Phentermine Hydrochloride (Adipex-P)
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Phentermine Hydrochloride (Adipex-P)

Adipex-P®
(phentermine hydrochloride) 37.5 mg Tablets, USP

DRUG DESCRIPTION

Phentermine hydrochloride USP has the chemical name of α α Dimethylphenethylamine hydrochloride. The structural formula is as follows:

ADIPEX-P®(Phentermine Hydrochloride USP, 37.5 mg) Structural Formula Illustration

Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.

ADIPEX-P® (phentermine hydrochloride) , an anorectic agent for oral administration, is available as a capsule or tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base).

ADIPEX-P® (phentermine hydrochloride) Capsules contain the inactive ingredients Corn Starch, Gelatin, Lactose Monohydrate, Magnesium Stearate, Titanium Dioxide, Black Iron Oxide, FD&C Blue #1, FD&C Red #40 and D&C Red #33.

ADIPEX-P® (phentermine hydrochloride) Tablets contain the inactive ingredients Corn Starch, Lactose (Anhydrous), Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Sucrose, and FD&C Blue #1.

What are the possible side effects of phentermine (Adipex-P, Oby-Cap, T-Diet, Zantryl)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • feeling short of breath, even with mild exertion;
  • chest pain, feeling like you might pass out;
  • swelling in your ankles or feet;
  • pounding heartbeats or fluttering in your chest;
  • confusion or irritability, unusual thoughts or behavior;
  • feelings of extreme happiness or sadness;...

Read All Potential Side Effects and See Pictures of Adipex-P »

What are the precautions when taking phentermine hydrochloride (Adipex-P)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to any other sympathomimetic amines (e.g., decongestants such as pseudoephedrine, stimulants such as amphetamine, appetite suppressants such as diethylpropion); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled high blood pressure, glaucoma, history of alcohol/drug abuse, vascular heart disease (e.g., chest pain, heart attack), mental/mood problems (e.g., severe anxiety, bipolar disorder, psychosis,...

Read All Potential Precautions of Adipex-P »

Last reviewed on RxList: 10/29/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

ADIPEX-P® (phentermine hydrochloride) is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia).

Below is a chart of Body Mass Index (BMI) based on various heights and weights.

BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

BODY MASS INDEX (BMI), kg/m2 Height (feet, inches)

Weight (pounds) 5'0” 5'3” 5'6” 5'9” 6'0” 6'3”
140 27 25 23 21 19 18
150 29 27 24 22 20 19
160 31 28 26 24 22 20
170 33 30 28 25 23 21
180 35 32 29 27 25 23
190 37 34 31 28 26 24
200 39 36 32 30 27 25
210 41 37 34 31 29 26
220 43 39 36 33 30 28
230 45 41 37 34 31 29
240 47 43 39 36 33 30
250 49 44 40 37 34 31

The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.

DOSAGE AND ADMINISTRATION

Exogenous Obesity: Dosage should be individualized to obtain an adequate response with the lowest effective dose.

The usual adult dose is one capsule or tablet (37.5 mg) daily, administered before breakfast or 1-2 hours after breakfast. For tablets, the dosage may be adjusted to the patient's need. For some patients 1/2 tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give 1/2 tablet (18.75 mg) two times a day.

Late evening medication should be avoided because of the possibility of resulting insomnia.

Phentermine is not recommended for use in patients sixteen (16) years of age and under.

HOW SUPPLIED

Available in tablets and capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base). Each blue and white, oblong, scored tablet is debossed with "ADIPEX-P (phentermine hydrochloride) " and "9"-"9". The #3 capsule has an opaque white body and an opaque bright blue cap. Each capsule is imprinted with "ADIPEX-P (phentermine hydrochloride) " - "37.5" on the cap and two stripes on the body using dark blue ink.

Tablets are packaged in bottles of 30 (NDC 57844-009-56); 100 (NDC 57844-009-01); and 1000 (NDC 57844-009-10).

Capsules are packaged in bottles of 100 (NDC 57844-019-01).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Manufactured for: GATE PHARMACEUTICALS, Div. of Teva Pharmaceuticals USA, Sellersville, PA 18960. Manufactured by: TEVA PHARMACEUTICALS USA. Sellersville, PA 18960. Rev. 7/2005. FDA Rev date: 10/15/2002

Last reviewed on RxList: 10/29/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Cardiovascular: Primary pulmonary hypertension and/or regurgitant cardiac valvular disease (see WARNINGS), palpitation, tachycardia, elevation of blood pressure.

