1. Name of the medicinal product

Levofloxacin Tablets USP 250mg Taj Pharma
Levofloxacin Tablets USP 500mg Taj Pharma
Levofloxacin Tablets USP 750mg Taj Pharma

  1. Qualitative and quantitative composition

a) Levofloxacin Tablets USP 250mg Taj Pharma
Each film-coated tablet contains:
Levofloxacin Hemihydrate USP
Equivalent to Levofloxacin 250mg
Excipients: Q.S.

b) Levofloxacin Tablets USP 500mg Taj Pharma
Each film-coated tablet contains:
Levofloxacin Hemihydrate USP
Equivalent to Levofloxacin 500mg
Excipients: Q.S.

c) Levofloxacin Tablets USP 750mg Taj Pharma
Each film-coated tablet contains:
Levofloxacin Hemihydrate USP
Equivalent to Levofloxacin 750mg
Excipients: Q.S.

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Film-coated tablet
Each film-coated tablets contains 250mg/500mg/750mg of Levofloxacin Taj Pharma.

  1. Clinical particulars
  • Therapeutic indications

Levofloxacin Taj Pharma Tablets is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):

  • Acute bacterial sinusitis
  • Acute exacerbation of chronic obstructive pulmonary disease including bronchitisUncomplicated cystitis (see section 4.4)
  • Community-acquired pneumonia
  • Complicated skin and soft tissue infections
  1. For the above-mentioned infections Levofloxacin Taj Pharma Tablets should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
  • Acute pyelonephritis and complicated urinary tract infections (see section 4.4)Chronic bacterial prostatitis
  • Inhalation Anthrax: postexposure prophylaxis and curative treatment (see section 4.4)
  1. Levofloxacin Taj Pharma Tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
  • Posology and method of administration
  1. Levofloxacin Taj Pharma Tablets are administered once or twice daily. The dosage depends on the type and severity of the infection and the sensitivity of the presumed causative pathogen.Treatment timeThe duration of therapy varies according to the course of the disease (see table below). As with antibiotic therapy in general, administration of Levofloxacin Taj Pharma Tablets should be continued for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.

    The following dose recommendations can be given for Levofloxacin Taj Pharma Tablets:

    Dosage in patients with normal renal function

    (creatinine clearance > 50 ml/min)

    Indication Daily dose regimen (according to severity) Duration of treatment (according to severity)
    Acute bacterial sinusitis 500 mg once daily 10 – 14 days
    Acute exacerbations of chronic obstructive pulmonary disease including bronchitis 500 mg once daily 7 – 10 days
    Community-acquired pneumonia 500 mg once or twice daily 7 – 14 days
    Acute pyelonephritis 500 mg once daily 7 – 10 days
    Complicated urinary tract infections 500 mg once daily 7 – 14 days
    Uncomplicated cystitis 250 mg once daily 3 days
    Chronic bacterial prostatitis 500 mg once daily 28 days
    Complicated Skin and soft tissue infections 500 mg once or twice daily 7 – 14 days
    Inhalation Anthrax 500 mg once daily 8 weeks

    Special Populations

    Impaired renal function (creatinine clearance ≤ 50 ml/min)

    Creatinine clearance Dosage regimen
    250 mg/24 h 500 mg/24 h 500 mg/12 h
    First dose: 250 mg First dose: 500 mg First dose: 500 mg
    50-20 ml/min Then:125 mg/24h Then: 250 mg/24 h Then:250 mg/12 h
    19-10 ml/min Then: 125 mg/48 h Then: 125 mg/24 h Then:125 mg/12 h
    < 10 ml/min (including haemodialysis and CAPD)1 Then: 125 mg/48 h Then: 125 mg/24 h Then:125 mg/24 h

    1 No additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

    Impaired liver function

    No adjustment of dosage is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.

    Elderly population

    No adjustment of dosage is required in the elderly, other than that imposed by consideration of renal function (see section 4.4 “Tendinitis and tendon rupture” and “QT interval prolongation”).

    Paediatric population

    Levofloxacin Taj Pharma is contraindicated in children and growing adolescents (see section 4.3).

    Method of administration

    Levofloxacin Taj Pharma Tablets should be swallowed without crushing and with sufficient amount of liquid. They may be divided at the score line to adapt the dose. The tablets may be taken during meals or between meals. Levofloxacin Taj Pharma Tablets should be taken at least two hours before or after iron salts, zinc salts, magnesium- or aluminium-containing antacids, or didanosine (only didanosine formulations with aluminium or magnesium containing buffering agents), and sucralfate administration since reduction of absorption can occur (see section 4.5).

    • Contraindications

    Levofloxacin Taj Pharma Tablets must not be used:

    • in patients hypersensitive to levofloxacin or other quinolones or to any of the excipients listed in section 6.1,
    • in patients with epilepsy,
    • in patients with history of tendon disorders related to fluoroquinolone administration,
    • in children or growing adolescents
    • during pregnancy,
    • in breast-feeding women.
  • Special warnings and precautions for use
  • The use of levofloxacin should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8). Treatment of these patients with Levofloxacin Taj Pharma should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3).Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, hypertension, known atherosclerosis).

    In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.

    Methicillin-resistant Staphylococcus aureus (MRSA)

    Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including levofloxacin. Therefore levofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the organism to levofloxacin (and commonly recommended antibacterial agents for the treatment of MRSA-infections are considered inappropriate).

    Levofloxacin Taj Pharma may be used in the treatment of Acute Bacterial Sinusitis and Acute Exacerbation of Chronic Bronchitis when these infections have been adequately diagnosed.

    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.

    Inhalation Anthrax: Use in humans is based on in vitro Bacillus anthracis susceptibility data and on animal experimental data together with limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax.

