Vasopressin

Vasopressin clasification

ADH Antidiuretic hormone ,is also called commonly arginine vasopressin. It's a hormone made by the hypothalamus in the brain and stored in the posterior pituitary gland. It tells your kidneys how much water to conserve. ADH constantly regulates and balances the amount of water in your blood. is a nine amino acid peptide secreted from the posterior pituitary. Produced in the Hypothalamus Within hypothalamic neurons, the hormone is packaged in secretory vesicles with a carrier protein called neurophysin, and both are released upon hormone secretion. Antidiuretic hormone, also known as vasopressin is a hormone released by the posterior pituitary. It is important mainly for its actions on the kidneys where it increases the re-absorption of water. Vasopressin is also a powerful vasoconstrictor. Its effects are through two types of receptors, V1 and V2. Water retention is mediated through V2 receptors, occurs at low plasma concentrations of vasopressin and is due to activation of adenylate cyclase and increased cAMP production in the collecting ducts of the nephrons. It increases the permeability of the membrane to water. Vasopressin causes contraction of smooth muscle, mainly in the cardiovascular system. Vasocontriction occurs by mediation of V1 receptors and requires higher concentrations if vasopressin.

Vasopressin systemic is used in the treatment of:

Abdominal Distension Prior to Abdominal X-ray Abdominal Radiological Procedure Asystole Diabetes Insipidus Esophageal Varices with Bleeding Gastrointestinal Hemorrhage Postoperative Gas Pains Ventricular Fibrillation Ventricular Tachycardia

DRUG INTERACTIONS

Amitriptyline: (Minor) Tricyclic antidepressants have been implicated in the syndrome of inappropriate secretion of antidiuretic hormone and can enhance the antidiuretic effect of vasopressin. Amitriptyline; Chlordiazepoxide: (Minor) Tricyclic antidepressants have been implicated in the syndrome of inappropriate secretion of antidiuretic hormone and can enhance the antidiuretic effect of vasopressin. Carbamazepine: (Minor) Carbamazepine may cause additive hyponatremia or antidiuretic effects when combined with vasopressin, ADH. Chlorpropamide: (Minor) Chlorpropamide has been implicated in the syndrome of inappropriate secretion of antidiuretic hormone and can enhance the antidiuretic effect of vasopressin. Clomipramine: (Minor) Tricyclic antidepressants have been implicated in the syndrome of inappropriate secretion of antidiuretic hormone and can enhance the antidiuretic effect of vasopressin. Corticorelin, Ovine: (Major) The coadministration of corticorelin, ovine and vasopressin, ADH has resulted in a synergistic effect on the secretion of corticotropin, with a less marked synergistic response on cortisol secretion. The concomitant use of corticorelin and vasopressin should be avoided. Demeclocycline: (Major) Demeclocycline reduces the antidiuretic response to vasopressin by interfering with the cellular action of ADH at the collecting ducts of the nephron. Desipramine: (Minor) Tricyclic antidepressants have been implicated in the syndrome of inappropriate secretion of antidiuretic hormone and can enhance the antidiuretic effect of vasopressin. Desmopressin: (Moderate) Although the pressor activity of desmopressin is very low compared to its antidiuretic activity, large doses of desmopressin should be used with other pressor agents like vasopressin, ADH only with careful patient monitoring. Doxepin: (Minor) Tricyclic antidepressants have been implicated in the syndrome of inappropriate secretion of antidiuretic hormone and can enhance the antidiuretic effect of vasopressin. Fludrocortisone: (Minor) Fludrocortisone can enhance the antidiuretic effect of vasopressin. Heparin: (Minor) Heparin can decrease the antidiuretic response to vasopressin. Imipramine: (Minor) Tricyclic antidepressants have been implicated in the syndrome of inappropriate secretion of antidiuretic hormone and can enhance the antidiuretic effect of vasopressin. Lithium: (Major) Lithium reduces the antidiuretic response to vasopressin by interfering with the cellular action of ADH at the collecting ducts of the nephron. Nortriptyline: (Minor) Tricyclic antidepressants have been implicated in the syndrome of inappropriate secretion of antidiuretic hormone and can enhance the antidiuretic effect of vasopressin. Perphenazine; Amitriptyline: (Minor) Tricyclic antidepressants have been implicated in the syndrome of inappropriate secretion of antidiuretic hormone and can enhance the antidiuretic effect of vasopressin. Protriptyline: (Minor) Tricyclic antidepressants have been implicated in the syndrome of inappropriate secretion of antidiuretic hormone and can enhance the antidiuretic effect of vasopressin. Tricyclic antidepressants: (Minor) Tricyclic antidepressants have been implicated in the syndrome of inappropriate secretion of antidiuretic hormone and can enhance the antidiuretic effect of vasopressin. Trimipramine: (Minor) Tricyclic antidepressants have been implicated in the syndrome of inappropriate secretion of antidiuretic hormone and can enhance the antidiuretic effect of vasopressin. Urea: (Minor) Systemic urea can potentiate the antidiuretic effect of vasopressin, ADH when both drugs are used concurrently. Dosage adjustments may be required.

