NITROFURANTOIN 100 MG TABLETS

Active substance: NITROFURANTOIN

View full screen / Print PDF » Download PDF ⇩

Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Nitrofurantoin 100 mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of Nitrofurantoin.
For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Tablet.
Yellow tablet, round, flat, bevel edged tablets. Engraving: ‘Biorex’ on one side
and a scoreline on the reverse or ‘7N3’ on one side and a scoreline on reverse.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of and prophylaxis against acute or recurrent, uncomplicated
lower urinary tract infections or pyelitis either spontaneous or following
surgical procedures.
Nitrofurantoin is specifically indicated for the treatment of infections, when
due to susceptible strains of Escherichia coli, Enterococci, Staphylococci,
Citrobacter, Kiebsiella and Enterobacter.

4.2

Posology and method of administration
For oral administration.
Dosage:

Adults
Acute Uncomplicated Urinary Tract Infections: 50 mg four times daily for
seven days
Severe Chronic Recurrence: 100 mg four times a day for seven days
Long Term Suppression: 50 mg-100 mg once a day.
Prophylaxis: 50 mg four times daily for the duration of procedure and 3 days
thereafter.
Children and Infants over three months of age
Acute Urinary Tract Infections: 3 mg/kg/day in four divided doses for seven
days.
Suppressive: 1 mg/kg, once a day.
For children under 25 kg body weight consideration should be given to the use
of nitrofurantoin
suspension.
Elderly
Provided there is no significant renal impairment, in which nitrofurantoin is
contraindicated, the dosage should be that for any normal adult. See
precaution and risks to elderly patients associated with long-term therapy
(Section 4.8.)

4.3

Contraindications
Patients suffering from renal dysfunction with a creatinine clearance of less
than 60 ml/minute or elevated serum creatinine.
Patients suffering from renal dysfunction with an eGFR of less than 45
ml/minute. Nitrofurantoin may be used with caution as short-course therapy
only for the treatment of uncomplicated lower urinary tract infection in
individual cases with an eGFR between 30-44 ml/min to treat resistant
pathogens, when the benefits are expected to outweigh the risks.
In infants under three months of age as well as pregnant patients at term
(during labour and delivery) because of the theoretical possibility of
haemolytic anaemia in the foetus or in the new-born infant, due to immature
erythrocyte enzyme systems.
Patients with known hypersensitivity to nitrofurantoin or other nitrofurans.

4.4

Special warnings and precautions for use
Nitrofurantoin is not effective for the treatment of parenchymal infections of
unilaterally non-functioning kidney. A surgical cause for infection should be
excluded in recurrent or severe cases.

Since pre-existing conditions may mask adverse reactions, nitrofurantoin
should be used with caution in patients with pulmonary disease, hepatic
dysfunction, neurological disorders, and allergic diathesis.
Peripheral neuropathy, which may become severe or irreversible, has occurred
and may be life threatening. Therefore, treatment should be stopped at the
first signs of neural involvement (paraesthesiae). Nitrofurantoin should be
used in caution with patients with anaemia, diabetes mellitus, electrolyte
imbalance, debilitating conditions and vitamin B (particularly folate)
deficiency.
Chronic pulmonary reactions can develop insidiously, and may occur
commonly in elderly patients. Close monitoring of pulmonary conditions of
patients receiving long-term therapy is warranted.
Nitrofurantoin should be discontinued at any sign of haemolysis in those with
suspected glucose-6-phosphate dehydrogenase deficiency.
Gastrointestinal reactions may be minimised by taking the drug with food or
milk, or by adjustment of dosage.
Discontinue treatment with Nitrofurantoin if otherwise unexplained
pulmonary, hepatic, haematological or neurological syndromes occur.
For long-term treatment, monitor patients closely for evidence of hepatitis or
pulmonary symptoms or other evidence of toxicity.

4.5

Interaction with other medicinal products and other forms of interaction
1. Increased absorption with food or agents delaying gastric emptying
2. Decreased absorption with magnesium trisilicate.
3. Decreased renal excretion of nitrofurantoin by probenecid and
sulphinpyrazone.
4. Decreased anti-bacterial activity by carbonic anhydrase inhibitors and
urine alkalisation.
5. Anti-bacterial antagonism by quinolone anti-infectives.
6. Interference with some tests for glucose in urine.

4.6

Pregnancy and lactation
Animal studies with nitrofurantoin have shown no teratogenic effects.
Nitrofurantoin has been in extensive use since 1952, and its suitability in
human pregnancy has been well documented. However, as with all drugs, the
maternal side effects may adversely affect the course of pregnancy. The drug

should be used at the lowest dose as appropriate for specific indication, only
after careful assessment.
Nitrofurantoin is however contraindicated in infants under three months of age
and in pregnant women during labour and delivery, because of the possible
risk of haemolysis of the infants immature red cells. Caution should be
exercised while breast-feeding an infant known or suspected to have an
erythrocyte enzyme deficiency, since nitrofurantoin is detected in trace
amounts in breast milk.

4.7

Effects on ability to drive and use machines
Nitrofurantoin should not affect the ability of the patient to drive or use
machinery.

