Tarivid

Tarivid

ofloxacin

Manufacturer:

Daiichi Sankyo

Distributor:

Ranbaxy
Full Prescribing Info
Contents
Ofloxacin.
Description
Each tablet has a diameter of 8.1 mm, with a thickness of 3.8 mm and weighs about 204 mg.
Ofloxacin is (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3,-de][1,4]benzoxazine-6-carboxylic acid.
Ofloxacin has a molecular formula of C18H20FN3O4, molecular weight of 361.37 and melting point of 260-270°C (decomposition). Ofloxacin occurs as pale yellowish-white to light yellowish-white crystals or crystalline powder, is odorless and has a bitter taste. It is freely soluble in glacial acetic acid, sparingly soluble in chloroform, slightly soluble in water, methanol, ethanol and acetone and very slightly soluble in ethyl acetate. It is slowly colorized by light and has no specific rotation.
Action
Tarivid is a broad-spectrum antibacterial agent of pyridonecarboxylic acid derivative originated in Daiichi Pharmaceutical Co., Ltd. Tarivid shows more potent antibacterial activities against gram-negative bacteria eg, E. coli, K. pneumoniae, Serratia and Proteus spp, P. aeruginosa and H. influenzae than the other formerly developed derivatives of pyridonecarboxylic acid. Moreover, ofloxacin has antibacterial activities against gram-positive bacteria eg, Staphylococcus sp, Streptococcus hemolyticus and Enterococcus sp. Tarivid, which is transferred rapidly to each tissue in high concentrations without being accumulated there, is mostly excreted in the urine almost unchanged. It shows clinical effects on respiratory, genitourinary, biliary and intestinal tract infections and other various infections in the gynecological, dermatological, otorhinolaryngological, ophthalmological and oral surgery fields.
Pharmacology: Mechanism of Action: Ofloxacin is considered to specifically inhibit DNA synthesis in microorganisms. Its antibacterial activity is bactericidal and causes bacteriolysis at MIC.
Non-Clinical Studies: Absorption and Distribution: 14C-Ofloxacin, when administered orally to rats at a dose of 20 mg/kg, was absorbed primarily from the small intestine and the maximum tissue concentrations were reached 2 hrs after administration. Except for the levels in the central nervous system, the drug concentrations in all tissues of the body were higher than the blood level (2.59 mcg/mL), demonstrating the ready transference to tissues. Regarding the drug concentrations in the main organs, the maximal level of 14 mcg/g in the kidney was followed by 8.2 mcg/g in the liver and 3.3 mcg/g in the lung. Also, following 2-week oral administration to beagle dogs at a dose of 20 mg/kg, levofloxacin, the optically active (-)S-form of racemate ofloxacin, was distributed in high concentrations in the iris, ciliary body, choroid and pigmented layer of retina, those eye tissues containing melanin pigments. Concentrations were decreased to 20-30% one week after the termination of drug administration. On the other hand, drug distribution to retina excluding pigmentated layer was minimal.
Single-Dose Toxicity: LD50 values after oral administration were 5450 mg/kg in mice, 3590 mg/kg in rats, >200 mg/kg in dogs and 500-1000 mg/kg in monkeys.
Repeated Dose Toxicity: Following 4-week administration to rats, no changes were observed up to 90 mg/kg in general condition, hematology, urinalysis and histology. At a dose of ≥270 mg/kg, rats showed roughened fur, soft stool and depression of body weight gain. In addition to these changes, rarefaction of articular cartilage matrix was observed in rats given 810 mg/kg. When dogs were orally administered for 4 weeks, no noticeable changes were observed at a dose of 12.5 mg/kg. However, at 50 and 200 mg/kg, vomiting, salivation and blister or erosion of the articular cartilage were observed.
Following 6-month administration to rats, no noticeable changes were observed up to 30 mg/kg. At 90 and 270 mg/kg, salivation, soft stool, enhancement of spontaneous lesions in the cartilage and of lipid deposition in cortical cells of the adrenal glands were observed.
