RIFADIN rifampicin 600mg powder for injection vial with diluent ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rifampicin, Quantity: 600 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Rifampicin

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium hydroxide; sodium formaldehyde sulfoxylate

Administration route:

Intravenous

Units in package:

1 vial of powder - 600mg, 1 ampoule of water 10mL

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Therapeutic indications:

Tuberculosis. In the initial treatment and in re-treatment of patients with tuberculosis, RIFADIN must be used in conjunction with at least one other antituberculosis drug. Leprosy. In the management of lepromatous leprosy and dimorphous leprosy to effect speedy conversion of the infectious state to the noninfectious state, which may be expected to occur in 3 to 4 months of treatment. As an alterantive drug in lepromatous, dimorphous, indeterminate and tuberculoid leprosy resistant to sulfones and other antileprosy drugs. As an alternative drug in all those patients having true drug allergy to the more commonly used antileprosy drugs. Meningococcal disease. Prophylaxis of meningococcal disease in close contacts of known cases and in carriers. (RIFADIN is not indicated for the treatment of meningococcal infections). Haemophilus influenzae. Prophylaxis of household contacts of patients with H. influenzae type B.

Product summary:

Visual Identification: Powder, red; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-01-21

Patient Information leaflet

RIFADIN
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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 BEING GIVEN 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 being given Rifadin? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN 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 am
being given 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 IS RIFADIN GIVEN?
Rifadin is diluted and given by intravenous infusion. Rifadin must
only be given by a doctor or nurse.
More instructions can be found in Section 4. How is Rifadin given? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN RIFADIN?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist, surgeon or pharmacist you visit that you
are using Rifadin.
•
If you have to have any blood or urine tests tell your doctor you are
being given Rifadin.
•
If you are about to be started on a new medicine, including oral
contraceptives, tell your doctor
you are taking Rifadin.
THINGS YOU SHOULD NOT
DO

Summary of Product characteristics

rifadin-ccdsv17-piv18-17feb22
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION – RIFADIN
® (RIFAMPICIN)
1
NAME OF THE MEDICINE
Rifampicin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rifadin 150 mg capsules contain 150 mg of rifampicin per capsule.
Rifadin 300 mg capsules contain 300 mg of rifampicin per capsule.
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: contains methyl hydroxybenzoate, propyl hydroxybenzoate,
potassium sorbate,
sodium metabisulfite and saccharin.
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)
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
In the initial treatment and in re-treatment of patients with
tuberculosis, Rifadin must be used
in conjunction with at least one other antituberculosis drug.
rifadin-ccdsv17-piv18-17feb22
Page 2 of 17
Leprosy
In the management of lepromatous leprosy and dimorphous leprosy to
effect speedy
conversion of the infectious state to the noninfectious state, which
may be expected to occur
in 3 to 4 months of treatment.
As an alternative drug in lepromatous, dimorphous, indeterminate and
tuberculoid leprosy
resistant to sulfones and other antileprosy drugs.
As an alternative drug in all those patients having true drug allergy
to the more commonly
used antileprosy drugs.
Meningococcal Disease
Prophylaxis of meningococcal disease in close contacts of known cases
and in carriers
(Rifadin is not indicated for the treatment of meningococcal
infections).
Haemophilus Influenzae
Prophylaxis of household contacts of patients with
_H. influenzae_
type B.
4.2
DOSE AND METHOD OF ADMINISTRATION
ORAL
It is recommended that oral Rifadin be administered once daily, on an
em