Linkabs Ciprofloxacin Ophthalmic Solution

LINKABS CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0.3%

 

COMPOSITION

Ciprofloxacin Hydrochloride USP Eq. to Ciprofloxacin 0.3% w/v

Benzalkonium Chloride solution USP 0.02% v/v (As preservative)

Sterile Aqueous Base q.s.

 

PHARMACOLOGY

Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms. The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.

Ciprofloxacin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections:

Gram-Positive
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus (Viridans Group)

Gram-Negative
Haemophilus influenzae
Pseudomonas aeruginosa
Serratia marcescens

 

INDICATIONS & USES

Ciprofloxacin Ophthalmic Solution USP 0.3% is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

Cornea Ulcers
Pseudomonas aeruginosa
Serratia marcescens
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus (Viridans Group)

Conjunctivitis
Haemophilus influenzae
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumonia

 

DOSAGE AND ADMINISTRATION

Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.

Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.

 

CONTRAINDICATIONS

A history of hypersensitivity to ciprofloxacin or any other component of the medication is a contraindication to its use. A history of hypersensitivity to other quinolones may also contraindicate the use of ciprofloxacin.

 

WARNINGS & PRECAUTIONS

FOR EXTERNAL USE ONLY. NOT FOR INJECTION.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching.

As with other antibacterial preparations, prolonged use of ciprofloxacin may result in overgrowth of no susceptible organisms, including fungi. If super infection occurs, appropriate therapy should be initiated. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

 

SIDE EFFECTS

The most frequently reported drug related adverse reaction was local burning or discomfort. Other reactions occurring in less than 10% of patients included lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia and a bad taste following instillation. Additional events occurring in less than 1% of patients included corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision.

 

STORAGE

Store in a cool dark place. Do not freeze. Keep out of reach of children.

 

PRESENTATION

10 ml sterile plastic bottle.

 

Manufactured By

DEEPCARE HEALTH PVT. LTD.

804, GIDC, Dholka,

Ahmedabad — 382 225

NAFDAC Reg. No.: B4-5344

Advertisements

Leave a Reply