Regimex

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

Benzphetamine is used together with diet and exercise to treat obesity (overweight).

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

Benzphetamine can harm an unborn baby or cause birth defects. Do not use benzphetamine if you are pregnant.

Do not use benzphetamine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Taking benzphetamine together with other diet medications (including medicines available over the counter) can cause a rare fatal lung disorder called pulmonary hypertension. Do not take benzphetamine with any other diet medications without your doctor's advice.

Benzphetamine may be habit-forming and should be used only by the person it was prescribed for. Never share benzphetamine 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. Benzphetamine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not use benzphetamine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Taking benzphetamine together with other diet medications (including medicines available over the counter) can cause a rare fatal lung disorder called pulmonary hypertension. Do not take benzphetamine with any other diet medications without your doctor's advice.

You should not take benzphetamine if you are allergic to it, or if you have:

• coronary artery disease (hardening of the arteries);
• heart disease, heart rhythm disorder;
• severe or uncontrolled high blood pressure;
• overactive thyroid;
• glaucoma;
• if you are pregnant;
• if you have a history of drug or alcohol abuse; or
• if you have used any other diet pills within the past year.

To make sure benzphetamine is safe for you, tell your doctor if you have:

• high blood pressure;
• diabetes; or
• a thyroid disorder.

Benzphetamine may be habit-forming and should be used only by the person it was prescribed for. Never share benzphetamine 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. This medication can harm an unborn baby or cause birth defects. Do not use benzphetamine if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication.

Benzphetamine can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking benzphetamine.

Do not give this medication to a child younger than 12 years old.

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

Stop using benzphetamine and call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• chest pain, feeling like you might pass out;
• pounding heartbeats or fluttering in your chest;
• confusion or irritability, unusual thoughts or behavior; or
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Common side effects may include:

• feeling restless or hyperactive;
• headache, dizziness, tremors;
• sleep problems (insomnia);
• increased sweating;
• dry mouth or an unpleasant taste in your mouth;
• nausea, diarrhea upset stomach; or
• skin rash.

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.

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

Benzphetamine is used together with diet and exercise to treat obesity (overweight).

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

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Benzphetamine is usually taken once each day, mid-morning or mid-afternoon.

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.

Benzphetamine should be taken only for a short time, such as a few weeks. Tell your doctor if you have not lost any weight after 4 weeks of treatment.

Benzphetamine 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.

Store at room temperature away from moisture and heat.

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

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with benzphetamine, especially:

• an antidepressant--citalopram, escitalopram, desvenlafaxine, duloxetine, fluoxetine, paroxetine, sertraline, venlafaxine, vilazodone, and others; or

• a stimulant or ADHD medication such as Adderall or Ritalin.

This list is not complete. Other drugs may interact with benzphetamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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 Regimex™ 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. Regimex™ 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.

NDC 66992-399-10                  100 Tablets

Regimex ™

Benzphetamine CIII
Hydrochloride Tablets

Start Your Regimen
with Regimex™

25 mg         Rx Only

Applies to benzphetamine: oral tablet

Cardiovascular

Frequency not reported: Palpitation, tachycardia, elevated blood pressure, cardiomyopathy, ischemic cardiac events with chronic amphetamine use[Ref]

Nervous system

Frequency not reported: Overstimulation, restlessness, dizziness, tremor, sweating, headache[Ref]

Psychiatric

Frequency not reported: Insomnia, psychotic episodes, depression following drug withdrawal[Ref]

Endocrine

Frequency not reported: Libido changes[Ref]

Gastrointestinal

Frequency not reported: Dry mouth, unpleasant taste, nausea, diarrhea, other GI disturbances[Ref]

Hypersensitivity

Frequency not reported: Urticaria, other allergic skin reactions[Ref]

Some side effects of Regimex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.