Dicyclomine hydrochloride 10 mg Capsule, 1,000-count
Other active recalls for Dicyclomine Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Anticholinergic class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Dicyclomine is used to treat the symptoms of irritable bowel syndrome. Dicyclomine is in a class of medications called anticholinergics. It relieves muscle spasms in the gastrointestinal tract by blocking the activity of a certain natural substance in the body.
Read the full MedlinePlus article ↗- Dicyclomine relaxes the overactive muscles in your intestines that cause IBS cramping and pain — it works both by blocking certain nerve signals and by directly calming the gut mus...
- What exactly does dicyclomine do, and how quickly will I notice it working?
- The most common ones are dizziness, dry mouth, and blurred vision — these showed up in a significant number of patients in clinical trials. You might also notice some nausea, drows...
- What are the most common side effects I should expect?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII PN2ZH5LOQY
A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
7 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.076 | $75.80 / 1000 capsules |
| Medicaid paysCMS SDUD · 12 mo | $0.1991 | $199.10 / 1000 capsules |
| Medicare drug plans payPart D · Q2 2026 | $0.1589 | $158.90 / 1000 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dicyclomine hydrochloride 10 mg 00054-0748-25 | Hikma | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 00527-0586-01 | Lannett | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 00591-0794-01 | Actavis | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine hydrochloride 10 mgthis 00832-6053-10 | Upsher-Smith | 1000 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 00904-6987-61 | Major | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 16571-0260-01 | Rising | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 24979-0201-01 | Upsher-Smith | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine hydrochloride 10 mg 31722-0052-01 | Camber | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine hydrochloride 10 mg 43547-0634-10 | Solco | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 50268-0199-15 | AvPAK | 50 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 59651-0719-01 | Aurobindo | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 60687-0369-01 | American | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 62135-0718-90 | Chartwell | 90 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine Hydrochloride 10 mg 73473-0800-01 | Solaris | 100 capsules | $0.076 | AB | Availability likely | — |
| Dicyclomine hydrochloride 10 mg 00615-8483-39 | NCS | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 42708-0160-56 | QPharma, | 56 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 43063-0112-04 | PD-Rx | 4 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 43063-0629-28 | PD-Rx | 28 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 50090-0126-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 50090-0127-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 50090-7340-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 50090-7341-01 | A-S | 28 capsules | — | AB | FDA listed | — |
| Dicyclomine hydrochloride 10 mg 50090-7729-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine hydrochloride 10 mg 51407-0783-01 | Golden | 100 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 51655-0219-27 | Northwind | 12 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 55154-3565-00 | Cardinal | 10 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 55154-8183-00 | Cardinal | 10 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 55289-0923-20 | PD-Rx | 20 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 55700-0766-30 | Quality | 30 capsules | — | AB | Discontinued | — |
| Dicyclomine Hydrochloride 10 mg 63187-0196-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 66267-0291-30 | NuCare | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 67046-1258-03 | Coupler | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine hydrochloride 10 mg 67046-1513-03 | Coupler | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine hydrochloride 10 mg 67296-2158-03 | Redpharm | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 68071-3035-03 | NuCare | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 68071-3310-01 | NuCare | 16 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 68071-3674-03 | NuCare | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 68788-8578-01 | Preferred | 100 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 70518-4331-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 70518-4432-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 71205-0428-15 | Proficient | 15 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 71335-0471-01 | Bryant | 30 capsules | — | AB | Discontinued | — |
| Dicyclomine Hydrochloride 10 mg 71335-0938-01 | Bryant | 30 capsules | — | AB | Discontinued | — |
| Dicyclomine Hydrochloride 10 mg 71335-2316-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 71335-9709-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 71610-0265-09 | Aphena | 9000 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 72162-2613-00 | Bryant | 1000 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 72789-0522-01 | PD-Rx | 100 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 72789-0546-28 | PD-Rx | 28 capsules | — | AB | FDA listed | — |
| Dicyclomine hydrochloride 10 mg 72888-0105-00 | Advagen | 1000 capsules | — | AB | FDA listed | — |
| Dicyclomine Hydrochloride 10 mg 67296-2310-03 | Redpharm | 30 capsules | — | AB | FDA listed | — |
| dicyclomine hydrochloride 10 mg 00054-0883-25 | Hikma | 100 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00832-6053-10 You're viewing this | 1000 CAPSULE in 1 BOTTLE (0832-6053-10) | $0.0758 / ea | $75.78 | 2023-04-13 | Active |
| 00832-6053-11 | 100 CAPSULE in 1 BOTTLE (0832-6053-11) | $0.0758 / ea | $7.58 | 2023-04-13 | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0758 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 60% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00832-6053-10?
What is the difference between NDC 00832-6053-10 and NDC 00832-6053-11?
What NDC number is used to bill for this package of Dicyclomine hydrochloride 10 mg Capsule?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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 ).
