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Timolol 0.5% Oph Drop 10 Ml By Akorn Inc.

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Timolol 0.5% Oph Drop 10 Ml By Akorn Inc.

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Timolol 0.5% Oph Drop 10 Ml By Akorn Inc. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD2609949/RXB10103587/RXa288118
Size : 10 ML
Selling UoM : EA
NDC: 17478-0288-11
UPC Barcode : 317478288114
Supplier: 0050001091 AKORN INC
Supplier Material : 028811
Generic Code : 007856 TIMOLOL MALEATE OPHTHALMIC DROPS 0.5 %
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic RX

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Product Description.:

Drops , clear , clear
Colorless to light yellow

TIMOPTIC (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.

Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol.

TIMOPTIC is stable at room temperature. TIMOPTIC Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of TIMOPTIC 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 TIMOPTIC 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection. Benzalkonium chloride 0.01% is added as preservative.

INDICATIONS

TIMOPTIC Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

SIDE EFFECTS

The most frequently reported adverse experiences have been burning and stinging upon instillation (approximately one in eight patients). The following additional adverse experiences have been reported less frequently with ocular administration of this or other timolol maleate formulations:
Body As A Whole

Headache, asthenia/fatigue, and chest pain.
Cardiovascular

Bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud's phenomenon, and cold hands and feet.
Digestive

Nausea, diarrhea, dyspepsia, anorexia, and dry mouth.
Immunologic

Systemic lupus erythematosus.
Nervous System/Psychiatric

Dizziness, increase in signs and symptoms of myasthenia gravis, paresthesia, somnolence, insomnia, nightmares, behavioral changes and psychic disturbances including depression, confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss.
Skin

Alopecia and psoriasiform rash or exacerbation of psoriasis.
Hypersensitivity

Signs and symptoms of systemic allergic reactions, including anaphylaxis, angioedema, urticaria, and localized and generalized rash.
Respiratory

Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, nasal congestion, cough and upper respiratory infections.

WARNINGS

As with many topically applied ophthalmic drugs, this drug is absorbed systemically.

The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate