Azithromycin 250mg capsules

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Azithromycin dihydrate
Available from:
Somex Pharma
ATC code:
J01FA10
INN (International Name):
Azithromycin dihydrate
Dosage:
250mg
Pharmaceutical form:
Capsule
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 05010500; GTIN: 15060089611117 15060089611100
Authorization number:
PL 15764/0110

Read the complete document

Read all of this leaflet carefully before you start taking

this medicine because it contains important information

for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it

on to others. It may harm them, even if their signs of illness are

the same as yours.

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet

1. What Azithromycin is and what it is used for

2. What you need to know before you take Azithromycin

3. How to take Azithromycin

4. Possible side effects

5. How to store Azithromycin

6. Contents of the pack and other information

1.What Azithromycin is and what it is used for

This medicine contains azithromycin, which is one of a group of

antibiotics called macrolides. It is used to treat infections caused

by certain bacteria and other micro-organisms, which include:

Chest, throat or nasal infections (such as bronchitis, pneumonia,

tonsillitis, sore throat (pharyngitis) and sinusitis)

ear infections

skin and soft tissue infections (such as an abscess or boil)

sexually transmitted diseases caused by an organism called

Chlamydia trachomatis and Neisseria gonorrhoea.

You must talk to a doctor if you do not feel better or if you feel

worse.

2. What you need to know before you take

Azithromycin

Do not take Azithromycin:

if you are allergic to Azithromycin or any other macrolide

antibiotic such as erythromycin or clarithromycin or any of the

ingredients of this medicine (listed in section 6). An allergic

reaction may cause skin rash or wheezing.

if you are taking any ergot derivatives such as ergotamine

(used to treat migraine) as these medicines should not be taken

together with Azithromycin.

Warnings and precautions

Talk to your doctor or pharmacist before taking Azithromycin

Your doctor needs to know before you take Azithromycin if you

have or have had any of the following conditions:

kidney problems

heart conditions

liver problems: your doctor may need to monitor your liver

function or stop the treatment

If you are taking any ergot derivatives such as ergotamine

(used to treat migraine) as these medicines should not be taken

together with Azithromycin.

Tell your doctor immediately if you feel your heart beating in your

chest or have an abnormal heartbeat, or get dizzy or faint or suffer

from any muscle weakness when taking Azithromycin.

If you develop diarrhoea or loose stools during or after treatment,

tell your doctor at once. Do not take any medicine to treat your

diarrhoea without first checking with your doctor. If your diarrhoea

continues, please inform your doctor.

Other medicines and Azithromycin

Tell your doctor or pharmacist if you are taking, have recently taken

or might take any other medicines.

In particular, Azithromycin may interact with the medicines listed

below:

ergot or ergotamine – see ‘Warnings and precautions’ section

warfarin or any similar medicine to prevent blood clots

ciclosporin (used to suppress the immune system to prevent

and treat rejection of a transplanted organ or bone marrow)

antacids (for indigestion)

digoxin (used to treat heart failure)

terfenadine (for hay fever or a skin allergy)

Azithromycin with food and drink

You should take Azithromycin either 1 hour before a meal or 2

hours after a meal.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant

or are planning to have a baby, ask your doctor or pharmacist for

advice before taking this medicine.

Driving and using machines

Azithromycin is not expected to affect your ability to drive or use

machines.

Important information about some of the ingredients of

this medicine

If you have been told by your doctor that you have an intolerance to

some sugars, contact your doctor before taking this medicinal product.

3. How to take Azithromycin

Always take Azithromycin exactly as your doctor has told you.

Check with your doctor or pharmacist if you are not sure.

The capsules should be swallowed whole.

The usual dose in adults and children over 7 stones (45 kg) is 500 mg

(2 capsules) taken together, once a day, for 3 days. For some diseases

such as Chlamydia the dose is 1 g (4 capsules) taken all together on

one day only. For gonorrhoea the recommended dose is 1 g or 2 g

of azithromycin in combination with 250 or 500 mg of ceftriaxone.

Azithromycin capsules should not be taken by children weighing

less than 45 kg.

You should tell your doctor if you have kidney or liver problems

as your doctor may need to alter the normal dose.

Doctors sometimes prescribe different doses to these. The label

on the pack will tell you which dose you should take. If you are

still not sure, ask your doctor or pharmacist.

