DORZOLAMIDE HYDROCHLORIDE - dorzolamide hydrochloride solution/ drops

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1)
Available from:
Alembic Pharmaceuticals Inc.
Administration route:
OPHTHALMIC
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.1) ]. Teratogenic Effects . Pregnancy Category C. Developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥ 2.5 mg/kg/day revealed malformations of the vertebral bodies. These malformations occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased fetal weights. No treatment-related malformations were seen at 1 mg/kg/day. These doses represent estimated plasma Cmax levels in rabbits, 37 and 15 times higher than the lower limit of detection in human plasma following ocular administration, respectively. There are no adequate and well-controlled studies in pregnant women. Dorzolamide hydrochloride o
Product summary:
Dorzolamide hydrochloride ophthalmic solution, USP 2% is supplied in sterile white low density polyethylene round screw neck bottle with high density polyethylene orange screw cap. 10 mL in a 10 mL bottle NDC 62332-519-10 Storage: Store Dorzolamide hydrochloride ophthalmic solution, USP at 20° - 25° C (68° - 77° F) [see USP Controlled Room Temperature].Excursions permitted to 15° - 30° C (59° - 86° F). Protect from light.
Authorization status:
Abbreviated New Drug Application
Authorization number:
62332-519-10

DORZOLAMIDE HYDROCHLORIDE - dorzolamide hydrochloride solution/ drops

Alembic Pharmaceuticals Inc.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DORZOLAMIDE HYDROCHLORIDE

OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for DORZOLAMIDE

HYDROCHLORIDE OPHTHALMIC SOLUTION.

DORZOLAMIDE HYDROCHLORIDE ophthalmic solution

Initial U.S. Approval: 1994

INDICATIONS AND USAGE

Dorzolamide hydrochloride ophthalmic solution is a carbonic anhydrase inhibitor indicated in the treatment of elevated

intraocular pressure in patients with ocular hypertension or open-angle glaucoma. (1)

DOSAGE AND ADMINISTRATION

The dose is one drop of dorzolamide hydrochloride ophthalmic solution in the affected eye(s) three times daily.

Dorzolamide hydrochloride ophthalmic solution 2% may be used concomitantly with other topical ophthalmic drug

products to lower intraocular pressure. (2)

DOSAGE FORMS AND STRENGTHS

Solution containing 20 mg/mL dorzolamide. (3)

CONTRAINDICATIONS

Dorzolamide hydrochloride ophthalmic solution 2% is contraindicated in patients who are hypersensitive to any component

of this product. (4,5.1)

WARNINGS AND PRECAUTIONS

Sulfonamide Hypersensitivity. (5.1)

Bacterial Keratitis (5.2)

Corneal Endothelium (5.3)

Allergic Reactions (5.4)

Acute Angle-Closure Glaucoma (5.5)

ADVERSE REACTIONS

The most frequently reported adverse reactions associated with dorzolamide hydrochloride ophthalmic solution 2% were

ocular burning, stinging, or discomfort immediately following ocular administration (approximately one-third of patients).

Approximately one-quarter of patients noted a bitter taste following administration, Superficial punctate keratitis occurred

in 10 to 15% of patients and signs and symptoms of ocular allergic reaction in approximately 10%. (6).

To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Inc. at 1-866-210-9797 or

FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

Potential additive effect of oral carbonic anhydrase inhibitor with dorzolamide hydrochloride ophthalmic solution 2%.

(7.1)

Potential acid-base and electrolyte disturbances. (7.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2019

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS & USAGE

2 DOSAGE & ADMINISTRATION

3 DOSAGE FORMS & STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Sulfonamide Hypersensitivity

5.1 Sulfonamide Hypersensitivity

5.2 Bacterial Keratitis

5.3 Corneal Endothelium

5.4 Allergic Reactions

5.5 Acute Angle-Closure Glaucoma

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

6.2 Post-marketing Experience

7 DRUG INTERACTIONS

7.1 Oral Carbonic Anhydrase Inhibitors

7.2 High-Dose Salicylate Therapy

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal and Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis & Mutagenesis & Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Sulfonamide Reactions

17.2 Intercurrent Ocular Conditions

17.3 Handling Ophthalmic Solutions

17.4 Concomitant Topical Ocular Therapy

17.5 Contact Lens Use

17.6 Patient Instructions

FULL PRESCRIBING INFORMATION

1 INDICATIONS & USAGE

Dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular

pressure in patients with ocular hypertension or open-angle glaucoma.

