Rinofla Oz

Rinofla Oz Uses, Dosage, Side Effects, Food Interaction and all others data.

Ofloxacin: It is active after oral administration. It inhibits bacterial DNA replication by blocking DNA topo-isomerases, in particular DNA gyrase. Omidazole: After passive absorption inte bacterium cell, the nitro group of Omidazole is reduced to amine group by ferredoxin type redox system. The formation of redox intermediate intracellular metabolites is believed to be the key component of microorganism killing for Omnidazole. The mechanism of action is similar in protozoa.

Microbiology: Microbiclogical results indicate that the following pathogens may be regarded as sensitive: Staphylococcus aureus (including methicillin resistant staphylococci), Staphylococcus epidermidis, Neisseria species, Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Hafnia, Proteus (indole- negative and indole-positive strains), Haemophilus influenzae, Chlamydiae, Legionella, Gardnerella. Variable sensitivity is shown by Streptococci, Serratia marcescens, Pseudomonas aeruginosa and Mycoplasmas. Anaerobic bacteria (e.g. Fusobacterium species, Bacteroides species, Eubacterium species, Peptococci, Peptostreptococci) are normally resistant. Ofloxacin is not active against Treponema pallidum.

Pharmacokinetics: Ofloxacin: Ofloxacin is almost completely absorbed after oral administration. Maximal blood levels occur 1-3 hours after dosing and the elimination half-life is 4-6 hours. Ofloxacin is primarily excreted unchanged in the urine. In renal insufficiency the dose should be reduced.

Ornidazole: Ornidazole is readily absorbed from the GIT and peak plasma concentrations of about 30 meg/ml are achieved within 2 hours of a single dose of 1.5 g. Food does not affect extent but rate of absorption of Ornidazole. Ornidazole is less than 15% bound to plasma proteins. It is widely distributed in body tissues and fluids, including cerebrospinal fluid. Antibacterial concentrations are achieved in vaginal secretions, amniotic fluid, appendix and intestinal tissues. More than 90% of Ornidazole dose is metabolized in liver. The metabolites are active and have same activity against anaerobic bacteria as the Ornidazole.

The elimination half-life (t1/2) of Ornidazole is 12-14 hours. It is excreted in the urine, mainly as conjugates and metabolites and to a lesser extent in the feces. Biliary excretion may be important in the elimination of Ornidazole and its metabolites.

Trade Name Rinofla Oz
Generic Ofloxacin + Ornidazole
Type Tablet, Syrup
Therapeutic Class
Manufacturer Aarin Labs
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Rinofla Oz
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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FAQ

What is Rinofla Oz used for?

Rinofla Oz is used in the treatment of bacterial & parasitic infections. It is used to treat gastrointestinal infections such as acute diarrhea or dysentery, gynecological infections, lung infections and urinary infections.

What is Rinofla Oz?

Rinofla Oz is a combination of Ofloxacin and Ornidazole belonging to the class antibacterial and anti-amoebic respectively. It is primarily prescribed to treat infectious diarrhoea and dysentery.

How does Rinofla Oz works?

Rinofla Oz is a combination of two antibiotics: Ofloxacin and Ornidazole. 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.

What are the side effects of Rinofla Oz?

Most side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you’re worried about them
Common side effects of Rinofla Oz

  • Nausea
  • Loss of appetite
  • Dizziness
  • Headache

What are the benefits of using Rinofla Oz?

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.

Is Rinofla Oz safe?

Rinofla Oz is safe for most of the patients. In some patients, it may cause common side effects like nausea, vomiting, stomach pain, dizziness, headache, dryness in the mouth, heartburn and other uncommon or rare side effects. Consult your doctor if you experience any persistent problem while taking this medication.

Are there any specific contraindications associated with the use of Rinofla Oz?

The use of Rinofla Oz is considered to be harmful for patients with known allergy to ofloxacin or to ornidazole or any medicine which belongs to the quinolone or nitroimidazole group of antimicrobial agents.

Can I take a higher dose of Rinofla Oz than the recommended ?

No, taking a higher than the recommended dose of Rinofla Oz can increase the risks of side effects. If you are experiencing increased severity of your symptoms which are not relieved by the recommended doses, please consult your doctor for re-evaluation.

Can I take alcohol while taking Rinofla Oz?

You should avoid alcohol since it may add to the dizziness and sleepiness caused by Rinofla Oz. Consult with your doctor, if you are not sure about the effects of the medicine.

What if I don't get better after using Rinofla Oz?

Inform your doctor if you don't feel better after finishing the full course of treatment. Also, inform him if your symptoms are getting worse while using this medicine.

Can I stop taking Rinofla Oz when I feel better?

No, do not stop taking Rinofla Oz and complete the full course of treatment even if you are feeling better. Your symptoms may improve before the infection is completely cured.

What if I miss my dose?

Take Rinofla Oz as soon as you remember it. However, do not take it if it's almost time for your next dose. Also, do not take an extra dose to make up for your missed dose.

Is Rinofla Oz safe during pregnancy?

Rinofla Oz may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

Is Rinofla Oz safe during breastfeeding?

In lactating females, a single dose of Rinofla Oz 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.


*** Taking medicines without doctor's advice can cause long-term problems.
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