ADIPEX-P (Phentermine Hydrochloride) Tablet [PD-Rx Pharmaceuticals, Inc.]

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


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