Framycetin: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 13, 2026🚩 Report this page

Framycetin

Active ingredient · 3 therapeutic classes

GB MHRA

Drug class: Medicated Dressings With Antiinfectives
Availability: See label
Markets covered: 1
Products on record: 1

D09AAMedicated Dressings With Antiinfectives R01AXOther Nasal Preparations S01AAAntibiotics

Overview

Framycetin is an active pharmaceutical ingredient in the Medicated Dressings With Antiinfectives group (D09AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	March 13, 2026

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised March 13, 2026[1]

In the Eye:
For the short term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral disease.
In the Ear:
Otitis Externa

How to take

Sources & citations

[1]MHRA (UK) · PL450430115 · revised March 13, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised March 13, 2026[1]

The following CIOMS frequency rating is used:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data). 4) Topical steroid use may result in increased intraocular pressure leading to optic nerve damage, reduced visual acuity and visual field defects.
Intensive or prolonged use of topical corticosteroids may lead to formation of posterior subcapsular cataracts. In those diseases causing thinning of the cornea or sclera, corticosteroid therapy may result in the thinning of the globe leading to perforation.
Immune system disorders:
Not known: Hypersensitivity reactions, usually of the delayed type, may occur leading to irritation, burning, stinging, itching and dermatitis. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised March 13, 2026[1]

Treatment should be discontinued if there are signs of sensitivity to any of its ingredients. Treatment with corticosteroid/antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement, since prolonged use may lead to occult extension of infections due to the masking effect of the steroid.
Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms. 3). Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular, pressure, cataract formation or unsuspected infections. Antibiotics Ototoxicty Aminoglycosides antibiotics may cause irreversible, partial or total deafness when given systemically or when applied topically to open wounds or damaged skin.
This effect is dose related and is enhanced by renal or hepatic impairment. Although this effect has not been reported following ocular use, the possibility should be considered when high dose topical is given to small children or infants.
1555A>G mutation, which suggests an increased risk of ototoxicity in these patients, including cases where the patient's aminoglycoside serum levels were within the recommended range. Some cases were associated with a maternal history of deafness and/or mitochondrial mutation.
Mitochondrial mutations are rare, and the penetrance of this observed effect is unknown. Although no cases were identified with topical preparations of neomycin, framycetin or gentamicin, the potential for a similar effect with neomycin and other aminoglycosides administered topically cannot be ruled out.
Paediatric Population Although it is unlikely that infants will be treated with Sofradex for prolonged periods, there is a risk of adrenal suppression, even without occlusive dressings, after prolonged treatment of these patients with topical steroids.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

Drugs in the same class

Sources & citations