Valtoco (diazepam nasal spray) is a prescription medication used for the short-term treatment of seizure clusters in patients with epilepsy who are two years of age and older. Unlike daily maintenance medications, Valtoco is a rescue therapy, administered on an as-needed basis to stop episodes of frequent seizures that are distinct from a person's usual seizure pattern. Because Valtoco is a powerful benzodiazepine, adhering to the specific dosing and frequency guidelines prescribed by a healthcare provider is paramount to ensure safety and effectiveness.
Understanding Valtoco's Frequency Restrictions
To prevent the risks of tolerance, physical dependence, and adverse side effects, the use of Valtoco is carefully controlled. These restrictions include limits on both the number of doses per episode and the frequency of episodes treated over time. These guidelines are based on clinical studies and FDA recommendations to maximize benefit while minimizing risk.
Maximum doses per seizure cluster
For a single episode of a seizure cluster, patients should use no more than two doses of Valtoco. A second dose is only administered if necessary and if the patient's breathing and level of consciousness are stable.
Time between doses
If a second dose is required to treat the same seizure cluster, it must be administered at least four hours after the initial dose. This waiting period allows the first dose to take effect and helps prevent over-sedation or respiratory depression. It is critical to use a new, single-use Valtoco device for each dose.
Limits on monthly use
Beyond the limits per single episode, there are broader restrictions on overall use to prevent dependence. Valtoco should not be used to treat more than one seizure cluster episode every five days. Additionally, the medication should not be used for more than five episodes per month. If a patient's seizure clusters become more frequent than this, a healthcare provider should be consulted to re-evaluate the patient's long-term epilepsy management plan.
The Risks of Overusing Valtoco
Overusing benzodiazepines like Valtoco, either by exceeding the recommended dosage per episode or by using it more frequently than prescribed, carries significant risks. Chronic or excessive use can lead to the development of tolerance, meaning the medication becomes less effective over time. It can also result in physical dependence, where the body relies on the drug to function normally. Abruptly stopping the medication in this state can cause severe withdrawal reactions, which may be life-threatening and can include an increase in seizure frequency or severity.
Valtoco vs. Nayzilam: A Comparison of Nasal Sprays
Valtoco is not the only rescue nasal spray available for seizure clusters. Nayzilam (midazolam) is another benzodiazepine option, and it's helpful to understand the key differences between the two, particularly concerning dosing and approved age ranges.
| Feature | Valtoco (Diazepam Nasal Spray) | Nayzilam (Midazolam Nasal Spray) |
|---|---|---|
| Active Ingredient | Diazepam | Midazolam |
| Approved Age | 2 years and older | 12 years and older |
| Max Doses Per Episode | 2 doses | 2 doses |
| Time Between Doses | At least 4 hours | After 10 minutes, if unresponsive |
| Usage Frequency Limit | Not more than 1 episode every 5 days and 5 episodes per month | Not more than 1 episode every 3 days and 5 episodes per month |
| Onset of Action | Typically works within 4 minutes | Takes up to 10 minutes |
| Side Effects | Drowsiness, headache, nasal discomfort | Drowsiness, headache, nasal discomfort |
Safe Administration and Important Considerations
Administering Valtoco requires careful attention to detail to ensure the patient receives the full dose and to avoid misuse. Here are some key points to remember:
- Proper Technique: The single-use device should be inserted into one nostril. For certain higher weight-based doses (15 mg or 20 mg), two devices are used, one in each nostril.
- Ready-to-Use: Valtoco is ready-to-use and does not need to be primed. Each device delivers a single, full spray and should be discarded immediately after use.
- Watch for Adverse Reactions: After administering the medication, the patient should be carefully monitored. Emergency medical care should be sought if seizure symptoms do not improve, or if the patient experiences excessive sleepiness or breathing problems.
- Do Not Combine with CNS Depressants: A boxed warning on Valtoco emphasizes the risk of profound sedation, respiratory depression, coma, and death when used with opioids, alcohol, or other central nervous system depressants.
- Mental Health Monitoring: Like other antiepileptic drugs, Valtoco carries a risk of suicidal thoughts or behavior. Patients and caregivers should watch for any unusual changes in mood or behavior.
Conclusion
Valtoco nasal spray is a valuable rescue medication for managing intermittent seizure clusters, but its use requires strict adherence to dosing frequency. A maximum of two doses can be administered per seizure cluster, with at least a four-hour waiting period between doses. Patients should not exceed more than one episode treated every five days or five episodes per month. Overuse can lead to dangerous side effects, including tolerance and dependence. Anyone involved in administering Valtoco should be thoroughly trained on the proper technique and must closely monitor the patient for any signs of adverse reactions. As a Schedule IV controlled substance, proper storage and disposal are also necessary. For any questions or changes in a seizure cluster pattern, always consult with a healthcare professional for guidance. For more information, the official FDA prescribing information can provide additional detail.
