Otostar
Otostar Uses, Dosage, Side Effects, Food Interaction and all others data.
Benzocaine, an ester local anaesthetic, blocks the initiation and conduction of nerve impulses by decreasing the neuronal membrane’s permeability to Na ions, which results in inhibition of depolarisation with resultant blockade of conduction.
Benzocaine is indicated for use as a topical anesthetic. It has a duration of action of approximately 10 minutes and a wide therapeutic window. Patients should be counselled regarding the risks of methemoglobinemia.
Chlorobutanol, or chlorbutol, is an alcohol-based preservative with no surfactant activity . It also elicits sedative-hypnotic and weak local anesthetic actions in addition to antibacterial and antifungal properties. Similar in nature to chloral hydrate, it is formed by the simple nucleophilic addition of chloroform and acetone.
As a long-term stabilizer of multi-ingredient preparations, chlorobutanol is normally used at a concentration of 0.5%. At this concentration, it also conserves its antimicrobial activity.
Due to the long terminal half-life of 37 days, the use of chlorobutanol as a sedative is limited because of the considerable accumulation which will occur following multiple dosing . Chlorobutanol is a common detergent preservative in eye drops and other ophthalmic therapeutic formulations .
Dichlorobenzene refers to any of, or a mixture of, three isomers consisting of benzene in which two of the hydrogen atoms are replaced by chlorine atoms: ortho-, meta-, and paradichlorobenzene. It is a constituent of the ear-wax removal product Cerumol.
Trade Name | Otostar |
Generic | Benzocaine + Chlorobutanol + Dichlorobenzene + Turpentine Oil |
Weight | 2.5% |
Type | Ear Drops |
Therapeutic Class | |
Manufacturer | Mankind Pharmaceuticals Ltd |
Available Country | India |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
For the temporary relief of pain due to minor injury or irritation of the mouth and gums like Toothache, Sore gums, Canker sores, Braces, Minor dental procedures, Dentures
No approved therapeutic indications on its own.
Otostar 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 anesthesiaAcute Rhinosinusitis, Acute Sinusitis, Infective otitis externa, Pollen Allergy, Rhinitis, Acute RhinitisCerumen impaction
How Otostar 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.
As a detergent, chlorobutanol disrupts the lipid structure of the cell membrane and increases the cell permeability, leading to cell lysis . It induces conjunctival and corneal cell toxicity via causing cell retraction and cessation of normal cytokines, cell movement, and mitotic activity . It disrupts the barrier and transport properties of the corneal epithelium as well as inhibits the utilization of oxygen by the cornea . Chlorobutanol also inhibits oxygen use by the cornea, which increases susceptibility to infection .
Dosage
Otostar dosage
Apply to the affected area up to 4 times daily or as directed by a doctor/dentist. Children under 12 years of age should be supervised during the use of this product. Children under 2 years of age should be consulted to a doctor/dentist prior to the use of this product. An easy application might be done by fixing applicator on the tube’s nozzle. After application, supplied cap should be fixed on top of the applicator.
Side Effects
Side effects are less common. The side effects include allergies, swelling in the mouth or throatetc.
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.
Oral LD50 of anhydrous chlorobutanol in rat is 510 mg/kg . Chlorobutanol was shown to induce conjunctival and corneal cell toxicity in vitro
Precaution
Patient with asthma, bronchitis, emphysema, heart disease; smokers. Children, Pregnancy and lactation.
Interaction
May antagonise the therapeutic effect of sulfonamides. Anticholinesterases may inhibit the metabolism benzocaine.
Volume of Distribution
The volume of distribution was approximately 233 ± 141 L in healthy individuals receiving oral chlorobutanol .
Elimination Route
Following oral administration in healthy subjects, the plasma concentration fell by 50% in 24 hours post-administration .
Half Life
Following oral administration, the terminal elimination half life in healthy subjects was 10.3 ± 1.3 days .
Clearance
In healthy subjects, the clearance was approximately 11.6 ± 1.0 mL/min following oral administration .
Elimination Route
Under physiological conditions, chlorobutanol is unstable. The mean urinary recovery accounts for 9.6% of the dose orally administered .
Pregnancy & Breastfeeding use
Pregnancy Category C. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
Contraindication
Epiglottis (oral spray), methaemoglobinaemia.
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.
Storage Condition
Store between 15-30° C.
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