TOBRAMYCIN solution/ drops

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

TOBRAMYCIN (UNII: VZ8RRZ51VK) (TOBRAMYCIN - UNII:VZ8RRZ51VK)

Tersedia dari:

Proficient Rx LP

Rute administrasi :

OPHTHALMIC

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Tobramycin ophthalmic solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution. Clinical studies have shown tobramycin to be safe and effective for use in children. Tobramycin ophthalmic solution is contraindicated in patients with known hyper sensitivity to any of its components.

Ringkasan produk:

5 mL sterile solution is packaged in a 10 mL white LDPE bottle and natural LDPE nozzle and White HDPE cap (NDC 71205-101-05) containing Tobramycin ophthalmic solution. TAMPER EVIDENT SEAL Storage: Store at 2° - 25°C (36° - 77°F). For Product Inquiry call [phone] Revised: October, 2019 Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 Made in India Code No.: KR/DRUGS/KTK/28/289/97 ST-TBR11/P/01 Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

TOBRAMYCIN- TOBRAMYCIN SOLUTION/ DROPS
PROFICIENT RX LP
----------
RX ONLY
FOR TOPICAL OPHTHALMIC USE ONLY
DESCRIPTION
Tobramycin ophthalmic solution is a sterile topical ophthalmic
antibiotic formulation
prepared specifically for topical therapy of external ophthalmic
infections.
Each mL of Tobramycin ophthalmic solution USP, 0.3% contains: ACTIVE:
tobramycin
0.3% (3 mg). PRESERVATIVE: Benzalkonium chloride 0.01% (0.1 mg).
INACTIVES: boric
acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide
and/or sulfuric acid
(to adjust pH) and water for injection. Tobramycin ophthalmic solution
has a pH range
between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg.
Tobramycin is a water-soluble aminoglycoside antibiotic active against
a wide variety of
gram-negative and gram-positive ophthalmic pathogens.
The chemical structure of tobramycin is:
Molecular Weight = 467.52
Molecular Formula: C
H
N O
18
37
5
9
Chemical name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4)
}-0-{2,6-diamino-
2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine.
CLINICAL PHARMACOLOGY
_In Vitro Data:_ _In vitro_ studies have demonstrated tobramycin is
active against
susceptible strains of the following microorganisms: _Staphylococci_,
including _S. aureus_
and _S. epidermidis_ (coagulase-positive and coagulase-negative),
including penicillin-
resistant strains.
_Streptococci_, including some of the Group A-beta-hemolytic species,
some nonhemolytic
species, and some _Streptococcus pneumoniae._
_Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae,
Enterobacter_
_aerogenes, Proteus mirabilis, Morganella morganii, _most_ Proteus
vulgaris strains,_
_Haemophilus influenzae _and_ H. aegyptius, Moraxella lacunata,
Acinetobacter_
_calcoaceticus _and some_ Neisseria species._ Bacterial susceptibility
studies demonstrate
that in some cases, microorganisms resistant to gentamicin retain
susceptibility to
tobramycin.
INDICATIONS AND USAGE
Tobramycin ophthalmic solution is a topical antibiotic indicated in
the treatment