Rulide D

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Roxithromycin 50 mg
Available from:
sanofi-aventis new zealand limited
INN (International Name):
Roxithromycin 50 mg
Dosage:
50 mg
Pharmaceutical form:
Dispersible tablet
Composition:
Active: Roxithromycin 50 mg Excipient: Colloidal silicon dioxide Crospovidone Fumaric acid Glycyrrhiza glabra Macrogol 6000 Magnesium stearate Methacrylic acid copolymer Microcrystalline cellulose Purified talc Saccharin sodium Sodium hydroxide Sodium laureth sulfate Strawberry Flavour Triethyl citrate
Prescription type:
Prescription
Manufactured by:
Sanofi Chimie
Therapeutic indications:
Rulide D 50mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by, or likely to be caused by susceptible micro-organisms: - Acute pharyngitis - Acute tonsillitis - Impetigo
Product summary:
Package - Contents - Shelf Life: Blister pack, polyamide/aluminium/PVC laminate blister sheet in carton - 2 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, polyamide/aluminium/PVC laminate blister sheet in carton - 4 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, polyamide/aluminium/PVC laminate blister sheet in carton - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, polyamide/aluminium/PVC laminate blister sheet in carton - 20 tablets - 36 months from date of manufacture stored at or below 30°C
Authorization number:
TT50-4780/5
Authorization date:
2014-07-09

Read the complete document

Rulide

® D Tablets

Rulide® D Tablets

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1.

Why am I using Rulide D?

Rulide D contains the active ingredient roxithromycin. Rulide D is mainly used to treat respiratory tract infections, and skin and

soft tissue infections. For more information, see Section 1. Why am I using Rulide D? in the full CMI.

2.

What should I know before I use Rulide D?

Do not use if you have ever had an allergic reaction to roxithromycin or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become

pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Rulide D?

in the full CMI.

3.

What if I am taking other medicines?

Some medicines may interfere with Rulide D and affect how it works. A list of these medicines is in Section 3. What if I am taking

other medicines? in the full CMI.

4.

How do I use Rulide D?

For children weighing less than 40 kg, the dosage can range from one half a tablet, one tablet or two tablets twice a day.

Your doctor will tell you the correct number of tablets to give your child

More instructions can be found in Section 4. How do I use Rulide D? in the full CMI.

5.

What should I know while using Rulide D?

Things you

should do

Remind any doctor or dentist you visit that your child is taking Rulide D.

If symptoms of your child's infection do not improve with a few days, or if they become worse, tell

your doctor.

If your child is about to start taking any new medicine, tell your doctor or pharmacist that they are

taking Rulide D

Things you

should not do

Rulide D has been prescribed for your child. Do not give to anyone else, even if they have the same

condition as your child.

Do not use Rulide D to treat any other complaints unless your doctor tells you to

Looking after

your medicine

Keep the tablets in a cool dry place where the temperature stays below 30°C

Keep the tablets in the foil until its time to take them

For more information, see Section 5. What should I know while using Rulide D? in the full CMI.

6.

Are there any side effects?

Common side effects include: rash; loss of appetite. Refer to the CMI for all side effects. For more information, including what to

do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Rulide

® D Tablets

Rulide® D Tablets

(roo-lied)

Active ingredient: Roxithromycin (rocks-e-throw-my-sin)

Consumer Medicine Information (CMI)

This leaflet provides important information about using

Rulide D. You should also speak to your doctor or

pharmacist if you would like further information or if you

have any concerns or questions about using Rulide D.

Where to find information in this leaflet:

Why am I using Rulide D?

What should I know before I use Rulide D?

What if I am taking other medicines?

How do I use Rulide D?

What should I know while using Rulide D?

Are there any side effects?

Product details

1.

Why am I using Rulide D?

Rulide D contains the active ingredient roxithromycin.

Rulide is an antibiotic that belongs to a group of medicines

called macrolides. These antibiotics work by killing or

stopping the growth of the bacteria that are causing the

infection.

Rulide D, like other antibiotics, does not work against viral

infections such as the flu.

Rulide D is used mainly to treat respiratory tract

infections, and skin and soft tissue infections

2.

What should I know before I use Rulide

D?

Warnings

Do not use Rulide D if:

your child has an allergy to roxithromycin, or any

other macrolide antibiotic e.g. azithromycin,

clarithromycin or erythromycin, any of the ingredients

listed at the end of this leaflet. Symptoms of an

allergic reaction may include skin rash, itching,

shortness of breath or swelling of the face, lips or

tongue which cause difficulty in swallowing or

breathing.

