Phenteral

Phenteral 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.

Height (feet, inches)

The limited usefulness of agents of this class, including Phenteral, should be measured against possible risk factors inherent in their use such as those described below.

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

Phenteral 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.

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

Exogenous Obesity

Dosage should be individualized to obtain an adequate response with the lowest effective dose.

The usual adult dose is one tablet as prescribed by the physician, administered in the morning, with or without food. Phenteral is not recommended for use in pediatric patients less than or equal to 16 years of age.

Late evening medication should be avoided because of the possibility of resulting insomnia.

With dry hands, gently remove the Phenteral (Phenteral hydrochloride ODT) tablet from the bottle. Immediately place the Phenteral tablet on top of the tongue where it will dissolve, then swallow with or without water.

How supplied

Dosage Forms And Strengths

Orally disintegrating tablets (ODT) containing 15 mg, 30 mg, or 37.5 mg Phenteral hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg Phenteral base, respectively). The tablets are not scored. The 15 mg ODT is a yellow with blue spots round tablet embossed with AX4 on one side. The 30 mg ODT is a yellow round tablet embossed with AX7 on one side. The 37.5 mg ODT is a white with blue spots round tablet embossed with AX8 on one side.

Storage And Handling

Available as orally disintegrating tablets (ODT) containing 15 mg, 30 mg, or 37.5 mg of Phenteral hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg Phenteral base, respectively). The tablets are not scored. The 15 mg ODT is a yellow with blue spots round tablet embossed with AX4 on one side. The 30 mg ODT is a yellow round tablet embossed with AX7 on one side. The 37.5 mg ODT is a white with blue spots round tablet embossed with AX8 on one side.

Phenteral is available as described in Table 2.

Table 2: Phenteral

Orally Disintegrating Tablet Presentations

Phenteral 15 mg, 30 mg, and 37.5 mg ODT are packaged in bottles of 30.

Store at 20° to 25°C (68° to 77°F).

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Keep out of the reach of children.

Manufactured for Akrimax Pharmaceuticals, LLC Cranford, NJ 07016. by: Alpex Pharma SA, Lugano, Switzerland. Marketed and Distributed by: Akrimax Pharmaceuticals, LLC Cranford, NJ 07016. Revised: 06/2013

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What is the most important information I should know about Phenteral?

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

Do not use Phenteral 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.

Taking Phenteral together with other diet medications such as fenfluramine (Phen-Fen) or dexfenfluramine (Redux) can cause a rare fatal lung disorder called pulmonary hypertension. Do not take Phenteral with any other diet medications without your doctor's advice.

Phenteral may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of Phenteral.

Phenteral 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.

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

Do not stop using Phenteral suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using Phenteral.

Use Phenteral orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Phenteral orally disintegrating tablets by mouth with or without food.
• Take Phenteral orally disintegrating tablets in the morning unless your doctor directs you otherwise. Taking Phenteral orally disintegrating tablets in the evening may cause trouble sleeping.
• Make sure that your hands are dry before removing Phenteral orally disintegrating tablets from the bottle. Place the tablet on the top of your tongue where it will dissolve. The tablet dissolves quickly and can be swallowed with saliva. Phenteral orally disintegrating tablets may be taken with or without water. Take the tablet immediately after removing it from the bottle. Do not store the removed tablet for future use.
• If you miss a dose of Phenteral orally disintegrating tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Phenteral orally disintegrating tablets.

Phenteral is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life.

It is not known how this medication helps people to lose weight. It may work by decreasing your appetite, increasing the amount of energy used by your body, or by affecting certain parts of the brain. This medication is an appetite suppressant and belongs to a class of drugs called sympathomimetic amines.

How to use Phenteral

Take this medication by mouth as directed by your doctor, usually once a day, 1 hour before breakfast or 1 to 2 hours after breakfast. If needed, your doctor may adjust your dose to take a small dose up to 3 times a day. Carefully follow your doctor's instructions. Taking this medication late in the day may cause trouble sleeping (insomnia).

If you are using sustained-release capsules, the dose is usually taken once a day before breakfast or at least 10 to 14 hours before bedtime. Swallow the medication whole. Do not crush or chew sustained-release capsules. Doing so can release all of the drug at once, increasing the risk of side effects.

If you are using the tablets made to dissolve in the mouth, the dose is usually taken once a day in the morning, with or without food. First, dry your hands before handling the tablet. Place your dose on top of the tongue until it dissolves, then swallow it with or without water.

The dosage is based on your medical condition and response to therapy. Your doctor will adjust the dose to find the best dose for you. Use this medication regularly and exactly as prescribed in order to get the most benefit from it. To help you remember, take it at the same time(s) each day.

This medication is usually taken for only a few weeks at a time. It should not be taken with other appetite suppressants. The possibility of serious side effects increases with longer use of this medication and use of this drug along with certain other diet drugs.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as depression, severe tiredness) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.

This medication may stop working well after you have been taking it for a few weeks. Talk with your doctor if this medication stops working well. Do not increase the dose unless directed by your doctor. Your doctor may direct you to stop taking this medication.

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What other drugs will affect Phenteral?

Monoamine Oxidase Inhibitors

Use of Phenteral® 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 Phenteral® may result in an adverse drug reaction.

Insulin And

Oral Hypoglycemic Medications

Requirements may be altered.

Adrenergic Neuron Blocking Drugs

Phenteral® may decrease the hypotensive effect of adrenergic neuron blocking drugs.

Drug Abuse And Dependence

Controlled Substance

Phenteral is a Schedule IV controlled substance.

Abuse

Phenteral is related chemically and pharmacologically to the amphetamines. Amphetamines and other stimulant drugs have been extensively abused and the possibility of abuse of Phenteral should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program.

Dependence

Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of these drugs to many times than recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

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What are the possible side effects of Phenteral?

Applies to Phenteral: oral capsule, oral capsule extended release, oral tablet, oral tablet disintegrating

In addition to its needed effects, some unwanted effects may be caused by Phenteral (the active ingredient contained in Phenteral). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Phenteral:

Rare

• Seeing, hearing, or feeling things that are not there
• severe mental changes

• Chest pain
• decreased ability to exercise
• dizziness
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• headache
• numbness or tingling in the arms or legs
• swelling of the feet or lower legs
• trembling or shaking of the legs, arms, hands, or feet
• trouble breathing
• trouble with thinking, speaking, or walking
• weakness

Minor Side Effects

Some of the side effects that can occur with Phenteral may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Incidence not known:

• Decreased interest in sexual intercourse
• difficulty having a bowel movement (stool)
• dry mouth
• false or unusual sense of well-being
• hives or welts
• inability to have or keep an erection
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• itching
• loss in sexual ability, desire, drive, or performance
• redness of the skin
• skin rash
• unpleasant taste

A central nervous system stimulant and sympathomimetic with actions and uses similar to those of dextroamphetamine. It has been used most frequently in the treatment of obesity. [PubChem]. Some common brand names for Phenteral are Phenteral® and Phenteral™. Phenteral is also available in combination medications such as Qsymia®.