Reproductive and Developmental Toxicity: Administration Prior to and in the Early Stage of Pregnancy: No effects were observed on fertility of both sexes and on the fetuses after administration of 360 mg/kg to rats.
Administration During the Period of Organogenesis: In rats, growth retardation in the fetuses at a dose of ≥90 mg/kg and skeletal variations in the fetuses at a dose of 810 mg/kg were observed. However, no teratogenesis was observed up to 810 mg/kg. In rabbits, no teratogenesis was observed up to 160 mg/kg.
Administration During the Perinatal and Lactation Periods: No effects were observed in the female parturition and on pups after administration of 360 mg/kg to rats.
Antigenicity: No antigenicity was suggested from the systematic anaphylaxis test, PCA reaction, hemagglutination reaction and precipitation reactions in guinea pigs, from the PCA reaction and hemagglutination reaction in rabbits and from the detection test of specific IgE antibody in mice.
Mutagenicity: The sister chromatid exchange test, unscheduled DNA synthesis test, reverse mutation test, chromosomal aberration test (in vitro and in vivo), micronucleus test and dominant lethal test showed no mutagenic potential of the drug.
Effects on Kidney: Following oral administration to rabbits for 10 days, no abnormalities were observed in renal functional parameters and morphological studies up to 200 mg/kg.
Effects on Eye: Following oral administration to rats for 4 weeks, no abnormalities were observed in ophthalmological tests and morphological studies up to 100 mg/kg.
Effects on Articulation: When ofloxacin was administered orally to juvenile rats (4 weeks of age) or juvenile dogs (3-4 months of age) for 7 days, blisters or erosions occurred in the articular cartilage in rats on ≥300 mg/kg and in dogs on ≥10 mg/kg. After termination of administration, however, it was confirmed that these symptoms tended to subside gradually without showing any sign of deterioration. In mature rats (8-10 weeks of age) and mature dogs (12-13 months of age), repeated administration did not cause any change.
Others: Animal studies have shown that ofloxacin may produce arthropathy in dogs and rats.
Clinical Studies: Clinical Efficacy: The results of the clinical trials carried out in Japan in cases of various infections of each field and those of the double-blind comparative tests are summarized in the following:
Respiratory Tract Infections: Clinical efficacy rate was 80.7% (668/828) in patients with respiratory tract infections eg, pharyngolaryngitis, acute bronchitis, tonsillitis, chronic bronchitis, bronchiectasis with infection, diffuse panbronchiolitis, secondary infections of chronic respiratory diseases and pneumonia. The main causative organisms were Staphylococcus and Streptococcus spp, S. pneumoniae, K. pneumoniae, P. aeruginosa and H. influenzae. Most of the patients received a daily dose of 300-600 mg. Moreover, usefulness of the drug in acute lacunar tonsillitis, chronic respiratory tract infections and pneumonia and bronchitis were confirmed by respective double-blind comparative studies.
Urinary Tract Infections: Clinical efficacy rate was 85.6% (1339/1564) in patients with urinary tract infections eg, pyelonephritis, cystitis, prostatitis, gonococcal urethritis, nongonococcal urethritis. The main causative organisms were Staphylococcus sp, S. faecalis, E. coli, Citrobacter sp, K. pneumoniae, Enterobacter sp, Serratia sp and Proteus sp, P. aeruginosa and N. gonorrhoeae. Most of the patients received a daily dose of either 300 or 400 mg. Moreover, usefulness of ofloxacin in acute simple cystitis and in complicated urinary tract infections has been confirmed by respective double-blind comparative studies.
Gynecological Field Infections: Clinical efficacy rate was 92.7% (140/151) in patients with gynecological field infections, eg uterine adnexitis, intrauterine infection and bartholinitis. The main causative organisms were E. coli and Peptostreptococcus sp. Most of the patients received a daily dose of either 300 or 600 mg. Moreover, usefulness of ofloxacin in these infections has been confirmed by a double-blind comparative study.
Chlamydial Urethritis and Cervicitis: Clinical efficacy rates were 82.6% (300/363), 90.2% (166/184) in patients with male urethritis or cervicitis, respectively. The main causative organism was Chlamydia trachomatis. Most of the patients received a daily dose of 600 mg.
Skin and Soft Tissue Infections: Clinical efficacy rate was 85.7% (323/377) in patients with skin and soft tissue infections eg, folliculitis, furuncle, phlegmon, felon, subcutaneous abscess and infectious atheroma. The main causative organism was Staphylococcus sp. Most of the patients received a daily dose of 300 mg. Moreover, usefulness of the drug in these infections has been confirmed by a double-blind comparative study.
Infections in the Field of Surgery and Orthopedics: Clinical efficacy rate was 75.8% (72/95) in patients with surgical and orthopedical infections eg, secondary infections of trauma, burn and surgical trauma. The main causative organism was Staphylococcus sp. Most of the patients received a daily dose of either 300 or 400 mg.
Biliary Tract Infections: Clinical efficacy rate was 73.9% (68/92) in patients with biliary tract infections eg, cholecystitis and cholangitis. The main causative organisms were E. coli, K. pneumoniae and Enterobacter sp. Most of the patients received a daily dose of either 300 or 600 mg.
Infections in the Field of Otorhinolaryngology: Clinical efficacy rate was 71.7% (76/106) in patients with otorhinolaryngological infections eg, otitis media and sinusitis. The main causative organism was Staphylococcus sp. Most of the patients received a daily dose of 600 mg. Moreover, usefulness of the drug in otitis media has been confirmed by a double-blind comparative study.
Infections in the Field of Ophthalmology: Clinical efficacy rate was 94.6% (141/149) in patients with ophthalmological infections eg, hordeolum, dacryocystitis, tarsadenitis and keratohelcosis. The main causative organism was Staphylococcus sp. Most of the patients received a daily dose of 400 mg.
Infectious Enteritis: Clinical efficacy rate was 99.1% (107/108) in patients with infectious enteritis eg, bacillary dysentery and colitis. The main causative organisms were Shigella sp and Campylobacter sp. Most of the patients received a daily dose of either 400 or 600 mg. Moreover, usefulness of the drug in these infections has been confirmed by a double-blind comparative study.
Infections in the Field of Dental Surgery: Clinical efficacy rate was 80.9% (212/262) in patients with dental surgical infections eg, periodontitis, pericoronitis and gnathitis. The main causative organism was Peptostreptococcus sp. Most of the patients received a daily dose of either 300 or 600 mg. Moreover, usefulness of the drug in these infections has been confirmed by a double-blind comparative study.
Adverse Reactions and Abnormal Laboratory Findings: A total of 6514 cases were treated with ofloxacin and adverse reactions were observed in 239 cases (3.7%). The major adverse reactions were gastrointestinal system disorders (159 cases; 2.4%) eg, abdominal pain, diarrhea, nausea and anorexia, psychoneurologic symptoms (48 cases; 0.7%) eg, insomnia and dizziness, hypersensitivity (33 cases; 0.5%) eg, rash. The major changes in the laboratory values were increase in GOT (2%; 63/3211), GPT (2.2%; 70/3168), BUN (0.8%; 23/2965), eosinophiles (2%; 46/2281) and decrease in leucocytes (0.5%; 18/3418).
In drug use investigation after approval, a total of 17,670 cases were treated with ofloxacin and adverse reactions were observed in 248 cases (1.4%).
Pharmacokinetics: Blood Concentration: The serum concentration of Tarivid increases dose-dependently when orally administered to healthy adults in a single dose.
When Tarivid was administered orally after meals at doses of 100, 200 and 300 mg, the maximal serum levels (1, 1.65 and 2.8 mcg/mL, respectively) were reached 2 or 3 hrs after administration. Its biological half-life at each dose was 3.6, 4.5 and 5.5 hrs, respectively.