2 DOSAGE & ADMINISTRATION

The dose is one drop of dorzolamide hydrochloride ophthalmic solution in the affected eye(s) three

times daily. Dorzolamide hydrochloride ophthalmic solution may be used concomitantly with other

topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic

drug is being used, the drugs should be administered at least five minutes apart.

Sections or subsections omitted from the full prescribing information are not listed.

3 DOSAGE FORMS & STRENGTHS

Solution containing 20 mg/mL dorzolamide (22.3 mg of dorzolamide hydrochloride, USP).

4 CONTRAINDICATIONS

Dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to

any component of this product [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Sulfonamide Hypersensitivity

Dorzolamide hydrochloride ophthalmic solution contain dorzolamide, a sulfonamide; and although

administered topically, it is absorbed systemically. Therefore, the same types of adverse reactions that

are attributable to sulfonamides may occur with topical administration of dorzolamide hydrochloride

ophthalmic solution. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides

including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis,

agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitization may recur when a

sulfonamide is readministered irrespective of the route of administration. If signs of serious reactions

or hypersensitivity occur, discontinue the use of this preparation [see Contraindications (4) and Patient

Counseling Information (17.3)].

5.2 Bacterial Keratitis

There have been reports of bacterial keratitis associated with the use of multiple-dose containers of

topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in

most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.

5.3 Corneal Endothelium

Carbonic anhydrase activity has been observed in both the cytoplasm and around the plasma membranes

of the corneal endothelium. There is an increased potential for developing corneal edema in patients

with low endothelial cell counts. Caution should be used when prescribing dorzolamide hydrochloride

ophthalmic solution to this group of patients.

5.4 Allergic Reactions

In clinical studies, local ocular adverse effects, primarily conjunctivitis and lid reactions, were reported

with chronic administration of dorzolamide hydrochloride ophthalmic solution. Many of these reactions

had the clinical appearance and course of an allergic-type reaction that resolved upon discontinuation of

drug therapy. If such reactions are observed, dorzolamide hydrochloride ophthalmic solution should be

discontinued and the patient evaluated before considering restarting the drug [see Adverse Reactions (6)].

5.5 Acute Angle-Closure Glaucoma

The management of patients with acute angle-closure glaucoma requires therapeutic interventions in

addition to ocular hypotensive agents.

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed

in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug

and may not reflect the rates observed in practice.

Controlled clinical trials: The most frequent adverse reactions associated with dorzolamide

hydrochloride ophthalmic solution were ocular burning, stinging, or discomfort immediately following

ocular administration (approximately one-third of patients). Approximately one-quarter of patients noted

a bitter taste following administration. Superficial punctate keratitis occurred in 10 to 15% of patients

and signs and symptoms of ocular allergic reaction in approximately 10%. Reactions occurring in

approximately 1 to 5% of patients were conjunctivitis and lid reactions [see Warnings and Precautions

(5.5)], blurred vision, eye redness, tearing, dryness, and photophobia. Other ocular reactions and

systemic reactions were reported infrequently, including headache, nausea, asthenia/fatigue; and, rarely,

skin rashes, urolithiasis, and iridocyclitis.

In a 3-month, double-masked, active-treatment-controlled, multicenter study in pediatric patients, the

adverse reactions profile of dorzolamide hydrochloride ophthalmic solution was comparable to that

seen in adult patients.

6.2 Post-marketing Experience

The following adverse reactions have been identified during post-approval use of dorzolamide

hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a population

of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal

relationship to drug exposure: signs and symptoms of systemic allergic reactions including angioedema,

bronchospasm, pruritus, and urticaria; Stevens-Johnson syndrome and toxic epidermal necrolysis;

dizziness, paresthesia; ocular pain, transient myopia, choroidal detachment following filtration surgery,

eyelid crusting; dyspnea; contact dermatitis, epistaxis, dry mouth and throat irritation.

