      Document 0122
 DOCN  DRG0122
 UNIQUE IDENTIFIER        DRG-0125
 NAME OF SUBSTANCE        Pyridoxine hydrochloride [USAN 1996]
 REGISTRY NUMBER          58-56-0
 RELATED REGISTRY NUMBER  65-23-6
 STANDARD CHEMICAL NAME   3,4-Pyridinedimethanol, 5-hydroxy-6-methyl-,
                          hydrochloride [USAN 1996]
 SYNONYMS                 Vitamin B6 hydrochloride [Merck Index 1989]
 SYNONYMS                 2-Methyl-3-hydroxy-4,5-bis(hydroxymethyl)
                          pyridine hydrochloride [Merck Index 1989]
 SYNONYMS                 5-Hydroxy-6-methyl-3,4-pyridinedicarbinol
                          hydrochloride [Merck Index 1989]
 SYNONYMS                 3-Hydroxy-4,5-dimethylol-alpha-picoline
                          hydrochloride [Merck Index 1989]
 SYNONYMS                 Bonasanit [Merck Index 1989]
 SYNONYMS                 Paxadon [Merck Index 1989]
 SYNONYMS                 Becilan [Merck Index 1989]
 SYNONYMS                 Campoviton 6 [Merck Index 1989]
 SYNONYMS                 Hexabione hydrochloride [Merck Index 1989]
 SYNONYMS                 Pyridoxinium Chloride [Merck Index 1989]
 SYNONYMS                 Adermine Hydrochloride [Merck Index 1989]
 SYNONYMS                 Hexabetalin [Merck Index 1989]
 SYNONYMS                 Hexavibex [Merck Index 1989]
 SYNONYMS                 Pyridipca [Merck Index 1989]
 SYNONYMS                 Pyridox [Merck Index 1989]
 SYNONYMS                 Benadon [Merck Index 1989]
 SYNONYMS                 Hexermin [Merck Index 1989]
 SYNONYMS                 Hexobion [Merck Index 1989]
 SYNONYMS                 Beesix [USAN 1996]
 SYNONYMS                 Pyridoxol hydrochloride [USAN 1996]
 PROTOCOL ID NUMBERS      NIAID ACTG 177
 PROTOCOL ID NUMBERS      NIAID ACTG 222
 PROTOCOL ID NUMBERS      NIAID ACTG 238
 PROTOCOL ID NUMBERS      NIAID CPCRA 004
 PROTOCOL ID NUMBERS      NIAID DATRI 008
 PROTOCOL ID NUMBERS      NIAID CPCRA 005
 PROTOCOL ID NUMBERS      NIAID ACTG 309
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Vitamin B6 (pyridoxine) acts
                          as a coenzyme in the metabolism of protein,
                          carbohydrates, and fat.  In protein
                          metabolism, it participates in the
                          decarboxylation of amino acids; conversion of
                          tryptophan to niacin or serotonin
                          (5-hydroxytryptamine); and deamination,
                          transamination, and transulfuration of amino
                          acids. In carbohydrate metabolism, it is
                          responsible for the breakdown of glycogen to
                          glucose-1-phosphate. It is readily absorbed
                          from the GI tract. The half-life appears to
                          be 15 to 20 days. It is degraded to
                          4-pyridoxic acid in the liver and this
                          metabolite is excreted in the urine. [Facts
                          and Comparisons 1995]
 DISEASES STUDIED/TREATED Indicated to prevent or treat peripheral
                          neuritis caused by drugs that act as
                          pyridoxine antagonist (eg, isoniazid) and /or
                          increase its excretion in the urine [Drug
                          Evaluations Annual 1995]
 CLASSIFICATION CODE      Vitamin (Coenzyme) [USAN 1996]
 OTHER MAJOR USES         Pyridoxine is indicated to prevent or treat
                          peripheral neuritis caused by certain drugs.
                          Pyridoxine deficiency, including: inadequate
                          diet, drug-induced deficiency, inborn errors
                          of metabolism. Reported to improve symptoms
                          such as cheilosis, seborrheic dermatitis,
                          glossitis, and stomatitis, and relieve the
                          symptoms associated with premenstrual tension
                          [Drug Evaluations Annual 1995] [USP DI 1995]
 SUBSTANCE INTERACTIONS   Interacts with levodopa, INH, cycloserine,
                          penicillamine, hydralazine, oral
                          contraceptives, phenobarbital, phenytoin, and
                          tiopronin. [Drug Evaluations Annual 1995]
                          [Facts and Comparisons 1995]
 ADVERSE EFFECTS          Adverse effects include sensory neuropathic
                          syndromes; unstable gait; numb feet;
                          awkwardness of hands; perioral numbness;
                          decreased sensation to touch, temperature and
                          vibration; paresthesia; somnolence; and low
                          serum folic acid levels. Symptoms resolve
                          over a period of months once the intake of
                          pyridoxine is stopped. [Drug Evaluations
                          Annual 1995] [Facts and Comparisons 1995]
 CONTRAINDICATIONS        Contraindicated in patients with sensitivity
                          to pyridoxine. [Facts and Comparisons 1995]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: White to pratically
                          white crystals or crystalline powder.