CONTRAINDICATIONS:

Anaphylaxis or hypersensitivity to the drug or its components.

Nursing Process Focus: Patients Receiving Vasopressin (Petressin)

Assessment Prior to administration: • Obtain complete health history including allergies, drug history and possible drug interactions. • Assess for presence/history of diabetes insipidus, antidiuretic hormone deficiency. • Obtain urine specific gravity. Potential Nursing Diagnoses • Risk for Imbalanced Fluid Volume, related to patient response to drug therapy • Ineffective Tissue Perfusion, related to vasoconstriction • Decreased Cardiac Output, related to vasoconstriction • Risk for Injury, related to side effect of drug therapy • Deficient Knowledge, related to drug action and side effects Implementation: Interventions and (Rationales) Patient Education/Discharge Planning *Monitor capillary refill in the extremities of the patient. (The vasoconstricting effects of this medication have caused gangrene in extremities. Use caution when administering this medication to patients with preexisting vascular disease.) *Instruct patient to notify health care provider of any tingling, pain or lack of sensation in an extremity. *Periodically monitor urine specific gravity during therapy. (Low specific gravity indicates lack of response to the medication.) *Instruct patient to check urine specific gravity and report significant changes to the health care provider. *Monitor vital signs, especially pulse and blood pressure. (The medication has vasoconstricting effect.) *Instruct patient to take own pulse and monitor for any irregularities. *Monitor cardiovascular status. (The use of this medication is contraindicated in patients with preexisting heart disease. It should be used cautiously in elderly patients because of the possibility of undiagnosed heart disease.) *Advise patient to report to the health care provider any irregular heart beats, severe headaches, or dizziness. *Monitor weight and intake and output. (The effects of this drug may cause excess water retention. Lack of response to this medication will be shown by loss of weight and output greater than intake.) Advise patient: • to keep an accurate record of both intake and output. • to weigh regularly and report weight gain or loss to the health care provider. • to take in fewer fluids than prior to starting this medication to help prevent the development of water intoxication. *Monitor the neurological status of the patient. (Water intoxication may be first indicated by Advise patient: • to report any excess sleepiness, dizziness orheadache accompanied by confusion and drowsiness.) confusion to the health care provider. • to use caution when driving or operating heavy machinery until response to the medication is known. Evaluation of Outcome Criteria Evaluate the effectiveness of drug therapy by confirming that patient goals and expected outcomes have been met (see "Planning")

Geriatric

Clinical studies involving vasopressin did not contain sufficient numbers of patients aged > 65 years to determine if they respond differently than younger patients. Reported clinical experiences with vasopressin have not identified differences in response between geriatric and younger patients. In general, dose selection should initiate at the low end of the dosing range, taking into account the greater frequency of decreased hepatic, renal, and cardiac function, and of concomitant disease or drug use.

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.

Adverse Effects

Due to potent vasoconstrictor action, there is always a concern that vasopressin therapy may impair capillary blood flow and tissue oxygenation. Safety data of vasopressin in pediatric patients are limited and a number of adverse effects were reported depending upon dose and duration, underlying disease process, co-morbidities, and concurrent use of other vasopressors. Complications are more common when vasopressin is co-administered with moderate to high dose of norepinephrine . Cardiac complications include coronary ischemia, myocardial infarction, ventricular arrhythmias (ventricular tachycardia and asystole), and severe hypertension . Other reported adverse effects include severe GI ischemia leading to bowel necrosis, hyponatremia, anaphylaxis, bronchospasm, urticaria, angioedema, rashes, venous thrombosis, local irritation at injection site, and peripheral vasoconstriction leading to cutaneous gangrene

Laboratory Tests

Electrocardiograms (ECG) and fluid and electrolyte status determinations are recommended at periodic intervals during therapy.

