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Rx Item-NOCDURNA desmopressin acetate SUBLINGUAL RAPDIS 55.3 MCG SUB TAB 30 by

RX791929Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-NOCDURNA desmopressin acetate SUBLINGUAL RAPDIS 55.3 MCG SUB TAB 30 by

$504.00$449.00

NDC No. 55566-5070-01 55566-5070-1 5556650701 55566507001 UPC/GTIN No. 3-55566-50511-8 355566-505118 355566-505118 MPN No. Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, & Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.

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For: Nocturia

Nocdurna (desmopressin acetate) is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults. NOCDURNA (desmopressin acetate) sublingual tablets are available as:

27.7 mcg of desmopressin acetate (equivalent to 25 mcg of desmopressin): White, round, sublingual tablet with "25" on one side.
NDC 55566-5050-1 Carton of 30 sublingual tablets (3 blister packs with 10 tablets each)

55.3 mcg of desmopressin acetate (equivalent to 50 mcg of desmopressin): White, round, sublingual tablet with "50" on one side.
NDC 55566-5070-1 Carton of 30 sublingual tablets (3 blister packs with 10 tablets each)

Store at 20 to 25C (68 to 77F); excursions permitted between 15 and 30C (59 and 86F) [See USP Controlled Room Temperature]. Keep in original package to protect from moisture and light. Use immediately upon opening individual tablet blister. These highlights do not include all the information needed to use NOCDURNA safely and effectively. See full prescribing information for NOCDURNA.



NOCDURNA (desmopressin acetate) sublingual tablets

Initial U.S. Approval: 1978
WARNING: HYPONATREMIA
See full prescribing information for complete boxed warning.

NOCDURNA can cause hyponatremia, which may be life-threatening if severe (5.1)
NOCDURNA 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. (4, 5.1)
Ensure serum sodium concentration is normal before starting or resuming NOCDURNA. Measure serum sodium within 1 week 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 (2.2,5.1)
If hyponatremia occurs, NOCDURNA may need to be temporarily or permanently discontinued (5.1)

INDICATIONS AND USAGE

NOCDURNA is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void. (1)
DOSAGE AND ADMINISTRATION

Dosing Information (2.1):

Women: 27.7 mcg daily, one hour before bedtime, administered sublingually without water
Men: 55.3 mcg daily, one hour before bedtime, administered sublingually without water

DOSAGE FORMS AND STRENGTHS

Sublingual Tablets: 27.7 mcg of desmopressin acetate (equivalent to 25 mcg of desmopressin) and 55.3 mcg of desmopressin acetate (equivalent to 50 mcg of desmopressin) (3)
CONTRAINDICATIONS

Hyponatremia or a history of hyponatremia (4)
Polydipsia (4)
Concomitant use with loop diuretics or systemic or inhaled glucocorticoids (4)
Estimated glomerular filtration rate below 50 mL/min/1.73 m2 (4)
Syndrome of inappropriate antidiuretic hormone secretion (SIADH) (4)
During illnesses that can cause fluid or electrolyte imbalance (4)
Heart failure (4)
Uncontrolled hypertension (4)

WARNINGS AND PRECAUTIONS

Limit fluid intake to a minimum from 1 hour before until 8 hours after administration. Treatment without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia (5.1)
Fluid retention: Not recommended in patients at risk of increased intracranial pressure or history of urinary retention. (5.2)

ADVERSE REACTIONS

Common adverse reactions (> 2% incidence) included dry mouth, hyponatremia or blood sodium decreased, and dizziness. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Ferring at 1-888-337-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

Monitor serum sodium more frequently when NOCDURNA is concomitantly used with drugs that may increase the risk of hyponatremia (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, thiazide diuretics, NSAIDs, lamotrigine, chlorpropamide and, carbamazepine). (7.1)
USE IN SPECIFIC POPULATIONS

Pregnancy: Use of NOCDURNA is not recommended (8.1)
Geriatric use: Increased risk of hyponatremia if 65 years of age or older. Monitor serum sodium more frequently (8.5)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 6/2018

RX791929
Rx Item-NOCDURNA desmopressin acetate SU
RX791929

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-NOCDURNA desmopressin acetate SU
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop