/irritable bowel syndrome.
2 DOSAGE AND ADMINISTRATION
Dosage must be adjusted to individual patients needs.
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.
2.2 Intramuscular Dosage and Administration in Adults
BENTYL Intramuscular Injection must be administered via intramuscular route only. Do not administer by an 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.
2.3 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.
3 DOSAGE FORMS AND STRENGTHS
BENTYL 10 mg capsules: blue, imprinted BENTYL 10
BENTYL 20 mg tablets: compressed, light blue, round, debossed BENTYL 20
BENTYL syrup 10 mg/5 mL
BENTYL injection 20 mg/2 mL (10 mg/mL)
4 CONTRAINDICATIONS
BENTYL 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 (5.4)]
reflux esophagitis
5 WARNINGS AND PRECAUTIONS
5.1 Inadvertent Intravenousmuscular Administration
BENTYL solution for intramuscular administration only. Do not administer by any other route. Inadvertent intravenous administration may result in thrombosis, thrombophlebitis and injection site reactions such as pain, edema, skin colour change, and reflex sympathetic dystrophy syndrome [see Adverse Reactions (6.2)].
5.2 Cardiovascular 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)].
5.3 Peripheral 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 difficul |
