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Product Name
:
MINI-ZAFEN
Chemical Name
:
Ketotifen
Therapeutic Category
:
Ophthalmic drugs
Pharmacologic Category
:
Histamine H1; Antagonist - Histamine H1; Antagonist, Second Generation - Mast Cell Stabilizer - Piperidine Derivative
Pharmaceutical Form
:
S.D.Eye Drops
Composition
:
Ketotifen 0.4 ml
Monitoring Parameters
Dosing
 
Dosing: Adult
Allergic conjunctivitis: Ophthalmic: Instill 1 drop into the affected eye(s) twice daily, every 8-12 hours

Dosing: Pediatric

Allergic conjunctivitis: Children ≥3 years: Ophthalmic: Refer to adult dosing.

Dosing: Geriatric

Refer to adult dosing.
Use
 
Temporary relief of eye itching due to allergic conjunctivitis
Adverse Reactions
 
1% to 10%:
Ocular: Allergic reactions, burning or stinging, conjunctivitis, discharge, dry eyes, eye pain, eyelid disorder, itching, keratitis, lacrimation disorder, mydriasis, photophobia, rash
Respiratory: Pharyngitis
Miscellaneous: Flu syndrome
Contraindications
 
Hypersensitivity to ketotifen or any component of the formulation
Warnings / Precautions Drug
 
Special populations:
• Contact lens wearers: Ophthalmic solution: Not to treat contact lens-related irritation. After ketotifen use, soft contact lens wearers should wait at least 10 minutes before putting their lenses in. Do not wear contact lenses if eyes are red. Do not contaminate dropper tip or solution when placing drops in eyes.
• Self-medication (OTC use): When used for self-medication (OTC), notify healthcare provider if symptoms worsen or do not improve within 3 days. Contact healthcare provider if change in vision, eye pain, or redness occur. Do not use if solution is cloudy or changes color.
Interactions
 
Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central). Acetylcholinesterase Inhibitors (Central) may diminish the therapeutic effect of Anticholinergics. If the anticholinergic action is a side effect of the agent, the result may be beneficial. Risk C: Monitor therapy
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
Amphetamines: May diminish the sedative effect of Antihistamines. Risk C: Monitor therapy
Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: Levocabastine (Nasal); Paliperidone. Risk C: Monitor therapy
Benzylpenicilloyl Polylysine: Antihistamines may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Risk D: Consider therapy modification
Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Exceptions: Levocabastine (Nasal). Risk C: Monitor therapy
Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Risk D: Consider therapy modification
HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Pramlintide: May enhance the anticholinergic effect of Anticholinergics. These effects are specific to the GI tract. Risk D: Consider therapy modification
Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Risk C: Monitor therapy
Pregnancy
 
C
Pregnancy Implications
Topical ocular administration has not been studied.
Lactation
 
Excretion in breast milk unknown/use caution
Breast-Feeding Considerations
Ketotifen has been identified in rat breast milk. It is not known whether detectable levels of ketotifen would appear in human breast milk following topical ocular administration.
Mechanism of Action
 
Exhibits noncompetitive H1-receptor antagonist and mast cell stabilizer properties. Efficacy in conjunctivitis likely results from a combination of anti-inflammatory and antihistaminergic actions including interference with chemokine-induced migration of eosinophils into inflamed conjunctiva.
Pharmacodynamics / Kinetics
 
Onset of action: Minutes
Duration: 8-12 hours
Absorption: Minimally systemic
 
   
 
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