Osani M

Osani M Uses, Dosage, Side Effects, Food Interaction and all others data.

Osani M is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. Osani M is thought to exert bactericidal effect by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription and repair of bacterial DNA.

Osani M is a quinolone/fluoroquinolone antibiotic. Osani M is bactericidal and its mode of action depends on blocking of bacterial DNA replication by binding itself to an enzyme called DNA gyrase, which allows the untwisting required to replicate one DNA double helix into two. Notably the drug has 100 times higher affinity for bacterial DNA gyrase than for mammalian. Osani M is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria.

Trade Name Osani M
Availability Prescription only
Generic Ofloxacin
Ofloxacin Other Names Ofloxacin, Ofloxacine, Ofloxacino, Ofloxacinum, OFLX
Related Drugs amoxicillin, doxycycline, ciprofloxacin, cephalexin, metronidazole, azithromycin, clindamycin, ceftriaxone, levofloxacin, Augmentin
Type Tablet
Formula C18H20FN3O4
Weight Average: 361.3675
Monoisotopic: 361.143784348
Protein binding

32%

Groups Approved
Therapeutic Class 4-Quinolone preparations, Ophthalmic antibacterial drugs
Manufacturer Sanify Healthcare
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Osani M
Osani M

Uses

Osani M Eye: It is used for the treatment of external ocular infections such as acute & sub-acute conjunctivitis, keratitis, kerato-conjunctivitis, blepharo-conjunctivitis, blepharitis, corneal ulcer and pre-operative prophylaxis in ocular surgery.

Osani M Ear: It is used for the treatment of external ear infections (otitis externa) and certain middle ear infections (otitis media).

Osani M Oral/Injection are used for the treatment of adults with mild to moderate infections caused by susceptible strains.

  • Lower Respiratory Tract: Acute bacterial exacerbation of chronic bronchitis lung abscess, pneumonia.
  • Gastrointestinal Tract: Enteric fever, shigellosis.
  • Multi-drug-resistant Tuberculosis.
  • Skin and skin structures: Uncomplicated skin and skin structure infections.
  • Sexually Transmitted Diseases: Acute, Uncomplicated urethral and cervical gonorrhoea. Nongonococcal urethritis and cervicitis. Mixed infections of the urethra and cervix.
  • Urinary tract: Uncomplicated Urinary Tract Infections, Complicated urinary tract infections.

Osani M 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 Cystitis

How Osani M works

Osani M 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

Osani M dosage

Osani M Eye: Instill 1 drop in the affected eye(s) every 2 to 4 hours for the first two days and then 4 times daily. The length of treatment should not exceed ten days.

Osani M Ear: Instill 1-2 drops in the affected ear(s) twice daily or as needed.

Osani M Intravenous (Adult):

  • Skin and soft tissue infections: 400 mg bid infused over at least 1 hr.
  • Complicated urinary tract infections: 200 mg daily by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
  • Lower respiratory tract infections, Septicaemia: 200 mg bid by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.

Osani M Oral (Adult):

General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses. Osani M tablets should be swallowed with liquid; they should not be taken within two hours of intake of magnesium/aluminium containing antacids or iron preparations since reduction of absorption of ofloxacin can occur.

  • Enteric fever: For adults 200 mg, every 12 hours, for 5 days. For children 15 mg/kg/day in 2 divided doses for 3 days.
  • Shigellosis: 400 mg single dose.
  • Multi-drug-resistant tuberculosis: 400 mg twice daily along with conventional anti-tuberculosis drugs.
  • Lower respiratory tract infection: 400 mg daily, increasing, if necessary, to 400 mg twice daily.
  • Uncomplicated Urinary Tract Infections: A single dose of 200/400 mg.
  • Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
  • Non-gonococcal urethral and cervicitis: 400 mg daily in single or divided doses.
  • Complicated Urinary Tract Infection: 200/400 mg/day for 7 days.

Children: Osani M is usually not indicated for use in children or growing adolescents.

Elderly: No adjustment of dosage is required in the elderly.

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

Osani M Eye: Transient ocular irritation, burning, stinging, redness, itching or photophobia have been reported.

Osani M Ear: Mild irritation or mild discomfort in the ear may occur. Symptoms of an allergic reaction include rash, itching, swelling or trouble breathing.

Osani M tablet or injection is generally well tolerated and clinical side-effects of ofloxacin has been quite low. Among the adverse effects gastrointestinal and central nervous systems' reactions are common. Nausea, rash, vomiting, abdominal pain, diarrhoea and gastrointestinal distress are the gastrointestinal adverse effects. Common central nervous system reactions are headache, dizziness and insomnia.

Toxicity

LD50=5450 mg/kg (orally in mice)

Precaution

Patients being treated with Osani M 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.

Interaction

Antacids containing magnesium, aluminium or calcium may decrease absorption of ofloxacin. Iron or Zinc may decrease oral absorption of ofloxacin.

Food Interaction

  • Limit caffeine intake.
  • Take with or without food. The absorption is unaffected by food.

Osani M multivitamins interaction

[Moderate] ADJUST DOSING INTERVAL: Oral preparations that contain magnesium, aluminum, or calcium may significantly decrease the gastrointestinal absorption of quinolone antibiotics.

