Ofloxacin 200 mg Tabl ets SMPC, Taj Phar maceuticals

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• Uncomplicated urethral and cervical

RX gonorrhoea, non-gonococcal urethritis and
cervicitis.
OFLOXACIN Consideration should be given to official
guidance on the appropriate use of anti-bacterial
TABLETS agents.
200MG 4.2 Posology and method of administration

1.NAME OF THE MEDICINAL PRODUCT Posology

Ofloxacin 200 mg Tablets The dose of ofloxacin is determined by the type

and severity of the infection. The dosage range
2. QUALITATIVE AND QUANTITATIVE for adults is 200 mg to 800 mg daily.
COMPOSITION
Up to 400 mg may be given as a single dose,
Each film-coated tablet contains 200 mg of preferably in the morning. Generally, individual
ofloxacin. doses should be given at approximately equal
intervals.
Excipient with known effect:
In individual cases it may be necessary to
Each film-coated tablet also contains 96.00 mg
increase the dose to a maximum total dose of
of lactose, anhydrous.
800 mg daily, which should be given as 400 mg
For the full list of excipients, see section 6.1. twice daily, at approximately equal intervals.
This may be appropriate in infections due to
3. PHARMACEUTICAL FORM pathogens known to have reduced or variable
Film-coated tablet susceptibility to ofloxacin, in severe and/or
complicated infections (e.g. of the respiratory or
White biconvex capsule-shaped, film-coated urinary tracts) or if the patient does not respond
tablet. adequately.
The tablet can be divided into equal doses. The following doses are recommended:
4. CLINICAL PARTICULARS
Indications Single and Daily Doses
4.1 Therapeutic indications
Uncomplicated
The following indications are restricted to urethral/ cervical 400 mg
adults. gonorrhoea
Ofloxacin is suitable for treatment of the Uncomplicated
following bacterial infections if these are caused lower urinary tract 200 mg-400 mg daily
by pathogens sensitive to ofloxacin (see section infections
5.1): Complicated 400 mg daily, increasing if
infections of the necessary, to 400 mg twice a
• Lower respiratory tract infections including upper urinary tract day
pneumonia, bronchitits and acute exacerbations
400 mg daily, increasing, if
of chronic bronchitis caused by gram negative Lower respiratory
necessary, to 400 mg twice a
aerobic bacteria. (Ofloxacin tablets are not the tract infections
day
drug of first choice in pneumonia caused
Non-gonococcal
by Streptococcus pneumoniae, Mycoplasma urethritis and 400 mg daily
pneumoniae or Chlamydia pneumoniae); cervicitis
• Upper and lower urinary tract infections, A single dose of 400 mg of ofloxacin is
including uncomplicated (cystitis) and sufficient for the treatment of uncomplicated
complicated urinary tract infections. gonorrhoea.
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Special patient populations Treatment should not exceed 2 months duration.

Impaired renal function A daily dose of up to 400 mg ofloxacin may be
given as a single dose. In this case, it is
Following a normal initial dose, dosage should preferable to administer ofloxacin in the
be reduced in patients with impairment of renal morning.
function as determined by creatinine clearance
or plasma creatinine level. Daily doses of more than 400 mg must be
* According to indication or dose interval Creatinine Plasma Maintenance
Clearance Creatinine Dose*
** The serum concentration of ofloxacin should
be monitored in patients with severe renal 100 mg - 200
20 to 50 ml/min* 1.5 to 5 mg/dl mg ofloxacin
impairment and dialysis patients.
per day)
Patients undergoing haemodialysis or peritoneal 100 mg
dialysis should be given 100 mg ofloxacin per <20ml/min** >5 mg/dl ofloxacin per
day. day
divided into two separate doses and be given at
When creatinine clearance cannot be measured,
approximately equal intervals.
it can be estimated with reference to the serum
creatinine level using the following Cockcroft's Method of administration
formula for adults:
For oral use.
Ofloxacin tablets should be swallowed whole
with sufficient liquid before or during meal
times. They should not be taken within two
hours of mineral antacids, sucralfate or metal ion
preparations (aluminium, iron, magnesium or
zinc), didanosine chewable or buffered tablets
(for HIV), since reduction of absorption of
ofloxacin can occur (see section 4.5).
Impaired liver function 4.3 Contraindications
The excretion of ofloxacin may be reduced in The use of ofloxacin is contraindicated as
patients with severe hepatic dysfunction. follows:

