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Drug overview for NOCDURNA (desmopressin acetate):
Generic name: DESMOPRESSIN ACETATE (dess-mow-PRESS-in)
Drug class: Antidiuretic Hormone
Therapeutic class: Endocrine
Desmopressin is a synthetic polypeptide analog of arginine vasopressin (antidiuretic hormone (ADH)), the natural human pituitary hormone. Desmopressin reduces urinary outputand plasma osmolality, increases urine osmolality, and increases plasma levels of factor VIII (antihemophilic factor) activity.
Desmopressin acetate nasal spray is used as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients >=4 years of age. Desmopressin nasal spray is not indicated for the treatment of nephrogenic diabetes insipidus or treatment of primary nocturnal enuresis. The nasal spray is also not used in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy), patients with an impaired level of consciousness, or in those requiring doses <10 mcg or doses that are not multiples of 10 mcg.
Desmopressin acetate parenteral injection is used 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. Desmopressin injection is not indicated for the treatment of nephrogenic diabetes insipidus; the medication is ineffective for this condition. Desmopressin acetate parenteral injection is used in patients with hemophilia A with factor VIII coagulant activity levels >5% to maintain hemostasis during surgical procedures and reduce bleeding with episodes of spontaneous or traumatic injuries.
Desmopressin acetate parenteral injection is used in patients with mild to moderate type 1 von Willebrand disease with factor VIII levels >5% to maintain hemostasis during surgical procedures and reduce bleeding with episodes of spontaneous or traumatic injuries. Desmopressin acetate oral tablets are used 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. The tablets are also used for the management of primary nocturnal enuresis.
Generic name: DESMOPRESSIN ACETATE (dess-mow-PRESS-in)
Drug class: Antidiuretic Hormone
Therapeutic class: Endocrine
Desmopressin is a synthetic polypeptide analog of arginine vasopressin (antidiuretic hormone (ADH)), the natural human pituitary hormone. Desmopressin reduces urinary outputand plasma osmolality, increases urine osmolality, and increases plasma levels of factor VIII (antihemophilic factor) activity.
Desmopressin acetate nasal spray is used as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients >=4 years of age. Desmopressin nasal spray is not indicated for the treatment of nephrogenic diabetes insipidus or treatment of primary nocturnal enuresis. The nasal spray is also not used in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy), patients with an impaired level of consciousness, or in those requiring doses <10 mcg or doses that are not multiples of 10 mcg.
Desmopressin acetate parenteral injection is used 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. Desmopressin injection is not indicated for the treatment of nephrogenic diabetes insipidus; the medication is ineffective for this condition. Desmopressin acetate parenteral injection is used in patients with hemophilia A with factor VIII coagulant activity levels >5% to maintain hemostasis during surgical procedures and reduce bleeding with episodes of spontaneous or traumatic injuries.
Desmopressin acetate parenteral injection is used in patients with mild to moderate type 1 von Willebrand disease with factor VIII levels >5% to maintain hemostasis during surgical procedures and reduce bleeding with episodes of spontaneous or traumatic injuries. Desmopressin acetate oral tablets are used 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. The tablets are also used for the management of primary nocturnal enuresis.
DRUG IMAGES
NOCDURNA 55.3 MCG TABLET SL
NOCDURNA 27.7 MCG TABLET SL
The following indications for NOCDURNA (desmopressin acetate) have been approved by the FDA:
Indications:
Nocturia
Professional Synonyms:
Nycturia
Indications:
Nocturia
Professional Synonyms:
Nycturia
The following dosing information is available for NOCDURNA (desmopressin acetate):
Dosage of desmopressin acetate is expressed in terms of the salt.
Desmopressin acetate is administered intranasally, orally, and by subcutaneous injection, direct IV injection, or slow IV infusion.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| NOCDURNA 27.7 MCG TABLET SL | Maintenance | Adults place 1 tablet (27.7 mcg) under the tongue and allow to dissolve by sublingual route once daily 1 hour before bedtime (for female) |
| NOCDURNA 55.3 MCG TABLET SL | Maintenance | Adults place 1 tablet (55.3 mcg) under the tongue and allow to dissolve by sublingual route once daily 1 hour before bedtime (for male) |
No generic dosing information available.
