Metronidazole 500mg tablets smpc taj pharmaceuticals

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RX
METRONIDAZOLE
TABLETS
500MG
1.NAME OF THE MEDICINAL PRODUCT
Metronidazole 500mg Tablets
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each tablet contains metronidazole EP 500 mg
Excipients with known effect: lactose
monohydrate
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablets
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Metronidazole is active against a wide range of
pathogenic micro-organisms, notably species
of Bacteroids, Fusobacteria, Clostridia,
Eubacteria, anaerobic cocci and Gardnerella
vaginalis.
It is also active against Trichomonas vaginalis,
Entamoeba histolytica, Gardia
lamblia, Balantidium coli and Helicobacter
pylori.
Metronidazole is indicated in adults and children
for the following indications:
1) Prevention of post-operative infections due to
anaerobic bacteria, particularly species
of bacteroids and anaerobic streptococci.
2) The treatment of septicaemia, bacteraemia,
peritonitis, brain abscess, necrotising
pneumonia, osteomyelitis, puerperal sepsis,
pelvic abscess, pelvic cellulitis and post-
operative wound infections from which
pathogenic anaerobes have been isolated.
3) Urogenital trichomoniasis in the female
(Trichomonas vaginalis), and in man.
4) Bacterial vaginosis (also known as non-
specific vaginitis, anaerobic vaginosis
or Gardnerella vaginalis).
5) All forms of amoebiasis (intestinal and extra-
intestinal disease and asymptomatic cyst
passers).
6) Giardiasis.
7) Acute ulcerative gingivitis.
8) Acute dental infections (eg acute pericoronitis
and acute apical infections)
9) Anaerobically-infected leg ulcers and
pressure sores.
10) Treatment of Helicobacter pylori infection
associated with peptic ulcer as part of triple
therapy.
Consideration should be given to official
guidance on the appropriate use of antibacterial
agents.
4.2 Posology and method of administration
Posology
Metronidazole Tablets should be taken during or
after meals, swallowed with water and NOT
CHEWED.
Elderly: Caution is advised in the elderly,
particularly at high doses, although there is
limited information available on modification of
dosage.
Hepatic impairment: Caution is advised in
patients with hepatic encephalopathy. One third
of the daily dose given once a day should be
considered (see section 4.4).
1) Anaerobic infections:
Treatment for 7 days should be satisfactory for
most patients but, depending upon clinical and
bacteriological assessments, the physician may
decide to prolong treatment, eg for eradication
of infection from sites which cannot be drained
or are liable to endogenous recontamination by
anaerobic pathogens from the gut, oropharynx or
genital tract.
Children > 8 weeks to 12 years of age: The
usual daily dose is 20-30 mg/kg/day as a single

dose or divided into 7.5 mg/kg every 8 hours.
The daily dose may be increased to 40 mg/kg,
depending on the severity of the infection.
Duration of treatment is usually 7 days.
Children < 8 weeks of age: 15 mg/kg as a single
dose daily or divided into 7.5 mg/kg every 12
hours.
In newborns with a gestation age <40 weeks,
accumulation of metronidazole can occur during
the first week of life, why the concentrations of
metronidazole in serum should preferable be
monitored after a few days therapy.
Children under 10 years: A more suitable
dosage form should be used for this age group.
Prophylaxis against anaerobic infection - chiefly
in the context of abdominal (especially
colorectal) and gynaecological surgery.
Adults: 1g stat dose 24 hours pre-operatively,
followed by 400mg at 8 hourly intervals during
the 24 hours preceding operation followed by
post-operative iv or rectal administration until
the patient is able to take tablets.
Children < 12 years: 20-30 mg/kg as a single
dose given 1-2 hours before surgery.
Newborns with a gestation age <40 weeks: 10
mg/kg body weight as a single dose before
operation.
2) Treatment of established infections:
Adults and children over 10 years: 800mg
followed by 400mg 8 hourly.
3) Urogenital trichomoniasis:
Where reinfection is likely, sexual partners
should be treated concomitantly.