    Tendinitis and tendon rupture

    Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment in patients receiving daily doses of 1000 mg levofloxacin. The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, concomitant use of corticosteroids should be avoided. The daily dose should be adjusted in elderly patients based on creatinine clearance (see section 4.2).

    At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with Levofloxacin Taj Pharma should be discontinued and alternative treatment should be considered. The affected limb(s) should be appropriately treated (e.g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.

    Clostridium difficile-associated disease

    Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with Levofloxacin Taj Pharma (including several weeks after treatment), may be symptomatic of Clostridium difficile-associated disease (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 levofloxacin. If CDAD is suspected or confirmed, Levofloxacin Taj Pharma Tablets should be stopped immediately and appropriate treatment initiated without delay (e.g. oral metronidazole or vancomycin). Medicinal products inhibiting the peristalsis are contraindicated in this clinical situation.

    Patients predisposed to seizures

    Quinolones may lower the seizure threshold and may trigger seizures. Levofloxacin Taj Pharma is contraindicated in patients with a history of epilepsy (see section 4.3) and, as with other quinolones, should be used with extreme caution in patients predisposed to seizures, or concomitant treatment with active substances that lower the cerebral seizure threshold, such as theophylline (see section 4.5). In case of convulsive seizures (see section 4.8), treatment with levofloxacin should be discontinued.

    Patients with G-6- phosphate dehydrogenase deficiency

    Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents. Therefore, if levofloxacin has to be used in these patients, potential occurrence of haemolysis should be monitored.

    Patients with renal impairment

    Since levofloxacin is excreted mainly by the kidneys, the dose of Levofloxacin Taj Pharma Tablets should be adjusted in patients with renal impairment. (see section 4.2).

    Hypersensitivity reactions

    Levofloxacin Taj Pharma can cause serious, potentially fatal hypersensitivity reactions (e.g. angioedema to anaphylactic shock), occasionally following the initial dose (see section 4.8). Patients should discontinue treatment immediately and contact their physician or an emergency physician, who will initiate appropriate emergency measures.

    Severe cutaneous adverse reactions

    Severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN: also known as Lyell’s syndrome), Stevens Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS), which could be life-threatening or fatal, have been reported with levofloxacin (see section 4.8). At the time of prescription, patients should be advised of the signs and symptoms of severe skin reactions, and be closely monitored. If signs and symptoms suggestive of these reactions appear, levofloxacin should be discontinued immediately and an alternative treatment should be considered. If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of levofloxacin, treatment with levofloxacin must not be restarted in this patient at any time.

    Dysglycaemia

    As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia 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 diabetic patients, careful monitoring of blood glucose is recommended (see section 4.8).

    Prevention of photosensitisation

    Photosensitisation has been reported with levofloxacin (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.

    Patients treated with Vitamin K antagonists

    Due to possible increase in coagulation tests (PT/INR) and/or bleeding in patients treated with levofloxacin 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).

    Psychotic reactions

    Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin. In very rare cases these have progressed to suicidal thoughts and self-endangering behaviour- sometimes after only a single dose of levofloxacin (see section 4.8). In the event that the patient develops these reactions, levofloxacin should be discontinued and appropriate measures instituted. Caution is recommended if levofloxacin is to be used in psychotic patients or in patients with a history of psychiatric disease.

    QT interval prolongation

    Caution should be taken when using fluoroquinolones, including levofloxacin, 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 antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
    – uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesemia)
    – 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 levofloxacin, in these populations.

    (see section 4.2 Elderly, section 4.5, section 4.8, section 4.9).

    Peripheral neuropathy

    Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones.

    Patients under treatment with Levofloxacin Taj Pharma should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition. (see section 4.8).

    Hepatobiliary disorders

    Cases of hepatic necrosis up to fatal hepatic failure have been reported with levofloxacin, primarily in patients with severe underlying diseases, e.g. sepsis (see section 4.8). 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, pruritus or tender abdomen.

    Exacerbation of myasthenia gravis

    Fluoroquinolones, including levofloxacin, 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. Levofloxacin Taj Pharma is not recommended in patients with a known history of myasthenia gravis.

    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).

    Superinfection

    The use of levofloxacin, especially if prolonged, may result in overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.

    Interference with laboratory tests

    In patients treated with levofloxacin, determination of opiates in urine may give false-positive results. It may be necessary to confirm positive opiate screens by more specific method.

    Levofloxacin Taj Pharma may inhibit the growth of Mycobacterium tuberculosis and, therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis.

    Prolonged, disabling and potentially irreversible serious adverse drug reactions

    Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors. Levofloxacin Taj Pharma should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice.

  • Interaction with other medicinal products and other forms of interaction
  • Effect of other medicinal products on levofloxacinIron salts, zinc salts, magnesium- or aluminium-containing antacids, didanosineLevofloxacin Taj Pharma absorption is significantly reduced when iron salts, or magnesium- or aluminium-containing antacids, or didanosine (only didanosine formulations with aluminium or magnesium containing buffering agents) are administered concomitantly with Levofloxacin Taj Pharma Tablets. Concurrent administration of fluoroquinolones with multi-vitamins containing zinc appears to reduce their oral absorption. It is recommended that preparations containing divalent or trivalent cations such as iron salts, zinc salts or magnesium- or aluminium-containing antacids, or didanosine (only didanosine formulations with aluminium or magnesium containing buffering agents) should not be taken 2 hours before or after Levofloxacin Taj Pharma Tablets administration (see section 4.2). Calcium salts have a minimal effect on the oral absorption of levofloxacin.

    Sucralfate

    The bioavailability of Levofloxacin Taj Pharma Tablets is significantly reduced when administered together with sucralfate. If the patient is to receive both sucralfate and Levofloxacin Taj Pharma Tablets, it is best to administer sucralfate 2 hours after the Levofloxacin Taj Pharma Tablets administration (see section 4.2).

    Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs

    No pharmacokinetic interactions of levofloxacin 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, non-steroidal anti-inflammatory drugs, or other agents which lower the seizure threshold.

    Levofloxacin Taj Pharma concentrations were about 13 % higher in the presence of fenbufen than when administered alone.

    Probenecid and cimetidine

    Probenecid and cimetidine had a statistically significant effect on the elimination of levofloxacin. The renal clearance of levofloxacin was reduced by cimetidine (24 %) and probenecid (34 %). This is because both drugs are capable of blocking the renal tubular secretion of levofloxacin. However, at the tested doses in the study, the statistically significant kinetic differences are unlikely to be of clinical relevance.

    Caution should be exercised when levofloxacin is coadministered with drugs that effect the tubular renal secretion such as probenecid and cimetidine, especially in renally impaired patients.

    Other relevant information

    Clinical pharmacology studies have shown that the pharmacokinetics of levofloxacin were not affected to any clinically relevant extent when levofloxacin was administered together with the following drugs:

    – calcium carbonate

    – digoxin

    – glibenclamide

    – ranitidine.

    Effect of levofloxacin on other medicinal products

    Ciclosporin

    The half-life of ciclosporin was increased by 33 % when coadministered with levofloxacin.

    Vitamin K antagonists

    Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have been reported in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin). Coagulation tests, therefore, should be monitored in patients treated with vitamin K antagonists (see section 4.4).

    Drugs known to prolong the QT interval

    Levofloxacin Taj Pharma, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotic). (See section 4.4 QT interval prolongation).

    Other relevant information

    In a pharmacokinetic interaction study, levofloxacin did not affect the pharmacokinetics of theophylline (which is a probe substrate for CYP1A2), indicating that levofloxacin is not a CYP1A2 inhibitor.

    Other forms of interactions

    Meals

    There is no clinically relevant interaction with food. Levofloxacin Taj Pharma Tablets may therefore be administered regardless of food intake.

  • Fertility, pregnancy and lactation
  • PregnancyThere are limited amount of data with respect to the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). However in the absence of human data and due to that experimental data suggest a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, levofloxacin must not be used in pregnant women (see sections 4.3 and 5.3).Breast-feeding

    Levofloxacin Taj Pharma tablets are contraindicated in breast-feeding women. There is insufficient information on the excretion of levofloxacin in human milk; however other fluoroquinolones are excreted in breast milk. In the absence of human data and due to that experimental data suggest a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, levofloxacin must not be used in breast-feeding women (see sections 4.3 and 5.3).

    Fertility

    Levofloxacin Taj Pharma caused no impairment of fertility or reproductive performance in rats.

  • Effects on ability to drive and use machines
  • Some undesirable effects (e.g. dizziness/vertigo, drowsiness, visual disturbances) may impair the patient’s ability to concentrate and react, and therefore may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
  • Undesirable effects
  • The information given below is based on data from clinical studies in more than 8300 patients and on extensive post marketing experience.Frequencies are defined using the following convention: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
    System organ class Common

    (≥1/100 to <1/10 )

    Uncommon

    (≥1/1,000 to <1/100)

    Rare

    (≥1/10,000 to <1/1,000)

    Not known

    (cannot be estimated from available data)

    Infections and infestations Fungal infection including Candida infection

    Pathogen resistance

    Blood and lymphatic system disorders Leukopenia

    Eosinophilia

    Thrombocytopenia

    Neutropenia

    Pancytopenia

    Agranulocytosis

    Haemolytic anaemia

    Immune system disorders Angioedema

    Hypersensitivity (see section 4.4)

    Anaphylactic shocka

    Anaphylactoid shock a (see section 4.4)

    Metabolism and nutrition disorders Anorexia Hypoglycaemia particularly in diabetic patients (see section 4.4) Hyperglycaemia

    Hypoglycaemic coma (see section 4.4)

    Psychiatric disorders* Insomnia Anxiety

    Confusional state

    Nervousness

    Psychotic reactions (with e.g. hallucination, paranoia)

    Depression

    Agitation

    Abnormal dreams

    Nightmares

    Psychotic disorders with self-endangering behaviour including suicidal ideation or suicide attempt (see section 4.4)
    Nervous system disorders* Headache

    Dizziness

    Somnolence

    Tremor

    Dysgeusia

    Convulsion (see sections 4.3 and 4.4)

    Paraesthesia

    Peripheral sensory neuropathy (see section 4.4)

    Peripheral sensory motor neuropathy (see section 4.4)

    Parosmia including anosmia

    Dyskinesia

    Extrapyramidal disorder

    Ageusia

    Syncope

    Benign intracranial hypertension

    Eye disorders* Visual disturbances such as blurred vision (see section 4.4) Transient vision loss (see section 4.4)
    Ear and Labyrinth disorders* Vertigo Tinnitus Hearing loss

    Hearing impaired

    Cardiac disorders Tachycardia, Palpitation Ventricular tachycardia, which may result in cardiac arrest

    Ventricular arrhythmia and torsade de pointes (reported predominantly in patients with risk factors of QT prolongation), electrocardiogram QT prolonged (see sections 4.4 and 4.9)

    Vascular disorders Hypotension
    Respiratory, thoracic and mediastinal disorders Dyspnoea Bronchospasm

    Pneumonitis allergic

    Gastro-intestinal disorders Diarrhoea

    Vomiting

    Nausea

    Abdominal pain

    Dyspepsia

    Flatulence

    Constipation

    Diarrhoea – haemorrhagic which in very rare cases may be indicative of enterocolitis, including pseudomembranous colitis (see section 4.4)

