midazolam-injection, Versed (cont.)
HOW TO USE: This drug is given slowly by vein (IV) or into a large muscle (IM). The dosage is adjusted for your medical history, age and type of medical procedure or condition being treated. Drowsiness (sedative) effects usually are obvious within 15 minutes. The length of time before drug effects wear off varies considerably. Flumazenil is a medication that may be used to reverse the sedative effect of this drug.
SIDE EFFECTS: Dizziness, headache and pain or redness at the injection site might occur. If these persist or worsen, notify your doctor. Report promptly: unusually slow or shallow breathing. Very unlikely but report promptly: unusually fast/slow/ irregular heartbeat, fainting, confusion, mental/mood changes, trouble breathing, muscle twitching, uncontrolled movements. Seek immediate medical attention if an allergic reaction occurs, however unlikely. Symptoms include: throat discomfort, difficulty breathing, skin rash, hives, itching. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Tell your doctor your medical history, especially of: allergies (especially drug allergies), heart problems, kidney problems, liver problems, lung diseases, narrow-angle glaucoma. Avoid alcohol while using this drug. Side effects may be aggravated. Do not drive or use hazardous machinery until the effects of the drug have disappeared (e.g., drowsiness). A preservative (benzyl alcohol) which may be found in this product or in the liquid used to mix this product (diluent) can infrequently cause serious problems (sometimes death), if given in large amounts (more than 100 mg/kg daily) to an infant during the first months of life (neonatal period). The risk is also greater with low birth weight infants. Symptoms include sudden gasping, low blood pressure, or a very slow heartbeat. Report these symptoms to the doctor immediately should they occur. If possible, a preservative-free product should be used when treating neonates. This drug is not recommended for use during pregnancy. Consult your doctor before using this drug. This drug is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast- feeding. Caution is advised when this drug is used in the elderly as elderly patients are usually more sensitive to its effects.
Report Problems to the Food and Drug Administration
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.
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