APOHEALTH URINARY TRACT ANTIBACTERIAL methenamine hippurate 1 g tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

methenamine hippurate, Quantity: 1000 mg

Boleh didapati daripada:

Arrotex Pharmaceuticals Pty Ltd

Borang farmaseutikal:

Tablet, uncoated

Komposisi:

Excipient Ingredients: povidone; colloidal anhydrous silica; magnesium stearate

Laluan pentadbiran:

Oral

Unit dalam pakej:

20, 100

Jenis preskripsi:

Not scheduled. Not considered by committee

Tanda-tanda terapeutik:

Prophylaxis or suppression of bacteriuria associated with chronic or recurrent infection of the urinary tract.

Ringkasan produk:

Visual Identification: White to off-white, capsule-shaped, biconvex tablets, debossed with ?H? and ?1? on either side of breakline on one side, and is plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status kebenaran:

Registered

Tarikh kebenaran:

2021-12-03

Ciri produk

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AUSTRALIAN PRODUCT INFORMATION –
APOHEALTH URINARY TRACT ANTIBACTERIAL METHENAMINE HIPPURATE 1 G TABLET
1
NAME OF THE MEDICINE
Methenamine hippurate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 gram of methenamine hippurate.
For the full list of excipients, see _section 6.1 List of excipients_.
3
PHARMACEUTICAL FORM
White to off-white, capsule-shaped, biconvex tablets debossed with
‘H’ and ‘1’ on either side of
the scoreline on one side, and is plain on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Methenamine hippurate tablets are indicated for prophylaxis or
suppression of bacteriuria
associated with chronic or recurrent infection of the urinary tract.
4.2
D
OSE AND METHOD OF ADMINISTRATION
_Adults and children 12 years or older_: One tablet orally twice
daily.
_Children under 12 years_: Not recommended.
SPECIAL POPULATIONS
_Renal impairment_: No dose adjustments for patients with mild or
moderate renal
insufficiency.
Methenamine hippurate is not recommended for use by patients with
neurogenic bladder,
renal tract abnormalities or using long-term catheters. (see _section
4.3 Contraindications_).
4.3
C
ONTRAINDICATIONS
Hypersensitivity to methenamine hippurate, formaldehyde or to any of
the excipients listed
in _section 6.1_.
Patients with severe hepatic dysfunction, severe renal failure (eGFR <
10 mL/min/1.73m
2
),
severe dehydration, metabolic acidosis or gout.
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APOHEALTH URINARY TRACT ANTIBACTERIAL methenamine hippurate 1 g tablet
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
The underlying causes and risk factors for urinary tract infections
should be investigated,
and changes to perineal hygiene, sexual practices, urinary voiding and
diet to maintain the
normal urinary tract flora may be indicated before pharmacological
interventions.
The effectivity of methenamine hippurate as a prophylactic agent
depends on the acidity of
urine, the bacterial species and counts in urine, their susceptibility
to methenamine, and the
exp