Dicyclomine Hydrochloride 10 mg/1
Dicyclomine Hydrochloride · CAPSULE · Lannett Company, Inc.
Dicyclomine Hydrochloride is a capsule containing dicyclomine hydrochloride at 10 mg/1, taken oral. Manufactured by Lannett Company, Inc..
Key Facts
- Brand Name
- Dicyclomine Hydrochloride
- Generic Name
- Dicyclomine Hydrochloride
- NDC Code (Product)
0527-0586- Manufacturer
- Lannett Company, Inc.
- Strength
- 10 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA084285
- Marketing Start
- 09/30/1974
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Dicyclomine hydrochloride capsules, USP are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride capsules, USP are an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Dosage must be adjusted to individual patient needs. Dosage for dicyclomine hydrochloride capsules 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 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 not achieved or side effects require doses less than 80 mg per day after two weeks of treatment 2.1 Oral 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.
Contraindications
4 CONTRAINDICATIONS Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Use in Specific P opu l a ti on s (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)
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) 7.1 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 anticholin…
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 Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com 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 no…
Frequently Asked Questions
What is Dicyclomine Hydrochloride used for?
Dicyclomine Hydrochloride contains Dicyclomine Hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.
Is Dicyclomine Hydrochloride a controlled substance?
Dicyclomine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Dicyclomine Hydrochloride?
The generic name for Dicyclomine Hydrochloride is Dicyclomine Hydrochloride. There are 5 other brand versions of Dicyclomine Hydrochloride.
What is the NDC code for Dicyclomine Hydrochloride 10 mg/1?
The NDC (National Drug Code) for Dicyclomine Hydrochloride 10 mg/1 is 0527-0586, listed by Lannett Company, Inc..