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TSUMURA Bakumondoto Extract Granules for …

Tsumura & Co. 1 Revised: May 2007 (6th version) Standard Commodity Classification No. of Japan 875200 - Kampo-preparation- TSUMURA Bakumondoto Extract Granules for ...

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Tsumura & Co. 1 Revised: May 2007 (6th version) Standard Commodity Classification No. of Japan 875200 - Kampo-preparation- TSUMURA Bakumondoto Extract Granules for Ethical Use <bakumondoto> DESCRIPTION Composition g of TSUMURA Bakumondoto extract granules contains g of a dried extract of the following mixed crude drugs. JP Ophiopogon Tuber .......................... JP Brown Rice ..................................... JP Pinellia Tuber .................................. JP Jujube ........................................ ...... JP Glycyrrhiza ..................................... JP Ginseng ........................................ .. g g g g g g (JP: The Japanese Pharmacopoeia) Inactive ingredientsJP Magnesium Stearate JP Lactose Hydrate Sucrose Esters of Fatty AcidsDescription Dosage form Granules Color Light grayish brown Smell Characteristic smell Taste Sweet ID code TSUMURA/29 INDICATIONS Bakumondoto is indicated for the relief of the following symptoms: Coughing with a hard, obstructive sputum, bronchitis, and bronchial asthma DOSAGE AND ADMINISTRATION The usual adult dose is g/day orally in 2 or 3 divided doses before or between meals. The dosage may be adjusted ac-cording to the patient's age and body weight, and symptoms. PRECAUTIONS 1. Important Precautions (1) When this product is used, the patient s SHO (con-stitution/symptoms) should be taken into account. The patient s progress should be carefully monitored, and if no improvement in symptoms/findings is ob-served, continuous treatment should be avoided. (2) Since this product contains Glycyrrhiza, careful atten-tion should be paid to the serum potassium level, blood pressure, etc., and if any abnormality is observed, ad-ministration should be discontinued. (3) When this product is coadministered with other Kam-po-preparations (Japanese traditional herbal medi-cines), etc., attention should be paid to the duplication of the contained crude drugs. SHO: The term SHO refers to a particular pathological status of a patient evaluated by the Kampo diagnosis, and is patterned according to the patient s constitution, symp-toms, etc. Kampo-preparations (Japanese traditional her-bal medicines) should be used after confirmation that it is suitable for the identified SHO of the patient. 2. Drug Interactions Precautions for coadministration (Bakumondoto should be administered with care when coadministered with the following drugs.) Drugs Signs, Symptoms, and Treatment Mechanism and Risk Factors (1) Preparations contain- ing Glycyrrhiza (2) Preparations contain- ing glycyrrhizinic acid or glycyrrhizinates Pseudoaldosteronism is likely to occur. Besides, myopathy is likely to occur as a result of hypokale-mia. (Refer to the section Clinically signifi-cant adverse reac-tions .) Since glycyrrhizinic acid has an accelerat-ing action on the po-tassium excretion at the renal tubules, an acceleration of de-crease in the serum potassium level has been suggested. Storage Store in light-resistant, air-tight con-tainers. Expiration date Use before the expiration date indi-cated on the container and the outer package. Approval No. (61AM)3269 Date of listing in the NHI reimbursement price October 1986Date of initial marketing in Japan October 1986 2 Tsumura & Co. 3. Adverse Reactions This product has not been investigated (drug use investiga-tions, etc.) to determine the incidence of adverse reactions. Therefore, the incidence of adverse reactions is not known. (1) Clinically significant adverse reactions 1) Interstitial pneumonia: If fever, cough, dyspnea, abnormal pulmonary sound (fine crackle), etc. are observed, administration of this product should be discontinued, and examinations such as X-ray should be performed immediately and appropriate measures such as administration of adrenocortical hormones taken. Besides, the patient should be advised to discontinue this product immediately and to make contact with the physician in the event of fever, cough, dyspnea, etc. 2) Pseudoaldosteronism: Pseudoaldosteronism such as hypokalemia, increased blood pressure, retention of sodium/body fluid, edema, increased body weight, etc. may occur. The patient should be carefully monitored (measurement of serum potas-sium level, etc.), and if any abnormality is ob-served, administration should be discontinued and appropriate measures such as administration of po-tassium preparations should be taken. 3) Myopathy: Myopathy may occur as a result of hy-pokalemia. The patient should be carefully moni-tored, and if any abnormality such as weakness, convulsion/paralysis of limbs, etc. are observed, administration should be discontinued and appro-priate measures such as administration of potas-sium preparations should be taken. 4) Hepatic dysfunction and jaundice: Hepatic dys-function and/or jaundice with elevation of AST (GOT), ALT (GPT), Al-P and -GTP or other symptoms may occur. The patient should be carefully monitored for abnormal findings. Ad-ministration should be discontinued and appropriate therapeutic measures should be taken, if abnormali-ties are observed. (2) Other adverse reactions Incidence unknown Hypersensitivity Note 1) Rash, Urticaria, etc. Note 1) If such symptoms are observed, administration should be discontinued. 