CYSTOSPAZ® is a pale blue uncoated compressed tablet for oral administration. It contains the parasympatholytic agent hyoscyamine as the free base. Each tablet contains: hyoscyamine 0.15 mg.

CYSTOSPAZ-M® is a light blue timed-release capsule containing hyoscyamine sulfate 0.375 mg.

Through its parasympatholytic action, hyoscyamine relaxes smooth muscle spasm resulting from parasympathetic stimulation. It inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. It also controls excessive pharyngeal, tracheal and bronchial secretions. It is the(lambda)-isomer of atropine and therefore exhibits the same clinical effects as atropine. It is, however, approximately twice as active peripherally as atropine, since the latter is the racemic (d(lambda)) form of hyoscyamine and d-hyoscyamine possesses only a very weak anti-cholinergic action. Since only one-half the atropine dose is required for (lambda)-hyoscyamine, it has only one-half the unwanted central effects of atropine.

In the management of disorders of the lower urinary tract associated with hypermotility. Although specific therapy is often required to remove the underlying cause of spasm, CYSTOSPAZ Tablets and CYSTOSPAZ-M Capsules are offered as antispasmodic agent dosage forms which may be combined with other forms of therapy where indicated.

CYSTOSPAZ Tablets and CYSTOSPAZ-M capsules are effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome (irritable colon, spastic colon, mucous colitis), acute entercolitis and other functional gastrointestinal disorders.

CYSTOSPAZ Tablets and CYSTOSPAZ-M Capsules can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. They are indicated (along with appropriate analgesics) in symptomatic relief of biliary and renal colic.


Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis); paralytic ileus, intestinal atony of elderly or debilitated patients; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. Hypersensitivity to any of the ingredients.

In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, these products may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug.


General:   Use with caution in patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, and hypertension. Investigate any tachycardia before giving any anticholinergic drug since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis.

Information for Patients:   CYSTOSPAZ Tablets and CYSTOSPAZ-M Capsules may cause drowsiness, dizziness or blurred vision; patients should observe caution before driving, using machinery or performing other tasks requiring mental alertness. Use of CYSTOSPAZ Tablets or CYSTOSPAZ-M Capsules may decrease sweating resulting in heat prostration, fever or heat stroke; febrile patients or those who may be exposed to elevated environmental temperatures should use caution. Prolonged use of CYSTOSPAZ Tablets or CYSTOSPAZ-M Capsules may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidiasis, and discomfort.


Additive adverse effects resulting from cholinergic blockade may occur when CYSTOSPAZ® Tablets or CYSTOSPAZ-M Capsules are administered concomitantly with other antimuscarinics, amanatadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines. Antacids may interfere with the absorption of CYSTOSPAZ Tablets or CYSTOSPAZ-M Capsules; take CYSTOSPAZ Tablets or CYSTOSPAZ-M Capsules before meals and antacids after meals.

Carcinogenesis, Mutagenesis, Impairment Of Fertility: No long term studies in animals have been performed to determine the carcinogenic, mutagenic or impairment of fertility potential of CYSTOSPAZ Tablets or CYSTOSPAZ-M Capsules.

Pregnancy Category C-- Animal reproduction studies have not been conducted with CYSTOSPAZ Tablets or CYSTOSPAZ-M Capsules. It is also not known whether CYSTOSPAZ Tablets or CYSTOSPAZ-M Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CYSTOSPAZ Tablets or CYSTOSPAZ-M Capsules should be taken by a pregnant woman only if clearly needed.

Nursing Mothers --Hyoscyamine is excreted in human milk. Caution should be exercised when CYSTOSPAZ Tablets or CYSTOSPAZ-M Capsules are administered to a nursing woman.


Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; cycloplegia; increased ocular tension; headache; nervousness; drowsiness; weakness; suppression of lactation; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; and decreased sweating. Note: Slight dryness of the mouth is an indication that parasympathetic blockage is effective.


A dependence on the use of CYSTOSPAZ Tablets or CYSTOSPAZ-M Capsules has not been reported and due to the nature of their ingredients, abuse of CYSTOSPAZ Tablets or CYSTOSPAZ-M Capsules is not expected.


Symptoms of overdosage include severe dryness of the mouth, nose, throat, and hot dry flushed skin, hyperpyrexia (especially in children), difficulty or inability to swallow, difficult speech, dilated pupils until iris almost disappears, restlessness and garrulity indicating an irritability of the brain, marked tremors, convulsions, respiratory failure, death. In adults, symptoms of overdosage may begin in the range of ingestion of 0.6 to 1 mg with doses exceeding 1-2 mg eliciting more profound toxicity. Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 ml. of a 2% solution) by rectal infusion.


Adults:   CYSTOSPAZ Tablets--One or two tablets four times daily or fewer if needed. CYSTOSPAZ-M Capsules--One capsule every twelve hours.

Children (12 and under):   Reduce dosage in proportion to age and weight.


CYSTOSPAZ Tablets-- Bottles of 100 light blue tablets. Tablets are imprinted with a " W 2225". CYSTOSPAZ-M Capsules--Bottles of 100 light blue timed-release capsules. Capsules are identified with " W 2260" printed in black.