Abdominal Roentgenography

For the average case, two injections of 10 units (0.5 mL) each 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 Injection

DOSAGE & INDICATIONS

For the treatment of central diabetes insipidus. Intramuscular or Subcutaneous dosage Adults 5 to 10 units IM or subcutaneously every 3 to 4 hours or 2 to 3 times per day as needed. Infants, Children, and Adolescents 2.5 to 10 units IM or subcutaneously 2 to 4 times per day. The FDA-approved adult dosage is 5 to 10 units IM or subcutaneously every 3 to 4 hours or 2 to 3 times per day as needed with recommendation to reduce the dose proportionately for pediatric patients. Intranasal dosage Adults Intranasal dosages (on cotton pledgets or topically as a spray) must be determined for each patient individually. Children and Adolescents Intranasal dosages (on cotton pledgets or topically as a spray) must be determined for each patient individually. Intravenous dosage (continuous infusion)† Adults 0.0005 unit/kg/hour (0.5 milliunit/kg/hour) by continuous IV infusion; titrate by 0.0005 unit/kg/hour (0.5 milliunit/kg/hour) every 5 to 10 minutes to achieve a urine output of approximately 100 mL/hour. Infusion rates more than 0.01 unit/kg/hour (10 milliunits/kg/hour) are rarely required. However, reported doses are variable; weight-based infusion rates ranging from 0.00025 to 0.04 unit/kg/hour (0.25 to 4 milliunits/kg/hour) have been recommended and standard infusions of 2.5 units/hour (0.0025 milliunit/hour) have been used. Infants, Children, and Adolescents 0.0005 unit/kg/hour (0.5 milliunit/kg/hour) by continuous IV infusion; titrate by 0.0005 unit/kg/hour (0.5 milliunit/kg/hour) every 5 to 10 minutes until urine output is decreased to less than 2 mL/kg/hour. Infusion rates more than 0.01 unit/kg/hour (10 milliunits/kg/hour) are rarely required. For the treatment of hypotension in patients with post-cardiotomy shock or septic shock in patients who remain hypotensive despite fluids and catecholamines. For patients with post-cardiotomy shock. Intravenous dosage Adults Initially, 0.03 units/minute IV. Titrate by 0.005 units/minute every 10 to 15 minutes until target blood pressure is achieved to a maximum of 0.1 units/minute. After target blood pressure is maintained for 8 hours without the use of catecholamines, taper by 0.005 units/minute every 1 hour as tolerated to maintain target blood pressure. For patients with septic shock. Intravenous dosage Adults Initially, 0.01 units/minute IV. Titrate by 0.005 units/minute every 10 to 15 minutes until target blood pressure is achieved to a maximum of 0.07 units/minute. After target blood pressure is maintained for 8 hours without the use of catecholamines, taper by 0.005 units/minute every 1 hour as tolerated to maintain target blood pressure. Septic shock clinical practice guidelines recommend adding vasopressin (up to 0.03 units/minute) to norepinephrine to raise mean arterial pressure (MAP) to target or to decrease norepinephrine dosage. Target a MAP of 65 mmHg initially. Titrate to an endpoint reflecting perfusion; reduce rate or discontinue the vasopressor if worsening hypotension or arrhythmias occur. Vasopressin is not recommended as single initial vasopressor. Reserve vasopressin rates higher than 0.03 to 0.04 units/minute for salvage therapy (i.e., failure to achieve adequate MAP with other vasopressors). For the treatment of variceal bleeding† in patients with ruptured esophageal varices† or upper GI bleeding† or hemorrhage† in patients with peptic ulcer disease, esophagogastritis, esophageal laceration, acute gastritis, colitis associated with Behcet's disease, colonic diverticulosis, small intestinal typhoid infection, Mallory-Weiss syndrome, or intestinal perforation. Intravenous dosage† Adults Initially, 20 units IV bolus followed by 0.2—0.4 units/minute continuous IV infusion. Doses can be increased to 0.9 units/minute if necessary. Children Initially, 0.002—0.005 units/kg/minute by continuous IV infusion; titrate dose as needed. Maximum dose is 0.01 units/kg/minute. If bleeding stops for 12 hours, then taper off over 24—48 hours. Intra-arterial dosage Adults 0.1—0.5 units/minute by continuous intra-arterial infusion. The vasoconstrictive and clotting responses can be assessed by angiography, portal pressures, or hepatic wedge pressures after 20—30 minutes. After 24 hours, tapering of the dose according to patient response is recommended. For the treatment of cardiac arrest† including ventricular asystole† and pulseless electrical activity† (PEA) during cardiopulmonary resuscitation† (CPR). Intravenous Adults 20 units IV per CPR cycle (Max: 100 units) plus epinephrine IV for up to 5 CPR cycles and methylprednisolone IV once intra-arrest followed by stress-dose hydrocortisone IV beginning 4 hours after resuscitation for in-hospital cardiac arrest (IHCA) requiring vasopressors. Combined vasopressin, epinephrine, and methylprednisolone during CPR and stress-dose hydrocortisone postresuscitation improved survival to hospital discharge with favorable neurological status vs. epinephrine and placebo. Clinical practice guidelines no longer recommend vasopressin as the sole vasoactive drug during CPR as vasopressin offers no advantage as a substitute for epinephrine. The combination of intra-arrest vasopressin, epinephrine, and methylprednisolone and post-arrest hydrocortisone may be considered in IHCA; however, further studies are needed before suggesting routine use. †Indicates off-label use