7 DRUG INTERACTIONS

7.1 Oral Carbonic Anhydrase Inhibitors

There is a potential for an additive effect on the known systemic effects of carbonic anhydrase

inhibition in patients receiving an oral carbonic anhydrase inhibitor and dorzolamide hydrochloride

ophthalmic solution. The concomitant administration of dorzolamide hydrochloride ophthalmic solution

and oral carbonic anhydrase inhibitors is not recommended.

7.2 High-Dose Salicylate Therapy

Although acid-base and electrolyte disturbances were not reported in the clinical trials with

dorzolamide hydrochloride ophthalmic solution, these disturbances have been reported with oral

carbonic anhydrase inhibitors and have, in some instances, resulted in drug interactions (e.g., toxicity

associated with high-dose salicylate therapy). Therefore, the potential for such drug interactions

should be considered in patients receiving dorzolamide hydrochloride ophthalmic solution.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects. Pregnancy Category C. Developmental toxicity studies with dorzolamide

hydrochloride in rabbits at oral doses of ≥ 2.5 mg/kg/day revealed malformations of the vertebral

bodies. These malformations occurred at doses that caused metabolic acidosis with decreased body

weight gain in dams and decreased fetal weights. No treatment-related malformations were seen at 1

mg/kg/day. These doses represent estimated plasma C

levels in rabbits, 37 and 15 times higher than

the lower limit of detection in human plasma following ocular administration, respectively.

There are no adequate and well-controlled studies in pregnant women. Dorzolamide hydrochloride

ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential

risk to the fetus.

8.3 Nursing Mothers

In a study of dorzolamide hydrochloride in lactating rats, decreases in body weight gain of 5 to 7% in

offspring at an oral dose of 7.5 mg/kg/day were seen during lactation. A slight delay in postnatal

development (incisor eruption, vaginal canalization and eye openings), secondary to lower fetal body

weight, was noted. This dose represents an estimated plasma C

level in rats, 52 times higher than the

lower limit of detection in human plasma following ocular administration.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human

milk and because of the potential for serious adverse reactions in nursing infants from dorzolamide

hydrochloride ophthalmic solution, a decision should be made whether to discontinue nursing or to

discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

Safety and effectiveness of dorzolamide hydrochloride ophthalmic solution have been demonstrated in

pediatric patients in a 3-month, multicenter, double-masked, active-treatment-controlled trial.

8.5 Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger

patients.

8.6 Renal and Hepatic Impairment

Dorzolamide has not been studied in patients with severe renal impairment (CrCl < 30 mL/min). Because

dorzolamide and its metabolite are excreted predominantly by the kidney, dorzolamide hydrochloride

ophthalmic solution is not recommended in such patients.

Dorzolamide has not been studied in patients with hepatic impairment and should therefore be used with

caution in such patients.

10 OVERDOSAGE

Electrolyte imbalance, development of an acidotic state, and possible central nervous system effects

may occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

11 DESCRIPTION

Dorzolamide hydrochloride ophthalmic solution, USP is a carbonic anhydrase inhibitor formulated for

topical ophthalmic use.

Dorzolamide hydrochloride, USP is described chemically as: (4S, 6S)-4-(ethylamino)-5,6-dihydro-6-

methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide

hydrochloride, USP is optically active. The specific rotation is

α 25° (C=1, water) = ~ -17°.

Its empirical formula is C

H N O S .HCl and its structural formula is:

Dorzolamide hydrochloride, USP has a molecular weight of 360.9 and melting point of about 259 °C

to 267 °C. It is a white to off-white, crystalline powder, which is soluble in water, slightly soluble in

methanol, very slightly soluble in anhydrous ethanol.

