SIMBRINZA- brinzolamide/brimonidine tartrate suspension/ drops

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

Brinzolamide (UNII: 9451Z89515) (Brinzolamide - UNII:9451Z89515), Brimonidine Tartrate (UNII: 4S9CL2DY2H) (Brimonidine - UNII:E6GNX3HHTE)

Tersedia dari:

Novartis Pharmaceuticals Corporation

Rute administrasi :

OPHTHALMIC

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

SIMBRINZA (brinzolamide and brimonidine tartrate ophthalmic suspension) 1% and 0.2% is a fixed combination of a carbonic anhydrase inhibitor and an alpha-2 adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. SIMBRINZA is contraindicated in patients who are hypersensitive to any component of this product. SIMBRINZA is contraindicated in neonates and infants (under the age of two years) [see Use in Specific Populations (8.4)] . Pregnancy Category C: Developmental toxicity studies with brinzolamide in rabbits at oral doses of 1, 3, and 6 mg/kg/day (20, 60, and 120 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/k

Ringkasan produk:

SIMBRINZA is supplied in white low density polyethylene (LDPE) DROP-TAINER® bottles with a natural LDPE dispensing-tip and light green polypropylene cap as follows: 8 mL in a 10 mL bottle NDC 0078-0904-38 Storage and Handling Store SIMBRINZA at 2°C to 25°C (36 to 77°F).

Status otorisasi:

New Drug Application

Karakteristik produk

SIMBRINZA- BRINZOLAMIDE/BRIMONIDINE TARTRATE SUSPENSION/ DROPS
NOVARTIS PHARMACEUTICALS CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SIMBRINZA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SIMBRINZA.
SIMBRINZA (BRINZOLAMIDE AND BRIMONIDINE TARTRATE OPHTHALMIC
SUSPENSION)
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
SIMBRINZA is a fixed combination of a carbonic anhydrase inhibitor and
an alpha-2 adrenergic receptor
agonist indicated for the reduction of elevated intraocular pressure
(IOP) in patients with open-angle
glaucoma or ocular hypertension. (1)
DOSAGE AND ADMINISTRATION
Shake well before use. Instill one drop in the affected eye(s) three
times daily. If more than one topical
ophthalmic drug is being used, the drugs should be administered at
least five minutes apart. (2)
DOSAGE FORMS AND STRENGTHS
Suspension containing 10 mg/mL brinzolamide and 2 mg/mL brimonidine
tartrate. (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this product. (4.1)
Neonates and infants (Under the Age of two Years). (4.2)
WARNINGS AND PRECAUTIONS
Potential for sulfonamide hypersensitivity reactions because of the
brinzolamide component. (5.1)
Potential for corneal endothelium cell loss. (5.2)
Severe renal impairment may limit the metabolism of the brinzolamide
component. (5.3)
ADVERSE REACTIONS
Most common adverse reactions occurring in approximately 3% to 5% of
patients included blurred vision,
eye irritation, dysgeusia (bad taste), dry mouth, and eye allergy.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NOVARTIS
PHARMACEUTICALS CORPORATION
AT 1-888-669-6682 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Oral Carbonic Anhydrase Inhibitors (CAIs) (7.1)
High-dose Salicylate Therapy (7.2)
Central Nervous System (CNS) Depressants (7.3)
Antihypertensives/Cardiac Glycosides (7.4)
Tricyclic Antidepressants (7.5)
Monoamine Oxidase Inhibitors (MAOIs) (7.6)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
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