The following drug interaction information is available for NOCDURNA (desmopressin acetate):
There are 2 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Desmopressin/Glucocorticoids SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Glucocorticoids increase the risk of hyponatremia.(1-4) CLINICAL EFFECTS: Concurrent use of glucocorticoids may increase the risk of hyponatremia with desmopressin.(1-4) PREDISPOSING FACTORS: Predisposing factors for hyponatremia include: polydipsia, renal impairment (eGFR < 50 ml/min/1.73m2), illnesses that can cause fluid/electrolyte imbalances, age >=65, medications that cause water retention and/or increase the risk of hyponatremia (carbamazepine, chlorpromazine, lamotrigine, loop diuretics, NSAIDs, opioids, SSRIs, thiazide diuretics, and/or tricyclic antidepressants). PATIENT MANAGEMENT: The concurrent use of systemic or inhaled glucocorticoids with desmopressin is contraindicated.(1-4) Desmopressin may be initiated 3 days or 5 half-lives after glucocorticoid discontinuation, whichever is longer. If concurrent use is deemed medically necessary, make sure serum sodium levels are normal before beginning therapy and consider using the desmopressin nasal 0.83 mcg dose. Consider measuring serum sodium levels more frequently than the recommended intervals of: within 7 days of concurrent therapy initiation, one month after concurrent therapy initiation and periodically during treatment. Counsel patients to report symptoms of hyponatremia, which may include: headache, nausea/vomiting, feeling restless, fatigue, drowsiness, dizziness, muscle cramps, changes in mental state (confusion, decreased awareness/alertness), seizures, coma, and trouble breathing. Counsel patients to limit the amount of fluids they drink in the evening and night-time and to stop taking desmopressin if they develop a stomach/intestinal virus with nausea/vomiting or any nose problems (blockage, stuffy/runny nose, drainage).(1) DISCUSSION: In clinical trials of desmopressin for the treatment of nocturia, 4 of 5 patients who developed severe hyponatremia (serum sodium <= 125 mmol/L) were taking systemic or inhaled glucocorticoids. Three of these patients were also taking NSAIDs and one was receiving a thiazide diuretic.(2) Drugs associated with hyponatremia may increase the risk, including loop diuretics, carbamazepine, chlorpromazine, glucocorticoids, lamotrigine, NSAIDs, opioids, SSRIs, thiazide diuretics, and/or tricyclic antidepressants.(1,3-4) |
ADVAIR DISKUS, ADVAIR HFA, AGAMREE, AIRDUO DIGIHALER, AIRSUPRA, ALKINDI SPRINKLE, ALVESCO, ANALPRAM HC, ANUCORT-HC, ANUSOL-HC, ARMONAIR DIGIHALER, ARNUITY ELLIPTA, ASMANEX, ASMANEX HFA, BECLOMETHASONE DIPROPIONATE, BETALOAN SUIK, BETAMETHASONE ACETATE MICRO, BETAMETHASONE ACETATE-SOD PHOS, BETAMETHASONE DIPROPIONATE, BETAMETHASONE SOD PHOS-ACETATE, BETAMETHASONE SOD PHOS-WATER, BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE VALERATE, BREO ELLIPTA, BREYNA, BREZTRI AEROSPHERE, BUDESONIDE, BUDESONIDE DR, BUDESONIDE EC, BUDESONIDE ER, BUDESONIDE MICRONIZED, BUDESONIDE-FORMOTEROL FUMARATE, BUPIVACAINE-DEXAMETH-EPINEPHRN, CELESTONE, CLOBETASOL PROPIONATE MICRO, CORTEF, CORTENEMA, CORTIFOAM, CORTISONE ACETATE, DEFLAZACORT, DEPO-MEDROL, DESONIDE MICRONIZED, DESOXIMETASONE, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE ACETATE, DEXAMETHASONE ACETATE MICRO, DEXAMETHASONE INTENSOL, DEXAMETHASONE ISONICOTINATE, DEXAMETHASONE MICRONIZED, DEXAMETHASONE SOD PHOS-WATER, DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE-0.9% NACL, DMT SUIK, DOUBLEDEX, DULERA, EMFLAZA, EOHILIA, FLUDROCORTISONE ACETATE, FLUNISOLIDE, FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE MICRO, FLUOCINONIDE MICRONIZED, FLUTICASONE FUROATE, FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE HFA, FLUTICASONE PROPIONATE MICRO, FLUTICASONE-SALMETEROL, FLUTICASONE-SALMETEROL HFA, FLUTICASONE-VILANTEROL, HEMADY, HEMMOREX-HC, HEXATRIONE, HYDROCORTISONE, HYDROCORTISONE ACETATE, HYDROCORTISONE SOD SUCCINATE, HYDROCORTISONE-PRAMOXINE, JAYTHARI, KENALOG-10, KENALOG-40, KENALOG-80, KHINDIVI, KYMBEE, LIDOCAINE-HYDROCORTISONE, LIDOCIDEX-I, MAS CARE-PAK, MEDROL, MEDROLOAN II SUIK, MEDROLOAN SUIK, METHYLPREDNISOLONE, METHYLPREDNISOLONE AC MICRO, METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE SODIUM SUCC, MILLIPRED, MILLIPRED DP, MOMETASONE FUROATE, ORAPRED ODT, P-PACK PREDNISONE, PREDNISOLONE, PREDNISOLONE ACETATE MICRONIZE, PREDNISOLONE MICRONIZED, PREDNISOLONE SODIUM PHOS ODT, PREDNISOLONE SODIUM PHOSPHATE, PREDNISONE, PREDNISONE INTENSOL, PREDNISONE MICRONIZED, PROCORT, PROCTOCORT, PROCTOFOAM-HC, PULMICORT, PULMICORT FLEXHALER, PYQUVI, QVAR REDIHALER, SOLU-CORTEF, SOLU-MEDROL, SYMBICORT, TAPERDEX, TARPEYO, TRELEGY ELLIPTA, TRIAMCINOLONE, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE DIACETATE, TRIAMCINOLONE DIACETATE MICRO, TRILOAN II SUIK, TRILOAN SUIK, UCERIS, VERIPRED 20, WIXELA INHUB, ZCORT, ZILRETTA |
| Desmopressin/Loop Diuretics SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Loop diuretics increase the risk of hyponatremia.(1-4) CLINICAL EFFECTS: Concurrent use of loop diuretics may increase the risk of hyponatremia with desmopressin.(1-4) PREDISPOSING FACTORS: Predisposing factors for hyponatremia include: polydipsia, renal impairment (eGFR < 50 ml/min/1.73m2), illnesses that can cause fluid/electrolyte imbalances, age >=65, medications that cause water retention and/or increase the risk of hyponatremia (carbamazepine, chlorpromazine, glucocorticoids, lamotrigine, NSAIDs, opioids, SSRIs, thiazide diuretics, and/or tricyclic antidepressants). PATIENT MANAGEMENT: The concurrent use of loop diuretics with desmopressin is contraindicated.(1-4) If concurrent use is deemed medically necessary, make sure serum sodium levels are normal before beginning therapy and consider using the desmopressin nasal 0.83 mcg dose. Consider measuring serum sodium levels more frequently than the recommended intervals of: within 7 days of concurrent therapy initiation, one month after concurrent therapy initiation and periodically during treatment. Counsel patients to report symptoms of hyponatremia, which may include: headache, nausea/vomiting, feeling restless, fatigue, drowsiness, dizziness, muscle cramps, changes in mental state (confusion, decreased awareness/alertness), seizures, coma, and trouble breathing. Counsel patients to limit the amount of fluids they drink in the evening and night-time and to stop taking desmopressin if they develop a stomach/intestinal virus with nausea/vomiting or any nose problems (blockage, stuffy/runny nose, drainage).(1) DISCUSSION: In clinical trials of desmopressin for the treatment of nocturia, 4 of 5 patients who developed severe hyponatremia (serum sodium <= 125 mmol/L) were taking systemic or inhaled glucocorticoids. Three of these patients were also taking NSAIDs and one was receiving a thiazide diuretic.(2) Drugs associated with hyponatremia may increase the risk, including loop diuretics, carbamazepine, chlorpromazine, glucocorticoids, lamotrigine, NSAIDs, opioids, SSRIs, thiazide diuretics, and/or tricyclic antidepressants.(1,3-4) |
BUMETANIDE, EDECRIN, ENBUMYST, ETHACRYNATE SODIUM, ETHACRYNIC ACID, FUROSCIX, FUROSEMIDE, FUROSEMIDE-0.9% NACL, LASIX, LASIX ONYU, SOAANZ, TORSEMIDE |
There are 0 severe interactions.