Distribution: When a single dose of 200 mg of ofloxacin was administered to healthy adults or patients, the drug transferred to the following tissues in high concentrations: Sputum (3.08 mcg/mL 1 hr later), saliva (1.96 mcg/mL 2 hrs later), palatal tonsil (4.58 mcg/g approximately 1 hr later), prostate (6.25 mcg/g 2 hrs later), prostatic fluid (1.66 mcg/mL 2 hrs later), endometrium (4.76 mcg/g approximately 3 hrs later), oviduct (3.83 mcg/g approximately 3 hrs later), skin (2.24 mcg/g 2 hrs later), bile (2.57 mcg/mL 4 hrs later), gallbladder (2.3 mcg/g 4 hrs later), otorrhea, maxillary sinus mucosa and tears (1.36 mcg/mL 2 hrs later) and gingiva. The drug is also transferred to milk.
Metabolism and Excretion: The urinary concentration increased dose-dependently, when orally administered to healthy adults in a single dose. When 100 mcg of ofloxacin was administered after meal, the urinary concentration peaked at 115 mcg/mL in 2-4 hrs and declined to 36 mcg/mL in 12-24 hrs after administration. The majority of the drug is not metabolized in the body. More than 90% of the administered dose is excreted into the urine as an unchanged form and approximately 4% in the feces by 48 hrs after administration. When a single dose of 200 mg of ofloxacin was administered orally, the cumulative urinary excretion rates during the first 12 hrs after administration were 68% in the subjects with normal renal function (Clcr ≥70), 43% in those in the middle level of renal impairment (50>Clcr ≥30) and 14% in those in the severe stage of renal impairment (Clcr <30), demonstrating the decreasing urinary excretion rate relative to the decreasing renal function.
Microbiology: Ofloxacin has a wide range of antibacterial spectrum against various gram-positive and gram-negative bacteria. Antibacterial activities of ofloxacin are 2- to 4-fold stronger than those of norfloxacin against Staphylococcus sp, hemolytic streptococci and enterococci. Meanwhile, ofloxacin has excellent activities as those of norfloxacin against Enterobacteriaceae, including E. coli, K. pneumoniae, Serratia sp and Proteus sp, glucose nonfermentative gram-negative rods, including P. aeruginosa, H. influenzae and N. gonorrhoeae. Especially, it has excellent effects against nalidixic acid-resistant Enterobacteriaceae, ABPC-resistant N. gonorrhoeae and gentamicin-resistant P. aeruginosa. Furthermore, it has excellent effects against anaerobic Peptostreptococcus sp. The effective doses (ED50) of ofloxacin in experimentally produced infectious diseases in mice were between ¼ and ½ of norfloxacin and between 1/40 and 1/8 of pipemidic acid, thus indicating an excellent effect of this drug in the prevention of infections.
Antibacterial Spectrum: Microorganisms Regarded to be Susceptible to Ofloxacin: Staphylococcus aureus including methicillin-resistant staphylococcus, Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Hafnia, Proteus (indole-negative and indole-positive strains), Salmonella, Shigella, Yersinia enterocolitica, Campylobacter jejuni, Aeromonas, Plesiomonas, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydiae and Legionella.
Microorganisms that Vary in their Susceptibility: Enterococci, Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus viridans, Serratia marcescens, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma hominis, Mycoplasma pneumoniae, Mycobacterium tuberculosis and Mycobacterium fortuitum.
Microorganisms Resistant to Ofloxacin: Ureaplasma urealyticum, Nocardia asteroides, anaerobes (eg, Bacteroides sp, Peptococcus, Peptostreptococcus, Eubacterium sp and Fusobacterium sp, Clostridium difficile).
Ofloxacin is not effective against Treponema pallidum.
