Ofloxacin 200mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ofloxacin 200mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of ofloxacin.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film coated tablets.
The tablets are white capsule shaped and scored on both sides with ‘BL’ and ‘200’ embossed on one face of the tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Ofloxacin is indicated for the treatment of the following bacterial infections in adults when caused by sensitive organisms (see sections 4.4 and 5.1):
- Upper and lower urinary tract infections
- Uncomplicated urethral and cervical gonorrhoea
- Non-gonococcal urethritis and cervicitis
For the below-mentioned infections ofloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections:
- Complicated skin and soft-tissue infections
- Acute exacerbation of chronic bronchitis
- Community acquired pneumonia
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 Posology and method of administration
General dosage recommendations: The dose of ofloxacin is determined by the type and severity of infection. The dosage range for adults is 200mg to 800mg
daily. A daily dose of up to 400 mg ofloxacin may be given as a single dose.
In this case, it is preferable to administer ofloxacin in the morning. Larger doses should be given as two divided doses. Generally, individual doses are to be given at approximately equal intervals. Ofloxacin Film-coated tablets are to be swallowed with sufficient amount of liquids. They may be taken on an empty stomach or with meals. Concomitant administration with antacids should be avoided (see section 4.5: Interactions).
Lower urinary tract infection: 200-400mg daily.
Upper urinary tract infection: 200-400mg daily increasing, if necessary, to 400mg twice a day.
Acute exacerbation of chronic bronchitis, community acquired pneumonia:
400 mg daily increasing, if necessary, to 400mg twice daily.
Uncomplicated urethral and cervical gonorrhoea: A single dose of 400mg
Non-gonococcal urethritis and cervicitis: 400mg daily in single or divided doses.
Complicated skin and soft tissue infections: 400mg twice daily.
Posology in patients with renal insufficiency:
In patients with impaired renal function, the following oral or I.V. dosages are recommended:
|
CREATININE |
UNIT DOSE |
NUMBER / 24 |
INTERVALS |
|
CLEARANCE |
mg* |
h |
h |
|
50 - 20 ml/min |
100-200 |
1 |
24 |
|
< 20 ml/min** |
100 |
1 |
24 |
|
or haemodialysis |
or | ||
|
or peritoneal |
200 |
1 |
48 |
|
dialysis |
* According to indication or dose interval.
** The serum concentration of ofloxacin should be monitored in patients with sereve renal impairment and dialysis patients.
When creatinine clearance cannot be measured, it can be estimated with reference to the serum creatinine level using the following Cockcroft's formula for adults:
weight(kg) x (140 -age in years)
Men: ClCr (ml/min) = ---------------------------------------
72 x serum creatinine (mg/dl)
or
weight(kg) x (140 -age in years)
ClCr (ml/min) = --------------------------------------
0.814 x serum creatinine (pmol/l)
Women: ClCr (ml/min) = 0.85 x (above value)
Posology in hepatic insufficiency (e g. cirrhosis with ascites)
It is recommended that a maximum daily dose of 400 mg of ofloxacin be not exceeded, because of possible reduction of excretion.
Elderly: Age in itself does not impose to adapt the dosage of ofloxacin. However, special attention to renal function should be paid in elderly patients, and the dosage should be adapted accordingly. (See section 4.4 QT interval prolongation)
Children: Ofloxacin is not indicated for use in children or growing adolescents.
Duration of treatment: Duration of treatment is dependent on the severity of infection and response to treatment. The usual treatment period is 5-10 days except in uncomplicated gonorrhoea, where a single dose is recommended.
Treatment should not exceed 2 months duration.
4.3 Contraindications
Ofloxacin should not be used in patients with known hypersensitivity to other quinolones antibacterials, or any of the tablet excipients listed in section 6.1.
Ofloxacin should not be used in patients with a past history of tendinitis related to fluoroquinolone administration.
Ofloxacin, like other quinolones, is contra-indicated in patients with a history of epilepsy or with a lowered seizure threshold.