Always continue with the course even if you feel better. If your

infection gets worse or you do not start to feel better within a few

days or a new infection develops, go back and see your doctor.

If you take more Azithromycin than you should

If you take too much Azithromycin you may feel unwell. Tell your

doctor or contact your nearest hospital casualty department

immediately.

Package leaflet: Information for the user

Azithromycin 250 mg Capsules

Azithromycin dihydrate

If you forget to take Azithromycin

If you forget to take Azithromycin take it as soon as you can. Take

your next dose at the right time. Do not take a double dose to make

up for a forgotten dose.

If you stop taking Azithromycin

If you stop taking Azithromycin too soon, the infection may return.

Take the capsules for the full time of treatment, even when you

begin to feel better.

If you have any further questions about the use of this product,

ask your doctor or pharmacist for advice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although

not everybody gets them.

Tell your doctor immediately if you experience any of

the following symptoms after taking this medicine as

the symptoms can be severe.

sudden wheeziness, difficulty in breathing, swelling of eyelids,

face or lips, rash or itching (especially affecting the whole body)

severe or prolonged diarrhoea, which may have blood or mucus

in it, during or after treatment with Azithromycin as this may be

a sign of serious bowel inflammation

severe skin rash causing redness and flaking

rapid or irregular heartbeat

low blood pressure

The most common side effects that occur when taking Azithromycin

are listed below. These may go away during treatment as your body

adjusts to the medicine. Tell your doctor if any of these side effects

continue to bother you.

Very common side effects (may affect more than 1 in 10 people):

stomach cramps, feeling sick, diarrhoea, wind

Common side effects (may affect up to 1 in 10 people):

dizziness, headache

numbness or pins and needles

being sick, indigestion

loss of appetite, taste disturbance

visual disturbances, deafness

skin rash and /or itching

joint pain

low numbers of lymphocytes (type of white blood cells), higher

number of eosinophils (type of white blood cells)

low blood bicarbonate

tiredness or weakness

Uncommon side effects (may affect up to 1 in 100 people):

yeast infections of the mouth and vagina (thrush)

low numbers of leukocytes (type of white blood cells), low

number of neutrophils (type of white blood cells)

allergic reactions of various severity

blistering of the skin, mouth, eyes and genitals

skin more sensitive to sunlight than normal

feeling nervous

reduced sense of touch or sensation (hypoesthesia)

sleepiness or sleeplessness (insomnia)

poor hearing or ringing in the ears

heart palpitations, chest pain

constipation, stomach pain associated with diarrhoea and fever

inflammation of the liver (hepatitis), changes in liver enzymes

general loss of strength

swelling

general discomfort

abnormal laboratory test values (e.g. blood or liver tests).

Rare side effects (may affect up to 1 in 1,000 people):

agitation

vertigo

changes in liver function

Other side effects that have been reported, but frequency

cannot be estimated from the available data:

fits or fainting

aggression or anxiety

feeling hyperactive

localised muscle weakness

loss of smell or altered sense of smell, loss of taste

tongue discolouration

inflammation of the pancreas (pancreatitis)

inflammation of the kidney or kidney failure

yellowing of the skin or eyes (jaundice) or liver failure (rarely

life-threatening)

bruising or prolonged bleeding after injury

blistering of the skin, severe skin reaction

abnormal electrocardiogram (EEG)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or

nurse. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via The Yellow

Card Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting

side effects you can help provide more information on the safety

of this medicine.

5. How to store Azithromycin

Keep all medicines out of the sight and reach of children

Do not store above 30°C

Do not take this medicine after the expiry date which is stated

on the carton after EXP. The expiry date refers to the last day of

that month.

Do not throw away any medicines via wastewater or household

waste. Ask your pharmacist how to throw away medicines you no

longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Azithromycin contains

The active substance is azithromycin (250 mg).

The other ingredients (excipients) are: lactose, magnesium stearate,

maize starch, sodium lauryl sulphate.

The capsule shells contain: gelatin, titanium dioxide, shellac (E904).

Printing ink on capsule contains: propylene glycol (E1520), black

iron oxide, potassium hydroxide.

What Azithromycin looks like and contents of the pack

Azithromycin capsules are white marked SOMEX and 250. They

come in blister packs of 2, 4 or 6 capsules

Not all pack sizes may be marketed

Marketing Authorisation Holder

Strandhaven Limited t/a Somex Pharma.

