AZITHROMYCIN ALPHAPHARM Azithromycin (as monohydrate) 500mg Powder for Injection Vial

Main information

  • Trade name:
  • AZITHROMYCIN ALPHAPHARM Azithromycin (as monohydrate) 500mg Powder for Injection Vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AZITHROMYCIN ALPHAPHARM Azithromycin (as monohydrate) 500mg Powder for Injection Vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 191947
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

191947

AZITHROMYCIN ALPHAPHARM Azithromycin (as monohydrate) 500mg Powder for Injection Vial

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

19/09/2012

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. AZITHROMYCIN ALPHAPHARM Azithromycin (as monohydrate) 500mg Powder for Injection Vial

Product Type

Single Medicine Product

Effective date

11/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. In clinical studies efficacy has been

demonstrated against Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophilia, Moraxella catarrhalis, Mycoplasma pneumoniae,

Staphylococcus aureus and Streptococcus pneumoniae.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Store in Original

Container

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

(S4) Prescription Only Medicine

Components

1. AZITHROMYCIN ALPHAPHARM Azithromycin (as monohydrate) 500mg Powder for Injection Vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous Infusion

Visual Identification

A white to off-white lyophilized powder or cake.

Active Ingredients

Azithromycin

500 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 28.11.2017 at 09:38:16 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

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

Azithromycin

Alphapharm

contains the active ingredient azithromycin

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about AZITHROMYCIN

ALPHAPHARM.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking

AZITHROMYCIN ALPHAPHARM

against the benefits expected for you.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with your

medicine.

You may need to read it again.

What AZITHROMYCIN

ALPHAPHARM is

used for

AZITHROMYCIN ALPHAPHARM

is used to treat Pneumonia, a lung

infection caused by certain bacteria

including Legionella pneumophila.

This medicine is an antibiotic, which

belongs to a group of medicines

called azalides.

The azalides are a sub-class of a

group of antibiotics called

macrolides.

This medicine works by killing or

stopping the growth of bacteria

causing your infection.

AZITHROMYCIN ALPHAPHARM

will not work against viral infections

such as colds or flu.

Your doctor may have prescribed

AZITHROMYCIN ALPHAPHARM

for another reason.

Ask your doctor if you have any

questions about why

AZITHROMYCIN

ALPHAPHARM has been

prescribed for you.

This medicine is not addictive.

This medicine is available only with

a doctor's prescription.

This medicine is not expected to

affect your ability to drive a car or

operate machinery.

Before you are given

AZITHROMYCIN

ALPHAPHARM

When you must not be given

it

You must not be given

AZITHROMYCIN

ALPHAPHARM if you have an

allergy to:

Azithromycin or any other ketolide

or macrolide antibiotic (e.g.

roxithromycin, erythromycin,

clarithromycin, telithromycin) or any

of the ingredients listed at the end of

this leaflet.

If you are not sure if you are

allergic to any of the above, ask

your doctor.

Symptoms of an allergic reaction

may include shortness of breath,

wheezing or difficulty breathing;

swelling of the face, lips, tongue or

other parts of the body; skin rash,

itching or hives.

AZITHROMYCIN

ALPHAPHARM must not be given

if the expiry date (EXP) or use by

date printed on the pack has

passed. If you take this medicine

after this date, it may not work.

AZITHROMYCIN

ALPHAPHARM must not be given

if the packaging is torn or shows

signs of tampering.

If you are not sure whether you

should be given this medicine, talk to

your doctor.

Before you are given it, tell your

doctor if you have allergies to any

other medicines, foods,

preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

any kidney problems

any liver problems

any heart problems

low levels of potassium or

magnesium in your blood

myasthenia gravis

if you are pregnant or if you plan

to become pregnant or are

breastfeeding. Your doctor can

discuss with you the risks and

benefits involved.

If you have not told your doctor

about any of the above, tell him/

her before you are given

AZITHROMYCIN

ALPHAPHARM.

AZITHROMYCIN ALPHAPHARM

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

medicines you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Some medicines may interfere with

AZITHROMYCIN ALPHAPHARM.

These include:

antacids (a medicine used to treat

indigestion)

coumarin-type oral anticoagulants

(a medicine used to prevent blood

clots)

cyclosporin (a medicine used to

prevent organ transplant rejection

or to treat certain problems with

the immune system)

digoxin (a medicine used to treat

abnormal heart rhythm e.g. atrial

fibrillation)

ergot derivatives (such as

ergotamine, a medicine used to

treat migraines)

terfenadine or astemizole

(medicines used to treat allergies

and hayfever)

zidovudine (a medicine used to

treat patients with AIDS)

some medicines used to treat

heart rhythm problems (heart

arrhythmia) such as amiodarone,

disopyramide, ibutilide and

sotalol

antipsychotic medicines used to

treat schizophrenia or bipolar

mania such as haloperidol,

quetiapine and risperidone

medicines used to treat

depression (antidepressants) such

as fluoxetine, sertraline and

venlafaxine

fluoroquinolone antibiotics such

as ciprofloxacin, lomefloxacin,

moxifloxacin and norfloxacin.