Ofloxacin is contraindicated in children or growing adolescents, and in pregnant or breast-feeding women, since animal experiments do not entirely exclude the risk of damage to the cartilage of joints in the growing subject.
Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents.
4.4 Special warnings and precautions for use
Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including ofloxacin. Therefore ofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the organism to ofloxacin (and commonly recommended antibacterial agents for the treatment of MRSA-infections are considered inappropriate).
Ofloxacin is not the drug of first choice for pneumonia caused by Pneumococci or Mycoplama or infection caused by P-haemolytic Streptococci.
Resistance to fluoroquinolones of E. coli - the most common pathogen involved in urinary tract infections - varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in E. coli to fluoroquinolones.
Severe bullous reactions
Cases of severe bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with ofloxacin (see section 4.8). Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
Hypersensitivity and allergic reactions
Hypersensitivity and allergic reactions have been reported for
fluoroquinolones after first administration. Anaphylactic and anaphylactoid reactions can progress to life-threatening shock, even after the first administration. In these cases ofloxacin should be discontinued and suitable treatment (e.g. treatment for shock) should be initiated.
Clostridium difficile-associated disease
Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with ofloxacin (including several weeks after treatment), may be symptomatic of pseudo-membranous colitis (CDAD). CDAD may range in severity from mild to life threatening, the most severe form of which is pseudomembranous colitis (see section 4.8). It is therefore important to consider this diagnosis in patients who develop serious diarrhoea during or after treatment with ofloxacin. If pseudo-membranous colitis is suspected, ofloxacin must be stopped immediately. Appropriate specific antibiotic therapy must be started without delay (e.g. oral vancomycin, oral teicoplanin or metronidazole). Products inhibiting the peristalsis are contraindicated in this clinical situation
Patients predisposed to seizures
Quinolones may lower the seizure threshold and may trigger seizures. Ofloxacin is contraindicated in patients with a history of epilepsy (see section 4.3) and, as with other quinolones, ofloxacin should be used with extreme caution in patients predisposed to seizures.
Such patients may be patients with pre-existing central nervous system lesions, concomitant treatment with fenbufen and similar non-steroidal antiinflammatory drugs or with drugs which lower the cerebral seizure threshold, such as theophylline (see section 4.5: Interactions).
In case of convulsive seizures, treatment with ofloxacin should be discontinued.
Tendonitis
Tendonitis, rarely observed with quinolones, may occasionally lead to rupture involving Achilles tendon in particular. Tendinitis and tendon rupture, sometimes bilateral, may occur within 48 hours of starting treatment with ofloxacin and have been reported up to several months after discontinuation of. The risk of tendinitis and tendon rupture is increased in patients aged over 60 years and in patients using corticosteroids. The daily dose should be adjusted in elderly patients based on creatinine clearance (see section 4.2). Close monitoring of these patients is therefore necessary if they are prescribed ofloxacin. All patients should consult their physician if they experience symptoms of tendinitis. If tendinitis is suspected, treatment with ofloxacin must be halted immediately, and appropriate treatment (e.g. immobilisation) must be initiated for the affected tendon (see sections 4.3 and 4.8).
Patients with renal impairment
Since ofloxacin is mainly excreted by the kidneys, the dose of ofloxacin should be adjusted in patients with renal impairment (see section 4.2).
QT interval prolongation
Very rare cases of QT interval prolongation have been reported in patients taking fluoroquinolones. Caution should be taken when using fluoroquinolones, including ofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example:
• congenital long QT syndrome
• concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics)
• uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia)
• cardiac disease (e.g. heart failure, myocardial infarction, bradycardia)
• Elderly patients and women may be more sensitive to QTc-prolonging medications. Therefore, caution should be taken when using fluoroquinolones, including Ofloxacin, in these populations.
(See section 4.2 Elderly, section 4.5, section 4.8 section 4.9).
Patients with history of psychotic disorder
Psychotic reactions have been reported in patients receiving fluoroquinolones. In some cases these have progressed to suicidal thoughts or self-endangering behaviour including suicide attempt, sometimes after a single dose (see section 4.8). In the event that a patient develops these reactions, ofloxacin should be discontinued and appropriate measures instituted. Ofloxacin should be used with caution in patients with a history of psychotic disorder or in patients with psychiatric disease.
