Vasopressin injection

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# Overview
Vasopressin injection is a anti diuretic that is FDA approved for the treatment of prevention and treatment of postoperative abdominal distention, in abdominal roentgenography to dispel interfering gas shadows, and in diabetes insipidus.   Common adverse reactions include anaphylaxis, cardiac arrest, abdominal crams, vertigo, bronchial constriction, utricaria , gangrene.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Vasopressin is indicated for prevention and treatment of postoperative abdominal distention, in abdominal roentgenography to dispel interfering gas shadows, and in diabetes insipidus.
- Vasopressin may be administered intramuscularly or subcutaneously.
- Ten units of vasopressin (0.5 mL) will usually elicit full physiologic response in adult patients; 5 units will be adequate in many cases. Vasopressin should be given intramuscularly at three- or four-hour intervals as needed. The dosage should be proportionately reduced for children.
- When determining the dose of vasopressin for a given case, the following should be kept in mind.
- It is particularly desirable to give a dose not much larger than is just sufficient to elicit the desired physiologic response.  Excessive doses may cause undesirable side effects - blanching of the skin, abdominal cramps, nausea - which, though not serious, may be alarming to the patient. Spontaneous recovery from such side effects occurs in a few minutes. It has been found that one or two glasses of water given at the time vasopressin is administered reduce such symptoms.
- In the average postoperative adult patient, give 5 units (0.25 mL) initially, increase to 10 units (0.5 mL) at subsequent injections if necessary. It is recommended that vasopressin be given intramuscularly and that injections be repeated at three- or four-hour intervals as required. Dosage to be reduced proportionately for children.
- Vasopressin used in this manner will frequently prevent or relieve postoperative distension. These recommendations apply also to distention complicating pneumonia or other acute toxemias.
- For the average case, two injections of 10 units each (0.5 mL) are suggested. These should be given two hours and one-half hour, respectively, before films are exposed. Many roentgenologists advise giving an enema prior to the first dose of vasopressin.
- Vasopressin may be given by injection or administered intranasally on cotton pledgets, by nasal spray, or by dropper. The dose by injection is 5 to 10 units (0.25 to 0.5 mL) repeated two or three times daily as needed. When vasopressin is administered intranasally by spray or on pledgets, the dosage and interval between treatments must be determined for each patient.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Vasopressin injection in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Vasopressin injection in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Vasopressin injection in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Vasopressin injection in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Vasopressin injection in pediatric patients.

# Contraindications
- Anaphylaxis or hypersensitivity to the drug or its components.

# Warnings
- This drug should not be used in patients with vascular disease, especially disease of the coronary arteries, except with extreme caution. In such patients, even small doses may precipitate anginal pain, and with larger doses, the possibility of myocardial infarction should be considered.
- Vasopressin may produce water intoxication. The early signs of drowsiness, listlessness, and headaches should be recognized to prevent terminal coma and convulsions.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Vasopressin injection Clinical Trials Experience in the drug label.

## Postmarketing Experience
- Local or systemic allergic reactions may occur in hypersensitive individuals. The following side effects have been reported following the administration of vasopressin.
- Anaphylaxis (cardiac arrest and/or shock) has been observed shortly after injection of vasopressin.
- Cardiac arrest, circumoral pallor, arrhythmias, decreased cardiac output, angina, myocardial ischemia, peripheral vasoconstriction and gangrene.
- Abdominal cramps, nausea, vomiting, passage of gas
- Tremor, vertigo, pounding in head.
- Bronchial constriction.
- Sweating, urticaria, cutaneous gangrene.

# Drug Interactions
- The following drugs may potentiate the antidiuretic effect of vasopressin when used concurrently: carbamazepine; chlorpropamide; clofibrate; urea; fludrocortisone; tricyclic antidepressants.
- The following drugs may decrease the antidiuretic effect of vasopressin when used concurrently: demeclocyline; norepinephrine; lithium; heparin, alcohol.
- Ganglionic blocking agents may produce a marked increase in sensitivity to the pressor effects of vasopressin.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
- Animal reproduction studies have not been conducted with vasopressin. It is also not known whether vasopressin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Vasopressin should be given to a pregnant woman only if clearly needed.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Vasopressin injection in women who are pregnant.

### Labor and Delivery
- Doses of vasopressin sufficient for an antidiuretic effect are not likely to produce tonic uterine contractions that could be deleterious to the fetus or threaten the continuation of the pregnancy.

### Nursing Mothers
- Caution should be exercised when vasopressin is administered to a nursing woman.

### Pediatric Use
There is no FDA guidance on the use of Vasopressin injection with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Vasopressin injection with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Vasopressin injection with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Vasopressin injection with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Vasopressin injection in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Vasopressin injection in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Vasopressin injection in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Vasopressin injection in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Intramuscular
- Subcutaneous
- Intranasal

### Monitoring
There is limited information regarding Monitoring of Vasopressin injection in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Vasopressin injection in the drug label.

# Overdosage
- Water intoxication may be treated with water restriction and temporary withdrawal of vasopressin until polyuria occurs.
- Severe water intoxication may require osmotic diuresis with mannitol, hypertonic dextrose, or urea alone or with furosemide.

# Pharmacology

## Mechanism of Action
- The antidiuretic action of vasopressin is ascribed to increasing reabsorption of water by the renal tubules.
- Vasopressin can cause contraction of smooth muscle of the gastrointestinal tract and of all parts of the vascular bed, especially the capillaries, small arterioles and venules with less effect on the smooth musculature of the large veins. The direct effect on the contractile elements is neither antagonized by adrenergic blocking agents nor prevented by vascular denervation.

## Structure
- Vasopressin Injection, USP is a sterile, aqueous solution of synthetic vasopressin (8-L-arginine vasopressin) of the posterior pituitary gland for intramuscular or subcutaneous use. It is substantially free from the oxytocic principle and is standardized to contain 20 pressor units/mL. Each mL contains: Vasopressin 20 units, Sodium Chloride 9 mg, Chlorobutanol 0.5% (as a preservative), Water for Injection q.s. pH (range 2.5 - 4.5) adjusted with Acetic Acid. The structural formula is:

## Pharmacodynamics
- The majority of a dose of vasopressin is metabolized and rapidly destroyed in the liver and kidneys. Vasopressin has a plasma half-life of about 10 to 20 minutes. Approximately 5% of a subcutaneous dose of vasopressin is excreted in urine unchanged after four hours.

## Pharmacokinetics
- Following subcutaneous or intramuscular administration of vasopressin injection, the duration of antidiuretic activity is variable but effects are usually maintained for 2-8 hours.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Vasopressin injection in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Vasopressin injection in the drug label.

# How Supplied
- Vasopressin Injection, USP 20 units/mL is supplied as follows:
- For intramuscular or subcutaneous use:
- NDC 0517-0510-25   10 units per 0.5 mL multiple dose vial         Boxes of 25
- NDC 0517-1020-25   20 units per 1 mL multiple dose vial            Boxes of 25
- NDC 0517-0410-10   200 units per 10 mL multiple dose vial        Boxes of 10

## Storage
- Store below 23C (73F). Do not freeze.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Vasopressin injection in the drug label.

# Precautions with Alcohol
- Alcohol-Vasopressin injection interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- VASOPRESSIN 

# Look-Alike Drug Names
- A  B

# Drug Shortage Status

# Price