Pro-Fast (Oral)

Phentermine is used as part of a short-term plan, along with a low calorie diet, to help with weight loss. It is for obese patients who have not been able to lose weight through diet and exercise alone. Phentermine is in the group of medicines called appetite suppressants.

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

It is very important that your doctor checks your progress at regular visits to ensure 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 avoid 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.

Call your doctor right away if you notice a decrease in your ability to exercise, or if you faint, have chest pain, swelling of your feet or lower legs, or trouble with breathing. These may be symptoms of a very serious heart or lung problem.

This medicine may cause some people to feel dizzy, lightheaded, or less alert than usual. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you feel dizzy or not alert.

This medicine may affect blood sugar levels. Diabetic patients 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.

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.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it may provide. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Phentermine is not recommended for children aged 16 years and younger. Its safety and effectiveness have not been established for this age group.

Geriatric

Studies so far have not shown any specific problems in elderly patients that would limit the usefulness of phentermine. However, older patients may have age-related issues with their liver, kidneys, or heart, which may require caution and adjustments in the dosage for those taking phentermine.

Breast Feeding

Research on breastfeeding women has shown harmful effects on infants. You should either be prescribed a different medication or stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be taken together at all, while others may be used together even if there is a risk of interaction. If you are prescribed this medicine, it is very important for your healthcare professional to know if you are taking any of the following medicines. The following interactions have been highlighted for their potential significance but may not include all possible interactions.

It is not recommended to use this medicine with any of the following:

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

Using this medicine with any of the following is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency for one or both:

• Iobenguane I 131
• Venlafaxine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may impact how you can use this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Agitated state (very nervous or anxious) or
• Arrhythmias (abnormal heart rhythms), history of or
• Serious arteriosclerosis (hardening of the arteries) or
• History of congestive heart failure or
• History of drug abuse or dependence or
• Glaucoma or
• History of heart or blood vessel disease (e.g., coronary artery disease) or
• History of uncontrolled hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• History of stroke—Should not be used in patients with these conditions.

• Allergy to tartrazine—Suprenza™ contains tartrazine. Patients with this allergy may have a reaction.

• Heart valve disease or
• Hypertension (high blood pressure) or
• Pulmonary hypertension (elevated pressure in the lungs)—Use with caution. May worsen these conditions.

• Kidney disease—Use with caution. Effects may be stronger due to slower removal of the medicine from the body.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Check with your doctor right away 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. Additionally, your health care professional may be able to tell you about ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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 sexual ability, desire, drive, or performance
• Increased interest in sexual intercourse
• Loss of 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.

In the U.S.

• Adipex
• Adipex-P
• Atti-Plex P
• Fastin
• Ionamin
• Lomaira
• Phentercot
• Phentride
• Pro-Fast

Available Dosage Forms:

• Tablet
• Capsule

Therapeutic Class: Appetite Suppressant, Centrally Acting

Chemical Class: Amphetamine Related

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.

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