DIAMOX Sodium 500mg Powder for Solution for Injection

Ország: Malajzia

Nyelv: angol

Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Letöltés Termékjellemzők (SPC)
04-07-2022

Aktív összetevők:

ACETAZOLAMIDE

Beszerezhető a:

ZULAT PHARMACY SDN. BHD.

INN (nemzetközi neve):

ACETAZOLAMIDE

db csomag:

0.5gm mcg/mL

Gyártó:

BAG Health Care GMBH ( Bag Pharma)

Termékjellemzők

                                4
The condition invariably subsides upon diminution or discontinuation
of the
medication.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal
product is important. It allows continued monitoring of the
benefit/risk balance of
the medicinal product. Healthcare professionals are asked to report
any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google
Play or Apple App Store.
4.9. OVERDOSE
Management
No specific antidote. Supportive measures with correction of
electrolyte and fluid
balance. Force fluids.
5.
PHARMACOLOGICAL PROPERTIES
5.1.
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Carbonic anhydrase inhibitors.
ATC Code: S01EC01.
Mechanism of action
Acetazolamide is an inhibitor of carbonic anhydrase. By inhibiting the
reaction
catalysed by this enzyme in the renal tubules, acetazolamide increases
the
excretion of bicarbonate and of cations, chiefly sodium and potassium,
and so
promotes alkaline diuresis.
Pharmacodynamic effects
Continuous
administration
of
acetazolamide
is
associated
with
metabolic
acidosis and resultant loss of diuretic activity. Therefore the
effectiveness of
DIAMOX in diuresis diminishes with continuous use.
By inhibiting carbonic anhydrase in the eye acetazolamide decreases
intra-
ocular pressure and is therefore useful in the treatment of glaucoma.
5.2.
PHARMACOKINETIC PROPERTIES
Distribution
It is tightly bound to carbonic anhydrase and accumulates in tissues
containing
this enzyme, particularly red blood cells and the renal cortex. It is
also bound to
plasma proteins.
Elimination
Acetazolamide has been estimated to have a plasma half-life of about 4
hours. It
is excreted unchanged in the urine, renal clearance being enhanced in
the
alkaline urine.
5.3.
PRECLINICAL SAFETY DATA
Nothing of note to the prescriber.
6.
PHARMACEUTICAL
PARTICULARS
6.1.
LIST OF EXCIPIENTS
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
6.2.
                                
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