stimate
Pharmaranks rates Stimate 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Stimate (Desmopressin Acetate) is a factor viii activator used to treat Enuresis, Hemorrhage, Thrombocytopenia, Von Willebrand Diseases.
Desmopressin Acetate · by Ferring Pharms Inc
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Desmopressin Acetate
- Drug class
- Factor Viii Activator
- Form
- Spray/Inhaler, metered
- Strength
- Desmopressin Acetate 0.15MG/SPRAY
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- enuresis, hemorrhage, thrombocytopenia
- Manufacturer
- Ferring Pharms Inc
- What the pharmacy pays
- ~$0.37 per ml — not your price
- FDA application
- NDA020355
- Availability
- Discontinued (per FDA)
What is Stimate?
From the FDA label:STIMATE (desmopressin acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows: Molecular weight: 1183.34 Empirical formula: C 46 H 64 N 14 O 12 S 2 •C 2 H 4 O 2 •3H 2 O 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. STIMATE is an aqueous solution for intranasal use. Each mL contains: Benzalkonium chloride solution 0.1 mg, Citric acid monohydrate 1.7 mg, Desmopressin acetate 1.5 mg, Disodium phosphate dihydrate 3 mg, Purified water to 1 mL, Sodium chloride 7.5 mg. A black text on a white background AI-generated content may be incorrect.
How to use
Instruct patients to prime pump prior to use. ( 2 ) Patients weighing at least 50 kg: 300 mcg (one spray in each nostril). ( 2.2 ) Patients weighing less than 50 kg: 150 mcg administered as a single spray ( 2.2 ) Should not be used in infants younger than 11 months. ( 2.2 ) Not indicated for patients who require less than a 150 mcg dose. ( 2.2 ) 2.1 Pretreatment Testing and On-Treatment Monitoring Hemophilia A Laboratory tests for assessing patient status include levels of Factor VIII coagulant, Factor VIII antigen and Factor VIII ristocetin cofactor (von Willebrand factor) as well as activated partial thromboplastin time. Factor VIII coagulant activity should be determined before giving STIMATE for hemostasis. If Factor VIII coagulant activity is present at less than 5% of normal, STIMATE should not be relied on. von Willebrand's Disease Laboratory tests for assessing patient status include levels of Factor VIII coagulant activity, VWF:RCo and VWF:Ag. Fluid Restriction Instruct patients about appropriate fluid restriction during STIMATE treatment. Fluid restriction should be observed, and fluid intake should be limited to a minimum, from 1 hour before desmopressin administration, until at least 24 hours after administration [see Warnings and Precautions ( 5.1 )]. 2.2 Recommended Dosage The recommended dosage for patients weighing at least 50 kg is 300 mcg intranasal spray…
Side effects
The following serious reactions are described below and elsewhere in the labeling: Hyponatremia [see Warnings and Precautions ( 5.1 )]. Hypotension and Hypertension [see Warnings and Precautions ( 5.2 )] . Altered Absorption in Patients with Changes in Nasal Mucosa [see Warnings and Precautions ( 5.3 )] . Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] . Increased Risk of Thrombosis in Patients with von Willebrand’s Disease Type IIB [see Warnings and Precautions ( 5.5 )] . The following adverse reactions have been identified during post-approval use of desmopressin acetate intranasal formulations. 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: Cardiac disorders : Tachycardia, palpitations Eye disorders : Eye redness, eye itchiness, light sensitivity Gastrointestinal disorders : Nausea*, abdominal cramps/pain*, dyspepsia General disorders and administration site conditions : Peripheral edema*, fatigue*, chills, chest pain Immune system disorders : Hypersensitivity reactions Investigations : Weight increased* Metabolism and nutrition disorders : Hyponatremia Nervous system disorders : Headache, somnolence, dizziness, insomnia, hyponatremic convulsions Psychiatric disorders : Confusional state* Respiratory,…
Warnings
Important safety information
Hyponatremia : Excessive fluid intake when urine output is limited by the antidiuretic effect of desmopressin may lead to water intoxication with hyponatremia. ( 5.1 ) Hypotension and Hypertension : May cause hypotension with compensatory increase in heart rate or hypertension. Monitor blood pressure during STIMATE administration, especially in patients with heart disease. ( 5.2 ) Altered Absorption in Patients with Nasal Mucosa Abnormalities: changes in the nasal mucosa such as scarring, edema, or other disease may cause erratic, unreliable absorption. ( 5.3 ) Hypersensitivity Reactions : Severe reactions have occurred. Monitor for reactions during administration and interrupt if reaction occurs. ( 5.4 ) Increased Risk of Thrombosis in Patients with von Willebrand’s Disease Type IIB : Use of STIMATE in patients with Type IIB von Willebrand’s disease may cause thrombosis due to platelet aggregation. ( 5.5 ) 5.1 Hyponatremia Serious and fatal hyponatremia may occur with STIMATE use. STIMATE is contraindicated in patients with hyponatremia (or a history of it) and known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion [see Contraindications ( 4 )] . 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 post-marketing experience in patients treated with desmopressin acetate. Unless properly diagnosed and treated, hyponatremia can be fatal. Observe patients receiving STIMATE for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, malaise, fatigue, lethargy, disorientation, depressed reflexes, loss appetite, irritability, muscle weakness, muscle spasms or cramps, and abnormal mental status such as hallucinations, decreased consciousness, and confusion. Severe symptoms due to an extreme decrease in serum sodium and plasma osmolality may include one or a combination of the following: seizure, coma, and/or respiratory arrest. Advise patients to restrict fluids in order to decrease the risk of water intoxication with hyponatremia. Careful fluid intake restriction is particularly important in pediatric and geriatric patients because these patients are at greater risk of developing hyponatremia [see Use in Specific Populations ( 8.4 , 8.5 )]. More frequent monitoring of serum sodium levels is recommended in the following patients: those with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure, renal disorders, habitual or psychogenic polydipsia or those taking concomitant drugs that may cause hyponatremia or are known to induce SIADH . 