VIGAMOX OPHTHALMIC SOLUTION

VIGAMOX Ophthalmic Solution is a sterile topical antibiotic eye drop manufactured by Novartis India Ltd. It is a potent anti-infective designed for ocular use.

• Name:

  • Brand Name: Vigamox
  • Common Name: Moxifloxacin Ophthalmic Solution

• Composition:

  • Active Ingredient: Each mL of VIGAMOX solution contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg (0.5%) moxifloxacin base.
  • Inactive Ingredients: Boric acid, sodium chloride, and purified water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH to approximately 6.8. Some formulations may include Benzalkonium chloride as a preservative, while others are self-preserved.

• Uses: VIGAMOX Ophthalmic Solution is indicated for the treatment of bacterial infections of the eye caused by susceptible strains of microorganisms. These include:

  • Bacterial conjunctivitis (pink eye)
  • Keratitis (including corneal ulcer)
  • Blepharitis
  • Dacryocystitis
  • Hordeolum (stye)
  • Tarsadenitis It is also used for preoperative and postoperative prophylaxis in ophthalmic procedures. VIGAMOX is not effective against viral or fungal eye infections.

• Dosage and Administration:

  • Typical Dosage: Instill one drop in the affected eye(s) 3 times a day for 7 days.
  • Preoperative/Postoperative Prophylaxis: Typically, instill one drop in the affected eye 5 times per day for 2 days before operation, and 3 times a day up to 14 days after operation.
  • Administration: For topical ophthalmic use only. Do not inject subconjunctivally or directly into the anterior chamber of the eye.
  • If using other topical ophthalmic medications, administer them at least 5 minutes apart.

• Side Effects:

  • Common Ocular Side Effects (1-6% of patients): Eye discomfort, dry eye, burning sensation, eye pain, eye redness, itching, decreased visual acuity, keratitis, ocular hyperemia, ocular pruritus, subconjunctival hemorrhage, and tearing.
  • Serious Side Effects (Seek immediate medical attention): Signs of a severe allergic reaction (e.g., difficulty breathing, swelling of the face or throat, rash, hives), or symptoms of a new eye infection (e.g., increased eye discharge, redness, itchiness, or pain).

• Precautions:

  • Hypersensitivity: Contraindicated in patients with a history of hypersensitivity to moxifloxacin, other quinolones, or any component of the medication.
  • Contamination: Advise patients not to touch the dropper tip to any surface (including the eye) to avoid contaminating the contents.
  • Contact Lenses: Patients with bacterial conjunctivitis should avoid wearing contact lenses.
  • Superinfection: Prolonged use may result in the overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.
  • Pregnancy and Breastfeeding: It is not known if moxifloxacin ophthalmic solution passes into breast milk. Consult a doctor if pregnant or breastfeeding.
  • Pediatric Use: The safety and effectiveness have been established in all ages, including children and neonates.

• Storage:

  • Store at 2˚C to 25˚C (36˚F to 77˚F). Some sources state storage below 30°C.
  • Keep the bottle tightly closed when not in use.
  • Do not freeze.
  • Discard 28 days after opening.
  • Keep out of the reach and sight of children.

VIGAMOX Ophthalmic Solution: Frequently Asked Questions

What is VIGAMOX Ophthalmic Solution used for?

VIGAMOX Ophthalmic Solution is an antibiotic eye drop primarily used to treat bacterial eye infections, such as bacterial conjunctivitis (pink eye) and corneal ulcers. It is also indicated for preoperative and postoperative prophylaxis in some cases.

How does VIGAMOX Ophthalmic Solution work?

VIGAMOX Ophthalmic Solution contains moxifloxacin, a fluoroquinolone antibiotic. It works by preventing the bacteria from dividing and multiplying. This is achieved by inhibiting essential bacterial enzymes called DNA gyrase and topoisomerase IV, which are crucial for bacterial DNA replication, transcription, and repair.

What is the usual dosage for VIGAMOX Ophthalmic Solution?

For bacterial conjunctivitis, the typical dosage for patients one year of age and older is one drop in the affected eye(s) three times a day for seven days. For preoperative and postoperative prophylaxis, the dosage is usually one drop in the affected eye(s) five times per day for two days before surgery, and three times a day for up to 14 days after surgery. It is important to complete the full course of treatment as prescribed by your doctor, even if symptoms improve.

What are the possible side effects of VIGAMOX Ophthalmic Solution?

Most people do not experience severe side effects. Common ocular side effects, occurring in approximately 1-6% of patients, include conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia (redness), ocular pain, ocular pruritus (itching), subconjunctival hemorrhage, and tearing. Other reported side effects include mild burning, stinging, or dryness in the eye immediately after application, which usually subsides quickly. Serious allergic reactions, though rare, can occur and may include trouble breathing, swelling of the face or throat, and rash. If such symptoms occur, discontinue use and seek immediate medical attention.

Is VIGAMOX Ophthalmic Solution safe during pregnancy or breastfeeding?

Pregnancy: There are no adequate and well-controlled studies in pregnant women. VIGAMOX Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. However, no effects on pregnancy are anticipated since systemic exposure to moxifloxacin from topical ocular application is considered negligible.

Breastfeeding: It is unknown if moxifloxacin is excreted in human milk following topical ocular administration, although it can be presumed to be excreted in human milk given systemic absorption. Caution should be exercised when VIGAMOX Ophthalmic Solution is administered to a nursing mother. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects on the breastfed child.

Can VIGAMOX Ophthalmic Solution be taken with other medications?

Drug-drug interaction studies have not been conducted with VIGAMOX Ophthalmic Solution. However, given the low systemic concentration of moxifloxacin following topical ocular administration, drug interactions are unlikely to occur. If you are using more than one topical ophthalmic medicine, they should be administered at least five minutes apart.

What precautions should be taken when using VIGAMOX Ophthalmic Solution?

VIGAMOX Ophthalmic Solution is for topical ophthalmic use only and should not be injected. To avoid contamination, do not touch the dropper tip to any surface, including your eye or fingers. Patients with bacterial conjunctivitis should not wear contact lenses. Prolonged use of the solution may lead to the overgrowth of non-susceptible organisms, including fungi, or resistant bacteria. If a new infection or superinfection occurs, discontinue use and consult your doctor.

What happens if a dose is missed?

If you miss a dose, apply it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a missed one.

How should VIGAMOX Ophthalmic Solution be stored?

Store VIGAMOX Ophthalmic Solution at room temperature, between 2°C to 25°C (36°F to 77°F). Do not store above 30°C. Keep the bottle tightly closed when not in use. Once opened, the product must be used within 28 days, and any unused portion should be discarded. Keep all medications out of the reach of children and pets.