Adipex-P

Name: Adipex-P

Phentermine Interactions

It’s always important to tell your doctor and pharmacist about all of your treatments, including over-the-counter (OTC) medications; vitamins, nutritional shakes, protein powders, and other supplements; herbal treatments or other alternative medicines; and any illegal or recreational drugs.

The following drugs interact with phentermine:

  • Isoproterenol
  • Dopamine
  • Ephedrine
  • Epinephrine
  • Norepinephrine (Levophed)
  • Linezolid (Zyvox)
  • Phenylephrine injection
  • Venlafaxine (Effexor, Effexor XR)

Phentermine and Alcohol

You should not consume alcohol or any other medication that dulls the nervous system while taking phentermine, since it can work against the desired effects of phentermine.

Combining phentermine and alcohol may increase your risk of experiencing side effects of the drug, including stomach problems and diarrhea.

Phentermine and Other Interactions

  • Amphetamine (Adderall)
  • Benzphetamine (Didrex, Regimex)
  • Dexmethylphenidate (Focalin XR, Focalin)
  • Dextroamphetamine (Dexadrine)
  • Diethylpropion
  • Isocarboxazid (Marplan)
  • Lisdexamfetamine (Vyvanse)
  • Methamphetamine (Desoxyn)
  • Methylphenidate (Concerta, Metadate CD, Methylin, Ritalin)
  • Phendimetrazine (Bontril, Bontril PDM)
  • Henelzine (Nardil)
  • Procarbazine (Matulane)
  • Selegeline transdermal patches (Emsam)
  • Sibutramine (Meridia)
  • Tranylcypromine (Parnate)

What side effects can this medication cause?

Phentermine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • dry mouth
  • unpleasant taste
  • diarrhea
  • constipation
  • vomiting

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

  • increased blood pressure
  • heart palpitations
  • restlessness
  • dizziness
  • tremor
  • insomnia
  • shortness of breath
  • chest pain
  • swelling of the legs and ankles
  • difficulty doing exercise that you have been able to do

Phentermine may cause other side effects. Call your doctor if you have any unusual problems during your treatment with phentermine.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Side effects

The following adverse reactions are described, or described in greater detail, in other sections:

  • Primary pulmonary hypertension [see WARNINGS AND PRECAUTIONS]
  • Valvular heart disease [see WARNINGS AND PRECAUTIONS]
  • Effect on the ability to engage in potentially hazardous tasks [see WARNINGS AND PRECAUTIONS]
  • Withdrawal effects following prolonged high dosage administration [see Drug Abuse And Dependence]

The following adverse reactions to phentermine have been identified:

Cardiovascular

Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.

Central Nervous System

Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.

Gastrointestinal

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

Allergic

Urticaria.

Endocrine

Impotence, changes in libido.

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

Do not use phentermine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

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

  • a history of heart disease (coronary artery disease, heart rhythm problems, congestive heart failure, stroke);

  • a history of pulmonary hypertension;

  • severe or uncontrolled high blood pressure;

  • overactive thyroid;

  • glaucoma;

  • if you are pregnant or breast-feeding;

  • if you are in an agitated state;

  • if you have a history of drug or alcohol abuse; or

  • if you are allergic to other diet pills, amphetamines, stimulants, or cold medications.

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.

To make sure you phentermine is safe for you, tell your doctor if you have:

  • high blood pressure;

  • diabetes;

  • kidney disease;

  • a thyroid disorder; or

  • if you are allergic to aspirin or to yellow food dye (FD & C Yellow No. 5, or tartrazine).

Phentermine may be habit forming. 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.

FDA pregnancy category X. Weight loss during pregnancy can harm an unborn baby, even if you are overweight. Do not use phentermine if you are pregnant.

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.

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

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.

Before Using Adipex-P

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of phentermine is not recommended in children 16 years of age and younger. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of phentermine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving phentermine.