Always check the ingredients to make sure you can

use this medicine.

your child has severe liver problems

your child is taking certain medicines migraine

headache called ergot alkaloids e.g. Cafergot,

Dihydergot; (not all brands listed)

the product has expired or the packaging appears

tampered with.

Check with your doctor if your child:

have allergies to any other substances, such as foods,

preservatives or dyes

has or has had the following medical conditions:

kidney problems (impaired function)

liver problems (hepatic cirrhosis with jaundice

and /or ascites)

has any other medical conditions

takes any medicines for any other condition

plans to have surgery

During treatment, you may be at risk of developing certain

side effects. It is important you understand these risks and

how to monitor for them. See additional information

under Section 6. Are there any side effects

3.

What if I am taking other medicines?

Tell your doctor or pharmacist if your child is taking any

other medicines, including any medicines, vitamins or

supplements that you buy without a prescription from

your pharmacy, supermarket or health food shop.

Some medicines may be affected by Rulide D, or may

affect how well Rulide D works. These include:

theophylline (Neulin), a medicine used to treat asthma

some medicines for migraine headache such as

ergotamine (Cafergot)or dihydroergotamine

(Dihydergot tablets)

terfenadine, over the counter medicine used to treat

allergies

warfarin (Coumadin, Marevan), a medicine used to

prevent blood clots

digoxin (Lanoxin, Sigmaxin), a medicine used to treat

heart failure

midazolam (Hypnovel, Midazolam Sandoz), used to

induce sleep before operations

ciclosporin (Neoral, Cicoral, Cysporin, Sandimmun), a

medicine used to prevent organ transplant rejection

or to treat certain problems with the immune system

cisapride, a medicine used to treat gastrointestinal

problems

pimozide (Orap), an antipsychotic medicine

Check with your doctor or pharmacist if you are not sure

about what medicines, vitamins or supplements your

child is taking and if these affect Rulide D.

4.

How do I use Rulide D?

How much to take

For children weighing less than 40 kg, the dosage can

range from one half a tablet, one tablet or two tablets

twice a day.

Your doctor will tell you the correct number of tablets

to give your child

Rulide

® D Tablets

When to take Rulide

Rulide D works best on an empty stomach so it should

be taken at least 15 minutes before food or at least 3

hours after a meal

How to take it

Follow the instructions below on how to give your child

Rulide D.

The number of tablets your doctor has recommended

should be added to water

Remove the correct number of tablets from the foil.

If your child is only taking half a tablet at a time, place

the remaining half of the tablet back in the foil and

cover it up

Add half, one or two tablets as directed by your

doctor, to water and mix well. At least a spoonful of

water should be used

Wait about 30 or 40 seconds for the tablet to break

down into fine granules. (The tablets will not

completely dissolve). Stir if necessary

Have a glass of water ready and giver your child a

drink immediately after taking the medicine to ensure

all the Rulide D is swallowed

How long to take it

Rulide D is usually taken for 5 to 10 days. Children

should not take Rulide D for more than 10 days

Ask your doctor if you are not sure how long your

child should be taking it

Make sure your child takes Rulide D for the number of

days your doctor has prescribed, even if they begin to

feel better after a few days. If the full course is not

finished, the infection may not clear completely or

their symptoms may return

If you forget to use Rulide D

Rulide D should be used regularly at the same time each

day.

If it is almost time for your next dose, skip the dose you

missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you

missed.

If you use too much Rulide D

If you think that your child may have used too much

Rulide, your child may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre

(by calling 13 11 26), or the National Poisons Centre,

0800 POISON or 0800 764 766 (New Zealand).

contact your doctor, or

go to the Emergency Department at your nearest

hospital.

You should do this even if there are no signs of

discomfort or poisoning.

5.

What should I know while using Rulide

D?

Things you should do

If symptoms of your child's infection do not improve

with a few days, or if they become worse, tell your

doctor

If your child is about to start taking any new medicine,

tell your doctor or pharmacist that they are taking

Rulide D

Things you should not do

Rulide D has been prescribed for your child. Do not

give to anyone else, even if they have the same

condition as your child.

