Dicyclomine is an anticholinergic sold in the U.S. under 3 brand and generic names, for irritable bowel syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Bentyl Preservative Free (application NDA008370). Other dicyclomine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Dosage must be adjusted to individual patient needs. Dosage for dicyclomine hydrochloride must be adjusted to individual patient needs ( 2 ). If a dose is missed, patients should continue the normal dosing schedule ( 2 ). Intramuscular in adults ( 2.2 ): Intramuscular administration recommended no longer than 1 or 2 days when patients cannot take oral administration Recommended dose: 10 mg to 20 mg four times a day 2.1 Intramuscular Dosage and Administration in Adults Dicyclomine hydrochloride intramuscular injection must be administered via intramuscular route only. Do not administer by any other route. The recommended intramuscular dose is 10 mg to 20 mg four times a day [see Clinical Pharmacology (12) ]. The intramuscular injection is to be used only for 1 or 2 days when the patient cannot take oral medication. Intramuscular injection is about twice as bioavailable as oral dosage forms. 2.2 Preparation for Intramuscular Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Aspirate the syringe before injecting to avoid intravascular injection, since thrombosis may occur if the drug is inadvertently injected intravascularly.
The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors [see Clinical Pharmacology (12) ] . They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued. The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms [see Warnings and Precautions (5.2 , 5.3 )]. The most serious adverse reactions include cardiovascular and central nervous system symptoms. The most common adverse reactions (> 5% of patients) are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, Slate Run Pharmaceuticals, LLC at 1-888-341-9214 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Capsule | Generic | $2 | View → | |
| 2 | 70/100 | Prescription | Injectable | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| T;200 | 20 mg | blue | round | — |
| TWiT201;10mg | 10 mg | white | capsule | — |
| D20 | 20 mg | blue | round | — |
| D20 | 20 mg | blue | round | — |
| C;170 | 20 mg | blue | round | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Use in Specific Populations (8.4) ] , nursing mothers [see Use in Specific Populations (8.3) ] , and in patients with: unstable cardiovascular status in acute hemorrhage myasthenia gravis [see Warnings and Precautions (5.4) ] glaucoma [see Adverse Reactions (6.3) and Drug Interactions (7.1) ] obstructive uropathy [see Warnings and Precautions (5.8) ] obstructive disease of the gastrointestinal tract [see Warnings and Precautions (5.5) ] severe ulcerative colitis [see Warnings and Precautions (5.7) ] reflux esophagitis Infants less than 6 months of age ( 4 ) Nursing mothers ( 4 ) Unstable cardiovascular status in acute hemorrhage ( 4 ) Myasthenia gravis ( 4 ) Glaucoma ( 4 ) Obstructive uropathy ( 4 ) Obstructive disease of the gastrointestinal tract ( 4 ) Severe ulcerative colitis ( 4 ) Reflux esophagitis ( 4 )
Antiglaucoma agents : anticholinergics antagonize antiglaucoma agents and may increase intraocular pressure ( 7 ) Anticholinergic agents : may affect the gastrointestinal absorption of various drugs; may also increase certain actions or side effects of other anticholinergic drugs ( 7 ) Antacids : interfere with the absorption of anticholinergic agents ( 7 ) 7.1 Antiglaucoma Agents Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. Use of dicyclomine hydrochloride in patients with glaucoma is not recommended [see Contraindications (4) ]. 7.2 Other Drugs with Anticholinergic Activity The following agents may increase certain actions or side effects of anticholinergic drugs including dicyclomine hydrochloride: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity. 7.3 Other Gastrointestinal Motility Drugs Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide. 7.4…
| $2 |
| View → |
| 3 | 70/100 | Prescription | Capsule | Generic | $2 | View → |