Contraindications

General Information Vasopressin is contraindicated in patients with a known hypersensitivity to 8-L-arginine vasopressin or chlorobutanol. Coronary artery disease, heart failure Vasopressin should be administered with caution to patients with impaired cardiac response, like heart failure, as use in these patients may worsen cardiac output. Similarly, vasopressin should be used with caution or avoided, if possible, in patients with vascular disease, including coronary artery disease, as even small doses may precipitate anginal pain; with larger doses, the possibility of myocardial infarction should be considered. Renal disease Vasopressin is contraindicated for use in patients with chronic nephritis accompanied by nitrogen retention. The hormone should not be administered to patients with this renal disease until acceptable nitrogen concentrations are attained. Water intoxication Patients receiving vasopressin should be monitored for signs of water intoxication which include listlessness, drowsiness, confusion, and headache. Vasopressin-induced water intoxication can lead to seizures, coma, and death. Migraine, seizure disorder Use vasopressin with caution in patients with seizure disorder or migraine. A rapid addition to extracellular water may exacerbate these conditions. Asthma Use vasopressin with caution in patients with asthma. A rapid addition to extracellular water may exacerbate this condition.

Generic names of Vasopressin

Generic Name: vasopressin (VAY soe PRES in)

Abdominal Distention

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 Injection be given IM and that injections be repeated at three or four hour intervals as required. Dosage to be reduced proportionately for pediatric patients. Vasopressin Injection used in this manner will frequently prevent, or relieve, postoperative distention. These recommendations apply also to distention complicating pneumonia or other acute toxemias.

Common side effects of Vasopressin

Incidence Not Known Abdominal or stomach pain, usually after eating a meal agitation back pain chest pain or discomfort chest tightness or heaviness coma confusion constipation convulsions cough decreased urine output depression diarrhea difficulty with swallowing dilated neck veins dizziness extreme fatigue fainting fast or irregular heartbeat headache hives, itching, or rash hostility increased thirst irregular breathing irritability lethargy lightheadedness, dizziness, or fainting muscle pain or cramps muscle twitching nausea or vomiting no blood pressure or pulse pain in the shoulders, arms, jaw, or neck pale, cool, or blotchy skin on the arms or legs puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue rapid weight gain seizures slow or irregular heartbeat stopping of heart stupor sweating swelling of the face, ankles, fingers, feet, or lower legs troubled breathing unconsciousness unusual tiredness or weakness weak or absent pulse in the arms or legs

Breast-feeding

It is not known if vasopressin is present in human milk; however, oral absorption by a nursing infant is unlikely because vasopressin is rapidly degraded in the gastrointestinal tract. Consider advising a breast-feeding woman to pump and discard breast milk for 1.5 hours after receiving vasopressin. Women treated with vasopressin for diabetes insipidus have been reported to breast-feed without negative effects in the infant. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