Ilford, Essex. IG3 8BS. UK

Manufacturer

Strandhaven Limited t/a Somex Pharma.

Ilford, Essex. IG3 8RA. UK

This medicinal product is authorised in the Member

States of the EEA under the following names:

Azithromycin 250 mg Capsules.

This leaflet was last revised in: 03/2015

Read the complete document

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Azithromycin 250mg Capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains azithromycin dihydrate equivalent to 250mg of azithromycin.

Excipients with known effect:

Each capsule contains 226.70 mg lactose.

For a full list of excipients see section 6.1

3

PHARMACEUTICAL FORM

Capsule

White, opaque hard gelatin capsules. The capsule shells are printed in black with “SOMEX”

on white opaque body and “250” on white opaque cap.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Azithromycin is indicated for the treatment of the following infections when known or likely

to be due to one or more susceptible microorganisms (see Section 5.1 Pharmacodynamic

properties):

- bronchitis

- community-acquired pneumonia

- sinusitis

- pharyngitis/tonsillitis (see 4.4 regarding streptococcal infections)

- otitis media

- skin and soft tissue infections

- uncomplicated genital infections due to Chlamydia trachomatis.

Considerations

should

given

official

guidance

regarding

appropriate

antibacterial agents.

4.2

Posology and method of administration

Method of administration:

Azithromycin should be given as a single daily dose. In common with many other antibiotics

Azithromycin Capsules should be taken at least 1 hour before or 2 hours after food.

Children over 45 kg body weight and adults, including elderly patients: The total dose of

azithromycin is 1500 mg which should be given over three days (500 mg once daily).

In uncomplicated genital infections due to Chlamydia trachomatis, the dose is 1000 mg as a

single oral dose. For susceptible Neisseria gonorrhoeae the recommended dose is 1000 mg or

2000 mg of azithromycin in combination with 250 or 500 mg of ceftriaxone according to local

clinical treatment guidelines. For patients who are allergic to penicillin and/or cephalosporins,

prescribers should consult local treatment guidelines.

In children under 45 kg body weight: Azithromycin Capsules are not suitable for children

under 45 kg.

Renal failure:

No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 10

- 80 ml/min). Caution should be exercised when azithromycin is administered to patients with

severe renal impairment (GFR

<

ml/min) (see

Section 4.4

Special

warnings

precautions for use and Section 5.2 Pharmacokinetic properties).

Hepatic failure:

Since azithromycin is metabolised in the liver and excreted in the bile, the drug should not be

given

patients

suffering

from

severe

liver

disease.

studies have

been

conducted

regarding treatment of such patients with azithromycin (see Section 4.4 Special warnings and

precautions for use).

Azithromycin Capsules are for oral administration only.

4.3

Contraindications

Azithromycin is contra-indicated in patients with a known hypersensitivity to azithromycin or

any of the macrolide or ketolide antibiotics, erythromycin, or to any excipients thereof as (for

example) listed in Section 6.1 List of Excipients.

4.4

Special warnings and precautions for use

with

erythromycin

other

macrolides,

rare

serious

allergic

reactions

including

angioneurotic oedema and anaphylaxis (rarely fatal), have been reported. Some of these

reactions with azithromycin have resulted in recurrent symptoms and required a longer period

of observation and treatment.

Since the liver is the principal route of elimination for azithromycin, the use of azithromycin

should be undertaken with caution in patients with significant hepatic disease. Cases of

fulminant hepatitis potentially leading to life-threatening liver failure have been reported with

azithromycin (see Section 4.8 Undesirable effects). Some patients may have had pre-existing

hepatic disease or may have been taking other hepatotoxic medicinal products.

In case of signs and symptoms of liver dysfunction, such as rapid developing asthenia

associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy, liver

function tests/ investigations should be performed immediately. Azithromycin administration

should be stopped if liver dysfunction has emerged.

In patients receiving ergot derivatives, ergotism has been precipitated by co-administration of

some macrolide antibiotics. There are no data concerning the possibility of an interaction

between ergot and azithromycin. However, because of the theoretical possibility of ergotism,

azithromycin and ergot derivatives should not be co-administrated.

