Dorzolamide Hydrochloride and Timolol Maleate

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Overview

What is Dorzolamide Hydrochloride and Timolol Maleate?

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent.

Dorzolamide hydrochloride is described chemically as:

(4)-4-(ethylamino)-5,6-dihydro-6-methyl-4thieno[2,3-]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is:

[α] 25°C (C=1, water) = ~ -17°.

405nm

Its molecular formula is CHNOS•HCl and its structural formula is:

Dorzolamide hydrochloride has a molecular weight of 360.91. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol.

Timolol maleate is described chemically as:

(-)-1-(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:

[α] 25°C in 1N HCl (C = 5) = -12.2° (-11.7° to -12.5°).

405nm

Its molecular formula is CHNOS•CHO 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.

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied as a sterile, clear, colorless to nearly colorless, isotonic, buffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242-323 mOsM. Each mL of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution contains 20 mg dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (6.83 mg timolol maleate). Inactive ingredients are sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and water for injection. Benzalkonium chloride 0.0075% is added as a preservative.

What does Dorzolamide Hydrochloride and Timolol Maleate look like?

What are the available doses of Dorzolamide Hydrochloride and Timolol Maleate?

Solution containing 20 mg/mL dorzolamide and 5 mg/mL timolol. ()

What should I talk to my health care provider before I take Dorzolamide Hydrochloride and Timolol Maleate?

How should I use Dorzolamide Hydrochloride and Timolol Maleate?

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution adminstered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2 % dorzolamide administered three times a day. (see ).

The dose is one drop of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution in the affected eye(s) two times daily.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart (see also ).

What interacts with Dorzolamide Hydrochloride and Timolol Maleate?

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What are the warnings of Dorzolamide Hydrochloride and Timolol Maleate?

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What are the precautions of Dorzolamide Hydrochloride and Timolol Maleate?

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What are the side effects of Dorzolamide Hydrochloride and Timolol Maleate?

Sorry No records found

What should I look out for while using Dorzolamide Hydrochloride and Timolol Maleate?

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is contraindicated in patients with:

•Bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.()

•Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock. ()

•Hypersensitivity to any component of this product. (, )

What might happen if I take too much Dorzolamide Hydrochloride and Timolol Maleate?

Symptoms consistent with systemic administration of beta-blockers or carbonic anhydrase inhibitors may occur, including electrolyte imbalance, development of an acidotic state, dizziness, headache, shortness of breath, bradycardia, bronchospasm, cardiac arrest and possible central nervous system effects. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. [See Adverse Reactions ()].

A study of patients with renal failure showed that timolol did not dialyze readily.

How should I store and handle Dorzolamide Hydrochloride and Timolol Maleate?

Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.]For Single-use only.Discard unused portion.Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.]For Single-use only.Discard unused portion.Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.]For Single-use only.Discard unused portion.Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is a clear, colorless to nearlycolorless, slightly viscous solution. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied in a white LDPE plastic DROP-TAINER* bottle with a natural LDPE dropper tip and a blue polypropylene cap as follows:NDC 61314-030-01, 5 mL in a 8 mL capacity bottleNDC 61314-030-02, 10 mL in a 10 mL capacity bottle. StorageStore Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution at 2° to 25°C (36° to 77°F). Protect from light.Rx only*DROP-TAINER is a registered trademark of Alcon Research, Ltd.Manufactured byAlcon Laboratories, Inc.Fort Worth, Texas 76134 forSandoz Inc.Princeton, NJ 08540 9014300Revised September 2017Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is a clear, colorless to nearlycolorless, slightly viscous solution. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied in a white LDPE plastic DROP-TAINER* bottle with a natural LDPE dropper tip and a blue polypropylene cap as follows:NDC 61314-030-01, 5 mL in a 8 mL capacity bottleNDC 61314-030-02, 10 mL in a 10 mL capacity bottle. StorageStore Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution at 2° to 25°C (36° to 77°F). Protect from light.Rx only*DROP-TAINER is a registered trademark of Alcon Research, Ltd.Manufactured byAlcon Laboratories, Inc.Fort Worth, Texas 76134 forSandoz Inc.Princeton, NJ 08540 9014300Revised September 2017Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is a clear, colorless to nearlycolorless, slightly viscous solution. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied in a white LDPE plastic DROP-TAINER* bottle with a natural LDPE dropper tip and a blue polypropylene cap as follows:NDC 61314-030-01, 5 mL in a 8 mL capacity bottleNDC 61314-030-02, 10 mL in a 10 mL capacity bottle. StorageStore Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution at 2° to 25°C (36° to 77°F). Protect from light.Rx only*DROP-TAINER is a registered trademark of Alcon Research, Ltd.Manufactured byAlcon Laboratories, Inc.Fort Worth, Texas 76134 forSandoz Inc.Princeton, NJ 08540 9014300Revised September 2017Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is a clear, colorless to nearlycolorless, slightly viscous solution. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied in a white LDPE plastic DROP-TAINER* bottle with a natural LDPE dropper tip and a blue polypropylene cap as follows:NDC 61314-030-01, 5 mL in a 8 mL capacity bottleNDC 61314-030-02, 10 mL in a 10 mL capacity bottle. StorageStore Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution at 2° to 25°C (36° to 77°F). Protect from light.Rx only*DROP-TAINER is a registered trademark of Alcon Research, Ltd.Manufactured byAlcon Laboratories, Inc.Fort Worth, Texas 76134 forSandoz Inc.Princeton, NJ 08540 9014300Revised September 2017Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is a clear, colorless to nearlycolorless, slightly viscous solution. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied in a white LDPE plastic DROP-TAINER* bottle with a natural LDPE dropper tip and a blue polypropylene cap as follows:NDC 61314-030-01, 5 mL in a 8 mL capacity bottleNDC 61314-030-02, 10 mL in a 10 mL capacity bottle. StorageStore Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution at 2° to 25°C (36° to 77°F). Protect from light.Rx only*DROP-TAINER is a registered trademark of Alcon Research, Ltd.Manufactured byAlcon Laboratories, Inc.Fort Worth, Texas 76134 forSandoz Inc.Princeton, NJ 08540 9014300Revised September 2017Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is a clear, colorless to nearlycolorless, slightly viscous solution. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied in a white LDPE plastic DROP-TAINER* bottle with a natural LDPE dropper tip and a blue polypropylene cap as follows:NDC 61314-030-01, 5 mL in a 8 mL capacity bottleNDC 61314-030-02, 10 mL in a 10 mL capacity bottle. StorageStore Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution at 2° to 25°C (36° to 77°F). Protect from light.Rx only*DROP-TAINER is a registered trademark of Alcon Research, Ltd.Manufactured byAlcon Laboratories, Inc.Fort Worth, Texas 76134 forSandoz Inc.Princeton, NJ 08540 9014300Revised September 2017Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is a clear, colorless to nearlycolorless, slightly viscous solution. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied in a white LDPE plastic DROP-TAINER* bottle with a natural LDPE dropper tip and a blue polypropylene cap as follows:NDC 61314-030-01, 5 mL in a 8 mL capacity bottleNDC 61314-030-02, 10 mL in a 10 mL capacity bottle. StorageStore Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution at 2° to 25°C (36° to 77°F). Protect from light.Rx only*DROP-TAINER is a registered trademark of Alcon Research, Ltd.Manufactured byAlcon Laboratories, Inc.Fort Worth, Texas 76134 forSandoz Inc.Princeton, NJ 08540 9014300Revised September 2017Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is a clear, colorless to nearlycolorless, slightly viscous solution. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied in a white LDPE plastic DROP-TAINER* bottle with a natural LDPE dropper tip and a blue polypropylene cap as follows:NDC 61314-030-01, 5 mL in a 8 mL capacity bottleNDC 61314-030-02, 10 mL in a 10 mL capacity bottle. StorageStore Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution at 2° to 25°C (36° to 77°F). Protect from light.Rx only*DROP-TAINER is a registered trademark of Alcon Research, Ltd.Manufactured byAlcon Laboratories, Inc.Fort Worth, Texas 76134 forSandoz Inc.Princeton, NJ 08540 9014300Revised September 2017Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is a clear, colorless to nearlycolorless, slightly viscous solution. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied in a white LDPE plastic DROP-TAINER* bottle with a natural LDPE dropper tip and a blue polypropylene cap as follows:NDC 61314-030-01, 5 mL in a 8 mL capacity bottleNDC 61314-030-02, 10 mL in a 10 mL capacity bottle. StorageStore Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution at 2° to 25°C (36° to 77°F). Protect from light.Rx only*DROP-TAINER is a registered trademark of Alcon Research, Ltd.Manufactured byAlcon Laboratories, Inc.Fort Worth, Texas 76134 forSandoz Inc.Princeton, NJ 08540 9014300Revised September 2017Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is a clear, colorless to nearlycolorless, slightly viscous solution. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied in a white LDPE plastic DROP-TAINER* bottle with a natural LDPE dropper tip and a blue polypropylene cap as follows:NDC 61314-030-01, 5 mL in a 8 mL capacity bottleNDC 61314-030-02, 10 mL in a 10 mL capacity bottle. StorageStore Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution at 2° to 25°C (36° to 77°F). Protect from light.Rx only*DROP-TAINER is a registered trademark of Alcon Research, Ltd.Manufactured byAlcon Laboratories, Inc.Fort Worth, Texas 76134 forSandoz Inc.Princeton, NJ 08540 9014300Revised September 2017

