RETROVIR zidovudine 250mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

zidovudine, Quantity: 250 mg

Available from:

ViiV Healthcare Pty Ltd

INN (International Name):

Zidovudine

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: Gelatin; maize starch; microcrystalline cellulose; sodium starch glycollate; magnesium stearate; indigo carmine; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid; potassium hydroxide

Administration route:

Oral

Units in package:

60 capsules, 40 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Retrovir is indicated for: . Treatment of adult patients with severe symptomatic human immunodeficiency virus infection (AIDS or advanced AIDS related complex); . Treatment of other HIV-positive adult patients with less than 500 CD4 cells/mm3. Notes: (1) The limited available data currently support the extended use of Retrovir (Indication 2 above). (2) The optimal dosage for these indications has not been established. . Combination therapy in advanced HIV infection. The addition of HIVID (Zalcitabine) may be considered for the management of adult patients with advanced HIV infection and CD4 + cell counts less than or equal to 200/mm3, who have received Retrovir monotherapy for less than 12 months. Retrovir monotherapy is still indicated as initial therapy for adult patients with HIV infection who fulfil the approved indications. NEW INDICATIONS APPROVED 7TH FEBRUARY 1997: Retrovir (zidovudine) is indicated for the treatment of HIV infection, alone and in combination with other antiretroviral therapies. The optimum dosage for this indication has not been established.

Product summary:

Visual Identification: Opaque blue cap and opaque white body coded GSJV2; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-03-01

Patient Information leaflet

RETROVIR
_CAPSULES AND SYRUP_
_zidovudine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start RETROVIR.
This leaflet answers some common
questions about RETROVIR. It does
not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking RETROVIR
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT RETROVIR IS
USED FOR
RETROVIR contains zidovudine
which belongs to a group of
medicines called antiretrovirals.
RETROVIR is used, alone or with
other antiretrovirals, to slow down
the progression of human immuno-
deficiency virus (HIV) infection,
which can lead to Acquired Immune
Deficiency Syndrome (AIDS) and
other related illnesses (e.g. AIDS-
related Complex or ARC).
RETROVIR does not cure AIDS or
HIV infection, but slows production
of human immunodeficiency virus.
In this way it stops ongoing damage
to the body's immune system, which
fights infection.
You will still be able to pass on the
HIV virus by sexual activity or by
passing on blood or bodily
secretions, which carry the HIV
virus, although the risk is lowered by
effective antiretroviral therapy.
Discuss with your doctor the
precautions needed to avoid infecting
other people.
While taking RETROVIR and/or any
other therapy for HIV disease, you
may continue to develop other
infections and other complications of
HIV infection. You should keep in
regular contact with your doctor.
RETROVIR has been extensively
studied but for limited periods of
time. The long-term risks and
benefits of taking RETROVIR are
not known; especially in patients
without symptoms of HIV infection,
or with early HIV disease.
Your doctor may have prescribed
RETROVIR for another reason. Ask
your doctor if you have any questions
about why RE

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
RETROVIR (ZIDOVUDINE)
CAPSULES AND SYRUP
1
NAME OF THE MEDICINE
Zidovudine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zidovudine is a white to off-white, odourless crystalline solid.
RETROVIR Capsules 100 mg: Each capsule contains zidovudine 100 mg.
RETROVIR Capsules 250 mg: Each capsule contains zidovudine 250 mg.
RETROVIR Syrup: Each 5 mL contains zidovudine 50 mg, sodium benzoate,
saccharin
sodium, maltitol solution.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
RETROVIR Capsules 100 mg: Opaque white cap and body coded GSYJU.
RETROVIR Capsules 250 mg: Opaque blue cap and opaque white body coded
GSJV2.
RETROVIR Syrup: Pale yellow, strawberry flavoured.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RETROVIR (zidovudine) is indicated for use in the treatment of HIV
infection, alone and in
combination with other antiretroviral therapies. The optimal dosage
for this indication has not
been established.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS WEIGHING AT LEAST 30 KG
A broad range of dosage regimens has been employed; a daily dose of
500-600 mg in two to
five divided doses has been used commonly world wide.
DOSAGE IN COMBINATION THERAPY
RETROVIR may be administered separately or with other antiretroviral
therapies (see
Section 5.1 PHARMACODYNAMIC PROPERTIES - Clinical trials - Combination
therapy).
MONITORING OF PATIENTS
Haematologic toxicities appear to be related to pretreatment bone
marrow reserve and to
dose and duration of therapy. In patients with poor bone marrow
reserve, particularly in
patients with advanced symptomatic HIV disease, frequent monitoring of
haematologic
2
indices is recommended to detect serious anaemia or granulocytopenia
(see Section 4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE). In patients who experience
haematologic toxicity, reduction in haemoglobin may occur as early as
2 to 4 weeks, and
granulocytopenia usually occurs after 6 to 8 weeks.
DOSE ADJUSTMENT
Significant anaemia (haemoglobin of < 7.5 g/dL