NEXIUM 24HR ONCE DAILY DOSING esomeprazole 20 mg (as magnesium trihydrate) capsule

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

esomeprazole magnesium trihydrate, Quantity: 22.3 mg (Equivalent: esomeprazole, Qty 20 mg)

제공처:

Haleon Australia Pty Ltd

약제 형태:

Capsule, hard

구성:

Excipient Ingredients: hypromellose; propylene glycol; indigo carmine aluminium lake; carmine; magnesium stearate; Gelatin; purified talc; methacrylic acid copolymer; titanium dioxide; erythrosine; iron oxide yellow; indigo carmine; povidone; Shellac; triethyl citrate; sodium hydroxide; allura red AC; glyceryl monostearate; polysorbate 80; hyprolose; sucrose; hydrolysed maize starch

관리 경로:

Oral

패키지 단위:

14

처방전 유형:

(S2) Pharmacy Medicine

치료 징후:

NEXIUM 24HR ONCE DAILY DOSING is indicated for the symptomatic relief of frequent heartburn, acid regurgitation and other symptoms associated with gastro-oesophageal reflux disease (GORD).

제품 요약:

Visual Identification: A hard capsule with a clear amethyst cap and clear body. The capsule is sealed with a yellow band in radial format that covers the joined portions of the body and cap. Additionally, the cap is marked "NEXIUM 20 MG" printed in white in radial format.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

승인 상태:

Registered

승인 날짜:

2019-04-15

제품 특성 요약

Nexium 24HR Once Daily Dosing Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
NEXIUM
® 24HR ONCE DAILY DOSING
(ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)
1.
NAME OF THE MEDICINE
Esomeprazole magnesium trihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule or tablet of NEXIUM 24HR Once Daily Dosing (referred as
NEXIUM
24HR elsewhere in this Product Information) contains esomeprazole
magnesium
trihydrate 22.3 mg (equivalent to esomeprazole 20 mg) as
enteric-coated pellets.
Esomeprazole is the S-isomer of omeprazole. It is optically stable
_in vivo_
, with
negligible conversion to the R-isomer.
EXCIPIENT(S) WITH KNOWN EFFECT:
Sucrose
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
NEXIUM 24HR 20 mg capsules are approximately 11 x 5 mm with a clear
body, and
an amethyst cap imprinted with “NEXIUM 20 MG” in white. The
capsule has a yellow
centre band, and contains yellow and purple enteric coated pellets.
NEXIUM 24HR 20 mg tablets are light pink, oblong, biconvex,
film-coated tablet
engraved “20 mg” on one side and “A/EH” on the other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
NEXIUM 24HR is indicated for the symptomatic relief of frequent
heartburn, acid
regurgitation and other symptoms associated with gastro-oesophageal
reflux disease
(GORD).
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
For symptomatic treatment of gastro-oesophageal reflux disease (GORD),
take 1
capsule (20 mg) or tablet (20 mg) once daily for at least 7 days, and
up to 14 days.
Patients should be referred to their doctor if symptoms persist or
worsen while taking
this course, or if symptoms persist or recur within two weeks of
completing the course.
Nexium 24HR Once Daily Dosing Page 2 of 16
_CHILDREN BELOW THE AGE OF 18 YEARS: _
NEXIUM 24HR is not intended for use in children under the age of 18.
METHOD OF ADMINISTRATION
NEXIUM 24HR capsules or tablets should be swallowed whole with liquid.
The
capsules or tablets must not be chewed, crushed or opened.
If require