    Pancreatitis

    Hepatobiliary disorders Hepatic enzyme increased (ALT/AST, alkaline phosphatase, GGT) Blood bilirubin increased Jaundice and severe liver injury, including cases with fatal acute liver failure, primarily in patients with severe underlying diseases (see section 4.4)

    Hepatitis

    Skin and subcutaneous tissue disorders b Rash

    Pruritus

    Urticaria

    Hyperhidrosis

    Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (see section 4.4), Fixed drug eruption Toxic epidermal necrolysis

    Stevens-Johnson syndrome

    Erythema multiforme

    Photosensitivity reaction (see section 4.4)

    Leukocytoclastic vasculitis

    Stomatitis

    Endocrine disorders Syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
    Musculoskeletal and connective tissue disorders Arthralgia

    Myalgia

    Tendon disorders (see sections 4.3 and 4.4) including tendinitis (e.g. Achilles tendon)

    Muscular weakness which may be of special importance in patients with myasthenia gravis (see section 4.4 )

    Rhabdomyolysis

    Tendon rupture (e.g. Achilles tendon) (see sections 4.3 and 4.4)

    Ligament rupture

    Muscle rupture

    Arthritis

    Renal and Urinary disorders Blood creatinine increased Renal failure acute (e.g. due to interstitial nephritis)
    General disorders and administration site conditions* Asthenia Pyrexia Pain (including pain in back, chest, and extremities)

    a Anaphylactic and anaphylactoid reactions may sometimes occur even after the first dose

    b Mucocutaneous reactions may sometimes occur even after the first dose

    *Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see Section 4.4).

    Other undesirable effects which have been associated with fluoroquinolone administration include:

    • attacks of porphyria in patients with porphyria.

    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.

    • Overdose

    According to toxicity studies in animals or clinical pharmacology studies performed with supra-therapeutic doses, the most important signs to be expected following acute overdosage of levofloxacin are central nervous system symptoms such as confusion, dizziness, impairment of consciousness, and convulsive seizures, increases in QT interval as well as gastro-intestinal 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 event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Antacids may be used for protection of gastric mucosa. Haemodialysis, including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the body. No specific antidote exists.

    1. Pharmacological properties
  • Pharmacodynamic properties
  • Pharmacotherapeutic group: Antiifectives for systemic use – Antibacterials for systemic use – Quinolone antibasterials – FluoroquinolonesLevofloxacin Taj Pharma is a synthetic antibacterial agent of the fluoroquinolone class and is the S (-) enantiomer of the racemic drug substance ofloxacin.Mechanism of action

    As a fluoroquinolone antibacterial agent, levofloxacin acts on the DNA-DNA-gyrase complex and topoisomerase IV.

    PK/PD relationship

    The degree of the bactericidal activity of levofloxacin depends on the ratio of the maximum concentration in serum (Cmax) or the area under the curve (AUC) and the minimal inhibitory concentration (MIC).

    Mechanism(s) of resisance

    Resistance to levofloxacin 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 levofloxacin.

    Cross-resistance between levofloxacin and other fluoroquinolones is observed. Due to the mechanism of action, there is generally no cross-resistance between levofloxacin and other classes of antibacterial agents.

    Breakpoints

    The EUCAST recommended MIC breakpoints for levofloxacin, separating susceptible from intermediately susceptible organisms and intermediately susceptible from resistant organisms are presented in the below table for MIC testing (mg/L).

    EUCAST clinical MIC breakpoints for levofloxacin (version 2.0, 2012-01-01):

    Pathogen Susceptible Resistant
    Enterobacteriacae ≤1 mg/L >2 mg/L
    Pseudomonas spp. ≤1 mg/L >2 mg/L
    Acinetobacter spp. ≤1 mg/L >2 mg/L
    Staphylococcus spp. ≤1 mg/L >2 mg/L
    S.pneumoniae 1 ≤2 mg/L >2 mg/L
    Streptococcus A,B,C,G ≤1 mg/L >2 mg/L
    H.influenzae2, 3 M.catarrhalis 3 ≤1 mg/L >1 mg/L
    Non-species related breakpoints 4 ≤1 mg/L >2 mg/L
    1. 1. The breakpoints for levofloxacin relate to high dose therapy.
    2. Low-level fluoroquinolone resistance (ciprofloxacin MICs of 0.12-0.5 mg/l) may occur but there is no evidence that this resistance is of clinical importance in respiratory tract infections with H. influenzae.
    3. Strains with MIC values above the susceptible breakpoint are very rare or not yet reported. The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate must be sent to a reference laboratory. Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint they should be reported resistant.
    4. Breakpoints apply to an oral dose of 500 mg x 1 to 500 mg x 2 and an intravenous dose of 500 mg x 1 to 500 mg x 2.

    The prevalence of resistance may vary geographically and with 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
    Aerobic Gram-positive bacteria
    Bacillus anthracis

    Staphylococcus aureus methicillin-susceptible

    Staphylococcus saprophyticus

    Streptococci, group C and G

    Streptococcus agalactiae

    Streptococcus pneumoniae

    Streptococcus pyogenes

    Aerobic Gram- negative bacteria
    Eikenella corrodens

    Haemophilus influenzae

    Haemophilus para-influenzae

    Klebsiella oxytoca

    Moraxella catarrhalis

    Pasteurella multocida

    Proteus vulgaris

    Providencia rettgeri

    Anaerobic bacteria
    Peptostreptococcus
    Other
    Chlamydophila pneumoniae

    Chlamydophila psittaci

    Chlamydia trachomatis

    Legionella pneumophila

    Mycoplasma pneumoniae

    Mycoplasma hominis

    Ureaplasma urealyticum

    Species for which acquired resistance may be a problem
    Aerobic Gram-positive bacteria
    Enterococcus faecalis

    Staphylococcus aureus methicillin-resistant#

    Coagulase negative Staphylococcus spp

    Aerobic Gram- negative bacteria
    Acinetobacter baumannii

    Citrobacter freundii

    Enterobacter aerogenes

    Enterobacter cloacae

    Escherichia coli

    Klebsiella pneumoniae

    Morganella morganii

    Proteus mirabilis

    Providencia stuartii

    Pseudomonas aeruginosa

    Serratia marcescens

    Anaerobic bacteria
    Bacteroides fragilis
    Inherently resistant Strains
    Aerobic Gram-positive bacteria
    Enterococcus faecium

    # Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including levofloxacin.

