Loteprednol Etabonate (Lotemax Sm)

Trade Name : Lotemax SM

Bausch & Lomb Incorporated

GEL

Strength 3.8 mg/g

LOTEPREDNOL ETABONATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Loteprednol Etabonate (Lotemax Sm) which is also known as Lotemax SM and Manufactured by Bausch & Lomb Incorporated. It is available in strength of 3.8 mg/g per ml. Read more

Loteprednol Etabonate (Lotemax Sm) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
  • LOTEMAX SM is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. ()
  • Invert closed bottle and shake once to fill tip before instilling drops. Apply one drop of LOTEMAX SM into the conjunctival sac of the affected eye three times daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period.
  • Invert closed bottle and shake once to fill tip before instilling drops. ()
  • Apply one drop of LOTEMAX SM into the conjunctival sac of the affected eye three times daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. ()
  • LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% is a sterile preserved ophthalmic gel containing 3.8 mg of loteprednol etabonate per gram of gel.
  • LOTEMAX SM is a sterile preserved ophthalmic gel containing 3.8 mg of loteprednol etabonate per gram of gel. ()
  • LOTEMAX SM, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, in mycobacterial infection of the eye and fungal diseases of ocular structures.
  • LOTEMAX SM, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. ()
  • No data
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
  • There were no treatment-emergent adverse drug reactions that occurred in more than 1% of subjects in the three times daily group compared to vehicle.
  • There were no treatment-emergent adverse drug reactions that occurred in more than 1% of subjects in the three times daily group compared to vehicle. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or
  • No data
  • LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% contains a sterile, topical corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder.
  • Loteprednol etabonate is represented by the following structural formula:
  • Chemical Name:
  • chloromethyl 17u03b1-[(ethoxycarbonyl)oxy]-11u03b2-hydroxy-3-oxoandrosta-1,4-diene-17u03b2-carboxylate
  • Each gram contains:
  • No data
  • Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was not genotoxic in the Ames test, the mouse lymphoma tk assay, or in the chromosomal aberration test in human lymphocytes, or in the mouse micronucleus assay. Treatment of male and female rats with 25 mg/kg/day of loteprednol etabonate (533 times the RHOD based on body surface area, assuming 100% absorption) prior to and during mating caused preimplantation loss and decreased the number of live fetuses/live births. The NOAEL for fertility in rats was 5 mg/kg/day (106 times the RHOD).
  • In two randomized, multicenter, double-masked, parallel group, vehicle-controlled trials in patients who underwent cataract extraction with intraocular lens implantation, LOTEMAX SM administered three times daily to the affected eye beginning the day after cataract surgery was more effective compared to its vehicle in resolving anterior chamber inflammation and pain following surgery. In these studies, LOTEMAX SM had statistically significantly higher rates of subjects with complete clearing of anterior chamber cells and of subjects who were pain free at post-operative Day 8 compared to vehicle. Results are shown in the following table.
  • LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% is a sterile ophthalmic submicron gel supplied in a white low-density polyethylene plastic bottle with a white controlled drop tip and a pink polypropylene cap in the following size: 5 g in a 10 mL bottle (NDC 24208-507-07)
  • Use only if imprinted neckband is intact.
  • Storage:
  • Administration
  • Invert closed bottle and shake once to fill tip before instilling drops.
  • Risk of Contamination
  • Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the gel.
  • Contact Lens Wear
  • Advise patients contact lenses should not be worn when the eyes are inflamed.
  • Risk of Secondary Infection
  • Advise the patient to consult a physician if pain develops, redness, itching or inflammation becomes aggravated.
  • LOTEMAX is a trademark of Bausch & Lomb Incorporated or its affiliates.
  • u00a9 2019 Bausch & Lomb Incorporated
  • Bausch + Lomb, a division of
  • Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA
  • 9669600 (folded)
  • 9669700 (flat)
  • Revised 02/2019
  • NDC
  • Rx only
  • LOTEMAXSM(loteprednol etabonateophthalmic gel) 0.38%
  • FOR OPHTHALMIC USE.
  • Sterile5 g

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