Romazicon

Romazicon is a prescription medication used to manage an overdose of a certain class of sedative medications called benzodiazepines. It is also used following a medical procedure where benzodiazepines have been used. Romazicon belongs to a group of drugs called antidotes. These help to reverse the effects of an overdose of benzodiazepines.

This medication comes in an injectable form to be given directly into a vein (IV) and is administered as a one-time dose by a healthcare professional.

Common side effects of Romazicon include headache, increased sweating, and injection site pain.

Romazicon can also cause dizziness and blurred vision. Do not drive or operate heavy machinery until you know how Romazicon affects you.

Romazicon is a prescription medication used to manage an overdose of a certain class of sedative medications called benzodiazepines (such as alprazolam, diazepam, and many others). It is often used following a medical procedure where benzodiazepines have been used.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Roche Laboratories

Serious side effects have been reported with Romazicon. See the "Drug Precautions" section.

Common side effects of Romazicon include the following:

• Headache
• Injection site pain
• Increased sweating
• Dizziness
• Blurred vision
• Nausea
• Vomiting
• Flushing

This is not a complete list of Romazicon side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• zaleplon (Sonata)
• zolpidem (Ambien, Ambien CR)
• eszopiclone (Lunesta)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)

Drug interactions with other central nervous system depressants such as certain narcotics have not been studied specifically. Romazicon can potentially interact with other central nervous system depressants by blocking their effect.

In the case of drug overdose with multiple drugs, Romazicon should be used with caution. Benzodiazepines have anti-seizure activity. Romazicon reverses this activity, which may lead to convulsions, especially when drug overdose has occurred with medications that cause seizures.

This is not a complete list of Romazicon drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Romazicon including the following:

• Seizures and convulsions. Seizures and convulsions are more common if you have taken benzodiazepines for a long period of time.
• Resedation. You may experience serious sedation or stupor after administration of Romazicon. Your healthcare provider will monitor you for resedation following administration of Romazicon.
• Hypoventilation. Hypoventilation occurs when the lungs are slowed and are no longer able to perform adequate gas exchange. Symptoms include slowed or difficult breathing (respiratory depression). Your healthcare professional should monitor you for the return of these overdose symptoms while you are being treated with Romazicon.
• Panic attacks. Panic attacks include a feeling of sudden fear or worry, difficult or fast breathing, rapid heartbeat, flushing, and anxiety. Romazicon may cause panic attacks in patients with a history of panic disorder.
• Injection site reaction. You may experience pain, swelling, redness, itching, or rash at the injection site.
• Agitation. Symptoms may include nervousness, irritability, anger, and anxiety, insomnia, and rapid breathing.
• Vision problems such as double vision or changes in the field of vision.
• Hearing problems such as temporary difficulty hearing or sensitive hearing, and ringing in the ears.

Romazicon can cause drowsiness. Do not drive or operate heavy machinery until you know how Romazicon affects you.

Do not take Romazicon if you:

• are allergic to Romazicon or any of its ingredients.
• are allergic to benzodiazepines
• are taking a benzodiazepine for control of a potentially life-threatening condition such as continued uncontrolled seizures (for example, diazepam (Valium), midazolam (Versed), lorazepam (Ativan) or clonazepam (Klonopin))
• Have overdosed on tricyclic antidepressants (for example, trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Romazicon, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Romazicon, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Romazicon or any of its ingredients
• are allergic to benzodiazepines
• have liver problems
• have heart problems
• have lung problems
• are taking benzodiazepines
• are taking a class of medicines called tricyclic antidepressants
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Romazicon falls into category C.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Romazicon crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the medication. Your doctor and you will decide if the benefits outweigh the risk of using Romazicon.

Romazicon is available in injectable form to be given directly into a vein (IV) by a healthcare professional to reverse the effects of a class of sedative medicines called benzodiazepines.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• the amount of benzodiazepines you received during surgery or overdose
• severity of overdose symptoms
• how you respond to this medication
• the condition being treated
• other medical conditions you have
• other medications you are taking

The recommended dose of Romazicon for the treatment of benzodiazepine overdose is 0.2 mg initially followed by reassessment. If consciousness is not restored to the desired level, an additional 0.2 mg may be given 45 seconds later. Additional 0.2 mg doses may be repeated up to four additional times every 60 seconds until the desired level of consciousness is restored. No more than 3 mg should be given in any one hour. In rare cases, a maximum of 5 mg of Ro maziconmay be required to restore consciousness.

If Romazicon is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

The use of Romazicon has been associated with increased incidence of seizure.

This is most common in patients who have used benzodiazepines for long-term sedation or overdose cases where patients are showing signs of serious tricyclic antidepressant overdose.

Practitioners should individualize doses of Romazicon and prepare for management of seizures.