Rinofla Oz

Uses

Rinofla Oz is a combination medicine which can be used to treat infections caused by bacteria and parasites. It works by killing and stopping the growth of the bacteria and parasites causing the infection. This medicine usually makes you feel better quite quickly. However, you should continue taking it as long as it is prescribed even if you feel better, to make sure that all bacteria and parasites are killed and do not become resistant.

Ofloxacin works by preventing the bacterial cells from dividing and repairing, thereby killing the bacteria. Ornidazole kills parasites and anaerobic bacteria that cause infections by damaging their DNA. Together, they treat your infection effectively.

Rinofla Oz is also used to associated treatment for these conditions: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB), Acute Otitis Media, Bacterial Infections, Cervicitis, Community Acquired Pneumonia (CAP), Complicated Urinary Tract Infection, Conjunctivitis, Epididymitis, Hansen's Disease, Nongonococcal urethritis, Otitis Externa, Prostatitis, Skin and Subcutaneous Tissue Bacterial Infections, Spontaneous Bacterial Peritonitis (SBP), Traveler's Diarrhea, Ulcerative keratitis, Acute Pelvic inflammatory disease, Acute, uncomplicated Gonorrhea, Chronic suppurative Otitis media, Uncomplicated CystitisAmebiasis, Anaerobic Bacterial Infection, Chlamydial Infections, Gastrointestinal Infections caused by entamoeba histolytica, Giardiasis, Mixed Vaginal Infections, Surgical Site Infections, Trichomonal Vaginitis, Trichomoniasis

How Rinofla Oz works

Ofloxacin acts on DNA gyrase and toposiomerase IV, enzymes which, like human topoisomerase, prevents the excessive supercoiling of DNA during replication or transcription. By inhibiting their function, the drug thereby inhibits normal cell division.

Dosage

Rinofla Oz dosage

The duration of treatment depends upon the type & severity of the infection. Tablet & Infusion (Adults & children over 12 years of age). Tablet: One tablet of Rinofla Oz is recommended as twice daily. Infusion: 100 ml twice daily. Oral suspension: 5ml twice daily or as directed by the physician. Shake well before use.

May be taken with or without food. Avoid antacids or supplements containing Fe or Zn within 2 hr before or after ofloxacin. Ensure adequate hydration.

Side Effects

This medicine causes side effects such as:

• Abdominal Pain
• White Patches In The Mouth Or On The Tongue
• Joint Pain
• Black Or Tarry Stools
• Fever With Chills
• Chest Tightness
• Running Nose
• Sneezing
• Memory Impairment
• Nervousness
• Agitation
• Disorientation

Toxicity

LD₅₀=5450 mg/kg (orally in mice)

Precaution

Patients being treated with Ofloxacin should not expose themselves unnecessarily to strong sunlight and should avoid UV rays. Caution is recommended if the drug is to be used in psychotic patients or in-patients with a history of psychiatric disease.

Prolonged use of eye drops & ear drops may result in overgrowth of non-susceptible organisms and secondary infection respectively.

In patient with ataxia, vertigo, and mental confusion, Ornidazole should be prescribed with caution. During prolonged treatment with Ornidazole, blood dyscrasia namely mild leukopenia have been reported rarely. In case leukopenia occurs, the decision to discontinue the therapy should depend upon the gravity of infection.

Interaction

Ofloxacin: Co-administered magnesium/aluminium antacids, sucralfate or iron preparations can feduce absorption. Therefore, Ofloxacin should be taken 2 hours before such preparations. Prolongation of bleeding time has been reported during concomitant administration of Ofloxacin 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, e.g. Theophylline, NSAIDs. However Ofloxacin is not thought to cause a pharmacokinetic interaction with theophylline, unlike some other fluorcquinolones. Ofloxacin may cause a slight increase in serum concentrations of glibenclamide administered concurrently; patients treated with this combination should be closely monitored. With high doses of quinolones, impairment of excretion and an increase in serum levels may occur when co-administered with other drugs that undergo renal tubular secretion (e.g. probenecid, cimetidine, frusemide and methotrexate).

