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LUMIGAN (BIMATOPROST) OPHTHALMIC SOLUTION 0.01% AND 0.03%: PRESCRIBING INFORMATION
DOSAGE AND ADMINISTRATION
Lumigan dosage and administration
INDICATIONS AND USAGE
Lumigan 0.01% and 0.03% (Bimatoprost ophthalmic solution) is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Lumigan adverse reactions
USE IN SPECIFIC POPULATIONS
Lumigan use in specific populations
No information is available on overdosage in humans. If overdose with Lumigan 0.01% and 0.03% (Bimatoprost ophthalmic solution) 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/m2 is at least 70 times higher than the accidental dose of one bottle of Lumigan 0.03% for a 10 kg child.
Lumigan clinical pharmacology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Lumigan (Bimatoprost) was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 2 mg/kg/day and 1 mg/kg/day respectively (at least 192 and 291 times the recommended human exposure based on blood AUC levels respectively) for 104 weeks.
Bimatoprost (Lumigan) eye drops was not mutagenic or clastogenic in the Ames test, in the mouse lymphoma test, or in the in vivo mouse micronucleus tests.
Bimatoprost did not impair fertility in male or female rats up to doses of 0.6 mg/kg/day (at least 103 times the recommended human exposure 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 of Lumigan 0.03% (Bimatoprost ophthalmic solution) once daily (in the evening) was 7-8 mmHg.
In a 3 month clinical study of patients with open angle glaucoma or ocular hypertension with an average baseline IOP of 23.5 mmHg, the IOP-lowering effect of Lumigan 0.01% once daily (in the evening) was up to 7.5 mmHg and was approximately 0.5 mmHg less effective than LUMIGAN 0.03%. In this same study, Lumigan 0.01% also had a similar overall safety profile compared with Lumigan 0.03%. After 12 months of treatment, discontinuations were 8.1% for Lumigan 0.01% and 13.4% for Lumigan 0.03%.
HOW SUPPLIED / STORAGE AND HANDLING
Lumigan (Bimatoprost ophthalmic solution) 0.01% is supplied sterile in opaque white low density polyethylene ophthalmic dispenser bottles and tips with turquoise polystyrene caps in the following sizes:
1 ml fill in a 5 ml container
2.5 ml fill in a 5 ml container
5 e fill in a 10 ml container
7.5 ml fill in a 10 ml container
Lumigan (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
5 ml fill in 10 ml container
7.5 ml fill in 10 ml container
Lumigan 0.01% and 0.03% should be stored at 2° to 25°C (36° to 77°F).
Manufactured and distributed by Allergan pharmaceutical company and its divisions.
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