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- MYRTOZA TAB. 30MG MYRTAZAPINE ACTIVE PHARMACEUTICAL INGREDIENTS IN A TABLET MYRTOZA TAB. 30MG: MYRTAZAPINE......30MG DESCRIPTION MYRTOZA TAB. 30MG: RED-BROWN, OVAL, FILM-COATED TABLET INDICATION AND USAGE TREATMENT OF MAJOR DEPRESSIVE DISORDER DOSAGE AND ADMINISTRATION 1.ADULTS THE RECOMMENDED STARTING DOSE OF MYRTAZAPINE IS 15MG/DAY, INCREASING THE DOSE AS NECESSARY TO ACHIEVE ADEQUATE CLINICAL EFFECT. EFFECTIVE DOSES RANGE FROM 15-45MG PER DAY. 2.USE IN SPECIAL POPULATIONS 1)PATIENTS WITH RENAL IMPAIRMENT MYRTAZAPINE CLEARANCE IS REDUCED IN PATIENTS WITH MODERATE TO SEVERE RENAL IMPAIRMENT (CREATININE CLEARANCE <40MG/MIN). CAUTION IS REQUIRED WHEN USING MYRTAZAPINE IN PATIENTS WITH RENAL IMPAIRMENT. 2)PATIENTS WITH HEPATIC IMPAIRMENT MYRTAZAPINE CLEARANCE IS REDUCED IN PATIENTS WITH HEPATIC IMPAIRMENT. PARTICULAR CAUTION IS REQUIRED WHEN USING MYRTAZAPINE IN PATIENTS WITH HEPATIC IMPAIRMENT, AS THE DRUG HAS NOT BEEN STUDIED IN INDIVIDUALS WITH SEVERE HEPATIC IMPAIRMENT. 3)GERIATRIC PATIENTS THE RECOMMENDED DOSE IS THE SAME AS FOR ADULTS. CAREFUL OBSERVATION IS REQUIRED WHEN INCREASING THE DOSE TO ACHIEVE A SATISFACTORY AND SAFE EFFECT. 4)PEDIATRIC PATIENTS AND ADOLESCENTS (UNDER 18 YEARS OF AGE) TWO SHORT-TERM CLINICAL TRIALS DID NOT DEMONSTRATE EFFICACY AND SAFETY, THEREFORE THIS DRUG IS NOT USED IN CHILDREN AND ADOLESCENTS. 3.PATIENT TRANSITION FROM MAO INHIBITORS AND VICE VERSA, THERE MUST BE A MINIMUM OF 14 DAYS BETWEEN DISCONTINUING MAO AND STARTING TREATMENT WITH MYRTAZAPINE FOR PSYCHIATRIC DISORDERS. ADDITIONALLY, A MINIMUM OF 14 DAYS MUST PASS AFTER DISCONTINUING MYRTAZAPINE BEFORE STARTING MAO. 4.OTHER MAO INHIBITORS SUCH AS LINEZOLID AND METHYLENE BLUE DO NOT INITIATE MYRTAZAPINE IN A PATIENT RECEIVING LINEZOLID OR INTRAVENOUS METHYLENE BLUE DUE TO AN INCREASED RISK OF SEROTONIN SYNDROME. FOR A PATIENT REQUIRING MORE RAPID TREATMENT OF A PSYCHIATRIC CONDITION, CONSIDER ALTERNATIVE INTERVENTIONS, INCLUDING HOSPITALIZATION. IN SOME CASES, A PATIENT RECEIVING MYRTAZAPINE THERAPY MAY REQUIRE MORE RAPID TREATMENT WITH LINEZOLID OR INTRAVENOUS METHYLENE BLUE. IF THERE ARE NO ALTERNATIVES TO LINEZOLID OR INTRAVENOUS METHYLENE BLUE AND THE BENEFITS OF THEIR ADMINISTRATION IN A PARTICULAR PATIENT OUTWEIGH THE RISK OF SEROTONIN SYNDROME, MYRTAZAPINE SHOULD BE DISCONTINUED ACCORDINGLY, AND LINEZOLID OR INTRAVENOUS METHYLENE BLUE MAY BE ADMINISTERED. PATIENTS NEED TO BE MONITORED FOR SEROTONIN SYNDROME FOR TWO WEEKS OR