DailyMed – PHENTERMINE HYDROCHLORIDE tablet

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DailyMed – PHENTERMINE HYDROCHLORIDE tablet


Patients must be informed that phentermine hydrochloride 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 phentermine to take, and when and how to take it [see

Dosage and Administration(

2)].

Advice pregnant women and nursing mothers not to use phentermine [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 phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away Phentermine may harm others and is against the law.

Regitine® is a registered trademark of CIBA PHARMACEUTICAL PRODUCTS, INC.

Manufactured by:

KVK-TECH INC.

110 Terry Drive

Newtown, PA 18940

DailyMed – PHENTERMINE HYDROCHLORIDE tablet

Item ID # 006071/07 50/2021

Manufacturer’s Code: 10702


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