Dsuvia
- Generic Name: sufentanil sublingual tablet
- Brand Name: Dsuvia
- Drug Class: Opioid Analgesics, Synthetic, Opioids
Dsuvia (Sufentanil Sublingual Tablet) side effects drug center
Dsuvia Side Effects Center
What Is Dsuvia?
Dsuvia (sufentanil) is an opioid agonist indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
What Are Side Effects of Dsuvia?
Common side effects of Dsuvia include:
- nausea,
- headache,
- vomiting,
- dizziness, and
- low blood pressure (hypotension)
Dosage for Dsuvia
The recommended dosage of Dsuvia is 30 mcg sublingually as needed with a minimum of one hour between doses. Do not exceed 12 Dsuvia tablets in 24 hours.
What Drugs, Substances, or Supplements Interact with Dsuvia?
Dsuvia may interact with macrolide antibiotics, azole antifungals, protease inhibitors, rifampin, carbamazepine, phenytoin, alcohol, benzodiazepines, sedatives/hypnotics, anti-anxiety medications, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system, monoamine oxidase inhibitors (MAOIs), diuretics, and anticholinergics. Tell your doctor all medications and supplements you use.
Dsuvia During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Dsuvia; prolonged use of opioid analgesics such as Dsuvia during pregnancy may cause neonatal opioid withdrawal syndrome. Dsuvia passes into breast milk and may cause adverse effects in nursing infants. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Dsuvia.
Additional Information
Our Dsuvia (sufentanil) Sublingual Tablet, CII Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Dsuvia Professional Information
SIDE EFFECTS
The following serious adverse reactions are described, or described in greater detail, in other sections:
- Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS ]
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
- Severe hypotension [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In controlled and uncontrolled studies, the safety of DSUVIA was evaluated in a total of 646 patients with moderate-to-severe acute postoperative pain or pain due to trauma which required opioid analgesia.
The most frequently reported adverse reactions ≥ 2% that were probably or possibly related to study treatment in the one pivotal, placebo-controlled trial (Study SAP301) are presented in Table 1.
Discontinuation of study drug due to adverse events occurred in 0.9% of DSUVIA-treated patients (1 out of 107 patients) and 3.7% of placebo-treated patients (2 out of 54 placebo treated patients). The most common reasons for discontinuation of study drug due to adverse reactions in SAP301 were oxygen saturation decreased (0.9% in the DSUVIA group), and dizziness, hemiparesis, somnolence and syncope in the placebo group (1.9% each).
Table 1 : Adverse Reactions Occurring in ≥ 2% of Patients and for Which Rate is Higher in DSUVIA than Placebo Group: Placebo-Controlled Study SAP301
| Possibly or Probably Related Adverse Reactions | DSUVIA n=107 | Placebo * n=54 |
| Nausea | 29.0% | 22.2% |
| Headache | 12.1% | 11.1% |
| Vomiting | 5.6% | 1.9% |
| Dizziness | 5.6% | 3.7% |
| Hypotension | 4.7% | 3.7% |
| *Morphine 1 mg IV was permitted as rescue medication | ||
Other Reported Adverse Reactions
Additional treatment related adverse drug reactions which occurred in at least 0.1% of the patients exposed to 30 mcg or higher of sublingual sufentanil are described below.
Cardiac Disorders: sinus tachycardia, bradycardia.
Gastrointestinal Disorders: constipation, dyspepsia, flatulence, diarrhea, dry mouth, eructation, retching, abdominal discomfort, abdominal distension, abdominal pain upper, gastritis, postoperative ileus, hypoesthesia oral.
Investigations: oxygen saturation decreased, respiratory rate decreased, urine output decreased, aspartate aminotransferase increased, electrocardiogram abnormal, hepatic enzyme increased.
Musculoskeletal and Connective Tissue Disorders: muscle spasms.
Nervous System Disorders: somnolence, sedation, presyncope, lethargy, memory impairment.
Psychiatric Disorders: insomnia, confusional state, anxiety, agitation, disorientation, euphoric mood, hallucination, mental status changes.
Renal and Urinary Disorders: urinary retention, urinary hesitation, oliguria, renal failure.
Respiratory, Thoracic and Mediastinal Disorders: hypoxia, bradypnea, hiccups, apnea, atelectasis, hypoventilation, respiratory distress, respiratory failure.
Skin and Subcutaneous Tissue Disorders: pruritus, hyperhidrosis, rash.
Vascular Disorders: hypotension, hypertension, orthostatic hypotension, flushing.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of sufentanil. 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.
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis: Anaphylaxis has been reported with ingredients contained in DSUVIA.
Androgen Deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].
Read the entire FDA prescribing information for Dsuvia (Sufentanil Sublingual Tablet)
&Copy; Dsuvia Patient Information is supplied by Cerner Multum, Inc. and Dsuvia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.