Prolonged cardiac repolarisation and QT interval, imparting a risk of developing cardiac

arrhythmia and torsades de pointes, have been seen in treatment with other macrolides. A

similar effect with azithromycin cannot be completely ruled out in patients at increased risk

for prolonged cardiac repolarisation (see Section 4.8 Undesirable effects); therefore caution is

required when treating patients:

With congenital or documented QT prolongation

Currently receiving treatment with other active substance known to prolong QT interval such

as antiarrhytmics of classes Ia and III, cisapride and terfenadine

With electrolyte disturbance, particularly in case of hypokalaemia and hypomagnesemia

With clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency.

with

antibiotic

preparation,

observation

signs

superinfection

with

non-

susceptible organisms including fungi is recommended.

Clostridium difficile

associated diarrhoea (CDAD) has been reported with use of nearly all

antibacterial agents, including azithromycin, and may range in severity from mild diarrhoea to

fatal colitis. Strains of

C. difficile

producing hypertoxin A and B contribute to the development

CDAD.

Hypertoxin

producing

strains

C.

difficile

cause

increased

morbidity

mortality, as these infections can be refractory to antimicrobial therapy and may require

colectomy. Therefore, CDAD must be considered in patients who present with diarrhoea

during or subsequent to the administration of any antibiotics. CFareful medical history is

necessary since CDAD has been reported to occur over two months after the administration of

antibacterial agents. Discontinuation of therapy with azithromycin and the administration of

specific treatment for

C. difficile should be considered.

Streptococcal

infections:

Penicillin

usually

first

choice

treatment

pharyngitis/tonsillitis

Streptococcus

pyogenes

also

prophylaxis

acute

rheumatic fever. Azithromycin is in general effective against streptococcus in the oropharynx,

but no data are available that demonstrate the efficacy of azithromycin in preventing acute

rheumatic fever.

Use in renal impairment: In patients with severe renal impairment (GFR <10 ml/min) a 33%

increase in systemic exposure to azithromycin was observed (see Section 5.2 Pharmacokinetic

properties).

Exacerbations of the symptoms of myasthenia gravis and new onset of myasthenia syndrome

have been reported in patients receiving azithromycin therapy (See Section 4.8).

Safety and efficacy for prevention or treatment of MAC in children have not been established.

Azithromycin capsules are for oral administration only.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or

glucose-galactose malabsorption should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction

Antacids: In a pharmacokinetic study investigating the effects of simultaneous administration

of antacid with azithromycin, no effect on overall bioavailability was seen, although peak

serum

concentrations

were

reduced

approximately

25%.

patients

receiving

both

azithromycin and antacids, the drugs should not be taken simultaneously.

Cetirizine:

In healthy volunteers, co-administration of a 5-day regimen of azithromycin with

cetirizine 20 mg at steady-state resulted in no pharmacokinetic interaction and no significant

changes in the QT interval.

Didanosine

(Dideoxyinosine):

Co-administration

1200

mg/day

azithromycin

with

mg/day didanosine in 6 HIV-positive subjects did not appear to affect the steady-state

pharmacokinetics of didanosine as compared with placebo.

Digoxin:

Some of the macrolide antibiotics have been reported to impair the microbial

metabolism

digoxin

some

patients.

patients

receiving

concomitant

azithromycin, a related azalide antibiotic, and digoxin the possibility of raised digoxin levels

should be borne in mind.

Zidovudine:

Single 1000 mg doses and multiple 1200 mg or 600 mg doses of azithromycin

had little effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its

glucuronide metabolite. However, administration of azithromycin increased the concentrations

phosphorylated

zidovudine,

clinically

active

metabolite,

peripheral

blood

mononuclear cells. The clinical significance of this finding is unclear, but it may be of benefit

to patients.

Azithromycin does not interact significantly with the hepatic cytochrome P450 system. It is

not believed to undergo the pharmacokinetic drug interactions as seen with erythromycin and

other

macrolides.

Hepatic

cytochrome

P450

induction

inactivation

cytochrome-

metabolite complex does not occur with azithromycin.

Ergot derivatives:

Due to the theoretical possibility of ergotism, the concurrent use of

azithromycin with ergot derivatives is not recommended. (See Section 4.4 Special warnings

and precautions for use).

Pharmacokinetic studies have been conducted between azithromycin and the following drugs

known to undergo significant cytochrome P450 mediated metabolism.

Atorvastatin:

Co-administration of atorvastatin (10 mg daily) and azithromycin (500 mg

daily) did not alter the plasma concentrations of atorvastatin (based on a HMG CoA-reductase

inhibition assay).

Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, no significant

effect was observed on the plasma levels of carbamazepine or its active metabolite in patients

receiving concomitant azithromycin.

