Rifadin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Rifampicin 20 mg/mL (5% overage is added.)

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Rifampicin 20 mg/mL (5% overage is added.)

Dosage:

100 mg/5mL

Pharmaceutical form:

Oral suspension

Composition:

Active: Rifampicin 20 mg/mL (5% overage is added.) Excipient: Agar Diolamine Methyl hydroxybenzoate Polysorbate 80 Potassium sorbate Propyl hydroxybenzoate Purified water Raspberry Saccharin Sodium metabisulfite Sucrose

Units in package:

Bottle, 1x60ml, 60 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

sanofi-aventis SpA

Therapeutic indications:

Tuberculosis Rifampicin is indicated in the treatment of all forms of tuberculosis, including fresh, advanced, chronic and drug resistant cases. Rifampicin should be used in conjunction with at least one other antituberculosis medicine. Leprosy Rifampicin is indicated in the treatment of multibacillary and paucibacillary leprosy to effect a conversion of the infectious state to a non-infectious state. Rifampicin should be used in conjunction with at least one other anti-leprosy drug. Methicillin-resistant Staphylococcal infections (MRSA) Rifampicin can be used as an alternative to vancomycin in the treatment of MRSA. In such circumstances an appropriate companion antibiotic (e.g. fusidic acid) should always be employed. Serious Staphylococcal Infections Rifampicin has been used for the treatment of both life-threatening and serious staphylococcal infections. In such circumstances an appropriate companion antibiotic should be employed. Brucellosis Rifampicin may be used for the treatment of brucellosis. In such circumstances doxycycline should also be used. Meningococcal Carriers Rifampicin is indicated for the treatment of asymptomatic carriers of N. meningitidis to eliminate meningococci from the nasopharynx. (Rifampicin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms). Haemophilus Influenzae Rifampicin is indicated for the treatment of asymptomatic carriers of H influenzae and as chemoprophylaxis of exposed children of 4 years of age or younger. Other infections Infections caused by rifampicin-sensitive microorganisms such as staphylococci, streptococci, N gonorrhoeae, Proteus sp., H. influenzae, E. coli and Legionella sp. To prevent emergence of resistant organisms, rifampicin should be given with another antibacterial agent to which the organism has been shown to be susceptible.

Product summary:

Package - Contents - Shelf Life: Bottle, - 60 mL - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1971-11-23

Patient Information leaflet

Rifadin® ORAL
1
RIFADIN
® ORAL
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING RIFADIN?
Rifadin contains the active ingredient rifampicin. Rifadin is an
antibiotic taken with other medicines to treat tuberculosis and is
taken to treat leprosy. It is also taken to prevent meningococcal
disease and infections caused by _Haemophilus Influenza_ Type B.
For more information, see Section 1. Why am I taking Rifadin? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE RIFADIN?
Do not take Rifadin if you have ever had an allergic reaction to
Rifadin or any of the ingredients listed at the end of the CMI.
Do not take Rifadin if you have jaundice.
Do not take Rifadin if you are taking saquinavir or ritonavir. These
are medicines used to treat AIDS and HIV.
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 OR PLANNING TO BREASTFEED.
For more information, see Section 2. What should I know before I take
Rifadin? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Rifadin 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 TAKE RIFADIN?
Follow the instructions provided when Rifadin was prescribed,
including the number of days it should be taken.
More instructions can be found in Section 4. How do I take Rifadin? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING RIFADIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, surgeon, or pharmacist you visit that you
are taking Rifadin.
•
You should see your doctor monthly for a check-up.
•
Continue taking Rifadin exactly as prescribed by your doctor.
•
If you have a blood or urine test, tell your doctor you are taking
Rifadin.
•
If you are about to be started on a new medicine, including oral
contraceptive

Summary of Product characteristics

rifadin-ccdsv17-dsv20-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
RIFADIN 150 MG, 300 MG CAPSULES, 100 MG/5ML SYRUP, AND
600 MG INFUSION
Rifadin 150 mg capsules
Rifadin 300 mg capsules
Rifadin 100 mg/5 mL syrup
Rifadin IV 600 mg infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rifadin 150 mg and 300 mg capsules contain 150 mg and 300 mg of
rifampicin per capsule
respectively.
Rifadin syrup contains 100 mg of rifampicin per 5 mL of syrup.
Rifadin IV infusion contains 600 mg rifampicin per vial.
Excipients with known effect:
Capsules: contain sulfites.
Syrup: Methyl hydroxybenzoate, propyl hydroxybenzoate, potassium
sorbate, saccharin, sodium
metabisulfite.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Capsules:
150 mg (blue/red, marked R-150)
300 mg (red, marked R-300)
Syrup:
100 mg/5 mL (red, raspberry flavoured)
rifadin-ccdsv17-dsv20-20jun22
Page 2
IV infusion:
600 mg (spongy, fragile amorphous red powder), with 10 mL sterile
water for injection solvent
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tuberculosis
Rifampicin is indicated in the treatment of all forms of tuberculosis,
including fresh, advanced,
chronic and drug resistant cases. Rifampicin should be used in
conjunction with at least one other
antituberculosis medicine.
Leprosy
Rifampicin is indicated in the treatment of multibacillary and
paucibacillary leprosy to effect a
conversion of the infectious state to a non-infectious state.
Rifampicin should be used in
conjunction with at least one other anti-leprosy drug.
Methicillin-resistant Staphylococcal infections (MRSA)
Rifampicin can be used as an alternative to vancomycin in the
treatment of MRSA. In such
circumstances an appropriate companion antibiotic (e.g. fusidic acid)
should always be employed.
Serious Staphylococcal Infections
Rifampicin has been used for the treatment of both life-threatening
and serious staphylococcal
infections. In such circumstances an appropriate companion antibiotic
should be employed (see
Section 4.2).
Brucellosis
Rifam