💊 Diazepam (Valtoco)

🏷️ Brand names & manufacturers

Valtoco🏭 Neurelis, IncDailyMed

Valium🏭 Waylis Therapeutics LLCDailyMed

Diazepam🏭 Alembic Pharmaceuticals LimitedDailyMed

💊

Diazepam🏭 Natco Pharma USA LLC

Diazepam🏭 Hikma Pharmaceuticals USA Inc.DailyMed

✅ What it is used for

• Acute treatment of seizure clusters (acute repetitive seizures) distinct from the patient's usual seizure pattern
• In patients with epilepsy 2 years of age and older

🧪 Active ingredient

Diazepam: a benzodiazepine anticonvulsant. Its exact mechanism is not fully understood, but it is thought to involve potentiation of GABAergic neurotransmission by binding at the benzodiazepine site of the GABA-A receptor.

🌿 Benefits

• Treats acute seizure clusters via the nasal route
• No device assembly needed; can be given by a trained caregiver

📝 How to use

• For nasal use only
• The dose is set by your doctor or pharmacist based on age and weight; do not change it without consulting them
• 5 mg and 10 mg doses are given as a single spray into one nostril; 15 mg and 20 mg doses require two devices, one spray in each nostril
• No device assembly is required; the device delivers its entire contents when activated and must not be primed or used more than once
• Healthcare professionals should train the person giving the medicine to recognize seizure clusters and use the product correctly; read the Instructions for Use carefully
• A second dose, if required, may be given at least 4 hours after the first using a new blister pack; do not use more than 2 doses for a single episode
• It is recommended to treat no more than one episode every five days and no more than five episodes per month

💊 Dosage forms

• Nasal spray: 5 mg, 7.5 mg, or 10 mg of diazepam in 0.1 mL per device
• Packaged in doses of 5, 10, 15, or 20 mg

🔄 Drug interactions

• Opioids: risk of profound sedation, respiratory depression, coma, and death
• Alcohol and other CNS depressants (e.g., valproate): increased CNS-depressant effects
• CYP2C19 and CYP3A4 inhibitors (e.g., cimetidine, ketoconazole): may decrease diazepam elimination and increase adverse reactions
• CYP2C19 and CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital): may increase elimination and decrease efficacy
• May interfere with metabolism of other CYP2C19/CYP3A4 substrates such as omeprazole, propranolol, and imipramine

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👨‍⚕️ For healthcare professionals

Mechanism of action

Thought to potentiate GABAergic neurotransmission via the benzodiazepine site of the GABA-A receptor. Absolute bioavailability is 97% versus IV; peak plasma concentration at about 1.5 hours; mean elimination half-life about 49.2 hours (10 mg dose). Metabolized mainly by CYP2C19 and CYP3A4; 95-98% protein bound.

Labeled dosing

Recommended dose is 0.2 to 0.5 mg/kg by age and weight, set by the prescriber: ages 2-5 years 0.5 mg/kg; 6-11 years 0.3 mg/kg; 12 years and older 0.2 mg/kg. For patients 12 and older: 5 mg for 14-27 kg, 10 mg for 28-50 kg, 15 mg for 51-75 kg, 20 mg for 76 kg and up. A second dose may be given at least 4 hours after the first if needed; maximum 2 doses per episode, no more than one episode every five days or five per month.

• Intranasal use only
• Instruct the person administering on identifying seizure clusters and proper use
• Assess risk of abuse, misuse, and dependence before prescribing and throughout treatment
• In overdose, flumazenil may precipitate withdrawal seizures and should be an adjunct to, not a substitute for, supportive care

🎓 Key points for students

• Benzodiazepine enhancing GABA-A activity
• Indicated for acute seizure clusters in patients 2 years and older
• Contraindications: hypersensitivity and acute narrow-angle glaucoma
• Boxed warning: opioids, abuse/addiction, dependence and withdrawal
• Metabolized by CYP2C19 and CYP3A4; long half-life (about 49 hours)