Ofloxacin Tablets USP 400 mg
Each film coated Tablet contains:
Ofloxacin USP 400mg
Colour: Titanium Dioxide
A20.1.1 : Broad and medium spectrum antibiotics
Ofloxacin is a quinolone carboxylic acid derivative which has a broad spectrum of antibacterial activity against both Gram-positive and Gram-negative bacteria. Ofloxacin exerts its effect by inhibiting the bacterial DNA gyrase, which is responsible for coiling the genetic material as a prerequisite for bacterial multiplication. The mode of action, range of activities, duration of action and MIC levels have been established mainly by means of in vitro studies using bacterial isolates. Ofloxacin is readily absorbed and excreted mainly unchanged in the urine. The serum elimination half-life is approximately 6 to 8 hours. Following oral administration, ofloxacin peak serum concentrations are reached within one to two hours. The plasma level usually achieved by the recommended dosage regimens (3 to 4 micrograms/mL) is in excess of the average MIC which is 1 to 2 micrograms/mL for susceptible organisms.
Ofloxacin has a low (9.4%) plasma protein binding. Ofloxacin has a bactericidal effect. In vitro tests show that strains in which the sensitivity varies include pneumococci and ureaplasma urealyticum.
SIVOOFLOXACIN tablets are indicated for the treatment of the following bacterial infections if these are due to ofloxacin-sensitive pathogens:
Animal studies have shown that ofloxacin may affect joint development in immature animals. SIVOOFLOXACIN should therefore not be given to patients under 18 years of age.
Clostridium difficile – associated disease:
Diarhoea, particularly if severe and/or persistent, occurring during treatment or in the initial weeks following treatment with ofloxacin or with various other antibiotics, but especially broad spectrum antibiotics, may be symptomatic of Clostridium difficile-associated disease, the most severe form of which is pseudo-membranous colitis.
If a diagnosis of pseudomembranous colitis is suspected, ofloxacin should be stopped immediately and appropriate specified antibiotic therapy should be started without delay (e.g. vancomycin or metronidazole).
DOSAGE AND DIRECTIONS FOR USE
SIVOOFLOXACIN Tablets should be swallowed with a little liquid. They may be taken on an empty stomach or with meals. The dosage should be determined according to the sensitivity of the causative organism and the severity of the infection.
The following dosages are recommended
Uncomplicated Cystitis: 100mg twice daily for 3-7 days.
Pyelonephritis: 200mg twice daily for 5-7 days.
Infections of the lower respiratory tract: 400mg twice daily for 7-10 days. The daily dose may be altered depending on the severity of the infection.
Uncomplicated urethral and cervical gonorrhoea: A single dose Of 400 mg.
Urethritis and cervicitis due to Chlamydia trachomatis: 600mg daily in divided doses for up to 7 days.
For patients with impaired renal function and elderly patients, the dosage of SIVOOFLOXACIN Tablets should be adjusted according to the degree of impairment. With a creatinine clearance of less than 50 mL to 20 mL/minute a normal single dose should be administered every 24 hours, e.g. 200mg once daily.
With a creatinine clearance of less than 20 mL/minute, the normal single dose should be given initially. This dose should then be reduced to half and administered every 24 hours, e.g. 200 mg initially, thereafter 100mg once daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
There have been symptoms such as facial oedema, swollen tongue, glottal oedema, tachycardia, dyspnoea and signs of imminent shock and acute anaphylaxis. In the event of such reactions, SIVOOFLOXACIN Tablets should be discontinued immediately. Medical treatment (therapy for shock) is imperative.
Disturbances of the nervous system, headache, dizziness and restlessness are the most common.
Others include drowsiness, insomnia, weakness, sleep disturbances, nightmares, unsteady gait and tremor (disturbance of muscular co-ordination), numbness and tingling in the limbs (paraesthesia), peripheral neuropathy, visual disturbances such as double vision and abnormal colour vision, disturbances of the senses of taste and smell, hallucinations, convulsions, psychotic reactions, agitation, anxiety, depression and confusion. These reactions have occurred mainly in elderly patients and patients with impaired renal function, but not exclusively. In some cases these reactions have occurred already after the first dose in the event of such adverse reactions, SIVOOFLOXACIN
Tablets should be discontinued immediately and the doctor informed.
There have been reports of pain in joints and muscles.
Other side-effects: There have been cases of changes in the blood picture (leucopenia, eosinophilia, agranulocytosis, thrombocytopenia, anaemia), transient increases in liver enzymes and/or bilirubin and in serum creatinine. Crystalluria as well as interstitial nephritis and hepatitis may also occur.
Steady state theophylline levels may increase when ofloxacin and theophylline are given concurrently. Concomitant administration of ofloxacin with theophylline may prolong the half-life of theophylline, elevate serum theophylline levels and may increase the risk of theophylline-related adverse reactions. Products inhibiting peristalsis are contra-indicated. If antacids containing aluminium, including sucralfate, and magnesium hydroxide, aluminium phosphate or calcium, zinc, iron, are taken at the same time, absorption of ofloxacin may be reduced. Patients undergoing concomitant treatment with coumarin derivatives should be monitored carefully.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See “Side-effects and Special Precautions”. Treatment is symptomatic and supportive.
SIVOOFLOXACIN: A caplet shaped, white color, biconvex, film-coated tablet.
SIVOOFLOXACIN: 10 Tablets Alu Alu blister packed in monocarton, such 10 monocarton packed in one outer carton.
Store in a cool, dry and dark place. Protect from light.
Keep in the pack until required. Do not use later than the date of expiry.
KEEP OUT OF REACH OF CHILDREN
Mfg Lic: G/25/1749
Nafdac Reg. No. B4-4792
Manufactured in India by
GlobeIa Pharma Pvt. Ltd.
357, G.I.D.C., Sachin Surat- 394 230,
Adpharma Pharmaceutical Ind. Ltd.
60, Ajao Road, Surulere,