Drug information for ASTEPRO

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
SPRAY, METERED; NASAL EQ 0.125MG BASE/SPRAY Discontinued   AZELASTINE HYDROCHLORIDE azelastine MEDA PHARMS 22203
2011-01-25 Label
2011-01-25 Letter
2009-11-24 Letter
2009-11-06 Label
2009-08-14 Review
2009-08-14 Summary Review
2008-10-22 Letter
SPRAY, METERED; NASAL EQ 0.1876MG BASE/SPRAY Prescription  (Reference Drug) AZELASTINE HYDROCHLORIDE azelastine MEDA PHARMS 22371
2010-04-21 Review
2010-04-21 Summary Review
2009-09-21 Label
2009-09-09 Letter

Drug Adverse Effects information for ASTEPRO

Role code Indications Reaction # Reports
SS DYSPNOEA BLOOD PRESSURE INCREASED 2
SS DYSPNOEA CHEST PAIN 2
SS DYSPNOEA DRUG INEFFECTIVE 1
SS DYSPNOEA DYSPEPSIA 2
SS DYSPNOEA DYSPNOEA 1
SS DYSPNOEA HEART RATE INCREASED 2
SS DYSPNOEA MALAISE 2
SS MULTIPLE ALLERGIES BLOOD PRESSURE INCREASED 1
SS MULTIPLE ALLERGIES CHEST PAIN 1
SS MULTIPLE ALLERGIES DYSPEPSIA 1
SS MULTIPLE ALLERGIES HEART RATE INCREASED 1
SS MULTIPLE ALLERGIES MALAISE 1
SS PRODUCT USED FOR UNKNOWN INDICATION BLOOD PRESSURE INCREASED 2
SS PRODUCT USED FOR UNKNOWN INDICATION CHEST PAIN 2
SS PRODUCT USED FOR UNKNOWN INDICATION DYSPEPSIA 2
SS PRODUCT USED FOR UNKNOWN INDICATION HEART RATE INCREASED 2
SS PRODUCT USED FOR UNKNOWN INDICATION MALAISE 2
SS UPPER-AIRWAY COUGH SYNDROME DRUG INEFFECTIVE 1
SS UPPER-AIRWAY COUGH SYNDROME DYSPNOEA 1
C ANXIETY INSOMNIA 1
C ASTHMA ABDOMINAL PAIN 1
C ASTHMA ANAPHYLACTIC REACTION 1
C ASTHMA COUGH 1
C ASTHMA DIZZINESS 1
C ASTHMA DYSPNOEA 1
C ASTHMA FEELING ABNORMAL 1
C ASTHMA HYPERTENSION 1
C ASTHMA ILL-DEFINED DISORDER 1
C ASTHMA PRODUCT QUALITY ISSUE 1
C ASTHMA PRURITUS GENERALISED 1
C ASTHMA THROAT IRRITATION 1
C ATRIAL FIBRILLATION DYSGEUSIA 2
C ATRIAL FIBRILLATION HYPOGEUSIA 2
C BLOOD CHOLESTEROL INCREASED DYSGEUSIA 1
C BLOOD CHOLESTEROL INCREASED HYPOGEUSIA 1
C BLOOD TESTOSTERONE DECREASED INSOMNIA 1
C CONTRACEPTION ABDOMINAL PAIN UPPER 1
C CONTRACEPTION CHOLECYSTITIS CHRONIC 1
C CONTRACEPTION CHOLELITHIASIS 1
C CONTRACEPTION GALLBLADDER DISORDER 1
C COUGH ABDOMINAL PAIN UPPER 2
C COUGH CHOLECYSTITIS CHRONIC 2
C COUGH CHOLELITHIASIS 2
C COUGH GALLBLADDER DISORDER 2
C DEHYDRATION DEHYDRATION 2
C DEHYDRATION DERMATITIS ACNEIFORM 2
C DEHYDRATION ENTERITIS INFECTIOUS 1
C DEHYDRATION FALL 2
C DEHYDRATION FEMORAL HERNIA, OBSTRUCTIVE 1
C DEHYDRATION SMALL INTESTINAL OBSTRUCTION 1
C DEHYDRATION STOMATITIS 2
C DEHYDRATION TACHYCARDIA 2
C DEPRESSION INSOMNIA 1
C DERMATITIS DEHYDRATION 2
C DERMATITIS DERMATITIS ACNEIFORM 2
C DERMATITIS ENTERITIS INFECTIOUS 1
C DERMATITIS FALL 2
C DERMATITIS FEMORAL HERNIA, OBSTRUCTIVE 1
C DERMATITIS SMALL INTESTINAL OBSTRUCTION 1
C DERMATITIS STOMATITIS 2
C DERMATITIS TACHYCARDIA 2
C FAECES HARD DYSGEUSIA 1
C FAECES HARD HYPOGEUSIA 1