ADVERSE REACTIONS

Local or systemic allergic reactions may occur in hypersensitive individuals. The following side effects have been reported following the administration of Vasopressin: Body as a Whole Anaphylaxis (cardiac arrest and/or shock) has been observed shortly after injection of Vasopressin. Cardiovascular Cardiac arrest, circumoral pallor, arrhythmias, decreased cardiac output, angina, myocardial ischemia, peripheral vasoconstriction, and gangrene. Gastrointestinal Abdominal cramps, nausea, vomiting, passage of gas. Nervous System Tremor, vertigo, "pounding" in head. Respiratory Bronchial constriction. Skin and Appendages Sweating, urticaria, cutaneous gangrene. 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. Severe seizures / Delayed / Incidence not known coma / Early / Incidence not known water intoxication / Delayed / Incidence not known anuria / Delayed / Incidence not known cardiac arrest / Early / Incidence not known anaphylactic shock / Rapid / Incidence not known angioedema / Rapid / Incidence not known myocardial infarction / Delayed / Incidence not known bradycardia / Rapid / Incidence not known AV block / Early / Incidence not known thrombosis / Delayed / Incidence not known Moderate confusion / Early / Incidence not known hyponatremia / Delayed / Incidence not known wheezing / Rapid / Incidence not known peripheral vasoconstriction / Rapid / Incidence not known angina / Early / Incidence not known hypertension / Early / Incidence not known Mild vertigo / Early / Incidence not known tremor / Early / Incidence not known headache / Early / Incidence not known drowsiness / Early / Incidence not known weight gain / Delayed / Incidence not known urticaria / Rapid / Incidence not known premature atrial contractions (PACs) / Early / Incidence not known pallor / Early / Incidence not known nausea / Early / Incidence not known diarrhea / Early / Incidence not known flatulence / Early / Incidence not known eructation / Early / Incidence not known abdominal pain / Early / Incidence not known vomiting / Early / Incidence not known hyperhidrosis / Delayed / Incidence not known

MECHANISM OF ACTION

Mechanism of Action: Vasopressin exerts its antidiuretic effects by increasing the resorption of water at the renal collecting ducts. Subsequently, urinary flow is reduced and urine osmolality is increased, thereby maintaining serum osmolality within an acceptable physiological range. At the cellular level, vasopressin stimulates adenylate cyclase activity. Increased adenylate cyclase activity increases the levels of cyclic adenosine monophosphate (cAMP) in the distal convoluted tubule and the collecting duct, thereby enhancing the permeability of the membrane to free water. Physiologic doses of vasopressin are administered to patients with neurohypophyseal diabetes insipidus in order to conserve the large amounts of water that are normally lost in the urine. In contrast to desmopressin, vasopressin induces the release of adrenocorticotropic hormone, increases plasma cortisol concentrations, and exhibits vasopressive and contractile action on visceral smooth muscle.Vasopressin stimulates the contraction of vascular smooth muscle in coronary, splanchnic, GI, pancreatic, skin, and muscular vascular beds. This effect is most prominent in the capillaries, small arterioles, and venules with less effect on the smooth musculature of large veins. Neither adrenergic agents nor vascular denervation prevents the direct effect of vasopressin on smooth muscle contractile elements. This vasoconstrictive property has been used in managing massive GI hemorrhage; however, vasopressin is no longer indicated for this purpose.

pediatric doses

Nocturnal enuresis DDAVP Intranasally: 5-20 μg (in children > 6 years)Orally: 0.2-0.4 mg/d at bedtime Central diabetes insipidus DDAVP Intranasally: 5-30 μg/d Q 8-12 hr Orally: 0.05-0.2 mg/d Q 8-12 hr IV/SC: 2-4 μg/d Q 8-12 hr AVP IM/SC: 2.5-10U/dose 2-4 times/day IV infusion: 0.0005 U/kg/hr initially, double every 30 min upto 0.01 U/kg/hr Hemophilia-A, von Willebrand DDAVP Intranasally: <50 kg - 150 μg; disease, platelet dysfunctions >50 kg - 300 μg IV: 0.3 μg/kg (>3 months), repeat if needed, give 30 min before procedure Bleeding esophageal varices AVP Initial IV bolus 0.3 U/kg (maximum: 20 U) followed by infusion: 0.002-0.01 U/kg/min TP IV: 10 - 20 μg/kg every 4 - 6 hrs or 1 - 2 mg Q 4 - 6 hr (in adolescents & adults) Refractory vasodilatory shock AVP IV infusion: 0.0005-0.002 U/kg/min (variable, from as low as 0.00005 U/kg/min upto 0.008 U/kg/min) TP IV bolus: 10 - 20 μg/kg every 4 - 6 hrs IV infusion: 10 μg/kg/hr Cardiac arrest AVP IV bolus: 0.4 U/kg TP IV bolus: 10 - 20 μg/kg

Vasopressin: Classification

Nonadrenergic vasoconstrictor Vasopressor, Hormone Vasopressin is a man-made form of a hormone called "anti-diuretic hormone" that is normally secreted by the pituitary gland.

