Renix Furosemide Tablet

RENIX®
FUROSEMIDE BP 40 MG

 

COMPOSITION

Each uncoated tablet contains:
Furosemide BP 40 mg
Excipients q.s

 

Pharmacologial Action

Furosemide is a loop diuretic (water pill) that prevents your body from absorbing too much salt. This allows the salt to instead be passed in your urine.

It acts along the entire nephron with the exception of the distal exchange site. The main effect is the ascending limb of the loop of Henley with complex effect on renal circulation. Blood-flow is diverted from the juxta-medullary region to the outer cortex.

The principle renal action of furosemide is to inhibit active chloride transport in the thick ascending limb. Re-absorption of sodium chloride from the nephron is reduced and a hypotonic or isotonic urine is produced.

 

Therapeutic category

Loop diuretic.

 

Therapeutic Indications

Frosemide is a diuretic recommended for use in all indications where a prompt and effective diuresis is required.

The treatment of oedema associated with congestive heart failure, cirrhosis of the liver, renal disease including nephrotic syndrome and pulmonary oedema.

The treatment of peripheral oedema due to mechanical obstruction, venous insufficiency, mild to moderate hypertension.

 

Posology and Method of administration

Route of administration: Oral.

Adults and children over 12 years

Oedema: Initially 40 mg daily in the morning; ordinarily a prompt diuresis ensues and the starting dose can then be maintained or even reduced. Diuresis lasts for approximately 4 hours following administration and hence the time of administration can be adjusted to suit the patients requirements. Maintenance dose is 20 mg daily or 40mg on alternate days, increased in resistant oedama to 80mg daily.

Hypertension: 20 – 40 mg twice daily; if 40 mg twice daily does not lead to a clinically satisfactory response, the addition of other antihypertensive agents, rather than an increase in the dose of furosemide should be considered.

Children under 12 years: A more suitable dosage form should be used in this age group.

Elderly: Furosemide is generally eliminated more slowly. The dosage should be titrated until the required response is achieved.

 

Contraindications

Furosemide is contraindicated in the following circumstances:

•Hypersensitivity to furosemide, any of its excipients, sulphonamides, sulphonamide derivatives/amiloride.

• Anuria and impaired renal function and renal failure resulting from poisoning by nephrotosic and/or hepatotoxic agents.

• Electrolyte disturbances, dehydration and/or hypotension

• Concomitant potassium supplements or potassium sparing diuretics

• Pre-coma/coma associated with hepatic cirrhosis or encephalopathy

• Addison’s disease

• Digitalis intoxication

 

Warning and Precautions

Hypotension and/or hypovolaemia and any acid-base disturbances should be corrected before furosemide is started.

 

Dose titration/adjustment

• Patients with hypoproteinaemia (such as that associated with the nephotic syndrome) require careful dose titration (reduced furosemide effect: increased risk of ototoxicity)

• In moderate liver congestion dosage adjustment may be needed.

 

Caution required

• Impaired hepatic function and renal function

• Diabetes mellitus

• Elderly patients

• Difficulty with micturition/potential obstruction in the urinary tract including prostatic hypertrophy (increased risk of acute retention)

• Gout (increased risk of hyperuricaemia)

• Patients at risk of pronounced falls in blood pressure

 

Regular monitoring for

• Blood dyscrasias. Lf these occur, stop furosemide immediately

• Liver damage

• Idiosyncratic reactions

 

Pregnancy and Lactation

The drug should not be used is pregnant women unless the benefits to the patient outweigh the possible risk to the foetus which includes persistence of patent ductus arteriosus.

Furosemide may inhibit lactation or may pass into the breast milk, it should therefore be used with caution in nursing mothers.

 

Adverse effects

Nausea and gastric discomfort may occur but are rarely severe enough to necessitate cessation of treatment. Rapid diuresis may cause acute discomfort and incontinence is some elderly patients. Furosemide can cause skin rashes and if the drug is suspected as the cause of a rash, treatment should, be stopped. A small number of cases of exfoliative dermatitis have been associated with use of Furosemide.

As like other loop diuretics, it may cause ototoxicity. The deafness caused by Furosemide is usually reversible when the drug is stopped. Prolonged use of high doses of Furosemide in patients with severe disease, coupled with limitation of salt intake may lead to hyponatraemia.

Diuretics, including Furosemide may affect plasma lipid concentrations. Serum triglycerides levels and to lesser degree, serum cholesterol concentrations increase concomitantly with a rise of low density lipoprotein (LDL) Cholesterol and decrease of high density lipoprotein (HDL) Cholesterol.

 

Drug interactions

Antihypertensives – Enhanced hypotensive effect possible with all types. Concurrent use with ACE inhibitors can result in marked falls in blood pressure.

Antipsychotics – Furosemide induced hypokalaemia increases the risk of cardiac toxicity.

Drugs associated with QT prolongation – Cardiac toxicity may be increased by furosemide-induced hypokalaemia and/or hypomagnesaemia

Cardiac glycosides – Hypokalaemia and electrolyte disturbances increases the risk of cardiac toxicity

Vasodilators – Enhanced hypotensive effect with thymoxamine or hydralazine

Nitrates – Enhanced hypotensive effect

Lipid regulating drugs – Reduced absorption of furosemide

NSAIDs – Increased risk of nephrotoxicity. In patients with dehydration or hypovolaemia, NSAIDs may cause acute renal insufficiency.

Salicylates – Effects may be potentiated by furosemide.

Antibiotics – Increased risk of ototoxicity with aminoglycosides, polymixins or vancomycin. Furosemide can decrease vancomycin serum levels after cardiac surgery.

Antidepressants – Enhanced hypotensive effect with MAOIs. Increased risk of postural hypotension with tricyclic antidepressants.

Antidiabetics – Hypoglycaemic effects antagonised by furosemide.

Antieplieptics – Increased risk of hyponatraemia with carbamazepine. Diuretic effect reduced by phenytoin.

Antifugals – lncreased risk of hypokalaemia with amphoterecin.

Corticosteroids – Diuretic effectantagonised (sodium retention) and increased risk of hypokalaemia.

Oestrogens and progestogens – Diuretic effect antagonized.

Prostaglandins – Enhanced hypotensive effect with alprostadil.

Theophylilne – Enhanced hypotensive effect.

Probenecid – Reduced renal clearance of furosemide and decreased diuretic effect.

Anaesthetic agents – General anaesthetic agents may enhance the hypotensive effects of furosemide. The effects of curare may be enhanced by furosemide.

Alcohol – Enhanced hypotensive effect.

 

Overdosage

Symptoms include dehydration and electrolyte depletion due to excessive diuresis. In cirrhotic patients, overdosage may precipitate hepatic coma.

Treatment should be aimed at fluid replacement and correction of the electrolyte imbalance. The drug should be discontinued and electrolyte and water replacement instituted immediately; adjustment should be on the basis of careful monitoring.

 

Pharmaceutical information

Storage conditions
Do not store above 30oC. Protect from light and moisture.
Keep all medicine out of reach of children.

 

Shelf life

36 months

 

Pack size

Blister Pack of 10 tablets

 

Manufactured by

Fredun Pharmaceutical Ltd.

14, 15, 16, Zorabian Industrial Complex,

Veoor, Palghar (E) – 401 404, INDIA

 

Manufactured for

Reals Pharmaceutical Ltd.

1, Alh. Junaid Dosunmu Str. CBD,

Alausa, Ikeja, Lagos.

 

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