Determination of opiates or porphyrins in urine may give false-positive results during treatment with Ofloxacin. Ornidazole: Alcohol intolerance: Unlike other nitro-imidazoles, Ornidazole does not inhibit enzyme aldehyde dehydrogenase. No disulfiram like reaction has been Teported on consumption of alcohol. However, as is the case with all imidazoles, this drug should be avoided in concomittance with alcohol usage. No clinically relevant interactions were seen with food.

Elimination Route

Bioavailability of ofloxacin in the tablet formulation is approximately 98%

Half Life

9 hours

Elimination Route

Ofloxacin is mainly eliminated by renal excretion, where between 65% and 80% of an administered oral dose of ofloxacin is excreted unchanged via urine within 48 hours of dosing. About 4-8% of an ofloxacin dose is excreted in the feces and the drug is minimally subject to biliary excretion.

Pregnancy & Breastfeeding use

Pregnancy: No controlled studies of effect of the drug on pregnant women are available, Oflodazole should be prescribed to pregnant women only if the potential benefit to the mother outweighs potential risk to the foetus.

Lactation: In lactating females, a single oral 200 mg dose of Ofloxacin resulted in concentrations of Ofloxacin in milk that were similar to those found in plasma. Because of the potential for serious adverse reactions from Oflodazole in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Contraindication

It is contraindicated in patients who are hypersensitive to Ofloxacin or any other component of Ofloxacin (Eye/Ear Drops).

Ofloxacin tablet injection should not be used in-patients with known hypersensitivity to 4-fluoroquinolone antibacterials. It is contraindicated in-patients with a history of epilepsy or with a lowered seizure threshold. Ofloxacin is usually contraindicated in children or growing adolescents and in pregnant or breast feeding women.

Previous hypersensitivity to Ornidazole and to other nitroimidazoles. Ornidazole is contraindicated in central nervous system disorders, particularly in epilepsy or in peripheral neuropathy.

Special Warning

Administration of antibiotics, especially of prolonged use, may lead to proliferation of resistant micro-organisms. The patient's condition must therefore be checked at regular intervals. If a secondary infection occurs, appropriate measures Must be taken.

Ofloxacin: Patients being treated with Ofloxacin should not expose themselves unnecessarily to strong sunlight and should avoid UV rays (sun lamps, solaria).

Caution is recommended if the drug is to be used in psychotic patients or in patients with a history of psychiatric disease.

Ornidazole: Regular laboratory tests and clinical control are indicated in case of use of high Ornidazole doses or if duration of therapy exceeds 10 days.

Blood disorders: Leukocyte counts should be checked before and after start of therapy (especially in repeat therapy), in patients with history of blood discrders.

CNS: Severe diseases of central and peripheral nervous system may get aggravated on Ornidazole therapy. Treatment should be discontinued in case of onset of peripheral neuropathy, ataxia, vertigo or confusion.

Candidiasis: Ornidazole therapy may aggravate existing candidiasis. Necessary precautions should be taken.

Acute Overdose

Ofloxacin: The most important signs to be expected following acute over dosage are CNS symptoms such as confusion, dizziness, impairment of consciousness and convulsive seizures as well as gastrointestinal reactions such as nausea and mucosal erosions.

In the case of overdose steps to remove any unabsorbed Ofloxacin e.g. gastric lavage, administration of adsorbents and sodium sulphate, if possible during the first 30 minutes, are recommended; antacids are recommended for protection of the gastric mucosa.

Elimination of Ofloxacin may be increased by forced diuresis. In case of over dosage, the patient should be observed carefully and symptomatic treatment should be given. The stomach should be emptied by gastric lavage or vomiting. All the supportive measures and hydration should be maintained. In case of convulsions, intravenous diazepam is recommended.

Ornidazole: In cases of over dosage of Ornidazole the symptoms mentioned under adverse reaction occur in more severe form. No specific antidote is known. The administration of diazepam is recommended if cramps occur.

Storage Condition

Do not store above 30°C. Protect from sunlight and moisture. Keep out of reach of children. For oral use.

Innovators Monograph

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