Brimonidine Tartrate, Timolol Maleate (Combigan)

Trade Name : COMBIGAN

Allergan, Inc.

SOLUTION/ DROPS

Strength 25 mg/mLmg/mL

BRIMONIDINE TARTRATE; TIMOLOL MALEATE Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Brimonidine Tartrate, Timolol Maleate (Combigan) which is also known as COMBIGAN and Manufactured by Allergan, Inc.. It is available in strength of 2; 5 mg/mL; mg/mL per ml. Read more

Brimonidine Tartrate, Timolol Maleate (Combigan) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

No data

Contraindications, Reactive Airway Disease Including Asthma, COPD () 10/2015n
Warnings and Precautions, Potential for Severe Respiratory or Cardiac Reactions () 10/2015

COMBIGAN
COMBIGAN
1

The recommended dose is one drop of n in the affected eye(s) twice daily approximately 12 hours apart. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart.
One drop in the affected eye(s), twice daily approximately 12 hours apart. ()

Solution containing 2 mg/mL brimonidine tartrate and 5 mg/mL timolol (6.8 mg/mL timolol maleate).
Solution containing 2 mg/mL brimonidine tartrate and 5 mg/mL timolol. ()

No data

Bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease. (, , )n
Sinus bradycardia, atrioventricular block, overt cardiac failure, cardiogenic shock. (, )n
Neonates and infants (under the age of 2 years). ()n
Hypersensitivity to any component of this product. ()n

No data

Potential for Severe Respiratory or Cardiac Reactions ()n
Cardiac Failure ()n
Obstructive Pulmonary Disease ()n
Potentiation of Vascular Insufficiency ()n
Increased Reactivity to Allergens ()n
Potentiation of Muscle Weakness ()n
Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus ()n
Masking of Thyrotoxicosis () n
Ocular Hypersensitivity ()

Most common adverse reactions occurring in approximately 5 to 15% of patients included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging. ()

No data

Antihypertensives/cardiac glycosides may lower blood pressure. ()n
Concomitant use with systemic beta-blockers may potentiate systemic beta-blockade. ()n
Oral or intravenous calcium antagonists may cause atrioventricular conduction disturbances, left ventricular failure, and hypotension. ()n
Catecholamine-depleting drugs may have additive effects and produce hypotension and/or marked bradycardia. ()n
Use with CNS depressants may result in an additive or potentiating effect. ()n
Digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time. ()n
CYP2D6 inhibitors may potentiate systemic beta-blockade. ()n
Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. ()n
Monoamine oxidase inhibitors may result in increased hypotension. ()u00a0

Not for use in children below the age of 2 years. Use with caution in children u2265 2 years of age. ()

There have been reports of inadvertent overdosage with timolol ophthalmic solution resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest. With the exception of hypotension, very limited information exists on accidental ingestion of brimonidine in adults. Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving brimonidine ophthalmic solutions as part of medical treatment of congenital glaucoma or by accidental oral ingestion n n . Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

COMBIGANn- Array
nttu00a0u00a0u00a0u00a0u00a0nt
The structural formulae are:
Brimonidine tartrate:
5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24
Timolol maleate:
(-)-1-(-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.50 as the maleate salt
In solution, n (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3.
Brimonidine tartrate appears as an off-white, or white to pale-yellow powder and is soluble in both water (1.5 mg/mL) and in the product vehicle (3 mg/mL) at pH 7.2. Timolol maleate appears as a white, odorless, crystalline powder and is soluble in water, methanol, and alcohol.
Each mL of n contains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, monobasic;u00a0sodium phosphate, dibasic; purified water; and hydrochloric acid and/or sodium hydroxide to adjust pH.

