LONITEN minoxidil 10mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

minoxidil, Quantity: 10 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; maize starch; colloidal anhydrous silica

Administration route:

Oral

Units in package:

100

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 1 JANUARY 1991 : Indicated as adjunctive therapy in adults with severe refractory hypertension which has failed to respond to extensive multiple therapy. When used in combination with an accompanying diuretic and beta-blocker, minoxidil (LONITEN) has been shown to reverse encephalopathy and retinopathy in severe hypertensives.

Product summary:

Visual Identification: White, circular, half oval, scored tablet marked "10" on the obverse side and "U/137" on the reverse side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1991-08-02

Patient Information leaflet

LONITEN
®
L
o
n
i
t
e
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 LONITEN?
Loniten contains the active ingredient minoxidil. Loniten is used to
lower high blood pressure, also called hypertension.
For more information, see Section 1. Why am I using Loniten? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LONITEN?
Do not take if you have ever had an allergic reaction to minoxidil or
any of the ingredients listed at the end of the CMI.
Do not take if you have had phaeochromocytoma (rare tumour of the
adrenal gland) or pulmonary hypertension (high blood pressure
in the vessels of the lung).
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
Loniten? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Loniten 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 LONITEN?
•
The usual adult dosage range of Loniten is between 5 mg and 40 mg per
day. The maximum recommended dosage is 100 mg
per day.
More instructions can be found in Section 4. How do I use Loniten? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LONITEN?
THINGS YOU
SHOULD DO
•
Remind any doctor, pharmacist or dentist you visit that you are using
Loniten.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine or lower the dosage, without checking
with your doctor.
•
Do not give Loniten to anyone else, even if they have the same
condition as you.
•
Do not take Loniten to treat any other complaints unless your doctor
tells you to.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how Loniten
affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep your tablets in a c

Summary of Product characteristics

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Page 1 of 10
AUSTRALIAN
PRODUCT
INFORMATION
–
LONITEN
® (MINOXIDIL)
1.
NAME OF THE MEDICINE
Minoxidil.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
LONITEN (minoxidil) 10 mg tablets.
EXCIPIENT(S) WITH KNOWN EFFECT
lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
LONITEN 10 mg tablets are white, circular, half oval, scored tablets
marked “10” on one side
and “U/137” on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indicated as adjunctive therapy in adults with severe refractory
hypertension which has failed
to respond to extensive multiple therapy.
When used in combination with an accompanying diuretic and
beta-blocker, minoxidil
(LONITEN)
has
been
shown
to
reverse
encephalopathy
and
retinopathy
in
severe
hypertensives.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The
usual
adult
dosage
range
of
LONITEN
is
5 to 40 mg
per
day.
The
maximum
recommended dosage is 100 mg per day.
LONITEN therapy can be initiated with a single or divided daily
dosage. If the desired
reduction in diastolic pressure is greater than 30 mm Hg, divided
dosage will minimise diurnal
fluctuations. Dosage adjustments should be made at intervals of 3 days
or longer.
A more rapid reduction of pressure can be
achieved using continuous blood pressure
monitoring and incremental doses of 5 mg every 6 hours.
Dosage requirements may be lower in patients with renal failure or
undergoing chronic dialysis.
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Page 2 of 10
For patients with hepatic impairment dosage adjustment should be
considered, starting therapy
at a reduced dose once daily and titrating up to the lowest effective
dose to obtain desired
therapeutic effect (see section 5.2 Pharmacokinetic properties:
Special Populations).
Prior to introducing LONITEN, it is recommended that the
antihypertensive therapy be
adjusted to a regimen consisting of a diuretic and a beta-adrenergic
blocking agent. When
other sy