Phentermine Hydrochloride

Pronunciation
Pronouncation: (FEN-ter-meen)
Class: Anorexiant

Trade Names:
Phentermine Hydrochloride
- Tablets 8 mg (equiv. to 6.4 mg base)
- Tablets 30 mg (equiv. to 24 mg base)
- Tablets 37.5 mg (equiv. to 30 mg base)
- Capsules 15 mg (equiv. to 12 mg base)
- Capsules 18.75 mg (equiv. to 15 mg base)
- Capsules 37.5 mg (equiv. to 30 mg base)

Trade Names:
Ionamin
- Capsules 15 mg phentermine resin
- Capsules 15 mg (as resin complex)
- Capsules 30 mg (as resin complex)

Trade Names:
Adipex-P
- Tablets 37.5 mg (equiv. to 30 mg base)
- Capsules 37.5 mg (equiv. to 30 mg base)

Trade Names:
Obe-Nix 30
- Capsules 37.5 mg (equiv. to 30 mg base)

Trade Names:
Phentermine Resin
- Capsules 15 mg (as resin complex)
- Capsules 30 mg (as resin complex)

Pharmacology

May stimulate satiety center in brain, causing appetite suppression.

Pharmacokinetics

Metabolism

Phentermine hydrochloride metabolism is hepatic; it is not significantly biotransformed.

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Elimination

Phentermine hydrochloride excretion is primarily renal (70% to 80% excreted unchanged); excretion is increased by acidifying the urine. The t 1/ 2 is 19 to 24 h.

Indications and Usage

Short-term (few weeks) adjunct to diet plan to reduce weight.

Contraindications

Hypersensitivity to sympathomimetic amines; advanced arteriosclerosis; symptomatic CV disease; moderate to severe hypertension; hyperthyroidism; glaucoma; agitated states; history of drug abuse; during or within 14 days following the administration of an MAOI.

Dosage and Administration

8 Mg Dose
Adults and children (12 yr of age and older)

PO 8ߙmg up to 3 times daily ½ h before meals.

15 to 37.5 Mg Dose
Adults and children (older than 16ߙyr of age)

PO 15 to 37.5 mg as a single dose before breakfast or 2 h after breakfast.

General Advice

  • Discontinue MAOIs at least 14 days before initiating therapy.

Storage/Stability

Store at controlled room temperature (59° to 86°F).

Drug Interactions

Guanethidine

May decrease hypotensive effect of guanethidine.

MAOIs (eg, phenelzine); furazolidone

May cause hypertensive crisis and intracranial hemorrhage.

Selective serotonin reuptake inhibitors (eg, fluoxetine)

Sympathomimetic effects of phentermine and risk of “serotonin syndrome” may be increased.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Regurgitant cardiac valvular disease; palpitation; tachycardia; hypertension.

CNS

Overstimulation; restlessness; dizziness; insomnia; euphoria; dysphoria; tremor; headache; psychotic episodes.

Dermatologic

Allergic urticaria.

GI

Dry mouth; unpleasant taste; diarrhea; constipation.

Genitourinary

Impotence; changes in libido.

Respiratory

Primary pulmonary hypertension.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

8ߙmg dose

Safety and efficacy not established in children younger than 12 yr of age.

16 mg dose

Safety and efficacy not established in children 16 yr of age or younger.

Special Risk Patients

Use with caution in patients with glaucoma, hypertension, and diabetes mellitus.

Drug dependence

Psychological and physical dependence may occur with continued use; this class of drugs has been extensively abused.

Tolerance

Tolerance to the anorectic effect usually develops within a few weeks.

Primary pulmonary hypertension

Has been reported with concurrent use of phentermine and fenfluramine or dexfenfluramine.

Valvular heart disease

Serious regurgitant cardiac valvular disease has been reported with concurrent use of phentermine and fenfluramine or dexfenfluramine.

Overdosage

Symptoms

Restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, fatigue, depression, arrhythmias, hypertension, hypotension, circulatory collapse, nausea, vomiting, diarrhea, abdominal cramps, convulsions, coma, death.

Patient Information

  • Advise patient using 8 mg dose to take up to 3 times daily as prescribed, ½ hour before meals, and to take last dose several hours before bedtime.
  • Advise patient using 15 to 37.5 mg dose as a single daily dose before, or 2 h after, breakfast. Advise patient to swallow tablet or capsule whole and to not crush or chew the tablet or capsule.
  • Encourage patient to follow medically supervised weight reduction program. Emphasize that this medication will only work in conjunction with a caloric-restricted diet and exercise program.
  • Advise patient that medication should be taken as prescribed and to not stop taking or change the dose unless advised to do so by health care provider.
  • Explain that appetite suppressant effects are temporary and tolerance to medication and dependence can occur. Caution patient to not increase the dose in an effort to overcome the tolerance when it occurs.
  • Remind patients with diabetes to monitor blood sugar more frequently while implementing dietary restrictions and to notify health care provider if significant changes in blood sugar occur.
  • Caution patient that drug may impair the ability to drive or perform other tasks requiring mental alertness.
  • Advise patient to notify health care provider immediately if the following symptoms occur: decreased exercise tolerance, dyspnea, swelling of the feet or ankles, fainting, chest pain, palpitations, nervousness, or dizziness.
  • Advise patient to notify health care provider if experiencing any unusual or unexplained symptoms.
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