Dorzolamide HCl and Timolol Maleate (Page 5 of 6)

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (Patient Information).

17.1 Potential for Exacerbation of Asthma and COPD

Dorzolamide hydrochloride-timolol maleate ophthalmic solution may cause severe worsening of asthma and COPD symptoms including death due to bronchospasm. Advise patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease not to take this product. [see Contraindications ( 4.1)].

17.2 Potential of Cardiovascular Effects

Dorzolamide hydrochloride-timolol maleate ophthalmic solution may cause worsening of cardiac symptoms. Advise patients with sinus bradycardia, second or third degree atrioventricular block, or cardiac failure not to take this product. [see Contraindications ( 4.2)].

17.3 Sulfonamide Reactions

Dorzolamide hydrochloride-timolol maleate ophthalmic solution contains dorzolamide (which 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, including severe skin reactions. Advise patients that if serious or unusual reactions or signs of hypersensitivity occur, they should discontinue the use of the product and seek their physician’s advice. [see Warnings and Precautions ( 5.3)].

17.4 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. [see Warnings and Precautions ( 5.12)].

17.5 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.

17.6 Concomitant Topical Ocular Therapy

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

17.7 Contact Lens Use

Advise patients that dorzolamide hydrochloride-timolol maleate 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 administration of dorzolamide hydrochloride-timolol maleate ophthalmic solution.

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

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

Revised: September 2015

Patient Information about

Dorzolamide H ydrochloride- T imolol M aleate O phthalmic S olution , USP

(door-ZOLE-ah-mide hye-droe-klor-ide tye-MOE-lawl MAL-ee-ate)

Read this information before you start using dorzolamide hydrochloride-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-timolol maleate ophthalmic solution. Your doctor or pharmacist can give you more complete information about dorzolamide hydrochloride-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-timolol maleate ophthalmic solution when you start using your medicine at regular checkups. Only your doctor can prescribe dorzolamide hydrochloride-timolol maleate ophthalmic solution for you.

What is dorzolamide hydrochloride-timolol maleate ophthalmic solution ?
Dorzolamide hydrochloride-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-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-timolol maleate ophthalmic solution ?

Do not use dorzolamide hydrochloride-timolol maleate ophthalmic solution if you have:

  • 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-timolol maleate ophthalmic solution, contact your doctor or pharmacist.

What should I tell my doctor before and during treatment with dorzolamide hydrochloride-timolol maleate ophthalmic solution ?

Tell your doctor:

  • if you are pregnant or plan to become pregnant,
  • if you are breastfeeding or intend to breastfeed,
  • about any medical problems you have now or had in the past, especially heart problems or breathing problems including asthma,
  • if you now have or had in the past kidney or liver problems,
  • if you have diabetes, thyroid disease or muscle weakness,
  • about all medicines that you are taking or plan to take, including those you can get without a prescription,
  • about any allergies including allergies to any medications, especially sulfa drugs,
  • if you develop an eye infection, develop a red or swollen eye or eyelid, receive an eye injury, have eye surgery, or develop new or worsening eye symptoms,
  • if you plan on having any type of surgery.

How should I use dorzolamide hydrochloride-timolol maleate ophthalmic solution ? Dorzolamide hydrochloride-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-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-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-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.

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