WITHIN 24 HOURS OF THE LAST DOSE OF LINEZOLID OR INTRAVENOUS METHYLENE BLUE. THE RISK OF ADMINISTERING METHYLENE BLUE NON-INTRAVENOUSLY (SUCH AS ORAL TABLETS OR LOCAL INJECTION) OR INTRAVENOUS DOSES LESS THAN 1MG/KG CONCURRENTLY WITH MYRTAZAPINE IS UNKNOWN. HOWEVER, THE PHYSICIAN SHOULD BE PREPARED FOR THE POSSIBILITY OF DEVELOPING SYMPTOMS OF SEROTONIN SYNDROME IN THIS CASE. THE HALF-LIFE OF MYRTAZAPINE IS 20-40 HOURS, THEREFORE IT SHOULD BE TAKEN ONCE DAILY, PREFERABLY AT BEDTIME. ADDITIONALLY, THE DRUG CAN BE TAKEN TWICE DAILY WITH DOSE SPLITTING, ONE DOSE IN THE MORNING, ONE IN THE EVENING. DOSE CHANGES SHOULD NOT OCCUR AT INTERVALS LESS THAN 1-2 WEEKS TO ALLOW SUFFICIENT TIME TO ASSESS THE THERAPEUTIC EFFECT OF THE GIVEN DOSE. TREATMENT WITH AN APPROPRIATE DOSE WILL BE EFFECTIVE IN 2-4 WEEKS. IF THE THERAPEUTIC EFFECT IS INADEQUATE, THE DOSE CAN BE INCREASED TO THE MAXIMUM. IF TREATMENT CONTINUES FOR 2-4 WEEKS WITHOUT EFFECT, DISCONTINUE TREATMENT. TREATMENT SHOULD CONTINUE FOR 4-6 MONTHS UNTIL PATIENT SYMPTOMS SUBSIDE. GRADUAL WITHDRAWAL OF TREATMENT IS RECOMMENDED TO AVOID WITHDRAWAL SYMPTOMS. TAKE THE DRUG ORALLY WITH WATER, DO NOT CHEW. CONTRAINDICATIONS AND PRECAUTIONS 1.CONTRAINDICATIONS 1)HYPERSENSITIVITY TO MYRTAZAPINE OR ANY OF THE FORMULA'S INGREDIENTS. NOTE THAT THE DRUG CONTAINS SUNSET YELLOW FCF AND SHOULD BE USED WITH CAUTION IN PATIENTS WITH INCREASED SENSITIVITY OR A HISTORY OF ALLERGY TO SUNSET YELLOW FCF. 2)PATIENTS RECEIVING MAO INHIBITORS DUE TO INCREASED RISK OF SEROTONIN SYNDROME, THE USE OF MAO INHIBITORS FOR THE TREATMENT OF PSYCHIATRIC DISORDERS IS CONTRAINDICATED, CONCURRENTLY WITH MYRTAZAPINE OR WITHIN 14 DAYS OF ITS DISCONTINUATION. IT IS ALSO CONTRAINDICATED TO USE MYRTAZAPINE FOR THE TREATMENT OF PSYCHIATRIC DISORDERS WITHIN 14 DAYS OF DISCONTINUING MAO INHIBITORS (SEE DOSAGE AND ADMINISTRATION AND 5.GENERAL PRECAUTIONS). DUE TO THE INCREASED RISK OF SEROTONIN SYNDROME, IT IS ALSO CONTRAINDICATED TO INITIATE MYRTAZAPINE TREATMENT IN A PATIENT RECEIVING MAO INHIBITORS SUCH AS LINEZOLID OR INTRAVENOUS METHYLENE BLUE. 3)PATIENTS WITH RARE GENETIC PROBLEMS OF FRUCTOSE INTOLERANCE, GALACTOSE INTOLERANCE, LACTASE DEFICIENCY, SUCRASE-ISOMALTASE DEFICIENCY, OR GLUCOSE-GALACTOSE MALABSORPTION. 