Composition
Each 100ml of Samulgin® eye drops contains: Ketorolac tromethamine 0.5 g.
Pharmacological properties
Ketorolac a pyrrolizine carboxylic acid derivative, is a prototypical nonsteroidal anti-inflammatory agent (NSAID).
Following topical application to the eye, NSAIDs including Samulgin® ophthalmic drops reduce manifestations of ocular inflammation induced by ocular trauma (e.g. ocular surgery)or external agents (e.g. allergens, bacteria).
The mode of action is through inhibition of ocular prostaglandin synthesis, in the iris ciliary body , & the conjunctiva by inhibiting cyclooxygenase enzyme.
By reducing ocular production of prostaglandins, Samulgin® ophthalmic drops inhibits ocular inflammations & other reactions mediated by prostaglandins, thus treatment with Samulgin® ophthalmic drops inhibits ocular inflammatory reactions such as conjunctival erythema, chemosis, & mucous discharge.
It inhibits also the prostaglandin-mediated breakdown of the blood- aqueous barrier & resultant changes associated with the development of cystoid macular edema. Likewise, Samulgin® ophthalmic drops can reduce or inhibit corneal neovascularization & ocular trauma induced meiosis as well as relief of ocular manifestations of seasonal allergic conjunctivitis such as itching & irritation.
Topically applied Samulgin® ophthalmic drops does not appear to adversely affect intra-ocular pressure also application of Samulgin® to the eye does not exacerbate ocular bacterial, fungal or viral infections.
Pharmacokinetics
Following topical application to the eye of 0.5% solution of ketorolac tromethamine, the drug distributes throughout ocular tissues & fluids, including cornea, external tissues (e.g., sclera), intraocular tissues (e.g., aqueous humor, choroids-retina, iris, ciliary body) , lens, & vitreous humor.
O Concentrations are highest in scleral & corneal tissues & lowest in the lens
Indications
1-Conjunctivitis
2-Postoperative & post traumatic ocular
inflammation; after cataract extraction, with or without implantation of an intraocular lens, to prevent & relievepost operative ocular inflammation.
In controlled studies perioperative topical application to the eye of ketorolac tromethamine 0.5% reduced lid edema, conjunctival vasodilatation, ciliary flush, & the number of anterior chamber cells & flare as determined by slit lamp examination.
The drug also has reduced postoperative disruption of the blood aqueous barrier.
3-Cystoid macular edema
NSAIDs including ketorolac tromethamine have been used topically to the eye, with or without concomitant topical corticosteroid therapy, to relieve or prevent postoperative cystoid macular edema
4-NSAIDs also have been used prophylactically before ocular surgery (i.e. cataract extraction) to prevent or reduce intraoperative miosis, which may occur secondary to surgery-induced trauma despite preoperative induction of mydriasis.
5-Post operative ocular pain & photophobia are reduced with ketorolac tromethamine application, after refractive corneal surgery.
Adverse effects
Samulgin® ophthalmic drops is usually well tolerated following topical application to the eye.
The most frequent adverse effects are stinging & burning following instillation of the solution; that is usually transient.
Local irritation , allergic reactions, & superficial keratitis have been rarely reported.
Topically applied ketorolac tromethamine does not appear to affect intraocular pressure however, changes in IOP may occur following cataract surgery.
Topical NSAIDS should be used with caution in patients who may be affected adversely by prolongation of bleeding time, including those receiving drugs known to prolong bleeding time or with underlying bleeding tendencies.
Systemic side effects: Evidence suggests that the risk of systemic effects following topical application to the eye in usual dosage is low
Precautions & contraindication
There is potential for cross-sensitivity between ketorolac & other NSAIDs Samulgin® ophthalmic drops should be used with caution in patients in whom asthma ,rhinitis, or urticaria is precipitated by salicylates or other NASIDs.
Patients should remove the soft contact lenses prior to receiving a dose of Samulgin® ophthalmic drops.
Samulgin® ophthalmic drops is contraindicated in patients with known hypersensitivity to the drug or any ingredient in the formulation.
Safety & efficacy of Samulgin® ophthalmic drops in children younger than 12 years of age have not been established.
Drug interactions
Samulgin® ophthalmic drops has been usedsafely in conjunction with ophthalmic agents, including antibiotics, beta-adrenergic blocking agents, carbonic anhydrase inhibitors, cycloplegics, & mydriatics.
Ophthalmic NSAIDs including ketorolac tromethamine have been used concomitantly with ophthalmic corticosteroids, as they both inhibit prostaglandin synthesis, Samulgin® ophthalmic drops act at different sites in the synthesis pathway, this effect is used as a therapeutic advantage in some patients for the management of post operative ocular inflammation, including cystoid macular edema.
Dosage & administrations
For conjunctivitis(i.e. seasonal allergic conjunctivitis): The usual dose in adults is 1 drop of Samulgin® eye drops in the affected eye(s) 4 times daily.
For post operative & post traumatic ocular inflammation (i.e. cataract extraction) : The usual dose in adults is 1 or 2 drop(s) of Samulgin® ophthalmic drops, in the eye(s) undergoing surgery 4 times daily beginning 24 hours after surgery, & continued for 2 weeks after surgery.
For the prevention & relief of postoperative cystoid macular edema associated with cataract extraction: The usual dose in adults is1 or 2 drop(s) of Samulgin® ophthalmic drops, in the eyes undergoing surgery every 6-8 hours beginning 24 hours before the operation & continuing for 3-4 weeks after surgery.
For the active treatment of aphakic cystoid macular edema: The usual dose in adults is1 or 2 drop(s) of Samulgin® ophthalmic drops, in the affected eye(s) 4 times daily for 2-3 months.
For post operative ocular pain & photophobia in patients undergoing ocular refractive surgery: The usual dose is 1 drop of Samulgin® ophthalmic drops 4 times daily in the operated eyes for 3 days after surgery.
Patient information
- Do not touch the applicator tip
- Replace cap after use
- Not to be used by more than one patient
How supplied
Plastic dropper bottles of 10 ml sterile ophthalmic solution
Keep all medicaments out of reach of children
Product of: AMOUN PHARMACEUTICAL CO. El-Obour City, Cairo, Egypt. ATC Code: S01BC05
