Sodium Chloride (Parenteral-Local)

Primary: GU600

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

*Not commercially available in the U.S.

Not commercially available in Canada.




Note: Because sodium chloride for intra-amniotic use is not commercially available in the U.S. or Canada, the bracketed information and the use of the superscript 1 in the Indications section reflect the lack of labeled (approved) indications for this medication in these countries.

General considerations
For all amniotic instillation techniques, complications increase with increasing maternal age, parity, and prolongation of the injection-abortion interval. The highest rate of complications occurs after 48 hours {09} {15}. Dilation and evacuation (D & E) procedure is much more commonly used in conceptions up to 20 menstrual weeks. Labor induction methods, including sodium chloride, are more often used at 21 weeks and beyond, but few abortions are done after 20 weeks {29}.

The amount of amniotic fluid withdrawn (15 to 250 mL) and the amount of sodium chloride instilled may vary among institutions {17} {29}.


[Abortion, elective]1—Sodium chloride 20% {17} {19} solution is used by transabdominal intra-amniotic instillation for aborting late second-trimester pregnancy (between the 16th and 24th weeks of gestation as calculated from the first day of the last normal menstrual period). The severity of the potential complications limits the use of hypertonic sodium chloride for abortion and it has generally been replaced by D & E {03} {07}. The maternal case-fatality rate is 11.6 per 100,000 abortions {02} {13} {18}. Complications or method failure can occur if this method is used before the 16th week of gestation {02} {07} {18}.
—Treating or pretreating for cervical dilation with osmotic cervical dilators, such as laminaria, {13} {18} or cervical dinoprostone gel or vaginal system {18} {24} may help decrease complications of intra-amniotic sodium chloride {07} {13}. If this treatment is not sufficient to induce labor, hypertonic sodium chloride may be used very cautiously in a sequential treatment with labor-inducing agents, such as oxytocin or one of the prostaglandins—dinoprostone vaginal suppositories or vaginal gel, carboprost, or dinoprost {06} {08} {18}.
—If prostaglandins are used as the primary agent instead of sodium chloride, then a smaller dose of sodium chloride can be used to augment labor and prevent transient fetal survival, a possibility if a prostaglandin is used alone {29}.

Hypertonic sodium chloride solution is not recommended for abortion of a nonviable fetus; for this purpose oxytocin or the prostaglandins, dinoprost or carboprost, is used instead {11}.

1 Not included in Canadian product labeling.


Physicochemical characteristics:
Molecular weight—
    58.44 {05}

Mechanism of action/Effect:

The exact mechanism of action is not known but may be related to damage of decidual cells by hypertonic sodium chloride within 0.5 hour after amniotic instillation of sodium chloride {04} {21}. The subsequent release of endogenous prostaglandins induces uterine contractions at about the 11th hour and begins cervical dilation after 11 hours {04}. Hypertonic sodium chloride appears to increase the endogenous release of oxytocin via vasopressin and neurohypophysis stimulation {04}; endogenous oxytocin increases uterine contractions and can potentially further sensitize the uterus to exogenous oxytocin {04} {06}.

Efficacy varied widely in clinical studies using 40 grams of sodium chloride. The rate of failed abortions occurring between 24 and 120 hours from initial injection ranged from 0 to 28 per 100 abortions {16} {23} {25}. Incomplete abortions or the failure to expel the placenta within 2 to 4 hours of aborting the fetus occurred at a rate of 30 per 100 abortions (range, 0 to 53 per 100 abortions) {01} {16} {23} {24} {25}.

Intra-amniotic hypertonic sodium chloride use results in a live birth rate of 0.17 per 100 abortions, even though it is fetotoxic and a stillbirth usually results {21}. In the rare case of a live birth, fetal expiration usually occurs within hours of birth {01} {06} {13} {16} {18}.


Most of a dose is concentrated in the decidua and fetal part of the placenta; some diffuses into maternal blood. Systemic absorption is usually minimal with proper administration. {21}

Onset of action:

Labor usually starts within 13 to 24 hours {02} {06} {18}.

