LEXAPRO escitalopram (as oxalate) 20 mg/mL oral solution bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-03-2022
Summary of Product characteristics
(SPC)
04-02-2022
Public Assessment Report
(PAR)
11-11-2017
Active ingredient:
escitalopram oxalate, Quantity: 25.551 mg/mL (Equivalent: escitalopram, Qty 20 mg/mL)
Available from:
Lundbeck Australia Pty Ltd
INN (International Name):
escitalopram oxalate
Pharmaceutical form:
Oral Liquid, solution
Composition:
Excipient Ingredients: sodium hydroxide; ethanol; purified water; propyl gallate; citric acid
Administration route:
Oral
Units in package:
15 mL
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Treatment of major depression. Treatment of social anxiety disorder (social phobia). Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder.
Product summary:
Visual Identification: Clear, nearly colourless to yellowish solution; Container Type: Bottle; Container Material: Glass Type II Coloured; Container Life Time: 8 Weeks; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure and restricted flow insert
Authorization status:
Registered
Authorization date:
2014-03-27
Patient Information leaflet
LEXAPRO
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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 USING LEXAPRO?
LEXAPRO contains the active ingredient escitalopram. LEXAPRO is used
to treat depression.
For more information, see Section 1. Why am I using LEXAPRO? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LEXAPRO?
Do not use if you have ever had an allergic reaction to Escitalopram
or any of the ingredients listed at the end of the CMI.
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
LEXAPRO? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LEXAPRO 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 LEXAPRO?
•
Your doctor will decide what dose you will receive.
•
The standard dose for this medicine is 10 mg per day. This may be
increased by your doctor to 20 mg per day.
More instructions can be found in Section 4. How do I use LEXAPRO? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LEXAPRO?
THINGS YOU
SHOULD DO
•
REMIND ANY DOCTOR, DENTIST OR PHARMACIST YOU VISIT THAT YOU ARE USING
LEXAPRO.
•
IF YOU BECOME PREGNANT WHILE TAKING LEXAPRO, TELL YOUR DOCTOR
IMMEDIATELY.
•
TELL YOUR DOCTOR IMMEDIATELY IF YOU HAVE THOUGHTS ABOUT KILLING
YOURSELF.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly, or lower the dosage without
telling your doctor.
•
Do not give the oral solution to anyone else, even if they have the
same condition as you.
•
Do not let yourself run out of medicine over the weekend or on
holidays.
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how LEXAPRO affects
Read the complete document
Summary of Product characteristics
LEXAPRO® (escitalopram oxalate)
_ _
_Page 1 of 35 _
AUSTRALIAN PRODUCT INFORMATION – LEXAPRO
(ESCITALOPRAM OXALATE) FILM-COATED TABLETS AND
ORAL SOLUTION
1 NAME OF THE MEDICINE
Escitalopram oxalate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
LEXAPRO tablets 10mg and 20mg: Film-coated tablets containing 10mg and
20 mg
escitalopram (as oxalate)
LEXAPRO solution 20 mg/mL:_ _Oral solution containing 20 mg/mL
escitalopram (as oxalate)
Excipient with known effect: ethanol.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
LEXAPRO 10 mg tablets are oval, white, scored, film-coated tablets
marked with "E” and “L"
on one side.
LEXAPRO 20 mg tablets are oval, white, scored, film-coated tablets
marked with "E” and “N"
on one side.
LEXAPRO 20 mg/mL oral solution is a clear, nearly colourless to
yellowish solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depression.
Treatment of social anxiety disorder (social phobia).
Treatment of generalised anxiety disorder.
Treatment of obsessive-compulsive disorder.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS
Escitalopram is administered as a single oral dose and may be taken
with or without food.
The oral solution can be mixed with water, orange juice or apple
juice.
LEXAPRO® (escitalopram oxalate)
_ _
_Page 2 of 35 _
Turn the bottle completely upside down. If no drops come out, tap the
bottle lightly to start
the flow.
_Major depression _
Usually 2 - 4 weeks are necessary for antidepressant response,_ _
The recommended dose is 10 mg (one 10 mg tablet or 10 drops of the 20
mg/mL oral
solution) once daily. Depending on individual patient response, the
dose may be increased
to a maximum of 20 mg (one 20 mg tablet or 20 drops of the 20 mg/mL
oral solution) daily,
although the onset of therapeutic effect may be seen earlier. The
treatment of a single
episode of depression requires treatment over the acute and the medium
term. After the
symptoms resolve during acute treatment, a period of consolidation of
the
Read the complete document