Patients with impaired liver function
Ofloxacin should be used with caution in patients with impaired liver function, as liver damage may occur. Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with fluoroquinolones. Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritis or tender abdomen. (See section 4.8: Undesirable effects)
Patients treated with vitamin K antagonists
Due to possible increase in coagulation tests (PT/INR) and/or bleeding in patients treated with fluoroquinolones, including ofloxacin, in combination with a vitamin K antagonist (e.g.warfarin), coagulation tests should be monitored when these drugs are given concomitantly (see section 4.5)
Myasthenia gravis
Fluoroquinolones, including ofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Postmarketing serious adverse reactions, including deaths and the requirement for respiratory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. Ofloxacin is not recommended in patients with a known history of myasthenia gravis
Prevention of photosensitisation
Photosensitisation has been reported with ofloxacin (see section 4.8). It is recommended that patients should not expose themselves unnecessarily to strong sunlight or to artificial UV rays (e.g. sunray lamp, solarium) during treatment and for 48 hours following treatment discontinuation in order to prevent photosensitisation.
Superinfection
As with other antibiotics, the use of ofloxacin, especially if prolonged, may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If secondary infection occurs during therapy, appropriate measures should be taken.
Peripheral neuropathy
Sensory or sensorimotor peripheral neuropathy has been reported in patients receiving fluoroquinolones, including ofloxacin, which can be rapid in its onset. Ofloxacin should be discontinued if the patient experiences symptoms of neuropathy in order to prevent the development of an irreversible condition (see section 4.8).
Dysglycemia
As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycemia have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g. glibenclamide) or with insulin. Cases of hypoglycaemic coma have been reported. In these diabetic patients, careful monitoring of blood glucose is recommended.
Patients with glucose-6-phosphate-dehydrogenase deficiency
Patients with latent or diagnosed glucose-6-phosphate-dehydrogenase deficiency may be predisposed to haemolytic reactions if they are treated with quinolones. Therefore, if ofloxacin has to be used in these patients, potential occurrence of haemolysis should be monitored.
Vision disorders
If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately (see sections 4.7 and 4.8).
Interference with laboratory tests
In patients treated with ofloxacin, determination of opiates in urine may give false-positive results. It may be necessary to confirm positive opiate screens by more specific method.
Patients with rare hereditary disorders
Patients with rare hereditary disorders of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction Drugs known to prolong QT interval
Ofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class I A and III antiarrythmics, tricyclic antidepressants, macrolides, antipsychotics). (See section 4.4).
Antacids, Sucralfate, Metal Cations
Co-administered magnesium/aluminium antacids, sucralfate, zinc or iron preparations can reduce absorption. Therefore, ofloxacin should be taken 2 hours before such preparations.
Prolongation of bleeding time has been reported during concomitant administration of Ofloxacin tablets and anticoagulants.
Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs
No pharmacokinetic interactions of ofloxacin were found with theophylline in a clinical study. However, a pronounced lowering of the cerebral seizure threshold may occur when quinolones are given concurrently with theophylline, nonsteroidal antiinflammatory drugs, or other agents, which lower the seizure threshold.
In case of convulsive seizures, treatment with ofloxacin should be discontinued.
Glibenclamide
Ofloxacin may cause a slight increase in serum concentrations of glibenclamide administered concurrently; patients treated with this combination should be closely monitored.
Probenecid, cimetidine, furosemide and methotrexate
Probenecid decreased the total clearance of ofloxacin by 24%, and increased AUC by 16%. The proposed mechanism is a competition or inhibition for active transport at the renal tubular excretion. Caution should be exercised when ofloxacin is coadministered with drugs that affect the tubular renal secretion such as probenecid, cimetidine, furosemide and methotrexate.
Vitamin K antagonists
Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have been reported in patients treated with ofloxacin in combination with a vitamin K antagonist (e.g. warfarin). Coagulation tests should be monitored in patients treated with vitamin K antagonists (see section 4.4) because of a possible increase in the effect of coumarin derivatives.