These medicines may be affected by

AZITHROMYCIN ALPHAPHARM

or may affect how well it works. You

may need different amounts of your

medicines, or you may need to take

different medicines.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while taking

AZITHROMYCIN ALPHAPHARM.

Talk to your doctor about the need

for additional contraception while

taking AZITHROMYCIN

ALPHAPHARM.

Some antibiotics may decrease the

effectiveness of some birth control

pills, although this has not been

shown with AZITHROMYCIN

ALPHAPHARM.

How AZITHROMYCIN

ALPHAPHARM is

given

Follow all directions given to you

by your doctor and pharmacist

carefully.

They may differ from the

information contained in this leaflet.

How much is given

Your doctor will decide how much

AZITHROMYCIN ALPHAPHARM

you should receive and the length of

time for which you should receive it.

The usual dose of AZITHROMYCIN

ALPHAPHARM is 500 mg given as

an injection into a vein for 2 to 5

days.

This treatment may be followed by a

course of oral antibiotics.

How it is given

AZITHROMYCIN ALPHAPHARM

is given as an injection by a doctor or

trained nurse.

AZITHROMYCIN ALPHAPHARM

is a powder which is mixed with

Water for Injections and then diluted

by the pharmacist. It is then injected

into a vein which takes

approximately 60 minutes.

It may be given with or without food.

If you need to take an antacid (e.g.

Dexsal, gastrogel, Mylanta), take it

at least one hour before or one

hour after your dose of

AZITHROMYCIN

ALPHAPHARM.

This will avoid any possible effect of

the antacid on the absorption of

AZITHROMYCIN ALPHAPHARM

If too much is given

(overdose)

As AZITHROMYCIN

ALPHAPHARM is given under the

close supervision of your doctor, it is

very unlikely that you will receive

too much. If you experience any side

effects tell your doctor immediately.

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

taken too much AZITHROMYCIN

ALPHAPHARM. Do this even if

there are no signs of discomfort or

poisoning.

You may need urgent medical

attention.

While you are being

treated

Things you must do

If the symptoms of your infection

do not improve within a few days,

or if they become worse, tell your

doctor.

If you get severe diarrhoea, tell

your doctor, pharmacist or nurse

immediately. Do this even if it

occurs several weeks after

AZITHROMYCIN

ALPHAPHARM has been stopped.

Diarrhoea may mean that you have a

serious condition affecting your

bowel. You may need urgent medical

care. Do not take any diarrhoea

medicine without first checking with

your doctor.

If you get a sore, white mouth or

tongue while taking, or soon after

stopping AZITHROMYCIN

ALPHAPHARM, tell your doctor.

AZITHROMYCIN ALPHAPHARM

Also tell your doctor if you get

vaginal itching or discharge.

This may mean you have a yeast

infection called thrush. Sometimes

the use of AZITHROMYCIN

ALPHAPHARM allows yeast to

grow and the above symptoms to

occur. AZITHROMYCIN

ALPHAPHARM does not work

against yeast.

If you become pregnant while

taking this medicine, tell your

doctor.

If you are about to start any new

medicines, tell your doctor and

pharmacist that you are taking

AZITHROMYCIN

ALPHAPHARM.

Tell all doctors, dentists and

pharmacists who treat you that

you are taking this medicine.

Things to be careful of

Protect your skin when you are in

the sun, especially between 10am

and 3pm.

Some macrolide antibiotics may

cause your skin to be more sensitive

to sunlight than it is normally.

Exposure to sunlight may cause a

skin rash, itching, redness or severe

sunburn.

If outdoors, wear protective

clothing and use a 30+ sunscreen.

If your skin does appear to be

burning tell your doctor

immediately.

Things you must not do

Do not stop taking

AZITHROMYCIN

ALPHAPHARM or lower the

dosage without checking with your

doctor.

If you do not complete the full course

prescribed by your doctor, all the

organisms causing your infection

may not be killed. These organisms

may continue to grow and multiply

so that your infection may not clear

completely or may return.

Do not give AZITHROMYCIN

ALPHAPHARM to anyone else,

even if they have the same

condition as you.

Do not use AZITHROMYCIN

ALPHAPHARM to treat any other

medical complaints unless your

doctor tells you to.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

AZITHROMYCIN

ALPHAPHARM.