Adults and adolescents: 2000 mg as a single
dose or 200 mg 3 times daily for 7 days or 400
mg twice daily for 5-7 days.
Children < 10 years: 40 mg/kg orally as a single
dose or 15 – 30 mg/kg/day divided in 2-3 doses
for 7 days; not to exceed 2000 mg/dose.
4) Bacterial vaginosis
Adults: 400mg twice daily for 7 days, or 2g as a
single dose for one day only.
Adolescents: 400 mg twice daily for 5-7 days or
2000 mg as a single dose.
5) Amoebiasis
Adults> 10 years: 400 to 800 mg 3 times daily
for 5-10 days.
Children 7 to 10 years: 200 to 400 mg 3 times
daily for 5-10 days.
Alternatively, doses may be expressed by body
weight:
35 to 50 mg/kg daily in 3 divided doses for 5 to
10 days, not to exceed 2400 mg/day.
Children under 7 years: A more suitable dosage
form should be used for this age group.
6) Giardiasis:
Adults > 10 years: 2000 mg once daily for 3
days, or 400 mg. three times daily for 5 days, or
500 mg twice daily for 7 to 10 days.
Children 7 to 10 years: 1000 mg once daily for
3 days.
Children 3 to 7 years: 600 to 800 mg once daily
for 3 days.
Children 1 to 3 years: 500 mg once daily for 3
days.
Alternatively, as expressed in mg per kg of body
weight:
15-40 mg/kg/day divided in 2-3 doses.

Children under 7 years: A more suitable dosage
form should be used for this age group.
7) Acute ulcerative gingivitis (for 3 day
duration):
Adults and children over 10 years: 200mg three
times daily.
dosage form should be used for this age.
8) Acute dental infections (for 3-7 day
duration):
times daily.
9) Leg ulcers and pressure sores (for 7 day
duration):
times daily.
10) Treatment of Helicobacter pylori in
infected patients
As a part of a combination therapy, 20
mg/kg/day not to exceed 500 mg twice daily for
7-14 days. Official guidelines should be
consulted before initiating therapy.
Method of Administration
For oral administration.
4.3 Contraindications
• Known hypersensitivity to nitroimidazoles,
metronidazole or to any of the excipients listed
in 6.1.
• Pregnancy - metronidazole should not be used
in the first trimester in patients with
trichomoniasis or bacterial vaginosis (see section
4.6).
• Breast feeding should be discontinued for 12-
24 hours when single high dose (e.g. 2g) therapy
is used (see section 4.6).
4.4 Special Warnings and precautions for use
• Patients with rare hereditary problems of
galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption
should not take metronidazole as this product
contains lactose.
• Patients should abstain from alcohol for at least
48 hours following discontinuation of therapy
with metronidazole. A disulfiram-like reaction
with hypotension and flushing has occurred (see
section 4.5).
• Caution is advised in patients with porphyria.
• Metronidazole tablets should not be used in
patients with blood dyscrasias or with active
non-infectious disease of the central nervous
system. High doses of metronidazole may mask
the presence of syphilis.
• Caution in patients with epilepsy or those who
have had seizures as high doses of
Metronidazole can induce seizures.
• Use with caution in the second and third
trimester when used to treat trichomoniais or
bacterial vaginosis (see section 4.6.)
• Regular clinical and laboratory surveillance are
advised if treatment continues for more than 10
days.
• Consideration of the therapeutic benefit against
the risk of peripheral neuropathy is advised with
continuous therapy for chronic conditions.
• There is a possibility that after Trichomonas
vaginalis has been eliminated a gonococcal
infection might persist.
• The elimination half-life of metronidazole
remains unchanged in the presence of renal
failure. The dosage of metronidazole, therefore,
needs no reduction. Such patients, however,
retain the metabolites of metronidazole. The
clinical significance of this is not known at
present.
• In patients undergoing haemodialysis
metronidazole and metabolites are efficiently
rmoved during an eight-hour period of dialysis.
Metronidazole should, therefore, be
readministered immediately after haemodialysis.
