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National Drug Formulary

VALTOCO NASAL SPRAY 10MG/SPRAY [SIN17435P]

Active ingredients: VALTOCO NASAL SPRAY 10MG/SPRAY

View product's general information
Last updated 24 April 2026

Product Info

VALTOCO NASAL SPRAY 10MG/SPRAY

[SIN17435P]

Product information

Active Ingredient and Strength

DIAZEPAM - 10 MG/SPRAY

Dosage Form

SPRAY

Manufacturer and Country

RENAISSANCE LAKEWOOD LLC - UNITED STATES

Registration Number

SIN17435P

Licence Holder

RXILIENT MEDICAL PTE LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

N05BA01

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

1 INDICATIONS AND USAGE

VALTOCO® is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older.

Dosing

2 DOSAGE AND ADMINISTRATION

2.1 Instructions Prior to Dosing

Prior to treatment, healthcare professionals should instruct the individual administering VALTOCO on how to identify seizure clusters and use the product appropriately [see Dosage and Administration (2.3) and Patient Counseling Information (17) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.2 Dosing Information

The recommended dose of VALTOCO nasal spray is 0.2 mg/kg or 0.3 mg/kg, depending on the patient’s age and weight. See Table 1 for specific recommendations.

The following table provides the acceptable weight ranges for each dose and age category, such that patients will receive between 90% and 180% of the calculated recommended dose.

Valtoco Dosage Table 1



Second Dose (if needed): A second dose, when required, may be administered after at least 4 hours after the initial dose. If the second dose is to be administered, use a new blister pack of VALTOCO.

Maximum Dosage and Treatment Frequency: Do not use more than 2 doses of VALTOCO to treat a single episode.

It is recommended that VALTOCO be used to treat no more than one episode every five days and no more than five episodes per month.

2.3 Important Administration Instructions

VALTOCO is for intranasal use only.

No device assembly is required. VALTOCO is a ready-to-use nasal spray device. VALTOCO nasal spray delivers its entire contents upon activation. Do not prime or attempt to use for more than one administration per device.

Patients and caregivers should be counseled to read carefully the “Instructions for Use” for complete directions on how to properly administer VALTOCO.

Contraindications

4 CONTRAINDICATIONS

VALTOCO nasal spray is contraindicated in patients with:

  • Known hypersensitivity to diazepam

  • Acute narrow angle glaucoma [see Warnings and Precautions (5.6) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]