Dorzolamide hydrochloride sterile ophthalmic solution, USP is supplied as slightly opalescent, nearly

colorless, slightly viscous solution, free from foreign visible particles. The pH of the solution is

between 5.40 and 5.90, and the osmolarity is 260-330 mOsm/L. Each mL of Dorzolamide hydrochloride

ophthalmic solution, USP 2% contains 20 mg dorzolamide (22.3 mg of dorzolamide hydrochloride,

USP). Inactive ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium

hydroxide (to adjust pH) and water for injection. Benzalkonium chloride 0.0075% is added as a

preservative.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Carbonic anhydrase (CA) is an enzyme found in many tissues of the body including the eye. It catalyzes

the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid.

In humans, carbonic anhydrase exists as a number of isoenzymes, the most active being carbonic

anhydrase II (CA-II), found primarily in red blood cells (RBCs), but also in other tissues. Inhibition of

carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably

by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport.

The result is a reduction in intraocular pressure (IOP).

Dorzolamide hydrochloride ophthalmic solution contains dorzolamide hydrochloride, an inhibitor of

human carbonic anhydrase II. Following topical ocular administration, Dorzolamide hydrochloride

ophthalmic solution reduces elevated intraocular pressure. Elevated intraocular pressure is a major risk

factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss.

12.3 Pharmacokinetics

When topically applied, dorzolamide reaches the systemic circulation. To assess the potential for

systemic carbonic anhydrase inhibition following topical administration, drug and metabolite

concentrations in RBCs and plasma and carbonic anhydrase inhibition in RBCs were measured.

Dorzolamide accumulates in RBCs during chronic dosing as a result of binding to CA-II. The parent

drug forms a single N-desethyl metabolite, which inhibits CA-II less potently than the parent drug but

also inhibits CA-I. The metabolite also accumulates in RBCs where it binds primarily to CA-I. Plasma

concentrations of dorzolamide and metabolite are generally below the assay limit of quantitation (15nM).

Dorzolamide binds moderately to plasma proteins (approximately 33%).

Dorzolamide is primarily excreted unchanged in the urine; the metabolite also is excreted in urine. After

dosing is stopped, dorzolamide washes out of RBCs nonlinearly, resulting in a rapid decline of drug

concentration initially, followed by a slower elimination phase with a half-life of about four months.

Dorzolamide is primarily excreted unchanged in the urine; the metabolite also is excreted in urine. After

dosing is stopped, dorzolamide washes out of RBCs nonlinearly, resulting in a rapid decline of drug

concentration initially, followed by a slower elimination phase with a half-life of about four months.

To simulate the systemic exposure after long-term topical ocular administration, dorzolamide was given

orally to eight healthy subjects for up to 20 weeks. The oral dose of 2 mg twice daily closely

approximates the amount of drug delivered by topical ocular administration of dorzolamide 2% three

times daily. Steady state was reached within 8 weeks. The inhibition of CA-II and total carbonic

anhydrase activities was below the degree of inhibition anticipated to be necessary for a

pharmacological effect on renal function and respiration in healthy individuals.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis & Mutagenesis & Impairment of Fertility

In a two-year study of dorzolamide hydrochloride administered orally to male and female Sprague-

Dawley rats, urinary bladder papillomas were seen in male rats in the highest dosage group of 20

mg/kg/day. Papillomas were not seen in rats given oral doses of 1 mg/kg/day. These doses represent

estimated plasma C

levels in rats, 138 and 7 times higher than the lower limit of detection in human

plasma following ocular administration, respectively.

No treatment-related tumors were seen in a 21-month study in female and male mice given oral doses up

to 75 mg/kg/day. This dose represents an estimated plasma C

level in mice, 582 times higher than the

lower limit of detection in human plasma following ocular administration.

The increased incidence of urinary bladder papillomas seen in the high-dose male rats is a class-effect

of carbonic anhydrase inhibitors in rats. Rats are particularly prone to developing papillomas in

response to foreign bodies, compounds causing crystalluria, and diverse sodium salts.