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Desmopressin/Agents with Hyponatremia Risk SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Carbamazepine, chlorpromazine, lamotrigine, NSAIDs, opioids, SSRIs, thiazide diuretics, and/or tricyclic antidepressants increase the risk of hyponatremia.(1-3) CLINICAL EFFECTS: Concurrent use may increase the risk of hyponatremia with desmopressin.(1-3) PREDISPOSING FACTORS: Predisposing factors for hyponatremia include: polydipsia, renal impairment (eGFR < 50 ml/min/1.73m2), illnesses that can cause fluid/electrolyte imbalances, age >=65, medications that cause water retention and/or increase the risk of hyponatremia (glucocorticoids, loop diuretics). PATIENT MANAGEMENT: The concurrent use of agents with a risk of hyponatremia with desmopressin may increase the risk of hyponatremia. If concurrent use is deemed medically necessary, make sure serum sodium levels are normal before beginning therapy and consider using the desmopressin nasal 0.83 mcg dose. Consider measuring serum sodium levels more frequently than the recommended intervals of: within 7 days of concurrent therapy initiation, one month after concurrent therapy initiation and periodically during treatment. Counsel patients to report symptoms of hyponatremia, which may include: headache, nausea/vomiting, feeling restless, fatigue, drowsiness, dizziness, muscle cramps, changes in mental state (confusion, decreased awareness/alertness), seizures, coma, and trouble breathing. Counsel patients to limit the amount of fluids they drink in the evening and night-time and to stop taking desmopressin if they develop a stomach/intestinal virus with nausea/vomiting or any nose problems (blockage, stuffy/runny nose, drainage).(1) DISCUSSION: In clinical trials of desmopressin for the treatment of nocturia, 4 of 5 patients who developed severe hyponatremia (serum sodium <= 125 mmol/L) were taking systemic or inhaled glucocorticoids. Three of these patients were also taking NSAIDs and one was receiving a thiazide diuretic.(2) Drugs associated with hyponatremia may increase the risk, including loop diuretics, carbamazepine, chlorpromazine, glucocorticoids, lamotrigine, NSAIDs, opioids, SSRIs, thiazide diuretics, and/or tricyclic antidepressants.(1,3-4) |
ACETAMIN-CAFF-DIHYDROCODEINE, ACETAMINOPHEN-CODEINE, AMILORIDE-HYDROCHLOROTHIAZIDE, AMITRIPTYLINE HCL, AMLODIPINE-VALSARTAN-HCTZ, AMOXAPINE, ANAFRANIL, ANAPROX DS, ARTHROTEC 50, ARTHROTEC 75, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, ATACAND HCT, ATENOLOL-CHLORTHALIDONE, AVALIDE, BELBUCA, BELLADONNA-OPIUM, BENAZEPRIL-HYDROCHLOROTHIAZIDE, BENICAR HCT, BISOPROLOL-HYDROCHLOROTHIAZIDE, BRIXADI, BROMFENAC SODIUM, BUPIVACAINE-KETOROLAC-KETAMINE, BUPRENORPHINE, BUPRENORPHINE HCL, BUPRENORPHINE-NALOXONE, BUTALB-ACETAMINOPH-CAFF-CODEIN, BUTORPHANOL TARTRATE, BUTRANS, CALDOLOR, CAMBIA, CANDESARTAN-HYDROCHLOROTHIAZID, CAPTOPRIL-HYDROCHLOROTHIAZIDE, CARBAMAZEPINE, CARBAMAZEPINE