(e.g. cirrhosis of the liver with ascites). In such • Hypersensitivity to the active substance, to any
cases, it is recommended that the dose should other fluoroquinolone antibacterials, or to any of
not exceed 400 mg ofloxacin daily, because of the excipients listed in section 6.1.
possible reduction of excretion. • In patients with a history of epilepsy or an
Paediatric population existing central nervous system disorder with a
lowered seizure threshold.
Ofloxacin is contraindicated for use in children
or growing adolescents (see section 4.3). • In patients with a history of tendon disorders
related to fluoroquinolone administration
Elderly
• In children or growing adolescents, and in
No adjustment of dosage is required in the pregnant or breastfeeding women, since animal
elderly, other than that imposed by consideration experiments do not entirely exclude the risk of
of renal or hepatic function. (See section 4.4 QT damage to the growth-plate cartilage in the
interval prolongation). growing organism cannot be entirely excluded.
Duration • In patients with latent or actual defects in
glucose-6-phosphate dehydrogenase activity
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because they may be prone to haemolytic prescribed ofloxacin. All patients should consult
reactions when treated with quinolone their physician if they experience symptoms of
antibacterial agents. tendinitis. If tendinitis is suspected, treatment
with ofloxacin must be halted immediately, and
4.4 Special Warnings and precautions for use appropriate treatment (e.g. immobilisation) must
Ofloxacin tablets are not the drug of first choice be initiated for the affected tendon (see sections
in pneumonia caused by Streptococcus 4.3 and 4.8).
pneumoniae or Chlamydia pneumoniae.
Hypersensitivity
Methicillin-resistant S. aureus Hypersensitivity and allergic reactions have
Are very likely to possess co-resistance to been reported for fluoroquinolones after first
fluoroquinolones, including ofloxacin. Therefore administration. Anaphylactic and anaphylactoid
ofloxacin is not recommended for the treatment reactions can progress to life-threatening shock,
of known or suspected MRSA infections unless even after the first administration. In these cases
laboratory results have confirmed susceptibility ofloxacin should be discontinued and suitable
of the organism to ofloxacin (and commonly treatment (e.g. treatment for shock) should be
recommended antibacterial agents for the initiated.
treatment of MRSA-infections are considered
Diseases caused by Clostridium difficile
inappropriate).
Diarrhoea, especially if severe, persistent and/or
Resistance to fluoroquinolones of E. coli bloody, occurring during or after treatment with
The most common pathogen involved in urinary ofloxacin (including several weeks after
tract infections – varies across the European treatment), may indicate a condition caused
Union. Prescribers are advised to take into by Clostridium difficile, the most severe form of
account the local prevalence of resistance in E. which is pseudomembranous colitis (CDAD)
coli to fluoroquinolones. CDAD may range in severity from mild to life
threatening, the most severe form of which is
Severe bullous reactions pseudomembranous colitis (see section 4.8). It is
Cases of severe bullous skin reactions such as therefore important to consider this diagnosis in
Stevens-Johnson syndrome or toxic epidermal patients who develop serious diarrhoea during or
necrolysis have been reported with ofloxacin after treatment with ofloxacin. If pseudo-
(see section 4.8). Patients should be advised to membraneous colitis is suspected, treatment
contact their doctor immediately prior to should be discontinued immediately.
continuing treatment if skin and/or mucosal Appropriate specific antibiotic therapy must be
reactions occur. started without delay (e.g. oral vancomycin, oral
Tendonitis teicoplanin or metronidazole). Medicinal
products that inhibit peristalsis are
Tendonitis, rarely observed with quinolones, contraindicated in such cases.
may occasionally lead to rupture involving
Achilles tendon in particular. Tendinitis and Patients predisposed to seizures
tendon rupture, sometimes bilateral, may occur Quinolones may lower the seizure threshold and
within 48 hours of starting treatment with may trigger seizures. Ofloxacin is
ofloxacin and have been reported up to several contraindicated in patients with a history
months after discontinuation of ofloxacin. The epilepsy or with a known predisposition to
risk of tendinitis and tendon rupture is increased seizures (see section 4.3).
in patients aged over 60 years and in patients
using corticosteroids. The daily dose should be Patients with a known predisposition to seizures
adjusted in elderly patients based on creatinine may include those with pre-existing central
clearance (see section 4.2). Close monitoring of nervous system lesions, concomitant treatment
these patients is therefore necessary if they are with fenbufen and similar non-steroidal anti-
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inflammatory drugs (NSAIDs), or with drugs Fluoroquinolones, including ofloxacin, have

