Product Description.:
LAN 1282
tablet , blue , round round
DebossedFlat-faced beveled-edge
BENTYL is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following forms:
1. BENTYL capsules for oral use contain 10 mg dicyclomine hydrochloride USP. BENTYL 10 mg capsules also contain inactive ingredients: calcium sulfate, corn starch, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, magnesium stearate, pregelatinized corn starch, and titanium dioxide.
2. BENTYL tablets for oral use contain 20 mg dicyclomine hydrochloride USP. BENTYL 20 mg tablets also contain inactive ingredients: acacia, dibasic calcium phosphate, corn starch, FD&C Blue No. 1, lactose, magnesium stearate, pregelatinized corn starch, and sucrose.
3. BENTYL syrup for oral use contains 10 mg dicyclomine hydrochloride USP in each 5 mL (1 teaspoonful). BENTYL syrup also contains inactive ingredients: citric acid, D&C Red No. 33, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavors, glucose, methylparaben, propylene glycol, propylparaben, saccharin sodium, and water.
4. BENTYL injection is a sterile, pyrogen-free, aqueous solution for intramuscular injection (NOT FOR INTRAVENOUS USE).
Ampule. 20 mg/2 mL (10 mg/mL) -Each mL contains 10 mg dicyclomine hydrochloride USP in sterile water for injection, made isotonic with sodium chloride.
Dicyclomine hydrochloride 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.
INDICATIONS
For the treatment of functional bowel/irritable bowel syndrome.
DOSAGE AND ADMINISTRATION
DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS (See CLINICAL PHARMACOLOGY.)
Adults-Oral. The only oral dose clearly shown to be effective is 160 mg per day (in 4 equally divided doses). Since this dose is associated with a significant incidence of side effects, it is prudent to begin with 80 mg per day (in 4 equally divided doses). Depending upon the patient's response during the first week of therapy, the dose should be increased to 160 mg per 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.
Adults-Intramuscular Injection. NOT FOR INTRAVENOUS USE.
The intramuscular dosage form is to be used temporarily when the patient cannot take oral medication. Intramuscular injection is about twice as bioavailable as oral dosage forms consequently, the recommended intramuscular dose is 80 mg daily (in 4 equally divided doses). Oral dicyclomine hydrochloride should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.
ASPIRATE THE SYRINGE BEFORE INJECTING TO AVOID INTRAVASUCLAR INJECTION, SINCE THROMBOSIS MAY OCCUR IF THE DRUG IS INADVERTENTLY INJECTED INTRAVASCULARLY. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Elderly: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
SIDE EFFECTS
Controlled clinical trials have provided frequency information for reported adverse effects of dicyclomine hydrochloride listed in a decreasing order of frequency. (See CLINICAL PHARMACOLOGY.)
Not all of the following adverse reactions have been reported with dicyclomine hydrochloride.
Adverse reactions are included here that have been reported for pharmacologically similar drugs with anticholinergic/antispasmodic action.
Gastrointestinal: dry mouth, nausea, vomiting, constipation, bloated feeling, abdominal pain, taste loss, anorexia
Central Nervous System: dizziness, light-headedness, tingling, headache, drowsiness, weakness, nervousness, numbness, mental confusion and/or excitement (especially in elderly persons), dyskinesia, lethargy, syncope, speech disturbance, insomnia
Ophthalmologic: blurred vision, diplopia, mydriasis, cycloplegia, increased ocular tension
Dermatologic/Allergic: rash, urticaria, itching, and other dermal manifestations severe allergic reaction or drug idiosyncrasies including anaphylaxis
Genitourinary: urinary hesitancy, urinary retention
Cardiovascular: tachycardia, palpitations
Respiratory: dyspnea, apnea, asphyxia (see WARNINGS)
Other: decreased sweating, nasal stuffiness or congestion, sneezing, throat congestion, impotence, suppression of lactation (see PRECAUTIONS: Nursing Mothers)
With the injectable form, there
