Cosopt

DRUG DESCRIPTION

COSOPT (dorzolamide hydrochloride-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: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-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 nm

Its empirical formula is C10H16N2O4S3HCl and its structural formula is:

Dorzolamide hydrochloride Structural Formula Illustration

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-(tert-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:

[?] 25C in 1N HCl (C = 5) = -12.2 (?11.7 to -12.5).
405 nm

Its molecular formula is C13H24N4O3SC4H4O4 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.

COSOPT (dorzolamide hydrochloride-timolol maleate ophthalmic solution) is supplied as a sterile, 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 COSOPT (dorzolamide hydrochloride-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 are the possible side effects of dorzolamide and timolol ophthalmic (Cosopt)?

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

Read All Potential Side Effects and See Pictures of Cosopt

What are the precautions when taking dorzolamide hydrochloride-timolol maleate ophthalmic solution (Cosopt)?

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

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: lung disease (e.g., current or past history of asthma, severe chronic obstructive pulmonary disease), certain types of irregular heartbeats (e.g., sinus bradycardia, second or third degree AV block), certain types of heart disease (e.g., severe heart failure).

Before using this medication, tell your...

Read All Potential Precautions of Cosopt


Cosopt Consumer (continued)

SIDE EFFECTS: Temporary blurred vision, temporary burning/stinging/itching/redness of the eye, watery eyes, dry eyes, feeling as if something is in the eye, sensitivity of eyes to light, strange taste in the mouth, headache, dizziness, or drowsiness 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 unlikely but serious side effects occur: slow/irregular heartbeat, muscle weakness, mental/mood changes, coldness/numbness/pain in the hands or feet.

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/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, trouble breathing, sudden unexplained weight gain, chest pain, weakness on one side of the body, slurred speech, confusion, persistent dizziness, fainting.

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 timolol/dorzolamide, tell your doctor or pharmacist if you are allergic to these drugs; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: lung disease (e.g., current or past history of asthma, severe chronic obstructive pulmonary disease), certain types of irregular heartbeats (e.g., sinus bradycardia, second or third degree AV block), certain types of heart disease (e.g., severe heart failure).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, kidney stones, liver disease, diabetes, overactive thyroid disease, muscle weakness disorders, low blood flow to the brain (cerebrovascular insufficiency), severe allergies.

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 timolol/dorzolamide. You may be advised to start using a new bottle.

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy or drowsy or cause temporary blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

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

This drug passes into breast milk. Consult your doctor before breast-feeding.


Cosopt Patient Information Including Side Effects

Brand Names: Cosopt

Generic Name: dorzolamide and timolol ophthalmic (Pronunciation: dor ZOLE a mide and TYE moe lole)

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

What is dorzolamide and timolol ophthalmic (Cosopt)?

Dorzolamide ophthalmic reduces the amount of fluid in the eye, which decreases pressure inside the eye. Timolol ophthalmic is a beta-blocker that also reduces pressure inside the eye.

The combination of dorzolamide and timolol ophthalmic is used to treat certain types of glaucoma and other causes of high pressure inside the eye.

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

What are the possible side effects of dorzolamide and timolol ophthalmic (Cosopt)?

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, 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;
  • wheezing, gasping, or other breathing problems;
  • swelling, rapid weight gain; or
  • feeling short of breath, even with mild exertion.

Less serious side effects may include:

  • blurred vision, double vision, drooping eyelid;
  • burning or stinging in your eye;
  • unusual taste in your mouth;
  • stomach or back pain;
  • dizziness;
  • dry eyes;
  • nausea, upset stomach;
  • sore throat, stuffy nose; or
  • headache, or feeling light-headed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dorzolamide and timolol ophthalmic (Cosopt)?

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 and timolol ophthalmic. Do not use the medications at the same time.

Dorzolamide and timolol 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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