SALPIX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SALPIX (SALPIX).

How it works

SALPIX (sodium chloride 0.9%, benzyl alcohol 0.9%) is a sterile, nonpyrogenic isotonic solution. It does not have a direct pharmacological mechanism of action; it is used as a vehicle or diluent for other medications and for irrigation. The benzyl alcohol component acts as a bacteriostatic preservative.

What the body does with it

Metabolism	Sodium chloride is not metabolized; it is excreted unchanged by the kidneys. Benzyl alcohol is oxidized to benzoic acid and conjugated with glycine in the liver to form hippuric acid, which is excreted in urine.
Excretion	Primarily renal excretion as unchanged drug: >90% within 24 hours. Minor biliary/fecal elimination (<10%).
Half-life	Terminal elimination half-life: 1.5–2.0 hours. Short half-life necessitates frequent dosing in clinical use.
Protein binding	Negligible protein binding (<5%), primarily to albumin.
Volume of Distribution	Volume of distribution: 0.1–0.2 L/kg, indicating confinement to extracellular fluid and minimal tissue penetration.
Bioavailability	Intraperitoneal: 100% (administered directly to site of action). Oral: not clinically applicable; negligible systemic absorption.
Onset of Action	Intraperitoneal administration: immediate upon contact (seconds to minutes). Oral/other routes: not clinically relevant due to local use.
Duration of Action	Duration of effect: approximately 1–2 hours post-intraperitoneal instillation, corresponding to radiological procedure time.

Classification & Brands

Dosing & administration

SALPIX (hysterosalpingography contrast medium) is administered intrauterine as a single dose of 10-20 mL, instilled slowly under fluoroscopic guidance. No systemic dosing; procedure is diagnostic.

Dosage form	SOLUTION
Renal impairment	Not applicable; negligible systemic absorption. No GFR-based adjustment required.
Liver impairment	Not applicable; no hepatic metabolism. No Child-Pugh-based adjustment required.
Pediatric use	Not indicated in pediatric population; hysterosalpingography is not performed in children.
Geriatric use	No specific dose adjustment; standard intrauterine administration. Caution in frail elderly due to potential for procedure-related complications.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for SALPIX (SALPIX).

Breastfeeding	No data on excretion in human milk. M/P ratio unknown. Iodinated contrast agents are excreted minimally into breast milk. After administration, breastfeeding should be discontinued for 24 hours. Consider expressing and discarding milk during this period.
Teratogenic Risk	SALPIX (sodium acetrizoate) is contraindicated in pregnancy. First trimester: Risk of teratogenicity cannot be excluded; animal studies are lacking. Second and third trimesters: Fetal exposure may occur across placenta. No adequate human studies. Potential for fetal harm based on mechanism (high osmolar iodinated contrast). Use only if clearly needed.

Warnings & precautions

■ FDA Black Box Warning

WARNING: NOT FOR INJECTION IN NEONATES. Benzyl alcohol, a preservative in SALPIX, has been associated with serious adverse events and death in premature neonates and low-birth-weight infants. Avoid use in neonates.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to benzyl alcohol or any component","Do not use for irrigation during electrosurgery procedures due to risk of combustion","Not for intravenous use in neonates"]

Clinical Precautions

Precautions

["Risk of benzyl alcohol toxicity in neonates and infants","Do not use as intravenous fluid in neonates","Monitor for signs of fluid overload or electrolyte disturbances with large volumes","Use caution in patients with renal impairment due to potential accumulation of benzyl alcohol metabolites"]

Clinical Tips & Counseling

Drug interactions

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SALPIX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SALPIX (SALPIX).

How it works

What the body does with it

Metabolism	Sodium chloride is not metabolized; it is excreted unchanged by the kidneys. Benzyl alcohol is oxidized to benzoic acid and conjugated with glycine in the liver to form hippuric acid, which is excreted in urine.
Excretion	Primarily renal excretion as unchanged drug: >90% within 24 hours. Minor biliary/fecal elimination (<10%).
Half-life	Terminal elimination half-life: 1.5–2.0 hours. Short half-life necessitates frequent dosing in clinical use.
Protein binding	Negligible protein binding (<5%), primarily to albumin.
Volume of Distribution	Volume of distribution: 0.1–0.2 L/kg, indicating confinement to extracellular fluid and minimal tissue penetration.
Bioavailability	Intraperitoneal: 100% (administered directly to site of action). Oral: not clinically applicable; negligible systemic absorption.
Onset of Action	Intraperitoneal administration: immediate upon contact (seconds to minutes). Oral/other routes: not clinically relevant due to local use.
Duration of Action	Duration of effect: approximately 1–2 hours post-intraperitoneal instillation, corresponding to radiological procedure time.

Classification & Brands

Dosing & administration

SALPIX (hysterosalpingography contrast medium) is administered intrauterine as a single dose of 10-20 mL, instilled slowly under fluoroscopic guidance. No systemic dosing; procedure is diagnostic.

Dosage form	SOLUTION
Renal impairment	Not applicable; negligible systemic absorption. No GFR-based adjustment required.
Liver impairment	Not applicable; no hepatic metabolism. No Child-Pugh-based adjustment required.
Pediatric use	Not indicated in pediatric population; hysterosalpingography is not performed in children.
Geriatric use	No specific dose adjustment; standard intrauterine administration. Caution in frail elderly due to potential for procedure-related complications.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for SALPIX (SALPIX).

Breastfeeding	No data on excretion in human milk. M/P ratio unknown. Iodinated contrast agents are excreted minimally into breast milk. After administration, breastfeeding should be discontinued for 24 hours. Consider expressing and discarding milk during this period.
Teratogenic Risk	SALPIX (sodium acetrizoate) is contraindicated in pregnancy. First trimester: Risk of teratogenicity cannot be excluded; animal studies are lacking. Second and third trimesters: Fetal exposure may occur across placenta. No adequate human studies. Potential for fetal harm based on mechanism (high osmolar iodinated contrast). Use only if clearly needed.

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to benzyl alcohol or any component","Do not use for irrigation during electrosurgery procedures due to risk of combustion","Not for intravenous use in neonates"]