  • Pharmacokinetic properties
  • AbsorptionOrally administered levofloxacin is rapidly and almost completely absorbed with peak plasma concentrations being obtained within 1- 2 h. The absolute bioavailability is 99- 100 %.Food has little effect on the absorption of levofloxacin.

    Steady state conditions are reached within 48 hours following a 500 mg once or twice daily dosage regimen.

    Distribution

    Approximately 30 – 40 % of levofloxacin is bound to serum protein. The mean volume of distribution of levofloxacin is approximately 100 l after single and repeated 500 mg doses, indicating widespread distribution into body tissues.

    Penetration into tissues and body fluids:

    Levofloxacin Taj Pharma has been shown to penetrate into bronchial mucosa, epithelial lining fluid, alveolar macrophages, lung tissue, skin (blister fluid), prostatic tissue and urine. However, levofloxacin has poor penetration intro cerebro-spinal fluid.

    Biotransformation

    Levofloxacin Taj Pharma is metabolised to a very small extent, the metabolites being desmethyl-levofloxacin and levofloxacin N-oxide. These metabolites account for < 5 % of the dose excreted in urine. Levofloxacin Taj Pharma is stereochemically stable and does not undergo chiral inversion.

    Elimination

    Following oral and intravenous administration of levofloxacin, it is eliminated relatively slowly from the plasma (t½: 6 – 8 h). Excretion is primarily by the renal route > 85 % of the administered dose).

    The mean apparent total body clearance of levofloxacin following a 500 mg single dose was 175 +/-29.2 ml/min.

    There are no major differences in the pharmacokinetics of levofloxacin following intravenous and oral administration, suggesting that the oral and intravenous routes are interchangeable.

    Linearity

    Levofloxacin Taj Pharma obeys linear pharmacokinetics over a range of 50 to 1000 mg.

    Special populations

    Subjects with renal insufficiency

    The pharmacokinetics of levofloxacin are affected by renal impairment. With decreasing renal function renal elimination and clearance are decreased, and elimination half-lives increased as shown in the table below:

    Pharmacokinetics in renal insufficiency following single oral 500 mg dose

    Clcr [ml/min] < 20 20 – 49 50 – 80
    ClR [ml/min] 13 26 57
    t1/2 [h] 35 27 9

    Elderly subjects

    There are no significant differences in levofloxacin kinetics between young and elderly subjects, except those associated with differences in creatinine clearance.

    Gender differences

    Separate analysis for male and female subjects showed small to marginal gender differences in levofloxacin pharmacokinetics. There is no evidence that these gender differences are of clinical relevance.

  • Preclinical safety data
  • Non-clinical data reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential and toxicity to reproduction and development.Levofloxacin Taj Pharma caused no impairment of fertility or reproductive performance in rats and its only effect on fetuses was delayed maturation as a result of maternal toxicity.Levofloxacin Taj Pharma did not induce gene mutations in bacterial or mammalian cells but did induce chromosome aberrations in Chinese hamster lung cells in vitro. These effects can be attributed to inhibition of topoisomerase II. In vivo tests (micronucleus, sister chromatid exchange, unscheduled DNA synthesis, dominant lethal tests) did not show any genotoxic potential.

    Studies in the mouse showed levofloxacin to have phototoxic activity only at very high doses. Levofloxacin Taj Pharma did not show any genotoxic potential in a photomutagenicity assay, and it reduced tumour development in a photocarcinogenity study.

    In common with other fluoroquinolones, levofloxacin showed effects on cartilage (blistering and cavities) in rats and dogs. These findings were more marked in young animals.

    1. Pharmaceutical particulars
      • List of excipients

    Tablet core:

    Povidone
    Crospovidone (Type-B)
    Cellulose microcrystalline
    Magnesium stearate
    Silica colloidal anhydrous

    Tablet coating:

    Hypromellose Talc
    Titanium dioxide
    Macrogol 400
    Yellow ferric oxide
    Red ferric oxide

    • Incompatibilities

    Not applicable

    • Shelf life

    3 years

    • Special precautions for storage

    This medicinal product does not require any special storage conditions.

    • Nature and contents of container

    Tablets are packed in PVC/aluminium blisters.
    For 250mg, 500mg and 750mg the tablets are provided in pack sizes of 1, 2, 5, 7, 10, 30, 50, 200 and 500 tablets.

    Not all pack sizes may be marketed.

    • Special precautions for disposal and other handling

    No special requirements.
    Any unused product or waste material should be disposed of in accordance with local requirements.

    Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

     

Levofloxacin Tablets USP (Levotaj) 500mg Taj Pharma

  • PACKAGE LEAFLET: INFROMATION FOR THE USERLevofloxacin Taj Pharma 250 mg Film-coated Tablets
    Levofloxacin Taj Pharma 500 mg Film-coated Tablets
    Levofloxacin Taj Pharma 750 mg Film-coated TabletsLevofloxacin Taj Pharma

    Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

    • Keep this leaflet. You may need to read it again.
    • If you have any further questions, ask your doctor or pharmacist.
    • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
    • If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet.

