Moxifloxacin Ophthalmic

Prescription

Tên thương mại: Moxifloxacin Ophthalmic Solution

Dạng bào chế

Drops

Đường dùng

OPHTHALMIC

Nhà sản xuất

Gland Pharma Limited

About This Medication

11 DESCRIPTION Moxifloxacin ophthalmic solution USP, 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. The chemical name for moxifloxacin hydrochloride is 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol [3,4b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. The molecular formula for moxifloxacin hydrochloride is C 21 H 24 FN 3 O 4 •HCl and its molecular weight is 437.9 g/mol. The chemical structure is presented below: Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL of moxifloxacin ophthalmic solution USP, 0.5% contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base. Moxifloxacin ophthalmic solution contains Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and water for injection. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.3 to 7.3. Moxifloxacin ophthalmic solution is an isotonic solution with an osmolality of approximately 290 mOsm/kg. Moxifloxacin-Structure

Hoạt chất

Thành phần	Hàm lượng
Moxifloxacin Hydrochloride	-

Chỉ định & Cách dùng

1 INDICATIONS AND USAGE Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species * Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus viridans group Acinetobacter lwoffii* Haemophilus influenzae Haemophilus parainfluenzae* Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections. Moxifloxacin ophthalmic solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group , Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections. ( 1 )

Cơ chế hoạt động

12.1 Mechanism of Action Moxifloxacin is a member of the fluoroquinolone class of anti-infective drugs [see Microbiology (12.4) ].

Liều dùng & Cách dùng

2 DOSAGE AND ADMINISTRATION Instill one drop in the affected eye 3 times a day for 7 days. Moxifloxacin ophthalmic solution is for topical ophthalmic use. Instill one drop in the affected eye 3 times a day for 7 days. ( 2 )

Side Effects Overview

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1% to 6 % of patients. Nonocular adverse events reported at a rate of 1% to 4 % were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis. The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1% to 6% of patients. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 864-879-9994 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Cảnh báo & Thận trọng

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin. ( 5.1 ) Prolonged Use: may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. ( 5.2 ) Avoid Contact Lens Wear: Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. ( 5.3 ) 5.1 Hypersensitivity Reactions In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal hypersensitivity(anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated. 5.2 Growth of Resistant Organisms With Prolonged Use As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit- lamp biomicroscopy, and, where appropriate, fluorescein staining. 5.3 Avoidance of Contact Lens Wear Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

Chống chỉ định

4 CONTRAINDICATIONS Moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. Moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. ( 4 )

Dược động học

12.3 Pharmacokinetics Plasma concentrations of moxifloxacin were measured in healthy adult male and female subjects who received bilateral topical ocular doses of moxifloxacin ophthalmic solution 3 times a day. The mean steady-state C max (2.7 ng/mL) and AUC 0-∞ (41.9 ng •hr/mL) values were 1,600 and 1,100 times lower than the mean C max and AUC reported after therapeutic 400 mg doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours.

Frequently Asked Questions

1 INDICATIONS AND USAGE Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species * Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus viridans group Acinetobacter lwoffii* Haemophilus influenzae Haemophilus parainfluenzae* Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections. Moxifloxacin ophthalmic solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible …

2 DOSAGE AND ADMINISTRATION Instill one drop in the affected eye 3 times a day for 7 days. Moxifloxacin ophthalmic solution is for topical ophthalmic use. Instill one drop in the affected eye 3 times a day for 7 days. ( 2 )

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin. ( 5.1 ) Prolonged Use: may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. ( 5.2 ) Avoid Contact Lens Wear: Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. ( 5.3 ) 5.1 Hypersensitivity Reactions In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal …

4 CONTRAINDICATIONS Moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. Moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. ( 4 )

Moxifloxacin Ophthalmic is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Moxifloxacin Ophthalmic drug label (National Library of Medicine)
• openFDA — Moxifloxacin Ophthalmic label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 403818 (NLM Normalized Drug Names)
• NDC Directory — Moxifloxacin Ophthalmic (FDA National Drug Code)

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Nguồn dữ liệu: DailyMed (NLM), openFDA, MFDS