Phendimetrazine Tartrate

Name: Phendimetrazine Tartrate

Description

Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2S, 3S)-3, 4-Dimethyl-2-phenylmorpholine L-(+)-tartrate (1:1).

The structural formula is as follows:


 C12H17NO•C4H6O6       M.W. 341.36

Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene.

Each tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose and FD&C Blue #1 Lake or FD&C Yellow #6 and D&C Yellow #10 as coloring.

How supplied

Each single-scored, yellow, round tablet contains 35 mg phendimetrazine tartrate. Tablets are supplied in bottles of 100 (NDC 46672-138-10) and in bottles of 1000 (NDC 46672-138-11).

Each single-scored, blue, unimprinted round tablet contains 35 mg phendimetrazine tartrate. Tablets are supplied in bottles of 100 (NDC 46672-057-10) and in bottles of 1000 (NDC 46672-057-11).

Storage

Store at controlled room temperature 15°-30°C (59°-86°F).

Dispense in tight containers with child-resistant closures.

Manufactured by: Mikart, Inc., Atlanta, GA 30318. Rev. 05/96.

Overdose

Acute overdosage with phendimetrazine tartrate may manifest itself by the following signs and symptoms: unusual restlessness, confusion, belligerence, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension, or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Poisoning may result in convulsions, coma, and death. The management of overdosage is largely symptomatic. It includes 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.

What is the most important information i should know about phendimetrazine (adipost, bontril pdm, bontril slow release, melfiat)?

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

Phendimetrazine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Phendimetrazine may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

Do not stop using phendimetrazine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using phendimetrazine.

Do not crush, chew, break, or open the extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

What should i discuss with my healthcare provider before taking phendimetrazine (adipost, bontril pdm, bontril slow release, melfiat)?

Do not use phendimetrazine 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.

You should not use this medication if you are allergic to phendimetrazine, or if you have:

  • a history of heart disease (coronary artery disease, heart rhythm problems, congestive heart failure, pulmonary hypertension);
  • heart murmur or heart valve disorder;
  • severe or uncontrolled high blood pressure;
  • overactive thyroid;
  • glaucoma;
  • severe agitation or nervousness;
  • if you have a history of drug or alcohol abuse; or
  • if you are allergic to other diet pills, amphetamines, stimulants, or cold medications.

To make sure you can safely take phendimetrazine, tell your doctor if you have any of these other conditions:

  • high blood pressure;
  • kidney disease;
  • diabetes;
  • an anxiety disorder;
  • epilepsy or seizure disorder; or
  • if you have used other diet pills in the past year (prescription, over-the-counter, or herbal products).

Phendimetrazine may be habit forming and should be used only by the person for whom it was prescribed. Never share phendimetrazine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category X. Weight loss during pregnancy can harm an unborn baby, even if you are overweight. Do not use phendimetrazine if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

It is not known whether phendimetrazine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using phendimetrazine.

Phendimetrazine should not be given to a child younger than 17 years old.

Uses for Phendimetrazine Tartrate

Exogenous Obesity

Adjunct to caloric restriction in the short-term management (a few weeks) of exogenous obesity.a b c d f

Use only for short-term monotherapy; not for use in combination with any other drug for weight loss.100 120 d

Advice to Patients

  • Potential for drug to impair mental alertness or physical coordination; caution when driving or operating machinery until effects on individual are known.a b c d f

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., glaucoma, high BP, cardiac disease).a b d f

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a b d f

  • Importance of informing patients of other important precautionary information.a b d f (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Subject to control under the Federal Controlled Substances Act of 1970 as a schedule III (C-III) drug.a b c d f

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Phendimetrazine Tartrate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, extended-release

105 mg*

Bontril Slow Release (C-III)

Valeant

Phendimetrazine Tartrate Extended-release Capsules (C-III; with povidone)

Sandoz

Tablets

35 mg*

Bontril PDM (C-III; with isopropyl alcohol and povidone; scored)

Valeant

Phendimetrazine Tartrate Tablets (C-III; with povidone)

RLC, Sandoz

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