5. 2 Hypotension and Hypertension STIMATE may cause changes in blood pressure. Changes have included elevation or reduction in blood pressure which may also cause a compensatory increase in heart rate. Monitor blood pressure and pulse more frequently if used in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease. 5. 3 Altered Absorption in Patients with Nasal Mucosa Abnormalities Since STIMATE is used intranasally, changes in the nasal mucosa such as scarring, edema, or other disease may cause erratic, unreliable absorption in which case STIMATE should be discontinued until the nasal problems resolve. Avoid use of STIMATE in such patients and consider use of other formulations of desmopressin acetate given by other routes of administration [see Dosage and Administration ( 2.4 )] . 5.4 Hypersensitivity Reactions STIMATE is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of STIMATE [see Contraindications ( 4 )] . Severe allergic reactions, including fatal anaphylaxis, have been reported with desmopressin. It is not known whether antibodies to desmopressin acetate are produced after repeated administration. 5.5 Increased Risk of Thrombosis in Patients with von Willebrand’s Disease Type IIB STIMATE is contraindicated in patients with Type IIB von Willebrand's disease [see Contraindications ( 4 )] . Use of STIMATE in patients with Type IIB von Willebrand’s disease may result in platelet aggregation, thrombocytopenia, and possibly thrombosis.
Who should not take Stimate
STIMATE is contraindicated in patients with: Known hypersensitivity to desmopressin acetate or to any of the components of STIMATE. Severe allergic reactions and anaphylaxis have been reported [see Warnings and Precautions ( 5.4 )]. Hyponatremia or a history of hyponatremia [see Warnings and Precautions ( 5.1 )] . Type IIB von Willebrand's disease [see Warnings and Precautions ( 5.5 ) Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to desmopressin acetate or to any of the components of STIMATE ( 4 , 5.4 ) Hyponatremia or a history of hyponatremia ( 4 , 5.1 ) Type IIB von Willebrand's disease ( 4 , 5.5 ) Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion. ( 4 )
Overdose — what happens if you take too much
Signs of desmopressin acetate overdosage may include confusion, drowsiness, continuing headache, problems with passing urine, and rapid weight gain due to fluid retention [see Warnings and Precautions ( 5.1 )]. In case of overdosage, reduce the dosage, decrease the frequency of administration, or discontinue STIMATE. There is no known specific antidote for desmopressin acetate. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Other Drugs that may Increase Risk of Hyponatremia: Monitor serum sodium more frequently. ( 7.1 ) Other Vasoconstrictors: May require a reduction of the STIMATE dosage. ( 7.2 ) 7.1 Other Drugs that may Increase Risk of Hyponatremia The concomitant administration of STIMATE 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, NSAIDs, lamotrigine, and carbamazepine) requires more frequent serum sodium monitoring [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6 )] . 7.2 Other Vasoconstrictors Desmopressin acetate can elevate blood pressure. Use of large doses of STIMATE with other vasoconstrictors may require a reduction of the STIMATE dosage [ see Warnings and Precautions ( 5.2 ) ] .
Drug class
- Factor VIII Activator
- Vasopressin Analog
May treat (source: NIH RxClass)
- enuresis
- hemorrhage
- thrombocytopenia
- von willebrand diseases
- neurogenic diabetes insipidus
Dosage forms
Spray/Inhaler, metered
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Stimate treat?
- Stimate (Desmopressin Acetate) may be used to treat enuresis, hemorrhage, thrombocytopenia, von willebrand diseases, neurogenic diabetes insipidus, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Stimate rated?
- pharmaranks gives Stimate a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Stimate cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.37 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Stimate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Stimate. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Stimate?
- Stimate is marketed by Ferring Pharms Inc. You can see Ferring Pharms Inc's full profile, rating, and other products on pharmaranks.
- Is Stimate a brand-name or generic drug?
- Stimate is a brand-name product with the active ingredient Desmopressin Acetate.
- Is Stimate available over the counter?
- No. Stimate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Stimate come in?
- Stimate is currently marketed as spray/inhaler, metered, per the FDA's National Drug Code Directory.
- What class of drug is Stimate?
- Stimate is classified as factor viii activator, vasopressin analog, per the FDA's Established Pharmacologic Class.
- Is Stimate FDA-registered?
- Stimate is on record with the U.S. FDA under application number NDA020355. You can verify this on its official FDA label.
- Has Stimate been recalled by the FDA?
- Stimate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Stimate safe?
- There's no single safe-or-not verdict. pharmaranks gives Stimate a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Stimate?
- Stimate's side effects are taken directly from its FDA label. From the label: The following serious reactions are described below and elsewhere in the labeling: Hyponatremia [see Warnings and Precautions ( 5.1 )]. Hypotension and Hypertension [see Warnings and Precautions ( 5.2 )] .… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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stimate
72/100