Pharmaceutical composition formed by combining pyridoxamine compound and thiamine compound

Abstract

Vitamin B1 deficiency caused when a pyridoxamine compound is administered in a large amount is prevented and/or treated. A pharmaceutical composition formed by combining at least one pyridoxamine compound selected from the group consisting of pyridoxamine and pharmaceutically acceptable salts thereof and at least one thiamine compound selected from the group consisting of thiamine, derivatives thereof, and pharmaceutically acceptable salts thereof, is administered.

1 . A pharmaceutical composition formed by combining
 (1) at least one pyridoxamine compound selected from the group consisting of pyridoxamine and pharmaceutically acceptable salts thereof, and   (2) at least one thiamine compound selected from the group consisting of thiamine, derivatives thereof, and pharmaceutically acceptable salts thereof,   the daily dose of (1) the pyridoxamine compound being 300 mg or more calculated as pyridoxamine.   
     
     
         2 . The pharmaceutical composition according to  claim 1 , wherein the daily dose of (2) the thiamine compound is 1 to 20 parts by weight per 100 parts by weight of the daily dose of (1) the pyridoxamine compound. 
     
     
         3 . The pharmaceutical composition according to  claim 1 , wherein the pharmaceutical composition is administered to a subject having at least one disease or symptom selected from the group consisting of diabetes, diabetic complications, chronic renal failure, complications of chronic renal failure, nephropathy, nephritis, inflammatory diseases, atherosclerosis, age-related eye diseases, neurodegenerative diseases, alcoholism, autism, schizophrenia, malignant melanoma, osteoporosis, deterioration of the peritoneum in peritoneal dialysis, chronic rheumatism, and atopic dermatitis. 
     
     
         4 . The pharmaceutical composition according to  claim 1 , wherein the pharmaceutical composition is administered to a subject having at least one disease or symptom selected from the group consisting of beriberi, axial optic neuritis, polyneuritis, Wernicke's encephalopathy, decreased appetite, and digestion disorders. 
     
     
         5 . The pharmaceutical composition according to  claim 1 , wherein the pharmaceutical composition is a pharmaceutical composition for the treatment of an advanced glycation end product-related disease and the prevention and/or treatment of vitamin B1 deficiency. 
     
     
         6 . The pharmaceutical composition according to  claim 5 , wherein the vitamin B1 deficiency is caused by administration of a pyridoxamine compound. 
     
     
         7 . The pharmaceutical composition according to  claim 5 , wherein the advanced glycation end product-related disease is at least one disease selected from the group consisting of diabetes, diabetic complications, chronic renal failure, complications of chronic renal failure, nephropathy, nephritis, inflammatory diseases, atherosclerosis, age-related eye diseases, neurodegenerative diseases, alcoholism, autism, schizophrenia, malignant melanoma, osteoporosis, deterioration of the peritoneum in peritoneal dialysis, chronic rheumatism, and atopic dermatitis. 
     
     
         8 . The pharmaceutical composition according to  claim 1 , wherein (1) the pyridoxamine compound and (2) the thiamine compound are individually packaged alone or with a pharmaceutically acceptable carrier or additive, as separate preparations, and wherein the pyridoxamine compound or a preparation containing the pyridoxamine compound, and the thiamine compound or a preparation containing the thiamine compound, are administered to a subject at different times, at the same time, or in parallel. 
     
     
         9 . The pharmaceutical composition according to  claim 8 , wherein the pyridoxamine compound or the preparation containing the pyridoxamine compound is administered to the subject before the start of administration of the thiamine compound or the preparation containing the thiamine compound, or
 the pyridoxamine compound or the preparation containing the pyridoxamine compound is administered to the subject after the start of administration of the thiamine compound or the preparation containing the thiamine compound.   
     
     
         10 . The pharmaceutical composition according to  claim 1 , wherein the pyridoxamine compound or the preparation containing the pyridoxamine compound, and/or the thiamine compound or the preparation containing the thiamine compound, is in a dosage form for administration selected from the group consisting of oral administration, intramuscular injection, subcutaneous injection, and intravascular administration. 
     
     
         11 . The pharmaceutical composition according to  claim 1 , wherein the pharmaceutical composition is a combination drug in which (1) the pyridoxamine compound and (2) the thiamine compound are contained in the same preparation. 
     
     
         12 . The pharmaceutical composition according to  claim 11 , wherein the combination drug is in a dosage form for administration selected from the group consisting of oral administration, intramuscular injection, subcutaneous injection, and intravascular administration. 
     
     
         13 . A pharmaceutical product comprising:
 (A) a packaged pharmaceutical composition containing at least one pyridoxamine compound selected from the group consisting of pyridoxamine and pharmaceutically acceptable salts thereof as an active ingredient, and   (B) at least one document selected from the group consisting of a package insert, a product label, directions, and instructions, each stating that the pharmaceutical composition is used in combination with at least one thiamine compound selected from the group consisting of thiamine, derivatives thereof, and pharmaceutically acceptable salts thereof, for the treatment of an advanced glycation end product-related disease.   
     
     
         14 . The pharmaceutical product according to  claim 13 , wherein the daily dose of the pyridoxamine compound in (A) the packaged pharmaceutical composition is 300 mg or more calculated as pyridoxamine, and the daily dose is stated in (B). 
     
     
         15 . The pharmaceutical product according to  claim 13 , wherein the advanced glycation end product-related disease is at least one disease selected from the group consisting of diabetes, diabetic complications, chronic renal failure, complications of chronic renal failure, nephropathy, nephritis, inflammatory diseases, atherosclerosis, age-related eye diseases, neurodegenerative diseases, alcoholism, autism, schizophrenia, malignant melanoma, osteoporosis, deterioration of the peritoneum in peritoneal dialysis, chronic rheumatism, and atopic dermatitis. 
     
     
         16 . The pharmaceutical product according to  claim 13 , for use in administration to a subject having at least one disease or symptom selected from the group consisting of beriberi, axial optic neuritis, polyneuritis, Wernicke's encephalopathy, decreased appetite, and digestion disorders. 
     
     
         17 . A pharmaceutical composition comprising at least one pyridoxamine compound selected from the group consisting of pyridoxamine and pharmaceutically acceptable salts thereof as an active ingredient, the pharmaceutical composition being used in combination with at least one thiamine compound selected from the group consisting of thiamine, derivatives thereof, and pharmaceutically acceptable salts thereof, for the treatment of an advanced glycation end product-related disease at a daily dose of 300 mg or more calculated as pyridoxamine. 
     
     
         18 . The pharmaceutical composition according to  claim 17 , wherein the advanced glycation end product-related disease is at least one disease selected from the group consisting of diabetes, diabetic complications, chronic renal failure, complications of chronic renal failure, nephropathy, nephritis, inflammatory diseases, atherosclerosis, age-related eye diseases, neurodegenerative diseases, alcoholism, autism, schizophrenia, malignant melanoma, osteoporosis, deterioration of the peritoneum in peritoneal dialysis, chronic rheumatism, and atopic dermatitis. 
     
     
         19 . The pharmaceutical composition according to  claim 17 , wherein the pharmaceutical composition is administered to a subject having at least one disease or symptom selected from the group consisting of beriberi, axial optic neuritis, polyneuritis, Wernicke's encephalopathy, decreased appetite, and digestion disorders.