VALTOCO Dosage & Rx Info | Uses, Side Effects

Valtoco Generic Name & Formulations

Legal Class

CIV

General Description

Diazepam 5mg, 7.5mg, 10mg; per nasal spray; contains benzyl alcohol.

Pharmacological Class

Benzodiazepine.

How Supplied

Nasal spray 5mg—2; 7.5mg—4; 10mg—2, 4

Manufacturer

Neurelis, Inc.

Generic Availability

Valtoco Indications

Indications

Acute treatment of intermittent, stereotypic episodes of seizure activity (eg, seizure clusters, acute repetitive seizures) that are distinct from usual seizure pattern.

Valtoco Dosage and Administration

Adults and Children

For intranasal use only. Individualize. Calculate dose based on body weight (in kg) and round up to next available dosage strength. Treat no more than 1 episode every 5 days and no more than 5 episodes per month. <6yrs: not established. 6–11yrs: 0.3mg/kg. ≥12yrs: 0.2mg/kg. See full labeling for dosing chart. If needed, may give 2^nd dose at least 4 hours after 1^st dose. Max 2 doses/episode. Elderly: reduce dose.

Valtoco Contraindications

Contraindications

Acute narrow-angle glaucoma.

Valtoco Boxed Warnings

Boxed Warning

Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

Valtoco Warnings/Precautions

Warnings/Precautions

Risks from concomitant use with opioids; see Interactions. Caregiver must be fully able to identify cluster seizures, be able to decide when to treat, correctly administer dose, monitor patient, and assess response. CNS depression. Monitor for emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes. Untreated open-angle glaucoma. Compromised respiratory function. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Drug or alcohol abusers. Renal impairment. Elderly. Premature neonates/infants: gasping syndrome (due to benzyl alcohol content). Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: monitor infants.

Valtoco Pharmacokinetics

Distribution

95–98% plasma protein bound. The estimated volume of distribution of diazepam at steady-state is 0.8 to 1.0 L/kg.

Metabolism

Hepatic (CYP2C19, CYP3A4).

Elimination

Half-life: ~49.2 hours.

Valtoco Interactions

Interactions

Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. CNS depression potentiated with alcohol, other CNS depressants (eg, valproate). Caution with other psychotropics. May be potentiated by inhibitors of CYP2C19 (eg, cimetidine, quinidine, tranylcypromine) or CYP3A4 (eg, ketoconazole, troleandomycin, clotrimazole). May be antagonized by inducers of CYP2C19 (eg, rifampin) or CYP3A4 (eg, carbamazepine, phenytoin, dexamethasone, phenobarbital). Diazepam may interfere with the metabolism of drugs which are substrates for CYP2C19 (eg, omeprazole, propranolol, imipramine) or CYP3A4 (eg, cyclosporine, paclitaxel, theophylline, warfarin).

Valtoco Adverse Reactions

Adverse Reactions

Somnolence, headache, nasal discomfort; dependence, withdrawal reactions.

Valtoco Clinical Trials

See Literature

Valtoco Note

Not Applicable

Valtoco Patient Counseling