Do not use Rulide D to treat any other complaints

unless your doctor tells you to

Looking after your medicine

Keep the tablets in a cool dry place where the

temperature stays below 30°C

Keep your tablets in the foil until it is time to take

them

Follow the instructions in the carton on how to take care

of your medicine properly.

Store it in a cool dry place away from moisture, heat or

sunlight; for example, do not store it:

in the bathroom or near a sink, or

in the car or on window sills.

Do not use this medicine after the expiry date.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of

date, take it to any pharmacy for safe disposal.

6.

Are there any side effects?

All medicines can have side effects. If you do experience

any side effects, most of them are minor and temporary.

However, some side effects may need medical attention.

See the information below and, if you need to, ask your

doctor or pharmacist if you have any further questions

about side effects.

Inform your doctor as soon as possible if your child has any

problems while taking Rulide D, even if you do not think

the problems are connected with the medicine or they are

not listed in this leaflet

Rulide

® D Tablets

Less serious side effects

Less serious side effects

What to do

oral thrush - white, furry, sore

tongue and mouth

vaginal thrush - sore and itch

vagina and/or discharge

nausea, vomiting, stomach pain,

indigestion, diarrhoea, loss of

appetite, flatulence

rash

red and/or itchy skin

headache, dizziness, ringing in

the ears

hallucinations

confusion

tiredness

altered taste

blurred vision and/or visual

impairment

Speak to your

doctor if you

have any of

these less

serious side

effects and

they worry you.

Serious side effects

Serious side effects

What to do

frequent infections such as

fever, severe chills, sore throat

or mouth ulcers

severe persistent diarrhoea

an allergic reaction (for example,

itchy skin, rash, swelling, asthma

or wheezing)

swelling of the face lips mouth

and tongue which may cause

difficulty in swallowing or

breathing

Severe blisters and bleeding in

the lips, eyes, mouth, nose and

genitals

severe skin rash

Tell your doctor

or pharmacist

immediately or

go to the

Accident and

Emergency

Department at

your nearest

hospital.

These may be

serious side

effects or signs

of a serious

allergic

reaction

severe abdominal cramps or

stomach cramps

watery and severe diarrhoea,

which may sometimes be bloody

fever, in combination with one

or both of the above

Tell your doctor

immediately if

you notice any

of the following

symptoms,

particularly if

they occur

within several

weeks of

stopping

treatment with

Rulide D.

These are rare

but serious side

effects. Your

child may have

a serious

condition

affecting the

bowel.

Therefore, your

child may need

urgent medical

attention

Tell your doctor or pharmacist if you notice anything else

that may be making your child feel unwell.

Do not give your child any diarrhoea medicine without

first checking with your doctor.

Other side effects not listed here may occur in some

people.

Reporting side effects

After you have received medical advice for any side effects

you experience, you can report side effects to the

Therapeutic Goods Administration online at

www.tga.gov.au/reporting-problems

or medsafe at

https://nzphvc.otago.ac.nz/reporting/ (New Zealand).

By reporting side effects, you can help provide more

information on the safety of this medicine.

Rulide

® D Tablets

Always make sure you speak to your doctor or

pharmacist before you decide to stop taking any of your

medicines.

7.

Product details

This medicine is only available with a doctor's prescription.

What Rulide D contains

Active ingredient

(main ingredient)

Each tablet contains either 50

mg of roxithromycin

Other ingredients

(inactive ingredients)

cellulose - microcrystalline

fumaric acid

methacrylic acid copolymer

type c

crospovidone

macrogol 6000

talc - purified

saccharin sodium

silica - colloidal anhydrous

magnesium stearate

triethyl citrate

sodium lauryl sulfate

sodium hydroxide

Strawberry Flavour Dry

995/2L 1/1000 Essepi (PI

2338)

Liquorice Flavour Atomized

(PI 2341)

Do not take this medicine if your child is allergic to any of

these ingredients.

What Rulide D looks like

Rulide D tablets are round, off-white, scored tablets. Each

blister pack contains 10 tablets (Aust R 54811).

Who distributes Rulide D

Rulide D tablets are manufactured for:

sanofi aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

This leaflet was prepared in September 2020.

rulide-d-ccdsv7-cmiv5-11nov20

Read the complete document

rulide-d-ccdsv7-dsv5-11nov20

Page 1

NEW ZEALAND DATA SHEET

1

PRODUCT NAME

Rulide D 50 mg dispersible tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Rulide D tablets contain 50 mg of roxithromycin.