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is comprised of two components: dorzolamide hydrochloride and timolol maleate. Each of these two components decreases elevated intraocular pressure, whether or not associated with glaucoma, by reducing aqueous humor secretion. Elevated intraocular pressure is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss. The higher the level of intraocular pressure, the greater the likelihood of glaucomatous field loss and optic nerve damage.

Dorzolamide hydrochloride is an inhibitor of human carbonic anhydrase II. 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. 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. The combined effect of these two agents administered as Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution twice daily results in additional intraocular pressure reduction compared to either component administered alone, but the reduction is not as much as when dorzolamide administered three times daily and timolol twice daily are administered concomitantly. [See Clinical Studies ()].

Non-Clinical Toxicology

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is contraindicated in patients with:

•Bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.()

•Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock. ()

•Hypersensitivity to any component of this product. (, )

Read this information before you start using Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution and each time you refill your prescription.

This is in case any information has changed. This leaflet provides a summary of certain information about Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution. Your doctor or pharmacist can give you more complete information about Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution. This leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution when you start using your medicine at regular checkups. Only your doctor can prescribe Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution for you.

What is Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution?

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is an eyedrop. It contains dorzolamide hydrochloride, which is an ophthalmic carbonic anhydrase inhibiting drug. It also contains timolol maleate, which is a beta-blocking drug. Both drugs work to lower pressure in the eye, but in different ways.

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is a medicine for lowering pressure in the eye in people with open-angle glaucoma or ocular hypertension. It is used when a beta-blocker eyedrop alone is not adequate to control eye pressure.

What should I know about high pressure in the eye?

People with open-angle glaucoma or ocular hypertension have pressures in one or both of their eye(s) that are too high for them.

High pressure in the eye may damage the optic nerve. This may lead to loss of vision and possible blindness. There generally are few symptoms that you can feel to tell you whether you have high pressure within your eye. Your doctor needs to examine your eyes to determine this. If you have high pressure in your eye, you will need your pressure checked and your eyes examined regularly.

Who should not use Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution?

Do not use Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution if you have:

• asthma or have ever had asthma,

• severe lung problems, (such as chronic obstructive pulmonary disease),

•heart problems, including slow or irregular heartbeat or heart failure,

•allergies to any of its ingredients. See the list at the end of the leaflet.

If you are not sure whether you should use Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, contact your doctor or pharmacist.

What should I tell my doctor before and during treatment with Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution?

Tell your doctor:

How should I use Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution?

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is an eyedrop. The usual dose is one drop in the morning and one drop in the evening. Your doctor will tell you if just one or both eyes are to be treated.

If you are using Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution with another eyedrop, the eyedrops should be used at least 5 minutes apart. It is very important to use your medication exactly as directed by your doctor. If you stop using your medicine, contact your doctor immediately.

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution contains a preservative called benzalkonium chloride. This preservative may be absorbed by soft contact lenses. Contact lenses should be removed before using Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution. The lenses can be placed back into your eyes 15 minutes after using the eyedrops.

