Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
monoammonium glycyrrhizinate (glycyrrhizic acid), glycine, DL-methionine
Minophagen Pharmaceutical Co.
A05B
monoammonium glycyrrhizinate (glycyrrhizic acid), glycine, DL-methionine
35mg+ 25mg+ 25mg
tablets coated
(100/10x10/) in blister
Prescription
Registered
2016-06-08
Since hypokalaemia (feelings of weakness, muscular weakness, etc.) might develop, adequate measures should be taken with careful observation (including determination of serum potassium level). These diuretics enhance the potassium excreting effect of Glycyrrhizic acid contained in this product, thus tending to decrease serum potassium. Drug name Clinical symptoms / measures Mechanism / risk factor Loop diuretics Ethacrynic acid Furosemide, etc. Thiazide and similar antihypertensive diuretics Trichlormethiazide Chlortalidone, etc. Body fluid / Electrolytes Cardiovascular Others Abdominal pain, headache Ingredients per tablet Active ingredients Inactive ingredients Monoammonium Glycyrrhizinate (as Glycyrrhizic Acid) Glycine (JP) Methionine 35mg (25mg) 25mg 25mg Identification code Color / Dosage from Appearance Front Back Side White/ Sugar-coated tablets Diameter 8.1 mm Thickness 5.0 mm 0.1% to less than 5% Increase in blood pressure Decrease in serum potassium 4. ADVERSE REACTIONS Adverse reactions were observed in 7 (6.5%) out of 107 cases in the double-blind study 1) conducted for the chronic liver diseases. Notable ones were decrease in serum potassium in 2 cases (1.9%), increase in blood pressure in 2 cases (1.9%) and abdomi- nal pain in 2 cases (1.9%). (1)Clinically significant adverse reactions Pseudoaldosteronism (frequency unknown): There is a concern about occurrence of pseudoaldosteronism such as hypokalae- mia, increased blood pressure, sodium retention, fluid retention, oedema, decrease in urinary amount, increased weight and the like, patients should be carefullyobserved (including determination of serum potassium level). In the event of any abnormality, administration should be discontinued. The symptoms of rhabdomyolysis such as weakness, lowered muscle strength, myalgia, quadrispasm and quadriplegia may occur. In the event of elevation of CK(CPK) or elevation of the plasma and urine myoglobin level, administration should be discontinued and appropriate measures should be taken. (2)Other adverse rea Baca dokumen lengkap
1 SUMMARY OF PRODUCT CHARACTERISTICS GLYCYRON ® TABLETS Minophagen Pharmaceutical Co., Ltd. 2 1. NAME OF THE MEDICINAL PRODUCT GLYCYRON ® Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains the following active ingredients: Monoammonium glycyrrhizinate 35 mg (25 mg as Glycyrrhizic acid) Glycine 25 mg DL-Methionine 25 mg Each tablet contains: 29.7mg of Lactose Hydrate For a full list of excipients, see SECTION 6.1 3. PHARMACEUTICAL FORM White, sugar-coated tablets for oral administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GLYCYRON ® Tablets is indicated for the improvement of abnormal liver functions in chronic liver diseases, also for Eczema or dermatitis, infant strophulus and alopecia areata, stomatitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The usual dosage is 2 to 3 tablets in adults and 1 tablet in children, administered orally after meals three times a day. Dose may be adjusted according to the patient’s age and symptoms. 4.3 CONTRAINDICATIONS This product is contraindicated in the following patients: (1) Patients in the final stage of liver cirrhosis whose serum ammonium level tends to increase Since the metabolite of DL -Methionine contained in this product inhibits urea biosynthesis, ammoniua-decomposing ability any be decreased. (2) Patients with aldosteronism, myopathy and hypopotassemia There is a concern about aggravation of hypopotassemia, hypertension or the like. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Careful administration In the experience in the clinical use, incidence of the adverse reactions such as hypopotassemia tended to be higher in the elderly. Careful administration should be taken while observing patient’s conditions. Important precautions Since concomitant use with any other preparations containing Glycyrrhizae Radix brings about overlapping effect with glycyrrhizic acid contained in this product and it liable to cause pseudoaldosteronism, appropriate care should be taken. Precautions concerning use 3 When dispensing the drug: Fo Baca dokumen lengkap