Adipex-P

Name: Adipex-P

Phentermine Side Effects

If you experience any of the following more common side effects of phentermine and they don’t go away or become sever, call your doctor or seek emergency medical care:

  • Dry mouth
  • Constipation
  • Mild headache
  • Diarrhea
  • Itching

Serious Side Effects and Reactions

Phentermine may cause serious side effects. You should tell your doctor right away if you experience any of the following:

  • Chest, arm, or jaw pain
  • Very fast heartbeat
  • Swelling in your feet or legs
  • High blood pressure
  • Shortness of breath
  • Dizziness
  • Shaking or trembling
  • Weakness or problems walking
  • Unpleasant or bad taste in the mouth
  • Itching, skin redness, or rash

Tell your doctor if you experience any of the following, because they could be signs of a serious reaction to phentermine:

  • Upset stomach
  • Changes in sexual desire or inability to get an erection
  • Tirelessness or inability to sleep
  • Problems with thinking
  • Unusual feelings or behaviors, such as jitteriness, extra sensitivity, an unusual sense of well-being or invincibility (euphoria), or unease or dissatisfaction (dysphoria)
  • Hallucinations (hearing or seeing things that aren’t there)
  • Bad taste in the mouth
  • Become dependent on or addicted to phentermine

If you stop taking phentermine after taking it for a long period, you might experience symptoms of withdrawal, such as depression or fatigue.

How should this medicine be used?

Phentermine comes as tablets and extended-release capsules. It usually is taken as a single daily dose in the morning or three times a day 30 minutes before meals. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take phentermine exactly as directed.

Most people takephentermine for 3 to 6 weeks; the length of treatment depends on how you respond to the medication. Phentermine can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer period than your doctor tells you to.

If you are taking the extended-release (long-acting) tablets, do not split, chew, or crush them tablet. There are some tablets that can be crushed and mixed with food.

Brand names

  • Adipex-P®
  • Ionamin®

How supplied

Dosage Forms And Strengths

Capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).

Tablets containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).

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.

Manufactured By: Pliva Hrvats ka d.o.o. Zagreb, Croatia. Revised: March 2017

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

Taking this medicine with other stimulant drugs that make you restless or hyperactive can worsen these effects. Ask your doctor before taking phentermine with diet pills, other stimulants, or medicine to treat attention deficit hyperactivity disorder (ADHD).

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with phentermine, especially:

  • an antidepressant--citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline.

This list is not complete. Other drugs may interact with phentermine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Proper Use of phentermine

This section provides information on the proper use of a number of products that contain phentermine. It may not be specific to Adipex-P. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you take too much of this medicine, it may become habit-forming (causing mental or physical dependence).

This medicine is available in four forms: capsules, disintegrating tablets, extended-release capsules, and tablets. Carefully follow the dosing instructions for the form you are using.

Swallow the extended-release capsule whole. Do not crush, break, or chew it.

Take the disintegrating tablet with or without food. Make sure your hands are dry before touching the tablet. Place the tablet on the top of your tongue right after removing it from the bottle. It should melt quickly. After the tablet has melted, swallow or take a sip of water.

Swallow the tablet whole. Do not crush, break, or chew it.

Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. Talk with your doctor before starting an exercise program.

To avoid trouble with sleeping, take the last dose of the day about 4 to 6 hours before bedtime, unless your doctor tells you otherwise.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For treatment of obesity:
    • For oral dosage form (capsules):
      • Adults and children 17 years of age and older—15 to 30 milligrams (mg) once a day, taken at approximately 2 hours after breakfast.
      • Children 16 years of age and younger—Use is not recommended.
    • For oral dosage form (disintegrating tablets):
      • Adults and children 17 years of age and older—One tablet once a day, taken in the morning.
      • Children 16 years of age and younger—Use is not recommended.
    • For oral dosage form (extended-release capsules):
      • Adults and children 16 years of age and older—One capsule once a day, taken before breakfast or 10 to 14 hours before sleeping.
      • Children 15 years of age and younger—Use is not recommended.
    • For oral dosage form (tablets):
      • Adults and children 17 years of age and older—
        • Lomaira™: One tablet three times a day, taken 30 minutes before meals.
        • Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast.
      • Children 16 years of age and younger—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

What are some things I need to know or do while I take Adipex-P?

