Oxy Otic

Uses

Renamycin is used for bacterial eye infections, inflammation of the cornea

Oxy Otic is also used to associated treatment for these conditions: Acute Sore Throat Pain, Dental Pain, Gangrene Stomatitis, Gingivitis, Hemorrhoids, Laryngitis, Pharyngitis, Premature Ejaculation, Secondary Bacterial Infection caused by Tonsillectomy, Secondary Bacterial Infection caused by Tooth Extractions, Skin Irritation, Sore Throat, Stomatitis, Sunburn, Teething pain, Tonsillitis, Tooth Pain, Vomiting, Pruritic dermatosis, Ulceration of the mouth, Buccopharyngeal anesthesiaLocalized Infection, Skin Infections, Superficial ocular infections, Susceptible bacteriaAcute Otitis Media, Bacteremia caused by Enterobacter aerogenes, Bacterial Conjunctivitis, Bacterial Infections, Chronic Otitis Media, Escherichia urinary tract infection, Klebsiella bacteraemia, Meningitis caused by Haemophilus influenzae, Meningitis, Bacterial, Ocular Inflammation, Otitis Externa, Otorrhoea, Superficial ocular infections of the conjunctiva caused by susceptible bacteria, Superficial ocular infections of the cornea caused by susceptible bacteria, Urinary Tract Infection, Ocular bacterial infections

How Oxy Otic works

Benzocaine diffuses into nerve cells where it binds to sodium channels, preventing the channels from opening, and blocking the influx of sodium ions. Nerve cells unable to allow sodium into cells cannot depolarize and conduct nerve impulses.

Oxytetracycline inhibits cell growth by inhibiting translation. It binds to the 30S ribosomal subunit and prevents the amino-acyl tRNA from binding to the A site of the ribosome. The binding is reversible in nature. Oxytetracycline is lipophilic and can easily pass through the cell membrane or passively diffuses through porin channels in the bacterial membrane.

The alpha and gamma diaminobutyric acid of a positively charged polymyxin B forms an electrostatic interaction with the phosphate groups of a negatively charged lipid A on the outer membrane of a Gram negative bacterium. Calcium and Magnesium ions are displaced from phosphates of the membrane lipids, destabalising the lipopolysaccharide (LPS), increasing membrane permeability, causing cytoplasmic leaking, and killing the cell.

Polymyxin B can also bind and neutralize LPS released during bacterial lysis, preventing reactions to endotoxin.

A third activity of polymyxin B is the inhibition of type II NADH-quinone oxidoreductases in the bacterial inner membrane, which are essential for respiration.

Polymyxin is active against common Gram negative bacteria but not Gram negative cocci, Gram positive bacteria, or anaerobic bacteria.

Dosage

Oxy Otic dosage

1 to 2 drops in affected eye 2 to 4 times daily.

Should be taken on an empty stomach. Take 1 hr before or 2 hr after meals.

Side Effects

Local sensitivity, Lid itching, swelling, conjunctival erythema.

Toxicity

Patients experiencing an overdose may present with local anesthetic systemic toxicity syndrome, decreased cardiovascular function, decreased central nervous system function, cardiac arrest, bradycardia, hypotension, cardiac arrhythmias, syncope, and seizures. Patients should be treated with symptomatic and supportive measures which include airway maintenance, controlling seizures, and hemodynamic stabilization.

Adverse effects may include stomach or bowel upsets and rarely allergic reactions. Very rarely severe headache and vision problems may be signs of dangerous intracranial hypertenion.

Nephrotoxicity can occur in patients as polymyxin B is thought to accumulate in renal cells after renal tubular reabsorption. This accumulation can lead to apoptosis of renal cells and decrease in renal function. In recent studies, acute kidney injury (AKI) has been seen in 31.3% to 39.4% of patients receiving polymyxin B.

Overdose cases can cause neuromuscular block leading to apnea, muscular weakness, vertigo, transient facial parasthesia, slurred speed, vasomotor instability, visual disturbance, confusion, psychosis, and respiratory arrest. Renal failure has also been seen through decreased urine output, and increased serum concentrations of blood urea nitrogen.

Overdose of polymyxin B is treated by stopping the drug and beginning symptomatic treatment. Intravenous administration of mannitol may enhance renal clearance, and hemodialysis may manage renal complications.

Safety of polymyxin B has not been established in pregnancy, breast feeding, pediatrics, and geriatrics. Polymyxin B should no be used in pregnancy unless the benefit outweighs the risk. Nursing mothers should either stop nursing or stop polymyxin B treatment depending on the risks to both the mother and child. Pediatric patients should be frequently monitored for renal function and no dosing information is available in children under 2 years of age. Geriatric patients should have renal function assessed before and regularly during therapy.

Precaution

Prolonged use, perforated ear drum.

Interaction

There are no known drug interactions and none well documented.

Volume of Distribution

1 compartment models estimate the volume of distribution to be 34.3L to 47.2L. However, the general consensus is that the volume of distribution is yet to be determined.

Elimination Route

Readily absorbed following oral administration.

Administration by the oral route does not lead to absorption.

Half Life

In one study the half life was 9 to 11.5 hours. However, a Canadian monograph states the half life to be 6 hours, and 48-72 hours in patients with renal insufficiency.

Clearance

1 compartment models estimate clearance to be 2.37L/h to 2.5L/h.

Elimination Route

Polymyxin B is proposed to be primarily eliminated through renal tubular reabsorption and non-renal pathways. Urine collection in humans and animals show 1. However, a Canadian product monograph states the drug is primarily eliminated through the kidneys and that 60% of polymyxin B is recovered in the urine. This discrepancy can be explained by the 12 to 24 hour lag time between administration and significant elimination of polymyxin B. Non-renal elimination is not well understood but all 4 components of polymyxin B have been detected in bile.

Pregnancy & Breastfeeding use

Pregnancy Category: Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

Contraindication

Known hypersensitivity to any of the components.

Special Warning

Renal Impairment-

• Intramuscular: Dosage may need to be reduced.
• Oral: Dosage may need to be reduced.

Acute Overdose

Symptom: Methaemoglobinaemia, manifested by cyanotic (greyish) skin discolouration, unusual breathing or breathlessness.

Management: Symptomatic and supportive treatment. IV methylene blue 1% may be administered.

Polymyxin-induced toxicity associated with overdose has been reported. Overdose of Polymyxin can result in neuromuscular blockade, which can lead to apnea, muscular weakness, vertigo, transient facial paresthesia, slurred speech, vasomotor instability, visual disturbance, confusion, psychosis and possible respiratory arrest. Overdose can also cause renal failure characterized by decreased urine output and increased serum concentrations of BUN and creatinine. There is no specific antidote for Polymyxin B Sulfate overdose. In case of Polymyxin B Sulfate overdose, the drug should be stopped and symptomatic treatment instituted. Quick diuresis by IV administered mannitol may help to enhance renal clearance of the drug and thus to reduce serum drug levels. Hemodialysis or peritoneal dialysis may help in order to manage renal complications.

Storage Condition

Store between 15-30° C.

Before reconstitution, do not store above 30°C; and keep away from light and out of the reach of children. After reconstitution or dilution, unused portion must be stored at 2° to 8°C and should be discarded after 72 hours if not used.

Innovators Monograph

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