MIDAZOLAM - ORAL SYRUP

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MIDAZOLAM - ORAL SYRUP

PHONETIC PRONUNCIATION: (mid-AZE-oh-lam)

COMMON BRAND NAME(S): Versed

GENERIC NAME(S): midazolam HCl

Uses

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.


How to use MIDAZOLAM - ORAL SYRUP

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 right away. Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use 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

SIDE EFFECTS: See also Warning section. 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 your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., agitation, aggressive behavior), uncontrollable movements (e.g., shaking/tremor), slow/fast heartbeat, vision changes (e.g., blurred vision). Get medical help right away if you have any very serious side effects, including: fainting, rapid/slow/shallow breathing. A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch. 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

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 a substance use disorder (such as overuse of or addiction to drugs/alcohol). This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Before having surgery, tell the doctor or dentist that you are using this medication. Infants and children younger than 3 years using anesthesia or drugs for sedation (including midazolam) for procedures/surgeries may be at risk for slower brain growth. Talk to the doctor about the risks and benefits of 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.

Interactions

DRUG INTERACTIONS: See also Warning section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: delavirdine, HIV protease inhibitors (e.g., ritonavir, saquinavir, atazanavir), sodium oxybate. Other medications can affect the removal of midazolam from your body, which may affect how midazolam works. Examples include 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 blockers (such as diltiazem, verapamil), certain SSRIs (such as fluoxetine, fluvoxamine), nefazodone, conivaptan, among others. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. 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.

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Warning

WARNING: Midazolam has rarely caused very serious breathing problems (such as rapid/slow/shallow breathing, trouble breathing), especially if used with other medications that cause drowsiness (including opioid medications such as morphine). This medication should be used only in a hospital or medical office under the care of a health professional. See also Side Effects section.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.