• No routine adjustment in the dosage of
metronidazole need be made in patients with
renal failure undergoing intermittent peritoneal
dialysis (IPD) or continuous ambulatory
peritoneal dialysis (CAPD).
• Metronidazole is mainly metabolised by
hepatic oxidation. Substantial impairment of

metronidazole clearance may occur in the
presence of advanced hepatic insufficiency.
Signficant cumulation may occur in patients
with hepatic encephalopathy and the resulting
high plasma concentrations of metronidazole
may contribute to symptoms of the
encephalopathy. Therefore, metronidazole
should be administered with caution to patients
with hepatic encephalopathy. The daily dosage
should be reduced to one third and may be
administered once daily.
• Cases of severe hepatotoxicity/acute hepatic
failure, including cases with a fatal outcome
with very rapid onset after treatment initiation in
patients with Cockayne syndrome have been
reported with products containing metronidazole
for systemic use. In this population,
metronidazole should therefore be used after
careful benefit-risk assessment and only if no
alternative treatment is available. Liver function
tests must be performed just prior to the start of
therapy, throughout and after end of treatment
until liver function is within normal ranges, or
until the baseline values are reached. If the liver
function tests become markedly elevated during
treatment, the drug should be discontinued.
Patients with Cockayne syndrome should be
advised to immediately report any symptoms of
potential liver injury to their physician and stop
taking metronidazole.
• Patients should be warned that metronidazole
may darken urine.
• Due to inadequate evidence on the
mutagenicity risk in humans (see section 5.3),
the use of metronidazole for longer treatment
than usually required should be carefully
considered.
4.5 Interaction with other medicinal
products and other forms of interaction
Interactions to be used with caution:
• Lithium: Lithium retention accompanied by
evidence of possible renal damage has been
reported in patients treated simultaneously with
lithium and metronidazole. Lithium treatment
should be tapered or withdrawn before
administering metronidazole. Plasma
concentration of lithium, creatinine, and
electrolytes should be monitored in patients
under treatment with lithium while they receive
metronidazole.
• Anticoagulants: Some potentiation of
anticoagulant therapy has been reported when
metronidazole has been used with the warfarin
type oral anticoagulants. Dosage of the latter
may require reducing. Prothrombin times should
be monitored. No interactions have been
reported with anticoagulants of the heparin type.
However, anticoagulant activity should be
routinely monitored with these products.
• Alcohol: Patients should be advised not to take
alcohol during metronidazole therapy and for at
least 48 hours after because of the possibility of
a disulfiram-like reaction.
• Disulfiram: Psychotic reactions have been
reported.
• Immunosuppressants: Patients receiving
ciclosporin are at risk of elevated ciclosporin
serum levels. Serum ciclosporin and serum
creatinine should be closely monitored when
coadministration is necessary.
Pharmacokinetic interactions:
• Antiepileptics: Patients receiving phenobarbital
metabolise metronidazole at a much greater rate
than normally, reducing the half-life to
approximately 3 hours. Metronidazole inhibits
metabolism of phenytoin (increases plasma-
phenytoin concentration). Primidone accelerates
the metabolism of Metronidazole causing
reduced plasma concentrations.
• Cytotoxics: Metronidazole inhibits metabolism
of fluorouracil. Therefore, increased toxicity of
fluorouracil can result. Plasma levels of busulfan
may be increased by metronidazole which may
lead to severe busulfan toxicity.
• Ulcer-healing drugs: Cimetidine inhibits the
metabolism of metronidazole (increases plasma-
metronidazole concentration).
• Oestrogens: broad spectrum antibiotics
possibly reduce the contraceptive effect. See
local/national guidelines or BNF for specific
advice.

• Drug-lab modifications: Aspartate amino
transferase assays may give spuriously low
values in patients taking metronidazole,
depending on the method used.
4.6 Fertility, Pregnancy and lactation
Pregnancy
There is inadequate evidence of the safety of
metronidazole in pregnancy but it has been in
wide use for many years without apparent ill
consequence. As with all medicines,
metronidazole should not be given during
pregnancy or during lactation unless it is
considered essential, and in these circumstances
the short, high-dosage regimens are not
recommended.
