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phentermine (Adipex P, Lomaira)

 

Classes: CNS Stimulants, Anorexiants; Stimulants; Sympathomimetic

Dosing and uses of Adipex P, Lomaira (phentermine)

 

Adult dosage forms and 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

 

Pediatric dosage forms and 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

 

Adipex P, Lomaira (phentermine) adverse (side) effects

Frequency not defined

Bad taste in mouth

Blurred vision

Changes in libido

Chills

Constipation

Diarrhea

Drug-induced GI disturbance

Dry mouth

Dysphoric mood

Dysuria

Excitement

Hair loss

Headache

Hypertension

Impotence

Insomnia

Myalgia

Nausea

Nervousness

Palpitations

Restlessness

Tachycardia

Tremor

Urticaria

Vomiting

Serious

  • Heart valve disorder
  • Primary pulmonary hypertension
  • Psychotic disorder

 

Warnings

Contraindications

Known hypersensitivity or idiosyncratic reaction to sympathomimetic amines

History of cardiovascular disease (coronary artery disease, uncontrolled hypertension, arrhythmias, stroke, congestive heart failure)

Glaucoma

Agitated states

Hyperthyroidism

History of drug abuse

History of drug abuse

Use of monoamine oxidase inhibitors (MAOIs) within preceding 14 days; concomitant administration of other CNS stimulants

Pregnancy and breast feeding

 

Cautions

Primary pulmonary hypertension and valvular disease have been reported with therapy

Avoid use of stimulants in patients with serious heart rhythm disturbances, cardiac abnormalities, cardiomyopathies, or other cardiac problems (see Contraindications)

Caution in hypertension; risk of increase in blood pressure

Patients with diabetes mellitus should use caution with antidiabetic agents like insulin or other hypoglycemic agents; dietary restrictions may lower requirements for antidiabetic therapy

Drug has not been studied in renal impairment

Use with caution in patients with seizure disorders or Tourette syndrome

May impair ability to operate heavy machinery

Concomitant administration with other weight-loss agents (eg, selective serotonin reuptake inhibitors [SSRIs], herbal preparations, other over-the-counter products) has not been studied

Elderly are at high risk for myocardial infarction, hypertension, angina, or becoming dependent on phentermine with prolonged use

Discontinue if weight loss has not occurred with 4 weeks of therapy

Not approved for long-term use

Discontinue if tolerance develops, and do not exceed recommended dosage to overcome tolerance

 

Pregnancy and lactation

Pregnancy category: X

Lactation: Unknown if excreted in milk; contraindicated

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Adipex P, Lomaira (phentermine)

Mechanism of action

Amphetamine-related anorexigenic agent; action in reducing appetite may be secondary to CNS effects that may involve stimulation of hypothalamus to release norepinephrine

 

Absorption

Peak plasma time: 3.0-4.4 hr (orally disintegrating tablet)

 

Elimination

Excretion: Urine (primarily)