ER, CARBATROL, CARISOPRODOL-ASPIRIN-CODEINE, CELEBREX, CELECOXIB, CELEXA, CHLORDIAZEPOXIDE-AMITRIPTYLINE, CHLOROTHIAZIDE, CHLOROTHIAZIDE SODIUM, CHLORPROMAZINE HCL, CHLORTHALIDONE, CITALOPRAM HBR, CLOMIPRAMINE HCL, CODEINE PHOSPHATE, CODEINE SULFATE, COMBOGESIC, COMBOGESIC IV, CONSENSI, CONZIP, COXANTO, DEMEROL, DESIPRAMINE HCL, DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM ER, DICLOFENAC SODIUM MICRONIZED, DICLOFENAC SODIUM-MISOPROSTOL, DIFLUNISAL, DIHYDROCODEINE BITARTRATE, DILAUDID, DIOVAN HCT, DIPHENOXYLATE-ATROPINE, DISKETS, DOLOBID, DOXEPIN HCL, DSUVIA, DURAMORPH, EC-NAPROSYN, EDARBYCLOR, ELYXYB, ENALAPRIL-HYDROCHLOROTHIAZIDE, ENDOCET, EQUETRO, ESCITALOPRAM OXALATE, ETODOLAC, ETODOLAC ER, EXFORGE HCT, FELDENE, FENOPROFEN CALCIUM, FENOPRON, FENTANYL, FENTANYL CITRATE, FENTANYL CITRATE-0.9% NACL, FENTANYL CITRATE-D5W, FENTANYL CITRATE-STERILE WATER, FENTANYL CITRATE-WATER, FENTANYL-BUPIVACAINE-0.9% NACL, FENTANYL-BUPIVACAINE-NACL, FENTANYL-ROPIVACAINE-0.9% NACL, FENTANYL-ROPIVACAINE-NACL, FLUOXETINE DR, FLUOXETINE HCL, FLURBIPROFEN, FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE ER, FOSINOPRIL-HYDROCHLOROTHIAZIDE, HEMICLOR, HYCODAN, HYDROCHLOROTHIAZIDE, HYDROCODONE BITARTRATE, HYDROCODONE BITARTRATE ER, HYDROCODONE-ACETAMINOPHEN, HYDROCODONE-CHLORPHENIRAMNE ER, HYDROCODONE-HOMATROPINE MBR, HYDROCODONE-IBUPROFEN, HYDROMET, HYDROMORPHONE ER, HYDROMORPHONE HCL, HYDROMORPHONE HCL-0.9% NACL, HYDROMORPHONE HCL-D5W, HYDROMORPHONE HCL-NACL, HYDROMORPHONE HCL-WATER, HYSINGLA ER, HYZAAR, IBU, IBUPAK, IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN-FAMOTIDINE, IMIPRAMINE HCL, IMIPRAMINE PAMOATE, INDAPAMIDE, INDOCIN, INDOMETHACIN, INDOMETHACIN ER, INFLAMMACIN, INFLATHERM(DICLOFENAC-MENTHOL), INFUMORPH, INZIRQO, IRBESARTAN-HYDROCHLOROTHIAZIDE, KETOPROFEN, KETOPROFEN MICRONIZED, KETOROLAC TROMETHAMINE, LAMICTAL, LAMICTAL (BLUE), LAMICTAL (GREEN), LAMICTAL (ORANGE), LAMICTAL ODT, LAMICTAL ODT (BLUE), LAMICTAL ODT (GREEN), LAMICTAL ODT (ORANGE), LAMICTAL XR, LAMICTAL XR (BLUE), LAMICTAL XR (GREEN), LAMICTAL XR (ORANGE), LAMOTRIGINE, LAMOTRIGINE (BLUE), LAMOTRIGINE (GREEN), LAMOTRIGINE (ORANGE), LAMOTRIGINE ER, LAMOTRIGINE ODT, LAMOTRIGINE ODT (BLUE), LAMOTRIGINE ODT (GREEN), LAMOTRIGINE ODT (ORANGE), LEVORPHANOL TARTRATE, LEXAPRO, LISINOPRIL-HYDROCHLOROTHIAZIDE, LODINE, LOFENA, LOMOTIL, LOSARTAN-HYDROCHLOROTHIAZIDE, LOTENSIN HCT, LURBIRO, MECLOFENAMATE SODIUM, MEFENAMIC ACID, MELOXICAM, MEPERIDINE HCL, MEPERIDINE HCL-0.9% NACL, METHADONE HCL, METHADONE HCL-0.9% NACL, METHADONE HCL-NACL, METHADONE INTENSOL, METHADOSE, METHYLDOPA-HYDROCHLOROTHIAZIDE, METOLAZONE, METOPROLOL-HYDROCHLOROTHIAZIDE, MICARDIS HCT, MITIGO, MORPHINE SULFATE, MORPHINE SULFATE ER, MORPHINE SULFATE-0.9% NACL, MORPHINE SULFATE-NACL, MOTOFEN, MS CONTIN, NABUMETONE, NABUMETONE MICRONIZED, NALBUPHINE HCL, NALFON, NALOCET, NAPRELAN, NAPROSYN, NAPROTIN, NAPROXEN, NAPROXEN SODIUM, NAPROXEN SODIUM CR, NAPROXEN SODIUM ER, NAPROXEN-ESOMEPRAZOLE MAG, NEOPROFEN, NORPRAMIN, NORTRIPTYLINE HCL, NUCYNTA, NUCYNTA