Deptran 50 hexagonal tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

doxepin hydrochloride, Quantity: 56.5 mg (Equivalent: doxepin, Qty 50 mg)

から入手可能:

Alphapharm Pty Ltd

医薬品形態:

Tablet, film coated

構図:

Excipient Ingredients: microcrystalline cellulose; hypromellose; lactose monohydrate; Carnauba Wax; purified talc; sodium starch glycollate; diethyl phthalate; magnesium stearate; titanium dioxide; indigo carmine; erythrosine; povidone

投与経路:

Oral

パッケージ内のユニット:

1000, 50, 10

クラス:

Medicine Registered

処方タイプ:

(S4) Prescription Only Medicine

適応症:

The 50mg and 75mg tablets are indicated only for the maintenance treatment of major depression. (see Precautions).

製品概要:

Visual Identification: 8mm, hexagonal, normal convex, light violet, filmcoated tablet debossed DN over 50 on one side and 'a' on the other; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

認証ステータス:

Registered

承認日:

1991-09-20

情報リーフレット

DEPTRAN
_doxepin (as hydrochloride)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DEPTRAN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking DEPTRAN
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT DEPTRAN IS
USED FOR
DEPTRAN is used to treat
depression.
DEPTRAN 10 mg and DEPTRAN25
mg capsules can be used at any stage
in the treatment of depression.
However, the higher strength,
DEPTRAN50 mg tablets, is
approved only for the maintenance
treatment of depression (after your
symptoms have improved).
DEPTRAN belongs to a group of
medicines called tricyclic
antidepressants (TCAs).
Antidepressants are thought to work
by their action on brain chemicals
called amines which are involved in
controlling mood.
Your doctor, however, may prescribe
DEPTRAN for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DEPTRAN
HAS BEEN PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
DEPTRAN should not be used in
children and adolescents under the
age of 18 years.
The safety and effectiveness of
DEPTRAN in this age group has not
been satisfactorily established.
BEFORE YOU TAKE
DEPTRAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DEPTRAN IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing doxepin
hydrochloride
•
any other tricyclic antidepressants
such as amitriptyline and
imipramine
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction to
DEPTRAN may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
skin rash, itching or hives on the
skin
•
swelling of the face, lips, tongue
or other parts of the body
•
increased sensitivity of the skin to
the sun.
D

製品の特徴

AUSTRALIAN PRODUCT INFORMATION
DEPTRAN
_doxepin (as hydrochloride) _
1
NAME OF THE MEDICINE
Doxepin (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Doxepin hydrochloride, a dibenzoxepin derivative, consists of a
mixture of the
_cis-_
and
_trans-_
isomers in a
constant ratio (13 to 18.5%
_cis_
; 87 to 81.5%
_trans_
).
Each capsule contains either 10 mg or 25 mg of doxepin (as
hydrochloride) as the active ingredient.
Each tablet contains either 50 mg or 75 mg of doxepin (as
hydrochloride) as the active ingredient.
Excipients with known effect: sugars (as lactose), galactose and
sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Doxepin is a white, crystalline powder, with a slight and amine-like
odour. It is soluble in 1.5 parts of water, in
1 part of ethanol (96%) and in 2 parts of chloroform, and has a
melting point of 185°-191°.
DEPTRAN 10: size 3 capsule with a white opaque body and white opaque
cap with “DP 10” printed in black ink.
DEPTRAN 25: size 3 capsule with a white opaque body and blue cap.
DEPTRAN 50: violet film coated, hexagonal tablet, marked "DN" over
"50" on one side and "α" on reverse.
DEPTRAN 75: white film coated, hexagonal tablet, marked "DN" break
line "75" on one side and "α" on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of major depression.
The 50 mg and 75 mg tablets are indicated only for the maintenance
treatment of major depression (see section
4.4 Special Warnings and Precautions for Use).
4.2
DOSE AND METHOD OF ADMINISTRATION
The optimum oral dose depends on the severity of the condition and the
individual patient's response. The dose
varies from 30 mg to 300 mg daily, and is usually administered in a
three times daily regimen. When the optimum
dose has been reached, it may be given as a single daily dose up to a
maximum of 150 mg.
_For patients where the presenting symptoms are mild_
, it is advisable to initiate treatment at a dose of 30 mg daily;
a good clinical response is ob