Oral in adults ( 2.1 ): Starting dose: 20 mg four times a day. After a week of treatment with the starting dose, the dose may be escalated to 40 mg four times a day, unless side effects limit dosage escalation Discontinue dicyclomine hydrochloride if efficacy is not achieved or side effects require doses less than 80 mg per day after two weeks of treatment
2.1Oral Dosage and Administration in Adults The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation. If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued.
Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Dicyclomine hydrochloride capsules, USP, 10 mg are hard gelatin capsules, filled with white to off-white powder, blue transparent cap and body, and is imprinted with "C30" on the cap and body in white ink. Dicyclomine hydrochloride capsules, 10 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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 ) Glaucoma ( 4 ) Nursing mothers ( 4 ) Obstructive uropathy ( 4 ) Unstable cardiovascular status in acute hemorrhage ( 4 ) Obstructive disease of the gastrointestinal tract ( 4 ) Myasthenia gravis ( 4 ) Severe ulcerative colitis ( 4 ) Reflux esophagitis ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Cardiovascular conditions : worsening of conditions ( 5.2 ) Peripheral and central nervous system : heat prostration can occur with drug use (fever and heat stroke due to decreased sweating); drug should be discontinued, and supportive measures instituted ( 5.3 ) Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness) : signs and symptoms resolve within 12 to 24 hours after discontinuation of dicyclomine hydrochloride ( 5.3 ) Myasthenia Gravis : overdose may lead to muscular weakness and paralysis.
Dicyclomine hydrochloride should be given to patients with myasthenia gravis only to reduce adverse muscarinic effects of an anticholinesterase ( 5.4 ) Incomplete intestinal obstruction : diarrhea may be an early symptom especially in patients with ileostomy or colostomy. Treatment with dicyclomine hydrochloride would be inappropriate and possibly fatal ( 5.5 ) Salmonella dysenteric patients : due to risk of toxic megacolon ( 5.6 ) Ulcerative colitis : Dicyclomine hydrochloride should be used with caution in these patients; large doses may suppress intestinal motility or aggravate the serious complications of toxic megacolon ( 5.7 ) Prostatic hypertrophy : Dicyclomine hydrochloride should be used with caution in these patients; may lead to urinary retention ( 5.8 ) Hepatic and renal disease : should be used with caution ( 5.9 ) Geriatric : use with caution in elderly who may be more susceptible to dicyclomine hydrochloride's adverse events ( 5.10 )
5.2Cardiovascular Conditions Dicyclomine hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure and in cardiac surgery, where they may further accelerate the heart rate. Investigate any tachycardia before administration of dicyclomine hydrochloride. Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension [see Adverse Reactions (6.3) ] .
5.3Peripheral and Central Nervous System The peripheral effects of dicyclomine hydrochloride are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system. They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation [see Adverse Reactions (6) ] .
In the presence of high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever. If symptoms occur, the drug should be discontinued, and supportive measures instituted.
Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy. Central nervous system (CNS) signs and symptoms include confusional state, disorientation, amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. Psychosis and delirium have been reported in sensitive individuals (such as elderly patients and/or in patients with mental illness) given anticholinergic drugs.
These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug. Dicyclomine hydrochloride may produce drowsiness, dizziness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking dicyclomine hydrochloride.…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 at initial doses of 160 mg daily (40 mg four times a day).
In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients. Table 1 presents adverse reactions ( MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo. Table 1: Adverse reactions experienced in controlled clinical trials with decreasing order of frequency MedDRA Preferred Term Dicyclomine Hydrochloride (40 mg four times a day) Placebo % % Dry Mouth 33 5 Dizziness 40 5 Vision blurred 27 2 Nausea 14 6 Somnolence 9 1 Asthenia 7 1 Nervousness 6 2 Nine percent (9%) of patients were discontinued from dicyclomine hydrochloride because of one or more of these side effects (compared with 2% in the placebo group).
In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction. A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated.
6.2Post-Marketing Experience The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of dicyclomine hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac disorders: palpitations, tachyarrhythmias Eye disorders: cycloplegia, mydriasis, vision blurred Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting General disorders and administration site conditions: fatigue, malaise Immune System Disorders: drug hypersensitivity including face edema, angioedema, anaphylactic shock Nervous system disorders: dizziness, headache, somnolence, syncope Psychiatric disorders: As with the other anti-cholinergic drugs, cases of delirium or symptoms of delirium such as amnesia (or transient global amnesia), agitation, confusional state, delusion, disorientation, hallucination (including visual hallucination) as well as mania, mood altered and pseudodementia, have been reported with the use of dicyclomine.
Nervousness and insomnia have also been reported. Reproductive system and breast disorders: suppressed lactation Respiratory, thoracic and mediastinal disorders: dyspnoea, nasal congestion Skin and sub…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Antiglaucoma agents : anticholinergics antagonize antiglaucoma agents and may increase intraoccular 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 )
7.1Antiglaucoma 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) ] .
7.2Other 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.
7.3Other Gastrointestinal Motility Drugs Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide.
7.4Effect of Antacids Because antacids may interfere with the absorption of anticholinergic agents including dicyclomine hydrochloride, simultaneous use of these drugs should be avoided.