Indications/Uses
Infections caused by ofloxacin-susceptible bacteria: Staphylococcus sp, Streptococcus pyogenes, Streptococcus hemolyticus, Enterococcus sp, Streptococcus pneumoniae, Peptostreptococcus sp, Neisseria gonnorhoeae, Escherichia coli, Citrobacter sp and Shigella sp, Klebsiella pneumoniae, Enterobacter sp, Serratia sp and Proteus sp, Pseudomonas aeruginosa, Haemophilus influenzae, Acinetobacter sp and Campylobacter sp, Chlamydia trachomatis and Mycobacterium leprae.
Pneumonia, chronic bronchitis, diffuse panbronchiolitis, bronchiectasis with infection, secondary infections of chronic respiratory diseases.
Pharyngolaryngitis, tonsillitis, acute bronchitis.
Pyelonephritis, cystitis, prostatitis, epididymitis, gonococcal urethritis, nongonococcal urethritis.
Intrauterine infection, cervicitis, uterine adnexitis, bartholinitis.
Folliculitis, furuncle, furunculosis, carbuncle, erysipelas, phlegmon, lymphangitis/lymphadenitis, felon, subcutaneous abscess, spiradenitis, acne conglobata, infectious atheroma, perianal abscess.
Mastitis, superficial secondary infections in traumas, burns, operative wounds, etc.
Cholecystitis, cholangitis.
Otitis media, sinusitis.
Blepharitis, hordeolum, dacryocystitis, tarsadenitis, keratohelcosis.
Bacillary dysentery, enteritis.
Periodontitis, pericoronitis, gnathitis.
Leprosy.
Dosage/Direction for Use
Adults: Given orally in a usual daily dose of 300-600 mg of ofloxacin (3-6 tabs) divided into 2-3 doses. If used for leprosy, it is recommended to give a total of 400-600 of ofloxacin per day divided into 2-3 doses. In general, the dosage should be adjusted according to the causative organism and the severity of the symptoms. For leprosy, ofloxacin should as a rule be co-administered with other antileprosy drugs.
Urinary Tract Infections: 1 x 100 mg up to 2 x 100 mg (or 1 x 200 mg).
Kidney and Reproductive Organ Infections: 2 x 100 mg up to 2 x 200 mg.
Respiratory Tract and Ear, Nose and Throat: 2 x 200 mg.
Skin and Soft Tissue Infections: 2 x 200 mg.
Bones and Joint Infections: 2 x 200 mg.
Abdominal Infections: 2 x 200 mg.
Septicaemia: 2 x 200 mg.
It is important that the individual doses be given at approximately equal intervals.
Depending on the severity of the infection and on the presence of complicating factors or pathogens of moderate susceptibility, it may be necessary to increase the dose to up 2 x 400 mg daily.
Patients with Impaired Renal Function: The initial dose is the same as for patients with normal renal function, whereas the maintenance dose should be reduced as follows: Creatinine clearance: 50-20 mL/min: 100-200 mg every 24 hrs; <20 mL/min: 100 mg every 24 hrs; haemodialysis or peritoneal dialysis: 100 mg every 24 hrs. In individual instances, it may be necessary to increase the dosage.
Patients with Impaired Liver Function: The excretion of ofloxacin may be reduced in patients with severe impairment of liver function (eg, cirrhosis with ascites). A maximum daily dose of 400 mg of ofloxacin should therefore not be exceeded.
Duration of Treatment: The duration of treatment depends on the response of the causative organism and on the clinical picture. In most cases of acute infection, a course of treatment lasting 7-10 days is sufficient. In salmonelloses, the duration of treatment is usually 7-8 days, in shigelloses 3-5 days and in intestinal infections caused by E. coli 3 days.
For uncomplicated infections of the lower urinary tract, 3-day treatment is usually sufficient.
In case of infections with β-haemolytic streptococci (eg, purulent tonsillitis or erysipelas), treatment must be continued for at least 10 days in order to prevent late complications eg, rheumatic fever or inflammation of the renal glomeruli (glomerulonephritis). However, since β-haemolytic streptococci are of varying susceptibility to ofloxacin, treatment of such infections requires individual proof of susceptibility.
Until further experience is available, the duration of treatment should not exceed 2 months.
