Trotear Plus
Trotear Plus Uses, Dosage, Side Effects, Food Interaction and all others data.
Boric acid, also known as hydrogen borate, is a weak monobasic Lewis acid of boron with the chemical formula H3BO3. Boric acid is typically utilized in industrial processing and manufacturing, but is also used as an additive in pharmaceutical products, cosmetics, lotions, soaps, mouthwash, toothpaste, astringents, and eyewashes . It is known to exhibit some antibacterial activity against infections such as bacterial vaginosis and candidiasis .
Boric acid exhibits minimal bacteriostatic and antifungal activities . Boric acid is likely to mediate antifungal actions at high concentrations over prolonged exposures .
The higher strength of Carboxymethylcellulose Sodium USP-NF provides long-lasting relief from dryness by forming a soothing gel after administration of the drops on to the eyes.
In a randomized clinical study of patients with mild or moderate forms of eye dryness, ophthalmic treatment with sodium carboxymethylcellulose resulted in a diminished frequency of symptoms compared to the placebo group . Carboxymethylcellulose interacts with human corneal epithelial cells to facilitate corneal epithelial wound healing and attenuate eye irritation in a dose-dependent manner . It exhibits protective actions on the ocular surface in various applications; it mediates cytoprotective effects on the ocular surface when applied prior to contact lenses and reduces the incidence of epithelial defects during LASIK .
Glycerin is a hyperosmotic laxative, given rectally, which usually produces a bowel movement within 15 minutes to 1 hour. Hyperosmotic laxatives encourage bowel movements by drawing water into the bowel from surrounding tissues. This produces a softer stool mass and increased bowel action. These products are used for fast, predictable relief of occasional constipation.
Glycerin is commonly classified as an osmotic laxative but may act additionally or alternatively through its local irritant effects; it may also have lubricating and fecal softening actions. Glycerin suppositories usually work within 15 to 30 minutes.
| Trade Name | Trotear Plus |
| Generic | Boric Acid + Carboxymethylcellulose + Glycerin + N Acetylcarnosine |
| Type | Eye Drops |
| Therapeutic Class | |
| Manufacturer | Qualitron Bio Medica |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
No FDA- or EMA-approved therapeutic indications on its own.
Carboxymethylcellulose Sodium is used as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.
For the relief of occasional constipation
Trotear Plus is also used to associated treatment for these conditions: Acne, Asthenopia, Ocular Irritation, Skin Mycoses, Eye discomfort, Skin disinfection, Irrigation of the ocular surface therapyDry Eyes, Ocular IrritationCold Sore, Constipation, Dry Mouth, Dry Skin, Dry throat, Edema of the cerebrum, Hypertension Intracranial, Occasional Constipation, Ocular Discomfort, Ocular Hypertension, Ocular Irritation, Skin Infections, Sore Throat, Mouth soreness, Ocular burning, Bowel preparation therapy, Topical Antisepsis, Skin protection
How Trotear Plus works
Information regarding the mechanism of action of boric acid in mediating its antibacterial or antifungal actions is limited. Boric acid inhibits biofilm formation and hyphal transformation of Candida albicans, which are critical virulence factors . In addition, arrest of fungal growth was observed with the treatment of boric acid .
Carboxymethylcellulose binds to the surface of corneal epithelial cells via its glucopyranose subunits binding to glucose receptors GLUT-1 . The residence time of carboxymethylcellulose bound to corneal cells is approximately 2 hours as indicated by a short-term binding assay . Binding of carboxymethylcellulose to the matrix proteins stimulated corneal epithelial cell attachment, migration, and re-epithelialization of corneal wounds .
When administered rectally, glycerin exerts a hygroscopic and/or local irritant action, drawing water from the tissues into the feces and reflexively stimulating evacuation. Glycerin decreases intraocular pressure by creating an osmotic gradient between the blood and intraocular fluid, causing fluid to move out of the aqueous and vitreous humors into the bloodstream.
Dosage
Trotear Plus dosage
Install 1 or 2 drops in the affected eye(s) as needed or as directed by the physician.
Children under 2 years: Consult a physician.
Children (2 to 6 years): only 1 Glycerin 1.15 suppository per 24 hours or as directed by a physician.
Adults and Children (From 6 years): only 1 Glycerin 2.30 suppository per 24 hours or as directed by a physician
Insert suppository well up into rectum. Suppository need to melt completely to produce laxative action.
