Complete SPL Sections#
WARNING: HYPONATREMIA
BOXED WARNING SECTION
Desmopressin Acetate can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death [see Warnings and Precautions (5.1) ] . Desmopressin Acetate is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids [see Contraindications (4) and Warnings and Precautions (5.1) ] . Ensure the serum sodium concentration is normal before starting or resuming Desmopressin Acetate. Measure serum sodium within 7 days and approximately 1 month after initiating therapy, and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ] . If hyponatremia occurs, Desmopressin Acetate may need to be temporarily or permanently discontinued [see Warnings and Precautions (5.1) ] .
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
Injection: Desmopressin Acetate Injection USP is a sterile, aqueous, colorless solution available as: 4 mcg/mL in single-dose vial 40 mcg/10 mL (4 mcg/mL) in multiple-dose vial
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Desmopressin Acetate Injection USP is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of Desmopressin Acetate Injection USP [see Warnings and Precautions (5.4) , Adverse Reactions (6) , Description (11) ] . Desmopressin Acetate Injection USP is contraindicated in patients with the following conditions due to an increased risk of hyponatremia: Moderate to severe renal impairment defined as a creatinine clearance below 50 mL/min [see Use in Specific Populations (8.5 , 8.6) and Clinical Pharmacology (12.3) ] . Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ], Use in Specific Populations (8.4 , 8.5) ] . Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion [see Warnings and Precautions (5.1 )] . Polydipsia [see Warnings and Precautions (5.1) ] . Concomitant use with loop diuretics [see Boxed Warning ] . Concomitant use with systemic or inhaled glucocorticoids [see Boxed Warning ] . During illnesses that can cause fluid or electrolyte imbalance, such as gastroenteritis, salt-wasting nephropathies, or systemic infection [see Boxed Warning ] . Desmopressin Acetate Injection USP is contraindicated in patients with the following conditions because fluid retention increases the risk of worsening the underlying condition: Heart failure Uncontrolled hypertension
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following clinically significant adverse reactions are described elsewhere in the labeling: Hyponatremia [see Contraindications, Warnings and Precautions (5.1) ] Hypotension and Hypertension [see Warnings and Precautions (5.2) ] Increased risk of thrombosis in patients with von Willebrand’s Disease Type IIB [see Warnings and Precautions (5.3) ] Hypersensitivity reactions [see Warnings and Precautions (5.4) ] Fluid retention [see Warnings and Precautions (5.5) ] The following adverse reactions have been identified during post-approval use of Desmopressin Acetate Injection USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: Hypertension, hypotension, tachycardia, thrombotic events, fluid retention Digestive: Nausea, abdominal cramps Immune: Hypersensitivity reactions Integumentary: Erythema, swelling, burning pain, facial flushing Laboratory: Hyponatremia Nervous: Headache, hyponatremic seizures
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
Overdosage of Desmopressin Acetate Injection USP leads to prolonged duration of action with an increased risk of water retention and hyponatremia. Signs of overdose may include headaches, abdominal cramps, nausea, facial flushing, confusion, drowsiness, problems with passing urine and rapid weight gain due to fluid retention [see Warnings and Precautions (5.1) ] . In case of overdosage, the dosage should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition, serum sodium assessed, and hyponatremia treated appropriately. There is no known specific antidote for desmopressin acetate or Desmopressin Acetate Injection USP 4 mcg/mL.
11 DESCRIPTION
DESCRIPTION SECTION
Desmopressin Acetate Injection USP (desmopressin acetate) is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows: Mol. Wt. 1129.27 Empirical Formula: C 46 H 64 N 14 O 12 S 2 •C 2 H 4 O 2 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) Desmopressin Acetate solution for injection is a sterile solution in a 1 mL single-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin Acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
17 PATIENT COUNSELING INFORMATION
PATIENT COUNSELING INFORMATION
Hyponatremia and Fluid Restriction Inform patients that Desmopressin Acetate may cause severe hyponatremia, which may be life-threatening, if it is not promptly diagnosed and treated [see Warning and Precaution (5.1) ] . Inform them about the signs and symptoms associated with hyponatremia, to undergo recommended serum sodium measurements, and to inform their health care provider about new medications. Advise patients to contact a healthcare provider if symptoms of hyponatremia occur. Discuss adjustment of fluid intake and monitoring of urine output with patients. Manufactured for: UBI Pharma Inc. No. 45 Guangfu N. Rd., Hukou, Hsinchu 303036, Taiwan
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
1mL container label 1mL carton label 10mL container label 10mL carton label