Time to peak effect:

The mean induction-to-abortion time with hypertonic sodium chloride is about 30 hours (26.3 to 37.9 hours) {03} {14} {16} {24}. The mean induction-to-abortion time is 18 hours when sodium chloride administration is augmented with laminaria (an osmotic cervical dilator) and oxytocin {01} {06} {13}.

Precautions to Consider

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

» Oxytocin or other oxytocics    (concurrent use with hypertonic sodium chloride may result in uterine hypertonus, possibly causing uterine rupture or cervical laceration, especially in the absence of adequate cervical dilation. Although sequential treatment is sometimes used for therapeutic advantage, the patient should be closely monitored {12})

Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values

Note: A chemical-induced disseminated intravascular coagulopathy almost universally occurs in women given a full dose of intra-amniotic sodium chloride; there are few studies on the effects of using lower doses {29}.

Fibrin concentrations or
Plasma volume or
Thrombin, prothrombin, and partial thromboplastin times    (may be increased and become most pronounced between 12 and 24 hours after sodium chloride treatment is administered, although risk of hemorrhage is usually low {01} {26})

Fibrinogen and factor V and VIII concentrations or
Hematocrit concentrations or
Platelet counts    (may be decreased, especially between 12 and 24 hours following administration of hypertonic sodium chloride, although risk of hemorrhage is usually low {01} {26})

Sodium, serum    (may increase sharply to a critical concentration, especially with inadvertent intravascular administration, or decrease when oxytocin is used concurrently or for prolonged periods of time {07})

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).

Except under special circumstances, this medication should not be used when the following medical problems exist:
» Absolute contraindications to labor or
» Ruptured amniotic membranes    (hypertonic sodium chloride should not be used; prostaglandins, oxytocin, or D & E should be used instead)

» Actively contracting or hypertonic uterus    (increased intra-amniotic pressure may lead to necrosis of uterine musculature and increased risk of uterine rupture {01})

» Coagulation disorders    (patients with a compromised coagulation system may have an increased risk for developing bleeding complications because the use of hypertonic sodium chloride increases circulating serum procoagulants {08} {09} {10})

Risk-benefit should be considered when the following medical problems exist
» Cardiovascular disease or{10}
» Hypertension or{10}
» Renal function impairment, severe    (possibility of impaired clearance of sodium chloride may cause hypernatremia and make these conditions worse)

    (the rare inadvertent intravascular administration or rapid intravascular absorption of hypertonic sodium chloride can cause a shift of tissue fluids into the vascular bed, resulting in hypervolemia, electrolyte disturbances, circulatory failure, pulmonary embolism, or augmented hypertension {08} {09})

Cervical stenosis    (cervical injury, laceration, or avulsion may occur, especially when a full dose of sodium chloride is reinforced with sequential treatment of labor-inducing prostaglandins or oxytocin; osmotic dilators are commonly used prior to injection of sodium chloride to reduce cervical or uterine injury and may be particularly useful in patients with cervical stenosis {12} {13})

» Epilepsy    (may be exacerbated, especially if complications, such as hypervolemia, occur; incidence rate is 0.08 per 100 abortions {01} {09})

» Relative contraindications to labor    (hypertonic sodium chloride should not be used when a prostaglandin, oxytocin, or a D & E is more appropriate)

Uterine fibroids, large{12}    (large fibroids, particularly at an anterior location, can pose a technical problem for injection; ultrasound guidance may be useful)

» Uterine surgery, major, history of{12}    (may contribute to an increased risk of uterine rupture. Although uterine rupture has not been reported with use of hypertonic sodium chloride, careful monitoring may be needed, especially if oxytocin or a prostaglandin is used concurrently {11} {19})

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Contractions, frequency, duration, and force of, and
Temperature, pulse, and blood pressure determinations     (recommended at frequent intervals during labor and delivery)

