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Framycetin, gramicidin, and dexamethasone (United States: Not available): Drug information

Framycetin, gramicidin, and dexamethasone (United States: Not available): Drug information
(For additional information see "Framycetin, gramicidin, and dexamethasone (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • Sofracort
Pharmacologic Category
  • Anti-inflammatory Agent, Ophthalmic;
  • Antibiotic, Ophthalmic;
  • Antibiotic, Otic;
  • Corticosteroid, Ophthalmic;
  • Corticosteroid, Otic
Dosing: Adult
Ophthalmic infection/inflammation

Ophthalmic infection/inflammation: Ophthalmic: Acute conditions: Instill 1 or 2 drops in affected eye(s) every 1 to 2 hours usually for 2 or 3 days, then follow with 1 or 2 drops 3 to 4 times daily.

Otic infections/inflammation

Otic infections/inflammation: Otic: Instill 2 or 3 drops in affected ear(s) 3 or 4 times daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see Framycetin and Dexamethasone.

Frequency not defined:

Hypersensitivity: Hypersensitivity reaction

Ophthalmic: Burning sensation of eyes, corneal perforation, increased intraocular pressure, stinging of eyes

Postmarketing:

Dermatologic: Dermatitis, pruritus

Endocrine & metabolic: Adrenocortical insufficiency (adrenal atrophy), Cushing’s syndrome (iatrogenic), decreased glucose tolerance, diabetes mellitus

Hypersensitivity: Type IV hypersensitivity reaction

Ophthalmic: Blurred vision, cataract, decreased visual acuity, glaucoma, optic nerve damage, retinopathy (chorioretinopathy), visual field defect

Contraindications

Ophthalmic use: Hypersensitivity to framycetin, gramicidin, dexamethasone, or any component of the formulation; herpes simplex and other viral diseases of the cornea and conjunctiva; tuberculosis and fungal disease of the eye; trachoma; acute purulent, untreated ocular infections which may be masked or enhanced by the presence of a steroid; glaucoma.

Otic use: Hypersensitivity to framycetin, gramicidin, dexamethasone or any component of the formulation; viral and fungal infections; acute purulent, untreated infections; perforation of the eardrum.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

• Immunosuppression: Prolonged use may increase the hazard of secondary ocular infections. May mask infection or enhance existing infection. The possibility of persistent corneal fungal infection should be considered after prolonged use. Corticosteroids should not be used to treat ocular herpes simplex; use caution in patients with a history of ocular herpes simplex; reactivation of viral infection may occur.

• Ocular effects: Avoid prolonged use, which may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Monitor intraocular pressure with prolonged use. May cause transient blurred vision; patients must be cautioned about performing tasks that require clear vision (eg, operating machinery, driving).

• Ototoxicity: Irreversible, partial, or total deafness may occur with aminoglycoside antibiotic application to open wounds or damaged skin. Risk may be increased with prolonged use or in patients with renal impairment or hepatic impairment. Do not retreat after symptoms improve.

• Sensitivity reactions: Discontinue use if sensitivity occurs.

Disease-related concerns:

• Diabetes: Use with caution in patients with diabetes mellitus. Monitor for hyperglycemia; may alter glucose production/regulation leading to hyperglycemia. May require addition or adjustment of antidiabetic therapy.

• Ocular disease: Perforations may occur in diseases which cause thinning of the cornea or sclera. Avoid administration in patients with undiagnosed red eye.

• Pheochromocytoma: Pheochromocytoma crisis (may be fatal) has been reported after administration of corticosteroids. Consider the risk of pheochromocytoma crisis in patients with suspected or confirmed pheochromocytoma.

Product Availability

Not available in the US

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Combination:

Sofracort: Framycetin 5 mg, gramicidin 0.05 mg, and dexamethasone 0.5 mg per mL (8 mL)

Administration: Adult

Ophthalmic: Do not touch tip of container to eye or other surfaces.

Otic: Note: Otic preparations should not be used when the integrity of the tympanic membrane is in question (Ref).

Do not touch ear with dropper. Patient should lie down with affected ear upward. This position should be maintained after the drops have been instilled to facilitate penetration. Repeat, if necessary, for the opposite ear. If preferred, a saturated gauze wick may be inserted by the healthcare provider into the canal.

Use: Labeled Indications

Note: Not approved in the US

Ophthalmic infections/inflammation: Treatment of the following conditions: blepharitis and infected eczema of the eyelid; allergic, infective and rosacea conjunctivitis; rosacea keratitis; scleritis and episcleritis; iridocyclitis; other inflammatory conditions of the anterior segment of the eye

Otic infections/inflammation: Treatment of otitis externa (acute and chronic) and other inflammatory and seborrheic conditions of the external ear

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

CYP3A4 Inhibitors (Strong): May increase the serum concentration of DexAMETHasone (Ophthalmic). Risk C: Monitor therapy

Nirmatrelvir and Ritonavir: May increase the serum concentration of Corticosteroids (Ophthalmic). Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Risk C: Monitor therapy

Pregnancy Considerations

Refer to Dexamethasone (Ophthalmic) monograph.

Breastfeeding Considerations

Refer to Dexamethasone (Ophthalmic) monograph.

Monitoring Parameters

Intraocular pressure (with prolonged ophthalmic use)

Mechanism of Action

Framycetin is a broad spectrum aminoglycoside antibiotic that is usually bactericidal; appears to inhibit protein synthesis in susceptible bacteria by binding ribosomal subunits. Active against many aerobic gram-negative organisms and some aerobic gram-positive organisms.

Gramicidin is a cyclic polypeptide antibiotic that alters the cation content of the bacterial cell wall; primarily effective against gram-positive organisms.

Dexamethasone decreases inflammation by suppression of neutrophil migration, decreased production of inflammatory mediators, and reversal of increased capillary permeability; suppresses normal immune response.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Sofradex;
  • (AU) Australia: Otodex | Sofradex;
  • (BD) Bangladesh: Sofradex;
  • (CH) Switzerland: Sofradex;
  • (EE) Estonia: Sofradex;
  • (GB) United Kingdom: Sofradex;
  • (HK) Hong Kong: Framoptic-d | Sofradex;
  • (ID) Indonesia: Blecidex | Sofradex;
  • (IE) Ireland: Sofradex;
  • (JO) Jordan: Sofradex;
  • (KW) Kuwait: Sofradex;
  • (LB) Lebanon: Sofradex;
  • (LT) Lithuania: Sofradex;
  • (LV) Latvia: Sofradex;
  • (MY) Malaysia: Sofradex;
  • (NG) Nigeria: Framoptic d eye/ear drops;
  • (NL) Netherlands: Sofradex;
  • (NO) Norway: Sofradex;
  • (NZ) New Zealand: Sofradex;
  • (QA) Qatar: Otodex | Sofradex;
  • (RU) Russian Federation: Sofradex;
  • (SE) Sweden: Sofradex;
  • (SG) Singapore: Sofradex;
  • (TH) Thailand: Sofradex;
  • (TW) Taiwan: Sofradex;
  • (UA) Ukraine: Sofradex;
  • (ZA) South Africa: Sofradex
  1. Rosenfeld RM, Schwartz SR, Cannon CR, et al. Clinical practice guideline: acute otitis externa. Otolaryngol Head Neck Surg. 2014;150(1 suppl):S1-S24. doi: 10.1177/0194599813517083 [PubMed 24491310]
  2. Sofracort (framycetin sulphate, gramicidin, dexamethasone) [product monograph]. Laval, Quebec, Canada: Sanofi-Aventis Canada Inc; November 2022.
Topic 105437 Version 56.0

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