which lower the cerebral seizure threshold, such neuromuscular blocking activity and may
as theophylline (see section 4.5 interactions). exacerbate muscle weakness in patients with
myasthenia gravis. Postmarketing serious
In case of convulsive seizures, treatment with adverse reactions, including deaths and the
ofloxacin should be discontinued (see section requirement for respiratory support, have been
4.5). associated with fluoroquinolone use in patients
Patients with impaired renal function with myasthenia gravis. Ofloxacin is not
recommended in patients with a known history
Since ofloxacin is eliminated primarily via the of myasthenia gravis.
kidneys, the dose should be adjusted in patients
with impaired renal function (see section 4.2). Superinfection
Patients with history of psychotic disorder As with other antibiotics, the use of ofloxacin,
especially if prolonged, may result in
Psychotic reactions have been reported in overgrowth of non-susceptible organisms,
patients receiving fluoroquinolones including especially Enteracci, resistant strains of some
ofloxacin. In some cases these have progressed organisms or Candida. Repeated evaluation of
to suicidal thoughts or self-endangering behavior the patient's condition is essential and
including suicide attempt, sometimes after a periodic in vitro susceptibility tests may be
single dose of ofloxacin (see section 4.8). In the useful. If secondary infection occurs during
event that a patient develops these reactions, therapy, appropriate measures should be taken.
ofloxacin should be discontinued and
appropriate measures instituted. Prevention of photosensitisation
Ofloxacin should be used with caution in Photosensitisation has been reported with
patients with a history of psychotic disorder or ofloxacin (see section 4.8). It is recommended
in patients with psychiatric disease. that patients should not expose themselves
unnecessarily to strong sunlight or to artificial
Patients with impaired liver function UV rays (e.g. sunray lamp, solarium), during
Ofloxacin should be used with caution in treatment and for 48 hours following treatment
patients with impaired liver function, as liver discontinuation in order to prevent
damage may occur. Cases of fulminant hepatitis photosensitisation.
potentially leading to liver failure (including QT interval prolongation
fatal cases) have been reported with
fluoroquinolones. Patients should be advised to Very rare cases of QT interval proplongation
stop treatment and contact their doctor if signs have been reported in patients taking
and symptoms of hepatic disease develop such fluoroquinolones.
as anorexia, jaundice, dark urine, pruritus or Caution should be taken when using
tender abdomen (see section 4.8).
fluoroquinolones, including ofloxacin, in
Patients treated with vitamin K antagonists patients with known risk factors for prolongation
of the QT interval such as, for example:
Due to possible increase in coagulation tests
(PT/INR) and/or bleeding in patients treated - elderly patients and women may be more
with fluoroquinolones, including ofloxacin, in sensitive to QTc-prolonging medications.
combination with a vitamin K antagonist (e.g. Therefore, caution should be taken when using
warfarin), coagulation tests should be monitored fluoroquinolones, including ofloxacin, in these
when these drugs are given concomitantly (see populations.
section 4.5). - uncorrected electrolyte imbalance (e.g.
Myasthenia gravis hypokalemia, hypomagnesemia) - congenital
long QT syndrome
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- concomitant use of drugs that are known to consulted immediately (see sections 4.7 and
prolong the QT interval (e.g. Class IA and III 4.8).
anti-arrhythmics, tricyclic antidepressants,
macrolides, antipsychotics) Excipient with known effect

