MACROBID

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

NITROFURANTOIN ANHYDROUS; NITROFURANTOIN MACROCRYSTALS

متاح من:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

ATC رمز:

J01XE01

الشكل الصيدلاني:

CAPSULES

تركيب:

NITROFURANTOIN ANHYDROUS 75 MG; NITROFURANTOIN MACROCRYSTALS 25 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ALVOGEN MALTA OPERATIONS LTD., MALTA

المجال العلاجي:

NITROFURANTOIN

الخصائص العلاجية:

Treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus Saprophyticus in adult andadolescence 12 years and older.Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.

تاريخ الترخيص:

2022-09-11

نشرة المعلومات

PATIENT INFORMATION LEAFLET
IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) –
1986
Available by doctor’s prescription only
MACROBID
CAPSULES
EACH CAPSULE CONTAINS:
Nitrofurantoin (as macrocrystals) 25 mg
Nitrofurantoin (as anhydrous) 75 mg
For inactive ingredients and allergen information, please see Section
2, “Important
information about some of the ingredients of this medicine”, and
Section 6 – “Further
Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE YOU START TAKING
THIS MEDICINE. This
leaflet contains concise information about the medicine. If you have
any further
questions, please contact your doctor or pharmacist.
This medicine has been prescribed for your disease. Do not give it to
other people. It
may harm them, even if their disease seems to be the same as yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
This medicine is used to treat acute uncomplicated urinary tract
infections (acute
cystitis) caused by sensitive strains of _Escherichia coli_ (_E.
coli_) or _staphylococcus _
_saprophyticus_ in adults and children aged 12 years or older.
Nitrofurantoin is not indicated for the treatment of pyelonephritis
(kidney infection) or
abscesses in the area surrounding the kidneys.
Therapeutic group:
Systemic antibacterials, nitrofuran derivatives.
2. BEFORE USING THIS MEDICINE
DO NOT TAKE MACROBID IF:
-
You are allergic to nitrofurantoin or any of the other ingredients of
this
medicine (listed in Section 6)
-
You have a kidney disease which severely impairs their function (if
you
are unsure, please ask your doctor).
-
You have anuria, oliguria or severe kidney function impairment
(creatinine
clearance < 60 ml/min, or clinically significant increased serum
creatinine levels)
– those are contraindications.
-
You are 38-42 weeks pregnant, in labour, or about to give birth.
-
You have a history of cholestatic jaundice / impaired liver function
associated with nitrofurantoin treatment
-
Do not use Macrobid in infants younger than 1 month old
-
If you are unsure about an

خصائص المنتج

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SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
MACROBID
Nitrofurantoin (as macrocrystals) 25 mg
Nitrofurantoin (as anhydrous) 75 mg
capsules
1.
THERAPEUTIC INDICATIONS
Treatment of acute uncomplicated urinary tract infections (acute
cystitis) caused by
susceptible strains of Escherichia coli or Staphylococcus
Saprophyticus in adult and
adolescence 12 years and older.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or
perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Macrobid and other antibacterial drugs, Macrobid should be used only
to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
PHARMACOTHERAPEUTIC GROUP:
Antibacterials for systemic use, nitrofuran derivatives.
ATC CODE:
J01XE01
2.
DESCRIPTION
Nitrofurantoin is an antibacterial agent specific for urinary tract
infections. Macrobid
(Nitrofurantoin Capsules, USP) (monohydrate/macrocrystals) is a hard
gelatin capsule.
Each capsule contains 100 mg of nitrofurantoin in the form of 25 mg of
nitrofurantoin
macrocrystals and 75 mg of nitrofurantoin monohydrate.
The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-
furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical
structure is the
following:
Molecular Weight: 238.16
The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-
furanyl]methylene]amino]-2,4- imidazolidinedione monohydrate. The
chemical structure is
the following:
Molecular Weight: 256.17
INACTIVE INGREDIENTS:
Each capsule contains lactose monohydrate, gelatin, povidone, corn
starch, compressible sugar, talc, carbomer 934P, magnesium stearate,
titanium dioxide,
D&C Ye low No. 10, FD&C Red No. 40, FD&C Blue No. 1, gray ink,
purified water.
Meets USP Dissolution Test 8.
3.
CLINICAL PHARMACOLOGY
Each Macrobid capsule contains two forms of nitrofurantoin.
Twenty-five percent is
macrocrystaline nitrofurantoin, which has slower dissolution and
absorption than
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