Central Nervous System: Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache; rarely psychotic episodes at recommended doses.

Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Allergic: Urticaria.

Endocrine: Impotence, changes in libido.

Read the Adipex-P (phentermine hydrochloride) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 10/29/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

ADIPEX-P® (phentermine hydrochloride) is indicated only as short-term monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with phentermine and any other drug products for weight loss, including selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of these drug products for weight loss is not recommended.

Primary Pulmonary Hypertension (PPH) - a rare, frequently fatal disease of the lungs - has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of phentermine alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken phentermine alone. The initial symptom of PPH is usually dyspnea. Other initial symptoms include: angina pectoris, syncope or lower extremity edema. Patients should be advised to report immediately any deterioration in exercise tolerance. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema.

Valvular Heart Disease: Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine or dexfenfluramine for weight loss. The etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. The possibility of an association between valvular heart disease and the use of phentermine alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken phentermine alone.

Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

ADIPEX-P® (phentermine hydrochloride) may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

Drug Abuse And Dependence

ADIPEX-P® (phentermine hydrochloride) is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of ADIPEX-P® (phentermine hydrochloride) should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia.

Usage with Alcohol: Concomitant use of alcohol with ADIPEX-P® (phentermine hydrochloride) may result in an adverse drug interaction.

PRECAUTIONS

General

Caution is to be exercised in prescribing ADIPEX-P® (phentermine hydrochloride) for patients with even mild hypertension.

Insulin requirements in diabetes mellitus may be altered in association with the use of ADIPEX-P® (phentermine hydrochloride) and the concomitant dietary regimen. ADIPEX-P® (phentermine hydrochloride) may decrease the hypotensive effect of guanethidine. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed with ADIPEX-P® (phentermine hydrochloride) to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.

Pregnancy–Teratogenic Effects

Pregnancy Category C. Animal reproduction studies have not been conducted with ADIPEX-P® (phentermine hydrochloride) . It is also not known whether ADIPEX-P® (phentermine hydrochloride) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. ADIPEX-P® (phentermine hydrochloride) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Last reviewed on RxList: 10/29/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Manifestations of acute overdosage with phentermine include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning usually terminates in convulsions and coma.

Management of acute phentermine intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Acidification of the urine increases phentermine excretion. Intravenous phentolamine (Regitine®, CIBA) has been suggested for possible acute, severe hypertension, if this complicates phentermine overdosage.

CONTRAINDICATIONS

Advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Patients with a history of drug abuse.

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).

Last reviewed on RxList: 10/29/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

ADIPEX-P® (phentermine hydrochloride) is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved, for example.

Adult obese subjects instructed in dietary management and treated with "anorectic" drugs lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks' duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

Last reviewed on RxList: 10/29/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 10/29/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 10/29/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Adipex-P Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PHENTERMINE - ORAL

(FEN-ter-meen)

COMMON BRAND NAME(S): Adipex-P, Ionamin, Pro-Fast

USES: Phentermine is used along with a doctor-approved, reduced-calorie diet, exercise, and behavior change program to help you lose weight. It is used in people who are significantly overweight (obese) and have not been able to lose enough weight with diet and exercise alone. Losing weight and keeping it off can reduce 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 this medication by mouth as directed by your doctor, usually once a day, 1 hour before breakfast or 1 to 2 hours after breakfast. If needed, your doctor may adjust your dose to take a small dose up to 3 times a day. Carefully follow your doctor's instructions. Taking this medication late in the day may cause trouble sleeping (insomnia).

If you are using sustained-release capsules, the dose is usually taken once a day before breakfast or at least 10 to 14 hours before bedtime. Swallow the medication whole. Do not crush or chew sustained-release capsules. Doing so can release all of the drug at once, increasing the risk of side effects.

If you are using the tablets made to dissolve in the mouth, the dose is usually taken once a day in the morning, with or without food. First, dry your hands before handling the tablet. Place your dose on top of the tongue until it dissolves, then swallow it with or without water.

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.

This medication 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.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as depression, severe tiredness) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, 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 few weeks. 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.