Pregnancy
Metronidazole is contraindicated in the first
trimester (see section 4.3) and should be used
with caution in the second and third trimester
when used to treat trichomoniais or bacterial
vaginosis (see section 4.4).
For all other indications Metronidazole should
only be used if the benefits outweight the risks
or no other alternative is available especially in
the first trimester.
Breast-feeding
It is advisable to stop breast feeding until 12 –
24 hours after Metronidazole therapy has been
discontinued (see section 4.3).
4.7 Effects on ability to drive and use
machines
Patients should be warned about the potential for
drowsiness, dizziness, confusion, hallucinations,
convulsions or transient visual disorders, and
advised not to drive or operate machinery if
these symptoms occur.
4.8 Undesirable Effects
Frequency type and severity of adverse reactions
in children are the same as in adults.
The frequency of adverse events listed below is
defined using the following convention:
very common (≥ 1/10); common (≥ 1/100 to <
1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥
1/10,000 to < 1/1,000); very rare (< 1/10,000),
not known (cannot be estimated from the
available data).
Serious adverse reactions occur rarely with
standard recommended regimens.
Frequency, type and severity of adverse
reactions in children are the same as in adults.
Clinicians who contemplate continuous therapy
for the relief of chronic conditions, for periods
longer than those recommended, are advised to
consider the possible therapeutic benefit against
the risk of peripheral neuropathy.
Blood and
lymphatic
system
disorders:
Very rare Agranulocytosis, neutropenia,
thrombocytopenia, pancytopenia
Not known Leucopenia, bone marrow depression
disorders such as aplastic anaemia
Immune system
class:
Rare Anaphylaxis
Not known Angiodema, urticaria, fever
Metabolism and
nutrition
disorders:
Not known Anorexia
Psychiatric
disorders:
Very rare Psychotic disorders, including confusion and
hallucinations
Not known Depressed mood
Nervous system
disorders;
Very rare Encephalopathy (eg. confusion, fever,
headache, paralysis, light sensitivity,
disturbances in sight and movement, stiff
neck) and subacute cerebellar syndrome (eg.
ataxia, dysathria, gait impairment, nystagmus
and tremor) which may resolve in
discontinuation of the drug, drowsiness,
dizziness, convulsions, headaches
Not known Depression, paraesthesia, during intensive
and-or prolonged metronidazole therapy,
peripheral sensory neuropathy or transient
epileptiform seizures have been reported. In
most cases neuropathy disappeared after
treatment was stopped or when dosage was
reduced. Incoordination of movement, aseptic
meningitis
Eye disorders:
Very rare Diplopia, myopia
Not known Optic neuropathy/neuritis
Ear and labyrinth

disorders:
Not known Hearing impaired/hearing loss (including
sensorineural), tinnitus
Gastrointestinal
disorders:
Not known Unpleasant taste in the mouth, taste
disorders, oral mucositis, furred tongue,
nausea, vomiting, gastro-intestinal
disturbances, diarrhoea, abdominal pain,
anorexia
Hepatobiliary
disorders:
Very rare Abnormal liver function tests, cholestatic
hepatitis, jaundice and pancreatitis which is
reversible on drug withdrawal, cases of liver
failure requiring liver transplant have been
reported in patients treated with
metronidazole in combination with other
antibiotic drugs
Skin and
subcutaneous
tissue disorders:
Very rare Skin rashes, pustular eruptions, pruritus,
flushing
Not known Erythema multiforme, Stevens-Johnson
syndrome or toxic epidermal necrolysis, fixed
drug eruption
Musculoskeletal,
connective
tissue and bone
disorders:
Very rare Myalgia, arthralgia
Renal and
urinary
disorders:
Very rare Darkening of urine (due to metronidazole
metabolite)
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after
authorisation of the medicinal product is
important. It allows continued monitoring of the
benefit/risk balance of the medicinal product.
4.9 Overdose
Features:
Nausea, vomiting, diarrhoea, anorexia, metallic
taste, headache, dizziness and occasionally
insomnia and drowsiness. Transiently increased
liver enzyme activities have been reported
rarely.