For the full list of excipients, see Section 6.1 List of Excipients.

3

PHARMACEUTICAL FORM

Rulide D tablets are practically white, scored, cylindrical tablets, 8mm in diameter.

4

CLINICAL PARTICULARS

4.1

THERAPEUTIC INDICATIONS

Children

Rulide D 50mg tablets are indicated for the treatment of the following mild to moderately severe

infections in children caused by or likely to be caused by susceptible micro-organisms:

acute pharyngitis

acute tonsillitis

impetigo

Appropriate culture and sensitivity tests should be performed when necessary to determine an

organism’s susceptibility and thus treatment suitability. Therapy with roxithromycin may be

initiated before results of these tests are known; once results become available, appropriate

therapy should be continued.

rulide-d-ccdsv7-dsv5-11nov20

Page 2

4.2

DOSE AND METHOD OF ADMINISTRATION

Children

The recommended dose and duration of treatment should NOT be exceeded in children (see

Section 4.4 Special Warnings and Precautions for Use).

Rulide D should be taken at least 15 minutes before food or on an empty stomach (

i.e.

more than

3 hours after a meal).

Rulide D is administered twice daily at a dose of 5 to 8 mg/kg per day. Recommended dosage

regimens are presented in the following table:

BODYWEIGHT

RULIDE D 50mg TABLETS

6 - 11 kg

Half a tablet morning and evening

12 - 23 kg

One tablet morning and evening

24 - 40 kg

Two tablets morning and evening

> 40 kg

Three tablets morning and evening

Rulide D 50mg tablets are administered to children as an aqueous suspension that is made by

adding either a half, one, two or three tablets to a spoonful of water. After waiting for 30 to 40

seconds for the tablet(s) to disintegrate into fine granules, the suspension is given to the child. A

drink of water should follow the dose.

Note: Rulide D 50mg tablets are designed to be mixed with water. The usual duration of treatment

is 5 to 10 days depending on the indication and clinical response. Streptococcal throat infections

require 10 days of therapy. The duration of treatment should not exceed 10 days.

4.3

CONTRAINDICATION

Known hypersensitivity to macrolides, including erythromycin.

Severely impaired hepatic function (see Section 4.4 Special Warnings and Precautions for

Use).

Concomitant therapy with vasoconstrictive ergot alkaloids (see Section 4.5 Interaction

with other Medicines and other Forms of Interaction).

rulide-d-ccdsv7-dsv5-11nov20

Page 3

4.4

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

The safety of roxithromycin has not been demonstrated in patients with impaired hepatic or renal

function. Caution should be exercised if roxithromycin is administered to patients with impaired

hepatic or renal function. If administered to patients with severe impaired hepatic function (eg.

hepatic cirrhosis with jaundice and/or ascites), the dose should be reduced by half.

Renal excretion of roxithromycin and its metabolites accounts for a small percentage of an oral

dose. The dosage should be kept unchanged in renal insufficiency.

Prolonged or repeated use of antibiotics including roxithromycin may result in superinfection by

resistant organisms. In the event of superinfection, roxithromycin should be discontinued and

appropriate therapy instituted.

When indicated, incision, drainage or other appropriate surgical procedures should be performed

in conjunction with antibiotic therapy.

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics. A toxin

produced by

Clostridium difficile

appears to be the primary cause. The severity of the colitis may

range from mild to life threatening. It is important to consider this diagnosis in patients who

develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks

after cessation of antibiotic therapy). Mild cases usually respond to drug discontinuation alone.

However, in moderate to severe cases, appropriate therapy with a suitable oral antibacterial agent

effective against

Clostridium difficile

should be considered. Fluids, electrolytes and protein

replacement therapy should be provided when indicated.

Drugs which delay peristalsis,

eg.

opiates and diphenoxylate with atropine, may prolong and/or

worsen the condition and should not be used.

Roxithromycin, like erythromycin, has been shown

in vitro

to elicit a concentration - dependent

lengthening in cardiac action potential duration. Such an effect is manifested only at supra –

therapeutic concentrations. Accordingly, the recommended doses should not be exceeded.

In certain conditions macrolides, including roxithromycin, have the potential to prolong the QT

interval.