2.PRECAUTIONS EPILEPSY AND ORGANIC BRAIN SYNDROME: MYRTAZAPINE SHOULD BE USED WITH CAUTION IN PATIENTS WITH A HISTORY OF SEIZURES. TREATMENT SHOULD BE DISCONTINUED IN ANY PATIENT WHO DEVELOPS SEIZURES OR WHEN THE FREQUENCY OF SEIZURES INCREASES. LIVER DAMAGE: AFTER A SINGLE 15MG ORAL DOSE OF MYRTAZAPINE, MYRTAZAPINE CLEARANCE WAS REDUCED BY APPROXIMATELY 35% IN PATIENTS WITH MILD TO MODERATE HEPATIC IMPAIRMENT COMPARED TO HEALTHY INDIVIDUALS. THE MEAN PLASMA CONCENTRATION OF MYRTAZAPINE WAS INCREASED BY APPROXIMATELY 55%. RENAL DAMAGE: AFTER A SINGLE 15MG ORAL DOSE OF MYRTAZAPINE, MYRTAZAPINE CLEARANCE WAS REDUCED BY APPROXIMATELY 30% AND 50% IN PATIENTS WITH MODERATE (CREATININE CLEARANCE <40MG/MIN) AND SEVERE (CREATININE CLEARANCE ≤10MG/MIN) RENAL IMPAIRMENT, RESPECTIVELY, COMPARED TO HEALTHY SUBJECTS. THE MEAN PLASMA CONCENTRATION OF CREATININE WAS INCREASED BY APPROXIMATELY 55% AND 115%. NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN PATIENTS WITH MODERATE RENAL IMPAIRMENT (<80MG/MIN) COMPARED TO THE CONTROL GROUP. CARDIAC DISEASES SUCH AS CONDUCTION DISORDERS, CARDIAC ANGINA, AND RECENT MYOCARDIAL INFARCTION, WHERE USUAL PRECAUTIONS SHOULD BE TAKEN AND CONCOMITANT MEDICATIONS USED WITH CAUTION. LOW BLOOD PRESSURE DIABETES MELLITUS: IN DIABETIC PATIENTS, ANTIDEPRESSANTS MAY AFFECT GLYCEMIC CONTROL. DOSAGE ADJUSTMENTS OF INSULIN AND/OR ORAL HYPOGLYCEMIC AGENTS MAY BE NECESSARY, INTENSIVE MONITORING IS RECOMMENDED. AS WITH OTHER ANTIDEPRESSANTS, THE FOLLOWING SHOULD BE CONSIDERED: PSYCHIATRIC SYMPTOMS MAY WORSEN WHEN ANTIDEPRESSANTS ARE USED IN PATIENTS WITH SCHIZOPHRENIA OR OTHER PSYCHIATRIC DISORDERS; PARANOID THOUGHTS MAY BE INTENSIFIED. WHEN TREATING THE DEPRESSIVE PHASE OF BIPOLAR DISORDER, IT MAY SHIFT TO THE MANIC PHASE. PATIENTS WITH A HISTORY OF MANIA/HYPOMANIA REQUIRE INTENSIVE MONITORING. MYRTAZAPINE SHOULD BE DISCONTINUED IN THE MANIC PHASE. CAUTION IS REQUIRED IN PATIENTS WITH NOCTURIA, SUCH AS PROSTATE HYPERTROPHY, AND IN PATIENTS WITH ACUTE NARROW-ANGLE GLAUCOMA AND ELEVATED INTRAOCULAR PRESSURE AKATHISIA/PSYCHOMOTOR RESTLESSNESS: THE USE OF ANTIDEPRESSANTS IS ASSOCIATED WITH THE DEVELOPMENT OF AKATHISIA, CHARACTERIZED BY SUBJECTIVE UNPLEASANT OR DISTRESSING RESTLESSNESS AND A NEED TO MOVE FREQUENTLY, ACCOMPANIED BY AN INABILITY TO SIT OR STAND STILL. THE DEVELOPMENT OF THESE EVENTS IS MORE LIKELY DURING THE FIRST FEW WEEKS OF TREATMENT. DOSE INCREASES MAY BE DETRIMENTAL IN PATIENTS WHO DEVELOP THESE SYMPTOMS. ADVERSE REACTIONS BLOOD AND LYMPHATIC SYSTEM DISORDERS BONE MARROW DEPRESSION (GRANULOCYTOPENIA, AGRANULOCYTOSIS, APLASTIC ANEMIA, THROMBOCYTOPENIA) EOSINOPHILIA ENDOCRINE DISORDERS INAPPROPRIATE SECRETION OF ANTIDIURETIC HORMONE METABOLISM AND NUTRITION DISORDERS WEIGHT GAIN1 INCREASED APPETITE