Diazepam Intensol Concentrate

Diazepam Intensol Concentrate is used for:

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Managing anxiety disorders and for the short-term (less than 4 months) relief of symptoms of anxiety. It may also be used to relieve agitation, shakiness, and hallucinations during alcohol withdrawal, and relieve certain types of muscle pain. It may also be used for other conditions as determined by your doctor.

Diazepam Intensol Concentrate is a benzodiazepine. It works by slowing down the movement of chemicals in the brain. This results in a reduction in nervous tension (anxiety) and muscle spasm, and also causes sedation.

Do NOT use Diazepam Intensol Concentrate if:

• you are allergic to any ingredient in Diazepam Intensol Concentrate
• you have acute narrow-angle glaucoma, severe liver disease, or a mental state in which contact with reality is lost (psychosis)
• you are taking 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 Diazepam Intensol Concentrate:

Some medical conditions may interact with Diazepam Intensol Concentrate. 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 glaucoma or a predisposition for glaucoma, liver problems, lung problems or chronic obstructive pulmonary disease (COPD), muscle problems, depression, suicidal tendencies, a blood disorder known as porphyria, or a history of alcohol or other substance abuse or dependence

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

• Hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Diazepam Intensol Concentrate's effectiveness
• Clozapine, diltiazem, disulfiram, HIV protease inhibitors (eg, ritonavir), narcotic pain relievers (eg, morphine, codeine), nefazodone, omeprazole, sodium oxybate (GHB), or valproic acid because side effects such as increased sedation and confusion may occur
• Hydantoins (eg, phenytoin), narcotic pain relievers (eg, morphine, codeine), sodium oxybate (GHB), succinylcholine, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Diazepam Intensol Concentrate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Diazepam Intensol Concentrate 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 Diazepam Intensol Concentrate:

Use Diazepam Intensol Concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Diazepam Intensol Concentrate by mouth with a liquid or semi-solid food.
• Use the dropper that comes with Diazepam Intensol Concentrate to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Draw the prescribed amount into the dropper and then squeeze the dropper contents into a liquid or semi-solid food, such as water, juice, soda or a soda-like beverage, applesauce, or pudding before taking.
• Stir the liquid or food gently for a few seconds and then consume the entire amount of the mixture immediately. Do not store for future use.
• If you miss a dose of Diazepam Intensol Concentrate 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.

Ask your health care provider any questions you may have about how to use Diazepam Intensol Concentrate.

Important safety information:

• Diazepam Intensol Concentrate may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Diazepam Intensol Concentrate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Diazepam Intensol Concentrate; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• If you are taking Diazepam Intensol Concentrate for seizures, carry an ID card at all times that says you have seizure disorder and you take Diazepam Intensol Concentrate.
• Lab tests, including liver and kidney function and complete blood cell counts, may be performed while you use Diazepam Intensol Concentrate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Diazepam Intensol Concentrate should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Diazepam Intensol Concentrate may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Diazepam Intensol Concentrate while you are pregnant. Diazepam Intensol Concentrate is found in breast milk. Do not breast-feed while using Diazepam Intensol Concentrate.

When used for long periods of time or at high doses, Diazepam Intensol Concentrate may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Diazepam Intensol Concentrate stops working well. Do not take more than prescribed.

Some people who use Diazepam Intensol Concentrate for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Diazepam Intensol Concentrate suddenly, you may have WITHDRAWAL symptoms. These may include convulsions, tremor, stomach and muscle cramps, vomiting, or sweating. Do not suddenly stop taking Diazepam Intensol Concentrate without first checking with your doctor.

Possible side effects of Diazepam Intensol Concentrate:

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:

Blurred vision; dizziness; drowsiness; dry mouth; fatigue; headaches; incoordination; short-term memory loss; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; chest pain; difficulty breathing; difficulty sleeping; difficulty speaking; hallucinations; inability to control urination; increased muscle spasms; interrupted breathing; involuntary eye movement; sleep disturbances; stimulation; sudden rage; yellowing of the skin or eyes.

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; confusion; deep sleep; loss of consciousness; slow reflexes.

Store Diazepam Intensol Concentrate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tight, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Diazepam Intensol Concentrate out of the reach of children and away from pets.

General information:

• If you have any questions about Diazepam Intensol Concentrate, please talk with your doctor, pharmacist, or other health care provider.
• Diazepam Intensol Concentrate 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 Diazepam Intensol Concentrate. 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.

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Seizures, Anxiety, Muscle Spasm, Alcohol Withdrawal, Seizure Prevention, Light Sedation, ICU Agitation, Light Anesthesia, Status Epilepticus, Endoscopy or Radiology Premedication, Tetanus, Temporomandibular Joint Disorder

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