Do not allow the tip of the bottle to touch the eye or areas around the eye. The bottle may become contaminated with bacteria. This can cause eye infections leading to serious damage to the eye, even loss of vision. Keep the tip of the bottle away from contact with any surface to avoid contamination.

INSTRUCTION FOR USE

Please follow these instructions carefully when using Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution. Use Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution as prescribed by your doctor.

How to Use the DROP-TAINER** Bottle

The DROP-TAINER bottle is designed to assure the delivery of a precise dose of medication. Before using your DROP-TAINER bottle, read the complete instructions carefully.

1. If you use other topically applied ophthalmic medications, they should be administered at least 5 minutes before or after Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution.

2. Wash hands before each use.

3. Before using the medication for the first time, be sure the Safety Seal on the bottle is unbroken. A gap between the bottle and the cap is normal for an unopened bottle.

4. Tear off the Safety Seal to break the seal.

5. Before each use, shake once and remove the screw cap.

6. Invert the bottle and hold the bottle between your thumb and middle finger, with the tips of the fingers pointing towards you.

7. Tilt your head back and position the bottle above the affected eye.

8. With the opposite hand, place a finger under the eye. Gently pull down until a "V" pocket is made between your eye and lower lid.

DO NOT TOUCH YOUR EYE OR EYELID WITH THE TIP OF THE DROPPER TIP.

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.

9. With the hand holding the bottle, place your index finger on the bottom of the bottle. Push the bottom of the bottle to dispense one drop of medication.

DO NOT SQUEEZE THE SIDES OF THE BOTTLE.

KEEP YOUR HEAD TILTED BACKWARD AND CLOSE YOUR EYE TO ALLOW ABSORPTION OF THE MEDICATION INTO THE EYE.

10. Repeat 6, 7, 8, & 9 with other eye if instructed to do so by your doctor.

11. Replace screw cap by turning until firmly touching the bottle.

12. The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip.

13. After you have used all doses, there will be some Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution left in the bottle. You should not be concerned since an extra amount of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution has been added and you will get the full amount of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution that your doctor prescribed. Do not attempt to remove the excess medicine from the bottle.

Can I use Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution with other medicines?

Tell your doctor or pharmacist about all drugs that you are using or plan to use. This includes other eyedrops and drugs obtained without a prescription. This is particularly important if you are taking medicine to lower blood pressure or to treat heart disease, medicines to treat diabetes, or if you are taking large doses of aspirin.

Ask your doctor's advice about taking Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution if you are also using:

Your doctor or pharmacist can tell you if any of the drugs you are using are in the above list.

What are the possible side effects of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution?

Any medicine may have unintended or undesirable effects. These are called side effects. Side effects may not occur, but if they do occur, you may need medical attention. The most common side effects you may experience are:

• eye symptoms such as burning and stinging, redness of the eye(s), blurred vision, tearing or itching.

• a bitter, sour or unusual taste after putting in your eyedrops.

Other side effects may occur rarely, and some of these may be serious. Tell your doctor right away if you experience:

• shortness of breath

• visual changes

• an irregular heartbeat and/or a slowing of your heart rate.

• severe skin reactions

The above list is NOT a complete list of side effects reported with Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution. Your doctor can discuss with you a more complete list of side effects. Please tell your doctor [or pharmacist] promptly about any of these or any other unusual symptom.

What should I do in case of an overdose?

If you swallow the contents of the bottle, contact your doctor immediately. Among other effects, you may feel light-headed, have difficulty breathing, or feel your heart rate has slowed.

How should I store Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution?

Keep your medicine in a safe place where children cannot reach it. Store Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution at room temperature 36 to 77°F (2 to 25°C). Protect the bottle from light. Do not use your medicine after the expiration date on the bottle.

What else should I know about Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution?

Do not use Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution for a condition for which it was not prescribed. Do not give Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution to other people, even if they have the same condition you have. It may harm them.

Inactive ingredients:

The inactive ingredients of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution are sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, water for injection and benzalkonium chloride added as a preservative.

**DROP-TAINER® is a registered trademark of Alcon Research, Ltd.

* The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.

Manufactured byAlcon Laboratories, Inc.Fort Worth, Texas 76134 forSandoz Inc.Princeton, NJ 08540

9014300-0917

Revised: September 2017

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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