C FIBROMYALGIA ABDOMINAL PAIN UPPER 1
C FIBROMYALGIA BLADDER DISORDER 1
C FIBROMYALGIA CARDIAC OPERATION 1
C FIBROMYALGIA CATHETERISATION CARDIAC 1
C FIBROMYALGIA CHEST PAIN 1
C FIBROMYALGIA DIZZINESS 1
C FIBROMYALGIA DYSPEPSIA 1
C FIBROMYALGIA EAR DISORDER 1
C FIBROMYALGIA HEPATIC LESION 1
C FIBROMYALGIA HERNIA 1
C FIBROMYALGIA INCISION SITE COMPLICATION 1
C FIBROMYALGIA MOOD SWINGS 1
C FIBROMYALGIA MOTION SICKNESS 1
C FIBROMYALGIA NAUSEA 1
C FIBROMYALGIA PAIN 1
C FIBROMYALGIA RENAL HAEMORRHAGE 1
C FIBROMYALGIA RENAL MASS 1
C FIBROMYALGIA VOMITING 1
C FIBROMYALGIA WEIGHT INCREASED 1
C HERPES VIRUS INFECTION ABDOMINAL PAIN UPPER 1
C HERPES VIRUS INFECTION CHOLECYSTITIS CHRONIC 1
C HERPES VIRUS INFECTION CHOLELITHIASIS 1
C HERPES VIRUS INFECTION GALLBLADDER DISORDER 1
C HYPERSENSITIVITY INSOMNIA 3
C HYPERTENSION DEHYDRATION 2
C HYPERTENSION DERMATITIS ACNEIFORM 2
C HYPERTENSION ENTERITIS INFECTIOUS 1
C HYPERTENSION FALL 2
C HYPERTENSION FEMORAL HERNIA, OBSTRUCTIVE 1
C HYPERTENSION SMALL INTESTINAL OBSTRUCTION 1
C HYPERTENSION STOMATITIS 2
C HYPERTENSION TACHYCARDIA 2
C HYPOGAMMAGLOBULINAEMIA BLOOD PRESSURE ABNORMAL 9
C HYPOGAMMAGLOBULINAEMIA EAR INFECTION 9
C HYPOGAMMAGLOBULINAEMIA EYE INFECTION 9
C HYPOGAMMAGLOBULINAEMIA HAEMORRHOIDS 2
C HYPOGAMMAGLOBULINAEMIA HEADACHE 9
C HYPOGAMMAGLOBULINAEMIA HYPERTENSION 9
C HYPOGAMMAGLOBULINAEMIA INFUSION SITE ERYTHEMA 9
C HYPOGAMMAGLOBULINAEMIA INFUSION SITE EXTRAVASATION 9
C HYPOGAMMAGLOBULINAEMIA INFUSION SITE HAEMATOMA 1
C HYPOGAMMAGLOBULINAEMIA INFUSION SITE HAEMORRHAGE 2
C HYPOGAMMAGLOBULINAEMIA INFUSION SITE IRRITATION 9
C HYPOGAMMAGLOBULINAEMIA INFUSION SITE SWELLING 9
C HYPOGAMMAGLOBULINAEMIA INJECTION SITE HAEMATOMA 1
C HYPOGAMMAGLOBULINAEMIA INJECTION SITE HAEMORRHAGE 1
C HYPOGAMMAGLOBULINAEMIA MUSCLE SPASMS 9
C HYPOGAMMAGLOBULINAEMIA PHARYNGITIS 9
C HYPOGAMMAGLOBULINAEMIA RECTAL HAEMORRHAGE 2
C HYPOGAMMAGLOBULINAEMIA RHINITIS 9
C HYPOGAMMAGLOBULINAEMIA SINUSITIS 9
C IMMUNODEFICIENCY COMMON VARIABLE HAEMORRHOIDS 2
C IMMUNODEFICIENCY COMMON VARIABLE INFUSION SITE HAEMATOMA 1
C IMMUNODEFICIENCY COMMON VARIABLE INFUSION SITE HAEMORRHAGE 2
C IMMUNODEFICIENCY COMMON VARIABLE INJECTION SITE HAEMATOMA 1
C IMMUNODEFICIENCY COMMON VARIABLE INJECTION SITE HAEMORRHAGE 1
C IMMUNODEFICIENCY COMMON VARIABLE RECTAL HAEMORRHAGE 2
C INFECTION DEHYDRATION 1
C INFECTION DERMATITIS ACNEIFORM 1
C INFECTION ENTERITIS INFECTIOUS 1
C INFECTION FALL 1
C INFECTION SMALL INTESTINAL OBSTRUCTION 1
C INFECTION STOMATITIS 1
C INFECTION TACHYCARDIA 1
C MULTIPLE MYELOMA BLISTER 1
C MULTIPLE MYELOMA GALLBLADDER DISORDER 1
C NASAL CONGESTION ABDOMINAL PAIN UPPER 3
C NASAL CONGESTION CHOLECYSTITIS CHRONIC 3
C NASAL CONGESTION CHOLELITHIASIS 3
C NASAL CONGESTION DEHYDRATION 1
