Dicyclomine

Dicyclomine treats functional bowel / irritable bowel syndrome through antispasmodic / antimuscarinic activity. The reviewed dose regimens are adult regimens. This indication does not establish treatment of every abdominal pain, infectious diarrhea or obstruction.

This profile covers selected current generic oral products and short-term IM use when oral medication cannot be taken. Historical short trials do not establish long-term high-dose safety or a universal first-line IBS strategy. No off-label pediatric or compounded regimen is supplied.

Selected solution contains 10 mg / 5 mL:20 mg is 10 mL and 40 mg is 20 mL, a direct concentration calculation for the adult prescription only. Use a calibrated oral measuring device. The label advises continuing the normal schedule after a missed dose; do not double. No numeric renal / hepatic adjustment is supplied.

Give 10–20 mg IM four times daily for only 1 or 2 days when oral treatment cannot be taken. IM is approximately twice as bioavailable as oral forms; do not substitute mg-for-mg. Inspect for particles / discoloration and aspirate before injection per selected label to avoid intravascular administration. Never administer IV or by another route.

Infants<6 months; breastfeeding; unstable cardiovascular status in acute hemorrhage; myasthenia gravis; glaucoma; obstructive uropathy; GI obstruction; severe ulcerative colitis; reflux esophagitis. The warning section mentions a narrow myasthenia / anticholinesterase context despite the formal contraindication; no exception regimen is endorsed here. Injection is IM only.

The selected current labels have no boxed warning. The infant, breastfeeding and wrong-route restrictions remain serious.

Common trial-reported effects include dizziness, dry mouth, blurred vision, nausea, somnolence, weakness and nervousness. Other reports include constipation, urinary retention, tachyarrhythmia, hypersensitivity and delirium. Published infant reports include respiratory collapse, seizures, coma and death, though the label notes causality was not established. IM administration may cause local irritation; IV errors cause vascular / local injury. Historical 160 mg / day trial rates are not personal risk predictions.

The labels list additive effects with antihistamines, tricyclic antidepressants, antipsychotics, amantadine, class-I antiarrhythmics, opioids, benzodiazepines, MAO inhibitors and other agents. Review overall burden and symptoms instead of inventing a universal dose-reduction formula. Glaucoma medicines may be antagonized and intraocular pressure can rise; glaucoma is contraindicated.

Avoid simultaneous antacids because oral anticholinergic absorption may be impaired; the labels provide no universal spacing interval. Effects can oppose metoclopramide or other motility treatments. Altered GI transit may increase absorption of slowly dissolving digoxin forms; review concentrations / toxicity where appropriate. Agents testing / treating gastric acid secretion can oppose anticholinergic acid effects.

Use in pregnancy only if clearly needed. Controlled studies at 80–160 mg / day are absent; reassuring first-trimester epidemiology involved up to 40 mg / day and cannot establish safety at every regimen. Selected labels retain historical “Category B” language, which is not a contemporary proof of safety. Dicyclomine enters milk and is contraindicated during breastfeeding; coordinate maternal treatment and feeding decisions with the clinician.

Pediatric safety / effectiveness is not established; infants<6 months are contraindicated because serious events have been reported. No pediatric dose is supplied. Older adults may be more susceptible to CNS and other anticholinergic effects; select doses cautiously, consider organ function and monitor renal status when appropriate.

Organ-impairment effects on PK / safety / effectiveness have not been adequately studied in selected labeling. Renal excretion is substantial and toxicity risk can increase with impairment. Use caution with both renal and hepatic disease; no verified CrCl, dialysis or Child-Pugh dose table is supplied. The tablet’s hepatic subsection repeats “renal” in its study sentence; no hepatic study is inferred.

Dicyclomine relieves GI smooth-muscle spasm. Animal studies support antimuscarinic receptor effects plus a direct smooth-muscle effect; animal comparisons with atropine are not a human dose conversion. Saliva / sweat inhibition, pupil dilation and cardiac / CNS effects explain important adverse reactions.

After oral dosing, peaks occur around 60–90 minutes. Distribution is extensive; metabolism was not studied in the cited label data. Excretion is mainly urinary (79.5%) with some fecal elimination. One short sampling study estimated a 1.8 hour half-life, while longer sampling showed a secondary slower phase; no single universal terminal half-life is asserted. IM exposure differs as described above.

Review diagnosis, obstruction / red flags, glaucoma, urinary symptoms, cardiac disease, feeding / pregnancy status and interacting medicines before use. Assess benefit / tolerance during escalation and by 2 weeks. Follow mental status, heat tolerance, bowel / urinary function, pulse and renal function when clinically indicated. No universal blood-drug test or ECG / lab interval is specified.

Avoid driving or hazardous work with drowsiness or blurred vision. Be alert to impaired sweating during heat exposure; stop and seek care for heat illness. Report severe abdominal distension, new diarrhea with a stoma, urinary retention, confusion, rapid heartbeat or allergy. Do not give to an infant, use while breastfeeding or inject IV. Continue the normal schedule after a missed dose.

Contact emergency care or Poison Control immediately for excessive dosing or child exposure. Toxicity can include hot dry skin, dilated pupils, agitation / seizures and weakness / paralysis. The label contains historical clinician decontamination / antidote language; do not induce vomiting or attempt a home reversal. A toxic single-dose threshold and dialysis usefulness are not established.

Product

Remedy Repack dicyclomine hydrochloride 20 mg

Route

Oral prescription tablet

Appearance

Light blue / blue round with white spots; T 200

Example package

30-tablet blister · NDC 70518-3917-00

Selected tablet 20 mg; selected 10 mg capsule is light-blue / blue transparent hard gelatin with V 1 / 41 white imprints. Hikma oral solution 10 mg / 5 mL is clear pink, cherry-brandy flavor,473 mL NDC 0054-0622-63. Hikma IM injection 10 mg / mL in 2 mL single-dose vials, NDC 0641-6173-10 carton 10. Actual product imprints / excipients differ; verify the dispensed label.

Selected tablet:20–25°C, avoid direct sunlight to prevent fading. Hikma oral solution:20–25°C, protect from excessive heat. Hikma injection:20–25°C, protect from freezing; inspect before use. The selected repackaged capsule label provides package counts but no distinct storage specification; obtain its dispensing / manufacturer instructions rather than invent a universal liquid / capsule discard period.