Absorption may also be reduced by sucralfate, which contains aluminum, as well as other polyvalent cations such as iron and zinc.

The mechanism is chelation of quinolones by polyvalent cations, forming a complex that is poorly absorbed from the gastrointestinal tract.

The bioavailability of ciprofloxacin has been reported to decrease by as much as 90% when administered with antacids containing aluminum or magnesium hydroxide.

When coadministration cannot be avoided, quinolone antibiotics should be dosed either 2 to 4 hours before or 4 to 6 hours after polyvalent cation-containing products to minimize the potential for interaction.

When coadministered with Suprep Bowel Prep (magnesium

Please consult individual product labeling for specific recommendations.

Elimination Route

Bioavailability of ofloxacin in the tablet formulation is approximately 98%

Half Life

9 hours

Elimination Route

Osani M 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

Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation: It is not known whether Osani M is excreted in human milk. Cautions should be taken when Osani M eye & ear drops is administered during lactation.

Contraindication

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

Osani M 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. Osani M is usually contraindicated in children or growing adolescents and in pregnant or breast feeding women.

Special Warning

Renal Impairment:

  • CrCl <20 and patients on haemodialysis or peritoneal dialysis: 100 mg 24 hrly following usual initial dose.
  • CrCl 20-50: Reduce dose by half 24 hrly following usual initial dose.

Hepatic Impairment:Severe: Reduce dose. Max: 400 mg daily

Acute Overdose

Symptoms: Confusion, dizziness, impairment of consciousness, convulsive seizures, GI reactions (e.g. nausea, mucosal erosions).

Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.

Storage Condition

Store between 15-30° C. Protect from light.

Innovators Monograph

You find simplified version here Osani M

Osani M contains Ofloxacin see full prescribing information from innovator Osani M Monograph, Osani M MSDS, Osani M FDA label

FAQ

What is Osani M used to treat?

Osani M is used to treat certain infections including pneumonia, and infections of the skin, bladder, reproductive organs, and prostate.

How safe is Osani M?

Osani M can cause serious side effects, including tendon problems, side effects on your nerves, serious mood or behavior changes , or low blood sugar.

How does Osani M work?

Osani M works by stopping the growth of bacteria.

What are the common side effects of Osani M?

Common side effects of Osani M are include:

  • nausea
  • diarrhea
  • constipation
  • gas
  • vomiting
  • stomach pain or cramps
  • change in ability to taste food
  • loss of appetite
  • dry mouth
  • excessive tiredness
  • pale skin
  • pain, swelling, or itching of the vagina

Is Osani M safe during pregnancy?

Osani M is avoide during pregnancy because of concerns about cartilage toxicity.

Is Osani M safe during breastfeeding?

Use of Osani M is acceptable in nursing mothers with monitoring of the infant for possible effects on the flora, such as diarrhea or candidiasis. Avoiding breastfeeding for 4 to 6 hours after a dose should decrease the exposure of the infant to Osani M in breastmilk.

Can I drink alcohol with Osani M?

It is generally safe to drink alcohol in moderation while taking Osani M.

Can I drive after taking Osani M?

Taking Osani M may make you feel sleepy, dizzy or could affect your eyesight. Do not drive or use machines until you know how this medicine affects you. Drinking alcohol may make these symptoms worse.

How long does Osani M take to work?

Most people feel better within 48 to 72 hours and have minimal or no symptoms by 7 days

Can Osani M treat stomach pain?

Osani M is also sometimes used to treat other types of infection, including Legionnaires' disease, certain sexually transmitted diseases, infections of the bones and joints and of the stomach and intestines.

How long does Osani M stay in the body?

Administered oral dose of Osani M is excreted unchanged via the kidneys within 48 hours of dosing.

Who should not take Osani M?

Osani M may cause problems with bones, joints, and tissues around joints in children. Osani M should not be given to children younger than 18 years of age.

Can Osani M cause liver damage?

The severity of Osani M induced liver injury ranges from mild and transient serum enzyme elevations to self-limited jaundice to acute liver failure.

Can Osani M cause kidney problems?

Fluoroquinolone antibiotics have rarely been associated with renal failure.

Can Osani M raise blood sugar?

Medications like Osani M can sometimes affect blood glucose levels. Both hyperglycemia and, less frequently, hypoglycemia have been reported.

Can Osani M cause chest pain?

Osani M may cause damage to your aorta, which could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Does Osani M increase heart rate?

For patients with an abnormally slow heartbeat or low potassium levels in the blood, ofloxacin may increase your risk of having a fast, slow, or irregular heartbeat.

Is Osani M well tolerated?

Osani M in well tolerated, and in comparison with other available fluoroquinolones is less likely to cause clinically relevant drug interactions.

Does Osani M cause insomnia?

Brand can causes insomnia also eith other side effects.

Is Osani M an anti inflammatory?

Osani M is also used to treat pelvic inflammatory disease and Chlamydia or gonorrhea.

Does Osani M cause thrombocytopenia?

Fluoroquinolones are known to cause thrombocytopenia, Osani M induced thrombocytopenia cases are reported rarely.

Is it safe to take Osani M at night?

Osani M is best to take the doses at evenly spaced times, day and night. For example, if you are to take one dose a day, try to take it at the same time each day.

What happens if I miss a dose?

Take Osani M as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose of Osani M?

Osani M may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

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