;s adverse events (5.10)
ADVERSE REACTIONS
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 AXCAN Pharma US, Inc. at 1-800-472-2634 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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)
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)
See 17 for PATIENT COUNSELING INFORMATION
Revised: 07/2011
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Oral Dosage and Administration in Adults
2.2 Intramuscular Dosage and Administration in Adults
2.3 Preparation for Intramuscular Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Inadvertent Intravenousmuscular Administration
5.2 Cardiovascular Conditions
5.3 Peripheral and Central Nervous System
5.4 Myasthenia Gravis
5.5 Intestinal Obstruction
5.6 Toxic Dilatation of Intestinemegacolon
5.7 Ulcerative Colitis
5.8 Prostatic Hypertrophy
5.9 Hepatic and Renal Disease
5.10 Geriatic Population
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Postmarketing Experience
6.3 Adverse Reactions Reported with Similar Drugs with Anticholinergic/Antispasmodic Action
7 DRUG INTERACTIONS
7.1 Antiglaucoma Agents
7.2 Other Drugs with Anticholinergic Activity
7.3 Other Gastrointestinal Motility Drugs
7.4 Effect of Antacids
7.5 Effect on Absorption of Other Drugs
7.6 Effect on Gastric Acid Secretion
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Inadvertent Intravenous Administration
17.2 Use in Infants
17.3 Use in Nursing Mothers
17.4 Peripheral and Central Nervous System
Principal Display Panel
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
BENTYL® (dicyclomine hydrochloride) is indicated for the treatment of patients with functional bowel |