HYPONATREMIA PSYCHIATRIC DISORDERS ABNORMAL DREAMS CONFUSION ANXIETY INSOMNIA NIGHTMARES MANIA AGITATION HALLUCINATIONS PSYCHOMOTOR RESTLESSNESS (INCLUDING AKATHISIA, HYPERKINESIA) AGGRESSION SUICIDAL IDEATION6 SUICIDAL BEHAVIOR NERVOUS SYSTEM DISORDERS DROWSINESS SEDATION HEADACHE LETHARGY DIZZINESS TREMOR PARESTHESIA RESTLESS LEGS SYNDROME SYNCOPE MYOCLONUS CONVULSIONS (STROKES) SEROTONIN SYNDROME ORAL PARESTHESIA DYSARTHRIA VASCULAR DISORDERS ORTHOSTATIC HYPOTENSION HYPOTENSION GASTROINTESTINAL DISORDERS DRY MOUTH NAUSEA DIARRHEA VOMITING CONSTIPATION ORAL HYPOOESHTHESIA PANCREATITIS MOUTH SWELLING INCREASED SALIVATION HEPATOBILIARY DISORDERS INCREASED SERUM TRANSAMINASE ACTIVITY MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS ARTHRALGIA, MYALGIA, BACK PAIN RHABDOMYOLYSIS RENAL AND URINARY TRACT DISORDERS PERIPHERAL EDEMA1 FATIGUE DROWSINESS INVESTIGATIONS INCREASED CREATINE KINASE PREGNANCY AND LACTATION PREGNANCY ANIMAL STUDIES DID NOT REVEAL CLINICALLY SIGNIFICANT TERATOGENIC EFFECTS, ALTHOUGH DEVELOPMENTAL TOXICITY WAS OBSERVED. IF MYRTAZAPINE IS USED SHORTLY BEFORE OR AFTER DELIVERY, POSTNATAL MONITORING OF THE NEWBORN IS RECOMMENDED TO DETECT WITHDRAWAL EFFECTS. EPIDEMIOLOGICAL DATA HAVE SHOWN THAT THE USE OF SSRIS DURING PREGNANCY, ESPECIALLY IN THE LATE STAGE, MAY INCREASE THE RISK OF PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN). ALTHOUGH STUDIES HAVE NOT INVESTIGATED THE ASSOCIATION OF PPHN WITH MYRTAZAPINE TREATMENT, A POTENTIAL RISK CANNOT BE EXCLUDED CONSIDERING THE MECHANISM OF ACTION (INCREASED SEROTONIN CONCENTRATION). LACTATION ANIMAL STUDIES AND LIMITED HUMAN DATA HAVE SHOWN THAT MYRTAZAPINE IS EXCRETED IN BREAST MILK IN VERY SMALL AMOUNTS. THE DECISION TO CONTINUE/DISCONTINUE BREASTFEEDING OR TO CONTINUE/DISCONTINUE MYRTAZAPINE THERAPY SHOULD CONSIDER THE BENEFITS OF BREASTFEEDING FOR THE CHILD AND THE BENEFITS OF MYRTAZAPINE THERAPY FOR THE WOMAN. OVERDOSE EXPERIENCE WITH MYRTAZAPINE OVERDOSE TO DATE INDICATES THAT SYMPTOMS ARE USUALLY MILD. CENTRAL NERVOUS SYSTEM DEPRESSION WITH DISORIENTATION AND PROLONGED SEDATION, ACCOMPANIED BY TACHYCARDIA AND MILD HYPER OR HYPOTENSION, HAS BEEN DESCRIBED. STORAGE STORE IN A LIGHT-RESISTANT SOLID CONTAINER IN A DRY PLACE (2-30°C). SHELF LIFE: 36 MONTHS FROM THE DATE OF MANUFACTURE. DISPENSING RULE: PHARMACEUTICAL PRODUCT GROUP II, DISPENSED WITH FORM N3 PRESCRIPTION. PACKAGING UNIT MYRTOZA TAB. 30MG ... 30 TABLETS MANUFACTURER 50, GONGDAN-RO, ANSEONG-SI, GYEONGGI-DO, REPUBLIC OF KOREA