Cimetidine:

pharmacokinetic

study

investigating

effects

single

dose

cimetidine, given 2 hours before azithromycin, on the pharmacokinetics of azithromycin, no

alteration of azithromycin pharmacokinetics was seen.

Coumarin-Type Oral Anticoagulants:

In a pharmacokinetic interaction study, azithromycin

did not alter the anticoagulant effect of a single 15 mg dose of warfarin administered to

healthy

volunteers.

There

have

been

reports

received

post-marketing

period

potentiated anticoagulation subsequent to co-administration of azithromycin and coumarin-

type

oral

anticoagulants.

Although

causal

relationship

been

established,

consideration

should

given

frequency

monitoring

prothrombin

time

when

azithromycin is used in patients receiving coumarin-type oral anticoagulants.

Ciclosporin:

In a pharmacokinetic study with healthy volunteers that were administered a 500

mg/day oral dose of azithromycin for 3 days and were then administered a single 10 mg/kg

oral

dose

ciclosporin,

resulting

ciclosporin

were

found

significantly elevated (by 24% and 21% respectively), however no significant changes were

seen in AUC

. Consequently, caution should be exercised before considering concurrent

administration of these drugs. If co-administration of these drugs is necessary, ciclosporin

levels should be monitored and the dose adjusted accordingly.

Efavirenz:

Co-administration of a 600 mg single dose of azithromycin and 400 mg efavirenz

daily for 7 days did not result in any clinically significant pharmacokinetic interactions.

Fluconazole:

Co-administration of a single dose of 1200 mg azithromycin did not alter the

pharmacokinetics of a single dose of 800 mg fluconazole. Total exposure and half-life of

azithromycin were unchanged by the co-administration of fluconazole, however, a clinically

insignificant decrease in Cmax (18%) of azithromycin was observed.

Indinavir:

Co-administration of a single dose of 1200 mg azithromycin had no statistically

significant effect on the pharmacokinetics of indinavir administered as 800 mg three times

daily for 5 days.

Methylprednisolone:

pharmacokinetic

interaction

study

healthy

volunteers,

azithromycin had no significant effect on the pharmacokinetics of methylprednisolone.

Midazolam:

In healthy volunteers, co-administration of azithromycin 500 mg/day for 3 days

did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of

a single 15 mg dose of midazolam.

Nelfinavir:

Co-administration of azithromycin (1200 mg) and nelfinavir at steady state (750

three

times

daily)

resulted

increased

azithromycin

concentrations.

clinically

significant adverse effects were observed and no dose adjustment is required.

Rifabutin:

Co-administration

azithromycin

rifabutin

affect

serum

concentrations of either drug.

Neutropenia was observed in subjects receiving concomitant treatment of azithromycin and

rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal

relationship to combination with azithromycin has not been established (see Section 4.8.

Undesirable effects).

Sildenafil:

normal

healthy

male

volunteers,

there

evidence

effect

azithromycin (500 mg daily for 3 days) on the AUC and Cmax, of sildenafil or its major

circulating metabolite.

Terfenadine:

Pharmacokinetic studies have reported no evidence of an interaction between

azithromycin and terfenadine. There have been rare cases reported where the possibility of

such an interaction could not be entirely excluded; however there was no specific evidence

that such an interaction had occurred.

Theophylline:

There is no evidence of a clinically significant pharmacokinetic interaction

when azithromycin and theophylline are co-administered to healthy volunteers.

Triazolam:

In 14 healthy volunteers, co-administration of azithromycin 500 mg on Day 1 and

250 mg on Day 2 with 0.125 mg triazolam on Day 2 had no significant effect on any of the

pharmacokinetic variables for triazolam compared to triazolam and placebo.

Trimethoprim/sulfamethoxazole:

Co-administration of trimethoprim/ sulfamethoxazole DS

(160 mg/800 mg) for 7 days with azithromycin 1200 mg on Day 7 had no significant effect on

peak

concentrations,

total

exposure

urinary

excretion

either

trimethoprim

sulfamethoxazole. Azithromycin serum concentrations were similar to those seen in other

studies.

4.6

Fertility, pregnancy and lactation

Animal reproduction studies have been performed at doses up to moderately maternally toxic

dose concentrations. In these studies, no evidence of harm to the fetus due to azithromycin

was found. There are, however, no adequate and well-controlled studies in pregnant women.