- - cardiac disease (e.g. heart failure, myocardial Ofloxacin contains lactose anhydrous. Patients
infarction, bradycardia) with rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency, or
(See section 4.2 Elderly, section 4.5, section 4.8 glucose-galactose malabsorption should not take
and section 4.9). this medicine.
Dysglycaemia For treatment of severe and/or life-threatening
infections parenteral therapy is indicated.
As with all quinolones, disturbances in blood
glucose, including both hypoglycaemia and 4.5 Interaction with other medicinal products
hyperglycaemia have been reported, usually in and other forms of interaction
diabetic patients receiving concomitant
treatment with an oral hypoglycaemic agent Antacids, Sucralfate, Metal Cations
(e.g., glibenclamide) or with insulin. Cases of Co-administered magnesium/aluminum antacids,
hypoglycaemic coma have been reported. In sucralfate, zinc or iron preparations and
these diabetic patients, careful monitoring of didanosine chewable/buffered tablets can reduce
blood glucose is recommended (see section 4.8). absorption of ofloxacin tablets. Therefore,
ofloxacin should be taken 2 hours before such
Peripheral neuropathy
preparations.
Sensory or sensorimotor peripheral neuropathy
has been reported in patients receiving Theophylline, fenbufen or similar non-
fluoroquinolones, including ofloxacin, which steroidal anti-inflammatory drugs
can be rapid in its onset. Ofloxacin should be No pharmacokinetic interactions of ofloxacin
discontinued if the patient experiences were found with theophylline in a clinical study.
symptoms of neuropathy. This would minimise However, a pronounced lowering of the cerebral
the possible risk of developing an irreversible seizure threshold may occur when quinolones
condition (see section 4.8). are given concurrently with theophylline,
nonsteroidal antiinflammatory drugs, or other
Patients with glucose-6-phosphate-
agents, which lower the seizure threshold.
dehydrogenase deficiency
Patients with latent or diagnosed glucose-6- Probenecid, cimetidine, furosemide, and
phosphate-dehydrogenase deficiency may be methotrexate
predisposed to haemolytic reactions if they are Probenecid decreased the total clearance of
treated with quinolones. Therefore if ofloxacin ofloxacin by 24%, and increased AUC by 16%.
has to be used in these patients, potential The proposed mechanism is a competition or
occurrence of haemolysis should be monitored. inhibition for active transport at the renal tubular
excretion. Caution should be exercised when
Interference with laboratory tests
ofloxacin is coadministered with drugs that
In patients treated with ofloxacin, determination affect the tubular renal secretion such as
of opiates or porphyrin levels in urine may give probenecid, cimetidine, furosemide and
false-positive results. It may be necessary to methotrexate.
confirm positive opiate or porphyrin screens by
more specific methods. Drugs known to prolong QT interval
Ofloxacin, like other fluoroquinolones, should
Vision disorders
be used with caution in patients receiving drugs
If vision becomes impaired or any effects on the known to prolong the QT interval (e.g. Class IA
eyes are experienced, an eye specialist should be and III antiarrhythmics, tricyclic antidepressants,
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macrolides, and antipsychotics) (see section 4.4 situations where these abilities are of special
QT interval prolongation). importance (e.g. driving a car or operating
machinery), patients should know how they
Vitamin K antagonists react to ofloxacin before they drive or operate
Increased coagulation tests (PT/INR) and/or machinery. These effects may be enhanced by
bleeding, which may be severe, have been alcohol.
reported in patients treated with ofloxacin in
4.8 Undesirable Effects
combination with a vitamin K antagonist (e.g. The information given below is based on data
warfarin). Coagulation tests should, therefore, be
from clinical studies and on extensive post
monitored in patients treated with vitamin K marketing experience.
antagonists because of a possible increase in the
effect of coumarin derivatives (see section 4.4). System Uncomm Rare Very rare Not known
organ class on (≥1/10,000 (< 1/10,000) (cannot be
(≥1/1,000 to <1/1,000) estimated from
Glibenclamide to <1/100) available data)*
Infections Fungal
Ofloxacin may cause a slight increase in plasma and infection,
glibenclamide levels when administered infestations Pathogen
resistance
concurrently, it is therefore recommended that
Blood and Anaemia, Agranulocytosis,
patients treated concomitantly with ofloxacin lymphatic Haemolytic Bone marrow
system anaemia, failure,
and glibenclamide be monitored particularly disorders Leucopenia, Pancytopenia
closely. Since hypoglycaemia is then more likely Eosinophilia,
Thrombocytop
to occur, close monitoring of blood sugar levels enia
is recommended in such cases. Immune Anaphylactic Anaphylactic
system reaction*, shock*,
4.6 Fertility, Pregnancy and lactation disorders Anaphylactoi Anaphylactoid
d reaction*, shock*
Angioedema*
Pregnancy
Metabolism Anorexia Hypoglycaemia in
and diabetics treated
Based on a limited amount of human data, the Nutrition with
use of fluoroquinolones in the first trimester of disorders hypoglycaemic
agents (see
pregnancy has not been associated with an section 4.4),
increased risk of major malformations or other Hyperglycaemia,
Hypoglycaemic
adverse effects on pregnancy outcome. Animal coma
studies have shown damage to the joint cartilage Psychiatric Agitation, Psychotic Psychotic disorder
disorders Sleep disorder (for and depression
in immature animals but no teratogenic effects disorder, e.g. with self-
(see section 5.3). Therefore ofloxacin must not Insomnia hallucination endangering
), behaviour
be used during pregnancy (see section 4.3). Anxiety, including suicidal
Confusional ideation or suicide
Breast-feeding state, attempt (see
Nightmares, Section 4.4),
Depression Nervousness
Ofloxacin is excreted into human breast milk in
Nervous Dizziness, Somnolence, Peripheral Tremor,
small amounts. Because of the potential for system Headache Paraesthesia sensory Dykinesia,
arthropathy and other serious toxicity in the disorders , neuropathy*, Ageusia,
Dysgeusia, Peripheral Syncope
nursing infant, breast-feeding should be Parosmia sensory motor
neuropathy* ,
discontinued during treatment with ofloxacin Convulsion*,
(see section 4.3). Extra-
pyramidal
symptoms or
4.7 Effects on ability to drive and use other
machines disorders of
muscular
Since there have been occasional reports of coordination
drowsiness/somnolence, impairment of skills, Eye Eye Visual Uveitis
dizziness/vertigo and visual disturbances, which disorders irritation disturbance

