MACRODANTIN CAPSULES 100 mg

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pharmacare Limited û Woodmead

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS NITROFURANTOIN MACROCRYSTALS 100 mg

Authorization status:

Registered

Authorization date:

1975-11-06

Summary of Product characteristics

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Page 1 of 10
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1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S4
PROPRIETARY NAME AND DOSAGE FORM
MACRODANTIN CAPSULES 50 MG (hard-gelatin capsule)
MACRODANTIN CAPSULES 100 MG (hard-gelatin capsule)
COMPOSITION
MACRODANTIN CAPSULES 50 MG:
Each hard-gelatin capsule contains 50 mg of nitrofurantoin
macrocrystals.
_Excipients: _
Black iron oxide (C.I. 77499), erythrosine (C.I. 45430), gelatin,
lactose, maize starch, purified
talc, quinolene yellow (C.I. 47005), titanium dioxide (C.I. 77891)
Contains sugar: Lactose 160,57 mg
MACRODANTIN CAPSULES 100 MG:
Each hard-gelatin capsule contains 100 mg of nitrofurantoin
macrocrystals.
_Excipients: _
Black iron oxide (C.I. 77499), erythrosine (C.I. 45430), gelatin,
lactose, maize starch, purified
talc, quinolene yellow (C.I. 47005), titanium dioxide (C.I. 77891)
Contains sugar: Lactose 192,04 mg
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Page 2 of 10
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CATEGORY AND CLASS
A 18.5 Urinary tract antiseptics
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PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Nitrofurantoin is an antibacterial medicine for specific urinary tract
infections.
Nitrofurantoin exerts bacteriostatic activity against many strains of:
_Escherichia coli _
_Enterococci _
Anti-bacterial activity is higher in acidic urine.
Many strains of _Enterobacter_ species and _Klebsiella_ species are
resistant to nitrofurantoin.
It is not active against most strains of _Proteus_ and _Pseudomonas_
species.
PHARMACOKINETIC PROPERTIES
Nitrofurantoin is rapidly and completely absorbed from the
gastrointestinal tract. Anti-
bacterial concentrations are not achieved in plasma following
ingestion of recommended
doses because of rapid elimination.
INDICATIONS
MACRODANTIN is indicated for the treatment and prevention of
recurrence of
uncomplicated lower urinary tract infections, e.g. pyelonephritis,
pyelitis and cystitis.
It is not indicated for the treatment of associated renal, cortical or
perinephric abscesses.
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Page 3 of 10
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CONTRAINDICATIONS
Anuria, oliguria and renal impairment are contraindications to therapy
wit