FDA Label for Vasostrict
View Indications, Usage & Precautions
- 1 INDICATIONS AND USAGE
- 2.1 PREPARATION OF DILUTED SOLUTIONS
- 2.2 ADMINISTRATION
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5.1 WORSENING CARDIAC FUNCTION
- 6 ADVERSE REACTIONS
- 7.1 CATECHOLAMINES
- 7.2 INDOMETHACIN
- 7.3 GANGLIONIC BLOCKING AGENTS
- 7.4 FUROSEMIDE
- 7.5 DRUGS SUSPECTED OF CAUSING SIADH
- 7.6 DRUGS SUSPECTED OF CAUSING DIABETES INSIPIDUS
- 8.3 NURSING MOTHERS
- 8.4 PEDIATRIC USE
- 8.5 GERIATRIC USE
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12.1 MECHANISM OF ACTION
- 12.2 PHARMACODYNAMICS
- 12.3 PHARMACOKINETICS
- 13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
- 14 CLINICAL STUDIES
- 16 HOW SUPPLIED/STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL – 1 ML VIAL BAG
Vasostrict Product Label
The following document was submitted to the FDA by the labeler of this product Medical Purchasin Solutions, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
1 Indications And Usage
Vasostrict ® is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.
2.1 Preparation Of Diluted Solutions
Dilute Vasostrict ® in normal saline (0.9% sodium chloride) or 5% dextrose in water (D5W) prior to use for intravenous administration. Discard unused diluted solution after 18 hours at room temperature or 24 hours under refrigeration.
Fluid restriction? | Final concentration | Mix | |
---|---|---|---|
Vasostrict ® | Diluent | ||
No |
0.1 units/mL |
2.5 mL (50 units) |
500 mL |
Yes |
1 unit/mL |
5 mL (100 units) |
100 mL |
Inspect parenteral drug products for particulate matter and discoloration prior to use, whenever solution and container permit.
2.2 Administration
The goal of treatment is optimization of perfusion to critical organs, but aggressive treatment can compromise perfusion of organs, like the gastrointestinal tract, whose function is difficult to monitor. The following advice is empirical. In general, titrate to the lowest dose compatible with a clinically acceptable response.
For post-cardiotomy shock, start with a dose of 0.03 units/minute. For septic shock, start with a dose of 0.01 units/minute. If the target blood pressure response is not achieved, titrate up by 0.005 units/minute at 10- to 15-minute intervals. The maximum dose for post-cardiotomy shock is 0.1 units/minute and for septic shock 0.07 units/minute. After target blood pressure has been maintained for 8 hours without the use of catecholamines, taper Vasostrict ® by 0.005 units/minute every hour as tolerated to maintain target blood pressure.
3 Dosage Forms And Strengths
Vasostrict ® (vasopressin injection, USP) is a clear, practically colorless solution for intravenous administration available as 20 units/mL in a single dose vial and 200 units/10 mL (20 units/mL) in a multiple dose vial.
4 Contraindications
Vasostrict ® is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol.
5.1 Worsening Cardiac Function
Use in patients with impaired cardiac response may worsen cardiac output.
6 Adverse Reactions
The following adverse reactions associated with the use of vasopressin were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Bleeding/lymphatic system disorders: Hemorrhagic shock, decreased platelets, intractable bleeding
Cardiac disorders: Right heart failure, atrial fibrillation, bradycardia, myocardial ischemia
Gastrointestinal disorders: Mesenteric ischemia
Hepatobiliary: Increased bilirubin levels
Renal/urinary disorders: Acute renal insufficiency
Vascular disorders: Distal limb ischemia
Metabolic: Hyponatremia
Skin: Ischemic lesions
7.1 Catecholamines
Use with catecholamines is expected to result in an additive effect on mean arterial blood pressure and other hemodynamic parameters.
7.2 Indomethacin
Use with indomethacin may prolong the effect of Vasostrict ® on cardiac index and systemic vascular resistance [see Clinical Pharmacology (12.3)].
7.3 Ganglionic Blocking Agents
Use with ganglionic blocking agents may increase the effect of Vasostrict ® on mean arterial blood pressure [see Clinical Pharmacology (12.3)].
7.4 Furosemide
Use with furosemide increases the effect of Vasostrict ® on osmolar clearance and urine flow [see Clinical Pharmacology (12.3)].
7.5 Drugs Suspected Of Causing Siadh
Use with drugs suspected of causing SIADH (e.g., SSRIs, tricyclic antidepressants, haloperidol, chlorpropamide, enalapril, methyldopa, pentamidine, vincristine, cyclophosphamide, ifosfamide, felbamate) may increase the pressor effect in addition to the antidiuretic effect of Vasostrict ®.
7.6 Drugs Suspected Of Causing Diabetes Insipidus
Use with drugs suspected of causing diabetes insipidus (e.g., demeclocycline, lithium, foscarnet, clozapine) may decrease the pressor effect in addition to the antidiuretic effect of Vasostrict ®.