Transient epileptiform seizures have been
reported following intensive or prolonged
therapy. Other adverse effects occurring in these
circumstances include peripheral motor
neuropathy, blood dyscrasias and liver damage.
The combination of alcohol and metronidazole
has been said to cause disulfiram type reactions
in about 10% of individuals with sudden onset
of excitement, giddiness, flushing, nausea,
headache, hypotension and dyspnoea. However
the mechanism of this reaction has been
questioned.
Treatment:
Unlikely to be required.
Disulfiram type reactions should be treated with
intravenous fluids and plasma expanders if
necessary. Symptomatic and supportive.
In more serious cases:
1. Single brief convulsions do not require
treatment. If frequent or prolonged control with
intravenous diazepam (10-20mg in adults; 0.1-
0.3mg/kg body weight) or lorazepam (4mg in an
adult and 0.05mg/kg in a child). Give oxygen
and correct acid base and metabolic disturbances
as required.
2. Other measures as indicated by the patient's
clinical condition.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Nitroimidazole
derivatives
Mechanism of action
Metronidazole has antiprotozoan and
antibacterial effects. It is effects
against Trichomonas vaginalis, Gardnerella
vaginalis and other protazoa
including Entamoeba histolytica, Gardia
lamblia and anaerobic bacteria.
5.2 Pharmacokinetic properties
Absorption
Metronidazole is readily absorbed following
administration by mouth and bioavailability is
90-100%. Peak plasma concentrations occur
after 20 minutes to 3 hours. Absorption may be

delayed, but is not reduced overall, by
administration with food.
Distribution
Metronidazole is widely distributed. It appears
in most body tissues and fluids. It also crosses
the placenta and rapidly enters foetal circulation.
No more than 20% is bound to plasma proteins.
Biotransformation
Metronidazole is metabolised in the liver by
side-chain oxidation and glucuronide formation.
The half-life of metronidazole is 6.5 ± 2.9 hours.
The half-life of metronidazole is reported to be
longer in neonates and in patients with severe
liver disease.
Elimination
The majority of a dose of metronidazole is
excreted in the urine, mainly as metabolites; a
small amount appears in the faeces.
Metronidazole can be used in chronic renal
failure; it is rapidly removed from the plasma by
dialysis. Metronidazole is excreted in milk but
the intake of a suckling infant of a mother
receiving normal dosage would be considerably
less than the therapeutic dosage for infants.
5.3 Preclinical safety data
Metronidazole has been shown to be
carcinogenic in the mouse and in the rat
following chronic oral administration however
similar studies in the hamster have given
negative results. Epidemiological studies have
provided no clear evidence of an increased
carcinogenic risk in humans.
Metronidazole has been shown to be mutagenic
in bacteria in vitro. In studies conducted in
mammalian cells in vitro as well as in rodent or
humans in vivo, there was inadequate evidence
of a mutagenic effect of metronidazole, with
some studies reporting mutagenic effects, while
others studies were negative.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose, maize starch, povidone, magnesium
stearate, carmellose sodium, microcrystalline
cellulose, purified water,
methylhydroxypropylcellulose, macrogol 400,
titanium dioxide (E-171).
6.2 Incompatibilities
None.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store below 25°C. Protect from light.
6.5 Nature and contents of container
Polyethylene container with pilfer-proof
polyethylene closure,
pack sizes of 50, 100, 250 and 500 tablets.
Amber glass bottles,
pack sizes of 50, 100, 250 and 500 tablets.
Blister pack (aluminium (20 µm)/PVC (250
µm)),
pack sizes of 14 and 21 tablets.
Not all pack sizes may be marketed
6.6 Special precautions for disposal and
other handling
Not applicable.
7. MANUFACTURER:
Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
At:388/34, Changodar Industrial Estate
Changodar- 382 210
Dist- Ahmedabad. Gujarat (India)
MFG. LIC NO: G/25A/4795-A

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Metronidazole 500mg tablets smpc taj pharmaceuticals