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midazolam-injection (cont.)

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.

DRUG INTERACTIONS: Tell your doctor of all nonprescription and prescription medication you use, especially of: H2 blockers (e.g., cimetidine), fluconazole, theophylline, aminophylline, erythromycin. Also report use of drugs that make you drowsy, such as: narcotic pain relievers (e.g., morphine, codeine), psychiatric medicines, other anti-anxiety drugs, anti-seizure drugs, certain antihistamines (e.g., diphenhydramine), other muscle relaxants, sleeping pills, sedatives. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include confusion, slow reflexes, clumsiness, deep sleep, and loss of consciousness.

NOTES: Tests such as breathing rate and blood pressure are done periodically during treatment.

MISSED DOSE: If you miss a dose, contact your doctor to establish a new dosing schedule. Do not "double-up" the doses.

STORAGE: Store at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture.


Last Editorial Review: 3/2/2005




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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.


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