4.6. Fertility, pregnancy and lactation Pregnancy
Based on a limited amount of human data, the use of fluoroquinolones in the first trimester of pregnancy has not been associated with an increased risk of major
malformations or other adverse effects on pregnancy outcome. Animal studies have shown damage to the joint cartilage in immature animals but no teratogenic effects. Therefore ofloxacin should not be used during pregnancy. (See section 4.3: Contraindications)
Breast-feeding
Ofloxacin is excreted into human breast milk in small amounts. Because of the potential for arthropathy and other serious toxicity in the nursing infant, breast feeding should be discontinued during treatment with ofloxacin. (See section 4.3: Contraindications)
4.7 Effects on ability to drive and use machines
Since there have been occasional reports of somnolence, impairment of skills, dizziness and visual disturbances, patients should know how they react to Ofloxacin Tablets before they drive or operate machinery. These effects may be enhanced by alcohol.
4.8 Undesirable effects
The information given below is based on data from clinical studies and on extensive post marketing experience.
|
System organ class |
Commo n (*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 available data)* |
|
Infections and infestations |
Fungal infection, Pathogen resistance | ||||
|
Blood and the lymphatic system disorders |
Anaemia Haemolytic anaemia, Leukopenia, Eosinophilia, |
Agranulocytosis Bone marrow failure |
|
Thrombocyto penia | |||||
|
Immune system disorders |
Anaphylactic reaction*, Anaphylactoid reaction*, Angioedema* |
Anaphylactic shock*, Anaphylactoi d shock* | |||
|
Metabolism and Nutrition disorders |
Anorexia |
Hypoglycaemia in diabetics treated with hypoglycaemic agents (see Section 4.4) Hyperglycaemia Hypoglycaemic coma | |||
|
Psychiatric disorders |
Agitation, Sleep disorder, Insomnia |
Psychotic disorder (for eg. hallucination), Anxiety, Confusional state, Nightmares, Depression |
Psychotic disorder and depression with self-endangering behaviour including suicidal ideation or suicide attempt (see Section 4.4) Nervousness | ||
|
Nervous system disorders |
Dizziness, Headache |
Somnolence, Paraesthesia, Dysgeusia, Parosmia |
Peripheral sensory neuropathy * Peripheral sensory motor neuropathy* |
Tremor Dyskinesia Ageusia Syncope |
|
Convulsion*, Extrapyramidal symptoms or other disorders of muscular coordination | |||||
|
Eye disorders |
Eye irritation |
Visual disturbance |
Uveitis | ||
|
Ear and labyrinth disorders |
Vertigo |
Tinnitus, Hearing loss |
Hearing impaired | ||
|
Cardiac disorders |
Tachycardia |
Ventricular arrhythmias, torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged (see section 4.4 and 4.9) | |||
|
Vascular disorders |
applies only to the solution for_ infusion: Phlebitis |
Hypotension |
applies only to the solution for infusion: During infusion of ofloxacin, tachycardia and hypotension may occur. Such a decrease in blood pressure may, in very rare cases, be |
|
severe. | |||||
|
Respiratory, |
Cough, |
Dyspnoea, |
Allergic | ||
|
thoracic and mediastinal |
Nasopharyng |
Bronchospas |
pneumonitis, | ||
|
disorders |
itis |
m |
Severe dyspnoea | ||
|
Gastrointesti |
Abdominal |
Enterocolitis, |
Pseudomembr |
Dyspepsia | |
|
nal disorders |
pain, |
sometimes |
anous colitis* |
Flatulence | |
|
haemorrhagic |
Constipation | ||||
|
Diarrhoea, |
Jaundice cholestatic |
Pancreatitis | |||
|
Nausea, | |||||
|
Vomiting | |||||
|
Hepatobilary |
Hepatic |
Hepatitis, which | |||
|
disorders |
enzymes |
may be severe, | |||
|
increased |
Severe liver injury, | ||||
|
(ALAT, |
including cases | ||||
|
ASAT, LDH, |
with acute liver | ||||
|
gamma-GT |
failure, sometimes | ||||
|
and/or |
fatal, have been | ||||
|
alkaline |
reported with | ||||
|
phosphatase) |
