What is OLANZAPINE AND SAMIDORPHAN L-MALATE used for?

OLANZAPINE AND SAMIDORPHAN L-MALATE is a Atypical Antipsychotic indicated for an atypical antipsychotic, and samidorphan, an opioid antagonist.

What are the most common side effects of OLANZAPINE AND SAMIDORPHAN L-MALATE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for OLANZAPINE AND SAMIDORPHAN L-MALATE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is OLANZAPINE AND SAMIDORPHAN L-MALATE the same as its brand-name version?

OLANZAPINE AND SAMIDORPHAN L-MALATE is the generic name. The active ingredient is the same across any brand-name or generic versions approved by the FDA.

OLANZAPINE AND SAMIDORPHAN L-MALATE

Q: How does OLANZAPINE AND SAMIDORPHAN L-MALATE work?

OLANZAPINE AND SAMIDORPHAN L-MALATE works through the following mechanism: 12.1 Mechanism of Action The mechanism of action of olanzapine is unclear; however, its efficacy in the treatment of schizophrenia or bipolar I disorder could be mediated through a combination of dopamine and serotonin type 2 (5HT 2 ) antagonism. The mechanism of action of samidorphan could be mediated through opioid receptor antagonism..

Atypical Antipsychotic

Oral

Mechanism of Action

12.1 Mechanism of Action The mechanism of action of olanzapine is unclear; however, its efficacy in the treatment of schizophrenia or bipolar I disorder could be mediated through a combination of dopamine and serotonin type 2 (5HT 2 ) antagonism. The mechanism of action of samidorphan could be mediated through opioid receptor antagonism.

Indications

an atypical antipsychotic

and samidorphan

an opioid antagonist

Contraindications

• 4 CONTRAINDICATIONS LYBALVI is contraindicated in patients: who are using opioids [ see Warnings and Precautions ( 5.3
• 5.4 )
• Drug Interactions ( 7.3 )] . who are undergoing acute opioid withdrawal [see Warnings and Precautions ( 5.3
• 5.4 )
• Drug Interactions ( 7.3 )] . If LYBALVI is administered with lithium or valproate

FDA Warnings

5 WARNINGS AND PRECAUTIONS Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis : Increased incidence of cerebrovascular adverse reactions (e
, stroke, transient ischemic attack, including fatalities)
3 ) Vulnerability to Life-Threatening Opioid Overdose : Risk of Opioid Overdose from Attempts to Overcome LYBALVI Opioid Blockade: Attempts to overcome LYBALVI opioid blockade with high or repeated doses of opioids may lead to fatal opioid intoxication, particularly if LYBALVI therapy is interrupted or discontinued
4 ) Risk of Resuming Opioids in Patients with Prior Opioid Use : Patients with a history of chronic opioid use prior to LYBALVI treatment may have decreased opioid tolerance if LYBALVI therapy is interrupted or discontinued

Known Side Effects

8 documented side effects by frequency

Drug Not Working

>10%

Weight Gain

>10%

Drowsiness

1-10%

Nausea

1-10%

Fatigue

1-10%

Anxiety

1-10%

Vomiting

1-10%

Condition Worsened

0.1-1%

Community Discussions

No community discussions found for OLANZAPINE AND SAMIDORPHAN L-MALATE yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → OLANZAPINE AND SAMIDORPHAN L-MALATE openFDA label JSON → OLANZAPINE AND SAMIDORPHAN L-MALATE FAERS adverse-event reports → OLANZAPINE AND SAMIDORPHAN L-MALATE ClinicalTrials.gov → completed Phase 2+ trials of OLANZAPINE AND SAMIDORPHAN L-MALATE

Compare With

9 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral