TIMOLOL MALEATE solution/ drops

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)

Sẵn có từ:

REMEDYREPACK INC.

Tuyến hành chính:

OPHTHALMIC

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Timolol Maleate Ophthalmic Solution is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.

Tóm tắt sản phẩm:

Sterile ophthalmic solution of timolol maleate is a clear, colorless solution. Timolol maleate ophthalmic solution USP, 0.25% timolol equivalent, is supplied in a labeled translucent LDPE bottle with insert cap assembly comprising of a yellow colored HDPE screw cap over a LDPE nozzle with tamper-evident LDPE dust- cover sealing the bottle cap. NDC 64980-513-05,  5 mL in a 5 mL bottle NDC 64980-513-01,  10 mL in a 10 mL bottle NDC 64980-513-15,  15 mL in a 15 mL bottle Timolol maleate ophthalmic solution USP, 0.5% timolol equivalent, is supplied in a labeled translucent LDPE bottle with insert cap assembly comprising of a yellow colored HDPE screw cap over a LDPE nozzle with tamper-evident LDPE dust- cover sealing the bottle cap. NDC 64980-514-05,  5 mL in a 5 mL bottle NDC 64980-514-01,  10 mL in a 10 mL bottle NDC 64980-514-15,  15 mL in a 15 mL bottle Storage Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F)[See USP controlled room temperature] Protect from freezing. Protect from light. Manufactured by: FDC Limited, B-8, MIDC Industrial Area, Waluj, Aurangabad - 431 136, Maharashtra, India Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Toll free number: 1-800-521-5340 Revised : 02/2018 Rx only STERILE OPHTHALMIC SOLUTION TIMOLOL MALEATE OPHTHALMIC SOLUTION USP 0.25% AND 0.5% INSTRUCTIONS FOR USE Please follow these instructions carefully when using Timolol Maleate Ophthalmic Solution. Use Timolol Maleate Ophthalmic Solution as prescribed by your doctor. 1.      If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after the use of Timolol Maleate Ophthalmic Solution. 2.      Wash hands before each use. 3.      Before using the medication for the first time, be sure the dust cover seal is unbroken. 4.      Refer (I-VI) 5.      OPHTHALMIC MEDICATIONS, IF HANDLED IMPROPERLY, CAN BECOME CONTAMINATED BY COMMON BACTERIA KNOWN TO CAUSE EYE INFECTIONS. SERIOUS DAMAGE TO THE EYE AND SUBSEQUENT LOSS OF VISION MAY RESULT FROM USING CONTAMINATED OPHTHALMIC MEDICATIONS. IF YOU THINK YOUR MEDICATION MAY BE CONTAMINATED, OR IF YOU DEVELOP AN EYE INFECTION, CONTACT YOUR DOCTOR IMMEDIATELY CONCERNING CONTINUED USE OF THIS BOTTLE. 6.      Repeat (V) and (VI) with the other eye if instructed to do so by your doctor. 7.      The insert tip is designed to provide a premeasured drop; therefore, do NOT enlarge the hole of the insert tip. 8.      After you have used all doses, there will be some Timolol Maleate Ophthalmic Solution left in the bottle. You should not be concerned since an extra amount of Timolol Maleate Ophthalmic Solution has been added and you will get the full amount of Timolol Maleate Ophthalmic Solution that your doctor prescribed. Do not attempt to remove excess medicine from the bottle. WARNING:  KEEP OUT OF REACH OF CHILDREN. IF YOU HAVE ANY QUESTIONS ABOUT THE USE OF TIMOLOL MALEATE OPHTHALMIC SOLUTION, PLEASE CONSULT YOUR DOCTOR.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION/ DROPS
REMEDYREPACK INC.
----------
STERILE OPHTHALMIC SOLUTION TIMOLOL MALEATEOPHTHALMIC
SOLUTIONUSP 0.25% AND 0.5%
DESCRIPTION
Timolol maleate ophthalmic solution is a non-selective beta-adrenergic
receptor blocking agent. Its
chemical name is (-)-1-(
_tert_-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol
maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon
atom in its structure and is
provided as the levo-isomer. The optical rotation of Timolol maleate
is:
Its molecular formula is C
H
N
O
S•C
H
O
and its structural formula is:
Timolol maleate has a molecular weight of 432.50. It is a white,
odorless, crystalline powder which is
soluble in water, methanol, and alcohol. Timolol Maleate is stable at
room temperature. Timolol
Maleate Ophthalmic Solution is supplied as a sterile, isotonic,
buffered, aqueous solution of Timolol
maleate in two dosage strengths: Each mL of Timolol Maleate Ophthalmic
Solution 0.25% contains 2.5
mg of timolol (3.4 mg of Timolol Maleate). The pH of the solution is
approximately 7.0, and the
osmolarity is 274-328 mOsm. Each mL of Timolol Maleate Ophthalmic
Solution 0.5% contains 5 mg of
timolol (6.8 mg of timolol maleate).
Inactive ingredients: monobasic and dibasic sodium phosphate, sodium
chloride, sodium hydroxide to
adjust pH, and water for injection. Benzalkonium chloride 0.01% is
added as preservative.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Timolol maleate is a beta
and beta
(non-selective) adrenergic receptor blocking agent that does not
have significant intrinsic sympathomimetic, direct myocardial
depressant, or local anesthetic
(membrane-stabilizing) activity.
Beta-adrenergic receptor blockade reduces cardiac output in both
healthy subjects and patients with
heart disease. In patients with severe impairment of myocardial
function, beta-adrenergic receptor
blockade may inhibit the stimulatory effect of the sympathetic nervous
system necessary to maintain
adequate cardiac function.
Beta-adrenergic rec