ER, OLANZAPINE-FLUOXETINE HCL, OLMESARTAN-AMLODIPINE-HCTZ, OLMESARTAN-HYDROCHLOROTHIAZIDE, OPIUM TINCTURE, ORUDIS, OXAPROZIN, OXYCODONE HCL, OXYCODONE HCL ER, OXYCODONE HYDROCHLORIDE, OXYCODONE-ACETAMINOPHEN, OXYCONTIN, OXYMORPHONE HCL, OXYMORPHONE HCL ER, PAROXETINE CR, PAROXETINE ER, PAROXETINE HCL, PAROXETINE MESYLATE, PAXIL, PAXIL CR, PENTAZOCINE-NALOXONE HCL, PERCOCET, PERPHENAZINE-AMITRIPTYLINE, PHENYLBUTAZONE, PIROXICAM, PRIMLEV, PROLATE, PROMETHAZINE-CODEINE, PROPRANOLOL-HYDROCHLOROTHIAZID, PROTRIPTYLINE HCL, PROZAC, QDOLO, QUINAPRIL-HYDROCHLOROTHIAZIDE, R.E.C.K.(ROPIV-EPI-CLON-KETOR), RELAFEN DS, REMIFENTANIL HCL, ROPIVACAINE-CLONIDINE-KETOROLC, ROPIVACAINE-KETOROLAC-KETAMINE, ROXICODONE, ROXYBOND, SERTRALINE HCL, SILENOR, SPIRONOLACTONE-HCTZ, SPRIX, SUBLOCADE, SUBOXONE, SUBVENITE, SUBVENITE (BLUE), SUBVENITE (GREEN), SUBVENITE (ORANGE), SUFENTANIL CITRATE, SULINDAC, SUMATRIPTAN SUCC-NAPROXEN SOD, SYMBRAVO, TAPENTADOL ER, TAPENTADOL HCL, TEGRETOL, TEGRETOL XR, TELMISARTAN-HYDROCHLOROTHIAZID, TENORETIC 100, TENORETIC 50, THALITONE, TOLECTIN 600, TOLECTIN DS, TOLMETIN SODIUM, TORONOVA II SUIK, TORONOVA SUIK, TOXICOLOGY SALIVA COLLECTION, TRAMADOL HCL, TRAMADOL HCL ER, TRAMADOL HCL-ACETAMINOPHEN, TRESNI, TREXIMET, TREZIX, TRIAMTERENE-HYDROCHLOROTHIAZID, TRIBENZOR, TRICHLORMETHIAZIDE, TRIMIPRAMINE MALEATE, TUXARIN ER, ULTIVA, VALSARTAN-HYDROCHLOROTHIAZIDE, VASERETIC, VIBERZI, VIVLODEX, VYSCOXA, WIDAPLIK, XIFYRM, XTAMPZA ER, XYVONA, ZESTORETIC, ZIPSOR, ZOLOFT, ZORVOLEX, ZUBSOLV, ZYBIC, ZYNRELEF |
The following contraindication information is available for NOCDURNA (desmopressin acetate):
Drug contraindication overview.
*Hypersensitivity to desmopressin acetate or any ingredient in the formulation. *Moderate to severe renal impairment (creatinine clearance<50 mL/minute). *Hyponatremia or a history of hyponatremia.
*Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion (desmopressin injection). *Polydipsia (desmopressin injection). *Concomitant use with loop diuretics, or systemic or inhaled glucocorticoids (desmopressin injection).
*Use during illnesses that can cause fluid or electrolyte imbalance (e.g., gastroenteritis, salt-wasting nephropathies, or systemic infection) (desmopressin injection). *Heart failure (desmopressin injection). *Uncontrolled hypertension (desmopressin injection).
*Hypersensitivity to desmopressin acetate or any ingredient in the formulation. *Moderate to severe renal impairment (creatinine clearance<50 mL/minute). *Hyponatremia or a history of hyponatremia.
*Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion (desmopressin injection). *Polydipsia (desmopressin injection). *Concomitant use with loop diuretics, or systemic or inhaled glucocorticoids (desmopressin injection).
*Use during illnesses that can cause fluid or electrolyte imbalance (e.g., gastroenteritis, salt-wasting nephropathies, or systemic infection) (desmopressin injection). *Heart failure (desmopressin injection). *Uncontrolled hypertension (desmopressin injection).