Because

animal

reproduction

studies

always

predictive

human

response,

azithromycin should be used during pregnancy only if clearly needed.

There are no data on secretion in breast milk. As many drugs are excreted in human milk,

azithromycin should not be used in the treatment of a lactating woman unless the physician

feels that the potential benefits justify the potential risks to the infant.

4.7

Effects on ability to drive and use machines

There is no evidence to suggest that Azithromycin may have an effect on a patient's ability to

drive or operate machinery.

4.8

Undesirable effects

Azithromycin is well tolerated with a low incidence of side effects.

The section below lists the adverse reactions identified through clinical trial experience and

postmarketing surveillance by system organ class and frequency. Adverse reactions identified

from post-marketing experience are included in italics. The frequency grouping is defined

using

following

convention:

Very

common

1/10);

Common

1/100

<1/10);

Uncommon (

1/1,000 to <1/100); Rare (

1/10,000 to <1/1,000); Very Rare (< 1/10,000); and

Not known (cannot be estimated from the available data). Within each frequency grouping,

undesirable effects are presented in order of decreasing seriousness.

Adverse reactions possibly or probably related to azithromycin based on clinical trial

experience and post-marketing surveillance:

Infections and Infestations

Uncommon

(

1/1,000 to <1/100)

Candidiasis, oral candidiasis, vaginal infection

Not known

(cannot be estimated from available data)

Pseudomembranous colitis

(See Section 4.4)

Blood and Lymphatic System Disorders

Uncommon

(

1/1,000 to < 1/100)

Leukopenia, neutropenia

Not known

(cannot be estimated from available data)

Thrombocytopenia, haemolytic anaemia

Immune System Disorders

Uncommon

(

1/1,000 to <1/100)

Angioedema, hypersensitivity

Not known

(cannot be estimated from available data)

Anaphylactic reaction

(See Section 4.4)

Metabolism and Nutrition Disorders

Common

(> 1/100, < 1/10)

Anorexia

Psychiatric Disorders

Uncommon

(

1/1,000 to <1/100)

Nervousness

Rare

(> 1/10000, < 1/1000)

Agitation

Not known

(cannot be estimated from available data)

Aggression, anxiety

Nervous System Disorders

Common

(> 1/100, < 1/10)

Dizziness, headache, paraesthesia, dysgeusia

Uncommon

(

1/1,000 to <1/100)

Hypoaesethesia, somnolence, insomnia

Not known

(cannot be estimated from available data)

Syncope, convulsion, psychomotor hyperactivity, anosmia, ageusia, parosmia, Myasthenia

gravis

(See Section 4.4).

Eye Disorders

Common

(> 1/100, < 1/10)

Visual impairment

Ear and Labyrinth Disorders

Common

(> 1/100, < 1/10)

Deafness

Uncommon

(

1/1,000 to <1/100)

Hearing impaired, tinnitus

Rare

(> 1/10000, < 1/1000)

Vertigo

Cardiac Disorders

Uncommon

(

1/1,000 to <1/100)

Palpitations

Not known

(cannot be estimated from available data)

Torsades de pointes

(See Section 4.4),

arrhythmia

(See Section 4.4) including

ventricular

tachycardia

Vascular Disorders

Not known

(cannot be estimated from available data)

Hypotension

Gastrointestinal Disorders

Very common

(

1/10)

Diarrhoea, abdominal pain, nausea, flatulence

Common

(> 1/100, < 1/10)

Vomiting, dyspepsia

Uncommon

(> 1/1000, < 1/100)

Gastritis, constipation

Not known

(cannot be estimated from available data)

Pancreatitis, tongue discolouration

Hepatobiliary Disorders

Uncommon

(> 1/1000, < 1/100)

Hepatitis

Rare

(> 1/10000, < 1/1000)

Hepatic function abnormal

Not known

(cannot be estimated from available data)

Hepatic failure

(See Section 4.4), which has rarely resulted in death,

hepatitis fulminant,

hepatic necrosis, jaundice cholestatic

Skin and Subcutaneous Tissue Disorders

Common

(> 1/100, < 1/10)

Pruritus and rash

Uncommon

(> 1/1000, < 1/100)

Stevens-Johnson syndrome, photosensitivity reaction, urticaria

Not known

(cannot be estimated from available data)

