Classes
DEA Class; Rx
Common Brand Names; Donnaphen, Donnatal, Donnatal Extentabs, Haponal, Hypersed, Phenohytro, Spacol
- Belladonna (incl derivatives) and Psycholeptic Combinations
Description
Phenobarbital; hyoscyamine; atropine; scopolamine are used together orally to treat GI-related problems such as irritable bowel syndrome. Atropine, hyoscyamine, and scopolamine are the anticholinergic agents found in belladonna. They are used in this combination product to decrease GI motility and for their antisecretory effects. Phenobarbital is a barbiturate agent used for its sedative actions.
Indications
For the adjunctive treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis), acute enterocolitis, or duodenal ulcer.
Indicates off-label use
Contraindications
Phenobarbital; hyoscyamine; atropine; scopolamine combinations are contraindicated in patients with known belladonna alkaloids hypersensitivity or barbiturate hypersensitivity because they may develop an allergic or other adverse reaction.
Adverse Effects
- Ileus
- Hypertension
- Bradycardia
- Stevens-Johnson syndrome
- Megaloblastic anemia
- Nephritis
- Confusion
- Dysphagia
- Photophobia
- Blurred vision
- Sinus tachycardia
- Urinary retention
- Constipation
- Angina
- Bullous rash
- Depression
- Cycloplegia
- Delirium
- Hallucinations
- Ataxia
- Osteopenia
- Thrombocytopenia
- Nystagmus
- Impotence (erectile
- Dysfunction)
Warnings
–
Pregnancy and Lactation
There are no adequate and well-controlled studies in pregnant women; drug should be used during pregnancy only if anticipated benefit justifies potential risk to fetus
Breast-feeding is not recommended while taking phenobarbital; hyoscyamine; atropine; scopolamine. Phenobarbital is excreted into breast milk and can cause CNS depression in infants.
Maximum Dosage
How supplied
atropine sulfate/hyoscyamine sulfate/phenobarbital/scopolamine hydrobromide
tablet
oral solution