Therefore

roxithromycin

should

used

with

caution

patients

with

congenital

prolongation

interval,

with

ongoing

proarrhythmic

conditions

uncorrected

hypokalemia or hypomagnesaemia, clinically significant bradycardia), and in patients receiving

Class IA and III antiarrhythmic agents and drugs such as astemizole, cisapride or pimozide (see

Section 4.5 Interaction with other Medicines and other Forms of Interaction).

As with other macrolides, roxithromycin may have the potential to aggravate myasthenia gravis.

Clostridium

difficile-associated

disease:

Diarrhoea,

particularly

severe,

persistent

and/or

bloody, during or after treatment with roxithromycin, may be symptomatic of pseudomembranous

colitis

(See

Section

Undesirable

Effects).

pseudomembranous

colitis

suspected,

roxithromycin must be stopped immediately.

rulide-d-ccdsv7-dsv5-11nov20

Page 4

Cases of severe bullous skin reactions such as Stevens Johnson Syndrome or Toxic Epidermal

Necrosis have been reported with roxithromycin (see Section 4.8 Undesirable Effects). If

symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal

lesions) are present, roxithromycin treatment should be discontinued.

Severe vasoconstriction (“ergotism”) with possibly necrosis of the extremities has been reported

when macrolides antibiotics have been associated with vasoconstrictive ergot alkaloids. Absence

of treatment by these alkaloids must always be checked before prescribing roxithromycin.

Use in Children

In young animal studies, high oral doses of roxithromycin were associated with bone growth plate

abnormalities. However no abnormalities were observed in the animals at doses resulting in

unbound plasma roxithromycin concentrations that were 10 to 15 times higher than the unbound

concentration measured in children receiving the therapeutic dose. The maintenance of such

safety margins is primarily dependent on high affinity binding of roxithromycin to plasma alpha-

1-acid glycoprotein and will be compromised by any circumstances attenuating the extent of this

binding. It is recommended that the approved paediatric dosage regimen (i.e. 5 to 8 mg/kg/day for

a maximum of 10 days) be adhered to strictly.

Neutropenia was observed in children treated with roxithromycin. 31.6% of 402 children in

clinical trials had a neutrophil count below the lower limit of the normal range (3500/mm

) at the

conclusion of therapy with roxithromycin. Of these, 4% had a neutrophil count of less than

1500/mm

and 1.2% had a count of less than 1000/mm

. It is not known whether this is an effect

of the drug or whether it reflects a normal fluctuation of the neutrophil count or a response to

infection in children.

Use in the Elderly

No dosage adjustment is required in elderly patients.

4.5

INTERACTION WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION

Roxithromycin

much

lower

affinity

cytochrome

P450

than

erythromycin

consequently has fewer interactions.

Roxithromycin does not appear to interact with oral contraceptives containing oestrogens and

progestogens, prednisolone, carbamazepine, ranitidine or antacids.

Theophylline

A study in normal subjects concurrently administered roxithromycin and theophylline has shown

some increase in plasma concentration of the latter. While a change in dosage is usually not

required, patients with high levels of theophylline at commencement of treatment should have

levels monitored.

rulide-d-ccdsv7-dsv5-11nov20

Page 5

Ergot alkaloids

Reactions of ergotism with possible peripheral necrosis have been reported after concomitant

therapy

macrolides

with

vasoconstrictive

ergot

alkaloids,

particularly

ergotamine

dihydroergotamine.

Because

clinical

interaction

with

roxithromycin

cannot

excluded,

administration of roxithromycin to patients taking ergot alkaloids is contraindicated. Absence of

treatment with these alkaloids must always be checked before prescribing roxithromycin.

Terfenadine

Some macrolide antibiotics (

eg.

erythromycin) may increase serum levels of terfenadine. This can

result in severe cardiovascular adverse events, including QT prolongation,

Torsades de Pointes

and other ventricular arrhythmias. Such a reaction has not been documented with roxithromycin

which has a much lower affinity for cytochrome P450 than erythromycin. However, in the

absence of a systematic interaction study, concomitant administration of roxithromycin and

terfenadine is not recommended.

Astemizole, Cisapride, Pimozide

Other drugs, such as astemizole, cisapride or pimozide, which are metabolized by the hepatic

isozyme CYP3A4, have been associated with QT interval prolongation and/or cardiac arrhythmias

(typically

Torsades de Pointes

) as a result of an increase in their serum level subsequent to

interaction with significant inhibitors of this isozyme, including some macrolide antibacterials.

