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|Levo-Dromoran Tablets

Levo-Dromoran

Levo-Dromoran is used for:

Treating or preventing moderate to severe pain. It may also be used before surgery for pain management and for other conditions as determined by your doctor.

Levo-Dromoran is a narcotic analgesic. It works by acting in the brain and spinal cord to decrease the feeling of pain.

Do NOT use Levo-Dromoran if:

• you are allergic to any ingredient in Levo-Dromoran or similar medicines (eg, morphine)
• you are taking a monoamine oxidase (MAO) inhibitor (eg, phenelzine), a narcotic agonist/antagonist medicine (eg, pentazocine), or sodium oxybate (GHB)
• you are having certain types of surgery (eg, biliary surgery)
• you are having an asthma attack, have severe asthma, or have severe diarrhea due to antibiotic use

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

Before using Levo-Dromoran:

Some medical conditions may interact with Levo-Dromoran. 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 a history of prostate problems, seizures, heart problems or a recent heart attack, kidney problems, liver disease, an underactive thyroid, severe inflammatory bowel disease, lung problems, asthma, a head injury or increased pressure within the head, a brain tumor, trouble urinating, or low blood pressure
• if you have a history of mental or mood problems or suicidal thoughts
• if you will be having surgery on the stomach, intestines, liver, or gallbladder
• if you consume large amounts of alcohol or have a history of substance abuse or dependence

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

• Cimetidine, MAO inhibitors (eg, phenelzine), or sodium oxybate (GHB) because side effects of Levo-Dromoran may be increased
• Naltrexone or narcotic agonist/antagonists (eg, pentazocine) because the effectiveness of Levo-Dromoran may be decreased
• Antihistamines (eg, diphenhydramine), barbiturates (eg, phenobarbital), muscle relaxants (eg, methocarbamol), other narcotic pain medicines (eg, codeine), phenothiazines (eg, chlorpromazine), sleeping medicines (eg, zolpidem), or tricyclic antidepressants (eg, amitriptyline) because severe side effects, such as severe drowsiness, low blood pressure, or trouble breathing, may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Levo-Dromoran 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 Levo-Dromoran:

Use Levo-Dromoran as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Levo-Dromoran may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you miss a dose of Levo-Dromoran, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Levo-Dromoran.

Important safety information:

• Levo-Dromoran may cause drowsiness, dizziness, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Levo-Dromoran. Using Levo-Dromoran 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 taking Levo-Dromoran. Levo-Dromoran will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Levo-Dromoran may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
• Risk of severe drowsiness, low blood pressure, and severe breathing problems may be increased with high doses or prolonged use. Do NOT exceed the recommended dose or use Levo-Dromoran for longer than prescribed without checking with your doctor.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Levo-Dromoran.
• Use Levo-Dromoran with caution in the ELDERLY because they may be more sensitive to its effects.
• Levo-Dromoran is not recommended for use in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is unknown if Levo-Dromoran can cause harm to the fetus. If you become pregnant while taking Levo-Dromoran, discuss with your doctor the benefits and risks of using Levo-Dromoran during pregnancy. It is unknown if Levo-Dromoran is excreted in breast milk. Do not breast-feed while taking Levo-Dromoran.

When used for long periods of time or at high doses, Levo-Dromoran 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 Levo-Dromoran stops working well. Do not take more than prescribed.

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

If you suddenly stop taking Levo-Dromoran, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Levo-Dromoran:

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:

Altered mood and thoughts; constipation; dizziness; drowsiness; flushing; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); depression; difficulty urinating; fainting; fast, slow, or irregular heartbeat; itching; seizures.

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 cold and clammy skin; deep sleep; dizziness; drowsiness; lightheadedness; loss of consciousness; slowed breathing; slowed heartbeat.

Store Levo-Dromoran 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. Do not store in the bathroom. Keep Levo-Dromoran out of the reach of children and away from pets.

General information:

• If you have any questions about Levo-Dromoran, please talk with your doctor, pharmacist, or other health care provider.
• Levo-Dromoran 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 Levo-Dromoran. 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.