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|Midazolam Syrup

Midazolam Syrup

Midazolam Syrup is used for:

Reducing anxiety or producing drowsiness or memory loss in children before certain medical procedures or surgery. It may also be used for other conditions as determined by your doctor.

Midazolam Syrup 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.

Do NOT use Midazolam Syrup if:

• you are allergic to any ingredient in Midazolam Syrup or to cherries
• you have acute narrow-angle glaucoma, severe mental problems (eg, psychosis), or severe liver disease
• you have alcohol intoxication with abnormal vital signs
• you are taking delavirdine, efavirenz, an HIV protease inhibitor (eg, ritonavir), or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Midazolam Syrup:

Some medical conditions may interact with Midazolam Syrup. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have lung, airway, or breathing problems (eg, COPD); glaucoma or risk for glaucoma; heart, liver, or kidney problems; the blood disease porphyria; severe depression; myasthenia gravis; or a history of drug abuse or dependence; or if you have consumed alcohol recently
• if you have a severe infection

Some MEDICINES MAY INTERACT with Midazolam Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Carbamazepine, phenobarbital, phenytoin, rifampin, or St. John"s wort because the effectiveness of Midazolam Syrup may be decreased
• Azole antifungals (eg, itraconazole), barbiturate anesthetics (eg, thiopental), calcium channel blockers (eg, diltiazem, verapamil), clozapine, delavirdine, diltiazem, disulfiram, efavirenz, HIV protease inhibitors (eg, ritonavir, saquinavir), ketolides (eg, telithromycin), macrolides (eg, erythromycin), narcotic pain medicines (eg, codeine), nefazodone, omeprazole, sodium oxybate (GHB), or valproic acid because serious side effects, such as low blood pressure, breathing problems, and excessive sedation, may occur
• Hydantoins (eg, phenytoin) because side effects may be increased by Midazolam Syrup

This may not be a complete list of all interactions that may occur. Ask your health care provider if Midazolam Syrup may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Midazolam Syrup:

Use Midazolam Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Midazolam Syrup is intended for a single use only. You should not use Midazolam Syrup for long-term use.
• Midazolam Syrup is usually administered at your doctor"s office, hospital, or clinic. If you are using Midazolam Syrup at home, carefully follow the directions provided by your doctor or other health care provider.
• Avoid eating grapefruit or drinking grapefruit juice while you are taking Midazolam Syrup.
• If you miss a dose of Midazolam Syrup, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Midazolam Syrup.

Important safety information:

• Midazolam Syrup may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until the effects of Midazolam Syrup have disappeared or until the day after you receive Midazolam Syrup, whichever is longer. Using Midazolam Syrup 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 (eg, sedatives, tranquilizers) while using Midazolam Syrup. Midazolam Syrup will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Midazolam Syrup can cause partial or complete memory loss for several hours.
• Use of Midazolam Syrup is not recommended in ELDERLY patients. Safety and effectiveness have not been established.
• Caution is advised when using Midazolam Syrup in CHILDREN because they may be more sensitive to its effects.
• Use Midazolam Syrup with extreme caution in CHILDREN younger than 6 months of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Midazolam Syrup has been shown to cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Midazolam Syrup during pregnancy. Midazolam Syrup is not recommended for use during labor and delivery. Midazolam Syrup is excreted in breast milk. If you are or will be breast-feeding while you are using Midazolam Syrup, check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, some people develop a need to continue taking Midazolam Syrup. This is known as DEPENDENCE or addiction.

If you use Midazolam Syrup for long periods of time or at high doses and suddenly stop taking Midazolam Syrup, you may experience WITHDRAWAL symptoms, including fast heartbeat, hallucinations, muscle cramps, seizures, stomach cramps or bloating, sweating, tremor, and vomiting.

Possible side effects of Midazolam Syrup:

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:

Dizziness; drowsiness; nausea; short-term memory loss; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; combativeness; hyperactivity; irregular breathing patterns; prolonged drowsiness; skipped heartbeats; slow or fast heartbeat; slow or difficult breathing; seizure; severe dizziness; unusual or involuntary muscle movements or muscle tremor.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include clumsiness; coma; confusion; deep sleep; loss of consciousness; loss of coordination; severe drowsiness; slow reflexes.

Store Midazolam Syrup at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Midazolam Syrup out of the reach of children and away from pets.

General information:

• If you have any questions about Midazolam Syrup, please talk with your doctor, pharmacist, or other health care provider.
• Midazolam Syrup is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Midazolam Syrup. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.