Dsuvia

SUFENTANIL

Manufacturer: AcelRx Pharmaceuticals, Inc.

Score: 144.0

Quick Summary

Dsuvia (sufentanil) is an opioid agonist used for the management of acute pain severe enough to require an opioid analgesic in a certified medically supervised healthcare setting. It is available as a single 30 mcg sublingual tablet and should be administered by a healthcare provider. The recommended dosage is 30 mcg as needed with a minimum of 1 hour between doses, not to exceed 12 tablets in 24 hours. Dsuvia has a boxed warning for serious and life-threatening risks, including accidental exposure, addiction, abuse, and misuse, life-threatening respiratory depression, and risks from concomitant use with benzodiazepines or other CNS depressants. Special population considerations include use in pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Management of acute pain severe enough to require an opioid analgesic
Certified medically supervised healthcare setting
Sublingual administration

Important Safety Information

Warning

Serious and life-threatening risks from use of Dsuvia, including accidental exposure, addiction, abuse, and misuse, life-threatening respiratory depression, and risks from concomitant use with benzodiazepines or other CNS depressants

Contraindications

Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Known hypersensitivity to sufentanil or components of Dsuvia

Adverse Reactions

Nausea
Headache
Vomiting
Dizziness
Hypotension

Dosing Recommendations

General Guidance

Do not exceed 12 tablets in 24 hours

Acute pain

Adult Dose

30 mcg sublingually as needed with a minimum of 1 hour between doses

Pediatric Dose

Not recommended for use in pediatric patients

Special Population Considerations

Pregnancy

Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome
Dsuvia is not recommended for use in pregnant women during or immediately prior to labor

Nursing Mothers

Pediatric Use

The safety and efficacy of the use of Dsuvia in pediatric patients has not been established
Not recommended for use in pediatric patients

Geriatric Use

No special population studies were performed using Dsuvia in elderly patients
Monitor geriatric patients closely for signs of central nervous system and respiratory depression

Similar Drugs

Codeine Sulfate

CODEINE SULFATE

Lannett Company, Inc.

Similarity: 64.0%

Codeine sulfate

CODEINE SULFATE

Hikma Pharmaceuticals USA Inc.

Similarity: 64.0%

Methadone Hydrochloride

METHADONE HYDROCHLORIDE

Hikma Pharmaceuticals USA Inc.

Similarity: 61.7%

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

NuCare Pharmaceuticals,Inc.

Similarity: 60.2%