  • Tell all of your health care providers that you take Adipex-P. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
  • People who take drugs for weight loss like Adipex-P may have a higher chance of having raised pressure in the lungs. This is rare but is often deadly. Talk with your doctor.
  • Do not take this medicine for longer than you were told by your doctor.
  • If you have been taking Adipex-P for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine stops working well. Do not take more than ordered.
  • If you have been taking Adipex-P for many weeks, talk with your doctor before stopping. You may want to slowly stop this medicine.
  • This medicine may be habit-forming; avoid long-term use. Tell your doctor if you have a history of drug or alcohol abuse.
  • This medicine may cause unsafe heart-related side effects. Tell your doctor if you have any heart disease.
  • Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
  • If you have high blood sugar (diabetes), talk with your doctor.
  • Follow the diet and workout plan that your doctor told you about.
  • Talk with your doctor before you drink alcohol.
  • Do not give to a child younger than 17 years of age.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Adipex-P (phentermine capsules and tablets), call your doctor right away.

Warnings and Precautions

Coadministration With Other Drug Products for Weight Loss

Adipex-P® is indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with Adipex-P® and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of Adipex-P® and these drug products is not recommended.

Primary Pulmonary Hypertension

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 Adipex-P® 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 may 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, and patients should be evaluated for the possible presence of pulmonary hypertension.

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 possible role of phentermine in 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 Adipex-P® alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken phentermine alone.

Development of Tolerance, Discontinuation in Case of Tolerance

When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

Effect on the Ability to Engage in Potentially Hazardous Tasks

Adipex-P® 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.

Risk of Abuse and Dependence

Adipex-P® is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and to other related stimulant drugs that have been extensively abused. The possibility of abuse of Adipex-P® should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. See Drug Abuse and Dependence (9) and Overdosage (10).

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Usage With Alcohol

Concomitant use of alcohol with Adipex-P® may result in an adverse drug reaction.

Use in Patients With Hypertension

Use caution in prescribing Adipex-P® for patients with even mild hypertension (risk of increase in blood pressure).

Use in Patients on Insulin or Oral Hypoglycemic Medications for Diabetes Mellitus

A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.

Adipex-P Overview

Adipex-P is a prescription medicine used for weight loss. It is taken for a limited amount of time (a few weeks) by overweight adults, along with exercise and a low-calorie diet. Adipex-P belongs to a group of drugs called anorectics. It works by decreasing appetite.

Adipex-P comes in tablet and capsule form. It usually taken by mouth once daily in the morning before breakfast or 1 to 2 hours after breakfast.

Common side effects of Adipex-P include dry mouth, fast heart beat, insomnia, and dizziness. Do not drive or operate heavy machinery until you know how Adipex-P affects you.

 

Side Effects of Adipex-P

Adipex-P can cause primary pulmonary hypertension, a rare but serious and sometimes fatal side effect. This is a condition where the pressure of the arteries in your lungs increases, causing more pressure on your heart which can lead to heart failure and death. The first symptoms is often shortness of breath or lightheadedness during activity. Other symptoms include:

  • Ankle and leg swelling
  • Bluish color of the lips or skin 
  • Chest pain or pressure, usually in the front of the chest
  • Dizziness or fainting spells
  • Tiredness
  • Increased abdomen size
  • Weakness

Common side effects include:

  • High blood pressure
  • fast heart beats
  • insomnia
  • dizziness
  • rash
  • diarrhea
  • tremors
  • constipation

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

  • Obesity
  • Weight Loss Drugs Prescription and OTC
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