ofloxacin, primarily in | ||||
|
Blood |
patients with | ||||
|
bilirubin |
underlying liver | ||||
|
increased |
disorders (see section 4.4). | ||||
|
Skin and |
Pruritus, |
Urticaria, |
Erythema |
Stevens-Johnson | |
|
subcutaneou s tissue |
Rash |
Hot flushes, |
multiforme, |
syndrome; | |
|
disorders |
Toxic |
Acute generalized | |||
|
Hyperhidrosis |
epidermal |
exanthemous | |||
|
Pustular rash |
necrolysis, |
pustulosis; | |||
|
Photosensitivi |
drug rash | ||||
|
ty reaction*, |
Stomatitis | ||||
|
Drug eruption | |||||
|
Vascular |
Exfoliative | ||||
|
purpura, |
|
Vasculitis, which can lead in exceptional cases to skin necrosis |
dermatitis | ||||
|
Musculoskel |
Tendonitis |
Arthralgia, |
Rhabdomyolysis | ||
|
etal and Connective |
Myalgia, |
and/or Myopathy, | |||
|
tissue |
Muscular | ||||
|
disorders |
Tendon |
weakness | |||
|
rupture (e.g. Achilles |
Muscle tear, | ||||
|
tendon) which |
muscle rupture | ||||
|
may occur within 48 hours of treatment start |
Ligament rupture | ||||
|
and may be bilateral. |
Arthritis | ||||
|
Renal and |
Serum |
Acute renal |
Acute interstitial | ||
|
Urinary |
creatinine |
failure |
nephritis | ||
|
disorders |
increased | ||||
|
Congenital |
Attacks of | ||||
|
and |
porphyria in | ||||
|
familial/gene |
patients with | ||||
|
tic disorders |
porphyria | ||||
|
General |
applies |
Asthenia Pyrexia | |||
|
disorders |
only to |
Pain (including | |||
|
and |
the |
pain in back, chest, | |||
|
administratio |
solution |
and extremities) | |||
|
n site |
jor | ||||
|
conditions |
infusion: | ||||
|
Infusion site reaction (pain, reddenin g) |
* post-marketing experience
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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at:www.mhra.gov.uk/yellowcard
4.9 Overdose
The most important signs to be expected following acute overdosage are CNS symptoms such as confusion, dizziness, impairment of consciousness, and seizures, increases QT interval as well as gastrointestinal reactions such as nausea and mucosal erosions.
CNS effects including confusional state, convulsion, hallucination, and tremor have been observed in post marketing experience
In the case of overdose steps to remove any unabsorbed ofloxacin e.g. gastric lavage, administration of adsorbents and sodium sulphate, if possible during the first 30 minutes, are recommended; antacids are recommended for protection of the gastric mucosa. A fraction of ofloxacin may be removed from the body with haemodialysis. Peritoneal dialysis and CAPD are not effective in removing ofloxacin from the body. No specific antidote exists.
Elimination of ofloxacin may be increased by forced diuresis.
In the event of overdose symptomatic treatment should be implemented, ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Quinolone antibacterials, Fluoroquinolones. ATC code J01M A01.
Mechanism of action
Ofloxacin is a quinolone-carboxylic acid derivative with a wide range of antibacterial activity against both gram-positive and gram-negative organisms. It is active after oral administration.
The primary mode of action of the quinolones is the specific inhibition of bacterial DNA gyrase. This enzyme is required for DNA replication, transcription, repair and recombination. Its inhibition leads to expansion and destabilisation of the bacterial DNA and hence to cell death.
It appears that certain quinolones, including ofloxacin, have a second non RNA dependent action on bacterial cells, which enhances bactericidal effectiveness. The nature of this second action has not yet been clarified
PK/PD relationship
Fluoroquinolones have a concentration-dependent bactericidal activity, with a moderate post antibiotic effect. For this class of antimicrobials, the ratio between AUC and MIC or Cmax and MIC is predictive of clinical success.
