Synalar Otic Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Per mL Fluocinolone acetonide 250 mcg, polymyxin B sulfate 10,000 IU, neomycin sulfate 5 mg

Indications/Uses

Otitis externa & other steroid responsive inflammatory conditions where bacterial infection is present or suspected.

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Dosage/Direction for Use

3-4 drops bid-qid.

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Contraindications

Hypersensitivity. Untreated fungal or viral ear infections, herpes simplex, vaccinia & varicella; perforated eardrum. Not for ophth use.

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Special Precautions

Allergic cross-reactions. May produce skin atrophy. May mask some signs of infection & new infections may appear. Overgrowth of non-susceptible organisms & fungi. Patients transferring from systemic steroid therapy to otic soln. Suspected impaired adrenal function. Avoid prolonged use. Pregnancy (especially 1st trimester). Childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

Fluocinolone: Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, allergic contact dermatitis, secondary infections, skin atrophy. Neomycin: Nephrotoxicity, ototoxicity.

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Storage

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Description

View Synalar Otic description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Ear Antiseptics with Corticosteroids

ATC Classification

S02CA05 - fluocinolone acetonide and antiinfectives ; Belongs to the class of combinations of corticosteroids and antiinfectives used in the treatment of ear diseases.

Regulatory Classification

Presentation/Packing

Form

Synalar Otic otic soln

Packing/Price

5 mL x 1's (P369.6/bottle)

Synalar Otic

Manufacturer:

Euro-Med

Distributor:

Euro-Med