Optrex Infected Eyes 1% eye ointment

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Chloramphenicol

Sẵn có từ:

Reckitt Benckiser Healthcare (UK) Ltd

Mã ATC:

S01AA01

INN (Tên quốc tế):

Chloramphenicol

Liều dùng:

10mg/1gram

Dạng dược phẩm:

Eye ointment

Tuyến hành chính:

Ocular

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 11030100; GTIN: 0000050065660

Đặc tính sản phẩm

OPTREX INFECTED EYE OINTMENT
Summary of Product Characteristics Updated 07-Mar-2012 | Reckitt
Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Optrex Infected Eye Ointment
When sold by Boots The Chemist, the name will be Boots Pharmacy
Antibiotic Eye Ointment
2. Qualitative and quantitative composition
Chloramphenicol 1.0% w/w.
Each 1 gram of ointment contains 10mg chloramphenicol
For excipients, see 6.1.
3. Pharmaceutical form
Eye ointment.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of acute bacterial conjunctivitis.
4.2 Posology and method of administration
Topical administration to the eye only.
Adults, children aged 2 years and over and elderly
The recommended dose is a small amount of ointment (~ 1cm) to be
applied to the affected eye(s). The
ointment should be applied either at night if eye drops are used
during the day, or 3 to 4 times a day if eye
ointment is used alone
The pharmacist will advise on the most suitable treatment. Treatment
should continue for 5 days even if
symptoms improve.
4.3 Contraindications
Chloramphenicol eye ointment must not be administered to:
• Patients who have a history of hypersensitivity to chloramphenicol
or to any other ingredient of the
ointment.
• Patients who have experienced myelosuppression during previous
exposure to chloramphenicol.
• Patients with a family history of blood dyscrasias.
4.4 Special warnings and precautions for use
Chloramphenicol is absorbed systemically from the eye and systemic
toxicity has been reported (see
section 4.8).
In severe bacterial conjunctivitis and in cases where infection is not
confined to the conjunctivae, the
topical use of chloramphenicol should be supplemented by appropriate
systemic treatment. Therefore, the
patient should be referred to seek medical advice.
The use of topical chloramphenicol may occasionally result in
overgrowth of non-susceptible organisms
including fungi. If any new infection appears during treatment, the
patient should be referred to the
doctor.
Prolonged or frequent int