Dicyclomine Hydrochloride

Dicyclomine hydrochloride injection is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.

Dosage must be adjusted to individual patients needs.

• Dicyclomine Hydrochloride Injection, USP, 20 mg/2 mL (10 mg/mL)

• Pregnancy: use only if clearly needed

  8.1 Pregnancy

  Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy.

  Reproduction studies have been performed in rats and rabbits at doses of up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine.  Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

• Pediatric Use: Safety and effectiveness not established

  8.4 Pediatric Use

  Safety and effectiveness in pediatric patients have not been established.

  Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see

  CONTRAINDICATIONS

  (4)

  ]. There are published cases reporting that the administration of dicyclomine hydrochloride to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established.

• Hepatic and renal impairment: caution must be taken with patients with significantly impaired hepatic and renal function

  8.6 Renal Impairment

  Effects of renal impairment on PK, safety and efficacy of dicyclomine hydrochloride have not been studied.  Dicyclomine hydrochloride drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Dicyclomine hydrochloride should be administered with caution in patients with renal impairment.
  See 17 for PATIENT COUNSELING INFORMATION
  Revised 05/2017

• For Intramuscular injection only; should not be administered by any other route. Intravenous injection may result in thrombosis or thrombophlebitis and injection site reactions (

  5.1 Inadvertent Intravenous Administration

  Dicyclomine hydrochloride solution is 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 color change, and reflex sympathetic dystrophy syndrome [see

  ADVERSE REACTIONS (6.2)]

  .
  )

• Cardiovascular conditions
  : worsening of conditions
  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)]

  .

• Peripheral and central nervous system
  : heat prostration can occur with drug use (fever and heat stroke due to decreased sweating); drug should be discontinued and supportive measures instituted
  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 difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation [see

  ADVERSE REACTIONS (6)]

  .

  In the presence of high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever. If symptoms occur, the drug should be discontinued and supportive measures instituted. Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy.

  Central nervous system (CNS) signs and symptoms include confusion, disorientation, amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.

  Psychosis and delirium have been reported in sensitive individuals (such as elderly patients and/or in patients with mental illness) given anticholinergic drugs. These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug.

  Dicyclomine hydrochloride may produce drowsiness, dizziness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking dicyclomine hydrochloride.

• Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness)
  : signs and symptoms resolve within 12 to 24 hours after discontinuation of dicyclomine hydrochloride (
  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 difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation [see

  ADVERSE REACTIONS (6)]

  .

  In the presence of high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever. If symptoms occur, the drug should be discontinued and supportive measures instituted. Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy.

  Central nervous system (CNS) signs and symptoms include confusion, disorientation, amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.

  Psychosis and delirium have been reported in sensitive individuals (such as elderly patients and/or in patients with mental illness) given anticholinergic drugs. These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug.

  Dicyclomine hydrochloride may produce drowsiness, dizziness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking dicyclomine hydrochloride.
  )

• Myasthenia Gravis
  : overdose may lead to muscular weakness and paralysis. Dicyclomine hydrochloride should be given to patients with myasthenia gravis only to reduce adverse muscarinic effects of an anticholinesterase (
  5.4 Myasthenia Gravis

  With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). It should not be given to patients with myasthenia gravis except to reduce adverse muscarinic effects of an anticholinesterase [see

  CONTRAINDICATIONS (4)]

  .
  )

• Incomplete intestinal obstruction
  : diarrhea may be an early symptom especially in patients with ileostomy or colostomy. Treatment with dicyclomine hydrochloride would be inappropriate and possibly fatal (
  5.5 Intestinal Obstruction

  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 [see

  CONTRAINDICATIONS (4)]

  .

  Rarely development of Ogilvie's syndrome (colonic pseudo-obstruction) has been reported. Ogilvie's syndrome is a clinical disorder with signs, symptoms, and radiographic appearance of an acute large bowel obstruction but with no evidence of distal colonic obstruction.
  )

• Salmonella dysenteric patients
  : due to risk of toxic megacolon (
  5.6 Toxic Dilatation of Intestinemegacolon

  Toxic dilatation of intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery.
  )

• Ulcerative colitis
  : dicyclomine hydrochloride should be used with caution in these patients; large doses may suppress intestinal motility or aggravate the serious complications of toxic megacolon (
  5.7 Ulcerative Colitis

  Caution should be taken in patients with ulcerative colitis. Large doses may suppress intestinal motility to the point of producing a paralytic ileus and the use of this drug may precipitate or aggravate the serious complication of toxic megacolon [see

  ADVERSE REACTIONS (6.3)]

  . Dicyclomine hydrochloride is contraindicated in patients with severe ulcerative colitis [see

  CONTRAINDICATIONS (4)]

  .
  )

• Prostatic hypertrophy
  : dicyclomine hydrochloride should be used with caution in these patients; may lead to urinary retention (
  5.8 Prostatic Hypertrophy

  Dicyclomine hydrochloride should be used with caution in patients with known or suspected prostatic enlargement, in whom prostatic enlargement may lead to urinary retention [see

  ADVERSE REACTIONS (6.3)]

  .

  )

• Hepatic and renal disease
  : should be used with caution (
  5.9 Hepatic and Renal Disease

  Dicyclomine hydrochloride should be used with caution in patients with known hepatic and renal impairment.
  )

• Geriatric
  : use with caution in elderly who may be more susceptible to dicyclomine hydrochloride’s adverse events (
  5.10 Geriatric Population

  Dicyclomine hydrochloride should be used with caution in elderly who may be more susceptible to its adverse effects.
  )