Auroxetil

Main information

  • Trade name:
  • Auroxetil Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Auroxetil Tablet
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL11125015, MAL11125016, MAL11125017
  • Last update:
  • 28-05-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

AUROXETIL

Consumer Medication Information Leaflet (RiMUP)

Cefuroxime axetil (125mg, 250mg, 500mg)

What is in this leaflet

What Auroxetil is used for

How Auroxetil works

Before you take Auroxetil

How to take Auroxetil

While you are using Auroxetil

Side effects

Storage and Disposal of

Auroxetil

Product Description

Manufacturer and Product

Registration Holder

Date of revision

What Auroxetil is used for

Your

doctor

have

prescribed

Auroxetil tablets to treat one of the

following infections:

Upper respiratory tract infections

(including infections occurring in

the ears, sinuses, tonsils and throat).

Lower respiratory tract infections,

inflammation

lungs

(Pneumonia), inflammation of the

lung air passages (acute bronchitis)

and acute exacerbations of chronic

bronchitis.

Bladder infections.

Skin

infections

recurring

boils,

ulcers, contagious infection of the

skin (Impetigo).

Sexually

transmitted

infections

such

Gonorrhoea,

Gonococcal

urethritis and inflammation of the

cervix (cervicitis).

How Auroxetil works

Auroxetil is an antibiotic and belongs

class

medicines

called

“cephalosporins”. It is active against a

wide range of bacteria. It is used to

treat certain types of infections and

works

killing

certain

types

bacteria.

Before you take Auroxetil

- When you must not take it

If you are hypersensitive (allergic) to

Cephalosporin class of antibiotics or

other

ingredients

Auroxetil.

Tell your doctor if you are not sure

about any of the above: your doctor

will be able to advise you.

- Before you start to take it

Tell your doctor before you start to

take this medicine if:

You have previously suffered from

an allergic reaction to penicillins or

other beta-lactam antibiotics.

suffer

from

other

condition which causes vomiting,

diarrhea

this

could

stop

your

medicine

from

being

absorbed

properly. In this case your doctor

recommend

injection

Cefuroxime.

If after starting treatment, you begin

to experience symptoms of an allergic

reaction stop taking your medicine

and contact your doctor immediately.

during

treatment,

develop

sickness

diarrhea

then

contact

your doctor as this could stop your

medicine from being absorbed

properly.

Indicate

that

suffering

from

serious

condition

called “pseudomembranous colitis”.

Your medicine may cause overgrowth

of other microorganisms which occur

naturally in your body. This can lead

to other conditions such as vaginal

thrush and stomach upsets.

Pregnancy and breast-feeding

This medicine may not be suitable for

pregnant

breast

feeding. Talk to your doctor about

using Auroxetil if you are pregnant or

planning

becoming

pregnant.

Auroxetil is excreted in breast milk,

consult your doctor before you use

Auroxetil whilst breast-feeding.

- Taking other medicines

Talk to your doctor if you are taking

medicines

which

decrease

stomach

acidity (such as medicines used to

treat

indigestion,

heartburn

stomach

ulcers).

These

could

stop

your medicine from being absorbed

properly.

Taking Auroxetil can interfere with

certain medical test including those

used to determine levels of glucose

(sugar) in your blood. If you are due

to have a medical test make sure that

your doctor knows that you are taking

Auroxetil before test. If you monitor

the levels of glucose in your blood or

urine yourself (e.g. diabetic patients)

speak to your doctor or

Pharmacist to see if your medicine

could affect the results of your test.

How to take Auroxetil

- How much to take

Take your medicine as your doctor

has told you. The label on it will

usually tell you how many to take

often.

Auroxetil

works

best

taken

immediately

after

food. If you are not sure, ask your

doctor

pharmacist.

usual

dose is:

Adults:Most

Infections:

twice daily.

Children:Most Infections: 125 mg

twice daily, to a maximum of 250

mg daily.

Children ≥ 2 years: Otitis Media or

Where

Appropriate,

with

More

Severe Infections: 250 mg twice

daily, to a maximum of 500 mg

daily.

- When to take it

You may take your tablets together

with food or immediately after a meal.

You should swallow the tablets with a

glass of water.

- How long to take it

Keep

taking

Auroxetil

until

treatment is finished, even if you feel

better do not stop taking the tablets,

stopping the tablets may lead

to return of infection.

If you have any further questions on

the use of this medicine, ask your

doctor or pharmacist.

- If you forget to take it

Take

Auroxetil

prescribed.

However if you miss a dose, take the

missed dose as soon as you

remember. If it is almost time for your

next dose, skip the missed dose and

return

your

normal

dosing

schedule.