Contraindications
Patients with a history of hypersensitivity to any ingredients of Tarivid or to levofloxacin. Children or adolescents in the growth phase, during pregnancy or in breastfeeding women (since judging from animal experiments, risk of damage to the cartilage of joints in growing organism cannot be excluded) (see Use in pregnancy & lactation and Use in children under Precautions).
Special Precautions
As a general rule, the duration of treatment with Tarivid should be limited to a minimum required for the treatment of diseases, after the susceptibility being confirmed, in order to avoid possible occurrence of resistant bacteria.
Careful Administration: Tarivid should be administered with caution in the following patients: Patients with severe nephropathy. (Persistence of high serum level has been reported.) Patients with or with a history of convulsive diseases eg, epilepsy. (Convulsions may occur.)
Patients with a history of severe adverse reactions [eg, inflammation of a tendon (tendinitis), severe neurological reactions] to other quinolones may be at increased risk of similar reactions to ofloxacin.
Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant microorganisms. The patient's condition must therefore be checked at regular intervals, if a secondary infection occurs, appropriate measures must be taken.
Effects on the Ability to Drive or Operate Machinery: Some adverse effects (see Adverse Reactions) may impair the ability to concentrate and react, and therefore, constitute a risk in situations where these abilities are of particular importance (eg, driving a car or operating machinery).
Use in pregnancy & lactation: Since the safety of Tarivid in pregnant women has not been established, this product should not be administered to pregnant women or women suspected of being pregnant.
Since ofloxacin is excreted in breast milk, it is recommended to refrain from using this drug in nursing mothers. However, if the administration is absolutely necessary, breastfeeding should be avoided.
Use in children: Since safety in children has not been established, Tarivid should not be administered to children.
Use in the elderly: Tarivid is mainly excreted by the kidneys (see Pharmacology: Pharmacokinetics under Actions). Since the elderly often have renal hypofunction and are in danger of continuous high blood concentration, administer Tarivid with caution.
Since the duration of therapy for leprosy is often long, observe the patient carefully. In the event of any abnormalities, therapy should be discontinued and appropriate measures should be taken.
Use In Pregnancy & Lactation
Since the safety of Tarivid in pregnant women has not been established, this product should not be administered to pregnant women or women suspected of being pregnant.
Since ofloxacin is excreted in breast milk, it is recommended to refrain from using this drug in nursing mothers. However, if the administration is absolutely necessary, breastfeeding should be avoided.
Adverse Reactions
Liver: Rarely, an increase in serum levels of hepatic enzymes or impairment of liver function with an increase in serum bilirubin may occur. Very rarely, jaundice due to impairment of bile flow (cholestatic jaundice), inflammation of the liver (hepatitis) or severe liver damage may develop.
Nervous System: Headache, dizziness, sleep disorders, agitation and confusion may occur. In rare cases, drowsiness, unsteadiness of gait and tremor (due to disorders of muscular coordination), extrapyramidal symptoms (increased or decreased muscle tone, involuntary movements of the face and body, tremor at rest, a decrease in spontaneous movements or slowness in initiating movements), convulsions, numbness and tingling (paraesthesia or hypaesthesia) may occur. Rarely, visual disorders eg, blurred vision, double vision and abnormal colour vision, disorders of taste and smell (including loss of state and smell) and of equilibrium may develop. Noises in the ears (tinnitus) and disorders of hearing (in exceptional cases even loss of hearing) are rare with ofloxacin.
In very rare cases, vivid dreaming (sometimes amounting to nightmares) and psychotic reactions eg, anxiety, depression and hallucinations may occur. Certain psychotic reactions may, in some cases, lead to self-endangering behaviour.
Cardiovascular System: During infusion, acceleration of the heart beat (tachycardia) and a temporary decrease in blood pressure may develop. In rare cases, as a consequence of a pronounced drop in blood pressure, circulatory collapse may occur. In the event of a conspicuous drop in blood pressure, the infusion must be halted immediately.