Examination of fetus, placenta, and membranes, postabortion{12}    (recommended to prevent undetected, incomplete abortion or failed abortion {07} {14} {18})

    (many clinicians recommend not re-treating the failed abortions or method failures using sodium chloride; other delivery methods should be used instead. In some cases, hypertonic sodium chloride may be readministered after 24 hours when labor is not established or within 48 hours if delivery is not clinically imminent, provided that the membranes are still intact {11} {20})

    (administering appropriate doses of oxytocin 1 hour after the fetus is delivered, if the placenta fails to abort spontaneously in an incomplete abortion; alternatively, manual removal or curettage may be done {23})

Examination of fluid samples or ultrasonography    (frequent examination of fluid samples or visualization by ultrasonography is recommended to confirm placement of sodium chloride into amniotic space)

    (routine use of ultrasonography is recommended to confirm gestational age before procedure or, if difficulty is encountered, to aid in intra-amniotic instillation of sodium chloride, and evaluate for a retained placenta {29})

Examination of skin puncture sites    (recommended at frequent intervals to evaluate any bleeding that might be occurring, including inspecting the site of amniocentesis, if done {12})

Fluid intake and output, maternal, and
Electrolytes, serum, especially sodium concentration{07}    (regular assessment of maternal fluid intake and output, and assessment of serum electrolytes every 12 hours, or as clinically necessary, for checking hypernatremia or possible electrolyte imbalance. These are especially important with concurrent and prolonged use of intravenous oxytocin, which may cause hyponatremia and water intoxication {07} {25})

Vaginal examination    (recommended postdelivery to check for signs of cervical trauma)

Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent
Blood loss, excessive —greater than 300 mL, 1.5 to 16%{06}{13}{16}{18}{25}
hyperpyrexia (high fever)—14.8 to 16.6%{16}

Note: In several studies, one fourth of the patients with excessive blood loss did not require blood transfusions {06} {16} {22} {25}. The incidence of hemorrhagic diathesis associated with hypertonic sodium chloride is 0.3 per 100 abortions {01}. Similarly, only one half of the patients with hyperpyrexia require antibiotics; fever is generally considered transient (1 to 3 days) and unrelated to an infection {18} {22} {25}; septicemia-induced deaths rarely occur {16} {22}.

Incidence rare
Amniotic fluid embolism or pulmonary embolism {10}{16}(anxiety; burning pain in lower abdomen; chest pain, severe; chills; coughing; convulsions; feeling of heat; feeling of warmth in lips and tongue; headache, severe; nervousness; numbness of the fingertips; pain in lower back, pelvis, or stomach; ringing in the ears; shortness of breath; sudden thirst or salty taste; sweating)—inadvertent intravascular, myometrial, or intraperitoneal administration or excessive quantity administered
electrolyte imbalance, including hypernatremia (confusion; unconsciousness; weakness)
hypertension {12}{13}{20}(headache, dull; nervousness)—usually transient{13}
hypotension (dizziness; vision problems){12}{13}{20}—usually transient{13}

Note: Amniotic fluid embolism or electrolyte imbalance, including hypernatremia, when caused by inadvertent intravascular, myometrial, or intraperitoneal administration of hypertonic sodium chloride, may lead to myometrial necrosis, cortical necrosis of the kidneys, cerebral or pulmonary embolism, hemorrhage with or without disseminated intravascular coagulation, cardiovascular collapse, seizures, and death {02} {07} {10} {16} {25} {25}. Instillation should be discontinued immediately {20}. Between 1972 and 1979, only two clinically significant cases of hypernatremia in 24,000 hypertonic sodium chloride–induced abortions and only one death caused by hypernatremia have been reported to the U.S. Centers for Disease Control and Prevention {01}.

Those indicating possible postabortion complications and the need for medical attention if they occur after medication is discontinued
Bleeding at site of abdominal injection or injection site for intravenous solutions {12}{23}
endometritis or pelvic infection (abdominal cramping; chills; shivering; fever; foul-smelling vaginal discharge; pain in lower abdomen){02}{07}{08}{13}{23}
incomplete abortion (passing pieces of tissue from uterus){12}
infection at injection site (redness at place of injection){07}
retained placenta (increase in uterine bleeding){08}{23}

Note: Incomplete abortion may lead to hemorrhage and severe endometritis {29}.

Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Sodium Chloride (Intra-amniotic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Other medications, especially oxytocin or other oxytocics
Other medical problems, especially absolute or relative contraindications to labor; actively contracting or hypertonic uterus; cardiovascular disease; coagulation disorders; epilepsy; hypertension; major uterine surgery, history of; renal function impairment, severe; ruptured amniotic membranes

Proper use of this medication
» Communicating to physician any symptoms that are occurring during procedure to obtain prompt resolution to limit severity of adverse effects

Precaution after receiving this medication
Abstaining from sexual intercourse, and avoiding use of douches or tampons for 2 to 3 weeks after abortion until cervix closes properly; this helps heal and protects against vaginal or uterine infection

Spotting may continue for 2 weeks; reporting any increase in uterine bleeding to health care professional

Counseling for future contraception because ovulation is possible within the first menstrual cycle; menses returns in 4 to 6 weeks

Side/adverse effects
Signs of potential side effects, especially excessive blood loss; hyperpyrexia; amniotic fluid embolism or pulmonary embolism; electrolyte imbalance, including hypernatremia; hypertension; hypotension

Signs of potential postabortion complications include bleeding at injection site(s), endometritis or pelvic infection, incomplete abortion, infection at injection site

General Dosing Information
It is recommended that intra-amniotic sodium chloride be administered in a hospital setting {25}. The amount of amniotic fluid withdrawn (15 to 250 mL) and the amount of sodium chloride instilled can vary per institution. In one study, clinicians did not remove any amniotic fluid but administered 100 mL of 23.4% sodium chloride intra-amniotically in 1000 successful cases {17}.

Sodium Chloride Injection should not be administered intra-amniotically if a bloody amniotic tap is obtained {16}.

It is recommended that sedatives or general anesthetics not be administered to patients receiving hypertonic sodium chloride to keep them alert and able to report potential adverse reactions {08}.

On discharge, the patient should be counseled to refrain from intercourse or use of douches or tampons for 2 to 3 weeks until cervix closes to decrease risk of any infection. Spotting may continue for 2 weeks and the menstrual cycle will be re-established at 4 to 6 weeks. Immediate planning for subsequent contraception is advised because 80% of patients ovulate within the first cycle {08} {22}.

Hypertonic sodium chloride as the primary agent has been used cautiously in combination with adjunctive agents under close medical supervision to decrease the induction-to-abortion time. These include:    • Cervical ripening agents—such as prostaglandins (dinoprostone cervical gel or vaginal system).
   • Cervical osmotic dilators—such as laminaria tents {15} prior to sodium chloride instillation.
   • Labor-inducing agents—such as oxytocin or prostaglandins (dinoprost, carboprost, or dinoprostone vaginal gel or vaginal suppository) {15}. The benefit of a decrease in the induction-to-abortion time should be weighed against the increased risks of coagulopathy, water intoxication, and uterine rupture when oxytocin is used with hypertonic sodium chloride {15} {25}.
To reduce the incidence of complications, the labor-inducing adjunct agents usually are given in a sequential manner after the oxytocic effects of hypertonic sodium chloride on the uterus have significantly subsided—contractions are not tetanic, abnormal, or frequent—and the cervix is adequately dilated {15}. When a dilute solution of intravenous oxytocin is used sequentially with hypertonic sodium chloride, oxytocin dosage is increased in a stepwise fashion every 15 to 30 minutes until adequate labor is attained {12}.

If sodium chloride is used as the adjunctive agent to prostaglandins, a lower volume, 50 to 60 mL of 20% sodium chloride, is given intra-amniotically at a constant high rate of instillation {29}.

For treatment of adverse effects
For abdominal cramping and pain—Treating with appropriate analgesics and according to severity of pain to diminish pain and abdominal cramping {28}.