Do not take a double dose to make up

for a forgotten tablet.

AUROXETIL

Consumer Medication Information Leaflet (RiMUP)

Cefuroxime axetil (125mg, 250mg, 500mg)

often

forget

take

your

medicine,

your

doctor

pharmacist know.

- If you use too much (overdose)

accidentally

take

many

tablets, or if someone else or a child

takes your medicine, talk to a doctor

or pharmacist immediately.

Over dosage of cephalosporins can

cause convulsions.

While you are using Auroxetil

- Things you must do

If you feel unwell or if you have

concerns about a side effect, you will

need to seek advice. If you feel very

ill, get medical help straight away. If

you have any unused medicine, return

it to your pharmacist who will dispose

it of safely. These measures will help

to protect the environment.

- Things you must not do

You must not take the medicine after

expiry

date

shown

packaging.

- Things to be careful of

Treatment with antibiotic Cefuroxime

Axetil is unlikely to interfere with the

ability to drive and use machines.

Side effects

Adverse

reactions

Cefuroxime

axetil have been generally mild and

transient

nature.

with

other

cephalosporins, there have been rare

reports of serious skin reactions:

- Erythema multiforme

- Stevens-Johnson syndrome

-Toxic

epidermal

necrolysis

(exanthematic necrolysis)

- Hypersensitivity reactions including

skin

rashes,

hives,

itchiness,

drug

fever,

serum

sickness,

very

rarely,anaphylaxis

There have been rare reports of

Thrombocytopenia

(low

platelet

count)

- Leucopenia (decrease in the number

white

blood

cell,

sometimes

profound

- Jaundice

Small

number

consumers

have

experienced

Gastrointestinal

disturbances,

including

diarrhea,

nausea

vomiting

- Pseudomembranous colitis

- Headache

-Eosinophilia (increase in eosinophils

in blood)

- Transient increases of liver enzyme

levels

Cephalosporins

class

interact

with

blood

produce

positive

Coombs'

test

(which

interfere

with

cross-matching

blood) and very rarely, haemolytic

anaemia (abnormal breakdown of red

blood cell).

If any of the side effects gets serious,

or if you notice any side effects not

listed in this leaflet, please tell your

doctor or pharmacist.

You may report any side effects or

adverse drug reactions directly to the

National

Centre

Adverse

Drug

Reaction Monitoring by calling

Tel:

03-78835550,

visiting

website npra.moh.gov.my (Public

Reporting Medicinal Problems / Side

Effects / AEFI / Vaccine Safety).

Storage and Disposal of Auroxetil

- Storage

Keep out of the reach and sight of

children.

Do not store above 30ºC.

Do not use Auroxetil after the expiry

date which is stated on the carton/

blister after EXP.

The expiry date refers to the last day

of that month.

- Disposal

Medicines should not be disposed of

via waste water or household waste.

Ask your pharmacist how to dispose

medicines

longer

required.

These measures will help to protect

the environment.

Product Description

- What it looks like

Cefuroxime Axetil Tablets 125 mg:

White to off-white, uncoated, capsule

shaped tablets with 'A32' debossed on

one side and plain on the other side.

Cefuroxime Axetil Tablets 250 mg:

White to off-white, uncoated, capsule

shaped tablets with 'A33' debossed on

one side and plain on the other side.

Cefuroxime Axetil Tablets 500 mg:

White to off-white, uncoated, capsule

shaped tablets with 'A34' debossed on

one side and plain on the other side.

- Ingredients

Active ingredient(s)

Cefuroxime Axetil.

Inactive ingredients

Microcrystalline cellulose (E 460),

croscarmellose sodium,sodium

lauryl sulphate, hydrogenated

vegetable oil and colloidal silicon

dioxide.

- MAL number:

Auroxetil 125 mg:MAL11125015AZ

Auroxetil 250 mg:MAL11125016AZ

Auroxetil 500mg:MAL11125017AZ

Manufacturer

Aurobindo Pharma Limited,

Unit-VI,

Survey

329/39

&

329/47,

Chitkul

(V),

Patancheru

Mandal, Medak, District, Telangana

State, India.

Regd. Office:

Plot No.: 2, Maitrivihar

Ameerpet, Hyderabad – 500 038,

Telangana State, India.

Product Registration Holder in

Malaysia:

Healol Pharmaceuticals Sdn Bhd,

74-3, Jalan Wangsa Delima 6, KLSC

Wangsa Maju, 53300 Kuala Lumpur.

Date of revision

11/10/2017.

Serial Number

BPFK(R4/1)140717/00172