HOW SUPPLIED

Pitressin/Vasopressin/Vasostrict Intramuscular Inj Sol: 1mL, 20U Pitressin/Vasopressin/Vasostrict Subcutaneous Inj Sol: 1mL, 20U Vasostrict Intravenous Inj Sol: 1mL, 20U

PREGNANCY AND LACTATION CONT.

Pregnancy Vasopressin is classified as FDA pregnancy category C. No adequate studies have been conducted in pregnant women. It is not known if vasopressin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Due to increased drug clearance in the second and third trimesters, the dose of vasopressin may need to be increased to doses exceeding 0.1 units/minute in post-cardiotomy shock and 0.07 units/minute in septic shock. While the antidiuretic doses of vasopressin are not likely to produce tonic uterine contractions, doses for shock may do so and could threaten the pregnancy. Vasopressin should be used during pregnancy only when clearly needed. It is not known if vasopressin is present in human milk; however, oral absorption by a nursing infant is unlikely because vasopressin is rapidly degraded in the gastrointestinal tract. Consider advising a breast-feeding woman to pump and discard breast milk for 1.5 hours after receiving vasopressin. Women treated with vasopressin for diabetes insipidus have been reported to breast-feed without negative effects in the infant. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA. 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. Nursing Mothers Caution should be exercised when Vasopressin is administered to a nursing woma

HOW SUPPLIED:

Product No. NDC No. 30201 63323-302-01 Vasopressin Injection, USP 20 units, 1 mL in a 2 mL flip-top vial in packages of 25.

Information for Patients

Side effects such as blanching of skin, abdominal cramps, and nausea may be reduced by taking 1 or 2 glasses of water at the time of Vasopressin administration. These side effects are usually not serious and probably will disappear within a few minutes.

Interactions

Some vitamines and herbals may interact

label 20 U

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Vial stoppers do not contain natural rubber late

CLINICAL PHARMACOLOGY:

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. Following subcutaneous or intramuscular administration of Vasopressin injection, the duration of antidiuretic activity is variable but effects are usually maintained for 2 to 8 hours. 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 4 hours.

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.

Adult ranges

Usual Adult Dose for Hypotension Post-Cardiotomy Shock: -Initial dose: 0.03 units/min IV infusion -If target blood pressure response is not achieved: titrate up by 0.005 units/min at 10 to 15 minute intervals -Maximum dose: 0.1 units/min Septic Shock: -Initial dose: 0.01 units/min IV infusion -If target blood pressure response is not achieved: titrate up by 0.005 units/min at 10 to 15 minute intervals -Maximum dose: 0.07 units/min Comments: -After target blood pressure has been maintained for 8 hours without use of catecholamines, taper by 0.005 units/min every hour as tolerated to maintain target blood pressure. -The goal of treatment is optimization of perfusion to critical organs, however, aggressive treatment can compromise perfusion of organs; titrate to the lowest dose compatible with a clinically acceptable response. Use: To increase blood pressure in patients with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines Usual Adult Dose for Shock Post-Cardiotomy Shock: -Initial dose: 0.03 units/min IV infusion -If target blood pressure response is not achieved: titrate up by 0.005 units/min at 10 to 15 minute intervals -Maximum dose: 0.1 units/min Comments: -May be administered intranasally on cotton pledgets, by nasal spray, or by dropper as well; the dose and interval between treatments must be determined for each patient. -This drug has not been found by the by the US FDA to be safe and effective and the labeling has not been approved by the US FDA. Usual Adult Dose for Abdominal Distension 5 units (0.25 mL) IM or subcutaneously initially; increase to 10 units (0.5 mL) at subsequent injections if necessary and repeated at 3 to 4 hour intervals as required Comments: -This drug has not been found by the by the US FDA to be safe and effective and the labeling has not been approved by the US FDA. Usual Adult Dose for Abdominal Radiological Procedure 2 injections of 10 units (0.5 mL) each IM or subcutaneously given 2 hours and one-half hour, respectively, before films are exposed Comments: -This drug has not been found by the by the US FDA to be safe and effective and the labeling has not been approved by the US FDA. -Some roentgenologists advise giving an enema prior to the first injection

DOSAGE AND ADMINISTRATION:

Vasopressin Injection may be administered IM or subcutaneously. Ten units (0.5 mL) of Vasopressin Injection will usually elicit full physiologic response in adult patients; 5 units (0.25 mL) will be adequate in many cases. Vasopressin Injection should be given IM at three or four hour intervals as needed. The dosage should be proportionately reduced for pediatric patients. (For an additional discussion of dosage, consult the sections below.) When determining the dose of Vasopressin Injection 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 Injection is administered reduces such symptoms.