No data

With brimonidine tartrate, no compound-related carcinogenic effects were observed in either mice or rats following a 21-month and 24-month study, respectively. In these studies, dietary administration of brimonidine tartrate at doses up to 2.5 mg/kg/day in mice and 1 mg/kg/day in rats achieved 150 and 210 times, respectively, the plasma C drug concentration in humans treated with one drop of n into both eyes twice daily, the recommended daily human dose.
In a two-year study of timolol maleate administered orally to rats, there was a statistically significant increase in the incidence of adrenal pheochromocytomas in male rats administered 300 mg/kg/day [approximately 25,000 times the maximum recommended human ocular dose of 0.012 mg/kg/day on a mg/kg basis (MRHOD)]. Similar differences were not observed in rats administered oral doses equivalent to approximately 8,300 timesu00a0the daily dose of n in humans.
In a lifetime oral study of timolol maleate in mice, there were statistically significant increases in the incidence of benign and malignant pulmonary tumors, benign uterine polyps and mammary adenocarcinomas in female mice at 500 mg/kg/day, (approximately 42,000 times the MRHOD), but not at 5 or 50 mg/kg/day (approximately 420 to 4,200u00a0times higher, respectively, than the MRHOD). In a subsequent study in female mice, in which post-mortem examinations were limited to the uterus and the lungs, a statistically significant increase in the incidence of pulmonary tumors was again observed at 500 mg/kg/day.
The increased occurrence of mammary adenocarcinomas was associated with elevations in serum prolactin which occurred in female mice administered oral timolol at 500 mg/kg/day, but not at doses of 5 or 50 mg/kg/day. An increased incidence of mammary adenocarcinomas in rodents has been associated with administration of several other therapeutic agents that elevate serum prolactin, but no correlation between serum prolactin levels and mammary tumors has been established in humans. Furthermore, in adult human female subjects who received oral dosages of up to 60 mg of timolol maleate (the maximum recommended human oral dosage), there were no clinically meaningful changes in serum prolactin.
Brimonidine tartrate was not mutagenic or clastogenic in a series of and studies including the Ames bacterial reversion test, chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells, and three studies in CD-1 mice: a host-mediated assay, cytogenetic study, and dominant lethal assay.
Timolol maleate was devoid of mutagenic potential when tested (mouse) in the micronucleus test and cytogenetic assay (doses up to 800 mg/kg) and in a neoplastic cell transformation assay (up to 100 mcg/mL). In Ames tests the highest concentrations of timolol employed, 5,000 or 10,000 mcg/plate, were associated with statistically significant elevations of revertants observed with tester strain TA100 (in seven replicate assays), but not in the remaining three strains. In the assays with tester strain TA100, no consistent dose response relationship was observed, and the ratio of test to control revertants did not reach 2. A ratio of 2 is usually considered the criterion for a positive Ames test.
Reproduction and fertility studies in rats with timolol maleate and in rats with brimonidine tartrate demonstrated no adverse effect on male or femaleu00a0fertility at doses up to approximately 100 times the systemic exposure following the maximum recommended human ophthalmic dose of n .

Clinical studies were conducted to compare the IOP-lowering effect over the course of the day of n administered twice a day (BID) to individually-administered brimonidine tartrate ophthalmic solution, 0.2% administered three times per day (TID) and timolol maleate ophthalmic solution, 0.5% BID in patients with glaucoma or ocular hypertension. n BID provided an additional 1 to 3 mm Hg decrease in IOP over brimonidine treatment TID and an additional 1 to 2 mm Hg decrease over timolol treatment BID during the first 7 hours post dosing. However,u00a0the IOP-lowering of n BID was less (approximately 1-2 mmu00a0Hg) than that seen with the concomitant administration of 0.5% timolol BID and 0.2% brimonidine tartrate TID. n administered BID had a favorable safety profile versus concurrently administered brimonidine TID and timolol BID in the self-reported level of severity of sleepiness for patients over age 40.

COMBIGANn- Array
5 mL in 10 mL bottlenttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-9211-05
10 mL in 10 mL bottlenttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-9211-10
15 mL in 15 mL bottlenttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-9211-15
Storage:

Patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiac failure should be advised not to take this product n n n n .
Patients should be instructed that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures,u00a0can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions or by inadvertent contact with the dropper tipu00a0n n . Always replace the cap after using. If solution changes color or becomes cloudy, do not use. Do not use the product after the expiration date marked on the bottle.
Patients also should be advised that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
Patients should be advised that n contains benzalkonium chloride which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of n .
As with other similar medications, n may cause fatigue and/or drowsiness in some patients. Patients who engage in hazardous activities should be cautioned of the potential for a decrease in mental alertness.
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u00a9 2015 Allergan.u00a0All rights reserved.
Irvine, CA 92612, U.S.A.
All trademarks are the property of their respective owners.
Patented. See: www.allergan.com/products/patent_notices
Made in the U.S.A.
72060US15

NDC 0023-9211-05CombiganRx Only5 mLsterile

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Brimonidine Tartrate, Timolol Maleate (Combigan)

Trade Name : COMBIGAN

SOLUTION/ DROPS

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Brimonidine Tartrate, Timolol Maleate (Combigan)

Trade Name : COMBIGAN

SOLUTION/ DROPS

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Disclaimer

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