Hypnovel

Uses

What is Hypnovel® (midazolam) used for?

Hypnovel ® is commonly used for reducing anxiety or producing drowsiness or anesthesia before certain medical procedures or surgery. It may also be given continuously to maintain sedation or anesthesia in certain patients. It is used for other conditions as determined by your doctor.

Midazolam is a benzodiazepine. It works in the central nervous system (brain) to cause sleepiness, muscle relaxation, and short-term memory loss, and to reduce anxiety.

How should I take Hypnovel® (midazolam)?

Midazolam is usually administered as an injection at your doctor’s office, clinic, or hospital. Ask your doctor or pharmacist any questions that you may have about midazolam.

How do I store Hypnovel® (midazolam)?

Hypnovel® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Hypnovel® in the bathroom or the freezer. There may be different brands of Hypnovel® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Hypnovel® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Hypnovel® (midazolam)?

Before using this drug, tell your doctor if:

• You are pregnant, planning to become pregnant, or are breastfeeding.
• You are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement.
• You have allergies to medicines, foods, or other substances.

Besides, you should notice that:

• Midazolam may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until the effects of midazolam have disappeared or until the day after you receive midazolam, whichever is longer. Using midazolam alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (e.g., sedatives, tranquilizers) while using midazolam. Midazolam will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Midazolam can cause partial or complete memory loss for several hours.
• Use midazolam with caution in the elderly because they may be more sensitive to its effects.
• Caution is advised when using midazolam in children because they may be more sensitive to its effects.
• When used for long periods of time or at high doses, some people develop a need to continue taking midazolam. This is known as dependence or addiction.
• If you use midazolam for long periods of time or at high doses and suddenly stop taking midazolam, you may experience withdrawal symptoms including fast heartbeat, hallucinations, muscle cramps, seizures, stomach cramps, sweating, tremor, and vomiting.

Is it safe during pregnancy or breastfeeding?

Pregnancy

Midazolam has been shown to cause harm to the fetus. If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using midazolam during pregnancy.

Breastfeeding:

Midazolam is excreted in breast milk. If you are or will be breastfeeding while you are using midazolam, check with your doctor or pharmacist to discuss the risks to your baby.

Side effects

What side effects can occur from Hypnovel® (midazolam)?

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most common side effects persist or become bothersome:

• Blurred vision
• Changes in blood pressure, breathing, and heartbeats
• Coughing
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• Hiccups
• Low blood pressure (children)
• Nausea
• Pain during injection
• Pain, redness, or tenderness at the injection site
• Short-term memory loss
• Slurred speech
• Vomiting

Seek medical attention right away if any of these severe side effects occur:

• Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue)
• Agitation
• Chest pain
• Combativeness
• Irregular breathing patterns
• Pain, swelling, or redness at the injection site
• Slow or difficult breathing
• Unusual or involuntary muscle movements or muscle tremor

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Hypnovel® (midazolam)?

Hypnovel® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products may interact with this drug, including:

• Delavirdine
• HIV protease inhibitors (e.g., ritonavir, saquinavir, atazanavir)
• Sodium oxybate
• Azole antifungals (such as itraconazole, ketoconazole)
• Macrolide antibiotics (such as erythromycin)
• Cimetidine, rifamycins (such as rifabutin, rifampin)
• St. John’s wort
• Certain anti-seizure medicines (such as carbamazepine, phenytoin)
• Calcium channel
• Carbamazepine
• Barbiturates (e.g., phenobarbital)
• Clozapine
• Diltiazem
• Disulfiram
• Efavirenz
• Grapefruit juice
• Ketolides (e.g., telithromycin)
• Macrolides (e.g., erythromycin)
• Narcotic pain medicines (e.g., codeine)
• Nefazodone
• Omeprazole
• Sodium oxybate (GHB)
• Valproic acid
• Verapamil
• Hydantoins

Does food or alcohol interact with Hypnovel® (midazolam)?

Hypnovel® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Hypnovel® (midazolam)?

Hypnovel® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

These health conditions are:

• Breathing problems (e.g., COPD)
• Open-angle glaucoma
• Heart, liver, or kidney problems
• The blood disease porphyria
• Severe depression
• A history of drug abuse or dependence

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Hypnovel® (midazolam).

What is the dose of Hypnovel® (midazolam) for an adult?

The recommended dose is 10 to 20 mg one time before procedure (IM or IV is preferred).

IV:

1 to 2.5 mg IV over 2 to 3 minutes before procedure. Wait an additional 2 or more minutes to fully evaluate the sedative effect. If additional titration is necessary, it should be given at a rate of no more than 1 mg over 2 minutes, waiting an additional 2 or more minutes each time to fully evaluate the sedative effect. Total doses greater than 5 mg are not usually necessary.

IM:

0.07 to 0.08 mg/kg 30 to 60 minutes prior to surgery. Reduce dose in patients with COPD, high risk patients, and when narcotics or other CNS depressants are used. Maximum dose 10 mg.

Light Anesthesia

Initial dose: 2 mg IV once at a rate not to exceed 1 mg/min immediately before the procedure. Additional doses of 0.5 to 2 mg may be administered after 2 minutes to achieve desired level of sedation. Most patients achieve adequate sedation with a total dose less than 5 mg.

Maintenance dose: Generally does not exceed 25% of the dose initially required to achieve sedation.

ICU Agitation

Initial dose: 0.01 to 0.08 mg/kg (usually 1 to 5 mg) IV over 2 to 3 minutes, every 5 to 15 minutes to control acute agitation.

Maintenance dose: 0.02 to 0.2 mg/kg/hour by continuous infusion. The patient should be assessed regularly and the infusion rate adjusted to maintain the desired level of sedation. The minimum effective rate is recommended. Lower infusion rates are required in patients also receiving opioid analgesics.

What is the dose of Hypnovel® (midazolam) for a child?.

Light Sedation

IV:

1 to 1.5 mg IV over 2 to 3 minutes before procedure. Wait an additional 2 or more minutes to fully evaluate the sedative effect. If additional titration is necessary, it should be given at a rate of no more than 1 mg over 2 minutes, waiting an additional 2 or more minutes each time to fully evaluate the sedative effect. Total doses greater than 3.5 mg are not usually necessary

IM:

0.02 to 0.05 mg/kg IM 30 to 60 minutes prior to surgery.

Usual doses are 1 to 3 mg. Some patients may respond to as little as 1 mg.

How is Hypnovel® (midazolam) available?

Hypnovel® is available in the following dosage forms and strengths:

• injections 5mg/ ml

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

Symptoms of overdose may include clumsiness; confusion; deep sleep; loss of consciousness; sleepiness; slow reflexes.

What should I do if I miss a dose?

Because you will receive midazolam in a clinical setting, you are not likely to miss a dose.