Product information

THERAPEUTIC INDICATIONS

Ciplox  Eye Ointment is used for the treatment of certain Eye infections caused by bacteria that are sensitive to it, such as:

• Blepharitis
• Bacterial conjunctivitis: (bacterial pink eye) is a bacterial infection of the eye which causes inflammation or swelling of the conjunctiva, Ciplox  Eye Ointment is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms:Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, Streptococcus pneumoniae and others.
• Bacterial keratitis: is an infection of the cornea (the clear dome covering the colored part of the eye) that is caused by bacteria.
• Corneal ulcers.
• superfacial infections of the eye.
• After eye surgeries to prevent infections or inflammations.

You must talk to a doctor if you do not feel better or if you feel worse.

COMPOSITION

Active ingredients: 

Each  1 g contains of Ciplox  eye ointment  contains: 

Ciprofloxacin (as hydrochloride) ……………………….. 3 mg.

Inactive ingredients: 

Anhydrous lanolin, chlorobutanol, yellow soft paraffin.

What you need to know before you take Ciplox  Eye Ointment?

Do not take Ciplox  Eye Ointment if:

• Hypersensitivity to the active substance or to any of the excipients.
• Hypersensitivity to quinolones: (ciprofloxacin) is contraindicated in persons with a history of hypersensitivity to (ciprofloxacin), any member of the quinolone class of antimicrobial agents, or any of the product components.

Warnings and precautions

• this product for ocular use only.
• Inform your doctor about any previous infections or other ocular conditions.
• Inform your doctor about all the medications you’re taking.
• Inform your doctor if you have any allergy to Ciprofloxacin, levofloxacin or any QUINOLONES  antibiotic. Mention any other allergies.
• If blurring of vision occurs, avoid driving or any other activity which requires clear vision until your vision stabilizes.
• It is not known whether Ciplox  can harm an unborn baby or if it can pass into the breast milk, however, inform your doctor if you’re pregnant or breast-feeding a baby.
• Prolonged and repeated use may result in other type of infection. Inform your doctor if you noticed any new or worsening signs and symptoms.
• Do not touch tip to any surface as this may contaminate the drug.
• Do not use the product if the imprinted carton seals have been damaged, or removed.
• Use of Ciplox  Sterile Eye Ointment in neonates with ophthalmia neonatorum is not recommended as ciprofloxacin has not been evaluated in such patients. Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition.
• When using Ciplox  Sterile Eye Ointment one should take into account the risk of a rhinopharyngeal passage which can contribute to the occurrence and the diffusion of bacterial resistance.

Other medicines and Ciplox  Eye Ointment

Drug interaction studies have not been conducted with Ciprofloxacin Eye Ointment.

If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

Pregnancy, breast-feeding 

Pregnancy: 

It is a drug of pregnancy category-C. There is no adequate and well-controlled study in pregnant women. So, Ciprofloxacin should be used during pregnancy only if clearly needed.

Systemic exposure to ciprofloxacin after topical use is expected to be low.

As a precautionary measure, it is preferable to avoid the use of Ciplox  during pregnancy, unless the therapeutic benefit is expected to outweigh the potential risk to the fetus.

Lactation: 

Orally administered ciprofloxacin is excreted in the human breast milk. It is unknown whether ciprofloxacin is excreted in human breast milk following topical ocular administration. A risk to the suckling child cannot be excluded. Therefore, caution should be exercised when Ciplox  is administered to nursing mothers.

 what is the recommended dose of  Ciplox  Eye Ointment?

Adults and Children 1 year and above: 

The recommended dosage regimens for adults (including the elderly) and children over the age of one year of age are as follows:

Corneal ulcers: 

1.25 cm ointment ribbon applied into the conjunctival sac every 1-2 hours around the clock for two days, then every 4 hours for a further 12 days. The dosing may be extended at the discretion of the physician.

Bacterial Conjunctivitis (and Blepharitis): 

1.25 cm ointment ribbon applied into the conjunctival sac (or on the lid margin, respectively) three times daily for two days, then twice daily for a further five days. The dosing may be extended at the discretion of the physician.

Use in elderly: 

Clinical studies have indicated dosage modifications are not required for the elderly.

Use in children: 

Clinical studies have indicated that dosage modifications are not required for children.

There is no experience in children less than 1 year old.

Use in hepatic and renal impairment: 

No studies have been performed in patients with kidney or liver problems.

