Diazepam Solution

GENERIC NAME: DIAZEPAM (dye-AZ-e-pam)

COMMON USES: This medicine is a benzodiazepine used to treat anxiety disorders or for the short-term relief of the symptoms of anxiety. It is also used to treat seizures, certain types of muscle spasms, and symptoms of alcohol withdrawal (eg, agitation, tremor, hallucinations). This medicine is also used before surgery or other medical procedures to help reduce anxiety and tension. It may also be used for other conditions as determined by your doctor.

HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. THIS MEDICINE IS USUALLY GIVEN AS AN INJECTION at your doctor's office, hospital, or clinic. If you will be using this medicine at home, a health care provider will teach you how to use it. Be sure you understand how to use this medicine. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. CHECK WITH YOUR DOCTOR before you eat grapefruit or drink grapefruit juice while you use this medicine. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 to 25 degrees C), away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE AND YOU ARE TAKING IT REGULARLY, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. DO NOT take 2 doses at once.

CAUTIONS: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or if you are allergic to any ingredient in this product. IF YOU TAKE THIS MEDICINE REGULARLY OVER A LONGER PERIOD OF TIME (eg, several months), do not suddenly stop it without first talking with your doctor. You may have an increased risk of side effects (eg, mood changes, trouble sleeping). IF YOU NEED TO STOP THIS MEDICINE or add a new medicine, your doctor may need to gradually lower your dose. WHEN USED FOR AN EXTENDED PERIOD OF TIME, this medicine may not work as well and may require different dosing. Talk with your doctor if this medicine stops working well. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. Laboratory and/or medical tests, including liver function and blood counts, may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. This medicine may cause drowsiness, dizziness, or blurred vision. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. DO NOT DRINK ALCOHOL OR USE MEDICINES THAT MAY CAUSE DROWSINESS (eg, sleep aids, muscle relaxers) while you are using this medicine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. IF YOU ARE TAKING THIS MEDICINE FOR SEIZURES, carry an ID card at all times that says you have seizure disorder and you take this medicine. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of the medicine, especially drowsiness, incoordination, and mental or mood changes. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN CHILDREN because they may be more sensitive to the effects of the medicine, especially mental or mood changes. FOR WOMEN: THIS MEDICINE MAY CAUSE HARM to the human fetus. IF YOU THINK YOU MAY BE PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS FOUND in breast milk. DO NOT BREAST-FEED while taking this medicine.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while using this medicine include drowsiness; incoordination; pain, redness, or swelling at the injection site; tiredness. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience confusion; difficulty breathing; fainting; fever, chills, or persistent sore throat; hallucinations; inability to control urination or difficulty urinating; memory problems or memory loss; new or worsening mental or mood changes (eg, agitation, aggressiveness, behavior changes, depression, irritability, rage, restlessness); severe or persistent dizziness or lightheadedness; severe or persistent pain, redness, or swelling at the injection site; slow heartbeat; slurred speech; tremor; trouble sleeping; vision changes (eg, blurred vision, double vision); yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BEFORE USING THIS MEDICINE: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking an HIV protease inhibitor (eg, ritonavir) or sodium oxybate (GHB). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking rifamycins (eg, rifampin), St. John's wort, azole antifungals (eg, ketoconazole), barbiturates (eg, phenobarbital), cimetidine, clozapine, diltiazem, macrolide antibiotics (eg, erythromycin), methadone, nefazodone, omeprazole, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, fluvoxamine), telithromycin, disulfiram, hormonal contraceptives (eg, birth control pills), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic pain medicines (eg, morphine, codeine), hydantoins (eg, phenytoin), or phenothiazines (eg, thioridazine) or other medicines for mood or mental problems (eg, olanzapine). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including glaucoma or increased pressure in the eye, liver or kidney problems, muscle problems or weakness, a blood disorder (eg, porphyria), allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD]), seizures, mood or mental problems (eg, depression, psychosis), suicidal thoughts or actions, or alcohol or other substance abuse or dependence. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have acute narrow-angle glaucoma, untreated open-angle glaucoma, certain muscle problems (eg, myasthenia gravis), severe liver problems, severe breathing problems, or sleep apnea. Use of this medicine in children younger than 6 months old is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

OVERDOSE: IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include clumsiness; coma; confusion; deep sleep; fainting; loss of consciousness; severe drowsiness; slow or shallow breathing; slow reflexes.

ADDITIONAL INFORMATION: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.