Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

CMI
File ref: TT50-9899
Trade NameDose FormStrengthIdentifier
MacrobidModified release capsule100 mg
SponsorApplication dateRegistration situationClassification
Te Arai BioFarma Limited
P O Box 46-205
Herne Bay
Auckland 1147
8/12/2015Consent given
Approval date: 1/10/2020
Prescription
 

Composition

ComponentIngredientManufacturer
modified release capsuleActive 
 Nitrofurantoin 25 mg (macrocrystals)F.I.S. Fabbrica Italiana Sintetici SpA
Viale Milano 26
Montecchio Maggiore
Vicenza 36075
Italy
 Nitrofurantoin monohydrate 80.7 mgF.I.S. Fabbrica Italiana Sintetici SpA
Viale Milano 26
Montecchio Maggiore
Vicenza 36075
Italy
 Excipient 
 Carbomer 934P
 Gelatin
 Lactose monohydrate
 Magnesium stearate
 Maize starch
 Povidone
 Purified talc
 Sucrose

Production

Manufacturing stepManufacturer
Finished Product TestingNorwich Pharmaceuticals Inc
6826 State Highway 12
North Norwich
New York 13815
United States of America
Manufacture of Final Dose FormNorwich Pharmaceuticals Inc
6826 State Highway 12
North Norwich
New York 13815
United States of America
PackingNorwich Pharmaceuticals Inc
6826 State Highway 12
North Norwich
New York 13815
United States of America
NZ Site of Product ReleaseTe Arai BioFarma Limited
91 Red Hill Rd
Te Arai
Wellsford 0974

Packaging

PackageContentsShelf Life
Bottle, plastic, 150cc HDPE bottle with CRC cap100 capsules24 months from date of manufacture stored at or below 25°C
30 days opened stored at or below 25°C

Indications

Macrobid is indicated for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Therapy with nitrofurantoin may be initiated before results of culture and susceptibility tests are known; therapy should be continued or altered, as appropriate, in accordance with results of the tests.

Macrobid is indicated for the prophylaxis of urinary tract infections after surgery or procedures involving genitourinary tract.

Macrobid is not indicated for the treatment of pyelonephritis or peri-nephric abscesses.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
8/11/2020Changed Medicine NotificationExcipient specifications/test methods - Grade 2; Finished product specifications/test methods - Grade 1; Finished product specifications/test methods - Grade 3; Container/closure/packaging - Grade 1; Data sheet - miscellaneous changesInitial evaluation9/11/2020 
8/12/2015New Higher-risk Medicine ApplicationNew higher-risk medicine that does not contain a new active substanceGranted 1/10/202015/12/2015 
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