Brand Name

    US Brand Name

    Adipex

    Adipex-P

    Atti-Plex P

    Fastin

    Ionamin

    Lomaira

    Phentercot

    Phentride

    Pro-Fast


    Description

    Phentermine is used for weight reduction in patients with obesity. It is used in patients with obesity who have not been able to lose weight with diet and exercise alone. This medicine works by suppressing your appetite.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Tablet
    • Capsule

    Before Using

    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. 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.

    Breastfeeding

    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.

    Drug Interactions

    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.

    • Iobenguane I 131
    • Venlafaxine

    Other Interactions

    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 use disorder, history of or
    • Glaucoma or
    • Heart or blood vessel disease (eg, coronary artery disease), history of or
    • Heart rhythm problems (eg, arrhythmias), history of or
    • Hypertension (high blood pressure) uncontrolled, 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.
    • Diabetes or
    • 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.

    Proper Use

    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 Suprenza™ 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.

    Make sure your hands are dry before touching the Phentermine disintegrating tablet. Place the tablet on the top of your tongue right after removing it from the bottle. Swallow with or without 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. Your doctor may adjust your dose as needed.
        • 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.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and does not cause any unwanted effects.

    Do not use phentermine if you are also using similar medicines such as benzphetamine, diethylpropion, mazindol, phendimetrazine, Bontril®, or Didrex®. Do not use this medicine if you also take an MAO inhibitor (MAOI), such as isocarboxazid (Marplan®), phenelzine (Nardil®,), selegiline (Eldepryl®), or tranylcypromine (Parnate®), or if you have used an MAOI within the past 14 days. Using these medicines together may cause serious unwanted effects.

    Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

    This medicine may be habit-forming. If you think this medicine is not working properly after you have taken it for a few weeks, do not increase the dose. Instead, check with your doctor.

    This medicine may cause pulmonary hypertension (increased blood pressure in the lungs). Serious heart or blood vessel problems (eg, valvular heart disease) may also occur if you take more of it, if you take it for a longer time, or if you are taking other medicine that reduces appetite (eg, dexfenfluramine (Redux®), fenfluramine (Fintepla®)). Check with your doctor right away if you have chest pain, decreased ability to exercise, fainting, swelling of the feet or lower legs, or trouble breathing.

    This medicine may cause some people to become dizzy, lightheaded, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

    This medicine may affect blood sugar levels. Patients with diabetes may notice a change in blood or urine sugar tests. Check with your doctor if you have any questions.

    Avoid drinking alcohol while you are using this medicine.

    Symptoms of an overdose include: bigger, dilated, or enlarged pupils (black part of the eye), confusion, increased sensitivity of the eyes to light, overactive reflexes, panic states, physical attempt to injure, restlessness, seeing, hearing, or feeling things that are not there, shakiness in the legs, arms, hands, or feet, trembling or shaking of the hands or feet, violent actions.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter) medicines, dietary supplements, herbal remedies, or medicines for appetite control, asthma, colds, cough, hay fever, and sinus problems.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Rare

    • Seeing, hearing, or feeling things that are not there
    • severe mental changes

    Incidence not known

    • Chest pain
    • decreased ability to exercise
    • dizziness
    • fainting
    • fast, irregular, pounding, or racing heartbeat or pulse
    • headache
    • numbness or tingling in the arms or legs
    • swelling of the feet or lower legs
    • trembling or shaking of the legs, arms, hands, or feet
    • trouble breathing
    • trouble with thinking, speaking, or walking
    • weakness

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Incidence not known

    • Decreased interest in sexual intercourse
    • difficulty having a bowel movement (stool)
    • dry mouth
    • false or unusual sense of well-being
    • hives or welts, itching, or skin rash
    • inability to have or keep an erection
    • increased in sexual ability, desire, drive, or performance
    • increased interest in sexual intercourse
    • loss in sexual ability, desire, drive, or performance
    • redness of the skin
    • unpleasant taste

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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