Although roxithromycin has no or limited ability to complex CYP3A4 and therefore to inhibit the

metabolism of other drugs processed by this isozyme, a potential for clinical interaction of

roxithromycin with the above mentioned drugs cannot be either ascertained or ruled out in

confidence;

therefore,

concomitant

administration

roxithromycin

such

drugs

recommended.

Roxithromycin, like other macrolides, should be used with caution in patients receiving class IA

and III antiarrhythmic agents (See Section 4.4 Special Warnings and Precautions for Use).

Vitamin K Antagonists

While no interaction was observed in volunteer studies, roxithromycin appears to interact with

warfarin. Increases in prothrombin time (international normalized ratio; INR) have been reported

in patients treated concomitantly with roxithromycin and warfarin or the related Vitamin K

antagonist phenprocoumon, and severe bleeding episodes have occurred as a consequence. INR

should be monitored during combined treatment with roxithromycin and Vitamin K antagonists.

Digoxin and Other Cardiac Glycosides

A study in healthy volunteers has shown that roxithromycin may increase the absorption of

digoxin. This effect, common to other macrolides, may very rarely result in cardiac glycoside

toxicity. This may be manifested by symptoms such as nausea, vomiting, diarrhoea, headache or

dizziness; cardiac glycoside toxicity may also elicit heart conduction and/or rhythm disorders.

Consequently, in patients treated with roxithromycin and digoxin or another cardiac glycoside,

ECG and, if possible, the serum level of the cardiac glycoside should be monitored; this is

mandatory if symptoms which may suggest cardiac glycoside overdosage occur.

rulide-d-ccdsv7-dsv5-11nov20

Page 6

Midazolam

Roxithromycin, like other macrolides, may increase the area under the midazolam concentration-

time curve and the midazolam half-life; therefore the effects of midazolam may be enhanced and

prolonged

patients

treated

with

roxithromycin.

There

conclusive

evidence

interaction between roxithromycin and triazolam.

Theophylline and Ciclosporin

A slight increase in plasma concentrations of theophylline or ciclosporin A has been observed.

This does not generally necessitate altering the usual dosage.

CYP3A

Roxithromycin is a weak CYP3A inhibitor. The effect of roxithromycin on exposure to drugs

predominantly cleared by CYP3A metabolism would be expected to be 2-fold or less. Caution

should be exercised when roxithromycin is concomitantly prescribed with drugs metabolised by

CYP3A (such as rifabutin and bromocriptine).

4.6

PREGNANCY AND LACTATION

Pregnancy

(Category B1)

Reproductive

studies

rats,

mice

rabbits

doses

100,

135mg/kg/day,

respectively, did not demonstrate evidence of developmental abnormalities. In rats, at doses above

180mg/kg/day,

there

evidence

embryotoxicity

maternotoxicity.

safety

roxithromycin for the human foetus has not been established.

Lactation

Small amounts of roxithromycin are excreted in the breast milk. Breast feeding or treatment of the

mother should be discontinued as necessary.

4.7

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Attention should be drawn to the possibility of dizziness, visual impairment and blurred vision.

4.8

UNDESIRABLE EFFECTS

Roxithromycin is generally well tolerated. In clinical trials, treatment discontinuation due to

adverse effects occurred in only 1.2% of adult patients and 1.0% of children. The following side-

effects or serious adverse events possibly associated with roxithromycin have been reported:

Gastrointestinal

Nausea, vomiting, epigastric pain (dyspepsia), diarrhoea (sometimes containing blood), anorexia,

flatulence, pseudomembranous colitis. In clinical studies, the incidence of gastrointestinal events

was higher with the 300 mg once daily dosage regimen than with 150 mg twice daily. Symptoms

rulide-d-ccdsv7-dsv5-11nov20

Page 7

of pancreatitis have been observed; most patients had received other drugs for which pancreatitis

is a known adverse effect.

Hypersensitivity

Urticaria, rash, pruritus, angioedema. Rarely, serious allergic reactions may occur such as asthma,

bronchospasm,

anaphylactic-like

reactions,

anaphylactic

shock,

purpura,

glottic

oedema,

generalised

oedema,

erythema

multiforme,

exfoliative

dermatitis,

acute

generalised

exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome and Toxic Epidermal Necrosis

(TEN) (See Section 4.4 Special Warnings and Precautions for Use).