may impair the patient's ability to concentrate Ear and Vertigo Tinnitus, Hearing impaired
labyrinth Hearing loss
and react, and therefore may constitute a risk in disorders
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Cardiac Tachycardia Ventricular conditions

disorders arrhythmias and
torsades de * postmarketing experience
pointes (reported
predominantly in Reporting of suspected adverse reactions
patients with risk
factors for QT
prolongation), ECG Reporting suspected adverse reactions after
QT prolonged (see authorisation of the medicinal product is
section 4.4 and
4.9) important. It allows continued monitoring of the
Vascular Hypotension benefit/risk balance of the medicinal product.
disorders
Respiratory, Cough, Dyspnoea, Allergic 4.9 Overdose
thoracic and Nasophar Bronchospas pneumonitis,
mediastinal yngitis m Severe dyspnoea Symptoms
disorders
Gastrointesti Abdominal Enterocolitis, Pseudomembr Dyspepsia, The most important signs to be expected
nal pain, sometimes anous colitis* Flatulence,
disorders Diarrhoea, haemorrhagi Constipation, following acute overdose are CNS symptoms
Nausea, c Pancreatitis
Vomiting
such as confusion, dizziness, impairment of
Hepatobiliar Hepatic Jaundice Hepatitis, which consciousness and convulsive seizures increases
y disorders enzymes cholestatic may be severe* in QT interval as well as gastrointestinal
increased Severe liver injury,
(ALAT, including cases reactions such as nausea and mucosal erosions.
ASAT, LDH, with acute liver
gamma-GT failure, sometimes CNS effects including confusional state,
and/or fatal, have been
alkaline reported with convulsion, hallucination, and tremor have been
phosphatase ofloxacin, primarily observed in post marketing experience.
), in patients with
Blood underlying liver
bilirubin disorders (see Management
increased section 4.4).
Skin and Pruritus, Urticaria, Erythema Stevens-Johnson In the case of overdose steps to remove any
subcutaneo Rash Hot flushes, multiforme, syndrome,
us tissue Hyperhidrosi Toxic Acute generalised
unabsorbed ofloxacin e.g. gastric lavage,
disorders s epidermal exanthemous administration of adsorbants and sodium
Pustular necrolysis, pustulosis,
rash Photo- Drug rash, sulphate, if possible during the first 30 minutes,
sensitivity Stomatitis are recommended; antacids are recommended
reaction*, Exfoliative
Drug eruption , dermatitis for protection of the gastric mucosa.
Vascular
purpura, In the event of overdose, symptomatic treatment
Vasculitis,
which can lead should be implemented. ECG monitoring should
in exceptional
cases to skin
be undertaken, because of the possibility of QT
necrosis interval prolongation. Antacids may be used for
Musculoskel Tendonitis Arthralgia, Rhabdomyolysis protection of gastric mucosa. A fraction of
etal and Myalgia, and/or Myopathy,
connective Tendon Muscular
ofloxacin may be removed from the body with
tissue rupture (e.g. weakness, haemodialysis. Peritoneal dialysis and CAPD
disorders Achilles Muscle tear,
tendon) which Muscle rupture, are not effective in removing ofloxacin from the
may occur Ligament rupture, body. No specific antidote exists.
within 48 Arthritis
hours of
treatment start Elimination of ofloxacin may be increased by
and may be forced diuresis.
bilateral
Renal and Serum Acute renal Acute interstitial 5. PHARMACOLOGICAL PROPERTIES
urinary creatinine failure nephritis
disorders increased
Congenital, Attacks of
5.1 Pharmacodynamic properties
familial and porphyria in
genetic patients with
disorders porphyria
Pharmacotherapeutic group: Quinolone
General Asthenia,
Antibacterials, Fluoroquinolones
disorders Pyrexia,
and Pain (including Mechanism of action
administrati pain in back, chest
on site and extremities)
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Ofloxacin inhibits bacterial DNA replication by Moraxella spp. 0-0.2%