Disclaimer

Adipex-P Consumer (continued)

SIDE EFFECTS: Dizziness, dry mouth, difficulty sleeping, irritability, nausea, vomiting, diarrhea, or constipation may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular/pounding heartbeat, mental/mood changes (e.g., agitation, uncontrolled anger, hallucinations, nervousness), uncontrolled muscle movements, change in sexual ability/interest.

Stop taking this medication and seek immediate medical attention if any of these rare but very serious side effects occur: severe headache, slurred speech, seizure, weakness on one side of the body, vision changes (e.g., blurred vision).

This drug may infrequently 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 unlikely but very serious side effects, stop taking this medication and consult your doctor or pharmacist immediately: 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, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Adipex-P (phentermine hydrochloride) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to any other sympathomimetic amines (e.g., decongestants such as pseudoephedrine, stimulants such as amphetamine, appetite suppressants such as diethylpropion); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled high blood pressure, glaucoma, history of alcohol/drug abuse, vascular heart disease (e.g., chest pain, heart attack), mental/mood problems (e.g., severe anxiety, bipolar disorder, psychosis, schizophrenia), high blood pressure in the lungs (pulmonary hypertension), stroke, overactive thyroid (hyperthyroidism).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, controlled high blood pressure, other heart problems (e.g., heart murmur, fast/irregular heartbeat, heart valve problems), kidney disease, seizure problem.

This drug may make you dizzy or (rarely) drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

If you are using the tablets made to dissolve in the mouth, your medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.

Before having surgery, tell your doctor or dentist that you are using this medication.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for dizziness and high blood pressure while using this drug.

This medication must not be used during pregnancy. It may harm an unborn baby. If you are pregnant or think you may be pregnant, tell your doctor immediately.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Disclaimer

Adipex-P Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

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 (e.g., diethylpropion, sibutramine, ephedra/ma huang), tell your doctor or pharmacist before starting this medication.

Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur.

If you are currently using any of these medications, tell your doctor or pharmacist before starting this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: drugs for depression (e.g., TCAs such as imipramine, SSRIs and SNRIs such as paroxetine, fluoxetine, venlafaxine, duloxetine), drugs for diabetes (e.g., insulin, sulfonylureas such as glipizide), high blood pressure medicine (e.g., guanethidine, methyldopa), phenothiazines (e.g., prochlorperazine, promethazine, chlorpromazine), other stimulants (e.g., amphetamines, methylphenidate, street drugs such as cocaine or MDMA/"ecstasy").

Tell your doctor or pharmacist if you also take drugs that cause dizziness or drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., risperidone, amitriptyline, trazodone).

Also report the use of drugs which might increase seizure risk when combined with this medication such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others.

Check the labels on all your medicines/herbal products (e.g., cough-and-cold products containing decongestants such as pseudoephedrine, diet aids such as phenylpropanolamine, ephedra/ma huang) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about using those products safely.

Caffeine can increase the side effects of this medication. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas) or eating large amounts of chocolate.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: rapid breathing, unusual restlessness, fast/slow/irregular heartbeat, chest pain, hallucinations, seizures, loss of consciousness.

NOTES: Appetite suppressants should not be used in place of proper diet. For best results, this drug must be used along with a doctor-approved diet and exercise program.

Do not share this medication with others. It is against the law.

Laboratory and/or medical tests (e.g., blood pressure, heart tests, kidney tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose or late in the evening, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store in a tightly closed container at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised January 2012. Copyright(c) 2012 First Databank, Inc.

Adipex-P Patient Information Including Side Effects

Brand Names: Adipex-P, Oby-Cap, T-Diet, Zantryl

Generic Name: phentermine (Pronunciation: FEN ter meen)

What is phentermine (Adipex-P)?

Phentermine is a stimulant that is similar to an amphetamine. Phentermine is an appetite suppressant that affects the central nervous system.

Phentermine is used togther with diet and exercise to treat obesity (overweight) in people with risk factors such as high blood pressure, high cholesterol, or diabetes.

Phentermine may also be used for other purposes not listed in this medication guide.

