RIMYCIN 300 rifampicin 300 mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rifampicin, Quantity: 300 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: purified talc; Gelatin; purified water; ascorbic acid; magnesium stearate; brilliant blue FCF; colloidal anhydrous silica; sodium lauryl sulfate; titanium dioxide; erythrosine; lactose monohydrate

Administration route:

Oral

Units in package:

10, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 5 DECEMBER 2001 : Tuberculosis. In the initial treatment and in retreatment of patients with tuberculosis, rifampicin 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 non-infectious state which may be expected to occur in three to four months of treatment. - As an alternative drug in lepromatous, dimorphous, indeterminate and tuberculoid leprosy resistant to sulfones and other anti-leprosy drugs. - As an alternative drug in all those patients having true drug allergy to the more commonly used anti-leprosy drugs.,Meningococcal Disease Prophylaxis of meningococcal disease in close contacts of known cases and in carriers (rifampicin is not indicated for the treatment of meningococcal infections).,Haemophilus Influenzae Prophylaxis of household contacts of patients with Haemophilus influenzae type B.,Buruli Ulcer For the treatment of Myc

Product summary:

Visual Identification: Size 1 hard gelatin capsule with maroon body and cap.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-03-10

Patient Information leaflet

RIMYCIN
R
i
m
y
c
i
n
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 RIMYCIN?
RIMYCIN contains the active ingredient rifampicin. RIMYCIN is an
antibiotic taken with other medicines to treat tuberculosis, leprosy
and mycobacterium ulcerans (Buruli ulcer). 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 using
RIMYCIN? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE RIMYCIN?
Do not take RIMYCIN if you have ever had an allergic reaction to
RIMYCIN or any of the ingredients listed at the end of the CMI.
Do not take RIMYCIN if you have jaundice.
Do not take RIMYCIN 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
RIMYCIN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with RIMYCIN 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 RIMYCIN?
Follow the instructions provided when RIMYCIN was prescribed,
including the number of days it should be taken.
More instructions can be found in Section 4. How do I take RIMYCIN? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RIMYCIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, surgeon, or pharmacist you visit that you
are taking RIMYCIN.
•
You should see your doctor monthly for a check-up.
•
Continue taking RIMYCIN exactly as prescribed by your doctor.
•
If you have a blood or urine test, tell your doctor you are taking
RIMYCIN.
•
If you are about to be started on a new medicine, including oral
contracep

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
RIMYCIN
_rifampicin capsules _
1
NAME OF THE MEDICINE
Rifampicin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each RIMYCIN capsule contains 150 mg or 300 mg of rifampicin as the
active ingredient.
Excipients with known effect: galactose, lactose and sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
RIMYCIN 150 capsules are a size 3 hard gelatin capsule, maroon body
with black cap.
RIMYCIN 300 capsules are a size 1 hard gelatin capsule with maroon
body and cap.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TUBERCULOSIS
In the initial treatment and in retreatment of patients with
tuberculosis, rifampicin must be used in conjunction
with at least one other anti-tuberculosis drug.
LEPROSY
•
In the management of lepromatous leprosy and dimorphous leprosy to
effect speedy conversion of the
infectious state to the non-infectious state which may be expected to
occur in three to four months of
treatment
•
As an alternative drug in lepromatous, dimorphous, indeterminate and
tuberculoid leprosy resistant to
sulfones and other anti-leprosy drugs
•
As an alternative drug in all those patients having true drug allergy
to the more commonly used anti-
leprosy drugs
MENINGOCOCCAL DISEASE
Prophylaxis of meningococcal disease in close contacts of known cases
and in carriers (rifampicin is not
indicated for the treatment of meningococcal infections).
HAEMOPHILUS INFLUENZAE
Prophylaxis of household contacts of patients with
_Haemophilus influenzae_
type B.
BURULI ULCER
For the treatment of Mycobacterium ulcerans infections (Buruli ulcer).
Rifampicin
must be used in
combination with another anti-Mycobacterium ulcerans antibiotic.
RIMYCIN – PRODUCT INFORMATION
2
4.2
DOSE AND METHOD OF ADMINISTRATION
It is recommended that rifampicin be administered once daily, either
30 minutes before or two hours after a
meal.
PULMONARY TUBERCULOSIS
Adults: 600 mg in a single daily administration.
Children: 10 to 20 mg/kg, not to exceed 600 mg/day.
LEPROSY
Adu