Method of administration

Apply eye ointment to the affected eye(s) as follows:

• Wash hands first.
• To avoid contamination, be careful not to touch the tube tip or let it touch your eye. Tilt your head back, look upward, and pull down your lower eyelid to make a pouch.
• Place a 1/2 inch (1.5 centimeters) strip of ointment into the pouch by squeezing the tube gently. Look downward and gently close your eyes for 1 to 2 minutes.
• Roll your eyeball in all directions to spread the medication. Try not to blink and do not rub your eye.
• Repeat these steps for your other eye if so directed. Apply as often as directed by your doctor.
• Wipe the tip of the ointment tube with a clean tissue to remove excess medication before recapping it.
• If you are using another kind of eye medication (e.g., drops or other ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.
• Avoid touching the applicator tip with your fingers and ensure that it doesn’t touch the eye when used.
• Avoid the use of contact lenses during the entire course of the disease.
• If any sign of allergic reaction occurs, immediately discontinue use and contact your doctor.
• Take the medication exactly as prescribed. Avoid missing doses and do not discontinue until full course of treatment has been completed.
• Once opened, the medication can be stored in room temperature for up to 28 days.
• Unopened bottles can be stored in the fridge. Do not freeze the medication.

Overdose

• A topical overdose of Ciplox  may be rinsed out from the eye(s) with warm tap water.
• Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, or in the event of accidental ingestion of the contents of one tube.

If you forget to take Ciplox  Eye Ointment

• If you forget to take Ciplox  Eye Ointment, take your dose as soon as possible. If it is almost time for the next dose, just skip that dose and take the next one when it is due. If in doubt, please contact your doctor or pharmacist. If you have to skip a dose, still take all of your dose. This means that you will finish your course a day later.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Ciplox  Eye Ointment

• Never stop the treatment with Ciplox  Eye Ointment on your own, but first discuss this with your doctor. If the prescribed treatment is not completely finished, the infection may come back again.
• If you have any further questions on the use of this medicine, ask your doctor or pharmacist

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible Side Effects of Ciplox  Eye Ointment:

• Temporary eye irritation.
• Eye pain.
• Sensitivity to light.
• Contact dermatitis.
• Blurring of vision.
• Eye discharge or crusting.
• Signs of allergic reactions such as itching, rashes, nasal congestion, difficulty of breathing, swelling (face, tongue and throat), and fever.
• corneal deposits.
• ocular hyperaemia.

Pharmacological Properties

Pharmacodynamic properties: 

Pharmacotherapeutic Group: Ophtalmogicals, Other Anti-infectives.

Mechanism of Action: 

Ciplox  Sterile Eye Ointment contains the fluoroquinolone ciprofloxacin. The cidal and inhibitory activity of ciprofloxacin against bacteria results from an interference with the DNA gyrase, an enzyme needed by the bacterium for the synthesis of DNA. Thus the vital information from the bacterial chromosomes cannot be transcribed which causes a breakdown of the bacterial metabolism.

Ciprofloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative bacteria.

Mechanism of Resistance: 

Fluoroquinolone resistance, particularly ciprofloxacin, requires significant genetic changes in one or more of five major bacterial mechanisms:

a) enzymes for DNA synthesis,

b) protecting proteins,

c) cell permeability,

d) drug efflux, or

e) plasmid-mediated aminoglycoside 6′-N-acetyltransferase, AAC (6′)-Ib.

Fluoroquinolones, including ciprofloxacin, differ in chemical structure and mode of action from aminoglycosides, beta-lactam antibiotics, macrolides, tetracyclines, sulfonamides, trimethoprim, and chloramphenicol. Therefore, organisms resistant to these drugs may be susceptible to ciprofloxacin.

Pharmacokinetic properties:

• Absorption studies in humans with the ointment have not been conducted; however exposure levels would be expected to be less than ciprofloxacin ophthalmic solution. Ciprofloxacin eye drops solution is rapidly absorbed into the eye following topical ocular administration. Systemic levels are low following topical administration.
• Plasma levels of ciprofloxacin in human subjects following 2 drops of 0.3% ciprofloxacin solution every 2 hours for two days and then every four hours for 5 days ranged from non-quantifiable (< 1.0 ng/mL) to 4.7 ng/mL . The mean peak ciprofloxacin plasma level obtained in this study is approximately 450-fold less than that seen following a single oral dose of 250 mg ciprofloxacin. The systemic pharmacokinetic properties of ciprofloxacin have been well studied. Ciprofloxacin widely distributes to tissues of the body. The apparent volume of distribution at steady state is 1.7 to 5.0 l/kg. Serum protein binding is 20-40%. The half-life of ciprofloxacin in serum is 3-5 hours. Both ciprofloxacin and its four primary metabolites are excreted in urine and faeces. Renal clearance accounts for approximately two-thirds of the total serum clearance with biliary and faecal routes accounting for the remaining percentages.
• In patients with impaired renal function, the elimination half-life of ciprofloxacin is only moderately increased due to extrarenal routes of elimination. Similarly, in patients with severely reduced liver function the elimination half-life is only slightly longer.
• There are no pharmacokinetic data available in respect of use in children.

How to store Ciplox  Eye Ointment?

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Store in a cool and dry place.
• Do not use longer than 30 days after first opening.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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