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What is it?
MYRTOZA TAB. 30MG MYRTAZAPINE ACTIVE PHARMACEUTICAL INGREDIENTS IN A TABLET MYRTOZA TAB. 30MG: MYRTAZAPINE......30MG DESCRIPTION MYRTOZA TAB. 30MG: RED-BROWN, OVAL, FILM-COATED TABLET INDICATION AND USAGE TREATMENT OF MAJOR DEPRESSIVE DISORDER DOSAGE AND ADMINISTRATION 1.ADULTS THE RECOMMENDED STARTING DOSE OF MYRTAZAPINE IS 15MG/DAY, INCREASING THE DOSE AS NECESSARY TO ACHIEVE ADEQUATE CLINICAL EFFECT. EFFECTIVE DOSES RANGE FROM 15-45MG PER DAY. 2.USE IN SPECIAL POPULATIONS 1)PATIENTS WITH RENAL IMPAIRMENT MYRTAZAPINE CLEARANCE IS REDUCED IN PATIENTS WITH MODERATE TO SEVERE RENAL IMPAIRMENT (CREATININE CLEARANCE <40MG/MIN). CAUTION IS REQUIRED WHEN USING MYRTAZAPINE IN PATIENTS WITH RENAL IMPAIRMENT. 2)PATIENTS WITH HEPATIC IMPAIRMENT MYRTAZAPINE CLEARANCE IS REDUCED IN PATIENTS WITH HEPATIC IMPAIRMENT. PARTICULAR CAUTION IS REQUIRED WHEN USING MYRTAZAPINE IN PATIENTS WITH HEPATIC IMPAIRMENT, AS THE DRUG HAS NOT BEEN STUDIED IN INDIVIDUALS WITH SEVERE HEPATIC IMPAIRMENT. 3)GERIATRIC PATIENTS THE RECOMMENDED DOSE IS THE SAME AS FOR ADULTS. CAREFUL OBSERVATION IS REQUIRED WHEN INCREASING THE DOSE TO ACHIEVE A SATISFACTORY AND SAFE EFFECT. 4)PEDIATRIC PATIENTS AND ADOLESCENTS (UNDER 18 YEARS OF AGE) TWO SHORT-TERM CLINICAL TRIALS DID NOT DEMONSTRATE EFFICACY AND SAFETY, THEREFORE THIS DRUG IS NOT USED IN CHILDREN AND ADOLESCENTS. 3.PATIENT TRANSITION FROM MAO INHIBITORS AND VICE VERSA, THERE MUST BE A MINIMUM OF 14 DAYS BETWEEN DISCONTINUING MAO AND STARTING TREATMENT WITH MYRTAZAPINE FOR PSYCHIATRIC DISORDERS. ADDITIONALLY, A MINIMUM OF 14 DAYS MUST PASS AFTER DISCONTINUING MYRTAZAPINE BEFORE STARTING MAO. 4.OTHER MAO INHIBITORS SUCH AS LINEZOLID AND METHYLENE BLUE DO NOT INITIATE MYRTAZAPINE IN A PATIENT RECEIVING LINEZOLID OR INTRAVENOUS METHYLENE BLUE DUE TO AN INCREASED RISK OF SEROTONIN SYNDROME. FOR A PATIENT REQUIRING MORE RAPID TREATMENT OF A PSYCHIATRIC CONDITION, CONSIDER ALTERNATIVE INTERVENTIONS, INCLUDING HOSPITALIZATION. IN SOME CASES, A PATIENT RECEIVING MYRTAZAPINE THERAPY MAY REQUIRE MORE RAPID TREATMENT WITH LINEZOLID OR INTRAVENOUS METHYLENE BLUE. IF THERE ARE NO ALTERNATIVES TO LINEZOLID OR INTRAVENOUS METHYLENE BLUE AND THE BENEFITS OF THEIR ADMINISTRATION IN A PARTICULAR PATIENT OUTWEIGH THE RISK OF SEROTONIN SYNDROME, MYRTAZAPINE SHOULD BE DISCONTINUED ACCORDINGLY, AND LINEZOLID OR INTRAVENOUS METHYLENE BLUE MAY BE ADMINISTERED. PATIENTS NEED TO BE MONITORED FOR SEROTONIN SYNDROME FOR TWO WEEKS OR WITHIN 24 HOURS OF THE LAST DOSE OF LINEZOLID OR INTRAVENOUS METHYLENE BLUE. THE RISK OF ADMINISTERING METHYLENE BLUE NON-INTRAVENOUSLY (SUCH AS ORAL TABLETS OR LOCAL INJECTION) OR INTRAVENOUS DOSES LESS THAN 1MG/KG CONCURRENTLY WITH MYRTAZAPINE IS UNKNOWN. HOWEVER, THE PHYSICIAN SHOULD BE PREPARED FOR THE POSSIBILITY OF DEVELOPING SYMPTOMS OF SEROTONIN SYNDROME IN THIS CASE. THE HALF-LIFE OF MYRTAZAPINE IS 20-40 HOURS, THEREFORE IT SHOULD BE TAKEN ONCE DAILY, PREFERABLY AT BEDTIME. ADDITIONALLY, THE DRUG CAN BE TAKEN TWICE DAILY WITH DOSE SPLITTING, ONE DOSE IN THE MORNING, ONE IN THE EVENING. DOSE CHANGES SHOULD NOT OCCUR AT INTERVALS LESS THAN 1-2 WEEKS TO ALLOW SUFFICIENT TIME TO ASSESS THE THERAPEUTIC EFFECT OF THE GIVEN DOSE. TREATMENT WITH AN APPROPRIATE DOSE WILL BE EFFECTIVE IN 2-4 WEEKS. IF THE THERAPEUTIC EFFECT IS INADEQUATE, THE DOSE CAN BE INCREASED TO THE MAXIMUM. IF TREATMENT CONTINUES FOR 2-4 WEEKS WITHOUT EFFECT, DISCONTINUE TREATMENT. TREATMENT SHOULD CONTINUE FOR 4-6 MONTHS UNTIL PATIENT SYMPTOMS SUBSIDE. GRADUAL WITHDRAWAL OF TREATMENT IS RECOMMENDED TO AVOID WITHDRAWAL SYMPTOMS. TAKE THE DRUG ORALLY WITH WATER, DO NOT CHEW. CONTRAINDICATIONS AND PRECAUTIONS 1.CONTRAINDICATIONS 1)HYPERSENSITIVITY TO MYRTAZAPINE OR ANY OF THE FORMULA'S INGREDIENTS. NOTE THAT THE DRUG CONTAINS SUNSET YELLOW FCF AND SHOULD BE USED WITH CAUTION IN PATIENTS WITH INCREASED SENSITIVITY OR A HISTORY OF ALLERGY TO SUNSET YELLOW FCF. 2)PATIENTS RECEIVING MAO INHIBITORS DUE TO INCREASED RISK OF SEROTONIN SYNDROME, THE USE OF MAO INHIBITORS FOR THE TREATMENT OF PSYCHIATRIC DISORDERS IS CONTRAINDICATED, CONCURRENTLY WITH MYRTAZAPINE OR WITHIN 14 DAYS OF ITS DISCONTINUATION. IT IS ALSO CONTRAINDICATED TO USE MYRTAZAPINE FOR THE TREATMENT OF PSYCHIATRIC DISORDERS WITHIN 14 DAYS OF DISCONTINUING MAO INHIBITORS (SEE DOSAGE AND ADMINISTRATION AND 5.GENERAL PRECAUTIONS). DUE TO THE INCREASED RISK OF SEROTONIN SYNDROME, IT IS ALSO CONTRAINDICATED TO INITIATE MYRTAZAPINE TREATMENT IN A PATIENT RECEIVING MAO INHIBITORS SUCH AS LINEZOLID OR INTRAVENOUS METHYLENE BLUE. 3)PATIENTS WITH RARE GENETIC PROBLEMS OF FRUCTOSE INTOLERANCE, GALACTOSE INTOLERANCE, LACTASE DEFICIENCY, SUCRASE-ISOMALTASE DEFICIENCY, OR GLUCOSE-GALACTOSE MALABSORPTION. 