Fastin

Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

Phentermine hydrochloride 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.

Drug Dependence: Phentermine hydrochloride is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of phentermine hydrochloride should be kept in mind when evaluating the desirability of including a drug as proof of a weight reduction program. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia.

Usage in Pregnancy: Safe use in pregnancy has not been established. Use of phentermine hydrochloride by women who are or who may become pregnant, and those in the first trimester of pregnancy, requires that the potential benefit be weighed against the possible hazard to mother and infant.

Usage in Children: Phentermine hydrochloride is not recommended for use in children under 12 years of age.

Phentermine is a prescription medicine used for weight loss.  It is taken for a limited amount of time by overweight adults, along with exercise and a low-fat diet. Phentermine belongs to a group of drugs called anorectics. It works by decreasing appetite.

Phentermine 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.

Phentermine also is available as an orally disintegrating tablet and is usually taken in the morning, with or without food.

Common side effects of phentermine include dry mouth, fast heart beat, insomnia, and dizziness.

Do not drive or operate heavy machinery until you know how phentermine affects you.

Phentermine is a prescription medicine used to help adults lose weight.  It is taken for a limited amount of time by overweight people who are exercising and eating a low-calorie diet.

Fastin is part of the drug class:

• Centrally acting antiobesity products

While there are no specific phentermine food interactions, you should avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas) or eating large amounts of chocolate while taking phentermine as caffeine can increase the side effects of this medicine.

Before taking phentermine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to phentermine or to any of its ingredients
• have high blood pressure
• drink alcohol
• a history of drug abuse or dependence
• decreased kidney function
• have diabetes
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if phentermine crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using phentermine.

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

Applies to phentermine: oral capsule, oral capsule extended release, oral tablet, oral tablet disintegrating

Along with its needed effects, phentermine (the active ingredient contained in Fastin) 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 while taking phentermine:

• 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 of phentermine 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