Product Details
ALGIC OPHTHALMIC SOLUTION
Mumbai
A Quality Product from
Sunways (I) Pvt. Ltd. [View Profile]
Mumbai - India
Description :
-Ketorolac Tromethamine U.S.P - 5 mg
-Benzalkonium Chloride Solution I.P (as preservative) - 0.0001ml
-Aqueous buffered vehicle - q.s
CLINICAL PHARMACOLOGY: Ketorolac Tromethamine is a non steroidal anti inflammatory drug which , when administered systematically , has demonstrated analgesic anti inflammatory and anti pyretic activity. The mechanism of its action is thought to be due, in part , to its ability to inhibit prostaglandin biosynthesis. Ocular administration of Ketorolac Tromethamine reduces prostaglandin E2 levels in aqueous humor. The mean concentration of PGE2 was 80 pg/ml in the aqueous humor of eyes receiving vehicle and 28 pg/ml in the eyes receiving 0.5% ALGIC OPHTHALMIC SOLUTION.
Kotorolac Tromethamine given systematically does not cause pupil constriction.
Results from clinical studies indicate that ALGIC OPHTHALMIC SOLUTION has no significant effect upon intra ocular pressure.
ALGIC OPHTHALMIC SOLUTION has been safely administered in conjunction with other ophthalmic medications, such as antibiotics, beta blockers, carbonic anhydrase inhibitors , cycloplegics and mydriatics.
INDICATIONS & USAGE: ALGIC OPHTHALMIC SOLUTION is indicated for the relief of ocular itching due to seasonal allergic conjunctivitis.
ALGIC IS ALSO INDICATED IN ALL OCULAR INFLAMMATORY CONDITIONS CAN BE USED AS A REGULAR MEDICATION PRE & POST OPERATIVELY.
CONTRAINDICATIONS: ALGIC OPHTHALMIC SOLUTION is contraindicated in patients while wearing soft contact lenses and in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.
WARNINGS: There is the potential for cross sensitivity to acetylsalicylic acid , phenylacetic acid derivatives and other non steroidal anti inflammatory agents. Therefore caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
With some non steroidal anti inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied non steroidal anti inflammatory drugs may cause increased bleeding , of ocular tissues(including hyphemas) in conjunction with ocular surgery.
PRECAUTIONS: General: It is recommended that ALGIC (KETOROLAC TROMETHAMINE) 0.5% OPHTHALMIC SOLUTION be used with caution in patients with known bleeding tendencies pr who are receiving other medications which may prolong bleeding time.
Carcinogenesis , Mutagenesis and impairment of fertility : An 18 month study in mice at oral doses of Ketorolac Tromethamine equal to the Parenteral MRHD (Maximum Recommended Human dose) and a 24 month study in rats at oral doses 2.5times the parenteral MRHD showed no evidence of tumorigenicity.
Ketorolac Tromethamine was not mutagenic in Ames Test, unscheduled DNA synthesis and repair, a nd in forward mutation assays. Ketorolac did not cause Chromosome breakage in the vivo mouse micronucleus assay. At 1590ug/ml (approx., 1000 times the average human plasma levels) and at higher concentration s, Ketorolac Tromethamine increased the incidence chromosomal aberrations in Chinese Hamster ovarian cells. Impairment of fertility did not occur in male or female rats at oral doses of 9mg/kg(53.1mg/m2 ) and 176mg/kg ( 94.4mg/m2) respectively.
PEDRIATIC USE: Safety and efficacy in children have not been established.
ADVERSE REACTIONS: In Patients with allergic conjunctivitis, the most frequent adverse events reported with the use of ALGIC ophthalmic Solution have been transient stinging and burning on instillation. These events were reported by approximately 40% of patients treated with ALGIC ophthalmic Solution in all development studies conducted, other adverse events reported during treatment with Algic include ocular
irritation (3%) allergic reactions (3 %) superficial ocular infections (0.5%) and superficial keratitis (1%)
DOSE: As directed by the physician.
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MANUFACTURER AND EXPORTER OF OPTHALMIC FORMULATIONS AND OTHER PHARMACEUTICAL DRUGS. ANTIINFECTIVES : CHLOROSUN OPHTHALMIC SOLUTION ULTIFLOX DROPS & OINT GENTAMIDE EYE EAR DROPS NEBRACIN DROPS & OINT LOFLOX EYE DROPS. ANTIVIRAL : XURIN EYE OPHTHALMIC SOLUTION. STEROIDS/ANTIINFECTIVES : DEKORTYN N OPHTHALMIC SOLUTION DEKORTYN C OPHTHALMIC SUSPENSION & OINTMENT GENTAMIDE DM OPHTHALMIC SOLUTION & OINTMENT NEBRACIN DM DROPS & OINTMENT. ANAESTHETICS : PARACAIN DROPS OCULAN 1% INJ., (INTRA CAMERAL). ANTI ALLERGICS : PHENIL OPHTHALMIC SOLUTION OPTICROM. ANTI INFLAMMATORY : DEKORTYN OPHTHALMIC SOLUTION ALGIC OPHTHALMIC SOLUTION. DECONGESTANTS : VASOZINE OPHTHALMIC SOLUTION. MIOTICS : CARPINOL 2% OPHTHALMIC SOLUTION CARPINOL 0.5%(INTRA CAMERAL). MYDRIATICS : SUNEPHRINE 10% OPHTHALMIC SOLUTION TROPICACYL 1% OPHTHALMIC SOLUTION MYDRYN OPHTHALMIC SOLUTION SUNEPHRINE H OPHTHALMIC SOLUTION TROPICACYL PLUS ATROSUN OPHTHALMIC SOLUTION. SYMPATHOMIMETIC AGENTS : EPITRATE (INTRACAMERAL). VISCO ELASTIC AGENTS : HYPROSOL VIALS HYPROSOL PREFILLED SYRINGES. ARTIFICIAL TEARS : ARTIFICIAL TEARS AT PLUS LACRIGEL OCULAR LUBRICANT SOLUTION LUBRILAC. NUTRITIONAL : EYE VITAL CAPSULES. GENERAL CARE : BIOCULA OPHTHALMIC SOLUTION. ANTI GLAUCOMA : TIMANOL - 0.25% OPHTHALMIC SOLUTION TIMANOL - 0.5% OPHTHALMIC SOLUTION.
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