2.PRECAUTIONS EPILEPSY AND ORGANIC BRAIN SYNDROME: MYRTAZAPINE SHOULD BE USED WITH CAUTION IN PATIENTS WITH A HISTORY OF SEIZURES. TREATMENT SHOULD BE DISCONTINUED IN ANY PATIENT WHO DEVELOPS SEIZURES OR WHEN THE FREQUENCY OF SEIZURES INCREASES. LIVER DAMAGE: AFTER A SINGLE 15MG ORAL DOSE OF MYRTAZAPINE, MYRTAZAPINE CLEARANCE WAS REDUCED BY APPROXIMATELY 35% IN PATIENTS WITH MILD TO MODERATE HEPATIC IMPAIRMENT COMPARED TO HEALTHY INDIVIDUALS. THE MEAN PLASMA CONCENTRATION OF MYRTAZAPINE WAS INCREASED BY APPROXIMATELY 55%. RENAL DAMAGE: AFTER A SINGLE 15MG ORAL DOSE OF MYRTAZAPINE, MYRTAZAPINE CLEARANCE WAS REDUCED BY APPROXIMATELY 30% AND 50% IN PATIENTS WITH MODERATE (CREATININE CLEARANCE <40MG/MIN) AND SEVERE (CREATININE CLEARANCE ≤10MG/MIN) RENAL IMPAIRMENT, RESPECTIVELY, COMPARED TO HEALTHY SUBJECTS. THE MEAN PLASMA CONCENTRATION OF CREATININE WAS INCREASED BY APPROXIMATELY 55% AND 115%. NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN PATIENTS WITH MODERATE RENAL IMPAIRMENT (<80MG/MIN) COMPARED TO THE CONTROL GROUP. CARDIAC DISEASES SUCH AS CONDUCTION DISORDERS, CARDIAC ANGINA, AND RECENT MYOCARDIAL INFARCTION, WHERE USUAL PRECAUTIONS SHOULD BE TAKEN AND CONCOMITANT MEDICATIONS USED WITH CAUTION. LOW BLOOD PRESSURE DIABETES MELLITUS: IN DIABETIC PATIENTS, ANTIDEPRESSANTS MAY AFFECT GLYCEMIC CONTROL. DOSAGE ADJUSTMENTS OF INSULIN AND/OR ORAL HYPOGLYCEMIC AGENTS MAY BE NECESSARY, INTENSIVE MONITORING IS RECOMMENDED. AS WITH OTHER ANTIDEPRESSANTS, THE FOLLOWING SHOULD BE CONSIDERED: PSYCHIATRIC SYMPTOMS MAY WORSEN WHEN ANTIDEPRESSANTS ARE USED IN PATIENTS WITH SCHIZOPHRENIA OR OTHER PSYCHIATRIC DISORDERS; PARANOID THOUGHTS MAY BE INTENSIFIED. WHEN TREATING THE DEPRESSIVE PHASE OF BIPOLAR DISORDER, IT MAY SHIFT TO THE MANIC PHASE. PATIENTS WITH A HISTORY OF MANIA/HYPOMANIA REQUIRE INTENSIVE MONITORING. MYRTAZAPINE SHOULD BE DISCONTINUED IN THE MANIC PHASE. CAUTION IS REQUIRED IN PATIENTS WITH NOCTURIA, SUCH AS PROSTATE HYPERTROPHY, AND IN PATIENTS WITH ACUTE NARROW-ANGLE GLAUCOMA AND ELEVATED INTRAOCULAR PRESSURE AKATHISIA/PSYCHOMOTOR RESTLESSNESS: THE USE OF ANTIDEPRESSANTS IS ASSOCIATED WITH THE DEVELOPMENT OF AKATHISIA, CHARACTERIZED BY SUBJECTIVE UNPLEASANT OR DISTRESSING RESTLESSNESS AND A NEED TO MOVE FREQUENTLY, ACCOMPANIED BY AN INABILITY TO SIT OR STAND STILL. THE DEVELOPMENT OF THESE EVENTS IS MORE LIKELY DURING THE FIRST FEW WEEKS OF TREATMENT. DOSE INCREASES MAY BE DETRIMENTAL IN PATIENTS WHO DEVELOP THESE SYMPTOMS. ADVERSE REACTIONS BLOOD AND LYMPHATIC SYSTEM DISORDERS BONE MARROW DEPRESSION (GRANULOCYTOPENIA, AGRANULOCYTOSIS, APLASTIC ANEMIA, THROMBOCYTOPENIA) EOSINOPHILIA ENDOCRINE DISORDERS INAPPROPRIATE SECRETION OF ANTIDIURETIC HORMONE METABOLISM AND NUTRITION DISORDERS WEIGHT GAIN1 INCREASED