipid profile by increasing VLDL or LDL-cholesterol and triglycerides. The clinical relevance of these observations is unclear.
Excipients This product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium-free’.