Lithium Carbonate

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Lithium carbonate 250mg

から入手可能:

Douglas Pharmaceuticals Limited

INN（国際名）:

Lithium carbonate 250 mg

投薬量:

250 mg

医薬品形態:

Capsule

構図:

Active: Lithium carbonate 250mg Excipient: Brilliant blue FCF Gelatin Lactose monohydrate Magnesium stearate Maize starch Quinoline yellow Sunset yellow FCF

パッケージ内のユニット:

Bottle, plastic, HDPE, 100 capsules

クラス:

Prescription

処方タイプ:

Prescription

製:

Aventis Pharma Dagenham Ltd

適応症:

· Treatment of mania and hypomania. · Treatment of some patients with recurrent bipolar depression, for which treatment with other antidepressants have been unsuccessful. · Prophylactic treatment of recurrent affective disorders.

製品概要:

Package - Contents - Shelf Life: Bottle, plastic, HDPE - 100 capsules - 36 months from date of manufacture stored at or below 30°C

承認日:

1985-11-08

情報リーフレット

CONSUMER MEDICINE INFORMATION
LITHIUM CARBONATE
_Lithium Carbonate _
250 mg Capsules
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING LITHIUM CARBONATE.
This
leaflet
answers
some
common
questions
about Lithium Carbonate Capsules. It does not
contain all 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
Lithium
Carbonate
Capsules
against
the
benefits
they
expect it will 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
LITHIUM
CARBONATE
CAPSULES ARE USED FOR
Lithium Carbonate Capsules are used to both
treat and prevent:
•
Mania - a mental illness characterised by
abnormal excitability and instability.
•
Depression - a mental illness
characterised by feelings of severe
sadness and unworthiness.
•
Manic depression - a mental illness which
alternates between attacks of mania and
depression.
Your
doctor
may
have
prescribed
Lithium
Carbonate Capsules for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY LITHIUM CARBONATE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with a doctor's
prescription.
BEFORE
YOU
TAKE
LITHIUM
CARBONATE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LITHIUM CARBONATE IF YOU HAVE AN
ALLERGY TO:
•
Any medicine containing lithium.
•
Any of the ingredients listed at the end of
this leaflet.
SOME OF THE SYMPTOMS OF AN ALLERGIC REACTION
MAY INCLUDE:
•
Asthma, shortness of breath, wheezing.
•
Swelling of the face, lips, or tongue which
may lead to difficulty swallowing or
breathing.
•
Rash, itching or hives.
•
Fainting.
DO NOT TAKE LITHIUM CARBONATE CAPSULES IF:
•
You are _TAKING OTHER MEDICINES,_ including
medicines that you buy without a
prescription without telling your doctor or
pharmacist.
•
You have severe kidney disease.
•
You have low levels of sodium in your
b

製品の特徴

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Lithium Carbonate 250 mg Capsule.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lithium Carbonate capsule contains 250 mg of lithium carbonate.
EXCIPIENT(S) WITH KNOWN EFFECT
Lithium Carbonate capsules contain lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Size one capsule with a clear body and a green cap containing white
powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
Treatment of mania and hypomania.
•
Treatment of some patients with recurrent bipolar depression, for
which treatment with
other antidepressants have been unsuccessful.
•
Prophylactic treatment of recurrent affective disorders.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
A simple treatment schedule has been evolved which, except for some
minor variations, should
be followed whether using Lithium Carbonate therapeutically or
prophylactically. The minor
variations to this schedule depend on the elements of the illness
being treated and these are
described later.
1.
In patients of average weight (70 kg) an initial dose of 400-1,200 mg
of Lithium
Carbonate may be given as a single daily dose in the morning or on
retiring.
Alternatively, the dose may be divided and given morning and evening.
When changing
from other lithium preparations serum lithium levels should first be
checked, then
Lithium Carbonate therapy commenced at a daily dose as close as
possible to the dose
of the other form of lithium. As bioavailability varies from product
to product
(particularly with regard to retard or slow-release preparations), a
change of product
should be regarded as initiation of new treatment.
2 | P a g e
2.
Four to five days after starting treatment (and never longer than one
week) a blood
sample should be taken for the estimation of serum lithium level.
3.
The objective is to adjust the Lithium carbonate dose to maintain the
serum lithium level
permanently within the diurnal range of 0.5 – 1.5 mmol/L. In
practice, the blood sample
should