DDAVP .1 mg/1

Desmopressin Acetate · TABLET · Ferring Pharmaceuticals Inc.

1 Recall on RecordCurrently in Shortage

Plain English

Desmopressin acetate is an oral tablet used to treat bedwetting in children and certain bleeding disorders by helping your body retain water and regulate fluid balance. It works by replacing or supplementing a natural hormone that controls urine production.

Key Facts

Brand Name: DDAVP
Generic Name: Desmopressin Acetate
NDC Code (Product): 55566-2600
Manufacturer: Ferring Pharmaceuticals Inc.
Strength: .1 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA019955
Marketing Start: 09/06/1995

Recall History

1 Recall on Record

Class I07/21/2020

Ferring Pharmaceuticals Inc

Superpotent Drug

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

hyponatraemia335 reports

drug ineffective216 reports

headache184 reports

nausea171 reports

fatigue143 reports

vomiting137 reports

off label use132 reports

dizziness112 reports

diarrhoea108 reports

pain104 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE DDAVP Injection is a vasopressin analog used for: Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. ( 1.1 ) Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. ( 1.2 ) von Willebrand's disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. ( 1.3 ) Limitations of Use DDAVP is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus. ( 1.3 ) von Willebrand's disease (severe Type I) - not indicated for the treatment of patients with severe Type I von Willebrand's disease and when there is evidence of an abnormal molecular fo…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Diabetes Insipidus: The daily dose is 2 mcg to 4 mcg administered as one or two divided doses by subcutaneous or intravenous injection. The dosage must be determined for each patient and adjusted according to the pattern of response. ( 2.1 ) Hemophilia A and von Willebrand's Disease (Type I): 0.3 mcg/kg (to a maximum of 20 mcg) administered by intravenous infusion. Dilute dose as appropriate. ( 2.1 ) See Full Prescribing Information for instructions on reconstitution, preparation, and administration ( 2 ). 2.1 Pretreatment Testing and On-Treatment Monitoring Diabetes Insipidus Prior to treatment with DDAVP, assess serum sodium, urine volume and osmolality. Intermittently during treatment, assess serum sodium, urine volume and osmolality or plasma osmolality. Hemophilia A Prior to treatment with DDAVP Injection, verify that factor VIII coagulant activity levels are >5% and exclude the presence of factor VIII autoantibodies. Also assess serum sodium and aPTT prior to treatment. In certain clinical situations, it may be justified to try DDAVP in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored. von Wil…

Contraindications

4 CONTRAINDICATIONS DDAVP Injection is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of DDAVP Injection [see Warnings and Precautions (5.4) , Adverse Reactions (6) , Description (11) ]. DDAVP Injection 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 ] . DDAVP Injection is contraindicated in pat…

Drug Interactions

7 DRUG INTERACTIONS Drugs that increase risk of hyponatremia: Require more frequent serum sodium monitoring. ( 7.1 ) Other vasoconstrictors: May require a reduction of the DDAVP dosage. ( 7.2 ) 7.1 Other Drugs that may Increase Risk of Hyponatremia The concomitant administration of DDAVP Injection 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), requires more frequent serum sodium monitoring. Monitor serum sodium more frequently in patients taking DDAVP Injection concomitantly with these drugs and when doses of these drugs are increased [see Contraindications (4) , Warnings and Precautions (5.1) , Drug Interactions (7.1) , Use in Specific Populations (8.4 , 8.5) ]. 7.2 Other Vasoconstrictors DDAVP Injection can elevate blood pressure. Use of DDAVP Injection with other vasoconstrictors may require a reduction of the DDAVP Injection dosage [see Warnings and Precautions (5.2) , Adverse Reactions (6) ].

Adverse Reactions

6 ADVERSE REACTIONS 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 DDAVP Injection. 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 Common adverse reactions are abdominal cramps, burning pain, erythema, facial flushing, fluid retention, headache, h…

Frequently Asked Questions

What is DDAVP used for?

Is DDAVP a controlled substance?

DDAVP is not classified as a controlled substance by the DEA.

What is the generic name for DDAVP?

The generic name for DDAVP is Desmopressin Acetate. There are 11 other brand versions of Desmopressin Acetate.

What is the NDC code for DDAVP .1 mg/1?

The NDC (National Drug Code) for DDAVP .1 mg/1 is 55566-2600, listed by Ferring Pharmaceuticals Inc..

Product NDC

55566-2600

Package NDC

55566-2600-0

Other Desmopressin Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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