Adipex-P

Name: Adipex-P

What Is Phentermine (Adipex-P)?

Phentermine is the generic form of the brand-name drugs Adipex-P, Suprenza, and Ionamin, which are used for weight loss.

Phentermine decreases appetite and stimulates the body to burn calories more quickly.

Fastin, a former brand name for phentermine, is no longer available in the United States.

Phentermine is a controlled substance, and should only be taken for a short period of time (no more than three weeks).

People taking phentermine should also cut back on calories and try to exercise while taking the drug.

Phentermine is generally prescribed for people who are very overweight with a body-mass index (BMI) greater than 30.

Phentermine makes the nervous system operate in a kind of "fight-or-flight" mode by stimulating brain chemicals known as neurotransmitters.

It was first approved as a diet drug in 1959, and has been on the market in various forms since then.

In the late 1990s, the Food and Drug Administration (FDA) removed a combination diet drug known as fen-phen (for fenfluramine and phentermine) from the market because of evidence that it could damage heart valves.

Since then, the FDA has approved phentermine combined with different drugs.

Phentermine 'High' and Abuse

Phentermine is a stimulant that is habit-forming and used by some people in dangerously large doses to get high.

If you take it for too long, or take more of it than your doctor prescribes, you may become dependent and develop depression or fatigue when you stop taking it.

Phentermine Warnings

The FDA warns that you should only take phentermine for a maximum of a few weeks, and you should not take it with any other weight-loss drugs or herbal treatments.

People who have any of the following should not take phentermine:

  • Severe hardening of the arteries (atherosclerosis)
  • Heart disease
  • Moderate-to-severe high blood pressure
  • Glaucoma
  • If you are feeling very irritable, jittery, or agitated
  • If you have taken a monoamine oxidase inhibitor (MAOI) such as Nardil or tranylcypromine within the past 14 days
  • Diabetes
  • Overactive thyroid
  • History of drug abuse

Your doctor will want to monitor you closely if you take phentermine and have high blood pressure, problems with your heart valves, reduced kidney function, or are elderly.

Phentermine may cause increased blood pressure in the lungs or problems with the valves in your heart.

You should stop taking phentermine right away and tell your doctor if you notice any of the following symptoms:

  • Difficulty breathing
  • Chest pain
  • Feeling faint
  • Swelling in the feet, ankles, and lower legs

Phentermine may lose its effect after you have been taking it for a while, and when that happens, you should stop taking it.

Pregnancy and Phentermine

Phentermine falls under the FDA’s Pregnancy Category C, which means harm to an unborn baby is possible.

You should tell your doctor if you are pregnant or plan to become pregnant before taking this medication.

You should also alert your physician if you are breastfeeding or plan to breastfeed.

It’s not recommended that women breastfeed while taking phentermine.

Clinical pharmacology

Mechanism Of Action

ADIPEX-P® is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics.” It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.

Pharmacodynamics

Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Pharmacokinetics

Following the administration of phentermine, phentermine reaches peak concentrations (C ) after 3.0 to 4.4 hours.

Drug Interactions

In a single-dose study comparing the exposures after oral administration of a combination capsule of 15 mg phentermine and 92 mg topiramate to the exposures after oral administration of a 15 mg phentermine capsule or a 92 mg topiramate capsule, there is no significant topiramate exposure change in the presence of phentermine. However in the presence of topiramate, phentermine C and AUC increase 13% and 42%, respectively.

Specific Populations

Renal Impairment

Cumulative urinary excretion of phentermine under uncontrolled urinary pH conditions was 62% to 85%.

Systemic exposure of phentermine may increase up to 91%, 45%, and 22% in patients with severe, moderate, and mild renal impairment, respectively [see DOSAGE AND ADMINISTRATION and Use In Specific Populations].

Clinical Studies

No clinical studies have been conducted with ADIPEX-P® .

