PATHILON

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PATHILON (PATHILON).

How it works

Anticholinergic agent that competitively inhibits muscarinic acetylcholine receptors, decreasing gastrointestinal motility and gastric acid secretion.

What the body does with it

Metabolism	Hepatic via CYP450 enzymes (major).
Excretion	Primarily renal (50-70% as unchanged drug and metabolites); biliary/fecal (20-30%); minor metabolism via hepatic ester hydrolysis.
Half-life	Terminal elimination half-life approximately 2-4 hours; may be prolonged in elderly or patients with hepatic/renal impairment.
Protein binding	Approximately 90% bound primarily to albumin.
Volume of Distribution	Approximately 2-4 L/kg; indicates extensive tissue distribution.
Bioavailability	Oral: approximately 60-70% due to first-pass metabolism; IM: nearly 100%.
Onset of Action	Oral: 1-2 hours; IM: 30-60 minutes; IV: immediate (within 5 minutes).
Duration of Action	Oral: 4-6 hours; IM: 6-8 hours; IV: 2-4 hours; anticholinergic effects may persist longer.

Classification & Brands

Dosing & administration

1-2 mg orally every 4-6 hours; maximum 12 mg/day. Alternatively, IM: 1-2 mg every 4-6 hours.

Dosage form	TABLET
Renal impairment	GFR 10-50 mL/min: administer 50% of normal dose; GFR <10 mL/min: administer 25% of normal dose.
Liver impairment	Child-Pugh Class A: no adjustment; Child-Pugh Class B: reduce dose by 50%; Child-Pugh Class C: avoid use or reduce dose by 75%.
Pediatric use	Children >2 years: 0.5-1 mg orally every 4-6 hours; maximum 6 mg/day.
Geriatric use	Initiate at 0.5 mg orally every 6 hours; titrate cautiously due to increased anticholinergic sensitivity and risk of cognitive impairment.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for PATHILON (PATHILON).

Breastfeeding	Excreted in breast milk in small amounts; M:P not established. Use caution due to potential anticholinergic effects in infant (constipation, dry mouth, tachycardia). Consider risk-benefit.
Teratogenic Risk	Category C: Fetal risk cannot be ruled out. First trimester: Potential for teratogenic effects based on animal studies; anticholinergic drugs may cause reduced uteroplacental perfusion. Second/third trimester: Use only if clearly needed; may cause neonatal anticholinergic effects (e.g., ileus, jitteriness) if used near term.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Glaucoma (narrow-angle)","Obstructive uropathy","Myasthenia gravis","Obstructive gastrointestinal disease","Severe ulcerative colitis"]

Clinical Precautions

Precautions

["May cause heat stroke due to anhidrosis","Caution in glaucoma","Caution in myasthenia gravis","Caution in gastric reflux","Caution in hepatic or renal impairment"]

Clinical Tips & Counseling

Drug interactions

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PATHILON

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PATHILON (PATHILON).

How it works

Anticholinergic agent that competitively inhibits muscarinic acetylcholine receptors, decreasing gastrointestinal motility and gastric acid secretion.

What the body does with it

Metabolism	Hepatic via CYP450 enzymes (major).
Excretion	Primarily renal (50-70% as unchanged drug and metabolites); biliary/fecal (20-30%); minor metabolism via hepatic ester hydrolysis.
Half-life	Terminal elimination half-life approximately 2-4 hours; may be prolonged in elderly or patients with hepatic/renal impairment.
Protein binding	Approximately 90% bound primarily to albumin.
Volume of Distribution	Approximately 2-4 L/kg; indicates extensive tissue distribution.
Bioavailability	Oral: approximately 60-70% due to first-pass metabolism; IM: nearly 100%.
Onset of Action	Oral: 1-2 hours; IM: 30-60 minutes; IV: immediate (within 5 minutes).
Duration of Action	Oral: 4-6 hours; IM: 6-8 hours; IV: 2-4 hours; anticholinergic effects may persist longer.

Classification & Brands

Dosing & administration

1-2 mg orally every 4-6 hours; maximum 12 mg/day. Alternatively, IM: 1-2 mg every 4-6 hours.

Dosage form	TABLET
Renal impairment	GFR 10-50 mL/min: administer 50% of normal dose; GFR <10 mL/min: administer 25% of normal dose.
Liver impairment	Child-Pugh Class A: no adjustment; Child-Pugh Class B: reduce dose by 50%; Child-Pugh Class C: avoid use or reduce dose by 75%.
Pediatric use	Children >2 years: 0.5-1 mg orally every 4-6 hours; maximum 6 mg/day.
Geriatric use	Initiate at 0.5 mg orally every 6 hours; titrate cautiously due to increased anticholinergic sensitivity and risk of cognitive impairment.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for PATHILON (PATHILON).

Breastfeeding	Excreted in breast milk in small amounts; M:P not established. Use caution due to potential anticholinergic effects in infant (constipation, dry mouth, tachycardia). Consider risk-benefit.
Teratogenic Risk	Category C: Fetal risk cannot be ruled out. First trimester: Potential for teratogenic effects based on animal studies; anticholinergic drugs may cause reduced uteroplacental perfusion. Second/third trimester: Use only if clearly needed; may cause neonatal anticholinergic effects (e.g., ileus, jitteriness) if used near term.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Glaucoma (narrow-angle)","Obstructive uropathy","Myasthenia gravis","Obstructive gastrointestinal disease","Severe ulcerative colitis"]

Clinical Precautions

Precautions

["May cause heat stroke due to anhidrosis","Caution in glaucoma","Caution in myasthenia gravis","Caution in gastric reflux","Caution in hepatic or renal impairment"]

Clinical Tips & Counseling

Drug interactions

Loading safety data…