DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Generic: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Basic Information
Manufacturer
Direct Rx
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
d9a36478-4788-4107-e053-2a95a90ad6da
Adverse Reactions
The following serious adverse reactions are described elsewhere in labeling: Respiratory and/or CNS depression (see WARNINGS) Anticholinergic and opioid-toxicities, including atroponism (see WARNINGS and PRECAUTIONS) Dehydration and electrolyte imbalance (see WARNINGS) GI Complications in patients with infectious diarrhea (see WARNINGS) Toxic megacolon in patients with acute ulcerative colitis (see WARNINGS) At therapeutic doses of diphenoxylate hydrochloride and atropine sulfate tablets, the following other adverse reactions have been reported; they are listed in decreasing order of severity, but not of frequency: Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache, hallucination Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus Gastrointestinal system: megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort The following adverse reactions related to atropine sulfate are listed in decreasing order of severity, but not of frequency: hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes.
CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS.
YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.
CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS.
YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.