MACROBID Prolonged-release capsule Ref.[7490] Active ingredients: Nitrofurantoin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK

Product name and form

Macrobid 100mg Prolonged-release Capsules.

Pharmaceutical Form

The 100mg capsule has an opaque blue cap and opaque yellow body and bears the monogram “GS 100”.

Qualitative and quantitative composition

Macrobid is a modified release, hard gelatin capsule containing the equivalent of 100mg of Nitrofurantoin in the form of nitrofurantoin macrocrystals and nitrofurantoin monohydrate.

Excipient(s) with known effect: Lactose 194.60 mg per capsule.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nitrofurantoin

Nitrofurantoin is a broad spectrum antibacterial agent, active against the majority of urinary pathogens. It is bactericidal in renal tissue and throughout the urinary tract. The wide range of organisms sensitive to the bacterial activity include Escherichia coli, Enteroccus faecalis, Klebsiella species, Enterobacter species, Staphylococcus species: (e.g. S. aureus, S. saprophyticus, S. epidermidis).

List of Excipients

Macrobid Capsules contain:

Talc
Corn starch
Lactose carbopol
Povidone
Sugar
Magnesium stearate
Gelatin
Colouring agents (E104, E171, E132)

Printing ink contains:

Shellac
Propylene glycol (E1520)
Titanium dioxide (E171)
Black iron oxide (E172)
Ammonium hydroxide (E527)
Simethicone

Pack sizes and marketing

There are two pack sizes, one consists of 14 capsules and the other is a sample pack containing 2 capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization dates and numbers

PL 12762/0052

31/03/2000

Drugs

Drug Countries
MACROBID Canada, Ireland, Israel, New Zealand, United Kingdom, United States

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