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Valtoco

Last reviewed on RxList: 9/10/2020
Valtoco Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Valtoco?

Valtoco (diazepam nasal spray) is a benzodiazepine used 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.

What Are Side Effects of Valtoco?

Side effects of Valtoco include:

  • drowsiness,
  • headache,
  • nasal discomfort,
  • diarrhea,
  • loss of coordination,
  • dizziness,
  • euphoria,
  • rash, and
  • asthma

Abrupt withdrawal of chronic Valtoco use may also be associated with a temporary increase in the frequency and/or severity of seizures.

Dosage for Valtoco

Valtoco 5 mg and 10 mg doses are administered as a single spray intranasally into one nostril. Administration of 15 mg and 20 mg doses requires two nasal spray devices, one spray into each nostril. A second dose, when required, may be administered at least 4 hours after the initial dose.

Valtoco In Children

Safety and effectiveness of Valtoco have been established in pediatric patients 6 years to 16 years of age.

What Drugs, Substances, or Supplements Interact with Valtoco?

Valtoco may interact with other medicines such as:

  • opioids,
  • other CNS depressants (e.g., valproate),
  • alcohol,
  • cimetidine,
  • quinidine,
  • tranylcypromine,
  • ketoconazole,
  • troleandomycin,
  • clotrimazole,
  • carbamazepine,
  • phenytoin,
  • dexamethasone,
  • phenobarbital,
  • omeprazole,
  • propranolol,
  • imipramine,
  • cyclosporine,
  • paclitaxel,
  • terfenadine,
  • theophylline, and
  • warfarin

Tell your doctor all medications and supplements you use.

Valtoco During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Valtoco; it may harm a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Valtoco, during pregnancy. Valtoco passes into breast milk. Postmarketing experience suggests that breastfed infants of mothers taking benzodiazepines, such as Valtoco, may have effects of lethargy, somnolence, and poor sucking. Consult your doctor before breastfeeding.

Additional Information

Our Valtoco (diazepam nasal spray), CIV Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Epilepsy: Symptoms, Causes and Treatment See Slideshow
Valtoco Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if the person receiving this medication has:

  • extreme weakness or drowsiness;
  • pale or discolored skin; or
  • worsening seizures, or seizures that seem different from the patient's other seizures.

The sedative effects of diazepam may last longer in older adults. Accidental falls are common in elderly patients who use benzodiazepines. Use caution to avoid falling or accidental injury while you are using diazepam nasal.

Common side effects may include:

  • drowsiness;
  • headache; or
  • discomfort in your nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Valtoco (Diazepam Nasal Spray)

IMAGES

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Valtoco Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Risk of Concomitant Use with Opioids [see WARNINGS AND PRECAUTIONS]
  • CNS depression [see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
  • Glaucoma [see WARNINGS AND PRECAUTIONS]
  • Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice. The safety of VALTOCO is supported by clinical trials using diazepam rectal gel, as well as open-label, repeat-dose studies of VALTOCO in healthy subjects and epilepsy patients.

Diazepam Rectal Gel

In studies previously conducted with diazepam rectal gel, adverse event data were collected from double-blind, placebo-controlled studies and open-label studies. The majority of adverse events were mild to moderate in severity and transient in nature.

Two patients who received diazepam rectal gel died seven to 15 weeks following treatment; neither of these deaths was deemed related to diazepam rectal gel.

The most frequent adverse reactions (at least 4%) in the two double-blind, placebo-controlled studies were somnolence, headache, and diarrhea. Adverse events were usually mild or moderate in intensity.

Approximately 1.4% of the 573 patients who received diazepam rectal gel in clinical trials of epilepsy discontinued treatment because of an adverse event. The adverse reaction most frequently associated with discontinuation (occurring in three patients) was somnolence. Other adverse reactions most commonly associated with discontinuation and occurring in two patients were hypoventilation and rash. Adverse reactions associated with discontinuation occurring in one patient were asthenia, hyperkinesia, incoordination, vasodilatation, and urticaria.

In the two double-blind, placebo-controlled, parallel-group studies [see Clinical Studies], the proportion of patients who discontinued treatment because of adverse events was 2% for the group treated with Diazepam rectal gel, versus 2% for the placebo group. In the diazepam rectal gel group, one patient discontinued because of rash and one patient discontinued because of lethargy.

Table 3: Adverse Reactions That Occurred in Greater Than 1% Of Patients in Parallel-Group, Placebo-Controlled Trials with Diazepam Rectal Gel and More Common Than Placebo

Adverse ReactionDiazepam Rectal Gel
N=101 %
Placebo
N=104 %
Somnolence238
Headache54
Diarrhea4<1
Ataxia3<1
Dizziness32
Euphoria30
Incoordination30
Rash30
Asthma20
Vasodilation20

VALTOCO (Diazepam Nasal Spray)

Clinical studies of patients with epilepsy 6 years of age and older were conducted to support the safety and tolerability of VALTOCO for the treatment of acute repetitive seizures. A total of 190 patients 6 years of age and older received VALTOCO, of whom 114 received VALTOCO for at least 6 months, and 67 for at least 1 year. Other than adverse reactions related to local nasal administration, the adverse reactions reported in these studies were similar to those seen in the efficacy trials of diazepam rectal gel.

The most common local adverse reactions that occurred in VALTOCO-treated patients were nasal discomfort (6%), nasal congestion (3%), epistaxis (3%), and dysgeusia (2%).

Other Adverse Reactions

Diazepam rectal gel has previously been administered to 573 patients with epilepsy during all clinical trials, only some of which were placebo-controlled. All of the events listed below occurred in at least 1% of the 573 individuals exposed to diazepam rectal gel.

Body as a Whole: Asthenia

Cardiovascular: Hypotension, vasodilatation

Nervous: Agitation, confusion, convulsion, dysarthria, emotional lability, speech disorder, thinking abnormal, vertigo

Respiratory: Hiccup

The following infrequent adverse events have been reported previously with diazepam use: depression, slurred speech, syncope, changes in libido, urinary retention, bradycardia, cardiovascular collapse, nystagmus, urticaria, neutropenia, and jaundice.

Paradoxical reactions such as acute hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia, rage, sleep disturbances and stimulation have been reported with other diazepam products. If these events occur with the use of VALTOCO, the prescriber should consider discontinuation of use.

Read the entire FDA prescribing information for Valtoco (Diazepam Nasal Spray)

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
Related Resources for Valtoco

Related Health

© Valtoco Patient Information is supplied by Cerner Multum, Inc. and Valtoco Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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