Abdorin

A. Approved Indications

• Irritable Bowel Syndrome (IBS)
• Management of functional bowel disorders with predominant abdominal cramping, bloating, or spasm.
• Intestinal Hypermotility Disorders
• Symptomatic relief of abdominal cramps associated with functional gastrointestinal disorders.
• Infantile Colic (in some countries; use is controversial)

B. Clinically Accepted Off-label Uses

• Biliary Colic
• Renal Colic
• Dysmenorrhea (in combination therapies)
• Acute enterocolitis (symptomatic relief)

Route of Administration: Oral and Intramuscular (IM)

Adults:

• Oral Tablet or Syrup:
• Initial: 20 mg orally four times daily
• May be increased to 40 mg four times daily if well tolerated after one week
• Intramuscular (IM):
• 10–20 mg four times daily
• Used for short-term treatment when oral route is not feasible
• Not for intravenous (IV) administration

Pediatrics:

• Children >6 months (oral syrup):
• 5–10 mg three to four times daily
• Use with caution; dosing should be individualized
• Infants (<6 months):
• Use not recommended due to serious side effect risks (e.g., respiratory distress)

Elderly:

• Start at lower doses due to increased anticholinergic sensitivity
• Monitor for CNS effects (confusion, memory loss)

Renal/Hepatic Impairment:

• No specific adjustments required, but use cautiously
• Monitor for enhanced side effects

Dicycloverine hydrochloride is an anticholinergic agent with direct smooth muscle relaxant properties. It blocks the action of acetylcholine at parasympathetic sites in smooth muscle, including the gastrointestinal tract. By antagonizing muscarinic M1 and M3 receptors, dicycloverine inhibits smooth muscle contractions, leading to decreased intestinal motility and relief from spasmodic pain. Additionally, its local direct myotropic action further contributes to its antispasmodic effects, making it effective for functional bowel disorders like IBS.

• Absorption: Rapidly absorbed from the gastrointestinal tract after oral administration
• Onset of Action: ~1–2 hours (oral); within 30 minutes (IM)
• Distribution: Widely distributed, including across the blood-brain barrier
• Plasma Protein Binding: ~84%
• Metabolism: Hepatic; detailed metabolic pathways not well characterized
• Elimination: Primarily renal (urine), mostly as metabolites
• Half-life: ~1.8–2 hours

• Pregnancy:
• FDA Pregnancy Category: B
• No adequate human studies; animal studies have not shown fetal risk
• Use only if clearly needed during pregnancy
• Lactation:
• Excreted into breast milk in small amounts
• Potential for serious anticholinergic effects (e.g., breathing difficulties) in infants
• Not recommended during breastfeeding

• Primary Class: Anticholinergic / Antispasmodic
• Subclass: Muscarinic receptor antagonist

• Hypersensitivity to dicycloverine or related compounds
• Obstructive uropathy (e.g., prostatic hypertrophy)
• Obstructive gastrointestinal conditions (e.g., pyloric stenosis, paralytic ileus)
• Severe ulcerative colitis (risk of toxic megacolon)
• Reflux esophagitis
• Myasthenia gravis
• Glaucoma (especially angle-closure type)
• Infants younger than 6 months

• CNS Effects: Drowsiness, dizziness, confusion, particularly in elderly or high doses
• Heat Sensitivity: May reduce sweating; risk of heatstroke in hot environments
• Tachycardia: Use caution in patients with cardiac conditions
• Psychiatric Symptoms: Delirium, hallucinations reported at high doses
• Infants: Severe respiratory side effects; use contraindicated under 6 months
• Monitor: Use with caution in those with hepatic, renal, or cardiovascular conditions

Common (dose-related):

• Dry mouth
• Blurred vision
• Drowsiness
• Dizziness
• Nausea
• Constipation

Less Common:

• Urinary retention
• Nervousness or agitation
• Difficulty sleeping

Serious/Rare:

• Tachycardia or palpitations
• Confusion, especially in elderly
• Hallucinations
• Respiratory distress (especially in infants)
• Allergic reactions (rash, swelling, anaphylaxis)

• Other anticholinergics (e.g., atropine): Additive side effects (e.g., dry mouth, urinary retention)
• CNS depressants (e.g., alcohol, benzodiazepines): Enhanced sedation
• Antacids: May interfere with absorption if taken concurrently
• Metoclopramide: Antagonizes prokinetic effect
• Potassium supplements: Risk of GI mucosal irritation or ulcers

• FDA and EMA maintain warnings against use in infants under 6 months due to respiratory risk
• Pediatric societies in some regions recommend avoiding dicycloverine for colic due to limited efficacy and potential harm
• Emphasis on minimizing anticholinergic burden in elderly patients by geriatric societies

• Tablets and Syrup:
• Store at 20°C to 25°C (68°F to 77°F)
• Protect from moisture and direct light
• Injection (IM):
• Store at 15°C to 30°C (59°F to 86°F)
• Do not freeze
• Use single-dose ampoules; discard unused portions