Select a medication above to begin.
Motilium
domperidone
Adult Dosing .
Dosage forms: TAB: 10 mg
Restricted Distribution in US
- [1-855-543-3784 or www.fda.gov/drugs/investigational-new-drug-ind-application/how-request-domperidone-expanded-access-use for more info]
Investigational New Drug (IND)
- [FDA expanded access investigational new drug (EA-IND)]
- Info: for pts w/ GI motility conditions who have failed standard tx, incl. pts w/ GERD w/ upper GI sx, gastroparesis, and chronic constipation; not FDA approved; avail. from Janssen Pharmaceuticals, Inc. or authorized distributors per the FDA; healthcare providers must enroll in the IND protocol and comply w/ provider requirements (www.fda.gov/drugs/investigational-new-drug-ind-application/how-request-domperidone-expanded-access-use); for clinical trial eligibility and enrollment info, check www.clinicaltrials.gov
- [mandatory reporting for EA-IND]
- Info: unexpected fatal or immediately life-threatening reactions must be reported w/in 7 days to FDA; serious, unexpected adverse experiences must be reported w/in 15 days to FDA; www.fda.gov/drugs/investigational-new-drug-ind-application/how-request-domperidone-expanded-access-use for more info
refractory GERD, symptomatic
- [10-30 mg PO tid-qid]
- Max: 30 mg qid; Info: may incr. dose after pt reevaluation (see Domperidone IND Packet); use lowest effective dose, shortest effective tx duration; give 15-30min before meals tid and before bedtime
gastroparesis, refractory
- [10-30 mg PO tid-qid]
- Max: 30 mg qid; Info: may incr. dose after pt reevaluation (see Domperidone IND Packet); use lowest effective dose, shortest effective tx duration; give 15-30min before meals tid and before bedtime
chronic constipation, refractory
- [10-30 mg PO tid-qid]
- Max: 30 mg qid; Info: may incr. dose after pt reevaluation (see Domperidone IND Packet); use lowest effective dose, shortest effective tx duration; give 15-30min before meals tid and before bedtime
renal dosing
- [see below]
- CrCl <90: avoid use
- HD/PD: avoid use
hepatic dosing
- [see below]
- Child-Pugh Class A: avoid use; Child-Pugh Class B or C: contraindicated
Peds Dosing .
- Dosage forms: TAB: 10 mg
Restricted Distribution in US
- [1-855-543-3784 or www.fda.gov/drugs/investigational-new-drug-ind-application/how-request-domperidone-expanded-access-use for more info]
Investigational New Drug (IND)
- [FDA expanded access investigational new drug (EA-IND)]
- Info: for pts w/ GI motility conditions who have failed standard tx, incl. pts w/ GERD w/ upper GI sx, gastroparesis, and chronic constipation; not FDA approved; avail. from Janssen Pharmaceuticals, Inc. or authorized distributors per the FDA; healthcare providers must enroll in the IND protocol and comply w/ provider requirements (www.fda.gov/drugs/investigational-new-drug-ind-application/how-request-domperidone-expanded-access-use); for clinical trial eligibility and enrollment info, check www.clinicaltrials.gov
- [mandatory reporting for EA-IND]
- Info: unexpected fatal or immediately life-threatening reactions must be reported w/in 7 days to FDA; serious, unexpected adverse experiences must be reported w/in 15 days to FDA; www.fda.gov/drugs/investigational-new-drug-ind-application/how-request-domperidone-expanded-access-use for more info
refractory GERD, symptomatic
- [12 yo and older]
- Dose: 10-30 mg PO tid-qid; Max: 30 mg qid; Info: may incr. dose after pt reevaluation (see Domperidone IND Packet); use lowest effective dose, shortest effective tx duration; give 15-30min before meals tid and before bedtime
gastroparesis, refractory
- [12 yo and older]
- Dose: 10-30 mg PO tid-qid; Max: 30 mg qid; Info: may incr. dose after pt reevaluation (see Domperidone IND Packet); use lowest effective dose, shortest effective tx duration; give 15-30min before meals tid and before bedtime
chronic constipation, refractory
- [12 yo and older]
- Dose: 10-30 mg PO tid-qid; Max: 30 mg qid; Info: may incr. dose after pt reevaluation (see Domperidone IND Packet); use lowest effective dose, shortest effective tx duration; give 15-30min before meals tid and before bedtime
renal dosing
- [see below]
- CrCl <90: avoid use
- HD/PD: avoid use
hepatic dosing
- [see below]
- Child-Pugh Class A: avoid use; Child-Pugh Class B or C: contraindicated