Side Effects
Visual disturbances, ocular discharge and eye pruritus are common adverse drug reactions were reported with Carboxymethylcellulose Sodium
Glycerin when used rectally may cause rectal discomfort or a burning sensation
Toxicity
Acute oral LD50 is 2660 mg/kg in rat . Individuals are likely to be exposed to boric acid from industrial manufacturing or processing. Local tissue injury from boric acid exposure is likely due to caustic effects. Systemic effects from boric acid poisoning usually occur from multiple exposures over a period of days and involve gastrointestinal, dermal, CNS, and renal manifestations. Gastrointestinal toxicity include persistent nausea, vomiting, diarrhea, epigastric pain, hematemesis, and blue-green discoloration of the feces and vomit . Following the onset of GI symptoms, a characteristic intense generalized erythroderma follows . Management of mild to moderate toxicity should be supportive. In case of severe toxicity, dialysis may be required in addition to supportive treatment.
Rat oral LD50, rabbit dermal LD50, and rat inhalation LC50 of sodium carboxymethyl cellulose are 27000 mg/kg, >2 g/kg, and >5800 mg/m^3 (4 hours), respectively .
Glycerol has very low toxicity when ingested ; Rat LD50 (oral)-12600mg/kg Mice LD50 (oral )-4090mg/kg Human TDLo (oral) - 1428mg/kg
Precaution
Concomitant ocular medication should be administered 15 minutes apart to the instillation of this eye drop.
Interaction
No information is available.
Volume of Distribution
Volume of distribution ranges from 0.17 to 0.5 L/kg in humans, where large amounts of boric acid are localized in brain, liver, and kidney .
No pharmacokinetic data available.
Glycerin is distributed throughout the blood. Although glycerin generally does not appear in ocular fluids, it may enter the orbital sac when the eye is inflamed, with a consequent decrease in osmotic effect.
Elimination Route
Boric acid is well absorbed from the gastrointestinal tract, open wounds, and serous cavities but displays limited absorption in intact skin . Following intraperitoneal injection in mice, the peak concentration was reached in about 1.0-1.5 hr in the brain whereas the value was 0.5 hr in other tissues .
No pharmacokinetic data available.
Well absorbed orally, poorly absorbed rectally. Studies in humans and animals indicate glycerol is rapidly absorbed in the intestine and the stomach
Half Life
According to human cases of poisoning, the elimination half-life of boric acid ranges from 13 to 24 hours .
No pharmacokinetic data available.
30 - 45 minutes
Clearance
A case report of acute boric acid poisoning following oral ingestion of 21 g of boric acid presents the total body clearance of 0.99 L/h before hemodialysis .
No pharmacokinetic data available.
Elimination Route
Regardless the route of administration, boric acid predominantly undergoes rapid renal excretion of >90% of total administered dose as unchanged form. Small amounts are also excreted into sweat, saliva, and feces. Following administration as ointment, urinary excretion of boric acid accounted for only 1% of the administered dose .
No pharmacokinetic data available.
Approx 7-14% of dose is excreted unchanged in the urine within 2.5 hr.
Pregnancy & Breastfeeding use
Use in Pregnancy: There is no data on the use of Carboxymethylcellulose Sodium 1% during pregnancy and lactation in human. Animal studies did not show harmful effects with the active ingredient Carboxymethylcellulose Sodium. Use in Lactation: Carboxymethylcellulose Sodium is not absorbed systemically; there is no known potential for excretion in human breast milk.
Pediatric use: The safety and effectiveness in pediatric patients have not been established.
Pregnancy category C. There are no controlled data in human pregnancy
Contraindication
Contraindicated in patients who are hypersensitive to any of the components of Carboxymethylcellulose Sodium.
Sensitivity to the ingredients. Do not use unless the patient to be treated is, in fact, constipated.
Special Warning
Use in children: No information available.
Use in elderly patients: No information available.
Acute Overdose
Since CMC is pharmacologically inert and not expected to be absorbed systemically, systemic effects from topical overdose are not expected from the administration of Carboxymethylcellulose sodium (Cellufresh) 0.5%. Additionally, no toxic side effects are expected should accidental systemic overdose occur.
Storage Condition
Store in a cool, dry place and protect from light. Keep out of the reach of children.
Store below 25° C. Protect from moisture.
Innovators Monograph
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