Phendimetrazine

What is Phendimetrazine?

• Phendimetrazine (Bontril, Adipost, Anorex-SR, Appecon, Melfiat, Obezine, Phendiet, Plegine, Prelu-2, Statobex) is a sympathomimetic amine with pharmacological activity similar to the prototype drugs of this class used in obesity, the amphetamines.
• Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics".

Phendimetrazine

Phendimetrazine molecule ball

Phendimetrazine molecule spacefill

What are the uses of this medicine?

• Phendimetrazine tartrate capsules are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 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) who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.

Weight loss:

• Adult obese subjects instructed in dietary management and treated with anorectic drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short term clinical trials.
• 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.

How does this medicine work?

• Phendimetrazine tartrate is a sympathomimetic amine with pharmacological activity similar to the prototype drugs of this class used in obesity, the amphetamines.
• Actions 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.
• Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics”.
• It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression.
• Other central nervous system actions or metabolic effects, may be involved.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension, pulmonary hypertension) During or within 14 days following the administration of monoamine oxidase inhibitors
• Hyperthyroidism
• Glaucoma
• Agitated states
• History of drug abuse
• Pregnancy
• Nursing
• Known hypersensitivity or idiosyncratic reactions to sympathomimetics

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention if you are taking any of the following:

• Monoamine Oxidase Inhibitors
• Insulin and Oral Hypoglycemic Medications
• Adrenergic Neuron Blocking Drugs

• Concomitant use of alcohol with phendimetrazine tartrate may result in an adverse drug reaction.

Is this medicine FDA approved?

• Phendimetrazine tartrate, is an FDA approved, schedule II prescription weight loss medication to treat obesity.

How should this medicine be used?

Recommended dosage: Adult Dosage:

• 1 tablet (35 mg) twice a day or three times a day one hour before meals.
• Dosage should be individualized to obtain an adequate response with the lowest effective dosage.
• In some cases, ½ tablet (17.5 mg) per dose may be adequate.
• Dosage should not exceed 2 tablets three times a day.

Administration:

• Phendimetrazine tartrate comes as tablets, capsules and extended release forms.
• Phendimetrazine tartrate tablet can be taken orally twice a day or three times a day one hour before meals.
• Extended-release capsule Since the product is an extended-release dosage form, limit to one extended-release capsule (105 mg phendimetrazine tartrate) in the morning (30 to 60 minutes before morning meal).

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As tablet, for oral administration, contains 35 mg of phendimetrazine tartrate
• Extended-release capsule, for oral administration, contains 105 mg phendimetrazine tartrate

This medicine is available in fallowing brand namesː

• Bontril
• Adipost
• Anorex-SR
• Appecon
• Melfiat
• Obezine
• Phendiet
• Plegine
• Prelu-2
• Statobex

What side effects can this medication cause?

The most common side effects of this medicine include:

• Primary pulmonary hypertension and/or regurgitant cardiac valvular disease
• palpitation
• tachycardia
• elevated blood pressure
• ischemic events
• Overstimulation
• restlessness
• insomnia
• agitation
• flushing
• tremor
• sweating
• dizziness
• headache
• psychotic state
• blurring of vision
• Dryness of the mouth
• nausea
• stomach pain
• diarrhea
• constipation
• Urinary frequency
• dysuria
• changes in libido

What special precautions should I follow?

• Caution is to be exercised in prescribing phendimetrazine tartrate for patients with even mild hypertension.
• Insulin or oral hypoglycemic medication requirements in diabetes mellitus may be altered in association with the use of phendimetrazine and the concomitant dietary regimen.
• Phendimetrazine may decrease the hypotensive effect of guanethidine.
• It is not known if phendimetrazine tartrate is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
• Phendimetrazine tartrate should not be used in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations and herbal products.
• In a case-control epidemiological study, the use of anorectic agents, including phendimetrazine tartrate, was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. Under these circumstances, phendimetrazine tartrate should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension.
• Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs.
• Because of the effect on the central nervous system, phendimetrazine 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.
• Phendimetrazine tartrate is not recommended for patients who used any anorectic agents within the prior year.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• unusual restlessness
• confusion
• belligerence
• hallucinations
• panic states
• Fatigue
• depression
• tachycardia
• arrhythmias
• hypertension
• hypotension
• circulatory collapse
• nausea
• vomiting
• diarrhea
• abdominal cramps
• convulsions
• coma

• Manifestations of chronic intoxication with anorectic drugs include sever dermatoses, marked insomnia, irritability, hyperactivity and personality changes.
• The most server manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia.

Management of overdosage:

• The management of acute overdosage is largely symptomatic.
• It includes lavage and sedation with a barbiturate.
• If hypertension is marked, the use of a nitrate or rapid-acting alpha receptor-blocking agent should be considered.
• Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations for its use.

Can this medicine be used in pregnancy?

• Pregnancy Category X.
• Phendimetrazine tartrate is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• PHENDIMETRAZINE TARTRATE

Inactive Ingredients:

• FD&C BLUE NO. 1
• FD&C RED NO. 40
• GELATIN, UNSPECIFIED
• POVIDONE, UNSPECIFIED
• SILICON DIOXIDE
• SODIUM LAURYL SULFATE
• STARCH, CORN
• SUCROSE
• TALC
• SHELLAC

Who manufactures and distributes this medicine?

• Manufactured for Sandoz Inc.
• Princeton, NJ

• Manufactured by Epic Pharma, LLC
• Laurelton, NY

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Protect from moisture.
• DISPENSE IN A TIGHT CONTAINER AS DEFINED IN THE USP.

• Dailymed label info on Phendimetrazine
• FDA Phendimetrazine

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