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Phentermine

Phentermine and topiramate

What is phentermine and topiramate?

Phentermine is a medication for chronic weight management. It is for people with overweight

and weight-related complications or obesity. Phentermine and topiramate is a medicine used together with diet and exercise to treat obesity.

Phentermine is indicated as a short-term (a few weeks) adjuncts 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.

PhentermineDESCRIPTION

Phentermine is an orally disintegrating tablet (ODT) of phentermine hydrochloride, USP.

Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α dimethyl phenethylamine hydrochloride. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.

Phentermine is available as an orally disintegrating tablet (ODT) containing 15 mg, 30 mg, or 37.5mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg of phentermine base).

Phentermine contains the inactive ingredients mannitol powder, citric acid powder, Povidone CL,Povidone K 30, sucralose, magnesium stearate, peppermint flavor, talc, sodium lauryl sulfate,and mannitol granulated. Phentermine 15 mg ODT also contains FD&C Blue # 1 lake and FD&C

Yellow # 5 lake. Phentermine 30 mg ODT also contains FD&C Yellow # 5 lake. Phentermine 37.5 mg ODT also contains FD&C Blue # 1 lake.

 

Who Is Phentermine For?

Phentermine is a medication for chronic weight management. It is for people with overweight and weight-related complications or obesity. It is meant to be used together with a lifestyle therapy regimen involving a reduced-calorie diet and increased physical activity.

How Does Phentermine Work?

Phentermine is an appetite suppressant that works in the brain.

Who Should Not Take Phentermine?

• People who have heart disease or uncontrolled hypertension

• Women who are pregnant, nursing, or planning to become pregnant

• People who have glaucoma

• People with uncontrolled hyperthyroidism (overactive thyroid)

• People who are taking a monoamine oxidase inhibitor (MAOI) now or have taken one within the past 14 days

• People who are prone to agitation (extreme restlessness and irritability)

• People with a history of drug abuse

How Is Phentermine Dosed?

Take 1 tablet or capsule once a day before breakfast or 1-2 hours after breakfast.

Phentermine is approved for short-term weight loss therapy. The usual duration of treatment is 12 weeks or less.

Is Phentermine a Controlled Substance?

Yes, phentermine is a federally controlled substance because it may be abused or lead to drug dependence. Some states only allow your doctor to prescribe one month at a time.

Which Medications Might Not Be Safe to Use with Phentermine?

Phentermine can affect how other medicines work in your body, and other medicines can affect how phentermine works or make side effects worse. Tell your doctor about all the medicines and supplements you take (ask your doctor or pharmacist for a list if you’re not sure), especially the following medicines:

• Monoamine oxidase inhibitors (MAOIs)—usually used to treat depression

• Adrenergic neuron blocking drugs—these are usually taken to treat high blood pressure or psychotic symptoms

• Other weight loss medications, including over the counter medications

• Selective serotonin reuptake inhibitors (SSRIs)—used to treat depression and anxiety

What Are the Common Side Effects of Phentermine?

• Dry mouth

• Restlessness

• Difficulty sleeping

• Increase in heart rate

• Increase in blood pressure

What Are the Possible Serious Side Effects of Phentermine?

Primary Pulmonary Hypertension

A rare but often fatal disease of the lungs known as primary pulmonary hypertension has been reported in patients taking phentermine and phentermine-like products. Stop taking phentermine and call your doctor if you experience any difficulty breathing, severe chest pain, fainting or swelling in the legs.

Heart Valve Disease

Serious heart valve problems or diseases have been reported in patients taking phentermine or other phentermine-like products for weight loss. The possibility of an association cannot be ruled out.

Low Blood Sugar (Hypoglycemia)

Weight loss can cause low blood sugar in people with type 2 diabetes who also take medicines used to treat type 2 diabetes. Test your blood sugar before and during treatment with phentermine.

Are There Any Special Precautions with Phentermine?

Do not drink alcohol while taking phentermine.

Do not drive a car or operate heavy machinery until you know how phentermine affects you.

Phentermine can slow your thinking and motor skills and also may affect your vision.

DOSAGE AND ADMINISTRATION

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. Phentermine 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 Phentermine (phentermine hydrochloride ODT) tablet from the bottle. Immediately place the Phentermine tablet on top of the tongue where it will dissolve, then swallow with or without water.

DOSAGE FORMS AND STRENGTHS

Orally disintegrating tablets (ODT) containing 15 mg, 30 mg, or 37.5 mg phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg phentermine base, respectively). The tablets are not scored. The 15 mg ODT is 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.

CONTRAINDICATIONS

History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled 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 idiosyncrasy to the sympathomimetic amines

WARNINGS AND PRECAUTIONS

Administration with Other Drug Products for Weight Loss Phentermine is indicated only as short-term (a few weeks) monotherapies for the management of exogenous obesity. The safety and efficacy of combination therapy with Phentermine and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of Phentermine and these drug products is not recommended.

Development of Tolerance, Discontinuation in Case of Tolerance when tolerance to the anorectal effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

Effect on the Ability to Engage in Potentially Hazardous Tasks Phentermine 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.

Risk of Abuse and Dependence

Phentermine is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and to other related stimulant drugs that have been extensively abused. The possibility of abuse phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. See Drug Abuse and Dependence and overdosage. The least amount feasible should be prescribed or dispensed at one time to minimize the possibility of overdosage.

Usage with Alcohol

Concomitant use of alcohol with Phentermine may result in an adverse drug reaction

Use in Patients with Hypertension

Use caution in prescribing Phentermine for patients with even mild hypertension (risk of an increase in blood pressure).

Use in Patients on Insulin or Oral Hypoglycemic Medications for Diabetes Mellitus

A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.

Risk of Allergic Reactions due to Tartrazine

Phentermine 15 mg and 30 mg ODT contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Abuse

Phentermine is related chemically and pharmacologically to the amphetamines. Amphetamines and other stimulant drugs have been extensively abused and the possibility of abuse of phentermine 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 that are 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.

Phentermine

OVERDOSAGE

The least amount feasible should be prescribed or dispensed at one time to minimize the possibility of overdosage. Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Fatigue and depression usually follow central stimulation. Cardiovascular effects include tachycardia, arrhythmia, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. The overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma.

Management of acute phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate.

HOW SUPPLIED/STORAGE AND HANDLING

Available as orally disintegrating tablets (ODT) containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg phentermine base, respectively). The tablets are not scored. The 15 mg ODT is 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.  

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