IPCA-FRUSEMIDE furosemide (frusemide) 40 mg tablet bottle

Main information

  • Trade name:
  • IPCA-FRUSEMIDE furosemide (frusemide) 40 mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • IPCA-FRUSEMIDE furosemide (frusemide) 40 mg tablet bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 186520
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

186520

IPCA-FRUSEMIDE furosemide (frusemide) 40 mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Ipca Pharma (Australia) Pty Ltd

Postal Address

6 Morotai Avenue,ASHBURTON, VIC, 3147

Australia

ARTG Start Date

28/06/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. IPCA-FRUSEMIDE furosemide (frusemide) 40 mg tablet bottle

Product Type

Single Medicine Product

Effective date

20/08/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Oedema

Frusemide is indicated in adults, infants and children for the treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal

disease including the nephrotic syndrome. Frusemide is particularly useful when an agent with greater diuretic potential than that of those commonly

employed is desired.,Parenteral therapy with frusemide should be reserved for patients unable to take oral medication or for patients in emergency

clinical situations. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, frusemide is indicated by the intravenous or

intramuscular route. Parenteral use should be replaced with oral frusemide as soon as practical.,Hypertension

Oral Frusemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive

patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with frusemide alone.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

1000

(S4) Prescription Only Medicine

Components

1. IPCA-FRUSEMIDE frusemide 40 mg tablet bottle

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White to off-white, round tablets, embossed 'F4' on one side and breakline

on the other side.

Active Ingredients

furosemide (frusemide)

40 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 02:46:03 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information