    In this leaflet:

    1. What Levofloxacin Taj Pharma Tablets are and what they are used for
    2. What you need to know before you take Levofloxacin Taj Pharma Tablets
    3. How to take Levofloxacin Taj Pharma Tablets
    4. Possible side effects
    5. How to store Levofloxacin Taj Pharma Tablets
    6. Contents of the pack and other information
    7. What Levofloxacin Taj Pharma Tablets are and what they are used for

    Levofloxacin Taj Pharma tablet contains a drug called levofloxacin. Levofloxacin Taj Pharma is an antibiotic which is used to treat bacterial infections of the

    • sinuses
    • lungs, in people with long-term breathing problems or Pneumonia
    • urinary tract, including your kidneys or bladder
    • prostate gland, where you have a long lasting infection
    • skin and underneath the skin, including muscles. This is sometimes called ‘soft tissue’

    In some special situations, Levofloxacin Taj Pharma Tablets may be used to lessen the chances of getting a pulmonary disease named anthrax or worsening of the disease after you are exposed to the bacteria causing anthrax.

    1. What you need to know before you take Levofloxacin Taj Pharma Tablets

    Do not take Levofloxacin Taj Pharma Tablets and tell your doctor if:

    • You are allergic to levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
    • If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.
    • You have ever had epilepsy
    • You have ever had a problem with your tendons such as tendonitis that was related to treatment with a ‘quinolone antibiotic’. A tendon is the cord that joins your muscle to your skeleton.
    • You are a child or a growing teenager
    • You are pregnant, trying to become pregnant or are breast-feeding.

    Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Levofloxacin Taj Pharma Tablets.

    Warnings and precautions

    Before taking this medicine

    You should not take fluoroquinolone/quinolone antibacterial medicines, including

    , if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your doctor as soon as possible.

    Talk to your doctor or pharmacist before taking Levofloxacin Taj Pharma Tablets if:

    • You are 60 years of age or older.
    • You are using corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacin Taj Pharma Tablets”).
    • You have ever had a fit (seizure).
    • You have had damage to your brain due to a stroke or other brain injury.
    • You have kidney problems.
    • You have something known as ‘glucose – 6 – phosphate dehydrogenase deficiency’. You are more likely to have serious problems with your blood when taking this medicine.
    • You have ever had mental health problems.
    • You have ever had Heart problems : Caution should be taken when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section Other medicines and Levofloxacin Taj Pharma Tablets).
    • if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
    • if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
    • if you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular

    Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet’s disease, high blood pressure, or known atherosclerosis).

    • You are diabetic
    • You have ever had liver problems
    • You have myasthenia gravis.
    • If you feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency room.
    • You have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking levofloxacin. 6

    Serious skin reactions

    Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of levofloxacin.

    • SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal.
    • DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

    If you develop a serious rash or another of these skin symptoms, stop taking levofloxacin and contact your doctor or seek medical attention immediately.

    Other warnings

    When taking this medicine

    • Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids. Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of Levofloxacin Taj Pharma Tablets therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Levofloxacin Taj Pharma Tablets, contact your doctor and rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture. You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms. If this happens, stop taking levofloxacin Tablets and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
    • If you start having severe, persistent and/or bloody diarrhoea during or after treatment with levofloxacin, tell your doctor immediately. This could mean you have serious inflammation of your bowel (pseudomembranous colitis), which can sometimes occur after antibiotic treatment.

    You may need to stop taking levofloxacin and for your doctor to give you another medicine.

    • Whilst taking Levofloxacin Taj Pharma Tablets you are advised to stay out of strong sunlight and not to use a sun lamp. This is because some patients may become more sensitive to light whilst taking the tablets and get a sun-burn like reaction.
    • Levofloxacin Taj Pharma is not a optimal therapy for most severe cases of Pneumococcal pneumonia.
    • Infections got from a hospital during treatment due to P.aeruginosa may require combination therapy.
    • Levofloxacin Taj Pharma is not effective against infections caused by MRSA. In infections suspicious for MRSA levofloxacin should be combined with an agent approved to treat MRSA infections.

    If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Levofloxacin Taj Pharma Tablets.

    Prolonged, disabling and potentially irreversible serious side effects

    Fluoroquinolone/quinolone antibacterial medicines, including

    , have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders.

    If you experience any of these side effects after taking levofloxacin tablets, contact your doctor immediately prior to continuing treatment. You and your doctor will decide on continuing the treatment considering also an antibiotic from another class.

    Other medicines and Levofloxacin Taj Pharma Tablets

    Tell your doctor or pharmacist if you are taking,have recently taken or might take any other medicines.

    This is because Levofloxacin Taj Pharma Tablets can affect the way some other medicines work. Also some medicines can affect the way Levofloxacin Taj Pharma Tablets work.

    In particular, tell your doctor if you are taking any of the following medicines. This is because it can increase the chance of you getting side effects, when taken with Levofloxacin Taj Pharma Tablets:

    • Corticosteroids, sometimes called steroids – used for inflammation. You may be more likely to have inflammation and/or rupture of your tendons.
    • Warfarin – used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot.
    • Theophylline – used for breathing problems. You are more likely to have a fit (seizure) if taken with Levofloxacin Taj Pharma Tablets
    • Non-steroidal anti-inflammatory drugs (NSAIDS) – used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. You are more likely to have a fit (seizure) if taken with Levofloxacin Taj Pharma Tablets
    • Ciclosporin – used after organ transplants. You may be more likely to get the side effects of ciclosporin
    • Medicines known to affect the way your heart beats. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (‘macrolide’ antibiotics such as erythromycin, azithromycin and clarithromycin)
    • Probenecid – used for gout and cimetidine – used for ulcers and heartburn. Special care should be taken when taking either of these medicines with Levofloxacin Taj Pharma Tablets. If you have kidney problems, your doctor may want to give you a lower dose.
    • Do not take Levofloxacin Taj Pharma Tablets at the same time as the following medicines. This is because it can affect the way Levofloxacin Taj Pharma Tablets work:
    • Iron tablets (for anemia), zinc supplements, magnesium or aluminum-containing antacids (for acid or heartburn), didanosine, or sucralfate (for stomach ulcers). See section 3 “If you are already taking iron tablets, zinc supplements, antacids, didanosine or sucralfate” below.