No changes in bladder urothelium were seen in dogs given oral dorzolamide hydrochloride for one

year at 2 mg/kg/day or monkeys dosed topically to the eye for one year. An oral dose of 2 mg/kg/day in

dogs represents an estimated plasma C

level, 137 times higher than the lower limit of detection in

human plasma following ocular administration. The topical ophthalmic dose in monkeys was

approximately equivalent to the human topical ophthalmic dose.

The following tests for mutagenic potential were negative: (1) in vivo (mouse) cytogenetic assay; (2) in

vitro chromosomal aberration assay; (3) alkaline elution assay; (4) V-79 assay; and (5) Ames test.

In reproduction studies of dorzolamide hydrochloride in rats, there were no adverse effects on the

reproductive capacity of males or females at doses of 15 and 7.5 mg/kg/day, respectively. These doses

represent estimated plasma C

levels in rats, 104 and 52 times higher than the lower limit of detection

in human plasma following ocular administration, respectively.

14 CLINICAL STUDIES

The efficacy of dorzolamide hydrochloride ophthalmic solution was demonstrated in clinical studies in

the treatment of elevated intraocular pressure in patients with glaucoma or ocular hypertension (baseline

IOP ≥23 mmHg). The IOP-lowering effect of dorzolamide hydrochloride ophthalmic solution was

approximately 3 to 5 mmHg throughout the day and this was consistent in clinical studies of up to one

year duration.

The efficacy of dorzolamide hydrochloride ophthalmic solution when dosed less frequently than three

times a day (alone or in combination with other products) has not been established.

In a one year clinical study, the effect of dorzolamide hydrochloride ophthalmic solution 2% three

times daily on the corneal endothelium was compared to that of betaxolol ophthalmic solution twice

daily and timolol maleate ophthalmic solution 0.5% twice daily. There were no statistically significant

differences between groups in corneal endothelial cell counts or in corneal thickness measurements.

There was a mean loss of approximately 4% in the endothelial cell counts for each group over the one

year period.

16 HOW SUPPLIED/STORAGE AND HANDLING

Dorzolamide hydrochloride ophthalmic solution, USP 2% is supplied in sterile white low density

polyethylene round screw neck bottle with high density polyethylene orange screw cap.

10 mL in a 10 mL bottle NDC 62332-519-10

Storage: Store Dorzolamide hydrochloride ophthalmic solution, USP at 20° - 25° C (68° - 77° F) [see

USP Controlled Room Temperature].Excursions permitted to 15° - 30° C (59° - 86° F). Protect from

light.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Instructions for Use).

17.1 Sulfonamide Reactions

Dorzolamide hydrochloride ophthalmic solution is a sulfonamide and although administered topically is

absorbed systemically. Therefore the same types of adverse reactions that are attributable to

sulfonamides may occur with topical administration. Advise patients that if serious or unusual reactions

including severe skin reactions or signs of hypersensitivity occur, they should discontinue the use of

the product [see Warnings and Precautions (5.1)].

17.2 Intercurrent Ocular Conditions

Advise patients 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.

17.3 Handling Ophthalmic Solutions

Instruct patients that ocular solutions, if handled improperly or if the tip of the dispensing container

contacts the eye or surrounding structures, can 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.

17.4 Concomitant Topical Ocular Therapy

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five

minutes apart.

17.5 Contact Lens Use

Advise patients that dorzolamide hydrochloride ophthalmic solution 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 Dorzolamide hydrochloride ophthalmic

solution administration.

17.6 Patient Instructions

Advise patients that if they develop any ocular reactions, particularly conjunctivitis and lid reactions,

they should discontinue use and seek their physician's advice.

Instruct patients to avoid allowing the tip of the dispensing container to contact the eye or surrounding

structures.

INSTRUCTIONS FOR USE

Dorzolamide Hydrochloride Ophthalmic Solution USP, 2%

(dor ZOL a mide)

Before using your dorzolamide hydrochloride ophthalmic solution

Before using your dorzolamide hydrochloride ophthalmic solution, for the first time, make sure the

tamper evident ring of the bottle is unbroken. A gap between the bottle and the cap is normal for an

unopened bottle.See Figure A.

Step 1. Wash your hands.

Step 2.Unscrew the cap by turning in the direction as shown in the Figure B.