inhibiting bacterial topoisomerases, particularly Morganella morganii 0-6.9%
DNA gyrase and topoisomerase IV. It is active N. gonorrhoeae 25%
after oral administration.
Proteus spp. 1-15%
Therapeutic doses of ofloxacin are devoid of Serratia marcescens 2-2.4%
pharmacological effects on the voluntary or Others
autonomic nervous system.
Chlamydia spp
The NCCLS MIC breakpoint recommendations L. pneumophila
are as follows: Intermediately susceptible
S ≤ 2 mg/l and R ≥ 1 mg/l Aerobic Gram-positive micro
organisms
Haemophilus influenzae and Neisseria S. pneumoniae 70%
gonorrhoea are exceptions with breakpoints at S
Providentia 17.1%
≤ 0.25 mg/l and R ≥ 1 mg/l
Aerobic Gram-negative micro
The BSAC general recommendations are S ≤ 2 organisms
mg/l and R ≥ 4 mg/l E. faecalis 50%

According to DIN 58 940, the following limits P. aeruginosa 20-30%

apply for ofloxacin: Serratia spp. 20-40%
Stenotrophomonas maltophilia 5.1-11%
S ≤ 1 mg/L, I = 2 mg/L, R ≥ 4 mg/L.
Others
The prevalence of resistance may vary Mycoplasma spp. 0-5.3%
geographically and with time for selected
Ureaplasma spp. 0-2.1%
species and local information on resistance is
desirable, particularly when treating severe Resistant
infections. This information gives only an Anaerobic bacteria
approximate guidance on probabilities whether S. aureus - methicillin-resistant 69.2-85.7%
micro-organisms will be susceptible to ofloxacin
T. pallidum
or not.
Only those pathogens relevant to the indications Resistance
are listed.
The main mechanism of bacterial resistance to
European range of acquired ofloxacin involves one or more mutations in the
bacterial resistance to target enzymes, which generally confer
ofloxacin resistance to other active substances in the class.
Normally susceptible Efflux pump and impermeability mechanisms of
Aerobic Gram-positive micro resistance have also been described and may
organisms confer variable resistance to active substances in
S. aureus - methicillin-sensitive 0.3-12.6% other classes.
S. pyogenes 2-5%
5.2 Pharmacokinetic properties
Aerobic Gram-negative micro
organisms Absorption
Acinetobacter spp 0.3-7.3%
The administration of oral doses to fasting
Citrobacter spp. 3-15% volunteers was followed by a rapid and almost
Enterobacter spp. 2-13% complete absorption of ofloxacin. The peak
E. coli 1-8% plasma concentration after a single oral dose of
H. influenzae 1% 200mg averaged 2.6 µg/ml and was reached
Klebsiella spp. 1-10%
within one hour. The plasma elimination half-
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life was 5.7 to 7.0 hours and was not dose photocarcinogenic potential of ofloxacin is
related. comparable with that of other gyrase inhibitors.
Distribution Preclinical data from conventional genotoxicity
studies reveal no special hazard to humans,
The apparent distribution volume was 120 litres. carcinogen potential has not be investigated.
The plasma concentration did not materially rise
with repeat doses (accumulation factor for twice Reproduction toxicity
daily dosage: 1.5). The plasma protein binding
was approx. 25%. Ofloxacin has no effect on fertility, peri- or
postnatal development, and therapeutic doses