Liver

Moderate increase in serum transaminases, AST-ALT and/or alkaline phosphatase levels have

been observed and are somewhat more likely to occur in the elderly (> 65 years of age). Acute

cholestatic

hepatitis

acute

hepatocellular

injury

(sometimes

with

jaundice),

rarely

reported.

Others

Eosinophilia,

agranulocytosis,

neutropenia,

thrombocytopenia,

bronchospasm,

hallucination,

confusion,

headache,

dizziness,

paraesthesia,

tinnitus,

malaise,

moniliasis,

pancreatitis,

prolongation,

disorders

taste

and/or

smell,

visual

impairment,

blurred

vision,

temporary

deafness, hypoacusis and vertigo.

Prolonged use of antibiotics including roxithromycin may result in superinfection; overgrowth of

non-susceptible organisms. Repeated evaluation of the patient’s condition is essential. In the event

of superinfection, appropriate measures should be taken.

Reporting of suspected adverse reaction

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows

continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are

asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.

4.9

OVERDOSE

Symptomatic treatment should be provided as required. There is no specific antidote.

For advice on the management of overdose please contact the New Zealand National Poisons

Centre on 0800 POISON (0800 764 766).

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5

PHARMACOLOGICAL PROPERTIES

Roxithromycin has the following structural formula:

The empirical formula for roxithromycin is C

. Its molecular weight is 837.07.

Roxithromycin is a white crystalline powder. Roxithromycin is very slightly soluble in water,

freely soluble in acetone, in alcohol and in methylene chloride. It is slightly soluble in dilute

hydrochloric acid.

CAS number

Chemical Abstracts Number: [80214-83-1]

5.1

PHARMACODYNAMIC PROPERTIES

Pharmacotherapeutic group: semi-synthetic macrolide antibiotic

Roxithromycin binds to the 50S subunit of the 70S ribosome thereby disrupting bacterial protein synthesis.

5.2

PHARMACOKINETIC PROPERTIES

Absorption

Roxithromycin

absorbed

after

oral

administration

with

absolute

bioavailability

approximately 50%. Peak plasma concentrations following administration of Rulide D 50 mg

tablets for suspension is achieved approximately 3 hours post dose.

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Page 9

As food intake decreases absorption, Rulide D should be administered at least 15 minutes before

food or, alternatively, on an empty stomach (

i.e.

more than 3 hours after a meal).

Distribution

Roxithromycin is 92-96% bound to plasma proteins (principally alpha-1-acid glycoprotein, but

also albumin) at concentrations less than 4.2mg/L. The binding is saturable: in subjects with

normal plasma levels of alpha-1-acid glycoprotein, the extent of binding decreases when plasma

concentrations

roxithromycin

exceed

4.2mg/L.

plasma

concentration

8.4mg/L,

approximately 87% of the drug is protein bound.

Roxithromycin is highly concentrated in polymorphonuclear leucocytes and macrophages, where

levels 30 times those in serum have been reported.

Elimination

The mean half-life of roxithromycin is approximately 12 hours in young adults and 20 hours in

children. The apparently longer half life in children does not cause excessive accumulation: Cmin

and AUC values are comparable for adults and children.

Metabolism

Roxithromycin undergoes limited metabolism in the body, presumably in the liver. The major

metabolite is descladinose roxithromycin. Two minor metabolites have also been identified.

Plasma levels of roxithromycin are approximately twice those of all metabolites; a similar ratio is

seen in the urine and faeces.

Approximately 7% of a dose is excreted in the urine and 13% is eliminated via the lungs. Faecal

excretion, which represents the unabsorbed fraction and the small proportion excreted by the liver,

accounts for approximately 53% of the dose. The fate of the remainder is unknown.

When roxithromycin plasma levels are above 4.2mg/L, renal clearance increases because reduced

plasma protein binding (see ‘Distribution’) causes increased levels of unbound roxithromycin,

which may be excreted by the kidneys.

Microbiology

Roxithromycin is bacteriostatic at low concentrations and bactericidal at high concentrations. A

prolonged post antibiotic effect has been observed with roxithromycin. Whilst the clinical

significance of this remains uncertain, it supports the rationale for once daily dosing. Although

clinical data has demonstrated the efficacy and safety of once daily dosing in adults, this has not

been demonstrated in children.