4. Use in the Elderly Because elderly patients often have reduced physiological function, careful supervision and measures such as reduc-ing the dose are recommended. 5. Use during Pregnancy, Delivery or Lactation The safety of this product in pregnant women has not been established. Therefore, the product should be used in pregnant women, women who may possibly be pregnant only if the expected therapeutic benefits outweigh the possible risks associated with treatment. 6. Pediatric Use The safety of this product in children has not been estab-lished. [Insufficient clinical data.] PHARMACOLOGY 1. Anti-tussive actions (1) Oral administration of Bakumondoto inhibited the cough reflex induced by mechanical or chemical (spray of citrate solution) stimulation of the tracheal mucosa in SO2 gas inhalation model of bronchitis in guinea pigs but not in normal animals1). (2) Oral administration of Bakumondoto inhibited the sub-stance P-related cough reflex in SO2 gas inhalation model of bronchitis in guinea pigs2). (3) Oral administration of Bakumondoto inhibited an in-crease in spontaneous discharge by the superior laryn-geal nerve in SO2 gas inhalation model of bronchitis in guinea pigs1). 2. Expectorant actions (1) Local administration of Bakumondoto into quail airway with DNA, a substance that enhances adhesiveness, restored mucociliary transport velocity (MCTV) reduc-tion induced by DNA3). (2) Oral administration of Bakumondoto inhibited the re-duction of MCTV in a quail model which decreased airway clearance by human neutrophil elastase or DNA 4). 3. Bronchodilative actions (1) Oral administration of Bakumondoto inhibited acetyl-choline-induced bronchoconstriction in SO2 gas inhala-tion model of bronchitis in guinea pigs5). (2) Oral administration of Bakumondoto inhibited a de-crease in the threshold of histamine, which induces airway hypersensitivity in ozone inhalation airway hypersensitivity model in guinea pigs6). (3) Oral administration of Bakumondoto inhibited an in-crease in immediate/delayed type respiratory resistance in ovalbumin-sensitized guinea pigs with asthma7). 4. Mechanisms of action Bakumondoto exhibits pharmacological effects via the fol-lowing actions: (1) Anti-tussive actions Oral administration of Bakumondoto inhibited the cough reflex induced by phospholamidon a neutral end peptidase (NEP) inhibitor, in guinea pigs. It also in-hibited the reduction of NEP activity in the trachea2). (2) Expectorant actions - Bakumondoto promoted the pulmonary secretion of a surfactant (phosphatidyl choline) in alveolar type II cells isolated from rats. It inhibited an increase in the pulmonary secretion of a surfactant (phosphatidyl choline) induced by polymorphonuclear leukocytes (PMN) activated by substance P (in vitro) 8). - Bakumondoto specifically increased the 1-adrenergic receptor mRNA level in alveolar type II cells isolated from rats. This action disappeared in the presence of a cyclic AMP-dependent protein kinase inhibitor, H-899). Furthermore, Bakumon- Tsumura & Co. 3 doto increased the intracellular level of cyclic AMP (in vitro) 9)10). - Bakumondoto inhibited the enhancement of mucus secretion induced by PMN activated by substance P (in vitro) in hamster tracheal epithelial cells8). - Oral administration of Bakumondoto inhibited in-creases in the airway surface fluid (ASF) levels of DNA, fucose, and protein in a quail model in which human neutrophil elastase decreased airway clear-ance4). - Administration of Bakumondoto on the mucosal side of cultured canine tracheal mucosa reduced the short-circuit current (SCC) reflecting active ion transport and was increased by submucosal adminis-tration. The reaction to submucosal treatment was not influenced by a Na-channel blocker, amiloride, but reduced under Cl-free conditions (in vitro) 11). (3) Bronchodilative actions Bakumondoto enhanced muscle relaxation and an in-crease in cyclic AMP by -adrenergic receptor stimula-tion in canine bronchial smooth muscle (in vitro) 12). (4) Anti-allergic actions - Bakumondoto reduced survival rate and inhibited de-granulation induced by ovalbumin in human eosino-phils (in vitro) 13). - Oral administration of Bakumondoto inhibited the production of IL-6 induced by bacterial LPS in mice pretreated with P. Acnes (in vivo). Bakumondoto inhibited the production of IL-6 induced by IL-1 stimulation in MG63 cells, macrophage-like cells (in vitro) 14). PACKAGING Bottles of 500 g and boxes of 5 kg (500 g 10 bottles) g 42 packets g 189 packets REFERENCES 1) Miyata, K. et al. Jpn. J. Thorac. Dis. 1989, 27(10), 2) Miyata, K. et al. Jpn. J. Inflammation. 1993, 13(5), 3) Miyata, K. et al. Kampo and Immuno-allergy Pharma International, 1997, 4) Tai, S. et al. Phytother. Res. 1999, 13, 5) Miyata, K. et al. Kampo and Immuno-allergy Pharma International, 1988, 6) Aizawa, H. et al. Respirology. 1999, 4, 7) Nagai, H. et al. Kampo and Immuno-allergy Pharma International. 1994, 8) Isohama, Y. et al. Kampo and Immuno-allergy Pharma International. 1994, 9) Isohama, Y. et al. J. Traditional Med. 2001, 18(1), 10) Isohama, Y. et al. J. Traditional Med. 2001, 18(1), 11) Chiyoya, A. et al. Kampo and Immuno-allergy Pharma International. 1994, 12) Tamaoki, J. et al. Japan. J. Pharcol. 1993, 62(2), 13) Ohkubo, Y. et al. Jpn. J. Oriental Medicine. 1994, 44(4), 14) Nagai, H. et al. Kampo and Immuno-allergy Pharma International. 1994, REQUEST FOR LITERATURE SHOULD BE MADE TO: Consumer Information Services Center Tsumura & Co. 2-17-11 Akasaka, Minato-ku, Tokyo 107-8521, Japan Manufactured and Distributed by: Tsumura & Co. 2-17-11 Akasaka, Minato-ku, Tokyo 107-8521, Japan

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