Giving your dorzolamide hydrochloride ophthalmic solution drops.

Step 3. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your

eyelid and your eye. See FIGURE C.

Step 4. Hold the dorzolamide hydrochloride ophthalmic solution, 2% bottle upside down. Place tip as

close as possible to the lower eyelid without touching the tip to the eye, and gently squeeze until a

single drop is placed in your eye. Do not touch your eye or eyelid with the dropper tip. See FIGURE

D.

Step 5.If your doctor has told you to use Dorzolamide Hydrochloride Ophthalmic Solution USP, 2% in

both eyes, repeat steps 3 and 4.

After using your dorzolamide hydrochloride ophthalmic solution

Step 6. Replace the cap by turning it until it is firmly touching your bottle.

After you have used all of your dorzolamide hydrochloride ophthalmic solution, 2% doses, there will

be some dorzolamide hydrochloride ophthalmic solution, 2% medicine left in the dispenser. Do not try

to remove the extra medicine from the dorzolamide hydrochloride ophthalmic solution, 2% dispenser.

Throw away your dorzolamide hydrochloride ophthalmic solution, 2% dispenser in your household

trash.

How should I store dorzolamide hydrochloride ophthalmic solution?

Store dorzolamide hydrochloride ophthalmic solution between 59°F to 86°F (15°C to 30°C)

Protect from light

Safely throw away medicine that is out of date or no longer needed.

KEEP DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION AND ALL

MEDICINES OUT OF THE REACH OF CHILDREN.

Important information about using dorzolamide hydrochloride ophthalmic solution

If you have any eye or skin reactions, especially conjunctivitis or eyelid reactions to dorzolamide

hydrochloride ophthalmic solution, stop using it and call your doctor right away.

If you have eye surgery or have a problem such as trauma or infection of your eye while using

dorzolamide hydrochloride ophthalmic solution, call your doctor right away.

If you do not handle eye medicines the right way the medicine can become contaminated. If the tip of

the dispenser touches your eye or areas around your eye, the tip can become contaminated with bacteria

which can cause an eye infection and other serious problems including loss of eyesight.

If you use other eye medicines dropped onto the eye like dorzolamide hydrochloride ophthalmic

solution, use the medicines at least 5 minutes before or after you use dorzolamide hydrochloride

ophthalmic solution.

Dorzolamide hydrochloride ophthalmic solution contains benzalkonium chloride which may be

absorbed by soft contact lenses. If you wear contact lenses, remove them before you use your

dorzolamide hydrochloride ophthalmic solution. You can place your contact lenses back into your eyes

15 minutes after using your dorzolamide hydrochloride ophthalmic solution.

Manufactured for:

Alembic Pharmaceuticals Inc.

750 Route 202, Bridgewater, NJ 08807

Manufactured by:

Gland Pharma Limited,

D.P. Pally, Dundigal Post,

Hyderabad - 500043, INDIA.

Revised 06/2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dorzolamide Hydrochloride Ophthalmic Solution USP 2% - Bottle Label

Dorzolamide Hydrochloride Ophthalmic Solution USP 2% - Carton Label

DORZOLAMIDE HYDROCHLORIDE

dorzolamide hydrochloride solution/ drops

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 2332-519

Route of Administration

OPHTHALMIC

Alembic Pharmaceuticals Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

DO RZO LAMIDE HYDRO CHLO RIDE (UNII: QZO536 6 EW7) (DORZOLAMIDE -

UNII:9 JDX0 55TW1)

DORZOLAMIDE

20 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

HYDRO XYETHYL CELLULO SE ( 2 0 0 0 MPA.S AT 1%) (UNII: S38 J6 RZN16 )

MANNITO L (UNII: 3OWL53L36 A)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 2332-519 -10

1 in 1 CARTON

0 8 /0 9 /20 19

1

10 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA2126 39

0 8 /0 9 /20 19

Labeler -

Alembic Pharmaceuticals Inc. (079288842)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Gland Pharma Limited

9 18 6 0 1238

MANUFACTURE(6 2332-519 )

Revised: 8/2019

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