    Urine tests for opiates

    Urine tests may show ‘false-positive’ results for strong painkillers called ‘opiates’ in people taking Levofloxacin Taj Pharma tablets. If your doctor is due to take a urine test, tell them you are taking Levofloxacin Taj Pharma tablets.

    Tuberculosis tests

    This medicine may cause “false negative” results for some tests used in laboratory to search for the bacteria causing tuberculosis.

    Taking Levofloxacin Taj Pharma Tablets with food and drink

    Take without regard to meals. Take with water, drink with plenty of water. Taking this product with orange juice can result in reduced quinolone plasma levels.

    Pregnancy and breast-feeding

    You must not take Levofloxacin Taj Pharma Tablets if you are pregnant, trying to become pregnant or are breastfeeding.

    Driving and using machines

    You may get side effects after taking this medicine, including feeling dizzy, sleepy, a spinning feeling (vertigo) or changes to your eyesight. Some of these side effects can affect you being able to

    concentrate and your reaction speed. If this happens, do not drive or carry out any work that requires a high level of attention.

    1. How to take Levofloxacin Taj Pharma Tablets

    Always take Levofloxacin Taj Pharma Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

    Taking this medicine

    • Take this medicine by mouth
    • Swallow the tablets whole with a drink of water
    • The tablets may be taken during meals or at any time between meals

    Protect your skin from sunlight

    Keep out of direct sunlight while taking this medicine and for 2 days after you stop taking it. This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions:

    • Make sure you use high factor sun cream
    • Always wear a hat and clothes which cover your arms and legs
    • Avoid sun beds

    If you are already taking iron tablets, zinc supplements, antacids, didanosine or sucralfate

    • Do not take these medicines at the same time as Levofloxacin Taj Pharma Tablets. Take your dose of these medicines at least 2 hours before or after Levofloxacin Taj Pharma Tablets.

    How much to take

    • Your doctor will decide on how many Levofloxacin Taj Pharma Tablets you should take
    • The dose will depend on the type of infection you have and where the infection is in your body.
    • The length of your treatment will depend on how serious your infection is.
    • If you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask your doctor.

    Adults and the elderly

    Sinuses infection

    • Two tablets of Levofloxacin Taj Pharma Tablets 250 mg, once each day
    • Or, one tablet of Levofloxacin Taj Pharma Tablets 500 mg, once each day Lungs infection, in people with long-term breathing problems
    • Two tablets of Levofloxacin Taj Pharma Tablets 250 mg, once each day
    • Or, one tablet of Levofloxacin Taj Pharma Tablets 500 mg, once each day

    Pneumonia

    • Two tablets of Levofloxacin Taj Pharma Tablets 250 mg, once or twice each day
    • Or, one tablet of Levofloxacin Taj Pharma Tablets 500 mg, once or twice each day
    • Infection of urinary tract, including your kidneys or bladder
    • One or two tablets of Levofloxacin Taj Pharma Tablets 250 mg, each day
    • Or, 1/2 or one tablet of Levofloxacin Taj Pharma Tablets 500 mg, each day

    Prostate gland infection

    • Two tablets of Levofloxacin Taj Pharma Tablets 250 mg, once each day Or, one tablet of Levofloxacin Taj Pharma Tablets 500 mg, once each day
    • Infection of skin and underneath the skin, including muscles
    • Two tablets of Levofloxacin Taj Pharma Tablets 250 mg, once or twice each day Or, one tablet of Levofloxacin Taj Pharma Tablets 500 mg, once or twice each day

    Adults and the elderly with kidney problems

    Your doctor may need to give you a lower dose.

    Children and adolescents

    This medicine must not be given to children or teenagers.

    If you take more Levofloxacin Taj Pharma Tablets than you should

    If you accidentally take more tablets than you should, tell a doctor or get other medical advice straight

    away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: convulsive fits (seizures), feeling confused, dizzy, less conscious, having tremor and heart problems – leading to uneven heart beats as well as feeling sick (nausea) or having stomach burning.

    If you forget to take a dose of Levofloxacin Taj Pharma Tablets

    If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose.

    Do not double-up the next dose to make up for the missed dose.

    If you stop taking Levofloxacin Taj Pharma Tablets

    Do not stop taking Levofloxacin Taj Pharma Tablets just because you feel better. It is important that you complete the course of tablets that your doctor has prescribed for you. If you stop taking the tablets

    too soon, the infection may return, your condition may get worse or the bacteria may become resistant to the medicine.

    If you have any further questions on the use of this product, ask your doctor or pharmacist.

    1. Possible Side Effects

    Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild or moderate and often disappear after a short time.

    Stop taking Levofloxacin Taj Pharma Tablets and see a doctor or go to a hospital straight away if you notice the following side effect:

    Very rare (may affect up to 1 in 10,000 people)

    • You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, or tongue

    Stop taking Levofloxacin Taj Pharma Tablets and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

    Rare (may affect up to 1 in 1,000 people)

    • Watery diarrhoea which may have blood in it, possibly with stomach cramps and a high temperature. These could be signs of a severe bowel problem
    • Pain and inflammation in your tendons or ligaments, which could lead to rupture. The Achilles tendon is affected most often
    • Fits (convulsions)
    • Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome). See also section 2.
    • Syndrome associated with impaired water excretion and low levels of sodium (SIADH)

    Very rare (may affect up to 1 in 10,000 people)

    • Burning, tingling, pain or numbness. These may be signs of something called ‘neuropathy’

    Other:

    • Loss of appetite, skin and eyes becoming yellow in colour, dark-coloured urine, itching, or tender stomach (abdomen). These may be signs of liver problems which may include a fatal failure of the liver

    Not known (frequency cannot be estimated from the available data)

    Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. See also section 2.