                          Slightly bitter, salty taste [AHFS Drug
                          Information 1995]
 CHEMICAL/PHYSICAL DATA   MOLECULAR FORMULA: C8H12ClNO3 [Merck Index
                          1989]
 CHEMICAL/PHYSICAL DATA   MOLECULAR WEIGHT: 205.64 [Merck Index 1989]
 CHEMICAL/PHYSICAL DATA   MELTING POINT: 160 C (Free base) [Merck Index
                          1989]
 CHEMICAL/PHYSICAL DATA   ELEMENTAL COMPOSITION: C46.72%, H5.88%,
                          Cl17.24%, N6.81%, O23.34% [Merck Index 1989]
 CHEMICAL/PHYSICAL DATA   SOLUBILITY: One gram dissolves in about 4.5
                          ml of water, 90 ml of alcohol. Soluble in
                          propylene glycol, sparingly soluble in
                          acetone, insoluble in ether, chloroform
                          [Merck Index 1989]
 CHEMICAL/PHYSICAL DATA   STABILITY: Reasonably stable in light and
                          air. Acidic aqueous solutions are stable
                          [Merck Index 1989]
 CHEMICAL/PHYSICAL DATA   PHYSICAL COMMENT: pH of 10% w/v soln in water
                          = 3.2 [Merck Index 1989]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Water soluble vitamin. One
                          of the vitamins of the B6 complex [AHFS Drug
                          Information 1995]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Tablets, capsules or injections.
                          [USP DI 1995]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Oral. [USP DI 1995]
 SUBSTANCE DELIVERY DATA  STORAGE: Store below 40 C (104 F), preferably
                          between 15 and 30 C (59 and 86 F), unless
                          otherwise specified. Store in a well-closed
                          container. Protect from light. [USP DI 1995]
 MANUFACTURERS            Rugby Laboratories Inc
 MANUFACTURERS            Trishcon Corporation
 REFERENCES               Baum M, Cassetti L, Bonvehi P, Shor-Posner G,
                          Lu Y Sauberlich H. Inadequate dietary intake
                          and altered nutrition status in early HIV-1
                          infection. Nutrition. 1994
                          Jan-Feb;10(1):16-20.
 REFERENCES               Rall LC, Meydani SN. Vitamins B6 and immune
                          competence. Nutr Rev. 1993 Aug;51(8):217-25.
 REFERENCES               Baum MK, Shor-Posner G, Quesada J, Cure N,
                          Fletcher MA, Page BJ. Nutritional
                          abnormalities in intravenous drug users
                          (IVDUs): impact of HIV-1 status. Int Conf
                          AIDS. 1993 Jun 6-11;9(2):703 (abstract no.
                          PO-C15-2917).
 REFERENCES               Valdespino JL, Garcia ML, Daniels E, Zacarias
                          G, Weissenbacher M, Peruga A, Palacios M,
                          Garcia-Sancho C, Loo E, Cruz C, et al.
                          Outcomes of the pilot study of TB
                          chemoprophylaxis trials. Int Conf AIDS. 1993
                          Jun 6-11;9(2):781 (abstract no. PO-C35-3387).
 REFERENCES               Garcia ML, Valdespino JL, Garcia-Sancho C,
                          Weissenbacher M, Daniels E, Peruga A,
                          Palacios M, Loo E, Cruz C, Luna JL, et al.
                          Compliance and side effects to
                          chemoprophylaxis for TB in HIV+. Mexican
                          experience. Int Conf AIDS. 1993 Jun
                          6-11;9(1):324 (abstract no. PO-B07-1133).
 REFERENCES               Pape JW, Jean SS, Ho HL, Hafner A, Johnson WD
                          Jr. Effect of isoniazid prophylaxis on
                          incidence of active tuberculosis and
                          progression of HIV infection [see comments].
                          Lancet. 1993 Jul 31;342(8866):268-72.
 REFERENCES               Shor-Posner G, Blaney N, Feaster D,
                          Manteroatienza E, et al. Anxiety and
                          depression in early HIV-1 infection and its
                          association with vitamin B6 status. Int Conf
                          AIDS. 1992 Jul 19-24;8(2):B209 (abstract no.
                          PoB 3711).
 REFERENCES               Vitamin B6 and immune function in the elderly
                          and HIV-seropositive subjects. Nutr Rev. 1992
                          May;50(5):145-7.
 REFERENCES               Baum MK, Mantero-Atienza E, Shor-Posner G,
                          Fletcher MA, Morgan R, Eisdorfer C,
                          Sauberlich HE, Cornwell PE, Beach RS.
                          Association of vitamin B6 status with
                          parameters of immune function in early HIV-1
                          infection. J Acquir Immune Defic Syndr.
                          1991;4(11):1122-32.
 REFERENCES               Mantero-Atienza E, Baum M, Beach R, Javier J,
                          Morgan R, Eisdorfer C. Vitamin B6 and immune
                          function in HIV infection. Int Conf AIDS.
                          1990 Jun 20-23;6(2):432 (abstract no. 3123).
 ENTRY MONTH              9111
 LAST REVISION DATE       960131
 

SOURCE: National Library of Medicine, Bethesda, MD.  Distributed by AEGIS.
