Metenix 5 Tablets

1. Name Of The Medicinal Product

Metenix 5mg Tablets

2. Qualitative And Quantitative Composition

Metolazone 5 mg

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Metenix 5mg Tablets is a diuretic for use in the treatment of mild and moderate hypertension. Metenix 5mg Tablets may be used in conjunction with non-diuretic antihypertensive agents and, in these circumstances, it is usually possible to achieve satisfactory control of blood pressure with a reduced dose of the non-diuretic agent. Patients who have become resistant to therapy with these agents may respond to the addition of Metenix 5mg Tablets to their antihypertensive regimen.

Metenix 5mg Tablets may also be used for the treatment of cardiac, renal and hepatic oedema, ascites or toxaemia of pregnancy.

4.2 Posology And Method Of Administration

Route of administration: Oral

Hypertension: The recommended initial dose in mild and moderate hypertension is 5 mg daily. After three to four weeks, the dose may be reduced if necessary to 5 mg on alternate days as maintenance therapy.

Oedema: In oedematous conditions, the normal recommended dose is 5-10 mg daily, given as a single dose. In resistant conditions, this may be increased to 20 mg daily or above. However, no more than 80 mg should be given in any 24-hour period.

Children: There is insufficient knowledge of the effects of Metenix 5mg Tablets in children for any dosage recommendations to be made.

Elderly: Metolazone may be excreted more slowly in the elderly.

4.3 Contraindications

Metenix 5mg Tablets is contra-indicated in electrolyte deficiency states, anuria, coma or pre-comatose states associated with liver cirrhosis; also in patients with known allergy or hypersensitivity to metolazone.

4.4 Special Warnings And Precautions For Use

Because of the antihypertensive effects of metolazone the dosage of concurrently administered non-diuretic antihypertensive agents may need to be reduced.

Caution should be exercised during Metenix 5mg Tablets therapy in patients liable to electrolyte deficiency.

Chloride deficit, hyponatraemia and a low salt syndrome may also occur, particularly when the patient is also on a diet with restricted salt intake. Hypomagnesaemia has been reported as a consequence of prolonged diuretic therapy.

Prolonged therapy with Metenix 5mg Tablets may result in hypokalaemia. Serum potassium levels should be determined at regular intervals and, if necessary, potassium supplementation should be instituted.

Fluid and electrolyte balance should be carefully monitored during therapy especially if Metenix 5mg Tablets is used concurrently with other diuretics. In particular, Metenix 5mg Tablets may potentiate the diuresis produced by furosemide and, if the two agents are used concurrently, patients should be carefully monitored.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The dosage of concurrently administered cardiac glycosides may require adjustment. Metenix 5mg Tablets may aggravate the increased potassium excretion associated with steroid therapy or diseases such as cirrhosis or severe ischaemic heart disease. Latent diabetes may become manifest or the insulin requirements of diabetic patients may increase.

Non steroidal anti-inflammatory drugs (e.g. Indometacin, Sulindac) may attenuate the action of Metolazone.

Prolongation of bleeding time has been reported during concomitant administration of Metenix and warfarin.

4.6 Pregnancy And Lactation

There is little evidence of safety of the drug in human pregnancy, but it has been in wide, general use for many years without apparent ill consequence, animal studies having shown no hazard.

If Metenix 5mg Tablets is given to nursing mothers, metolazone may be present in the breast milk.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Metenix 5mg Tablets is generally well tolerated. There have been occasional reports of headache, anorexia, vomiting, abdominal discomfort, muscle cramps and dizziness. There have been isolated reports of urticaria, leucopenia, tachycardia, chills and chest pain.

Hyperuricaemia or azotaemia may occur during treatment with Metenix 5mg Tablets, particularly in patients with impaired renal function. On rare occasions, clinical gout has been reported.

4.9 Overdose

In cases of overdose there is a danger of dehydration and electrolyte depletion. Treatment should therefore be aimed at fluid replacement and correction of the electrolyte imbalance.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Metolazone is a substituted quinazolinone diuretic.

5.2 Pharmacokinetic Properties

Diuresis and saluresis begin within one hour of administration of Metenix 5mg Tablets tablets, reaching a maximum in two hours and continuing for 12-24 hours according to dosage.

5.3 Preclinical Safety Data

None applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Microcrystalline cellulose, magnesium stearate, F D and C blue no 2 lake (E132)

6.2 Incompatibilities

None.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

Metenix 5mg Tablets tablets should be stored protected from light, in the original container or in containers similar to those of the manufacturer.

6.5 Nature And Contents Of Container

Blister pack of 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey, GU1 4YS, UK

8. Marketing Authorisation Number(S)

PL 04425/0212

9. Date Of First Authorisation/Renewal Of The Authorisation

5 November 2001

10. Date Of Revision Of The Text

21 September 2010

LEGAL STATUS

POM