    If your eyesight becomes impaired or if you have any other eye disturbances whilst taking Levofloxacin Taj Pharma Tablets, consult an eye specialist immediately.

    Tell your doctor if any of the following side effects gets serious or lasts longer than a few days:

    Common (may affect up to 1 in 10 people)

    • Sleeping problems
    • Headache, feeling dizzy
    • Feeling sick (nausea, vomiting) and diarrhoea
    • Increase in the level of some liver enzymes in your blood

    Uncommon (may affect up to 1 in 100 people)

    • Changes in the number of other bacteria or fungi, infection by fungi named Candida, which may need to be treated
    • Changes in the number of white blood cells shown up in the results of some blood tests (leukopenia, eosinophilia)
    • Feeling stressed (anxiety), feeling confused, feeling nervous, feeling sleepy, trembling, a spinning feeling (vertigo)
    • Shortness of breath (dyspnoea)
    • Changes in the way things taste, loss of appetite, stomach upset or indigestion (dyspepsia), pain in your stomach area, feeling bloated (flatulence) or constipation
    • Itching and skin rash, severe itching or hives (urticaria), sweating too much (hyperhidrosis)
    • Joint pain or muscle pain
    • Blood tests may show unusual results due to liver (bilirubin increased) or kidney (creatinine increased) problems
    • General weakness

    Rare (may affect up to 1 in 1,000 people)

    • Bruising and bleeding easily due to a lowering in the number of blood platelets (thrombocytopenia)
    • Low number of white blood cells (neutropenia)
    • Exaggerated immune response (hypersensitivity)
    • Lowering of your blood sugar levels (hypoglycaemia). This is important for people that have diabetes.
    • Seeing or hearing things that are not there (hallucinations, paranoia), change in your opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions
    • Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares
    • Tingly feeling in your hands and feet (paraesthesia)
    • Problems with your hearing (tinnitus) or eyesight (blurred vision)
    • Unusual fast beating of your heart (tachycardia) or low blood pressure (hypotension)
    • Muscle weakness. This is important in people with myasthenia gravis (a rare disease of the nervous system).
    • Changes in the way your kidney works and occasional kidney failure which may be due to an allergic kidney reaction called interstitial nephritis.
    • FeverSharply demarcated, erythematous patches with/without blistering that develop within hours of administration of levofloxacin and heals with postinflammatory residual hyperpigmentation; it usually recurs at the same site of the skin or mucous membrane upon subsequent exposure to levofloxacin

    Other side effects include:

    • Lowering in red blood cells (anemia): this can make the skin pale or yellow due to damage of the red blood cells; lowering in the number of all types of blood cells (pancytopenia)
    • Fever, sore throat and a general feeling of being unwell that does not go away. This may be due to a lowering in the number of white blood cells (agranulocytosis).
    • Loss of circulation (anaphylactic like shock)
    • Increase of your blood sugar levels (hyperglycaemia) or lowering of your blood sugar levels leading to coma (hypoglycaemic coma). This is important for people that have diabetes.
    • Changes in the way things smell, loss of smell or taste (parosmia, anosmia, ageusia)
    • Problems moving and walking (dyskinesia, extrapyramidal disorders)
    • Temporary loss of consciousness or posture (syncope)
    • Temporary loss of vision
    • Impairment or loss of hearing
    • Abnormal fast heart rhythm, life-threatening irregular heart rhythm including cardiac arrest, alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart)
    • Difficulty breathing or wheezing (bronchospasm)
    • Allergic lung reactions
    • Pancreatitis
    • Inflammation of the liver (hepatitis)
    • Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity)
    • Inflammation of the vessels that carry blood around your body due to an allergic reaction (vasculitis)
    • Inflammation of the tissue inside the mouth (stomatitis)
    • Muscle rupture and muscle destruction (rhabdomyolysis)
    • Joint redness and swelling (arthritis)
    • Pain, including pain in the back, chest and extremities
    • Attacks of porphyria in people who already have porphyria (a very rare metabolic disease)
    • Persistent headache with or without blurred vision (benign intracranial hypertension)

    Very rare cases of long lasting ( up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.

    Reporting of side effects

    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

    1. How to store Levofloxacin Taj Pharma Tablets
  • This medicinal product does not require any special storage conditions
  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton and blister strip after EXP. The expiry date refers to the last day of that month.
  • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
    1. Contents of the pack and other information

    What Levofloxacin Taj Pharma Tablets contains

    Each tablet contains either 250mg, 500mg and 750mg of Levofloxacin Taj Pharma as active substance corresponding to 256.23 mg or 512.46 mg of levofloxacin hemihydrate.

    The other ingredients are

    Core tablet: povidone, crospovidone (Type-B), cellulose microcrystalline, magnesium stearate, silica colloidal anhydrous, tablet coating: hypromellose, talc, titanium dioxide, macrogol 400, red iron oxide  and yellow iron oxide.

    What Levofloxacin Taj Pharma Tablets looks like and contents of the pack

    For 250mg, 500mg and 750mg tablets: Pink coloured, capsule shaped, biconvex, film coated tablet

    Pack size:
    Tablets are packed in PVC/aluminium blisters.

    For 250mg/500mg/750mg levofloxacin tablets are provided in pack sizes of 1, 2, 3, 5, 7, 10, 30, 50, 200 and 500 tablets.

    Not all pack sizes may be marketed.

    Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com