Pitressin

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.

For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact JHP at 1-866-923-2547 or MEDWATCH at 1-800-FDA-1088 (1- 800-332-1088) or http://www.fda.gov/medwatch/.

You should not receive this medication if you have a chronic kidney condition such as Bright's disease.

Before receiving vasopressin, tell your doctor if you are allergic to any drugs, or if you have:

• asthma;
• kidney disease;
• congestive heart failure;
• coronary artery disease, hardening of the arteries;
• circulation problems;
• migraine headaches; or
• epilepsy or other seizure disorder.

If you have any of these conditions, you may not be able to receive vasopressin, or you may need dosage adjustments or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Vasopressin may pass into breast milk and could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

Your doctor or pharmacist has information about vasopressin written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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• Cardinal Health, Inc.

• JHP Pharmaceuticals, LLC.

• Monarch Pharmaceuticals, Inc.

Pitressin is part of the drug class:

• Vasopressin and analogues

It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

Vasopressin may cause allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• 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

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach cramps
• feeling of constant movement of self or surroundings
• pale skin
• passing of gas
• pounding in the head
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• sweating
• trembling or shaking of the hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Applies to vasopressin: injection solution

Along with its needed effects, vasopressin (the active ingredient contained in Pitressin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking vasopressin:

• 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

Some side effects of vasopressin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach cramps
• feeling of constant movement of self or surroundings
• pale skin
• passing of gas
• pounding in the head
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• sweating
• trembling or shaking of the hands or feet

Applies to vasopressin: injectable solution, intravenous solution

Cardiovascular

Cardiovascular side effects have included cardiac arrest, circumoral pallor, decreased cardiac output, increased blood pressure, bradycardia, arrhythmias, venous thrombosis, myocardial ischemia, peripheral vasoconstriction at higher doses, and angina. The overall incidence of cardiovascular complications has been estimated to be 25%.[Ref]

Due to vasopressin-induced increased coronary and systemic vascular resistance, the drug can cause myocardial ischemia, reduced cardiac output, and systemic hypertension. Some clinicians choose to give nitroglycerin and/or isoproterenol during vasopressin administration to reduce the likelihood of some of these problems.

Cardiovascular side effects related to the pressor activity of vasopressin may be important in patients with a history of coronary artery or peripheral vascular disease. The vascular beds most affected (in decreasing order) are iliac, mesenteric, coronary, and renal. Cardiac arrest, circumoral pallor, arrhythmias (usually bradycardia; rarely torsades de pointes), decreased cardiac output, angina pectoris, myocardial ischemia, peripheral vasoconstriction and gangrene have been reported. Intoxication may result in water retention and/or hyponatremia, which can be effectively treated by withholding therapy and water restriction.[Ref]

Dermatologic

Dermatologic side effects of severe vasopressin-induced peripheral vasoconstriction have included sweating, alopecia, cutaneous necrosis or infarcts, and gangrene. These problems were more likely at the site of administration.[Ref]

While cutaneous necrosis has most commonly been associated with extravasation at or proximal to IV catheter sites, several cases of necrosis have been reported at sites distant from direct IV flow.

Rare cases of subcutaneous calcifications have been associated with the use of pitressin tannate, an oil-based injectable product, which is no longer marketed in the US.[Ref]

Hypersensitivity

Diabetes insipidus does not result from spontaneously occurring antibodies to vasopressin (the active ingredient contained in Pitressin) Such antibodies can develop during treatment with vasopressin, however, and can cause resistance to its diuretic effect.[Ref]

Hypersensitivity side effects have included rare cases of severe anaphylaxis and urticaria.[Ref]

Gastrointestinal

Mesenteric artery thrombosis (MAT) with retrograde propagation of the thrombus into the portal vein has been associated with selective arterial drug infusions for control of upper gastrointestinal hemorrhage. In some cases, small bowel necrosis with or without bacterial peritonitis secondary to thrombosis of the superior mesenteric artery has resulted. Because up to 10% of patients with liver cirrhosis develop portal vein thrombosis, an association between intra-arterial vasopressin (the active ingredient contained in Pitressin) and MAT may be coincidental.[Ref]

Gastrointestinal side effects have included abdominal cramps, nausea, vomiting, diarrhea, and flatus in 18% of patients. Unexplained abdominal pain associated with hemodynamic instability in patients receiving vasopressin has rarely been associated with mesenteric or portal vein thrombosis and bowel necrosis.[Ref]

Renal

Renal side effects have included reports of myoglobinuria with acute renal failure, which has been attributed to vasopressin-induced skeletal muscle ischemia in two patients.[Ref]

Nervous system

Nervous system side effects have included tremor, vertigo, and headache (usually described as a "pounding head").[Ref]

Respiratory

Respiratory side effects have included rare cases of bronchial constriction, pulmonary edema, and adult respiratory distress syndrome (ARDS).[Ref]

Some side effects of Pitressin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

There are no data on the excretion of vasopressin into human milk. Patients receiving vasopressin or other structurally related polypeptides have been reported to breast-feed without apparent adverse effects on the nursing infant. The manufacturer recommends that caution be used when administering vasopressin to nursing women.