Tarivid Tablet

TARIVID^®
Ofloxacin
film coated tablet

Composition
Each film coated tablet contains:
Ofloxacin ................................... 100 mg or 200 mg or 400 mg

Pharmacology
TARIVID^® (Ofloxacin) is one of the fluorinated quinolones. It is an orally administered broad spectrum antibacterial drug, active against most Gram-negative bacteria, many Gram-positive bacteria and some anaerobes.

The susceptible Gram-negative bacteria include Citrobacter, Enterobacter, Klebsiella, Proteus, Salmonella and Shigella species, Y. enterocolitica, E. coli, H. influenzae, N. gonorrhea, Providencia, Serratia and Pseudomonas species, V. cholerae, L. Pneumophila and C jejuni. Against P. aeruginosa, it is as potent as gentamicin and several times more potent than cefotaxime.

The susceptible Gram-positive.bacteria include S. aureus, S. pneumoniae, S. faecalis and L. monocytogenes. Some anaerobic organisms, including B. melaninogenicus, B. fragilis and C. welchii, are moderately susceptible, Ofloxacin is also active against C. trachomatis and M. pneumoniae.

Like other quinolones, ofloxacin is bactericidal through inhibition of the A sub-units of the enzyme DNA gyrase which controls supercoiling of DNA in bacteria. The antibacterial activity of ofloxacin is not influenced by the bacterial resistance to non-quinolone anti bacterial drugs, but it is markedly reduced in acid urine.

Oral administration of a single 300 mg dose of ofloxacin produces a peak serum concentration of about 3 μg/ml within 2 hours. A dosage of 300 mg twice daily for up to 14 days produces peak serum levels ranging from 3 to 6 μg/ml on the last day. Food only delays absorption, while antacid may markedly reduce absorption. Compared to norfloxacin and ciprofloxacin at the same dose, ofloxacin is more rapidly absorbed and produces a higher serum level and 4 times higher AUC (AUC represents the amount of drug absorbed).

Ofloxacin is widely distributed to most tissues and body fluids. The volume of distribution is more than 1 l/kg, and the tissue concentrations achieved are at least as high as the serum level for most tissues.

After single doses of 100 to 600 mg, 70% to 98% of the drug was excreted unchanged in the urine within 48 hours, and the urinary concentration remains above the MIC90 for most bacterial species at 48 hours after administration. The elimination half-life after doses of 200 mg or more is about 6 hours or more (up to 7.5 hours). In patients with renal impairment, peak serum concentrations are delayed, the elimination half-life and AUC are substantially increased depending on the degree of renal impairment, and thus dosage adjustments maybe necessary.

Indications
Treatment of serious infections caused by ofloxacin susceptible organisms, such as:

1. Upper and lower urinary tract infections.
2. Gonococcal and non-gonococcal urethritis and cervicitis.
3. Lower respiratory tract infections, except those caused by streptococcus.
4. Skin and soft tissue infections.
5. Gynecological infections.

Contraindicatlons

1. Hypersensitivity to ofloxacin and other quinolone derivatives.
2. Pregnant and nursing women.
3. Children and adolescents during the growth phase.

Warning and precautions

1. TARIVID^® is not recommended for the treatment of streptococcal infections and other infections caused by organisms susceptible to other long established antibiotics.
2. Use with caution in patients with reduced renal function; reduced the dose according to the severity of renal dysfunction. Elderly patients may also require a dosage reduction since they may have reduced creatinine clearance.
3. If shock or shock-like symptoms occur, discontinue the drug and give appropriate treatments.
4. If hypersensitivity reactions develop during therapy, discontinue the drug.
5. Gastrointestinal absorption of ofloxacin is markedly reduced by concurrent administration of antacids containing aluminium or magnesium hydroxide. Therefore, TARIVID^® should not be taken at the same time, but 1 to 2 hours before or after the antacid.
6. Unlike ciprofloxacin, pefloxacin and enoxacin, ofloxacin has no influence on the plasma concentration of theophylline.

Adverse reactions
The incidence of ofloxacin-related adverse reactions was 3.3% among nearly 16.000 patients in clinical trials (ranged from 2.5 to 8.5% in various studies).
The most frequent side effects were gastrointestinal symptoms (2.64%), mainly nausea, vomiting, epigastric discomfort, abdominal pain, diarrhea and anorexia. These were followed by CNS effects (0.89%; headache, dizziness and sleep disturbances) and dermatological or hypersensitivity reactions (0.53%, skin eruption, pruritus, rash eczema and itching). The incidence or severity of these various side effects did not appear to be dose related, and serious reactions were rare.

Minor changes in mean laboratory values were not considered clinically significant and were usually attributable to the diseases process, but some cases of eosinophilia were considered possibly drug related. Shock and shock-like symptoms (discomfort, perspiration, dyspnea and hypotension) may occasionally occur.

Dosage and administration
The recommended oral dosage of TARIVID^® is as follows (before or after meals);

1. Urinary tract infections: 100 - 400 mg daily in 1 to 2 divided doses for 1 - 10 days. Severe or complicated infections: up to 600 mg daily and/ or for up to 20 days.
2. Lower respiratory tract infections: 200 - 600 mg daily in 1 to 3 divided doses for 3 - 10 days. Severe or complicated infections; up to 800 mg daily and/or for up to 20 days. 
3. Skin and soft tissue infections, Gynecological infections 400 mg daily for 7 days. 
4. Uncomplicated gonococcal urethritis: a single dose of 100 - 400 mg.
5. Non-gonococcal urethritis: 400 mg daily for 9 days.

Presentation
Tablet 100 mg: Box of 3 strips x 10 tablets Reg. No. DKL8811608317A1
Tablet 200 mg: Box of 3 strips x 10 tablets Reg. No. DKL8811608317B1
Tablet 400 mg: Box of 3 strips x 10 tablets Reg. No. DKL9311608317C1

Store at room temperature (below 30°C)

ON MEDICAL PRESCRIPTION ONLY

Manufactured by:
PT. KALBE FARMA Tbk.
Bekasi - Indonesia

Under licence of:
Daiichi Pharmaceutical Co., Ltd.
14 - 10, Nihonbashi, 3-Chome,
Chuo-Ku, Tokyo 103 JAPAN

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