Sinpole

Sinpole

Manufacturer:

Samchundang

Distributor:

AA Medical
Full Prescribing Info
Contents
Chloramphenicol, dexamethasone disodium phosphate, tetrahydrozoline HCl.
Description
Each mL contains: Chloramphenicol 5 mg (titer), dexamethasone disodium phosphate 1 mg and tetrahydrozoline HCl 0.25 mg.
Excipients/Inactive Ingredients: Boric acid, sodium borate, disodium edetate, polysorbate 80, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate and sterile purified water.
Indications/Uses
Keratitis and conjunctivitis with severe swelling and surface congestion by allergy or infection. Scleritis. Iritis.
Dosage/Direction for Use
Adult: One drop in eye(s) 1-4 times daily.
Contraindications
Patients with hypersensitivity to this drug, corneal injury or ulcer, herpes simplex or smallpox virus infection, tuberculous infection, mycosis or glaucoma, pyogenic infection of conjunctiva and eyelid. Xerophthalmia, especially Sjogren's syndrome patients, children, patients with hypertension or hypotension, patients with such severe hemopathies as hypoplastic anemia, general marrow diseases, hemolytic jaundice, etc. and patients with hepatic failure.
Special Precautions
Patients with coronary disease, aneurysm, heart beat disorder, arteriosclerosis, diabetes, hyperthyroidism, patients with hypersensitivity or allergic history to propylene glycol because this drug contains propylene glycol.
General: If symptoms persist after 7-8 days of treatment, discontinue use and consult a doctor or a pharmacist. Don't wear soft contact lenses under the treatment.
Use only as an ophthalmic solution. At the time of administration, care should be taken not to touch the tip of the bottle to the eye directly. Don't use in common to avoid contamination.
Pediatric use: Safety and effectiveness in infants have not been established.
Use In Pregnancy & Lactation
This drug should be used in pregnant women or women who may possibly be pregnant, only if the expected therapeutic benefits are judged to outweigh the possible risks associated with treatment.
It was not reported that this drug is excreted in human milk, nursing mothers should quit lactation during this drug being administered.
Adverse Reactions
Irreversible pancytopenia, aplastic anemia, granulocytopenia, thrombocytopenia can rarely occur with prolonged use (over 3 months). Prolonged use may also result: Reversible intraocular tension rising; cataract; corneal mycosis and continuous keratohelcosis may come from mycosis and repair of wound may be in retard. Steroid may hide ocular pyogenic infection and make it worse. Secondary infection may occur after use of complex preparations containing steroid and antibacterial. Administration of this drug to disease that corneal tissue and sclera become thin, may result to perforation.
The following side effects may rarely occur: Neuropapillitis, allergic reaction, irritant and burning slightly, reactive hyperemia, glaucoma, visual decline. Tachycardia, hypertension, tremor, headache, diaphoresis, fatigue, lassitude, insomnia, etc, may also occur.
Inform the doctor in case of any adverse reactions related to drug use.
Drug Interactions
Administration with anticholinergics eg, atropine may result in increased intraocular tension.
Storage
Store at a dry and cool place in a tight container (under 15°C).
Shelf-Life: 3 years from manufacturing date.
ATC Classification
S01CA01 - dexamethasone and antiinfectives ; Belongs to the class of corticosteroids in combination with antiinfectives. Used in the treatment of eye diseases.
Presentation/Packing
Eye drops (colorless or almost colorless transparent solution) 10 mL x 1's.
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