4.8

Undesirable effects
Respiratory
If any of the following reactions occur the drug should be discontinued.
Acute pulmonary reactions usually occur within the first week of treatment
and are reversible with cessation of therapy.
Subacute reactions may take several months to resolve once the drug has been
stopped.
Chronic pulmonary reactions occur rarely in patients who have received
continuous therapy for six months or longer and are more common in elderly
patients. Changes to ECG have occurred, associated with pulmonary
reactions. Minor symptoms such as fever, chills, cough and dyspnoea may be
significant. Collapse and cyanosis have seldom been reported. The severity
of chronic pulmonary reactions and their degree of resolution appear to be
related to the duration of therapy after the first clinical signs appear. It is
important to recognise symptoms as early as possible. Pulmonary function
may be impaired permanently, even after cessation of therapy.
Hepatic

Hepatic reactions including cholestatic jaundice and chronic active hepatitis
occur rarely. Fatalities have been reported. Cholestatic jaundice is generally
associated with short-term therapy (usually up to two weeks). Chronic active

hepatitis, occasionally leading to hepatic necrosis is generally associated with
long-term therapy (usually after six months). The onset may be insidious.
Treatment should be stopped at the first sign of hepatotoxicity.
Neurological
Peripheral neuropathy (including optical neuritis) with symptoms of sensory as
well as motor involvement, which may become severe or irreversible, has been
reported infrequently. Less frequent reactions of unknown causal relationship
are depression, euphoria, confusion, psychotic reactions, nystagmus, vertigo,
dizziness, asthenia, headache and drowsiness. Treatment should be stopped at
the first sign of neurological involvement.
Gastrointestinal
Nausea and anorexia have been reported. Emesis, abdominal pain and
diarrhoea are less common gastrointestinal reactions.
Haematological

Agranulocytosis, leucopenia, granulocytopenia, haemolytic anemia,
thrombocytopenia, megaloblastic anaemia, glucose-6-phosphate
dehydrogenase deficiency anaemia, and eosinophila have been reported.
Aplastic anaemia have been reported rarely. Cessation of therapy has
generally returned the blood picture to normal.
Hypersensitivity
Allergic skin reactions manifesting in angioneurotic oedema, maculopapular,
erythematous or eczematous eruptions, urticaria, rash, and pruritus have
occurred.
Lupus-like syndrome associated with pulmonary reactions to Nitrofurantoin
has been reported.
Exfoliative dermatitis and erythema multiforme (including Steven-Johnson
Syndrome) have been reported rarely.

Other hypersensitivity reactions include anaphylaxis, sialadenitis, pancreatitis,
drug fever and arthralgia.
Miscellaneous
Transient alopecia and benign intracranial hypertension. As with other
antimicrobial agents, superinfections by fungi or resistant organisms such as
Pseudomonas may occur. However, these are limited to the genito-urinary
tract because suppression of normal bacteria flora does not occur elsewhere in
the body.

4.9

Overdose
Symptoms and signs of overdose include gastric irritation, nausea and
vomiting. There is no known specific antidote. However, nitrofurantoin can
be haemodialysed in cases of recent ingestion. Standard treatment is by
induction of emesis or by gastric lavage. Monitoring of full blood count, liver
function, and pulmonary function tests are recommended. A high fluid intake
should be maintained to promote urinary excretion of the drug.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC Code: G04A C (urinary antiseptics and antiinfectives, nitrofuran
derivatives).
Nitrofurantoin is a broad-spectrum antibacterial agent, active against the
majority of urinary pathogens. The wide range of organisms sensitive to the
bactericidal activity include:
Escherichia coli
Enterococcus Faecalis
Klebsiella Species
Enterobacter Species
Staphylococcus Species, e.g. S.Aureus, S.Saprophyticus, S.Epidermidis
Citrobacter Species
Clinically most common urinary pathogens are sensitive to nitrofurantoin. Most
strains of Proteus and Serratia are resistant. All pseudomonas strains are resistant.

5.2

Pharmacokinetic properties
Orally administered nitrofurantoin is readily absorbed in the upper
gastrointestinal tract and is rapidly excreted in the urine. Blood concentrations
at therapeutic dosages are usually low with an elimination half-life of about 30
minutes.
Maximum urinary excretion usually occurs 2-4 hours after administration of
nitrofurantoin. Urinary drug dose recoveries of about 40-45% are obtained.

5.3

Preclinical safety data
Preclinical information has not been included because the safety profile of
Nitrofurantoin has been established after many years of clinical use. Please
refer to section 4.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Maize Starch
Lactose
Alginic Acid
Magnesium Stearate (E572).

6.2

Incompatibilities
None known.

6.3

Shelf life
Three years.

6.4

Special precautions for storage
Store at a temperature not exceeding 25 C. Protect from light.

6.5

Nature and contents of container

ο

Polypropylene 'Securitainer' fitted with polythene cap. Containers of 28, 50,
100 and 1,000 tablets.

Aluminium/PVC Blisters in packs of 28 and 100 tablets.
Not all pack sizes may be marketed.
6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Teva UK Limited
Brampton Road
Hampden Park
Eastbourne
East Sussex
BN22 9AG

8

MARKETING AUTHORISATION NUMBER(S)
PL 00289/0770

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
26/01/2010

10

DATE OF REVISION OF THE TEXT
01/09/2014

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)