Toxic epidermal necrolysis, erythema multiforme

Musculoskeletal, Connective Tissue Disorders

Common

(> 1/100, < 1/10)

Arthralgia

Renal and Urinary Disorders

Not known

(cannot be estimated from available data)

Renal failure acute, nephritis interstitial

General disorders and Administration Site Conditions

Common

(> 1/100, < 1/10)

Fatigue

Uncommon

(> 1/1000, < 1/100)

Chest pain, oedema, malaise, asthenia

Investigations

Common

(> 1/100, < 1/10)

Lymphocyte count decreased, eosinophil count increased, blood bicarbonate decreased

Uncommon

(> 1/1000, < 1/100)

Aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin

increased, blood urea increased, blood creatinine increased, blood potassium abnormal

Not known

(cannot be estimated from available data)

Electrocardiogram QT prolonged

(See Section 4.4)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the Yellow

Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9

Overdose

Adverse events experienced in higher than recommended doses were similar to those seen at

normal doses. The typical symptoms of an overdose with macrolide antibiotics include

reversible loss of hearing, severe nausea, vomiting and diarrhoea. In the event of overdose, the

administration of medicinal charcoal and general symptomatic treatment and supportive

measures are indicated as required.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

General properties

Antibacterials for systemic use. ATC code: J01FA10

Mode of action:

Azithromycin is a macrolide antibiotic belonging to the azalide group. The molecule is

constructed by adding a nitrogen atom to the lactone ring of erythromycin A. The chemical

name of azithromycin is 9-deoxy-9a-aza-9a-methyl-9a-homoerythromycin A. The molecular

weight is 749.0. The mechanism of action of azithromycin is based upon the suppression of

bacterial protein synthesis by means of binding to the ribosomal 50s sub-unit and inhibition of

peptide translocation.

Mechanism of resistance:

Resistance to azithromycin may be inherent or acquired. There are three main mechanisms of

resistance in bacteria: target site alteration, alteration in antibiotic transport and modification

of the antibiotic.

Azithromycin

demonstrates

cross

resistance

with

erythromycin

resistant

gram

positive

isolates. A decrease in macrolide susceptibility over time has been noted particularly in

Streptococcus pneumoniae and Staphylococcus aureus. Similarly, decreased susceptibility has

been

observed

among

Streptococcus

viridans

Streptococcus

agalactiae

(Group

streptococcus against other macrolides and lincosamides.

Breakpoints

Azithromycin susceptibility breakpoints for typical bacterial pathogens, as published

by EUCAST are: (Clinical breakpoint table v.5.0, valid from 01/01/2015)

MIC breakpoints (mg/L)

Organism

Susceptible (S

)

Resistant (R>)

Staphylococcus spp.

Streptococcus groups A, B, C and

0.25

Streptococcus pneumoniae

0.25

Haemophilus influenzae

0.125

Moraxella catarrhalis

0.25

Neisseria gonorrhoeae

0.25

Susceptibility

The prevalence of acquired resistance may vary geographically and with time for selected

species and local information on resistance is desirable, particularly when treating severe

infections. As necessary, expert advice should be sought when the local prevalence of

resistance

such that the

utility

the agent in

at least

some

types of infections

questionable.

Table: Antibacterial spectrum of Azithromycin

Commonly susceptible species

Aerobic Gram-positive microorganisms

Staphylococcus aureus

Methycillin-susceptible

Streptococcus pneumoniae

Penicillin-susceptible

Streptococcus pyogenes (Group A)

Aerobic Gram-negative microorganisms

Haemophilus influenzae

Haemophilus parainfluenzae

Legionella pneumophila

Moraxella catarrhalis

Neisseria gonorrhoeae

Pasteurella multocida

Anaerobic microorganisms

Clostridium perfringens

Fusobacterium spp.

Prevotella spp.

Porphyromonas spp.

Other microorganisms

Chlamydia trachomatis

Species for which acquired resistance may be a problem

Aerobic Gram-positive microorganisms

Streptococcus pneumoniae

Penicillin-intermediate

Penicillin-resistant

Inherently resistant organisms

Aerobic Gram-positive microorganisms

Enterococcus faecalis

Staphylococci MRSA, MRSE*

Anaerobic microorganisms

Bacteroides fragilis group

* Methycillin-resistant staphylococci have a very high prevalence of acquired resistance to

macrolides and have been placed here because they are rarely susceptible to azithromycin.

5.2

Pharmacokinetic properties

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