Ciprodar is a solution for auricular (in the Eye & Ear) and ocular (in the eye) use. It contains: Ciprofloxacin, an antibiotic belonging to the group known as the fluoroquinolones. Ciprofloxacin works by killing bacteria that cause infections.

Product information

Product	Ciprodar eye drops
Available concentrations	0.3 %
Company	Dar Al Dawa Development and investment Co.
Country	Jordan.
Active Ingredients	Ciprofloxacin
Anatomical main group	ANTIINFECTIVES
Therapeutic subgroup	ANTIINFECTIVES OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
Pharmacological subgroup	QUINOLONE ANTIBACTERIALS (This group comprises quinolone antibacterials, inhibiting the bacterial DNA-gyrase.)
Chemical subgroup	Fluoroquinolones
ATC code	S03AA07
Legal status	Prescription only

THERAPEUTIC INDICATIONS

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

for Eye:

Bacterial conjunctivitis: (bacterial pink eye) is a bacterial infection of the eye which causes inflammation or swelling of the conjunctiva, Ciprodar eye drops 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.

for Ear:

It is used in adults and in children aged 6 months and older to treat Acute otitis externa (infection of the outer Eye & Ear).
It is used in adults and in children aged 6 months and older to treat Otitis media (infection of the middle Eye & Ear) with draining Eye & Ear tubes (tympanostomy tubes) of bacterial origin.
After Eye & Ear surgeries to prevent infections or inflammations.

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

COMPOSITION

Ciprodar (ciprofloxacin) ) eye and ear drops as:

Ciprodar 0.3 % Eye & Ear drops , Each 1 ml contains: (ciprofloxacin) 3 mg.

What you need to know before you take Ciprodar eye drops?

Do not take Ciprodar eye drops if:

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 Ciprodar 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.

Other medicines and Ciprodar eye drops

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

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 Ciprodar 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 Ciprodar is administered to nursing mothers.

what is the recommended dose of Ciprodar eye drops?

Eye:

Children of one year of age and adults: Instill 1 drop in the affected eye(s) four – six times daily.
Children less than one year of age: Not recommended.
Dose for corneal ulcers :
- Instill 2 drop in the affected eye(s) every 15 minutes for the first 6 hours, then 2 drops in the affected eye(s) every 30 minutes for the remainder of the day.
- second day: Instill 2 drop in the affected eye(s) every hour.
- third day: Instill 2 drop in the affected eye(s) every 4 hour for 7 -14 day.

Ear:

For all infections two to three drops every two to three hours initially. Frequency should be decreased gradually as warranted by improvement in clinical signs.

Method of administration

Eye:

1. Wash your hands properly before using the medication.
2. Turn the closed bottle upside down and shake to move the medicine into the tip of the bottle.
3. Continue holding the bottle upside down and remove the cap.
4. Tilt your head back and slightly pull your lower lid down.
5. Hold the bottle over your eye and gently squeeze the bottle. Instill the number of drops required for both eyes. If a drop misses the eye, do it again.
6. Put back the cap and close tightly. Keep in a cool, dry place.

Ear:

1. The person giving Ciprodar should wash his or her hands with soap and water.

2. Gently clean any discharge that can be removed easily from the outer Eye & Ear. Do not insert any object or swab into the Eye & Ear canal.

4. Warm the Eye & Ear drops by holding the container in your hands for 1 or 2 minutes to avoid dizziness.

5. Twist off the container cap.

6. Tilt your/your child’s head to one side to keep the affected Eye & Ear up.

7. Place 1 2 drops in the Eye & Ear.

8a. For patients with outer Eye & Ear canal infection, gently pull the outer Eye & Ear lobe upward and outward. This will allow the Eye & Ear drops to flow down into the Eye & Ear canal.

8b. For patients with middle Eye & Ear infection, pump the tragus (the small piece of cartilage found in front of the Eye & Ear canal) 4 times by pushing inward to allow the medicine to penetrate the middle Eye & Ear. This will allow the drops to pass through the tube in the Eye & Eardrum and into the middle Eye & Ear.

9. Keep the patient’s head tilted sideways for approximately 1 minute to allow the medicine time to penetrate the Eye & Ear. When instilling Eye & Ear drops, raising the head to the vertical position or moving too rapidly may cause some of the medicine to leak out of the Eye & Ear canal. This should be avoided as it may prevent the medicine from reaching the full depth of the Eye & Ear canal.

10. Repeat all steps, if necessary, for the opposite Eye & Ear.

It is important to follow these instructions to make sure this medicine works.

Avoid touching the applicator tip with your fingers and ensure that it doesn’t touch the Eye & Ear when used.
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.
If you are using any other eye medications such as drops or ointments, give at least 5 minutes interval between the medications.
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 Ciprodar 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 bottle.

If you forget to take Ciprodar eye drops

If you forget to take Ciprodar eye drops, 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 Ciprodar eye drops

Never stop the treatment with Ciprodar eye drops 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 Ciprodar eye drops:

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.

How to store Ciprodar eye drops?

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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