For amniotic fluid embolism (AFE), disseminated intravascular coagulation (DIC), or hypernatremia—Administering loop diuretics, such as ethacrynic acid or furosemide for AFE or hypernatremia. AFE is usually fatal, while hypernatremia is potentially fatal. Treating collapse, shock, tachycardia, cardiac irregularity, cardiac arrest, convulsions, and coma symptomatically. Monitoring electrolytes and correcting any imbalance {28} {29}. If patient survives the initial crisis, DIC almost always develops, usually occurring with fetal expulsion. Confirming DIC by measuring platelets. Treating DIC by correcting the underlying cause, such as treating patient with antibiotics for suspected gram-negative sepsis or evacuating the uterine contents of placental remnants, and treating with blood products—fresh frozen plasma, cryoprecipitate, and packed red blood cells {28} {29}.

For endometritis, infection at injection site, or pelvic infection—Treating the patient with appropriate broad-spectrum antibiotics. For endometritis, checking for an empty uterus, free of retained tissue from pregnancy, by doing a D & E, examining uterus, or using ultrasonography {28} {29}.

For excessive blood loss or increase in uterine bleeding—Massaging the uterus and injecting intravenous oxytocin slowly for traumatized or atonic uterus. Injecting carboprost or dinoprost into uterine myometrium can stimulate an atonic uterus. When the uterus is refractory to drug-induced stimulation; hypogastric artery ligation or hysterectomy should be considered. Treating for a retained placenta or infection may be necessary if an increase in uterine bleeding occurs after patient has been discharged. If bleeding persists, blood volume should be replenished, the cervix checked for lacerations, and the uterus explored for lacerations or retained placenta fragments or decidua {28}.

For incomplete abortion—Administering appropriate doses of oxytocin 1 hour after the fetus is delivered if the placenta fails to abort spontaneously; alternatively, manual removal or curettage may be done {23}.

For pulmonary embolism—Treating with continuous oxygen for arterial hypoxia, especially when accompanied by reduced cardiac output; beta-adrenergic agents for tissue perfusion maintainance; and appropriate medications to correct or prevent supraventricular tachyarrhythmias. Serial monitoring of arterial blood gases and hemodynamic parameters. If no hemorrhagic disorder exists and the active sites of bleeding stop, continuous heparin may be given for the first 48 hours, followed by oral doses of warfarin sodium initiated on the first day of heparin therapy. Duration of treatment is adjusted to individual patient needs {28}.

Parenteral Dosage Forms

Note: Because sodium chloride for intra-amniotic use is not commercially available in the U.S. or Canada, the bracketed information and the use of the superscript 1 in the Dosage Forms section reflect the lack of labeled (approved) indications for this medication in these countries.


Usual adult and adolescent dose
[Abortion, elective]1
Intra-amniotic, after 15 to 250 mL of amniotic fluid is removed by {15} {20} {24} {25} transabdominal tap of the amniotic sac, 40 grams of sodium chloride in solution (approximately 200 mL of 20% sodium chloride solution) is administered by syringe or gravity drip in an unsedated patient over approximately five to ten minutes {12} {13} {25} while the patient is observed for adverse reactions {01} {07}.

When used as an adjunctive agent with labor-inducing prostaglandins, 50 to 60 mL sodium chloride is given intra-amniotically at a constant high rate {29}.

Note: Although use of an alternate method is preferred for a failed abortion using hypertonic sodium chloride {12} {15}, the instillation may be repeated twenty-four hours after the initial dose if the abortion fails. Also, if delivery is not clinically imminent at forty-eight hours and the membranes are still intact, a second dose may be given {07} {13} {20} {23}.

Strength(s) usually available
Not commercially available. Compounding required for prescription {30}.

Not commercially available. Compounding required for prescription {30}.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing {27}.

Revised: 08/19/1997

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  1. Panelist comment, 4/92.
  1. Panelist comment, 4/92.
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