GENERIC NAME: MIDAZOLAM - ORAL SYRUP (mid-AZE-oh-lam)
BRAND NAME(S): Versed
WARNING: Midazolam has infrequently caused very serious breathing problems (e.g., rapid/slow/shallow breathing, trouble breathing), especially if used with other medications that cause drowsiness (e.g., narcotic pain medications such as morphine). This medication should be used only in a hospital or medical office under the care of a health professional.
USES: This medication is used in children before a procedure or anesthesia to cause drowsiness, decrease anxiety, and cause forgetfulness of the surgery or procedure. It should be used while the child is under the care of a health professional. It is not for home or long-term use.Midazolam belongs to a class of medications called benzodiazepines, which produce a calming effect on the brain and nerves (central nervous system). It is thought to work by increasing the effect of a certain natural chemical (GABA) in the brain.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This drug may also be used short-term for sleep problems (e.g., trouble sleeping, "night terrors").
HOW TO USE: A healthcare professional will prepare and measure your dose. Take this medication by mouth as directed by your doctor. It is usually given as a single dose before a procedure or anesthesia.The dosage is based on your medical condition, response to therapy, weight, and other medications you may be taking.This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as shaking, sweating, vomiting, abdominal/muscle cramps, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. To lessen the risk of becoming addicted, do not increase the dose, take it more frequently, or take it for a longer time than prescribed. Talk with the doctor if this medication stops working well. Properly stop the medication when so directed.Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless the doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in the bloodstream. Consult the doctor or pharmacist for more details.
SIDE EFFECTS: Nausea, vomiting, dizziness, or drowsiness may occur. If any of these effects persist or worsen, notify the doctor or pharmacist promptly.Remember that the doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell the doctor immediately if any of these unlikely but serious side effects occur: rapid/slow/shallow breathing, mental/mood changes (e.g., agitation, aggressive behavior), uncontrollable movements (e.g., shaking/tremor), slow/fast heartbeat, vision changes (e.g., blurred vision).Seek immediate medical attention if any of these rare but very serious side effects occur: fainting, trouble breathing.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking midazolam, tell the doctor or pharmacist if you are allergic to it; or to other benzodiazepines (e.g., diazepam); or if you have any other allergies. This product may contain inactive ingredients (such as cherry flavoring), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow-angle).Before using this medication, tell the doctor or pharmacist your medical history, especially of: kidney disease, liver disease, breathing problems (e.g., chronic obstructive pulmonary disease-COPD, sleep apnea), heart disease (e.g., congestive heart failure), glaucoma (open-angle), personal or family history of regular use/abuse of drugs/alcohol.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.Before having surgery, tell the doctor or dentist that you are using this medication.This medication is not recommended for use during pregnancy. It may harm an unborn baby. Infants born to mothers who used similar medications for an extended time have had withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Consult your doctor for more details.This medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: The doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with the doctor or pharmacist first.This drug should not be used with the following medications because very serious interactions may occur: delavirdine, efavirenz, HIV protease inhibitors (e.g., ritonavir, saquinavir, atazanavir), sodium oxybate.If you are currently using any of these medications listed above, tell the doctor or pharmacist before starting midazolam.Before using this medication, tell the doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs affecting liver enzymes that remove midazolam from your body (such as azole antifungals including itraconazole/ketoconazole, macrolide antibiotics including erythromycin, cimetidine, rifamycins including rifabutin/rifampin, St. John's wort, certain anti-seizure medicines including carbamazepine/phenytoin, calcium channel blockers including diltiazem/verapamil, certain SSRIs including fluoxetine/fluvoxamine, nefazodone, conivaptan, aprepitant).Tell the doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., phenobarbital), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine, morphine), psychiatric medicines (e.g., chlorpromazine, clozapine, amitriptyline, trazodone), a certain herbal product (kava).Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask the pharmacist about using those products safely.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: drowsiness, confusion, loss of coordination.
NOTES: Do not share this medication with others. It is against the law.This medication has been prescribed for your current procedure only. Do not use it later for another condition or procedure unless told to do so by the doctor. A different medication may be necessary in that case.Laboratory and/or medical tests (e.g., breathing, blood pressure, heartbeat) should be performed periodically to monitor your progress or check for side effects. Consult the doctor for more details.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.