Anti-vertigo compound and pharmaceutical compositions thereof
The present invention relates to uses of Levocloperastine for the treatment or prevention of vertigo, disease associated with vertigo or symptoms associated therewith. Further, the invention also relates to oral pharmaceutical composition comprising Levocloperastine and one or more pharmaceutical excipients and its preparation process.
1 . A method of treatment of vertigo, one or more symptoms of vertigo, or a disease associated with vertigo in a human subject, wherein the method comprises administering to the subject a therapeutically effective amount of levocloperastine or a pharmaceutically acceptable salt thereof.
2 . The method according to claim 1 , wherein the one or more symptoms of vertigo or the disease associated with vertigo are selected from the group consisting of Peripheral Vertigo, Meniere's disease, Tinnitus, Hearing loss, Giddiness, Dysesthesia of motion and position, Nystagmus, Dysequilibrium, Dizziness, Head deviation, Nausea, Vomiting, Sweating, Salivation and Tachycardia, Dysstasia and Walking unsteadiness, Staggering, Rotary sensation, Tendency to fall, Lift sensation, Blackout, Change of position (lying), Bowing, Getting up, driving, Head movements (inclination, twist), and eye movement.
3 . The method according to claim 1 , wherein levocloperastine or a pharmaceutically acceptable salt thereof is administered at a daily dose of about 10-1000 mg.
4 . The method according to claim 3 , wherein levocloperastine or a pharmaceutically acceptable salt thereof is administered at a daily dose of about 10-100 mg.
5 . The method according to claim 4 , wherein levocloperastine or a pharmaceutically acceptable salt thereof is administered at a daily dose of about 10-80 mg.
6 . The method according to claim 1 , wherein levocloperastine or a pharmaceutically acceptable salt thereof is administered in an amount from about 60-90 mg once daily, or about 30-45 mg twice a day, or about 20-30 mg thrice a day.
7 . The method according to claim 1 , wherein levocloperastine or a pharmaceutically acceptable salt thereof is administered in an amount of from about 70-120 mg once daily, or about 35-60 mg twice a day, or about 25-40 mg thrice a day.
8 . The method according to claim 1 , wherein levocloperastine or a pharmaceutically acceptable salt thereof is administered in an amount from about 90-160 mg once daily, or about 45-80 mg twice a day, or about 30-55 mg thrice a day.
9 . The method according to claim 1 , wherein levocloperastine or a pharmaceutically acceptable salt thereof is administered in an amount of from about 20-30 mg three times a day.
10 . The method according to claim 1 , wherein levocloperastine or a pharmaceutically acceptable salt thereof is administered in an amount of from about 30-55 mg three times a day.
11 . The method according to claim 1 , wherein levocloperastine is administered for a duration of the treatment that is shorter as compared to the standard of care therapy.
12 . The method according to claim 11 , wherein the standard of care therapy is selected from one or more of betahistine 16 mg tablets three times daily or betahistine 16 mg tablets three times daily plus acetazolamide 125 mg tablets two time daily or cinnarizine 25 mg tablets three times daily.
13 . The method according to claim 1 , wherein levocloperastine or a pharmaceutically acceptable salt is administered in a pharmaceutical composition.
14 . The method according to claim 13 , wherein the pharmaceutical composition is an oral composition.
15 . The method according to claim 14 , wherein the oral composition a tablet, capsule, granules, powder, solution, syrup, emulsion or suspension composition.