C NASAL CONGESTION DERMATITIS ACNEIFORM 1
C NASAL CONGESTION ENTERITIS INFECTIOUS 1
C NASAL CONGESTION FALL 1
C NASAL CONGESTION GALLBLADDER DISORDER 3
C NASAL CONGESTION SMALL INTESTINAL OBSTRUCTION 1
C NASAL CONGESTION STOMATITIS 1
C NASAL CONGESTION TACHYCARDIA 1
C NAUSEA DEHYDRATION 6
C NAUSEA DERMATITIS ACNEIFORM 6
C NAUSEA ENTERITIS INFECTIOUS 3
C NAUSEA FALL 6
C NAUSEA FEMORAL HERNIA, OBSTRUCTIVE 3
C NAUSEA SMALL INTESTINAL OBSTRUCTION 3
C NAUSEA STOMATITIS 6
C NAUSEA TACHYCARDIA 6
C PAIN DEHYDRATION 4
C PAIN DERMATITIS ACNEIFORM 4
C PAIN ENTERITIS INFECTIOUS 2
C PAIN FALL 4
C PAIN FEMORAL HERNIA, OBSTRUCTIVE 2
C PAIN SMALL INTESTINAL OBSTRUCTION 2
C PAIN STOMATITIS 4
C PAIN TACHYCARDIA 4
C PNEUMONIA DEHYDRATION 2
C PNEUMONIA DERMATITIS ACNEIFORM 2
C PNEUMONIA ENTERITIS INFECTIOUS 1
C PNEUMONIA FALL 2
C PNEUMONIA FEMORAL HERNIA, OBSTRUCTIVE 1
C PNEUMONIA SMALL INTESTINAL OBSTRUCTION 1
C PNEUMONIA STOMATITIS 2
C PNEUMONIA TACHYCARDIA 2
C PREMEDICATION DEHYDRATION 8
C PREMEDICATION DERMATITIS ACNEIFORM 8
C PREMEDICATION ENTERITIS INFECTIOUS 4
C PREMEDICATION FALL 8
C PREMEDICATION FEMORAL HERNIA, OBSTRUCTIVE 4
C PREMEDICATION SMALL INTESTINAL OBSTRUCTION 4
C PREMEDICATION STOMATITIS 8
C PREMEDICATION TACHYCARDIA 8
C PRIMARY IMMUNODEFICIENCY SYNDROME HAEMORRHOIDS 2
C PRIMARY IMMUNODEFICIENCY SYNDROME INFUSION SITE HAEMATOMA 1
C PRIMARY IMMUNODEFICIENCY SYNDROME INFUSION SITE HAEMORRHAGE 2
C PRIMARY IMMUNODEFICIENCY SYNDROME INJECTION SITE HAEMATOMA 1
C PRIMARY IMMUNODEFICIENCY SYNDROME INJECTION SITE HAEMORRHAGE 1
C PRIMARY IMMUNODEFICIENCY SYNDROME RECTAL HAEMORRHAGE 2
C PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL PAIN 8
C PRODUCT USED FOR UNKNOWN INDICATION ANAPHYLACTIC REACTION 8
C PRODUCT USED FOR UNKNOWN INDICATION DIZZINESS 8
C PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 8
C PRODUCT USED FOR UNKNOWN INDICATION HYPERTENSION 8
C PRODUCT USED FOR UNKNOWN INDICATION PRURITUS GENERALISED 8
C PROPHYLAXIS CHEMICAL BURN OF SKIN 1
C PROPHYLAXIS DEHYDRATION 2
C PROPHYLAXIS DERMATITIS ACNEIFORM 2
C PROPHYLAXIS ENTERITIS INFECTIOUS 1
C PROPHYLAXIS ERYTHEMA 1
C PROPHYLAXIS EYELID OEDEMA 1
C PROPHYLAXIS FALL 2
C PROPHYLAXIS FEMORAL HERNIA, OBSTRUCTIVE 1
C PROPHYLAXIS OCULAR HYPERAEMIA 1
C PROPHYLAXIS SKIN SWELLING 1
C PROPHYLAXIS SMALL INTESTINAL OBSTRUCTION 1
C PROPHYLAXIS STOMATITIS 2
C PROPHYLAXIS TACHYCARDIA 2
C PROSTATITIS DYSGEUSIA 1
C PROSTATITIS HYPOGEUSIA 1
C SEASONAL ALLERGY DEHYDRATION 6
C SEASONAL ALLERGY DERMATITIS ACNEIFORM 6
C SEASONAL ALLERGY ENTERITIS INFECTIOUS 3
C SEASONAL ALLERGY FALL 6
C SEASONAL ALLERGY FEMORAL HERNIA, OBSTRUCTIVE 3
C SEASONAL ALLERGY SMALL INTESTINAL OBSTRUCTION 3
C SEASONAL ALLERGY STOMATITIS 6
C SEASONAL ALLERGY TACHYCARDIA 6
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