Desmopressin Acetate 4 ug/mL
Desmopressin Acetate · INJECTION, SOLUTION · Dr. Reddy's Laboratories Inc.
Desmopressin Acetate is a injection, solution containing desmopressin acetate at 4 ug/mL, taken intravenous. Manufactured by Dr. Reddy's Laboratories Inc..
Key Facts
- Brand Name
- Desmopressin Acetate
- Generic Name
- Desmopressin Acetate
- NDC Code (Product)
43598-053- Manufacturer
- Dr. Reddy's Laboratories Inc.
- Strength
- 4 ug/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA215961
- Marketing Start
- 09/12/2022
Recall History
American Health Packaging
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Ferring Pharmaceuticals Inc
Superpotent Drug
Heritage Pharmaceuticals Inc
Subpotent Drug
Ferring Pharmaceuticals Inc
Superpotent Drug
Teva Pharmaceuticals USA
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Actavis Laboratories, FL, Inc.
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
American Health Packaging
GMP Deviations: Product bottle may be absent of desiccant.
American Health Packaging
GMP Deviations: Product bottle may be absent of desiccant.
Teva Pharmaceuticals USA
GMP Deviations: Product bottle may be absent of desiccant.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Central Diabetes Insipidus Desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality. Primary Nocturnal Enuresis Desmopressin acetate tablets are indicated for the management of primary nocturnal enuresis. Desmopressin acetate may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention.
Dosage & Administration
DOSAGE AND ADMINISTRATION Central Diabetes Insipidus The dosage of desmopressin acetate tablets must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients previously on intranasal desmopressin acetate therapy should begin tablet therapy twelve hours after the last intranasal dose. During the initial dose titration period, patients should be observed closely and appropriate safety parameters measured to assure adequate response. Patients should be monitored at regular intervals during the course of desmopressin acetate tablet therapy to assure adequate antidiuretic response. Modifications in dosage regimen should be implemented as necessary to assure adequate water turnover. Fluid restriction should be observed. (See WARNINGS , PRECAUTIONS, Pediatric Use and Geriatric Use .) Adults and Children It is recommended that patients be started on doses of 0.05 mg (1/2 of the 0.1 mg tablet) two times a day and individually adjusted to their optimum therapeutic dose. Most patients in clinical trials found that the opti…
Warnings
WARNINGS Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated desmopressin acetate. Desmopressin acetate is a potent antidiuretic which, when administered, may lead to water intoxication and/or hyponatremia. Unless properly diagnosed and treated hyponatremia can be fatal. Therefore, fluid restriction is recommended and should be discussed with the patient and/or guardian. Careful medical supervision is required. When desmopressin acetate tablets are administered, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward to decrease the potential occurrence of water intoxication and hyponatremia. (See PRECAUTIONS, Pediatric Use and Geriatric Use .) All patients receiving desmopressin acetate tablets therapy should be observed for the following signs of 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. Severe sym…
Contraindications
CONTRAINDICATIONS Desmopressin acetate tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate tablets. Desmopressin acetate tablets are contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50mL/min). Desmopressin acetate is contraindicated in patients with hyponatremia or a history of hyponatremia.
Drug Interactions
Drug Interactions Although the pressor activity of desmopressin acetate is very low compared to its antidiuretic activity, large doses of desmopressin acetate tablets should be used with other pressor agents only with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia, (e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine and carbamazepine) should be performed with caution.
Adverse Reactions
ADVERSE REACTIONS Infrequently, large doses of the intranasal formulations of desmopressin acetate tablets and injection have produced transient headache, nausea, flushing and mild abdominal cramps. These symptoms have disappeared with reduction in dosage. Central Diabetes Insipidus In long-term clinical studies in which patients with diabetes insipidus were followed for periods up to 44 months of desmopressin acetate tablet therapy, transient increases in AST (SGOT) no higher than 1.5 times the upper limit of normal were occasionally observed. Elevated AST (SGOT) returned to the normal range despite continued use of desmopressin acetate tablets. Primary Nocturnal Enuresis The only adverse event occurring in ≥3% of patients in controlled clinical trials with desmopressin acetate tablets that was probably, possibly, or remotely related to study drug was headache (4% desmopressin acetate, 3% placebo). Other The following adverse events have been reported; however their relationship to desmopressin acetate has not been established: abnormal thinking, diarrhea, and edema-weight gain. See WARNINGS for the possibility of water intoxication and hyponatremia. Post Marketing There have been…
Frequently Asked Questions
What is Desmopressin Acetate used for?
Desmopressin Acetate contains Desmopressin Acetate. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Desmopressin Acetate a controlled substance?
Desmopressin Acetate is not classified as a controlled substance by the DEA.
What is the generic name for Desmopressin Acetate?
The generic name for Desmopressin Acetate is Desmopressin Acetate. There are 5 other brand versions of Desmopressin Acetate.
What is the NDC code for Desmopressin Acetate 4 ug/mL?
The NDC (National Drug Code) for Desmopressin Acetate 4 ug/mL is 43598-053, listed by Dr. Reddy's Laboratories Inc..