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ALPHAGAN P Ophthalmic solution / drops (2013)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

Allergan, Inc.

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Δωρεάν εγγραφή

1. Indications and Usage

ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle ...

2. Dosage and Administration

The recommended dose is one drop of ALPHAGAN P in the affected eye(s) three times daily, approximately 8 hours apart. ALPHAGAN P ophthalmic solution may be used concomitantly with other topical ophthalmic ...

3. Dosage Forms and Strengths

Solution containing 1 mg/mL or 1.5 mg/mL brimonidine tartrate.

4. Contraindications

4.1 Neonates and Infants (under the age of 2 years) ALPHAGAN P is contraindicated in neonates and infants (under the age of 2 years). 4.2 Hypersensitivity Reactions ALPHAGAN P is contraindicated in patients ...

5. Warnings and Precautions

5.1 Potentiation of Vascular Insufficiency ALPHAGAN P may potentiate syndromes associated with vascular insufficiency. ALPHAGAN P should be used with caution in patients with depression, cerebral or coronary ...

6.1. Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of ...

6.2. Postmarketing Experience

The following reactions have been identified during postmarketing use of brimonidine tartrate ophthalmic solutions in clinical practice. Because they are reported voluntarily from a population of unknown ...

7. Drug Interactions

7.1 Antihypertensives/Cardiac Glycosides Because ALPHAGAN P may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with ALPHAGAN P is advised. 7.2 CNS Depressants ...

8. Use in Specific Populations

8.6 Special Populations ALPHAGAN P has not been studied in patients with hepatic impairment. ALPHAGAN P has not been studied in patients with renal impairment. The effect of dialysis on brimonidine pharmacokinetics ...

8.1. Pregnancy

Pregnancy Category B: Teratogenicity studies have been performed in animals. Brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 ...

8.3. Nursing Mothers

It is not known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk. Because of the potential for serious ...

8.4. Pediatric Use

ALPHAGAN P is contraindicated in children under the age of 2 years (see CONTRAINDICATIONS, 4.1). During postmarketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, ...

8.5. Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

10. Overdosage

Very limited information exists on accidental ingestion of brimonidine in adults; the only adverse reaction reported to date has been hypotension. Symptoms of brimonidine overdose have been reported in ...

11. Description

ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist (topical intraocular pressure lowering agent). The structural ...

12.1. Mechanism of Action

ALPHAGAN P is a relatively selective alpha-2 adrenergic receptor agonist with a peak ocular hypotensive effect occurring at two hours post-dosing. Fluorophotometric studies in animals and humans suggest ...

12.3. Pharmacokinetics

Absorption After ocular administration of either a 0.1% or 0.2% solution, plasma concentrations peaked within 0.5 to 2.5 hours and declined with a systemic half-life of approximately 2 hours. Distribution ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

No compound-related carcinogenic effects were observed in either mice or rats following a 21-month and 24-month study, respectively. In these studies, dietary administration of brimonidine tartrate at ...

14. Clinical Studies

Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. Brimonidine tartrate has the action ...

16.1. How Supplied

ALPHAGAN P is supplied sterile, in teal opaque plastic LDPE bottles and tips, with purple high impact polystyrene (HIPS) caps as follows: <u>0.1%:</u> 5 mL in 10 mL bottle NDC 0023-9321-05 10 mL in 10 ...

16.2. Storage and Handling

Store at 15°-25°C (59°-77°F).

17. Patient Counseling Information

Patients should be instructed that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria ...
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