Mechanisms of resistance
Resistance to ofloxacin is acquired through a stepwise process by target site mutations in both type II topoisomerases, DNA gyrase and topoisomerase IV. Other resistance mechanisms such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may also affect susceptibility to ofloxacin
Susceptibility testing breakpoints
Breakpoints separate susceptible strains from strains with intermediate susceptibility and the latter from resistant strains.
Breakpoints set by EUCAST:
|
Microorganism |
MIC breakpoint (mg/L) | |
|
Susceptible < |
Resistant > | |
|
Enterobacteriaceae |
0.5 |
1 |
|
Staphylococcus spp. |
1 |
1a |
|
Streptococcus pneumoniaeb |
0.125 |
4 |
|
Haemophilus influenzae |
0.5 |
0.5 |
|
Moraxella catarrhalis |
0.5 |
0.5 |
|
Neisseria gonorrheae |
0.125 |
0.25 |
a. Breakpoints relate to high dose therapy
b. Wild type S. pneumonia are not considered susceptible to ofloxacin and are therefore categorized as intermediat
Susceptibility
The prevalence of resistance may vary geographically and over time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Commonly susceptible species, including microorganisms with intermediate susceptibility
Aerobic Gram-positive micro-organisms
Bacillus anthracis
Bordetella pertussis
Corynebacteria
Streptococci
Aerobic Gram-negative micro-organisms
Campylobacter
Enterobacter
Haemophilus influenzae
Legionella pneumophila
Moraxella catarrhalis
Morganella morganii
Proteus vulgaris
Salmonella
Shigella
Yersinia
Other micro-organisms Chlamydia
Chlamydophila pneumonia Mycoplasma hominis Mycoplasma pneumoniae Ureaplasma urealyticum
Species for which acquired resistance may be a problem
Aerobic Gram-positive micro-organisms Staphylococci coagulase negative Staphylococcus aureus (methicillin-sensitive)
Streptococcus pneumoniae
Aerobic Gram-negative micro-organisms
Acinetobacter baumannii
Citrobacter freundii
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Neisseria gonorrhoeae
Proteus mirabilis
Pseudomonas aeruginosa Serratia
Inherently resistant organisms
Aerobic Gram-positive micro-organisms Enterococci
Listeria monocytogenes Nocardia
Staphylococci methi-R
Anaerobic micro-organisms Bacteroides spp.
Clostridium difficile
Therapeutic doses of ofloxacin are devoid of pharmacological effects on the voluntary or autonomic nervous systems.
5.2. Pharmacokinetic properties
Ofloxacin is almost completely absorbed after oral administration. Maximal blood levels occur 1-3 hours after dosing and the elimination half-life is 4-6 hours. Ofloxacin is primarily excreted unchanged in the urine.
In renal insufficiency the dose should be reduced.
No clinically relevant interactions were seen with food and no interaction was found between ofloxacin and theophylline.
5.3. Preclinical safety data
Not applicable.
6. PHARMACEUTICAL PARTICULARS 6.1. List of excipients
Microcrystalline cellulose, Sodium starch glycolate, Hydroxypropyl cellulose, Magnesium stearate, Hypromellose 2910, Macrogol 400, Titanium dioxide (E171).
6.2. Incompatibilities
None applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C.
Store in the original package.
6.5 Nature and contents of container
Ofloxacin 200mg Tablets are available in blister packs of 10, 20 and 100 tablets in Alu/PVC blisters.
6.6. Instructions for use and handling
Not applicable.
7. MARKETING AUTHORISATION HOLDER
Bristol Laboratories Ltd Unit 3, Canalside,
Northbridge Road,
Berkhamsted,
Hertfordshire HP4 1EG United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
Ofloxacin 200mg Tablets - PL 17907/0024
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 22/03/2004
10 DATE OF REVISION OF THE TEXT
18/11/2016