PREDNISOLONE SODIUM PHOSPHATE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM)

Available from:

Butler Animal Health Supply

INN (International Name):

PREDNISOLONE SODIUM PHOSPHATE

Composition:

PREDNISOLONE SODIUM PHOSPHATE 10 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prednisolone Sodium Phosphate Ophthalmic Solution 1% or 1/8% is for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation, corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, is recommended for moderate to severe inflammations, particularly when unusually rapid control is desired. In stubborn cases of anterior segment eye disease, systemic adrenocortical hormone therapy may be required. When deeper ocular structures are involved, systemic therapy is necessary. The use of this preparation is contraindicated in the presence of: 1] Acute superficial herpes simplex ke

Product summary:

Prednisolone Sodium Phosphate Ophthalmic Solution USP, 1% is supplied in a plastic squeeze bottle with a controlled drop tip in the following sizes: 5 mL bottle - Prod. No. 04307 10 mL bottle - Prod. No. 04309 15 mL bottle - Prod. No. 04311 Store between 15° - 30° C (59° - 86° F). Protect from light. Keep tightly closed. DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. KEEP OUT OF REACH OF CHILDREN. Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9101401 (Folded) 9101501 (Flat)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM PHOSPHATE SOLUTION/
DROPS
BUTLER ANIMAL HEALTH SUPPLY
----------
PREDNISOLONE SODIUM PHOSPHATE
OPHTHALMIC SOLUTION USP, 1% (STERILE)
RX ONLY
DESCRIPTION:
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, is a sterile
solution for ophthalmic
administration having the following composition:
EACH ML CONTAINS:
ACTIVE: Prednisolone Sodium Phosphate 10 mg (1%) [equivalent to 9.1
mg/mL prednisolone
phosphate] in a buffered isotonic solution containing INACTIVES:
Hypromellose, Monobasic and
Dibasic Sodium Phosphate, Sodium Chloride, Edetate Disodium and
Purified Water. Sodium Hydroxide
and/or Hydrochloric Acid may be added to adjust the pH (6.2 - 8.2).
PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
The chemical name for prednisolone sodium phosphate is Pregna-1,
4-diene - 3, 20-dione, 11, 17-
dihydroxy-21-(phosphonooxy)-, disodium salt, (11 β) -, which has the
following structural formula:
Molecular formula: C
H Na O P
Molecular Weight: 484.39
CLINICAL PHARMACOLOGY:
Prednisolone sodium phosphate causes inhibition of inflammatory
response to inciting agents of
mechanical, chemical, or immunological nature. No generally accepted
explanation of this steroid
property has been advanced.
INDICATIONS AND USAGE:
Prednisolone Sodium Phosphate Ophthalmic Solution 1% or 1/8% is for
the treatment of steroid
responsive inflammatory conditions of the palpebral and bulbar
conjunctiva, cornea, and anterior
segment of the globe, such as allergic conjunctivitis, acne rosacea,
superficial punctate keratitis, herpes
zoster keratitis, iritis, cyclitis, selected infective conjunctivitis
when the inherent hazard of steroid use
is accepted to obtain an advisable diminution in edema and
inflammation, corneal injury from chemical,
radiation, or thermal burns, or penetration of foreign bodies.
21
27
2
8
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, is recommended
for moderate to severe
inflammations, particularly when unusually rapid control is desired.
In stubborn cases of anteri