Diabetes Insipidus

Vasopressin Injection 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 Injection 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 paticulate matter and discoloration prior to administration, whenever solution and container permit.

DESCRIPTION:

Vasopressin Injection, USP is a sterile solution of synthetic Vasopressin of the posterior pituitary gland for intramuscular (IM) or subcutaneous use. It is substantially free from the oxytocic principle and is standardized to contain 20 pressor units/mL. The chemical name is Vasopressin, 8-L-arginine and has the following structural Each mL contains: 20 USP Vasopressin Units, chlorobutanol (anhydrous) 5 mg as preservative; Water for Injection q.s. Glacial acetic acid and/or sodium hydroxide may have been added for pH adjustment (2.4-4.5).

INDICATIONS AND USAGE:

Vasopressin Injection, USP is indicated for prevention and treatment of postoperative abdominal distention, in abdominal roentgenography to dispel interfering gas shadows and in diabetes insipidus.

PHARMACOKINETICS

Vasopressin is administered intramuscularly, intravenously, intra-arterially†, intraosseously†, or subcutaneously. It must be administered parenterally because it is degraded by trypsin in the GI tract. The hormone distributes throughout the extracellular fluid but does not bind to plasma proteins. Vasopressin is degraded primarily in the liver and kidneys, and has a plasma half-life of 10—20 minutes. Approximately 5% of a subcutaneously administered dose is excreted unchanged in the urine within 4 hours. Intramuscular Route The duration of antidiuretic effect following IM administration of vasopressin is approximately 2—8 hours. Subcutaneous Route The duration of antidiuretic effect following SC administration of vasopressin is approximately 2—8 hours.

Pregnancy

Vasopressin is classified as FDA pregnancy category C. No adequate studies have been conducted in pregnant women. It is not known if vasopressin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Due to increased drug clearance in the second and third trimesters, the dose of vasopressin may need to be increased to doses exceeding 0.1 units/minute in post-cardiotomy shock and 0.07 units/minute in septic shock. While the antidiuretic doses of vasopressin are not likely to produce tonic uterine contractions, doses for shock may do so and could threaten the pregnancy. Vasopressin should be used during pregnancy only when clearly needed.

Used for

Vasopressin is used to treat diabetes insipidus, which is caused by a lack of a naturally occurring pituitary hormone in the body. is also used to treat or prevent certain conditions of the stomach after surgery or during abdominal x-rays Vasopressin acts on the kidneys and blood vessels. Vasopressin helps prevent loss of water from the body by reducing urine output and helping the kidneys reabsorb water into the body. Used to prevent or control polyuria, polydipsia, and dehydration in central diabetes insipidus No longer a drug of choice for GI variceal bleeding due to significant risk of ADRs

Precautions

Vasopressin should be used cautiously in the presence of epilepsy, migraine, asthma, heart failure or any state in which a rapid addition to extracellular water may produce hazard for an already overburdened system. Chronic nephritis with nitrogen retention contraindicates the use of Vasopressin until reasonable nitrogen blood levels have been attained.

Physiologic action

Vasopressin, a nonapeptide with a disulphide bridge between two cysteines, is synthesized in the magnocellular neurons of the hypothalamic paraventricular and supraoptic nuclei as a prohormone "preprovasopressin". It is degraded to provasopressin before reaching posterior pituitary along the neuronal axons, and is finally converted to the active vasopressin releasing neurophysin-II and co-peptin was one of the first synthesized peptide hormones, used to treat diabetes insipidus (DI) and gastrointestinal (GI) hemorrhage AVP has two principle sites of action: the kidney and blood vessels.

Brand Name:

Vasostrict, Pitressin Product(s) containing vasopressin: vasopressin systemic

Drug class(es):

antidiuretic hormones

Study

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Where is vasopressin released from?

posterior pituitary