HEXAMINE MICRO methenamine hippurate 1 g tablet bottle

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

methenamine hippurate, Quantity: 1000 mg

Dostupné z:

Micro Labs Pty Ltd

Forma lieku:

Tablet, uncoated

Zloženie:

Excipient Ingredients: magnesium stearate; povidone; colloidal anhydrous silica

Spôsob podávania:

Oral

Počet v balení:

100

Typ predpisu:

Not scheduled. Not considered by committee

Terapeutické indikácie:

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

Prehľad produktov:

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: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Registered

Dátum Autorizácia:

2021-12-03

Súhrn charakteristických

vD0-4 (draft 8November 2021)
Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION –
HEXAMINE MICRO 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.
vD0-4 (draft 8November 2021)
Page 2 of 7
HEXAMINE MICRO 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