There are 5 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Hyponatremia |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Kidney disease with likely reduction in glomerular filtration rate (GFr) |
| Psychogenic polydipsia |
There are 5 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Chronic heart failure |
| Coronary artery disease |
| Cystic fibrosis |
| Hypertension |
| Water intoxication |
The following adverse reaction information is available for NOCDURNA (desmopressin acetate):
Adverse reaction overview.
Adverse effects reported in patients administered desmopressin nasal spray include headache, nasal congestion, rhinitis, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and mild abdominal cramps. Common adverse effects reported in patients administered desmopressin injection include abdominal cramps, burning pain, erythema, facial flushing, fluid retention, headache, hypersensitivity reactions, hypertension, hyponatremia, hyponatremic seizures, hypotension, nausea, swelling, tachycardia, and thrombotic events. In long-term clinical studies in which patients with diabetes insipidus receiving desmopressin tablet therapy were followed for periods up to 44 months, transient increases in AST (<=1.5 times the upper limit of normal) were occasionally observed; elevated levels returned to the normal range despite continued use of the tablets. In controlled clinical trials of desmopressin tablets, headache was the only adverse effect occurring in >=3% or more of patients assessed as being probably, possibly, or remotely related to the study medication.
Adverse effects reported in patients administered desmopressin nasal spray include headache, nasal congestion, rhinitis, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and mild abdominal cramps. Common adverse effects reported in patients administered desmopressin injection include abdominal cramps, burning pain, erythema, facial flushing, fluid retention, headache, hypersensitivity reactions, hypertension, hyponatremia, hyponatremic seizures, hypotension, nausea, swelling, tachycardia, and thrombotic events. In long-term clinical studies in which patients with diabetes insipidus receiving desmopressin tablet therapy were followed for periods up to 44 months, transient increases in AST (<=1.5 times the upper limit of normal) were occasionally observed; elevated levels returned to the normal range despite continued use of the tablets. In controlled clinical trials of desmopressin tablets, headache was the only adverse effect occurring in >=3% or more of patients assessed as being probably, possibly, or remotely related to the study medication.
There are 7 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Anaphylaxis Hypertension Hyponatremia Hypotension Seizure disorder Water intoxication |
There are 8 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Abdominal pain with cramps Headache disorder Nausea |
| Rare/Very Rare |
|---|
|
Diarrhea Disturbance in thinking Flushing Vulvodynia Weight gain |
The following precautions are available for NOCDURNA (desmopressin acetate):
Fluid intake should be carefully restricted during desmopressin therapy in pediatric patients to prevent possible hyponatremia and water intoxication; fluid restriction should be discussed with the patient and/or caregiver. Desmopressin nasal spray is not indicated in pediatric patients less than 4 years of age. The safety and effectiveness of desmopressin injection have not been established in infants less than 3 months of age with hemophilia A or von Willebrand disease, or pediatric patients less than 12 years of age with diabetes insipidus.
Desmopressin tablets have been used safely for up to 44 months in pediatric patients 4 years of age or older with diabetes insipidus. In younger patients, dosage adjustment of oral desmopressin should be individualized to prevent an excessive decrease in plasma osmolality leading to hyponatremia and possible seizures. Desmopressin tablets have been used safely for up to 6 months in pediatric patients 6 years of age and older with primary nocturnal enuresis.
In patients with primary nocturnal enuresis, desmopressin therapy should be interrupted during acute intercurrent illness characterized by fluid and/or electrolyte imbalance (e.g., systemic infections, fever, recurrent vomiting or diarrhea) and under conditions associated with increased water intake (e.g., extremely hot weather, vigorous exercise).
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Desmopressin tablets have been used safely for up to 44 months in pediatric patients 4 years of age or older with diabetes insipidus. In younger patients, dosage adjustment of oral desmopressin should be individualized to prevent an excessive decrease in plasma osmolality leading to hyponatremia and possible seizures. Desmopressin tablets have been used safely for up to 6 months in pediatric patients 6 years of age and older with primary nocturnal enuresis.
In patients with primary nocturnal enuresis, desmopressin therapy should be interrupted during acute intercurrent illness characterized by fluid and/or electrolyte imbalance (e.g., systemic infections, fever, recurrent vomiting or diarrhea) and under conditions associated with increased water intake (e.g., extremely hot weather, vigorous exercise).
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Extensive experience with desmopressin use in pregnant women over several decades, based on the available published data and case reports, has not demonstrated anassociated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In vitrostudies with human placenta indicate poor placental transfer of desmopressin. Furthermore, reproductive and developmental toxicity studies in pregnant rats and rabbits administered desmopressin during organogenesis found no evidence of adverse developmental effects.
