w/thioridazine than other phenothiazines. Interaction more likely in certain predisposed pts. only. thioridazine increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.thiothixeneMonitor Closely (1)thiothixene increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.topiramateMonitor Closely (1)topiramate increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.tramadolMonitor Closely (1)tramadol increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.tranylcypromineContraindicated (1)tranylcypromine increases effects of phendimetrazine by pharmacodynamic synergism. Contraindicated. Risk of acute hypertensive episode.trazodoneMonitor Closely (1)trazodone increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.Serious - Use Alternative (1)trazodone, phendimetrazine. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.triazolamMonitor Closely (1)triazolam increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.triclofosMonitor Closely (1)triclofos increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.trifluoperazineMonitor Closely (2)trifluoperazine, phendimetrazine. Mechanism: unknown. Use Caution/Monitor. Risk of cardiac arrhythmia or sudden death, more likely w/thioridazine than other phenothiazines. Interaction more likely in certain predisposed pts. only. trifluoperazine increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.trimipramineMonitor Closely (1)trimipramine increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.Serious - Use Alternative (1)trimipramine, phendimetrazine. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.triprolidineMonitor Closely (1)triprolidine increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.xylometazolineMonitor Closely (2)phendimetrazine and xylometazoline both decrease sedation. Use Caution/Monitor. phendimetrazine and xylometazoline both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.yohimbeSerious - Use Alternative (1)yohimbe, phendimetrazine. Mechanism: pharmacodynamic synergism. Contraindicated. Risk of acute hypertensive episode.yohimbineMonitor Closely (2)yohimbine and phendimetrazine both decrease sedation. Use Caution/Monitor. phendimetrazine and yohimbine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.ziconotideMonitor Closely (1)ziconotide increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.ziprasidoneMonitor Closely (1)ziprasidone increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor. Frequency Not Defined Abnormal heart valve findings Agitation Blurred vision Changes in libido Constipation Diarrhea Dizziness Dryness of the mouth Dysphoria Dysuria Euphoria Flushing Headache Impotence Increased BP Insomnia Nausea Palpitation Primary pulmonary HTN Stomach pain Sweating Tachycardia Tremor Unpleasant taste Urticaria Contraindications Hypersensitivity History of cardiovascular disease (eg, coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension, pulmonary hypertension) Hyperthyroidism Glaucoma Agitated states History of drug abuse Pregnancy Breast feeding Coadministration with other anorectic agents or CNS stimulants Do not administer within 14 days of administration of MAO inhibitors Cautions Impairs ability to drive or operate heavy machinery Primary pulmonary hypertension associated with treatment Use with other anorectic agents Possibility of addiction Caution advised; increased exposure expected when administered to patients with renal impairment; excreted in urine Pregnancy Category: X; weight loss offers no potential benefit to a pregnant woman and may result in fetal harm; a minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese Lactation: Contraindicated; do not nurse if taking this drugPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Anorectic; sympathomimetic amine similar to amphetmine; may act in CNS to reduce appetite Pharmacokinetics Metabolism: Forms 2 metabolites Metabolites: Phendimetrazine-N-oxide Absorption: readily absorbed from GI tract Duration: 4 hr Excretion: Urine Half-life: 1.9 hr (tablet); 9.8 hr (slow release) BRAND FORM. UNIT PRICE PILL IMAGE phendimetrazine tartrate oral- 35 mg tabletphendimetrazine tartrate oral- 35 mg tabletphendimetrazine tartrate oral- 105 mg capsulephendimetrazine tartrate oral- 35 mg tabletphendimetrazine tartrate oral- 35 mg tabletphendimetrazine tartrate oral- 35 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationphendimetrazine tartrate oral PHENDIMETRAZINE - ORAL (FEN-dye-meh-TRA-zeen) COMMON BRAND NAME(S): Bontril PDM, Plegine USES: Phendimetrazine is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life.It is not known how this medication helps people to lose weight. It may work by decreasing your appetite, increasing the amount of energy used by your body, or by affecting certain parts of the brain. This medication is an appetite suppressant and belongs to a class of drugs called sympathomimetic amines. HOW TO USE: Take the immediate-release form of this medication by mouth as directed by your doctor, usually 2 to 3 times a day (1 hour before meals). Taking this medication late in the day may cause trouble sleeping (insomnia).The sustained-release form of phendimetrazine is usually taken once a day 30 - 60 minutes before the morning meal. Swallow this medication whole. Do not crush, chew, or break the capsules. Doing so can destroy the long action of the drug and may increase side effects.The dosage is based on your medical condition and response to therapy. Your doctor will adjust the dose to find the best dose for you. Use this medication regularly and exactly as prescribed in order to get the most benefit from it. To help you remember, take it at the same time(s) each day.Phendimetrazine is usually taken for only a few weeks at a time. It should not be taken with other appetite suppressants (see also Drug Interactions section). The possibility of serious side effects increases with longer use of this medication and use of this drug along with certain other diet drugs.If you suddenly stop using this medication, you may have withdrawal symptoms (such as depression, severe tiredness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used phendimetrazine for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Properly stop the medication when so directed.This medication may stop working well after you have been taking it for a while. Talk with your doctor if this medication stops working well. Do not increase the dose unless directed by your doctor. Your doctor may direct you to stop taking this medication. SIDE EFFECTS: Dizziness, dry mouth, difficulty sleeping, irritability, nausea, vomiting, diarrhea, or constipation may occur. If these effects last or get worse, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.Tell your doctor right away if you have any serious side effects, including: fast/irregular/pounding heartbeat, mental/mood changes (such as agitation, uncontrolled anger, hallucinations, nervousness), uncontrolled muscle movements, change in sexual ability/interest.Get medical help right away if you have any very serious side effects, including: severe headache, trouble speaking, seizure, weakness on one side of the body, vision changes (such as blurred vision).This drug may rarely cause serious (sometimes fatal) lung or heart problems (pulmonary hypertension, heart valve problems). The risk increases with longer use of this medication and use of this drug along with other appetite-suppressant drugs/herbal products. If you notice any of the following serious side effects, stop taking this medication and tell your doctor or pharmacist right away: chest pain, difficulty breathing with exercise, decreased ability to exercise, fainting, swelling of the legs/ankles/feet.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before taking phendimetrazine, tell your doctor or pharmacist if you are allergic to it; or to any other sympathomimetic amines (including decongestants such as pseudoephedrine, stimulants such as amphetamine, appetite suppressants such as phentermine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, high blood pressure, glaucoma, heart problems (such as chest pain, heart attack, heart murmur, fast/irregular heartbeat, heart valve problems), mental/mood problems (such as severe anxiety/agitation, depression, psychosis, schizophrenia), high blood pressure in the lungs (pulmonary hypertension), kidney disease, seizure problem, stroke, overactive thyroid (hyperthyroidism), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol).This drug may make you dizzy or blur your vision. It may also rarely make you drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).If you have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication during treatment with this drug.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be at greater risk for dizziness and high blood pressure while using this drug.This medication must not be used during pregnancy. Weight loss offers no potential benefit to a pregnant woman and may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away.It is unknown if this drug passes into breast-milk. However, similar drugs pass into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: stimulants (including amphetamines, methylphenidate, street drugs such as cocaine or MDMA/"ecstasy").This drug should not be used with certain medications because very serious interactions may occur. If you are taking or have taken other appetite-suppressant drugs in the past year (such as phentermine, ephedra/ma huang), tell your doctor or pharmacist before starting this medication.Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should