Adipex 37.5 mg

oblong, blue/white specks, imprinted with ADIPEX-P, 99

Adipex-P 37.5 mg-TEV

blue/white, imprinted with ADIPEX-P 37.5

Phentermine 15 mg-EON

gray/yellow, imprinted with E882

Phentermine 30 mg-EON

blue/clear, imprinted with E 5000

Phentermine 30 mg-MUT

yellow, imprinted with MUTUAL 274

Phentermine 37.5 mg-MUT

oval, white/blue specks, imprinted with MP 273

Phentermine 37.5 mg-PUR

oblong, white, imprinted with P 316

Phentermine 37.5 mg-QUA

elliptical, white/blue specks, imprinted with A 159

Phentermine15 mg-TEV

gray/yellow, imprinted with barr 15 mg, 1112

Phentermine30 mg-TEV

yellow, imprinted with barr 30 mg, 1113

What are the possible side effects of phentermine (Adipex-P)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • feeling short of breath, even with mild exertion;
  • chest pain, feeling like you might pass out;
  • swelling in your ankles or feet;
  • pounding heartbeats or fluttering in your chest;
  • confusion or irritability, unusual thoughts or behavior;
  • feelings of extreme happiness or sadness; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • feeling restless or hyperactive;
  • headache, dizziness, tremors;
  • sleep problems (insomnia);
  • dry mouth or an unpleasant taste in your mouth;
  • diarrhea or constipation, upset stomach; or
  • increased or decreased interest in sex, impotence.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Adipex-P (phentermine hydrochloride) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about phentermine (Adipex-P)?

Taking phentermine together with other diet medications such as fenfluramine (Phen-Fen) or dexfenfluramine (Redux) can cause a rare fatal lung disorder called pulmonary hypertension. Do not take phentermine with any other diet medications without your doctor's advice.

Phentermine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of phentermine.

Phentermine is only part of a complete program of treatment that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Phentermine may be habit-forming and should be used only by the person it was prescribed for. Never share phentermine with another person, especially someone with a history of drug abuse or addiction. Keep track of the amount of medicine used from each new bottle. Phentermine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not stop using phentermine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using phentermine.

Side Effects Centers

Adipex-P Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking phentermine (Adipex-P)?

Do not use phentermine if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use phentermine before the MAO inhibitor has cleared from your body.

Taking phentermine together with other diet medications such as fenfluramine (Phen-Fen) or dexfenfluramine (Redux) can cause a rare fatal lung disorder called pulmonary hypertension. Do not take phentermine with any other diet medications without your doctor's advice.

You should not take phentermine if you are allergic to it, or if you have:

  • coronary artery disease (hardening of the arteries);
  • heart disease;
  • severe or uncontrolled high blood pressure;
  • overactive thyroid;
  • glaucoma;
  • if you have a history of drug or alcohol abuse; o
  • if you are allergic to other diet pills, amphetamines, stimulants, or cold medications.

If you have any of these other conditions, you may need a phentermine dose adjustment or special tests:

  • high blood pressure;
  • diabetes; or
  • a thyroid disorder.

FDA pregnancy category C. It is not known whether phentermine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Phentermine can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking phentermine.

Do not give this medication to a child younger than 16 years old.

Phentermine may be habit-forming and should be used only by the person it was prescribed for. Never share phentermine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

How should I take phentermine (Adipex-P)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

It is best to take phentermine on an empty stomach before breakfast or within 2 hours after breakfast.

To prevent sleep problems, take this medication early in the day, no later than 6:00 pm.

Talk with your doctor if you have increased hunger or if you otherwise think the medication is not working properly. Taking more of this medication will not make it more effective and can cause serious, life-threatening side effects.

Phentermine should be taken only for a short time, such as a few weeks.

Do not stop taking phentermine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using phentermine.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Phentermine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Side Effects Centers

Adipex-P Patient Information including If I Miss a Dose

What happens if I miss a dose (Adipex-P)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Adipex-P)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of phentermine can be fatal.

Overdose symptoms may include confusion, hallucinations, panic, feeling hostile or aggressive, nausea, vomiting, diarrhea, stomach cramps, irregular heartbeat, rapid breathing, overactive reflexes, confusion, hallucinations, seizure (convulsions), feeling light-headed, or fainting.

What should I avoid while taking phentermine (Adipex-P)?

Drinking alcohol can increase certain side effects of phentermine.

Phentermine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What other drugs will affect phentermine (Adipex-P)?

Tell your doctor about all other medicines you use, especially:

  • blood pressure medications;
  • insulin or oral diabetes medication;
  • guanethidine (Ismelin); or
  • an antidepressant such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Symbyax), paroxetine (Paxil), sertraline (Zoloft), and others.

This list is not complete and other drugs may interact with phentermine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about phentermine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.02. Revision date: 12/15/2010.

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Side Effects Centers

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