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Azopt Eye Drops |
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Azopt Structure
- 1% - Brinzolamide ophthalmic suspension;
Azopt Indications
Azopt eye drops 1% are indicated in the treatment of elevated intraocular pressure in patients
with ocular hypertension or open-angle glaucoma.
Azopt Contraindications
Azopt eye drops 1% are contraindicated in patients who are hypersensitive to any component of
Azopt eye drops.
Azopt and Pregnancy
Teratogenic Effects: Pregnancy Category C. Developmental toxicity studies with brinzolamide in rabbits at oral doses of 1, 3,
and 6 mg/kg/day (20, 62, and 125 times the recommended human ophthalmic dose) produced maternal toxicity at 6
mg/kg/day and a significant increase in the number of fetal variations, such as accessory skull bones, which was only slightly
higher than the historic value at 1 and 6 mg/kg. In rats, statistically decreased body weights of fetuses from dams receiving
oral doses of 18 mg/kg/day (375 times the recommended human ophthalmic dose) during gestation were proportional to the
reduced maternal weight gain, with no statistically significant effects on organ or tissue development. Increases in unossified
sternebrae, reduced ossification of the skull, and unossified hyoid that occurred at 6 and 18 mg/kg were not statistically
significant. No treatment-related malformations were seen. Following oral administration of 14C-brinzolamide to pregnant rats,
radioactivity was found to cross the placenta and was present in the fetal tissues and blood.
Azopt and Nursing Mothers
In a study of Azopt eye drops in lactating rats, decreases in body weight gain in offspring at an oral dose of 15 mg/kg/day (312
times the recommended human ophthalmic dose) were seen during lactation. No other effects were observed. However,
following oral administration of 14C-brinzolamide to lactating rats, radioactivity was found in milk at concentrations below
those in the blood and plasma.
Azopt Side Effects
In clinical studies of Azopt eye drops 1%, the most frequently reported adverse events
associated with Azopt eye drops 1% were:
- Unusual taste;
- Sour;
- Blurred vision;
- Bitter;
These events occurred in approximately 5-10% of patients:
- Rhinitis;
- Ocular pruritus;
- Ocular pain;
- Ocular keratitis;
- Ocular discomfort;
- Ocular discharge;
- Hyperemia;
- Headache;
- Foreign body sensation;
- Dry eye;
- Dermatitis;
- Blepharitis;
The following adverse reactions were reported at an incidence below 1%:
- Urticaria;
- Tearing;
- Sticky sensation;
- Pharyngitis;
- Nausea;
- Lid margin crusting;
- Kidney pain;
- Keratopathy;
- Keratoconjunctivitis;
- Hypertonia;
- Eye fatigue;
- Dyspnea;
- Dyspepsia;
- Dry mouth;
- Dizziness;
- Diplopia;
- Diarrhea;
- Conjunctivitis;
- Chest pain;
- Alopecia;
- Allergic reactions;
Azopt Overdosage
Although no human data are available, electrolyte imbalance, development of an acidotic state, and possible nervous system
effects may occur following oral administration of an overdose. Serum electrolyte levels (particularly potassium) and blood pH
levels should be monitored.
Azopt Dosage
Azopt eye drops recommended dose are 1 drop of Azopt eye drops 1% in the affected eye(s) 3 times daily.
Azopt eye drops 1% may be prescribed concomitantly with other topical ophthalmic drug products to
lower intraocular pressure.
If more than one topical ophthalmic drug is being prescribed, the drugs should be administered at least ten minutes apart.
Azopt Form
Azopt eye drops 1% is supplied in plastic dispensers with a controlled
dispensing-tip as follows:
- 5mL;
- 10 mL;
- 15 mL;
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