Drug information for METHADOSE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CONCENTRATE; ORAL 10MG/ML Prescription AA (Reference Drug) METHADONE HYDROCHLORIDE Methadone MALLINCKRODT 17116
2008-02-14 Label

2008-02-07 Letter

2006-11-27 Other Important Information from FDA

2005-08-08 Letter

2005-08-08 Letter

2005-05-27 Label

2005-05-27 Label

2005-05-27 Letter

2005-05-27 Letter

2002-03-27 Letter
TABLET; ORAL 10MG Prescription AA  METHADONE HYDROCHLORIDE Methadone MALLINCKRODT 40050
2006-11-27 Other Important Information from FDA
TABLET; ORAL 5MG Prescription AA  METHADONE HYDROCHLORIDE Methadone MALLINCKRODT   "
TABLET; ORAL 40MG Prescription AA  METHADONE HYDROCHLORIDE Methadone MALLINCKRODT 74184
2006-11-27 Other Important Information from FDA

Drug Adverse Effects information for METHADOSE

Role code Indications Reaction # Reports
PS BREAKTHROUGH PAIN NEUROTOXICITY 1
PS DRUG DEPENDENCE CONVULSION 1
PS DRUG DEPENDENCE DRUG WITHDRAWAL SYNDROME 1
PS DRUG DEPENDENCE HYPERTENSION 1
PS DRUG DEPENDENCE PARAESTHESIA 1
PS DRUG DEPENDENCE RESTLESSNESS 1
PS DRUG WITHDRAWAL MAINTENANCE THERAPY MATERNAL EXPOSURE DURING PREGNANCY 2
PS DRUG WITHDRAWAL MAINTENANCE THERAPY STILLBIRTH 2
PS PAIN BLOOD POTASSIUM DECREASED 1
PS PAIN CONSTIPATION 4
PS PAIN DRUG WITHDRAWAL SYNDROME 4
PS PAIN HEADACHE 4
PS PAIN HYPOXIC-ISCHAEMIC ENCEPHALOPATHY 1
PS PAIN MYOCARDIAL INFARCTION 1
PS PAIN NEUROTOXICITY 5
PS PAIN OVERDOSE 4
PS PAIN PAIN 4
PS PAIN SEDATION 4
PS PAIN VISUAL IMPAIRMENT 4
PS PAIN WITHDRAWAL SYNDROME 1
PS PRODUCT USED FOR UNKNOWN INDICATION BLOOD POTASSIUM DECREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPOXIC-ISCHAEMIC ENCEPHALOPATHY 1
PS PRODUCT USED FOR UNKNOWN INDICATION MYOCARDIAL INFARCTION 1
PS PRODUCT USED FOR UNKNOWN INDICATION WITHDRAWAL SYNDROME 1
SS BREAKTHROUGH PAIN NEUROTOXICITY 1
SS DRUG WITHDRAWAL MAINTENANCE THERAPY MATERNAL EXPOSURE DURING PREGNANCY 2
SS DRUG WITHDRAWAL MAINTENANCE THERAPY STILLBIRTH 2
SS PAIN NEUROTOXICITY 5
C RESORPTION BONE INCREASED BACK PAIN 2
C RESORPTION BONE INCREASED BREAST CANCER RECURRENT 2
C RESORPTION BONE INCREASED DECREASED INTEREST 2
C RESORPTION BONE INCREASED EMOTIONAL DISTRESS 2
C RESORPTION BONE INCREASED FACET JOINT SYNDROME 2
C RESORPTION BONE INCREASED FATIGUE 2
C RESORPTION BONE INCREASED HEPATIC STEATOSIS 2
C RESORPTION BONE INCREASED HEPATITIS C 2
C RESORPTION BONE INCREASED HIATUS HERNIA 2
C RESORPTION BONE INCREASED HYPOAESTHESIA 2
C RESORPTION BONE INCREASED HYPOKALAEMIA 2
C RESORPTION BONE INCREASED INJURY 2
C RESORPTION BONE INCREASED INTERVERTEBRAL DISC DEGENERATION 2
C RESORPTION BONE INCREASED INTERVERTEBRAL DISC PROTRUSION 2
C RESORPTION BONE INCREASED INTERVERTEBRAL DISC SPACE NARROWING 2
C RESORPTION BONE INCREASED LUNG NEOPLASM 2
C RESORPTION BONE INCREASED LYMPHADENOPATHY 2
C RESORPTION BONE INCREASED MALAISE 2
C RESORPTION BONE INCREASED MASS 2
C RESORPTION BONE INCREASED METASTASES TO BONE 2
C RESORPTION BONE INCREASED METASTASES TO LIVER 2
C RESORPTION BONE INCREASED METASTASES TO LUNG 2
C RESORPTION BONE INCREASED METASTASES TO PELVIS 2
C RESORPTION BONE INCREASED METASTASES TO SPINE 2
C RESORPTION BONE INCREASED OEDEMA 2
C RESORPTION BONE INCREASED OSTEONECROSIS OF JAW 2
C RESORPTION BONE INCREASED PAIN 2
C RESORPTION BONE INCREASED PAIN IN EXTREMITY 2
C RESORPTION BONE INCREASED PANCREATIC CYST 2
C RESORPTION BONE INCREASED PARAESTHESIA 2
C RESORPTION BONE INCREASED PLATELET COUNT DECREASED 2
C RESORPTION BONE INCREASED PULMONARY FIBROSIS 2
C RESORPTION BONE INCREASED RADICULITIS 2
C RESORPTION BONE INCREASED RENAL CYST 2
C RESORPTION BONE INCREASED SPINAL COMPRESSION FRACTURE 2
C RESORPTION BONE INCREASED SPLENOMEGALY 2
C RESORPTION BONE INCREASED SPONDYLOLISTHESIS 2
C RESORPTION BONE INCREASED VERTEBRAL FORAMINAL STENOSIS 2
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