RIYADH · 2016. 4. 14. · MEDICAL AND COSMETIC PRODUCTS COMPANY (M.C.P.C.) P.O. Box 442, Riyadh...
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MEDICAL AND COSMETIC PRODUCTS COMPANY (M.C.P.C.) P.O. Box 442, Riyadh 11411 3 rd Industrial Zone Riyadh, Exit 14 Kingdom of Saudi Arabia. RIYADH PHARMA COMPOSITION: Sterile Sterile Eye /Ear Drops: Each ml contains Ciprofloxacin Hydrochloride (USP) equivalent to Ciprofloxacin 3 mg, Benzalkonium Chloride Solution (BP) 0.2 mg (preservative) and excipients. Sterile Eye Ointment: Each g contains Ciprofloxacin Hydrochloride (USP) equivalent to Ciprofloxacin 3 mg, Benzalkonium Chloride Solution (BP) 0.2 mg (preservative) and excipients. CLINICAL PHARMACOLOGY: Ciprofloxacin is a broad spectrum antibacterial agent against ocular and otic infections. Ciprofloxacin acts by inhibiting the sub unit of DNA gyrase which is essential in the reproduction of bacterial DNA. INDICATIONS: CIPROCIN is indicated for the treatment of corneal ulcers and superficial infections of the eye caused by strains susceptible to Ciprofloxacin. CIPROCIN is indicated also in the ear for chronic otitis externa. CONTRAINDICATIONS: Hypersensitivity to Ciprofloxacin or any component of the drug. It is also contraindicated in patients with disrupted tympanic membranes. PRECAUTIONS: • Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction. To avoid contamination and cross infection, avoid the use of the same bottle of medication for treatment of otic and ocular infections. • It is not recommended for children under 1 year. • When using Ciprocin eye drops/ointment one should take into account the risk of a rhinopharyngeal passage which can contribute to the occurrence and the diffusion of bacterial resistance. • Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including ciprofloxacin, particularly in elderly patients and in those treated concurrently with corticosteroids. Therefore treatment with Ciprocin Eye drops/Ointment should be discontinued at the first sign of tendon inflammation. • During therapy, soft contact lenses should not be worn. • Ciprocin Eye drops contains benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses. • Contact lens wear is not recommended during treatment of an ocular infection. Therefore, patients should be advised not to wear contact lenses during treatment with Ciprocin eye drops/ointment WARNING: The product should not be used while wearing contact lenses, contact lens wearers should remove the contact lenses before the instillation and replace them 15 minutes after the instillation. ADVERSE REACTIONS: Transient local burning, itching, conjunctival hyperaemia, lid margin crusting; taste disturbance; corneal staining, keratitis, lid oedema, lacrimation, photophobia; nausea and visual disturbances. USE DURING PREGNANCY, LACTATION & FERTILITY: Pregnancy: There are no adequate data from the use of Ciprocin in pregnant women. Animal studies do not indicate direct harmful effects with respect to reproductive toxicity. Systemic exposure to ciprofloxacin after topical use is expected to be low. As a precautionary measure, it is preferable to avoid the use of Ciprocin during pregnancy, unless the therapeutic benefit is expected to outweigh the potential risk to the fetus. Lactation: Orally administered ciprofloxacin has been found in human breast milk. It is unknown whether ciprofloxacin is excreted to human milk following topical ocular or otic administration. Caution should be exercised when Ciprocin is administered to a nursing woman. Fertility: Studies have not been performed to evaluate the effect of topical administration of Ciprocin on fertility
Transcript of RIYADH · 2016. 4. 14. · MEDICAL AND COSMETIC PRODUCTS COMPANY (M.C.P.C.) P.O. Box 442, Riyadh...
MEDICAL AND COSMETIC PRODUCTS COMPANY (M.C.P.C.) P.O. Box 442, Riyadh 11411 3rd Industrial Zone Riyadh, Exit 14 Kingdom of Saudi Arabia.
RIYADH
PHARMA
COMPOSITION: Sterile Sterile Eye /Ear Drops: Each ml contains Ciprofloxacin Hydrochloride (USP) equivalent to Ciprofloxacin 3 mg, Benzalkonium Chloride Solution (BP) 0.2 mg (preservative) and excipients. Sterile Eye Ointment: Each g contains Ciprofloxacin Hydrochloride (USP) equivalent to Ciprofloxacin 3 mg, Benzalkonium Chloride Solution (BP) 0.2 mg (preservative) and excipients.
CLINICAL PHARMACOLOGY: Ciprofloxacin is a broad spectrum antibacterial agent against ocular and otic infections. Ciprofloxacin acts by inhibiting the sub unit of DNA gyrase which is essential in the reproduction of bacterial DNA.
INDICATIONS: CIPROCIN is indicated for the treatment of corneal ulcers and superficial infections of the eye caused by strains susceptible to Ciprofloxacin. CIPROCIN is indicated also in the ear for chronic otitis externa.
CONTRAINDICATIONS: Hypersensitivity to Ciprofloxacin or any component of the drug. It is also contraindicated in patients with disrupted tympanic membranes.
