Product image of Moxifloxacină Rompharm (Moxifloxacin Hydrochloride) supplied by GNH India

Moxifloxacină Rompharm

Active Ingredient:
Moxifloxacin Hydrochloride
Origin:
EU

Moxifloxacină Rompharm (Moxifloxacin Hydrochloride)

Moxifloxacin, the active ingredient in Moxifloxacină Rompharm, is a fluoroquinolone presented as a sterile ophthalmic preparation for ocular use. It is employed to treat bacterial infections of the eye, including conjunctivitis and keratitis, in adult patients.

GNH India supplies Moxifloxacină Rompharm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory‑approved batches to meet global demand. Its distribution network ensures timely delivery across Europe, Asia, Africa and the Americas.

Manufacturer / TM Owner

S.C. Rompharm Company S.R.L.

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Indications & Clinical Uses

Moxifloxacin is indicated for bacterial ocular infections, targeting common pathogens that affect the eye surface and cornea.

  • Bacterial conjunctivitis: reduces bacterial load and accelerates symptom resolution in acute conjunctival infection.
  • Bacterial keratitis: eradicates causative organisms and promotes corneal healing in infectious keratitis.
  • Post‑operative ocular infection: prevents or treats bacterial contamination following eye surgery.
  • Corneal ulcer: facilitates healing of bacterial corneal ulcers and limits scarring.

How It Works

  • Moxifloxacin inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for supercoiling and separation of replicated DNA. By binding to the quinolone‑resistance‑determining region of these enzymes, it prevents DNA replication and transcription, leading to bacterial cell death. The high affinity for both Gram‑positive and Gram‑negative ocular pathogens underlies its broad‑spectrum activity in eye infections.

Side Effects

Moxifloxacin eye drops may cause local and systemic adverse reactions, most of which are mild and transient.

Common Side Effects

  • Eye irritation: transient burning or stinging sensation after instillation.
  • Redness: mild conjunctival hyperemia.
  • Tearing: increased lacrimation.
  • Foreign body sensation: feeling of grit in the eye.
  • Blurred vision: temporary visual disturbance.
  • Photophobia: heightened sensitivity to light.

Serious or Rare Side Effects

  • Corneal ulceration: worsening of corneal lesions.
  • Allergic reaction: eyelid edema, rash, or anaphylaxis.
  • Stevens‑Johnson syndrome: severe mucocutaneous eruption.
  • Tendon rupture: rare systemic effect, especially with systemic exposure.
  • Severe ocular inflammation: uveitis or keratitis exacerbation.

Precautions & Warnings

Before prescribing Moxifloxacin ophthalmic solution, clinicians should consider several safety precautions to minimize risks.

  • Allergy assessment: avoid use in patients with known hypersensitivity to fluoroquinolones or any component of the formulation.
  • Contact lens use: discontinue contact lenses during treatment to prevent drug absorption and irritation.
  • Corneal disease: use with caution in patients with pre‑existing corneal epithelial defects or severe dry eye.
  • Systemic exposure: monitor for systemic fluoroquinolone adverse effects in patients receiving concurrent oral or intravenous therapy.
  • Concomitant steroids: avoid or limit topical corticosteroids as they may mask infection progression.
  • Pregnancy and lactation: prescribe only if the potential benefit justifies the potential risk, as safety data are limited.
  • Store at ambient temperature: keep the product in its original container, protect from light and moisture, and store below 25 °C.

Avoid Interactions

Moxifloxacin can interact with other ophthalmic or systemic agents, influencing its efficacy or safety.

Major Interactions (Avoid)

  • Systemic fluoroquinolones: concurrent use may increase risk of tendon rupture and central nervous system effects.
  • Cation‑containing eye drops (e.g., aluminum, calcium, magnesium): may chelate the drug and markedly reduce ocular absorption.

Moderate Interactions (Monitor Closely)

  • Topical corticosteroids: may suppress inflammatory signs and conceal worsening infection.
  • Non‑steroidal anti‑inflammatory eye drops: could increase irritation or affect healing.
  • Anticholinergic agents: may exacerbate dry eye, enhancing discomfort with the ophthalmic solution.

Frequently Asked Questions

Moxifloxacină Rompharm is an ophthalmic fluoroquinolone indicated for the treatment of bacterial eye infections such as acute bacterial conjunctivitis, infectious keratitis, and post‑operative ocular infections. It targets susceptible Gram‑positive and Gram‑negative bacteria that commonly cause these conditions.

Moxifloxacin blocks bacterial DNA gyrase and topoisomerase IV, enzymes required for DNA replication and transcription. By binding to the quinolone‑resistance‑determining region of these enzymes, it prevents bacterial DNA from unwinding and separating, leading to bacterial cell death and resolution of the infection.

The dosing regimen for Moxifloxacină Rompharm is determined by the prescribing clinician based on the specific infection, severity, and patient factors. The product is supplied as a prescription‑only medication, and the healthcare professional will specify the number of drops, frequency, and duration of therapy.

Safety data for ocular moxifloxacin in pregnancy and lactation are limited. It should be used only if the potential benefit to the mother outweighs any possible risk to the fetus or infant. The prescriber should evaluate the clinical situation and discuss potential risks with the patient.

To place an order, submit an enquiry on the product page at gnhindia.com, indicating the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and the necessary import documentation.

Moxifloxacin offers a broad spectrum of activity against both Gram‑positive and Gram‑negative ocular pathogens and has a higher potency against certain resistant strains compared with older fluoroquinolones such as ciprofloxacin. It also requires less frequent dosing in many regimens, which can improve patient compliance.

The product should be stored at ambient temperature, preferably below 25 °C, in its original container. Protect it from direct light and moisture. Do not freeze. Once opened, follow the manufacturer’s recommended period‑after‑opening (PAO) to ensure sterility.

Moxifloxacină Rompharm is applied as sterile eye drops. The patient should wash their hands, tilt the head back, pull down the lower eyelid, and instill the prescribed number of drops into the conjunctival sac. The eye should be closed gently for a few seconds to allow absorption.

Serious risks include severe ocular reactions such as corneal ulceration, allergic eye inflammation, or systemic hypersensitivity that may progress to Stevens‑Johnson syndrome. Rare systemic effects, such as tendon rupture, have been reported with fluoroquinolones and should be monitored, especially if systemic exposure occurs.

Patients with a known hypersensitivity to moxifloxacin, other fluoroquinolones, or any excipients in the formulation should avoid the product. Caution is advised in individuals with pre‑existing corneal epithelial defects, severe dry eye, or those receiving concurrent systemic fluoroquinolones. Pediatric use is generally not recommended unless specifically prescribed.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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