Pregnancy

Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Linezolid
  • Methylene Blue
  • Moclobemide
  • Nialamide
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Safinamide
  • Selegiline
  • Sibutramine
  • Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Fenfluramine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Agitated state (very nervous or anxious) or
  • Arrhythmias (abnormal heart rhythms), history of or
  • Arteriosclerosis (hardening of the arteries), serious or
  • Congestive heart failure, history of or
  • Drug abuse or dependence, history of or
  • Glaucoma or
  • Heart or blood vessel disease (eg, coronary artery disease), history of or
  • Hypertension (high blood pressure) that is not controlled, history of or
  • Hyperthyroidism (overactive thyroid) or
  • Stroke, history of—Should not be used in patients with these conditions.
  • Allergy to tartrazine—Suprenza™ contains tartrazine. Patients with this condition may have an allergic reaction.
  • Heart valve disease or
  • Hypertension (high blood pressure) or
  • Pulmonary hypertension (elevated pressure in the lungs)—Use with caution. May make these conditions worse.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

How is this medicine (Adipex-P) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take Adipex-P early in the day to prevent sleep problems.
  • Take before or after breakfast as your doctor has told you.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Indications and Usage for Adipex-P

Adipex-P® 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 greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled 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.

The limited usefulness of agents of this class, including Adipex-P®, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.

Adipex-P 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 (37.5 mg) daily as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast for appetite control.

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

Adipex-P® is not recommended for use in pediatric patients less than or equal to 16 years of age.

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

Dosage in Patients With Renal Impairment

The recommended maximum dosage of Adipex-P® is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2). Avoid use of Adipex-P® in patients with eGFR less than 15 mL/min/1.73 m2 or end-stage renal disease requiring dialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Adipex-P - Clinical Pharmacology

Mechanism of Action

Adipex-P® is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics.” It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.

Pharmacodynamics

Typical actions of amphetamines 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.

Pharmacokinetics

Following the administration of phentermine, phentermine reaches peak concentrations (Cmax) after 3.0 to 4.4 hours.

Drug Interactions

In a single-dose study comparing the exposures after oral administration of a combination capsule of 15 mg phentermine and 92 mg topiramate to the exposures after oral administration of a 15 mg phentermine capsule or a 92 mg topiramate capsule, there is no significant topiramate exposure change in the presence of phentermine. However in the presence of topiramate, phentermine Cmax and AUC increase 13% and 42%, respectively.

Specific Populations

Renal Impairment

Cumulative urinary excretion of phentermine under uncontrolled urinary pH conditions was 62% to 85%.

Systemic exposure of phentermine may increase up to 91%, 45%, and 22% in patients with severe, moderate, and mild renal impairment, respectively [see Dosage and Administration (2.2) and Use in Specific Populations (8.6)].

Clinical Studies

No clinical studies have been conducted with Adipex-P®.

In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with “anorectic” drugs lost more weight on the average than those treated with placebo and diet.

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 over several 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.

How Supplied/Storage and Handling

Available in tablets and capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base). Each blue and white, oblong, speckled, scored tablet is debossed with “Adipex-P” and “9”-“9”. The #3 capsule has an opaque white body and an opaque bright blue cap. Each capsule is imprinted with “Adipex-P” - “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).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Package/Label Display Panel

Adipex-P® Tablets 37.5 mg CIV 100s Label Text

NDC 57844-009-01

CIV

Adipex-P® 37.5 mg
(phentermine hydrochloride tablets USP)

Rx only

100 TABLETS

TEVA

Adipex-P Drug Class

Adipex-P is part of the drug class:

  • Centrally acting antiobesity products

Adipex-P Interactions

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • fluoxetine (Prozac)
  • fluvoxamine (Luvox) 
  • guanethidine
  • oral hypoglycemic medications for diabetes
  • insulin (you may need to increase your dose of insulin while taking Adipex-P)
  • medications for weight loss and depression
  • paroxetine (Paxil)
  • sertraline (Zoloft)
  • monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar) and tranylcypromine (Parnate)

This is not a complete list of Adipex-P drug interactions. Ask your doctor or pharmacist for more information.

 

Adipex-P Overdose

If you take too much Adipex-P, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

 

(web3)