Trusopt

DRUG DESCRIPTION

TRUSOPT (dorzolamide hydrochloride ophthalmic solution) is a carbonic anhydrase inhibitor formulated for topical ophthalmic use.

Dorzolamide hydrochloride is described chemically as: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is

? 25° (C=1, water) = ~ -17°.
405

Its empirical formula is C10H16N2O4S3•HCl and its structural formula is:

TRUSOPT®
(dorzolamide hydrochloride) Structural Formula Illustration

Dorzolamide hydrochloride has a molecular weight of 360.9 and a melting point of about 264°C. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol.

TRUSOPT (dorzolamide hydrochloride ophthalmic solution) Sterile Ophthalmic Solution is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride. The pH of the solution is approximately 5.6, and the osmolarity is 260-330 mOsM. Each mL of TRUSOPT 2% contains 20 mg dorzolamide (22.3 mg of dorzolamide hydrochloride). 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.

What are the possible side effects of dorzolamide ophthalmic (Trusopt)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • swelling or redness of your eyelids;
  • eye redness, pain, discomfort, or sensitivity to light;
  • drainage, crusting, or oozing of your eyes or eyelids;
  • fever, sore throat, and headache with a severe blistering, peeling, and...

Read All Potential Side Effects and See Pictures of Trusopt »

What are the precautions when taking dorzolamide hydrochloride ophthalmic solution (Trusopt)?

Before using dorzolamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, kidney stones, liver disease.

If you develop an eye infection or injury, or have eye surgery, check with your doctor about whether you should continue to use your current bottle of dorzolamide. You may be advised to start using a new bottle.

Your vision may be temporarily blurred or unstable after applying this drug. Do not drive, use machinery, or...

Read All Potential Precautions of Trusopt »


Trusopt Consumer (continued)

SIDE EFFECTS: Temporary blurred vision, temporary burning/stinging/itching/redness of the eye, watery eyes, dry eyes, sensitivity of eyes to light, bitter taste, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes, signs of a kidney stone (e.g., pain in the back/side/abdomen, nausea/vomiting, blood in the urine), yellowing eyes or skin, dark urine, unusual tiredness or weakness, easy bruising/bleeding, signs of infection (e.g., fever, chills, persistent sore throat).

Seek immediate medical attention if any of these rare but very serious side effects occur: persistent eye redness or discharge, eye or eyelid swelling, eye pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using dorzolamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, kidney stones, liver disease.

If you develop an eye infection or injury, or have eye surgery, check with your doctor about whether you should continue to use your current bottle of dorzolamide. You may be advised to start using a new bottle.

Your vision may be temporarily blurred or unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Trusopt Patient Information Including Side Effects

Brand Names: Trusopt

Generic Name: dorzolamide ophthalmic (Pronunciation: dor ZOL a mide)

  • What is dorzolamide ophthalmic (Trusopt)?
  • What are the possible side effects of dorzolamide ophthalmic (Trusopt)?
  • What is the most important information I should know about dorzolamide ophthalmic (Trusopt)?
  • What should I discuss with my healthcare provider before using dorzolamide ophthalmic (Trusopt)?
  • How should I use dorzolamide ophthalmic (Trusopt)?
  • What happens if I miss a dose (Trusopt)?
  • What happens if I overdose (Trusopt)?
  • What should I avoid while using dorzolamide ophthalmic (Trusopt)?
  • What other drugs will affect dorzolamide ophthalmic (Trusopt)?
  • Where can I get more information?

What is dorzolamide ophthalmic (Trusopt)?

Dorzolamide reduces the amount of fluid in the eye, which decreases pressure inside the eye.

Dorzolamide ophthalmic (for the eyes) is used to treat open-angle glaucoma and other causes of high pressure inside the eye.

Dorzolamide ophthalmic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of dorzolamide ophthalmic (Trusopt)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • swelling or redness of your eyelids;
  • eye redness, pain, discomfort, or sensitivity to light;
  • drainage, crusting, or oozing of your eyes or eyelids;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • burning or stinging in your eye;
  • bitter or unusual taste in your mouth;
  • blurred vision;
  • dry or watery eyes;
  • headache;
  • weakness, tired feeling;
  • nausea; or
  • dry mouth, sore throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dorzolamide ophthalmic (Trusopt)?

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using dorzolamide ophthalmic. Do not use the medications at the same time.

Dorzolamide ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

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