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Lumigan Eye Drops |
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Lumigan Indications
Lumigan eye drops are indicated for the reduction of elevated intraocular pressure in patients with
ocular hypertension or open angle glaucoma, who are intolerant of other intraocular pressure lowering drugs
or insufficiently responsive to another intraocular pressure lowering drug.
Lumigan Contraindications
Lumigan eye drops are contraindicated in patients with hypersensitivity to bimatoprost or any other ingredient in
Lumigan.
Lumigan and Pregnancy
Pregnancy Category C. In embryo/fetal developmental studies in pregnant mice and rats, abortion was observed at oral doses of
Lumigan eye drops, which achieved at least 32 or 98 times, respectively, the intended
human exposure based on blood AUC levels. At doses 42 times the intended human exposure based on blood AUC levels, the
gestation length was reduced in the dams, the incidence of dead fetuses, late resorptions, postnatal pup mortality
was increased, and pup body weights were reduced.
Lumigan and Nursing Mothers
It is not known whether this drug is excreted in human milk, although in
animal studies, bimatoprost has been shown to be excreted in breast milk. Because many drugs are excreted in human milk,
caution should be exercised when eye drops are administered to a nursing woman.
Lumigan Side Effects
In clinical trlals, the most frequent events associated with the use of Lumigan
0.04% occurring in approximately 14% to 44% of patients, in descending order of incidence, included:
- Ocular pruritus;
- Growth of eyelashes;
- Conjunctival hyperemia;
Approximately 4% of patients discontinued therapy due to conjunctival hyperemia.
Ocular adverse events occurrlng in approximately 3 to 10% qf patients, in descending order of incidence, included:
- Visual disturbance;
- Superficial punctate keratitis;
- Pigmentation of the pe6ocular skin;
- Ocular irritation;
- Ocular dryness;
- Ocular buming;
- Foreign body sensation;
- Eyelid erythema;
- Eyelash darkening;
- Eye pain;
- Cataract;
- Blepharitis;
The following ocular adverse events reported in approximately into 4% of patients, in descending order of incidence, included:
- Tearing;
- Photophobia;
- Increases in iris pigmentation;
- Eye discharge;
- Asthenopia;
- Allergic conjunctivitis;
In less than 2% of patients, intraocular inflammation was reported as iritis.
Systemic adverse events reported in approximately 11% of patients were infections. The following systemic adverse
events reported in approximately 0.9 to 4.9% of patients, in descending order of incidence, included:
- Abnormal liver function tests;
- Asthenia;
- Headaches;
- Hirsutism;
Lumigan Overdosage
No information is available on Lumigan eye drops overdosage in humans.
Lumigan Dosage
Lumigan eye drops dosage is one (1) drop in the affected eye(s) once daily in the evening.
The dosage of Lumigan eye drops should not exceed once daily since it has been shown that more
frequent administration may decrease the intraocular pressure lowering effect.
Reduction of the intraocular pressure starts approximately 3-5 hours after the first administration with maximum effect
reached within approximately 6-7 to 10-11 hours.
Lumigan eye drops 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 minutes apart.
Lumigan Form
Lumigan eye drops ophthalmic solution is supplied sterile in opaque white plastic dropper bottles in the following sizes:
- 3.0mL,
- 5.0mL,
- 7.5mL.
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