Adipex-P

Name: Adipex-P

Warnings

Included as part of the "PRECAUTIONS" Section

What is Adipex-P (phentermine)?

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

Phentermine 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.

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of phentermine can be fatal.

Precautions While Using Adipex-P

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and does not cause any unwanted effects.

Do not use phentermine if you are also using similar medicines such as benzphetamine, diethylpropion, mazindol, phendimetrazine, Bontril®, or Didrex®. Do not use this medicine if you also take an MAO inhibitor (MAOI), such as isocarboxazid (Marplan®), phenelzine (Nardil®,), selegiline (Eldepryl®), or tranylcypromine (Parnate®), or if you have used an MAOI within the past 14 days. Using these medicines together may cause serious unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may be habit-forming. If you think this medicine is not working properly after you have taken it for a few weeks, do not increase the dose. Instead, check with your doctor.

Call your doctor right away if you notice a decrease in your ability to exercise, or if you faint, have chest pain, swelling of your feet or lower legs, or trouble with breathing. These may be symptoms of a very serious heart or lung problem.

This medicine may cause some people to become dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

This medicine may affect blood sugar levels. Diabetic patients may notice a change in blood or urine sugar tests. Check with your doctor if you have any questions.

Avoid drinking alcohol while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter) medicines, dietary supplements, herbal remedies, or medicines for appetite control, asthma, colds, cough, hay fever, and sinus problems.

Dosage Forms and Strengths

Capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).

Tablets containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).

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 [see Use in Specific Populations (8.1)] • Nursing [see Use in Specific Populations (8.3)] • Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines

Use in specific populations

Pregnancy

Pregnancy Category X

Adipex-P® is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy. Phentermine has pharmacologic activity similar to amphetamine (d- and dll-amphetamine) [see Clinical Pharmacology (12.1)]. Animal reproduction studies have not been conducted with phentermine. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Nursing Mothers

It is not known if Adipex-P® is excreted in human milk; however, other amphetamines are present in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended.

Geriatric Use

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.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Renal Impairment

Based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment [see Clinical Pharmacology (12.3)].

Use caution when administering Adipex-P® to patients with renal impairment. In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2), limit the dosage of Adipex-P® to 15 mg daily [see Dosage and Administration (2.2)]. Adipex-P® has not been studied in patients with eGFR less than 15 mL/min/1.73 m2, including end-stage renal disease requiring dialysis; avoid use in these populations.

Patient Counseling Information

Patients must be informed that Adipex-P® is 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, and that coadministration of phentermine with other drugs for weight loss is not recommended [see Indications and Usage (1) and Warnings and Precautions (5)].

Patients must be instructed on how much Adipex-P® to take, and when and how to take it [see Dosage and Administration (2)].

Advise pregnant women and nursing mothers not to use Adipex-P® [see Use in Specific Populations (8.1, 8.3)].

Patients must be informed about the risks of use of phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. The risks include, but are not limited to:

• Development of primary pulmonary hypertension [see Warnings and Precautions (5.2)] • Development of serious valvular heart disease [see Warnings and Precautions (5.3)] • Effects on the ability to engage in potentially hazardous tasks [see Warnings and Precautions (5.5)] • The risk of an increase in blood pressure [see Warnings and Precautions (5.8) and Adverse Reactions (6)] • The risk of interactions [see Contraindications (4), Warnings and Precautions (5) and Drug Interactions (7)]

See also, for example, Adverse Reactions (6) and Use in Specific Populations (8).

The patients must also be informed about

• the potential for developing tolerance and actions if they suspect development of tolerance [see Warnings and Precautions (5.4)] and • the risk of dependence and the potential consequences of abuse [see Warnings and Precautions (5.6), Drug Abuse and Dependence (9), and Overdosage (10)].

Tell patients to keep Adipex-P® in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away Adipex-P® may harm others and is against the law.

All trademarks are the property of their respective owners.

Manufactured In Croatia By:

Pliva Hrvatska d.o.o. 

Zagreb, Croatia

Manufactured For:

Teva Select Brands, Horsham, PA 19044

Division of Teva Pharmaceuticals USA, Inc.

Rev. Z 3/2017

Uses of Adipex-P

Adipex-P is a prescription medicine used to help adults lose weight. It is taken for a limited amount of time by overweight people who are exercising and eating a low-calorie diet.

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

Adipex-P and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Adipex-P crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Adipex-P.

Adipex-P Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends will be individualized to obtain an adequate response with the lowest effective dose.

The typical adult dose is 37.5 mg daily administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient’s need. For some patients, 18.75 mg daily may be adequate. 

In some cases it may be desirable to give 18.75 mg two times a day.

Other Requirements

  • Store Adipex-P at 20° to 25°C (68° to 77°F).
  • Keep this and all medicines out of the reach of children.

Dosing & Uses

Dosage Forms & Strengths

capsule, HCl salt: Schedule IV

  • 15mg (generics)
  • 30mg (generics)
  • 37.5mg (Adipex P, generics)

tablet, HCl salt: Schedule IV

  • 8mg (Lomaira)
  • 37.5mg (Adipex P, generics)

Obesity

Short-term (few weeks) adjunctive use as part of weight-reduction regimen based on exercise, behavioral modification, and caloric restriction in management of exogenous obesity for patients with initial body mass index (BMI) ≥30 kg/m² or ≥27 kg/m² in presence of other risk factors (eg, controlled hypertension, diabetes, hyperlipidemia)

Adjust dosing according to patient's needs to achieve adequate response with lowest effective dosage

Adipex P or generic

  • 15-37.5 mg/day PO in single daily dose or divided q12hr before breakfast or 1-2 hr after breakfast

Lomaira

  • Typical dose is 8mg PO TID 30 minutes before meals

Dosage Forms & Strengths

capsule, HCl salt: Schedule IV

  • 15mg (generics)
  • 30mg (generics)
  • 37.5mg (Adipex P, generics)

tablet, HCl salt: Schedule IV

  • 8mg (Lomaira)
  • 37.5mg (Adipex P, generics)

Obesity

Short-term (few weeks) adjunctive use as part of weight-reduction regimen based on exercise, behavioral modification, and caloric restriction in management of exogenous obesity for patients with initial BMI ≥30 kg/m² or ≥27 kg/m² in presence of other risk factors (eg, controlled hypertension, diabetes, hyperlipidemia)

<16 years: Safety and efficacy not established

≥16 years

  • Adjust dosing according to patient's needs to achieve adequate response with lowest effective dosage
  • Adipex P or generic
    • 15-37.5 mg/day PO in single daily dose or divided q12hr before breakfast or 1-2 hr after breakfast
  • Lomaira
    • Typical dose is 8mg PO TID 30 minutes before meals
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