Desmopressin Acetate Oral Solution
Generic Name: desmopressin acetate oral solution
Brand Names:
Desmoda
11 DESCRIPTION DESMODA oral solution contains active moiety desmopressin, an analog of natural pituitary hormone 8-arginine vasopressin (antidiuretic hormone), in the form of acetate salt. The chemical name of desmopressin acetate is 1-desamino-8-D-arginine vasopressin acetate. Desmopressin acetate has a molecular weight of 1129.30 g/mol, an empirical formula of C 46 H 64 N 14 O 12 S 2 ·C 2 H 4 O 2 , and structural formula: Desmopressin acetate is white amorphous powder and is soluble in water.
Overview
11 DESCRIPTION DESMODA oral solution contains active moiety desmopressin, an analog of natural pituitary hormone 8-arginine vasopressin (antidiuretic hormone), in the form of acetate salt. The chemical name of desmopressin acetate is 1-desamino-8-D-arginine vasopressin acetate. Desmopressin acetate has a molecular weight of 1129.30 g/mol, an empirical formula of C 46 H 64 N 14 O 12 S 2 ·C 2 H 4 O 2 , and structural formula: Desmopressin acetate is white amorphous powder and is soluble in water.
Uses
1 INDICATIONS AND USAGE DESMODA is indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients. Limitations of Use • DESMODA is not indicated for the treatment of nephrogenic diabetes insipidus. DESMODA is a vasopressin analog indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients. Limitations of Use • DESMODA is not indicated for the treatment of nephrogenic diabetes insipidus.
Dosage
2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage for Central Diabetes Insipidus • Instruct patients about appropriate fluid restriction during DESMODA treatment due to risk of hyponatremia [see Warnings and Precautions (5.1)]. • Individualize the dosage of DESMODA for each patient and adjust the dosage according to the diurnal pattern of response. Estimate patient response by adequate duration of sleep and water turnover. • Recommended starting dosage of DESMODA for adults and pediatric patients is 0.05 mg orally twice daily. • Titrate the daily dosage as needed to obtain an adequate antidiuretic response. • Administer DESMODA on an empty stomach, at least 1 hour prior to or 2 hours after food. • Administer DESMODA using an oral syringe provided by the pharmacy.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: •Hyponatremia [see Warnings and Precautions (5.1)] •Fluid Retention [see Warnings and Precautions (5.2)] •Hypersensitivity [see Warnings and Precautions (5.3)] •Risk of Benzyl Alcohol Toxicity in Neonates [see Warnings and Precautions (5.4)] The following adverse reactions associated with the use of desmopressin acetate were identified in clinical studies or postmarketing reports. Because some of these reactions were 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.
Interactions
7 DRUG INTERACTIONS 7.1 Other Drugs that may Increase Risk of Hyponatremia Concomitant administration of DESMODA with other drugs that may increase the risk of water intoxication with hyponatremia, (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, thiazide diuretics, NSAIDs, lamotrigine, sulfonylureas, particularly chlorpropamide, oxybutynin and carbamazepine). Monitor serum sodium more frequently in patients taking DESMODA concomitantly with these drugs and when doses of these drugs are increased [see Warnings and Precautions (5.1), Adverse Reactions (6)]. 7.2 Other Vasoconstrictors Desmopressin acetate can elevate blood pressure.
Warnings
5 WARNINGS AND PRECAUTIONS 5.1 Hyponatremia Excessive fluid intake when urine output is limited by the antidiuretic effect of desmopressin may lead to water intoxication with hyponatremia. Cases of hyponatremia have been reported from postmarketing experience in patients treated with desmopressin acetate. Unless properly diagnosed and treated hyponatremia can be fatal. Observe all patients receiving DESMODA for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion. 4 CONTRAINDICATIONS DESMODA is contraindicated in patients with: •Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1)]. •Hypersensitivity to desmopressin acetate or any of the inactive ingredients of DESMODA.Reactions have included anaphylaxis [see Warnings and Precautions (5.3)].
Pregnancy
8.1 Pregnancy Risk Summary Available data on the use of desmopressin acetate during pregnancy over decades of use have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated central diabetes insipidus during pregnancy (see Clinical Considerations). In vitro studies with human placenta demonstrate poor placental transfer of desmopressin.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied DESMODA (desmopressin acetate) oral solution is a clear, colorless to slightly yellow colored solution supplied in an amber glass bottle: Strength Volume in Bottle NDC 0.05 mg/mL 145 mL 71863-123-14 Storage and Handling Store at 2°C to 25°C (36°F to 77°F). Excursions permitted to 30°C (86°F) [see USP refrigerated and controlled room temperature].
Frequently Asked Questions
What is Desmopressin Acetate Oral Solution used for?▼
1 INDICATIONS AND USAGE DESMODA is indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients. Limitations of Use • DESMODA is not indicated for the treatment of nephrogenic diabetes insipidus. DESMODA is a vasopressin analog indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients. Limitations of Use • DESMODA is not indicated for the treatment of nephrogenic diabetes insipidus.
What are the side effects of Desmopressin Acetate Oral Solution?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: •Hyponatremia [see Warnings and Precautions (5.1)] •Fluid Retention [see Warnings and Precautions (5.2)] •Hypersensitivity [see Warnings and Precautions (5.3)] •Risk of Benzyl Alcohol Toxicity in Neonates [see Warnings and Precautions (5.4)] The following adverse reactions associated with the use of desmopressin acetate were identified in clinical studies or postmarketing reports. Because some of these reactions were 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.
Can I take Desmopressin Acetate Oral Solution during pregnancy?▼
8.1 Pregnancy Risk Summary Available data on the use of desmopressin acetate during pregnancy over decades of use have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated central diabetes insipidus during pregnancy (see Clinical Considerations). In vitro studies with human placenta demonstrate poor placental transfer of desmopressin.
What are the important warnings for Desmopressin Acetate Oral Solution?▼
5 WARNINGS AND PRECAUTIONS 5.1 Hyponatremia Excessive fluid intake when urine output is limited by the antidiuretic effect of desmopressin may lead to water intoxication with hyponatremia. Cases of hyponatremia have been reported from postmarketing experience in patients treated with desmopressin acetate. Unless properly diagnosed and treated hyponatremia can be fatal. Observe all patients receiving DESMODA for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion. 4 CONTRAINDICATIONS DESMODA is contraindicated in patients with: •Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1)]. •Hypersensitivity to desmopressin acetate or any of the inactive ingredients of DESMODA.Reactions have included anaphylaxis [see Warnings and Precautions (5.3)].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.