PRECAUTIONS: • Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of
hypersensitivity reaction. To avoid contamination and cross infection, avoid the use of the same bottle of medication for treatment of otic and ocular infections.
• It is not recommended for children under 1 year. • When using Ciprocin eye drops/ointment one should take into account the risk of a rhinopharyngeal
passage which can contribute to the occurrence and the diffusion of bacterial resistance. • Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including ciprofloxacin,
particularly in elderly patients and in those treated concurrently with corticosteroids. Therefore treatment with Ciprocin Eye drops/Ointment should be discontinued at the first sign of tendon inflammation.
• During therapy, soft contact lenses should not be worn. • Ciprocin Eye drops contains benzalkonium chloride which may cause irritation and is known to discolour
soft contact lenses. • Contact lens wear is not recommended during treatment of an ocular infection. Therefore, patients should
be advised not to wear contact lenses during treatment with Ciprocin eye drops/ointment
WARNING: The product should not be used while wearing contact lenses, contact lens wearers should remove the contact lenses before the instillation and replace them 15 minutes after the instillation.
ADVERSE REACTIONS: Transient local burning, itching, conjunctival hyperaemia, lid margin crusting; taste disturbance; corneal staining, keratitis, lid oedema, lacrimation, photophobia; nausea and visual disturbances.
USE DURING PREGNANCY, LACTATION & FERTILITY: Pregnancy: There are no adequate data from the use of Ciprocin in pregnant women. Animal studies do not indicate direct harmful effects with respect to reproductive toxicity. Systemic exposure to ciprofloxacin after topical use is expected to be low. As a precautionary measure, it is preferable to avoid the use of Ciprocin during pregnancy, unless the therapeutic benefit is expected to outweigh the potential risk to the fetus. Lactation: Orally administered ciprofloxacin has been found in human breast milk. It is unknown whether ciprofloxacin is excreted to human milk following topical ocular or otic administration. Caution should be exercised when Ciprocin is administered to a nursing woman. Fertility: Studies have not been performed to evaluate the effect of topical administration of Ciprocin on fertility
MEDICAL AND COSMETIC PRODUCTS COMPANY (M.C.P.C.) P.O. Box 442, Riyadh 11411 3 rd Industrial Zone Riyadh, Exit 14 Kingdom of Saudi Arabia.
RIYADH
PHARMA
DOSAGE: Adults and children 1 year and above Eye Drops: Corneal ulcer : Apply throughout day & night. Day 1 : 1 or 2 drops apply every 15 minutes for 6 hours, then every hr. Day 2 : 1 or 2 drops apply every hr. Day 3-14 : 1 or 2 drops apply every 4 hrs. (If) longer treatment required, physician to decide frequency. Dose should be applied in the affected eye. Maximum duration of treatment is 21 days. Superficial Ocular infections: The usual dose is one or two drops in the affected eye(s) four times a day. In severe infections; the dosage for the first two days may be one or two drops every two hours during waking hours. For either indication a maximum duration of therapy of 21 days is recommended. Ear Drops: Thoroughly clean the ear canal of debris. The initial dosage is 3 - 4 drops, 2-4 times daily. The patient should lie with the affected ear turned upward; instill the solution and remain in this position for several minutes to insure penetration of the medication into the ear canal. Eye Ointment: 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. 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
STORAGE: Store below 25 °C, protect from light. Once the pack has been opened, the contents should be used within 1 month. Do not use the drug after the expiry date printed on the package.
PRESENTATIONS: Sterile Eye/Ear Drops: 5 ml dropper bottle. Sterile Eye Ointment: 5 g Aluminium tube.
Marketing Authorisation Holder and Manufacturer Medical and Cosmetic Products Company Ltd. (Riyadh Pharma) P.O.Box 442, Riyadh 11411 Fax: +966 11 265 0505 Email: contact(ariyadhpharma.com For any information about this medicinal product, please contact the local representative of marketing authorisation holder: Saudi Arabia Marketing department Riyadh Tel: +966 11 265 0111 Email: marketing(&riyadhpharma.com
For External Use Only
MEDICAL AND COSMETIC PRODUCTS COMPANY (M.C.P.C.) P.O. Box 442, Riyadh 11411 3 rd Industrial Zone Riyadh, Exit 14 Kingdom of Saudi Arabia.
RIYADH
PHARMA
To Report Any Side Effect(s) or Quality Problems:
National Pharmacovigilance Center (NPC)— o Fax :+966-1-205-7662 o E-mail: [email protected] o website: www.sfda.gov.sa/npc
This is a medicament
• A medicament is a product, which affects your health, and its consumption contrary to instructions is dangerous for you.
• Follow strictly the doctor's prescription, the method of use and the instructions of the pharmacist who sold the medicament.
• The doctor and the pharmacist are experts in medicine, its benefits and risks. • Do not by yourself interrupt the period of treatment prescribed for you. • Do not repeat the same prescription without consulting your doctor.
Keep medicaments out of the reach of children Council of Arab Health Ministers
Union of Arab Pharmacists
Manufactured by RIYADH PHARMA Medical and Cosmetic Products Co. Ltd. Riyadh, Saudi Arabia.
CIPROCIN is a trademark
