Trade Name: Bimatoprost

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Somerset Therapeutics, LLC

Presentation: SOLUTION/ DROPS, HUMAN PRESCRIPTION DRUG

Strength: 0.3 mg/mL

Storage and handling

BIMATOPROST Prostaglandin Analog [EPC],Prostaglandins [CS]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Contraindications, Hypersensitivity () 07/2017
  • Bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
  • Bimatoprost ophthalmic solution 0.03% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
  • The recommended dosage is one drop in the affected eye(s) once daily in the evening. Bimatoprost ophthalmic solution 0.03% should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect.
  • Reduction of the intraocular pressure starts approximately 4 hours after the first administration with maximum effect reached within approximately 8 to 12 hours.
  • Bimatoprost ophthalmic solution 0.03% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.
  • One drop in the affected eye(s) once daily in the evening.
  • Ophthalmic solution containing bimatoprost 0.3 mg/mL
  • Ophthalmic solution containing 0.3 mg/mL bimatoprost
  • Bimatoprost ophthalmic solution 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients .
  • Hypersensitivity.
  • No data
  • Pigmentation.n
  • Eyelash Changes.n
  • The following adverse reactions are described elsewhere in the labeling:
  • Most common adverse reaction is conjunctival hyperemia (45%). (6.1)
  • To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. ()
  • No information is available on overdosage in humans. If overdose with bimatoprost ophthalmic solution 0.03% occurs, treatment should be symptomatic.
  • In oral (by gavage) mouse and rat studies, doses up to 100 mg/kg/day did not produce any toxicity. This dose expressed as mg/mis at least 70 times higher than the accidental dose of one bottle of bimatoprost ophthalmic solution 0.03% for a 10 kg child.
  • Bimatoprost ophthalmic solution 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is ()-7-[(1,2,3,5)-3,5-Dihydroxy-2u00a0[(1,3) 3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5--ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is CHNO. Its chemical structure is:
  • Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. Bimatoprost ophthalmic solution 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately between 260 and 320 mOsmol/kg.
  • Bimatoprost ophthalmic solution 0.03% contains bimatoprost 0.3 mg/mL; benzalkonium chloride 0.05 mg/mL; sodium chloride; sodium phosphate, dibasic (Heptahydrate); citric acid monohydrate; and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8-7.8. u00a0
  • No data
  • Carcinogenesis
  • Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage for 104 weeks at doses of up to 2 mg/kg/day and 1 mg/kg/day respectivelyu00a0u00a0u00a0u00a0u00a0u00a0 (at least 192 and 291 times the human systemic exposure at the RHOD, respectively, based on blood AUC levels).
  • Mutagenesis
  • Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse lymphoma test, or in the mouse micronucleus tests.
  • Impairment of Fertility
  • Bimatoprost did not impair fertility in male or female rats at doses up to 0.6 mg/kg/day (at least 103 times the human system exposure at the RHOD, based on blood AUC levels).
  • In clinical studies of patients with open angle glaucoma or ocular hypertension with a mean baseline IOP of 26 mmHg, the IOP-lowering effect bimatoprost ophthalmic solution 0.03 once daily (in the evening) was 7-8 mmHg.
  • Bimatoprost ophthalmic solution 0.03% is supplied sterile in opaque white low density polyethylene ophthalmic dispenser bottles and tips with turquoise polystyrene caps in the following sizes:
  • 2.5 mL fill in 5 mL container -NDC 70069--01
  • 5 mL fill in 5 mL container -NDC 70069--01
  • 7.5 mL fill in 10 mL container -NDC 70069--01
  • Storage:
  • Potential for Pigmentation
  • Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Also inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of bimatoprost ophthalmic solution 0.03%.
  • Potential for Eyelash Changes
  • Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment with bimatoprost ophthalmic solution 0.03%. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment.
  • Handling the Container
  • Instruct patients to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
  • When to Seek Physician Advice
  • Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician's advice concerning the continued use of bimatoprost ophthalmic solution 0.03%.
  • Use with Contact Lenses
  • Advise patients that bimatoprost ophthalmic solution 0.03% contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of bimatoprost ophthalmic solution 0.03% and may be reinserted 15 minutes following its administration.
  • Use with Other Ophthalmic Drugs
  • Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications.
  • Manufactured for:
  • Somerset Therapeutics, LLC
  • Hollywood, FL 33024
  • Made in India
  • Code No.:KR/DRUGS/KTK/28/289/97
  • ST-BIM/P/01
  • 2.5 mL Container Label
  • 2.5 mL Monocarton Label
  • 5 mL Container Label
  • 5 mL Monocarton Label
  • 7.5 mL Container Label
  • 7.5 mL Monocarton Label

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Bimatoprost (Bimatoprost) which is also known as Bimatoprost and Manufactured by Somerset Therapeutics, LLC. It is available in strength of 0.3 mg/mL.

Bimatoprost (Bimatoprost) 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.

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