Ofloxa-Vision 3mg/ml Dosage

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Dosage of Ofloxa-Vision 3mg/ml in details

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The usual dose of Ofloxa-Vision 3mg/ml® (Ofloxa-Vision 3mg/ml tablets) Tablets is 200 mg to 400 mg orally every 12 h as described in the following dosing chart. These recommendations apply to patients with normal renal function (i.e., creatinine clearance > 50 mL/min). For patients with altered renal function (i.e., creatinine clearance < 50 mL/min), see the Patients with Impaired Renal Function Subsection.

Infection† Unit Dose Frequency Duration Daily Dose
Acute Bacterial Exacerbation of Chronic Bronchitis 400 mg q12h 10 days 800 mg
Comm. Acquired Pneumonia 400 mg q12h 10 days 800 mg
Uncomplicated Skin and Skin Structure Infections 400 mg q12h 10 days 800 mg
Acute, Uncomplicated Urethral and Cervical Gonorrhea 400 mg single dose 1 day 400 mg
Nongonococcal Cervicitis/Urethritis due to C. trachomatis 300 mg q12h 7 days 600 mg
Mixed Infection of the urethra and cervix due to C. trachomatis and N. gonorrhoeae 300 mg q12h 7 days 600 mg
Acute Pelvic Inflammatory Disease 400 mg q12h 10-14 days 800 mg
Uncomplicated Cystitis due to E. coli or K. pneumoniae 200 mg q12h 3 days 400 mg
Uncomplicated Cystitis due to other approved pathogens 200 mg q12h 7 days 400 mg
Complicated UTI's 200 mg q12h 10 days 400 mg
Prostatitis due to E.Coli 300 mg q12h 6 weeks 600 mg
† DUE TO THE DESIGNATED PATHOGENS

Antacids containing calcium, magnesium, or aluminum; sucralfate; divalent or trivalent cations such as iron; or multivitamins containing zinc; or Videx® (didanosine) should not be taken within the two-hour period before or within the two-hour period after taking Ofloxa-Vision 3mg/ml.

Patients with Impaired Renal Function: Dosage should be adjusted for patients with a creatinine clearance < 50 mL/min. After a normal initial dose, dosage should be adjusted as follows:

Creatinine Clearance Maintenance Dose Frequency
20-50 mL/min the usual recommended unit dose q24h
< 20 mL/min ½ the usual recommended unit dose q24h

When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance.

Men: Creatinine Clearance (mL/min) = (140 – age) x (actual body wt in kg)
72 x (serum creatinine)

Women: 0.85 x the value calculated for men

The serum creatinine should represent a steady-state of renal function.

Patients with Cirrhosis:

The excretion of Ofloxa-Vision 3mg/ml may be reduced in patients with severe liver function disorders (e.g., cirrhosis with or without ascites). A maximum dose of 400 mg of Ofloxa-Vision 3mg/ml per day should therefore not be exceeded.

How supplied

Ofloxa-Vision 3mg/ml® (Ofloxa-Vision 3mg/ml tablets) Tablets are supplied as 200 mg light yellow, 300 mg white, and 400 mg pale gold oval, straight-edged, coated tablets. Each tablet is distinguished by an imprint of “Ofloxa-Vision 3mg/ml (Ofloxa-Vision 3mg/ml) ” and the appropriate strength. Ofloxa-Vision 3mg/ml® (Ofloxa-Vision 3mg/ml) Tablets are packaged in bottles in the following configurations:

200 mg tablets - bottles of 50 (NDC 0062 - 1540-02)

300 mg tablets - bottles of 50 (NDC 0062 - 1541-02)

400 mg tablets - bottles of 100 (NDC 0062 - 1542-01)

Ofloxa-Vision 3mg/ml® (Ofloxa-Vision 3mg/ml) Tablets should be stored in well-closed containers. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Keep out of the reach of children.

Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, NJ USA 08869. Issued January 2011

What other drugs will affect Ofloxa-Vision 3mg/ml?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Ofloxa-Vision 3mg/ml, especially:

This list is not complete. Other drugs may interact with Ofloxa-Vision 3mg/ml, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Ofloxa-Vision 3mg/ml interactions

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Drugs Known to Prolong QT Interval: Ofloxa-Vision 3mg/ml, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (eg, class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).

Prolongation of bleeding time has been reported during concomitant administration of Ofloxa-Vision 3mg/ml and anticoagulants.

There may be a further lowering of the cerebral seizure threshold when quinolones are given concurrently with other drugs which lower the seizure threshold eg, theophylline. However, Ofloxa-Vision 3mg/ml is not thought to cause a pharmacokinetic interaction with theophylline, unlike some other fluoroquinolones.

Further lowering of the cerebral seizure threshold may also occur with certain nonsteroidal anti-inflammatory drugs.

In case of convulsive seizures, treatment with Ofloxa-Vision 3mg/ml should be discontinued.

Ofloxa-Vision 3mg/ml may cause a slight increase in serum concentrations of glibenclamide administered concurrently; patients treated with this combination should be closely monitored.

Vitamin K Antagonists: Coagulation tests should be monitored in patients treated with vitamin K antagonists because of a possible increase in the effect of coumarin derivatives.

Cimetidine: Cimetidine has demonstrated interference with the elimination of some quinolones. This interference has resulted in significant increases in t½ and AUC of some quinolones. The potential for interaction between Ofloxa-Vision 3mg/ml and cimetidine has not been reported.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): The concomitant administration of a NSAID with a quinolone, including Ofloxa-Vision 3mg/ml, may increasethe risk of CNS stimulation and convulsive seizures.

Probenecid: The concomitant use of probenecid with certain other quinolones has been reported to affect renal tubular secretion. The effect of probenecid on the elimination of Ofloxa-Vision 3mg/ml has not been reported.

Theophylline: Steady-state theophylline levels may increase when Ofloxa-Vision 3mg/ml and theophylline are administered concurrently. As with other quinolones, concomitant administration of Ofloxa-Vision 3mg/ml may prolong the t½ of theophylline, elevate serum theophylline levels and increase the risk of theophylline-related adverse reactions.

Theophylline levels should be closely monitored and theophylline dosage adjustments made, if appropriate, when Ofloxa-Vision 3mg/ml is co-administered. Adverse reactions (including seizures) may occur with or without an elevation in the serum theophylline level.

Warfarin: Some quinolones have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives. Therefore, if a quinolone antimicrobial is administered concomitantly with warfarin or its derivatives, the prothrombin time or other suitable coagulation test should be closely monitored.

Antidiabetic Agents (eg, Insulin, Glyburide/Glibenclamide): Since disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concurrently with quinolones and an antidiabetic agent, careful monitoring of blood glucose is recommended when these agents are used concomitantly.

Cyclosporine: Elevated serum levels of cyclosporine have been reported with concomitant use of cyclosporine with some other quinolones. The potential for interaction between Ofloxa-Vision 3mg/ml and cyclosporine has not been reported.

Drugs Metabolized by Cytochrome P450 (CYP450) Enzymes: Most quinolone antimicrobial drugs inhibit CYP450 enzyme activity. This may result in a prolonged t½ for some drugs that are also metabolized by this system (eg, cyclosporine, theophylline/methylxanthines, warfarin) when co-administered with quinolones. The extent of this inhibition varies among different quinolones.

Interactions with Laboratory Tests: Some quinolones, including Ofloxa-Vision 3mg/ml, may produce false-positive urine screening results for opiates using commercially available immunoassay kits. Confirmation of positive opiate screens by more specific methods may be necessary.


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References

  1. DailyMed. "OFLOXACIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "(+/-)-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: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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