APPETITE HYPONATREMIA PSYCHIATRIC DISORDERS ABNORMAL DREAMS CONFUSION ANXIETY INSOMNIA NIGHTMARES MANIA AGITATION HALLUCINATIONS PSYCHOMOTOR RESTLESSNESS (INCLUDING AKATHISIA, HYPERKINESIA) AGGRESSION SUICIDAL IDEATION6 SUICIDAL BEHAVIOR NERVOUS SYSTEM DISORDERS DROWSINESS SEDATION HEADACHE LETHARGY DIZZINESS TREMOR PARESTHESIA RESTLESS LEGS SYNDROME SYNCOPE MYOCLONUS CONVULSIONS (STROKES) SEROTONIN SYNDROME ORAL PARESTHESIA DYSARTHRIA VASCULAR DISORDERS ORTHOSTATIC HYPOTENSION HYPOTENSION GASTROINTESTINAL DISORDERS DRY MOUTH NAUSEA DIARRHEA VOMITING CONSTIPATION ORAL HYPOOESHTHESIA PANCREATITIS MOUTH SWELLING INCREASED SALIVATION HEPATOBILIARY DISORDERS INCREASED SERUM TRANSAMINASE ACTIVITY MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS ARTHRALGIA, MYALGIA, BACK PAIN RHABDOMYOLYSIS RENAL AND URINARY TRACT DISORDERS PERIPHERAL EDEMA1 FATIGUE DROWSINESS INVESTIGATIONS INCREASED CREATINE KINASE PREGNANCY AND LACTATION PREGNANCY ANIMAL STUDIES DID NOT REVEAL CLINICALLY SIGNIFICANT TERATOGENIC EFFECTS, ALTHOUGH DEVELOPMENTAL TOXICITY WAS OBSERVED. IF MYRTAZAPINE IS USED SHORTLY BEFORE OR AFTER DELIVERY, POSTNATAL MONITORING OF THE NEWBORN IS RECOMMENDED TO DETECT WITHDRAWAL EFFECTS. EPIDEMIOLOGICAL DATA HAVE SHOWN THAT THE USE OF SSRIS DURING PREGNANCY, ESPECIALLY IN THE LATE STAGE, MAY INCREASE THE RISK OF PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN). ALTHOUGH STUDIES HAVE NOT INVESTIGATED THE ASSOCIATION OF PPHN WITH MYRTAZAPINE TREATMENT, A POTENTIAL RISK CANNOT BE EXCLUDED CONSIDERING THE MECHANISM OF ACTION (INCREASED SEROTONIN CONCENTRATION). LACTATION ANIMAL STUDIES AND LIMITED HUMAN DATA HAVE SHOWN THAT MYRTAZAPINE IS EXCRETED IN BREAST MILK IN VERY SMALL AMOUNTS. THE DECISION TO CONTINUE/DISCONTINUE BREASTFEEDING OR TO CONTINUE/DISCONTINUE MYRTAZAPINE THERAPY SHOULD CONSIDER THE BENEFITS OF BREASTFEEDING FOR THE CHILD AND THE BENEFITS OF MYRTAZAPINE THERAPY FOR THE WOMAN. OVERDOSE EXPERIENCE WITH MYRTAZAPINE OVERDOSE TO DATE INDICATES THAT SYMPTOMS ARE USUALLY MILD. CENTRAL NERVOUS SYSTEM DEPRESSION WITH DISORIENTATION AND PROLONGED SEDATION, ACCOMPANIED BY TACHYCARDIA AND MILD HYPER OR HYPOTENSION, HAS BEEN DESCRIBED. STORAGE STORE IN A LIGHT-RESISTANT SOLID CONTAINER IN A DRY PLACE (2-30°C). SHELF LIFE: 36 MONTHS FROM THE DATE OF MANUFACTURE. DISPENSING RULE: PHARMACEUTICAL PRODUCT GROUP II, DISPENSED WITH FORM N3 PRESCRIPTION. PACKAGING UNIT MYRTOZA TAB. 30MG ... 30 TABLETS MANUFACTURER 50, GONGDAN-RO, ANSEONG-SI, GYEONGGI-DO, REPUBLIC OF KOREA