At plasma concentrations achieved with the recommended therapeutic doses, roxithromycin has

been demonstrated to have

in vitro

and clinical activity against the following microorganisms:

Streptococcus

pneumoniae

Streptococcus

pyogenes

Mycoplasma

pneumoniae

Moraxella

catarrhalis

Ureaplasma urealyticum

, Chlamydia spp.

Roxithromycin

been

demonstrated

have

clinical

activity

against

following

microorganisms which are partially sensitive

in vitro

to roxithromycin:

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Page 10

Haemophilus influenzae, Staphylococcus aureus

(except MRSA).

The following strains of microorganisms are resistant:

Multiresistant

Staphylococcus aureus,

Enterobacteriaceae, Pseudomonas spp., Acinetobacter spp.

Susceptibility Tests

Dilution or diffusion techniques – either quantitative (MIC) or breakpoint, should be used

following a regularly updated, recognised and standardised method (eg NCCLS). Standardised

susceptibility test procedures require the use of laboratory control microorganisms to control the

technical aspects of the laboratory procedures.

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial

compound in the blood reaches the concentrations usually achievable. A report of “Intermediate”

indicates that the result should be considered equivocal, and if the microorganism is not fully

susceptible to alternative, clinically feasible drugs, the test should be repeated. This category

implies possible clinical applicability in body sites where the drug is physiologically concentrated

or in situations where high dosage of drug can be used. This category also provides a buffer zone,

which

prevents

small-uncontrolled

technical

factors

from

causing

major

discrepancies

interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the

antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy

should be selected.

Note: The prevalence of resistance may vary geographically for selected species and local

information on resistance is desirable, particularly when treating severe infections.

Using the NCCLS method of susceptibility testing with a 15mcg roxithromycin disc, susceptible

organisms other than

Haemophilus influenzae

produce zones of inhibition 21mm or greater. A

zone size of 10 to 20mm should be considered intermediate and a zone size of 9mm or less

indicates resistance. A bacterial isolate may be considered susceptible if the MIC value for

roxithromycin is less than or equal to 1 mg/L. Organisms are considered resistant if the MIC value

is greater than 8 mg/L.

Haemophilus influenzae

, zones of inhibition 10 mm or greater indicate susceptibility when

incubation and the HTM agar is used with a 15mcg roxithromycin disc. An isolate may be

considered susceptible if the MIC value for roxithromycin is less than or equal to 8mg/L.

5.3

PRECLINICAL SAFETY DATA

Carcinogenesis, Mutagenesis and Effects of Fertility

Long term studies in animals have not been performed to evaluate the carcinogenic potential of

roxithromycin. Roxithromycin has shown no mutagenic potential in standard laboratory tests for

gene mutation and chromosomal damage.

There was no effect on the fertility of rats treated with roxithromycin at oral doses up to

180mg/kg/day.

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6

PHARMACEUTICAL PARTICULARS

6.1

LIST OF EXCIPIENTS

Microcrystalline cellulose, crospovidone, magnesium stearate, fumaric acid, colloidal anhydrous

silica, sodium saccharin, methacrylic acid copolymer, sodium hydroxide, purified talc, sodium

lauryl sulfate, macrogol 6000, triethyl citrate and liquorice and strawberry flavours.

RULIDE D IS GLUTEN FREE, HOWEVER, THE STRAWBERRY FLAVOUR CONTAINS

LACTOSE.

6.2

INCOMPATIBILITIES

Rulide D 50mg tablets are designed to be mixed with water.

6.3

SHELF LIFE

3 years.

6.4

SPECIAL PRECAUTIONS FOR STORAGE

Store in a cool place below 30°C.

6.5

NATURE AND CONTENTS OF CONTAINER

Available in aluminium blister packs of 10 tablets.

6.6

SPECIAL PRECAUTIONS FOR DISPOSAL

No special requirements for disposal.

7

MEDICINE SCHEDULE

Prescription Only Medicine

8

SPONSOR

sanofi-aventis new zealand limited

Level 8, 56 Cawley Street

Ellerslie, Auckland

rulide-d-ccdsv7-dsv5-11nov20

Page 12

New Zealand

Freecall : 0800 283 684

Email: medinfo.australia@sanofi.com

9

DATE OF FIRST APPROVAL

21 August 2014

10

DATE OF REVISION OF THE TEXT

11 November 2020

SUMMARY OF CHANGES

Section changed

Summary of new information

Interaction with disopyramide removed

2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.2

Editorial changes

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