Classes
DEA Class; Rx
Common Brand Names; Levbid, Levsin, Anaspaz, Cystospaz, NuLev, Symax Duotab
- Anticholinergic Agents
Description
Tertiary amine antimuscarinic; one of the isomers of atropine; used for hypermotility disorders of the lower urinary tract or to control excessive salivary or respiratory secretions.
Indications
Indicated for adjunctive treatment of irritable bowel syndrome and neurogenic bladder; also has been used historically as follows: to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps; to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis; as adjunctive therapy in the treatment of functional gastrointestinal disorders, and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon); drops are used in the treatment of infant colic (elixir and drops); for use along with opioid narcotics in symptomatic relief of biliary and renal colic; as a ‘drying agent’ for symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis; and adjunctive therapy of poisoning by anticholinesterase agents.
NOTE: These drug products have not been found by FDA to be safe and effective, and product labeling has not been approved by the FDA.
Peptic ulcer disease, abdominal cramps, spastic bladder, cystitis, pylorospasm, IBS, biliary and renal colic, urinary incontinence, Parkinsonism, acute rhinitis, sialorrhea, hyperhidrosis, cholinergic poisoning
Heat prostration may be caused due to suppression of sweating
Contraindications
Hypersensitivity to hyoscyamine or related compounds
Closed-angle glaucoma
Myasthenia gravis
Hemorrhage with cardiovascular instability
Paralytic ileus
Intestinal atony of elderly/debilitated patient
Obstructive uropathy
Toxic megacolon
GI obstruction
Tachycardia secondary to cardiac insufficiency or thyrotoxicosis
Breastfeeding
Adverse Effects
- Dry skin
- Blurred vision
- Constipation
- Dysphagia
- Photosensitivity
- Headache
- Orthostatic hypotension
- Tachycardia
- Xerostomia
- Urinary hesitancy/retention
- HTN
- Dysphagia
- Respiratory depression
- CNS stimulation
- Fever
- Ataxia
- Excitation
- Lethargy
Warnings
Discontinue treatment if diarrhea occurs; it may be a sign of incomplete intestinal obstruction, especially in colostomy or ileostomy
May cause drowsiness; caution patients about performing a hazardous task, like driving heavy machinery, that requires mental alertness
Use caution in hot weather or exercise; heat prostration reported in the presence of increased environmental temperature
Psychosis reported in patients susceptible to anticholinergic effects; usually resolved within 12-48 hr after therapy discontinuation
Use caution in patients with hyperthyroidism, prostatic hyperplasia, renal impairment, hiatal hernia, or cardiovascular disease, including heart failure, tachyarrhythmias, hypertension, or coronary artery disease; evaluate tachycardia prior to initiating therapy
Pregnancy and Lactation
Pregnancy category: C
Lactation: Enters breast milk; use not recommended
Maximum Dosage
4 oral biphasic tablets/day PO; all other oral dosage forms 1.5 mg/day PO; maximum IV dose is dependent on indication.
4 oral biphasic tablets/day PO; all other oral dosage forms 1.5 mg/day PO; maximum IV dose is dependent on indication.
4 oral biphasic tablets/day PO; all other oral dosage forms 1.5 mg/day PO; maximum IV dose is dependent on indication.
>= 12 years: 4 oral biphasic tablets/day PO; all other oral dosage forms 1.5 mg/day PO; maximum IV dose is dependent on indication.
2—11 years, weighing approximately 50 kg: 2 oral biphasic tablets/day PO; all other oral dosage forms 0.75 mg/day; 5 mcg/kg/dose given once IV, IM, or subcutaneous.
Weighing approximately 10 kg: Oral drops, 48 drops/day; safety and efficacy of other dosage forms has not been established.
Weighing approximately 7 kg: Oral drops, 36 drops/day; safety and efficacy of other dosage forms has not been established.
Weighing approximately 5 kg: Oral drops, 30 drops/day; safety and efficacy of other dosage forms has not been established.
Weighing approximately 3.4 kg: Oral drops, 24 drops/day; safety and efficacy of other dosage forms has not been established.
How supplied
Hyoscyamine sulfate
Capsule/tablet, extended release
- 0.375mg
Elixir
- 0.125mg/5mL
Oral spray
- 0.125 mg/mL (0.125 mg/spray)