Dorzolamide HCl and Timolol Maleate (Page 6 of 6)

INSTRUCTIONS FOR USE

Please follow these instructions carefully when using dorzolamide hydrochloride-timolol maleate ophthalmic solution. Use dorzolamide hydrochloride-timolol maleate ophthalmic solution as prescribed by your doctor.

1. If you use other topically applied ophthalmic medications, they should be administered at least 5 minutes before or after dorzolamide hydrochloride-timolol maleate ophthalmic solution.

2. Wash hands before each use.

3. Before using the medication for the first time, be sure the safety band around bottle neck is unbroken. A gap between the bottle cap and the safety band is normal for an unopened bottle.

Gap
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4. Turn the cap to break the safety band.

Turn cap
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5. To open the bottle, unscrew the cap by turning as indicated.

5. To open the bottle, unscrew the cap by turning as indicated.
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6. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.

6. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.
(click image for full-size original)

7. Invert the bottle, and squeeze lightly with the thumb or index finger (as shown) until a single drop is dispensed into the eye as directed by your doctor.

DO NOT TOUCH YOUR EYE OR EYELID WITH 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.

8. Repeat steps 6 & 7 with the other eye if instructed to do so by your doctor.

9. Replace the cap by turning until it is firmly on the bottle.

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

WARNING: Keep out of reach of children.

If you have any questions about the use of dorzolamide hydrochloride-timolol maleate ophthalmic solution, please consult your doctor.

Can I use dorzolamide hydrochloride-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-timolol maleate ophthalmic solution if you are also using:

  • oral carbonic anhydrase inhibitors (for example, acetazolamide, Diamox®)
  • oral beta-blockers (for example, propranolol, Inderal®)
  • calcium antagonists (for example, nifedipine, Procardia®)
  • catecholamine-depleting drugs (for example, reserpine)
  • digitalis in combination with calcium antagonists (for example, Lanoxin® with Procardia®)
  • quinidine (for example, Cardioquin®)
  • clonidine (for example, Catapres®)
  • injectable epinephrine (for example, EpiPen®)
  • certain antidepressants (for example, Prozac®)

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-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-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-timolol maleate ophthalmic solution ?

Keep your medicine in a safe place where children cannot reach it. Store dorzolamide hydrochloride-timolol maleate ophthalmic solution at room temperature (68 to 77°F, 20 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-timolol maleate ophthalmic solution ?

Do not use dorzolamide hydrochloride-timolol maleate ophthalmic solution for a condition for which it was not prescribed. Do not give dorzolamide hydrochloride-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-timolol maleate ophthalmic solution are sodium citrate, hydroxyethylcellulose, sodium hydroxide, mannitol, water for injection and benzalkonium chloride added as a preservative.

Manufactured by:
Indoco Remedies Limited
Verna, Goa – 403722, India

Distributed by:
Actavis Pharma, Inc. Parsippany, NJ 07054 USA

Revised: September 2015

Dorzolamide Hydrochloride and Timolol Maleate

Label ImageLabel Image
DORZOLAMIDE HCL AND TIMOLOL MALEATE dorzolamide hydrochloride and timolol maleate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2867(NDC:0591-2482)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DORZOLAMIDE HYDROCHLORIDE (DORZOLAMIDE) DORZOLAMIDE 20 mg in 1 mL
TIMOLOL MALEATE (TIMOLOL ANHYDROUS) TIMOLOL ANHYDROUS 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE, UNSPECIFIED FORM
SODIUM HYDROXIDE
MANNITOL
BENZALKONIUM CHLORIDE
WATER
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-2867-0 1 BOTTLE, DISPENSING in 1 CARTON contains a BOTTLE, DISPENSING
1 10 mL in 1 BOTTLE, DISPENSING This package is contained within the CARTON (50090-2867-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202054 02/17/2015
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-2867)

Revised: 02/2018 A-S Medication Solutions

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