8.3 Nursing Mothers
It is not known whether vasopressin is present in human milk. However, oral absorption by a nursing infant is unlikely because vasopressin is rapidly destroyed in the gastrointestinal tract. Consider advising a lactating woman to pump and discard breast milk for 1.5 hours after receiving vasopressin to minimize potential exposure to the breastfed infant.
8.4 Pediatric Use
Safety and effectiveness of Vasostrict ® in pediatric patients with vasodilatory shock have not been established.
8.5 Geriatric Use
Clinical studies of vasopressin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Warnings and Precautions (5), Adverse Reactions (6), and Clinical Pharmacology (12.3)] .
10 Overdosage
Overdosage with Vasostrict ® can be expected to manifest as consequences of vasoconstriction of various vascular beds (peripheral, mesenteric, and coronary) and as hyponatremia. In addition, overdosage may lead less commonly to ventricular tachyarrhythmias (including Torsade de Pointes), rhabdomyolysis, and non-specific gastrointestinal symptoms.
Direct effects will resolve within minutes of withdrawal of treatment.
11 Description
Vasopressin is a polypeptide hormone that causes contraction of vascular and other smooth muscles and antidiuresis. Vasostrict ® is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin 20 units/mL, Water for Injection, USP, and sodium acetate buffer adjusted to a pH of 3.8. The 10 mL solution contains vasopressin 20 units/mL, chlorobutanol, NF 0.5% as a preservative, and Water for Injection, USP and, sodium acetate buffer adjusted to a pH of 3.8.
The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is:
Molecular Formula: C 46H 65N 15O 12S 2 Molecular Weight: 1084.23
One mg is equivalent to 530 units.
12.1 Mechanism Of Action
The vasoconstrictive effects of vasopressin are mediated by vascular V 1 receptors. Vascular V 1 receptors are directly coupled to phopholipase C, resulting in release of calcium, leading to vasoconstriction. In addition, vasopressin stimulates antidiuresis via stimulation of V 2 receptors which are coupled to adenyl cyclase.
12.2 Pharmacodynamics
At therapeutic doses exogenous vasopressin elicits a vasoconstrictive effect in most vascular beds including the splanchnic, renal and cutaneous circulation. In addition, vasopressin at pressor doses triggers contractions of smooth muscles in the gastrointestinal tract mediated by muscular V 1-receptors and release of prolactin and ACTH via V 3 receptors. At lower concentrations typical for the antidiuretic hormone vasopressin inhibits water diuresis via renal V 2 receptors.
In patients with vasodilatory shock vasopressin in therapeutic doses increases systemic vascular resistance and mean arterial blood pressure and reduces the dose requirements for norepinephrine. Vasopressin tends to decrease heart rate and cardiac output. The pressor effect is proportional to the infusion rate of exogenous vasopressin. Onset of the pressor effect of vasopressin is rapid, and the peak effect occurs within 15 minutes. After stopping the infusion the pressor effect fades within 20 minutes. There is no evidence for tachyphylaxis or tolerance to the pressor effect of vasopressin in patients.
12.3 Pharmacokinetics
At infusion rates used in vasodilatory shock (0.01-0.1 units/minute) the clearance of vasopressin is 9 to 25 mL/min/kg in patients with vasodilatory shock. The apparent t 1/2 of vasopressin at these levels is ≤10 minutes. Vasopressin is predominantly metabolized and only about 6% of the dose is excreted unchanged in urine. Animal experiments suggest that the metabolism of vasopressin is primarily by liver and kidney. Serine protease, carboxipeptidase and disulfide oxido-reductase cleave vasopressin at sites relevant for the pharmacological activity of the hormone. Thus, the generated metabolites are not expected to retain important pharmacological activity.
13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility
No formal carcinogenicity or fertility studies with vasopressin have been conducted in animals. Vasopressin was found to be negative in the in vitro bacterial mutagenicity (Ames) test and the in vitro Chinese hamster ovary (CHO) cell chromosome aberration test. In mice, vasopressin has been reported to have an effect on function and fertilizing ability of spermatozoa.
14 Clinical Studies
Increases in systolic and mean blood pressure following administration of vasopressin were observed in 7 studies in septic shock and 8 in post-cardiotomy vasodilatory shock.
16 How Supplied/Storage And Handling
Vasostrict ® (vasopressin injection, USP) is a clear, practically colorless solution for intravenous administration available as:
NDC 42023-164-25: A carton of 25 single dose vials each containing vasopressin 1 mL at 20 units/mL.
NDC 42023-190-01: A carton of 1 multiple dose vial containing vasopressin 10 mL at 200 units/10 mL (20 units/mL).
Principal Display Panel – 1 Ml Vial Bag
NDC 71872-7014-1
Rx Only
Vasostrict®
(Vasopressin Injection, USP)
20 Units per mL
For Intravenous Infusion
Must be diluted prior to use
Store between 2°C and 8°C (36°F and 46°F).
Do not store above 25°C (77°F).
Vials may be held at 20°C to 25°C (68°F to 77°F) for up to 12 months.
1 mL Single Dose Vial
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