Simbrinza Ophthalmic Suspension 5 Ml

SIMBRINZA OPHTHALMIC SUSPENSION 5 ML

SIMBRINZA Ophthalmic Suspension is a prescription eye drop designed to reduce elevated intraocular pressure (IOP) in adults.

• Name:

  • Brand Name: SIMBRINZA® Ophthalmic Suspension
  • Common Name: Brinzolamide and Brimonidine Tartrate Ophthalmic Suspension

• Composition:

  • Active Ingredients: Each mL contains Brinzolamide 1% (10 mg/mL) and Brimonidine Tartrate 0.2% (2 mg/mL, equivalent to 1.3 mg as brimonidine free base).
  • Preservative: Benzalkonium chloride 0.03 mg/mL.

• Uses: SIMBRINZA is indicated for the reduction of elevated intraocular pressure (IOP) in patients with:

  • Open-angle glaucoma.
  • Ocular hypertension. It works by decreasing the production of fluid within the eye and increasing fluid drainage to help prevent optic nerve damage and vision loss.

• Dosage and Administration: The recommended dose is one drop in the affected eye(s) three times daily.

  • Shake well before use.
  • If using other topical ophthalmic medications, administer them at least five minutes apart.
  • Remove soft contact lenses before instilling drops and wait at least 15 minutes before reinsertion.
  • Avoid touching the dropper tip to the eye or any other surface to prevent contamination.

• Side Effects:

  • Common: Blurred vision, eye irritation (burning, stinging, redness, discomfort), bad taste in mouth, dry mouth, drowsiness, headache.
  • Serious: Allergic reactions (skin rash, itching, swelling of face, tongue, or throat), severe skin reactions (Stevens-Johnson syndrome), decreased blood pressure, severe eye pain or changes in vision, irregular heartbeat, difficulty breathing.

• Precautions:

  • Sulfa Allergy: Brinzolamide, an active ingredient, is a sulfonamide. Patients with a sulfa allergy may be allergic to SIMBRINZA.
  • Systemic Absorption: Although administered topically, systemic absorption can occur, potentially leading to systemic side effects similar to oral carbonic anhydrase inhibitors.
  • Medical Conditions: Use with caution in patients with severe renal impairment, liver disease, severe cardiovascular disease, depression, or vascular insufficiencies.
  • Pregnancy and Breastfeeding: Consult a doctor before use if pregnant or breastfeeding.
  • Pediatric Use: Contraindicated in children under 2 years of age. Use in children 2-17 years is not recommended as safety and efficacy have not been established.
  • Driving/Operating Machinery: May cause temporary blurred vision or drowsiness; exercise caution.

• Storage: Store at 2°C to 25°C (36°F to 77°F). Protect from light and keep the bottle tightly closed when not in use. Discard any remaining solution 4 weeks after opening.

Here are some frequently asked questions about SIMBRINZA Ophthalmic Suspension:

What is SIMBRINZA Ophthalmic Suspension used for?

SIMBRINZA Ophthalmic Suspension is used to lower high pressure inside the eye (elevated intraocular pressure, or IOP) in adults with open-angle glaucoma or ocular hypertension when a single medicine is not sufficient to reduce the pressure. This helps prevent damage to the optic nerve and potential vision loss.

How does SIMBRINZA Ophthalmic Suspension work?

SIMBRINZA contains two active ingredients: brinzolamide and brimonidine tartrate. Brinzolamide, a carbonic anhydrase inhibitor, and brimonidine tartrate, an alpha-2 adrenergic receptor agonist, work together to reduce the production of fluid (aqueous humor) inside your eye. Brimonidine also helps increase the drainage of this fluid from the eye, further contributing to lower eye pressure.

What is the usual dosage of SIMBRINZA Ophthalmic Suspension?

The typical recommended dosage is one drop in the affected eye(s) two times daily (twice a day). However, some prescribing information may indicate one drop three times daily. Always follow your doctor's specific instructions. Shake the bottle well before each use. If you are using other eye drops, wait at least 5 minutes between administering each medication.

What are the possible side effects of SIMBRINZA Ophthalmic Suspension?

Common mild side effects can include blurred vision, eye irritation, a burning or stinging sensation in the eye, a feeling that something is in your eye, changes in taste (often a bitter or unusual taste), dry mouth, dry eyes, eye redness, and headache.

More serious but less common side effects can include lowered blood pressure, slow or irregular heartbeat, fainting, severe dizziness, trouble breathing, and signs of an allergic reaction such as skin rash, redness, itching, or swelling of the face, tongue, or throat. If you experience any severe or concerning side effects, contact your doctor immediately.

Is SIMBRINZA Ophthalmic Suspension safe during pregnancy or breastfeeding?

SIMBRINZA Ophthalmic Suspension is generally not recommended during pregnancy, especially for women of childbearing potential who are not using contraception. It should only be used if the potential benefit to the mother outweighs the possible risks to the fetus, as animal studies suggest it can cross the placenta.

For breastfeeding mothers, use is also not recommended. It is not known if SIMBRINZA passes into human breast milk, though it has been found in animal milk. Your doctor will discuss the potential risks and benefits.

Can SIMBRINZA Ophthalmic Suspension be taken with other medications?

SIMBRINZA can be used alongside other topical eye medications for lowering intraocular pressure, provided they are administered at least 5 minutes apart.

However, certain medications can interact with SIMBRINZA. It should not be used if you are taking monoamine oxidase (MAO) inhibitors or certain antidepressants (like tricyclic antidepressants). Caution is advised when used with other medications that lower blood pressure (antihypertensives) or cardiac glycosides (e.g., digoxin), and with central nervous system (CNS) depressants (such as alcohol, sedatives, opiates). Concomitant use with oral carbonic anhydrase inhibitors is not recommended. Always inform your doctor about all medications, supplements, and herbal products you are taking.

What precautions should I take when using SIMBRINZA Ophthalmic Suspension?

Remove soft contact lenses before applying SIMBRINZA and wait at least 15 minutes before reinserting them, as the preservative (benzalkonium chloride) can be absorbed by the lenses and potentially cause discoloration or irritation.

Avoid touching the dropper tip to your eye or any other surface to prevent contamination of the medication.

SIMBRINZA may cause temporary blurred vision, dizziness, or drowsiness, so exercise caution when driving or operating machinery until you know how the medication affects you. Inform your doctor about any allergies, especially to sulfonamides, or existing medical conditions such as severe kidney disease, liver problems, heart conditions, depression, or compromised corneas. SIMBRINZA is contraindicated in infants younger than 2 years of age and its safety and efficacy in children aged 2-17 years have not been established.

What happens if I miss a dose of SIMBRINZA Ophthalmic Suspension?

If you miss a dose, simply continue with your next scheduled dose as planned. Do not use extra drops or a double dose to try and make up for the missed one.

How should SIMBRINZA Ophthalmic Suspension be stored?

Store SIMBRINZA Ophthalmic Suspension below 25°C (77°F), or between 2°C to 25°C (36°F to 77°F). Keep the bottle tightly closed and protect it from light. It is important to discard the bottle 4 weeks after opening to reduce the risk of contamination. Keep this medicine out of the sight and reach of children.