In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with “anorectic” drugs lost more weight on the average than those treated with placebo and diet.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an “anorectic” drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured over several years, whereas the studies cited are restricted to a few weeks’ duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

How should I take Adipex-P (phentermine)?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Some brands of phentermine should be taken on an empty stomach before breakfast or within 2 hours after breakfast.

Suprenza disintegrating tablets can be taken with or without food.

Using dry hands, remove the Suprenza tablet from the medicine bottle and place the tablet in your mouth. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To prevent sleep problems, take this medication early in the day, no later than 6:00pm.

Talk with your doctor if you have increased hunger or if you otherwise think the medication is not working properly. Taking more of this medication will not make it more effective and can cause serious, life-threatening side effects.

Phentermine should be taken only for a short time, such as a few weeks.

Do not stop using phentermine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using phentermine.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Phentermine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Adipex-P 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.

What are some other side effects of Adipex-P?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling nervous and excitable.
  • Headache.
  • Hard stools (constipation).
  • Loose stools (diarrhea).
  • Dry mouth.
  • Not able to sleep.
  • Bad taste in your mouth.
  • Lowered interest in sex.
  • Change in sex ability.
  • Restlessness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Adipex-P Precautions

Serious side effects have been reported with Adipex-P including the following:

  • Primary pulmonary hypertension. This is a condition when there is high blood pressure in the arteries to your lungs. Your doctor may stop treatment with Adipex-P if you develop this complication. Symptoms include
    • shortness of breath during routine activity, such as climbing two flights of stairs
    • tiredness
    • chest pain
    • a racing heartbeat
    • pain on the upper right side of the abdomen
    • decreased appetite
  • Development of Tolerance. Adipex-P is a controlled substance. There is a potential for developing tolerance. Tolerance to the anorectic effect usually develops within a few weeks. When tolerance to the Adipex-P develops, the recommended dose should not be exceeded in an attempt to increase the effect. Instead Adipex-P should be discontinued.
  • Effect on the Ability to Engage in Potentially Hazardous Tasks.  Adipex-P may impair the ability of the patient to drive or operate heavy machinery. Do not drive or operate heavy machinery until you know how Adipex-P affects you.

  • Risk of Abuse and Dependence. Adipex-P should not be stopped all of a sudden especially if Adipex-P dose is high. This can lead to serious problems.

  • Valvular heart disease.

Drinking alcohol with Adipex-P may result in an adverse drug reactions.

You should not take Adipex-P if you have:

  • are allergic to Adipex-P or to any of its ingredients
  • heart disease
  • lung disease
  • hyperthyroidism
  • glaucoma
  • a history of drug abuse or dependence
  • agitated state
  • depression being treated with certain antidepressant medications called MAOI inhibitors

Adipex-P should not be used during pregnancy or while breastfeeding.

Inform MD

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

  • are allergic to Adipex-P 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.

Adipex-P and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Adipex-P falls into category X. Adipex-P should not be used during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

What is the most important information i should know about phentermine (adipex-p, oby-cap, suprenza, t-diet, zantryl)?

Weight loss during pregnancy can harm an unborn baby, even if you are overweight. Do not use phentermine if you are pregnant.

Do not use phentermine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Taking phentermine together with other diet medications such as fenfluramine (Phen-Fen) or dexfenfluramine (Redux) can cause a rare fatal lung disorder called pulmonary hypertension. Do not take phentermine with any other diet medications without your doctor's advice.

Phentermine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of phentermine.

Phentermine is only part of a complete program of treatment that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Phentermine may be habit-forming and should be used only by the person it was prescribed for. Never share phentermine with another person, especially someone with a history of drug abuse or addiction. Keep track of the amount of medicine used from each new bottle. Phentermine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not stop using phentermine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using phentermine.

What should i avoid while taking phentermine (adipex-p, oby-cap, suprenza, t-diet, zantryl)?

Drinking alcohol can increase certain side effects of phentermine.

Phentermine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Where can i get more information?

Your pharmacist can provide more information about phentermine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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