Recede Tablets

General

Insulin requirements in diabetes mellitus may be altered in association with use of anorexigenic drugs and the concomitant dietary restrictions.

Psychological disturbances have been reported in patients who receive an anorectic agent together with a restrictive dietary regime.

Caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Information for Patients

Amphetamines 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 Interactions

Efficacy of RECEDETM tablets in combination with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems.

Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. RECEDETM tablets should not be used concomitantly with other CNS stimulants.

Amphetamines may decrease the hypotensive effect of antihypertensives. Amphetamines may enhance the effects of tricyclic antidepressants.

Urinary alkalinizing agents increase blood levels and decrease excretion of amphetamines. Urinary acidifying agents decrease blood levels and increase excretion of amphetamines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility have not been performed.

Pregnancy

(see CONTRAINDICATIONS section).

Nursing Mothers

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.

Geriatric Use

Clinical studies of benzphetamine hydrochloride tablets did not include sufficient numbers of subjects aged 65 and over to establish safety and efficacy in this population. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

The following have been associated with the use of benzphetamine hydrochloride:

Cardiovascular

Palpitation, tachycardia, elevation of blood pressure.

There have been isolated reports of cardiomyopathy and ischemic cardiac events associated with chronic amphetamine use.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination with other anorectic drugs, have been reported. However, no cases of this valvulopathy have been reported when RECEDETM tablets have been used alone.

CNS

Overstimulation, restlessness, dizziness, insomnia, tremor, sweating, headache; rarely, psychotic episodes at recommended doses; depression following withdrawal of the drug.

Gastrointestinal

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

Allergic

Urticaria and other allergic reactions involving the skin.

Endocrine

Changes in libido.

Dosage should be individualized according to the response of the patient. The suggested dosage ranges from 25 to 50 mg one to three times daily. Treatment should begin with 25 to 50 mg once daily with subsequent increase in individual dose or frequency according to response. A single daily dose is preferably given in mid-morning or mid-afternoon, according to the patient's eating habits. In an occasional patient it may be desirable to avoid late afternoon administration. Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.

RECEDETM tablets are supplied as pink, round tablets, debossed “EX” on one side and “25” on the other side in bottles of 100 tablets, NDC 50991-399-01.

Store at controlled room temperature 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].

Manufactured by:

Mikart, Inc.

Atlanta, GA 30318

Distributed by:

Poly Pharmaceuticals

Quitman, MS 39355

Code 1051A00

Rev. 11/11

Applies to benzphetamine: oral tablet

Along with its needed effects, benzphetamine (the active ingredient contained in Recede) 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 benzphetamine:

• Agitation
• anxiety
• confusion
• convulsions (seizures)
• dizziness
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling lightheaded or faint
• hallucinations
• headache
• hives or welts
• irritability
• itching
• lightheadedness
• mood or other mental changes
• nervousness
• nightmares
• numbness or tingling in the arms or legs
• redness of skin
• restlessness
• shakiness in the legs, arms, hands, or feet
• skin rash
• sleeplessness
• sweating
• trembling of the hands or feet
• trouble with sleeping
• trouble with thinking, speaking, or walking
• unable to sleep
• unusual feeling of excitement
• weakness

• Chest discomfort or pain
• difficulty breathing
• discouragement
• feeling sad or empty
• lack of appetite
• loss of interest or pleasure
• severe mental changes
• shortness of breath
• swelling of the feet or lower legs
• trouble with concentrating
• trouble with breathing
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking benzphetamine:

• Blurred vision
• change in consciousness
• dark-colored urine
• diarrhea
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fever
• loss of consciousness
• muscle cramps or spasms
• muscle pain or stiffness
• nausea
• nervousness
• physical attempt to injure oneself
• pounding in the ears
• rapid, shallow breathing
• severe anxiety or feeling of panic
• stomach cramps
• violent actions
• vomiting

Some side effects of benzphetamine 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:

• Decrease in sexual ability, desire, drive, or performance
• decreased interest in sexual intercourse
• dry mouth
• inability to have or keep an erection
• increase in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• unpleasant taste