Blood: Very rarely, a reduction in the numbers of both red and white blood cells (this can include the absence of certain white blood cells) and/or of platelets (anaemia, leucopenia including agranulocytosis, thrombopenia, pancytopenia) may occur. In some cases only, these changes result from reduced new cell formation in the bone marrow (bone marrow depression). Very rarely, a reduction in the number of red blood cells due to increased destruction (haemolytic anaemia) may develop.
Kidneys: Rarely, impairment of renal function with eg, an increase in serum creatinine may develop, as may, in isolated cases, acute inflammation of the kidney (interstitial nephritis). These reactions may sometimes progress to acute renal failure.
Skin, Mucous Membranes and Other Reactions: Cutaneous and mucosal reactions eg, itching and skin rashes (in exceptional cases, with blisters or small pus-filled vesicles) may develop. In very rare cases, reddening of the skin accompanied by heat sensations, severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome) and inflammation of the vessels (vasculitis) may occur. Generally, vasculitis can manifest itself in the form of tiny red dots caused by bleeding under the skin (petechiae), of blood-filled blisters (haemorrhagic bullae) and of small nodules with crust formation, but can also lead to skin lesions including irreversible damage (necrosis) in exceptional cases. Vasculitis may also involve internal organs.
Hypersensitivity to light may develop in very rare cases. This may resemble severe sunburn and in some cases also involve the nails (discolouration, loosening).
Fever, eosinophilia and allergic inflammation of the lungs (allergic pneumonitis) may develop in very rare cases.
Sweating may occur. In very rare cases, muscular complaints eg, pain or weakness (of special significance in patients with myasthenia gravis) may occur. In isolated cases, these may be symptoms of a muscle disease (rhabdomyolysis) entailing destruction of muscle tissue, which, in some cases, can lead to muscular atrophy and acute renal failure. Very rarely, joint and tendon discomfort (eg, pain) may occur.
In very rare cases, inflammation of tendons (tendinitis) and rupture (eg, of the Achilles tendon) may occur in isolated instances during treatment with quinolones. Such events have been observed particularly in patients treated concurrently with corticosteroids. If tendinitis is suspected, treatment with Tarivid must be halted immediately and appropriate treatment must be initiated for the affected tendon.
The possibility cannot be ruled out that ofloxacin may trigger an attack of porphyria in predisposed patients.
Excessive rises or falls in the blood sugar level (hyper- or hypoglycaemia) may occur in isolated cases.
Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant microorganisms (see Precautions).
Consult a physician if any of the adverse effects listed previously or any other undesired effects or unexpected changes are noticed. Since some adverse drug effects (eg, pseudomembranous colitis, some changes in blood picture, severe anaphylactic or anaphylactoid reactions, severe skin reactions) may under certain circumstances become life-threatening, it is essential that, if sudden or severe reactions do occur, a physician is informed at once.
Drug Interactions
Careful Co-Administration: NSAIDs of Phenylacetic and/or Propionic Acid Derivatives: Co-administration of ofloxacin with NSAIDs of phenylacetic and/or propionic acid derivatives may possibly cause convulsions.
Coumarin Derivatives (Warfarin): It has been reported that co-administration of ofloxacin with warfarin may enhance the effect of warfarin and prolong the prothrombin time.
Antacids Containing Aluminum or Magnesium and Drugs Containing Iron: Co-administration of ofloxacin with antacids containing aluminum or magnesium and drugs containing iron may interfere with the absorption of ofloxacin, resulting in attenuation of the efficacy of ofloxacin.
Caution For Usage
When handing over the medicine in the press-through package, the patient should be taught to take the tablets after pressing them out of the package. (It has been reported that the press-through package has mistakenly been swallowed causing serious complications, eg perforation and mediastinitis after a hard acute angle of the package has stuck into the esophageal mucosa.)
Storage
Store at room temperature.
MIMS Class
ATC Classification
J01MA01 - ofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Tab 100 mg (film-coated, white to pale yellowish-white, with identification code D721) x 10 x 10's.
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