Prelu-2 TR Sustained-Release Capsules

Generic Name: phendimetrazine (FEN-dye-MET-ra-zeen)
Brand Name: Generic only. No brand available.

Prelu-2 TR Sustained-Release Capsules are used for:

The short-term management of obesity combined with a diet and exercise program.

Prelu-2 TR Sustained-Release Capsules are an anorectic. Exactly how Prelu-2 TR Sustained-Release Capsules works is unknown, although one of its effects is to decrease your appetite.

Do NOT use Prelu-2 TR Sustained-Release Capsules if:

  • you are allergic to any ingredient in Prelu-2 TR Sustained-Release Capsules or to a sympathomimetic medicine (eg, pseudoephedrine)
  • you are pregnant or breast-feeding
  • you have glaucoma; an overactive thyroid; moderate, severe, or uncontrolled high blood pressure; are highly nervous or agitated; or have a history of drug abuse
  • you have a history of stroke; high blood pressure in the lungs (pulmonary hypertension); uncontrolled high blood pressure; or heart problems (eg, heart blood vessel disease, heart failure, irregular heartbeat, heart murmur, heart valve problems)
  • you are taking another anorectic medicine (eg, phentermine), or if you have taken one within the past year
  • you are taking guanadrel or guanethidine, or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

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Before using Prelu-2 TR Sustained-Release Capsules:

Some medical conditions may interact with Prelu-2 TR Sustained-Release Capsules. 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 kidney problems, diabetes, or high blood pressure
  • if you have had any type of unusual reaction to a sympathomimetic medicine (eg, pseudoephedrine, albuterol)

Some MEDICINES MAY INTERACT with Prelu-2 TR Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Other anorectic medicines (eg, phentermine) because the risk of certain heart valve problems may be increased
  • Furazolidone or MAOIs (eg, phenelzine), because severe side effects, such as severe high blood pressure, irregular heartbeat, high fever, tremors, and seizures, may occur
  • Insulin or oral diabetes medicines (eg, glyburide) because the risk of low blood sugar may be increased
  • Guanadrel or guanethidine because their effectiveness may be decreased by Prelu-2 TR Sustained-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prelu-2 TR Sustained-Release Capsules 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 Prelu-2 TR Sustained-Release Capsules:

Use Prelu-2 TR Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Prelu-2 TR Sustained-Release Capsules about 30 to 60 minutes before the morning meal, unless your doctor tells you otherwise.
  • Swallow Prelu-2 TR Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.
  • If you miss a dose of Prelu-2 TR Sustained-Release Capsules, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prelu-2 TR Sustained-Release Capsules.

Important safety information:

  • Prelu-2 TR Sustained-Release Capsules may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Prelu-2 TR Sustained-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol while you are taking Prelu-2 TR Sustained-Release Capsules.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Doing so may increase the risk of serious side effects.
  • Patients who take this type of medicine (anorectics) may have an increased risk of developing high blood pressure in the lungs. This condition is rare but often fatal. The risk may be higher in patients who take this type of medicine for longer than 3 months. It is not known if repeated treatment with this type of medicine may increase the risk. Discuss any questions or concerns with your doctor. Tell your doctor at once if you develop new or worsening shortness of breath, chest pain, fainting, or swelling of the legs or feet.
  • Heart valve problems have been reported in patients taking certain anorectic medicines. Discuss any questions or concerns with your doctor.
  • Tell your doctor or dentist that you take Prelu-2 TR Sustained-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
  • Diabetes patients - Prelu-2 TR Sustained-Release Capsules may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
  • Prelu-2 TR Sustained-Release Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Prelu-2 TR Sustained-Release Capsules.
  • Use Prelu-2 TR Sustained-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.
  • Prelu-2 TR Sustained-Release Capsules are not recommended for use in CHILDREN younger than 17 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Prelu-2 TR Sustained-Release Capsules if you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Prelu-2 TR Sustained-Release Capsules are found in breast milk. Do not breast-feed while taking Prelu-2 TR Sustained-Release Capsules.

After you have been taking Prelu-2 TR Sustained-Release Capsules for a few weeks, it may not work as well as when you started to take it. This is known as TOLERANCE. Talk with your doctor if Prelu-2 TR Sustained-Release Capsules stops working well. Do not take more than prescribed.

Some people who use Prelu-2 TR Sustained-Release Capsules 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 Prelu-2 TR Sustained-Release Capsules suddenly, you may have WITHDRAWAL symptoms. These may include extreme tiredness or mental depression.

Possible side effects of Prelu-2 TR Sustained-Release Capsules:

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:

Constipation; diarrhea; dizziness; dry mouth; flushing; headache; nausea; overstimulation; restlessness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; changes in sex drive; chest, jaw, or arm pain; fast or irregular heartbeat; frequent urination or trouble urinating; hallucinations; mental or mood changes; seizures; severe or persistent headache or dizziness; shortness of breath; stomach pain; sudden, severe nausea or vomiting; tremor; unusual sweating.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; confusion; diarrhea; fainting; fast or irregular heartbeat; hallucinations; mental or mood changes (eg, depression); nausea; panic attack; restlessness; seizures; severe dizziness or headache; stomach cramps; unusual tiredness; vomiting.

Proper storage of Prelu-2 TR Sustained-Release Capsules:

Store Prelu-2 TR Sustained-Release Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prelu-2 TR Sustained-Release Capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about Prelu-2 TR Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Prelu-2 TR Sustained-Release Capsules are 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Prelu-2 TR Sustained-Release Capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Prelu-2 TR Sustained-Release Capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Prelu-2 TR Sustained-Release Capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Prelu-2 TR Sustained-Release Capsules.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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