Question 1

What is Onfi?

Accepted Answer

Onfi is an antiepileptic medication that contains the active ingredient clobazam. It is classified as a benzodiazepine, which is a type of drug that affects chemicals in the brain that may be unbalanced.

This medication works by enhancing the effects of certain natural chemicals in the brain to decrease abnormal electrical activity. By calming the central nervous system, it helps to manage and prevent seizure activity.

Question 2

What is Onfi used for?

Accepted Answer

Onfi is used to treat adjunctive treatment of seizures associated with Lennox-Gastaut syndrome .

Question 3

How does Onfi work?

Accepted Answer

Mechanism of Action

Onfi belongs to a class of medications known as benzodiazepines. While the exact way it works to treat seizures is not fully understood, it is believed to interact with specific receptors in the central nervous system to regulate brain activity.

The medication enhances the activity of a natural chemical in the brain called gamma-aminobutyric acid (GABA). GABA is an inhibitory neurotransmitter, which means its primary role is to slow down or block certain signals in the nervous system. By increasing the effects of GABA, Onfi helps to:

Reduce the excessive electrical activity that leads to seizures.

Produce a calming effect on the central nervous system.

Stabilize nerve cell signals to prevent them from firing uncontrollably.

By modulating these chemical signals, Onfi helps to decrease the frequency and severity of seizures, particularly those associated with Lennox-Gastaut syndrome.

Question 4

What are the active ingredients in Onfi?

Accepted Answer

The active ingredient in Onfi is clobazam .

Question 5

What are the side effects of Onfi?

Accepted Answer

Common side effects of Onfi may include:

somnolence

fatigue

drooling

and others

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Onfi?

Accepted Answer

Onfi belongs to the benzodiazepine drug class.

Question 7

What is the dosage of Onfi and how do I take it?

Accepted Answer

How to Take Onfi

Onfi is available as a tablet or an oral suspension (liquid). It is usually taken once or twice a day. You can take this medication with or without food.

If you are taking the tablets, you may:

Swallow them whole.

Break them in half along the score line.

Crush them and mix with a small amount of applesauce. If mixed with food, the mixture should be swallowed immediately.

If you are using the oral suspension, shake the bottle well before each use. Always use the specific oral dosing syringe provided with the medication to ensure you receive the correct amount. Do not use a household spoon to measure your dose.

Missed Dose

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time to make up for a missed one.

Stopping Treatment

Do not stop taking this medication suddenly without talking to your healthcare provider. Stopping abruptly can cause serious withdrawal symptoms or increased seizures. Your doctor will provide instructions on how to gradually decrease your dose when it is time to stop treatment.

Question 8

Is Onfi safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

Onfi may cause harm to an unborn baby. Research suggests that using benzodiazepines during pregnancy may increase the risk of birth defects. Additionally, infants exposed to the drug late in pregnancy may experience withdrawal symptoms or respiratory depression. Symptoms in newborns may include:

Excessive sleepiness

Feeding difficulties

Decreased muscle tone

Breathing problems

It is important to discuss the risks and benefits of treatment with a healthcare provider. Do not stop taking Onfi suddenly, as this can cause serious seizures that may harm the pregnancy. Patients are encouraged to join the North American Antiepileptic Drug Pregnancy Registry to help monitor the safety of the medication.

Breastfeeding

Clobazam passes into breast milk and can cause side effects in a nursing infant, such as sedation or trouble feeding. Healthcare providers typically recommend weighing the necessity of the drug against the benefits of breastfeeding. If breastfeeding while taking Onfi, monitor the infant closely for signs of excessive drowsiness or poor weight gain.

Question 9

What forms and strengths does Onfi come in?

Accepted Answer

Onfi is provided in two different oral formulations:

Tablets: These are solid tablets that can be taken whole or crushed and mixed with applesauce. They are scored, which means they can be split into equal halves if a partial dose is required.

Oral Suspension: This is a liquid form of the medication. It is a suspension that must be shaken well before each use. It is intended to be measured and administered using the specific oral syringes provided with the medication to ensure the correct amount is taken.

Question 10

What is the FDA approval status of Onfi?

Accepted Answer

FDA Approval and Indications: Onfi was approved by the U.S. Food and Drug Administration (FDA) in 2011. It is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older.

Controlled Substance Status: As a benzodiazepine, Onfi is classified as a Schedule IV controlled substance. This designation indicates that the medication has a potential for abuse and may lead to physical or psychological dependence.

Boxed Warning: The FDA requires a boxed warning for Onfi due to several serious risks:

Risks from Concomitant Use with Opioids: Using benzodiazepines with opioid medications may result in profound sedation, respiratory depression, coma, and death.

Abuse, Misuse, and Addiction: The use of benzodiazepines, including clobazam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death.

Dependence and Withdrawal Reactions: Continued use may lead to clinically significant physical dependence. Abruptly stopping or reducing the dosage rapidly can cause life-threatening withdrawal reactions.

Safety Communications: The FDA has issued safety communications regarding serious skin reactions associated with Onfi. In 2013, the agency warned that the drug could cause Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be fatal. In 2023, the FDA issued an additional warning regarding the risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a serious hypersensitivity reaction that can affect internal organs and requires immediate medical attention.

Question 11

What should I know about Onfi and withdrawal?

Accepted Answer

Risks of Abrupt Discontinuation

Onfi is a benzodiazepine, and stopping it suddenly can lead to physical and psychological withdrawal symptoms. The most severe risk is the development of seizures, including status epilepticus, which is a life-threatening condition where seizures do not stop. These risks are higher if the medication has been used at high doses or for a long duration.

Common Withdrawal Symptoms

Withdrawal symptoms may begin shortly after the dose is reduced or stopped. They can include:

Anxiety, nervousness, or agitation

Insomnia or trouble sleeping

Tremors or muscle twitching

Sweating and rapid heartbeat

Stomach and muscle cramps

Hallucinations or confusion

Safe Tapering Process

To minimize the risk of withdrawal, Onfi should always be discontinued gradually under the supervision of a healthcare professional. Your doctor will provide a tapering schedule to slowly lower the dose. If you experience any unusual symptoms or a return of seizures during this process, seek medical attention immediately.

Onfi

Medication Quick Facts

📋Overview

What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

Withdrawal Information

FAQ

Found an Error?