7.5Effect on Absorption of Other Drugs Anticholinergic agents may affect gastrointestinal absorption of various drugs by affecting on gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result.
7.6Effect on Gastric Acid Secretion The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: use only if clearly needed ( 8.1 ) Pediatric Use: Safety and effectiveness not established ( 8.4 ) Hepatic and renal impairment: caution must be taken with patients with significantly impaired hepatic and renal function ( 8.6 )
8.1Pregnancy Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
8.3Nursing Mothers Dicyclomine hydrochloride is contraindicated in women who are breastfeeding. Dicyclomine hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in breast-fed infants from dicyclomine hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother [see Use in Specific Populations (8.4) ] .
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Contraindications (4) ] . There are published cases reporting that the administration of dicyclomine hydrochloride to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea, and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established.
8.5Geriatric Use Clinical studies of dicyclomine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range in adults, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
8.6Renal Impairment Effects of renal impairment on PK, safety, and efficacy of dicyclomine hydrochloride have not been studied. Dicyclomine hydrochloride drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Dicyclomine hydrochloride should be administered with caution in patients with renal impairment.
8.7Hepatic Impairment Effects of renal impairment on PK, safety, and efficacy of dicyclomine hydrochloride have not been studied. Dicyclomine hydrochloride should be administered with caution in patients with hepatic impairment.
🤰 Pregnancy ▾
8.1Pregnancy Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Contraindications (4) ] . There are published cases reporting that the administration of dicyclomine hydrochloride to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea, and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of dicyclomine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range in adults, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
10 OVERDOSAGE In case of an overdose, patients should contact a physician, poison control center (1-800-222-1222), or emergency room. The signs and symptoms of overdosage include: headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation including convulsion. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).
One reported event included a 37-year-old who reported numbness on the left side, cold fingertips, blurred vision, abdominal and flank pain, decreased appetite, dry mouth, and nervousness following ingestion of 320 mg daily (four 20 mg tablets four times daily). These events resolved after discontinuing the dicyclomine. The acute oral LD 50 of the drug is 625 mg/kg in mice.
The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life-threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10-month-old child and approximately 1,500 mg in an adult, each of whom survived. In three of the infants who died following administration of dicyclomine hydrochloride, the blood concentrations of drug were 200, 220, and 505 ng/mL.
It is not known if dicyclomine hydrochloride is dialyzable. Treatment should consist of gastric lavage, emetics, and activated charcoal. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement.
If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism: a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately ⅛ the milligram potency of atropine ( in vitro , guinea pig ileum); and a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine's antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum. Atropine did not affect responses to these two agonists.
In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl 2 )-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl 2 . Tests for mydriatic effects in mice showed that dicyclomine was approximately 1 / 500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1 / 300 as potent as atropine.
12.2Pharmacodynamics Dicyclomine hydrochloride can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.
12.3Pharmacokinetics Absorption and Distribution In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60 to 90 minutes. Mean volume of distribution for a 20 mg oral dose is approximately
3.65L/kg suggesting extensive distribution in tissues. Elimination The metabolism of dicyclomine was not studied. The principal route of excretion is via the urine (79.5% of the dose).
Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism: a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately ⅛ the milligram potency of atropine ( in vitro , guinea pig ileum); and a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine's antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum. Atropine did not affect responses to these two agonists.
In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl 2 )-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl 2 . Tests for mydriatic effects in mice showed that dicyclomine was approximately 1 / 500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1 / 300 as potent as atropine.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Dicyclomine hydrochloride capsules, USP 10 mg are hard gelatin capsules, filled with white to off-white powder. The capsule has a blue transparent cap and body, and is imprinted with "C30" on the cap and body in white ink. They are supplied as follows: Bottles of 100 with a child-resistant closure, NDC 0832-6053-11 Bottles of 1000 with a child-resistant closure, NDC 0832-6053-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
📋 Description ▾
11 DESCRIPTION Dicyclomine hydrochloride, USP is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form: Dicyclomine hydrochloride, USP is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C 19 H 35 NO 2 ∙HCl and the following structural formula: Dicyclomine hydrochloride, USP occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.
Dicyclomine hydrochloride capsules, USP for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: anhydrous lactose, FD&C Blue No. 1, FD&C Red No.
3, gelatin, magnesium stearate, microcrystalline cellulose and pregelatinized starch. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION
17.2Use in Infants Inform parents and caregivers not to administer dicyclomine hydrochloride in infants less than 6 months of age [see Use in Specific Populations (8.4) ] .
17.3Use in Nursing Mothers Advise lactating women that dicyclomine hydrochloride should not be used while breastfeeding their infants [see Use in Specific Populations (8.3 , 8.4) ] .
17.4Peripheral and Central Nervous System In the presence of a high environmental temperature, heat prostration can occur with dicyclomine hydrochloride use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued, and a physician contacted. Dicyclomine hydrochloride may produce drowsiness or blurred vision.
The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or to perform hazardous work while taking dicyclomine hydrochloride [see Warnings and Precautions (5.3) ] .