Adipex-P

Phentermine hydrochloride USP is a sympathomimetic amine anorectic. It has the chemical name of α,α,- Dimethylphenethylamine hydrochloride. The structural formula is as follows:

C10H15N•HCl       M.W. 185.7

Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.

ADIPEX-P® , an anorectic agent for oral administration, is available as a capsule or tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base).

ADIPEX-P® Capsules contain the inactive ingredients Black Iron Oxide, Corn Starch, D&C Red #33, FD&C Blue #1, Gelatin, Lactose Monohydrate, Magnesium Stearate, Propylene Glycol, Shellac, and Titanium Dioxide.

ADIPEX-P® Tablets contain the inactive ingredients Corn Starch, Lactose (Anhydrous), Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Sucrose, and FD&C Blue #1.

ADIPEX-P® is indicated as a 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 for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

Below is a chart of body mass index (BMI) based on various heights and weights.

BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

The limited usefulness of agents of this class, including ADIPEX-P®, [see CLINICAL PHARMACOLOGY] should be measured against possible risk factors inherent in their use such as those described below.

Do not use phentermine if you are pregnant or breast-feeding a baby.

You should not take phentermine if you have a history of heart disease (coronary artery disease, heart rhythm problems, congestive heart failure, stroke), severe or uncontrolled high blood pressure, overactive thyroid, glaucoma, a history of pulmonary hypertension, if you are in an agitated state, or if you have a history of drug or alcohol abuse.

Do not use phentermine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• feeling short of breath, even with mild exertion;

• chest pain, feeling like you might pass out;

• swelling in your ankles or feet;

• pounding heartbeats or fluttering in your chest;

• confusion or irritability, unusual thoughts or behavior;

• feelings of extreme happiness or sadness; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).

Common side effects may include:

• feeling restless or hyperactive;

• headache, dizziness, tremors;

• sleep problems (insomnia);

• dry mouth or an unpleasant taste in your mouth;

• diarrhea or constipation, upset stomach; or

• increased or decreased interest in sex, impotence.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Adipex-P or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Adipex-P. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

The following adverse reactions are described, or described in greater detail, in other sections:

The following adverse reactions to phentermine have been identified:

Cardiovascular

Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.

Central Nervous System

Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.

Gastrointestinal

Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Allergic

Urticaria.

Endocrine

Impotence, changes in libido.

Monoamine Oxidase Inhibitors

Use of Adipex-P® is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.

Alcohol

Concomitant use of alcohol with Adipex-P® may result in an adverse drug reaction.

Insulin and Oral Hypoglycemic Medications

Requirements may be altered [see Warnings and Precautions (5.9)].

Adrenergic Neuron Blocking Drugs

Adipex-P® may decrease the hypotensive effect of adrenergic neuron blocking drugs.

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Acute Overdosage

Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include tachycardia, arrhythmia, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma.

Management of acute phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Acidification of the urine increases phentermine excretion. Intravenous phentolamine (Regitine®, CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage.

Chronic Intoxication

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. See Drug Abuse and Dependence (9.3).

Phentermine hydrochloride USP is a sympathomimetic amine anorectic. It has the chemical name of α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows:

C10H15N•HCl M.W. 185.7

Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.

Adipex-P®, an anorectic agent for oral administration, is available as a capsule or tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base).

Adipex-P® Capsules contain the inactive ingredients Black Iron Oxide, Corn Starch, D&C Red #33, FD&C Blue #1, Gelatin, Lactose Monohydrate, Magnesium Stearate, Propylene Glycol, Shellac, and Titanium Dioxide.

Adipex-P® Tablets contain the inactive ingredients Corn Starch, Lactose (Anhydrous), Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Sucrose, and FD&C Blue #1.

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Phentermine is a stimulant that is similar to an amphetamine. Phentermine is an appetite suppressant that affects the central nervous system.

Phentermine is used together with diet and exercise to treat obesity (overweight) in people with risk factors such as high blood pressure, high cholesterol, or diabetes.

Phentermine may also be used for purposes not listed in this medication guide.