The manufacturer of desmopressin tablets states there are no adequate and controlled studies to date using desmopressin in pregnant females, and the medication should be used during pregnancy only if clearly needed. Although published reports state desmopressin, unlike preparations containing the natural hormones, has no uterotonic effect at usual antidiuretic doses, the clinician must weigh potential therapeutic benefits against possible risks. Pregnant females with hemophilia A or von Willebrand disease may have an elevated risk of bleeding diatheses and hemorrhagic complications during delivery. Newborns who are affected may also be at increased risk for bleeding diatheses.
The manufacturer of desmopressin tablets states there are no adequate and controlled studies to date using desmopressin in pregnant females, and the medication should be used during pregnancy only if clearly needed. Although published reports state desmopressin, unlike preparations containing the natural hormones, has no uterotonic effect at usual antidiuretic doses, the clinician must weigh potential therapeutic benefits against possible risks. Pregnant females with hemophilia A or von Willebrand disease may have an elevated risk of bleeding diatheses and hemorrhagic complications during delivery. Newborns who are affected may also be at increased risk for bleeding diatheses.
Clinically meaningful exposure of breast-fed infants to desmopressin is not expected following maternal administration, as transfer of desmopressin into human breast milk occurs at negligible levels. No data are available regarding effects of desmopressin on the breast-fed infant or on milk production. When considering use of desmopressin during lactation, weigh developmental and health benefits of breast-feeding against the mother's clinical need for therapy and any potential adverse effects on the breast-fed child from desmopressin or the underlying maternal condition. Caution should be exercised if desmopressin tablets are administered to breast-feeding mothers.
Fluid intake should be carefully restricted during desmopressin therapy in geriatric patients to prevent possible hyponatremia and water intoxication; fluid restriction should be discussed with the patient. Clinical studies of desmopressin did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. While other clinical experience has not revealed age-related differences in response, medication dosage generally should be titrated carefully in geriatric patients, usually initiating therapy at the low end of the dosage range.
The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and other medication therapies that may have interactions or contribute to adverse effects observed in the elderly should be considered. Desmopressin is known to be substantially excreted by the kidney and the risk of severe adverse reactions to the medication may be increased in patients with impaired renal function. Because geriatric patients may have age-related decreased renal function, renal function should be monitored and dosage adjusted accordingly.
The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and other medication therapies that may have interactions or contribute to adverse effects observed in the elderly should be considered. Desmopressin is known to be substantially excreted by the kidney and the risk of severe adverse reactions to the medication may be increased in patients with impaired renal function. Because geriatric patients may have age-related decreased renal function, renal function should be monitored and dosage adjusted accordingly.
The following prioritized warning is available for NOCDURNA (desmopressin acetate):
WARNING: Desmopressin can rarely cause low sodium levels in the blood (hyponatremia), which can be serious or even fatal. Your risk may be higher if you drink too much fluid, take certain medications (such as "water pills"/diuretics including furosemide, corticosteroids such as prednisone), are 65 years or older, or have certain medical conditions. To monitor your risk, your doctor should check your sodium blood level before you start taking this medication and while you are taking it.
Keep all medical and lab appointments. Tell your doctor right away if you develop symptoms of low sodium in the blood, such as nausea, vomiting, muscle weakness/cramps, unusual tiredness, unusual drowsiness, dizziness, restlessness, mental/mood changes including confusion/irritability. Get medical help right away if you have any very serious side effects, including seizures or trouble breathing.
WARNING: Desmopressin can rarely cause low sodium levels in the blood (hyponatremia), which can be serious or even fatal. Your risk may be higher if you drink too much fluid, take certain medications (such as "water pills"/diuretics including furosemide, corticosteroids such as prednisone), are 65 years or older, or have certain medical conditions. To monitor your risk, your doctor should check your sodium blood level before you start taking this medication and while you are taking it.
Keep all medical and lab appointments. Tell your doctor right away if you develop symptoms of low sodium in the blood, such as nausea, vomiting, muscle weakness/cramps, unusual tiredness, unusual drowsiness, dizziness, restlessness, mental/mood changes including confusion/irritability. Get medical help right away if you have any very serious side effects, including seizures or trouble breathing.
The following icd codes are available for NOCDURNA (desmopressin acetate)'s list of indications:
| Nocturia | |
| R35.1 | Nocturia |
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