Product Description.:
BENTYL 10, BENTYL 10
capsule , blue , oblong oblong
White ink
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.
INDICATIONS
For the treatment of functional bowel/irritable bowel syndrome.
SIDE EFFECTS
Controlled clinical trials have provided frequency information for reported adverse effects of dicyclomine hydrochloride listed in a decreasing order of frequency.
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 may be temporary sensation of light-headedness. Some local irritation and focal coagulation necrosis may occur following the I.M. injection of the drug.
Drug Abuse And Dependence
Abuse of and/or dependence on dicyclomine for anticholinergic effects have been rarely reported.