Biotransformation did not lead to any teratogenic or other
embryotoxic effects in animals. Ofloxacin
The biotransformation of ofloxacin was below
crosses the placenta and levels reached in the
5%. The two main metabolites found in the urine
amniotic fluid are about 30% of the maximal
were N-desmethyl-ofloxacin and ofloxacin-N- concentrations measured in maternal serum.
oxide.
6. PHARMACEUTICAL PARTICULARS
Elimination
Excretion is primarily renal. Between 80 and 6.1 List of excipients
90% of the dose were recovered from the urine Tablet core
as unchanged substance. Maize starch
Ofloxacin was present in the bile in Lactose, anhydrous
glucuronidised form. The pharmacokinetics of
ofloxacin after intravenous infusion are very Hydroxypropylcellulose
similar to those after oral doses. The plasma
Croscarmellose sodium
half-life is prolonged in persons with renal
insufficiency; total and renal clearance decrease Magnesium stearate
in accordance with the creatinine clearance. In
renal insufficiency the dose should be reduced. Film-coating

No clinically relevant interactions were seen Hypromellose

with food and no interaction was found between Titanium dioxide (E171)
ofloxacin and theophylline.
Macrogol 400
5.3 Preclinical safety data
Talc
Preclinical effects in conventional studies of
safety pharmacology, acute toxicity, repeated 6.2 Incompatibilities
dose toxicity, reproductive studies were Not applicable.
observed only at exposures considered 6.3 Shelf life
sufficiently in excess of the maximum human 2 years.
exposure indicating little relevance to clinical
use. Joint toxicity was observed at exposure in 6.4 Special precautions for storage
the human therapeutic range in juvenile rats and This medicinal product does not require any
dogs. Ofloxacin exhibits a neurotoxic potential special storage conditions.
and causes reversible testicular alterations at
6.5 Nature and contents of container
high doses.
Aluminium PVC/PVDC blisters and
Mutagenicity studies showed no evidence for
polypropylene bottles with polyethylene tamper
mutagenicity of ofloxacin. However, like some
evident closure (with optional polyethylene
other quinolones Ofloxacin is phototoxic in
ullage filler).
animals at exposure in the human therapeutic
range. The phototoxic, photomutagenic and
Ofloxacin 200 mg Tabl ets SMPC, Taj Phar maceuticals
Ofloxacin Taj Phar ma : Uses, Side Effects, Interactions, Pictures, Warnings, Ofloxacin Dosage & Rx Info | Ofloxacin Uses, Side Effects -: Indications, Side Effects, Warnings, Ofloxacin - Drug Information - Taj Phar ma, Ofloxacin dose Taj pharmaceuticals Ofloxacin interactions, Taj Pharmaceutical Ofloxacin contraindications, Ofloxacin price, Ofloxacin Taj Pharma Ofloxacin 200 mg Tablets SMPC - Taj Pharma . Stay connected to all updated on Ofloxacin Taj Pharmaceuticals Taj pharmac euticals Hyderabad.

Obtainable in the following pack sizes: 3, 5, 6, 7,

8, 10, 12, 14, 16, 20, 24, 30, 50, 100, 250 tablets.
Not all pack sizes may be marketed
6.6 Special precautions for disposal and
other handling
No special requirements.
7. MANUFACTURER:

Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad
438225, Gujarat, INDIA

This leaflet was last revised in October 2019