Like other medicines,

AZITHROMYCIN ALPHAPHARM

can cause some side effects. If they

occur, most are likely to be minor

and temporary. However some

maybe serious and need medical

attention.

Ask your doctor or pharmacist to

answer any questions you may

have.

Do not be alarmed by the following

list of side effects. You may not

experience any of them.

While taking it

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

pain or inflammation at the site of

infusion and pain during infusion

oral thrush - white, furry, sore

tongue and mouth

vaginal thrush - sore and itchy

vagina and/or white discharge

nausea (feeling sick), loss of

appetite, vomiting, stomach pain,

indigestion, wind, constipation,

loose bowel motions

dizziness, headache, spinning

sensation

tiredness, drowsiness, fatigue

muscle or joint aches

rash

hearing loss or ringing in the ears

altered taste and smell.

These side effects are usually mild.

Tell your doctor immediately if

you notice any of the following:

severe persistent diarrhoea

fast or irregular heart beat

symptoms of sunburn such as

redness, itching, swelling or

blistering which may occur more

quickly than normal

decreased feeling or sensitivity,

especially in the skin

hives, itching or skin rash

signs of frequent or worrying

infections such as fever, severe

chills, sore throat or mouth ulcers

bleeding or bruising more easily

than normal, reddish or purplish

blotches under the skin

dark urine or blood in the urine or

bowel motions

aggressive reaction, nervousness,

agitation or anxiety

severe upper stomach pain, often

with nausea and vomiting.

These are serious side effects. You

may need urgent medical attention.

Serious side effects are rare.

If any of the following happen, stop

taking AZITHROMYCIN

ALPHAPHARM and tell your

doctor immediately or go to

Accident and Emergency at your

nearest hospital:

sudden signs of allergy such as

rash, itching or hives on the skin,

swelling of the face, lips, tongue

or other parts of the body,

shortness of breath, wheezing or

trouble breathing

blisters or ulcers on the skin, in

the mouth or airways that may

occur after a period of fever

diarrhoea, usually with blood and

mucus, stomach pain and fever

yellowing of the eyes or skin, also

called jaundice

chest pain

fainting

convulsions (fits)

These are very serious side effects.

You may need urgent medical

AZITHROMYCIN ALPHAPHARM

attention or hospitalisation. These

side effects are rare.

After finishing it

Tell your doctor immediately if

you notice any of the following side

effects, particularly if they occur

several weeks after stopping

treatment with AZITHROMYCIN

ALPHAPHARM:

severe stomach cramps

watery and severe diarrhoea,

which may be bloody

fever, in combination with one or

both of the above

AZITHROMYCIN ALPHAPHARM

can cause some bacteria, which are

normally present in the bowel and

normally harmless to multiply and

therefore cause the above symptoms.

You may need urgent medical

attention. However, this side effect is

rare.

Do not take any medicine for this

diarrhoea without first checking

with your doctor.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Other side effects not listed above

may also occur in some patients.

Some of these side effects (for

example certain liver conditions, and

blood abnormalities) can only be

found when your doctor does tests

from time to time to check your

progress.

Do not be alarmed at this list of

possible side effects.

You may not experience any of them.

After using

AZITHROMYCIN

ALPHAPHARM

Storage

AZITHROMYCIN ALPHAPHARM

is stored in the pharmacy or on the

ward. It is kept in a cool dry place

where the temperature stays below

25°C.

Disposal

The hospital staff will dispose of any

left-over AZITHROMYCIN

ALPHAPHARM.

Product description

What it looks like

AZITHROMYCIN ALPHAPHARM

is a white to off-white powder, or

cake presented in a 10 mL glass vial.

AZITHROMYCIN ALPHAPHARM

contains 500 mg of azithromycin

powder for solution for infusion,

providing 100 mg/mL solution

following reconstitution.

Active Ingredient

The active ingredient is

azithromycin.

Other Ingredients

It also contains the following inactive

ingredients:

citric acid monohydrate

sodium hydroxide

This medicine does not contain

lactose, sucrose, gluten, tartrazine or

any other azo dyes.

Supplier

AZITHROMYCIN ALPHAPHARM

is supplied in Australia by:

Alphapharm Pty Limited

(ABN 93 002 359 739)

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

Phone: (02) 9298 3999

www.alphapharm.com.au

Australian registration numbers:

AZITHROMYCIN ALPHAPHARM

500 mg Powder for Injection:

AUST R 191947

This leaflet was prepared on

05 October 2016.

Azithromycin Alphapharm_cmi

\Oct16/00

AZITHROMYCIN ALPHAPHARM