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|Promethazine Tablets

Promethazine

Promethazine is used for:

Relieving allergy symptoms, including hives and nasal congestion. It is used to prevent and control pain and nausea during and after surgery. It is also used to help produce light sleep, and for the prevention of motion sickness. Promethazine is not to be used to treat asthma. It may also be used for other conditions as determined by your doctor.

Promethazine is a phenothiazine antihistamine. It works by blocking the sights where histamine acts.

Do NOT use Promethazine if:

• you are allergic to any ingredient in Promethazine
• you have a severe central nervous system depression or are in a coma
• you are also taking astemizole, cisapride, terfenadine, or tramadol

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

Before using Promethazine:

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

• if you are pregnant, plan 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 or other substances
• if you have nervous system problems, bone marrow depression, heart problems, a blood disease, glaucoma, increased eye pressure, low blood pressure, liver problems, prostate problems, Parkinson disease, seizures, or Reye syndrome
• if you regularly consume large amounts of alcohol

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

• Charcoal or lithium because the effectiveness of Promethazine may be decreased
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), astemizole, cisapride, general anesthetics (eg, thiopental), methyldopa, terfenadine, or tramadol because side effects such as low blood pressure and seizures may occur
• ACE inhibitors (eg, enalapril), haloperidol, lithium, meperidine, metrizamide, monoamine oxidase (MAO) inhibitors (eg, phenelzine), naltrexone, polypeptide antibiotics (eg, actinomycin), or trazodone because the actions and side effects of these medicines may be increased
• Bromocriptine, epinephrine, levodopa, or pergolide because the effectiveness of these medicines may be decreased

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

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

• Promethazine may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you are using Promethazine for motion sickness, take a dose at least 30 to 60 minutes before you begin traveling.
• If you miss a dose of Promethazine and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to you regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Promethazine may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Promethazine. Using Promethazine alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Promethazine. Promethazine will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Neuroleptic malignant syndrome (NMS) is a potentially deadly syndrome associated with Promethazine. Symptoms include increased body heat; muscle rigidness; altered mental abilities, including lack of response to your surroundings; irregular pulse and blood pressure; increased heart rate; sweating; irregular heart rhythm. Contact your doctor at once if any of these symptoms occur.
• Promethazine may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Promethazine. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• Use extreme caution when using Promethazine in the ELDERLY as they may be more sensitive to the effects of this medicine.
• Promethazine should not be used in CHILDREN under 2 years of age. Serious, and sometimes fatal, side effects (difficult or slowed breathing, drowsiness leading to coma) have occurred when Promethazine has been used in children in this age group. Promethazine should also be used with extreme caution in children 2 years of age and older. The lowest effective dose should be used in children 2 years of age and older.
• If you are pregnant or plan on becoming pregnant, discuss with your doctor the benefits and risks of using Promethazine during pregnancy. Promethazine is excreted in breast milk. If you are or will be breast-feeding while you are using Promethazine, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Promethazine:

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; dry mouth; increased or decreased blood pressure; nausea; occasional blurred vision; rash; sleepiness; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); sensitivity to light; uncontrolled muscle movements; yellowing of 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: convulsions; dry mouth; flushing; hallucinations; loss of consciousness; nightmares; seizures; shortness of breath; trouble breathing; unusual drowsiness or restlessness.

Store Promethazine at room temperature between 68 to 77 degrees F (20 to 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep tightly closed. Keep Promethazine out of the reach of children and away from pets.

General information:

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