Atti-Plex P

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

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

This section provides information on the proper use of a number of products that contain phentermine. It may not be specific to Atti-Plex 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.

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:

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

• 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:

• 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.

8 mg orally 3 times a day 30 minutes before meals, OR
15 to 37.5 mg orally once a day before breakfast or 1 to 2 hours after breakfast.

Use: 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 in patients with an initial body mass index (BMI) of 30 kg/m2 or greater, or BMI of 27 kg/m2 or greater in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

Age 17 Years and Older:
8 mg orally 3 times a day 30 minutes before meals, OR
15 to 37.5 mg orally once a day before breakfast or 1 to 2 hours after breakfast.

Use: 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 in patients with an initial body mass index (BMI) of 30 kg/m2 or greater, or BMI of 27 kg/m2 or greater in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

Data not available.

Use with caution; drug exposure increases may occur in those with renal impairment.

Safety and efficacy have not been established in patients younger than 17 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV