Lomaira

— THERAPEUTIC CATEGORIES —
  • Obesity
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Lomaira Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Phentermine HCl 8mg; scored tabs.

    Pharmacological Class

    Sympathomimetic.

    How Supplied

    Tabs—30, 60, 90, 250, 500, 1000

    How Supplied

    Lomaira 8mg is supplied as white butterfly shaped tablets with blue speckles, debossed “K1” on one side and bisected on the other side.

    The tablet is scored to facilitate administering one half of the usual dosage for patients not requiring the full dose.

    Storage

    Store at 20° to 25°C (68° to 77°F).

    Manufacturer

    KVK Tech, Inc.

    Generic Availability

    NO

    Lomaira Indications

    Indications

    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 for patients with an initial body mass index ≥30kg/m2, or ≥27kg/m2 in the presence of other risk factors (eg, hypertension, diabetes, hyperlipidemia).

    Lomaira Dosage and Administration

    Adult

    >16yrs: Individualize. Use lowest effective dose. Usual dose: 1 tab 3 times daily at approx. 30mins before meals. Avoid late PM dose.

    Children

    ≤16yrs: not recommended.

    Elderly

    Dose selection should be cautious, usually starting at the low end of the dosing range.

    Lomaira Contraindications

    Contraindications

    Cardiovascular disease (eg, coronary artery disease, stroke, arrhythmias, CHF, uncontrolled hypertension). During or within 14 days of MAOIs. Hyperthyroidism. Glaucoma. Agitated states. History of drug abuse. Pregnancy. Nursing mothers.

    Lomaira Boxed Warnings

    Not Applicable

    Lomaira Warnings/Precautions

    Warnings/Precautions

    Increased risk of primary pulmonary hypertension (PPH), valvular heart disease. Discontinue if new, unexplained dyspnea, angina, syncope, or lower extremity edema develops. Discontinue if tolerance to the anorectant effect develops. Mild hypertension. Diabetes. Renal impairment: monitor. Prescribe minimal supply to avoid overdose. Elderly.

    Warnings/Precautions

    Primary Pulmonary Hypertension (PPH)

    • PPH has been reported when phentermine was combined with fenfluramine or dexfenfluramine and with phentermine alone.
    • Treatment should be discontinued if patients report symptoms of PPH (eg, unexplained dyspnea, angina, syncope, lower extremity pain); evaluate for possible pulmonary hypertension.

    Valvular Heart Disease

    • Cardiac valvular disease has been reported in patients taking a combination of phentermine with fenfluramine or dexfenfluramine.
    • Rare cases of valvular heart disease have been reported with phentermine alone.

    Development of Tolerance

    • Recommended dose should not be exceeded in an attempt to increase the effect.
    • Discontinue phentermine if tolerance develops.

    Risk of Dependence

    • Consider abuse potential of phentermine when evaluating the desirability of including the drug as part of a weight reduction program.

    Hypertension

    • Use caution in patients with mild hypertension as phentermine may increase blood pressure.

    Pregnancy Considerations

    Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm.

    Nursing Mother Considerations

    It is not known if phentermine is excreted in human milk; however, other amphetamines are present in human milk.

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established. Phentermine is not recommended for pediatric obesity.

    Geriatric Considerations

    Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

    Renal Impairment Considerations

    Phentermine was not studied in patients with renal impairment. Use caution when administering phentermine to patients with renal impairment.

    Lomaira Pharmacokinetics

    See Literature

    Lomaira Interactions

    Interactions

    See Contraindications. Hypertensive crisis possible with MAOIs. Concomitant other weight loss drugs, OTC preps, herbals, including SSRIs (eg, fluoxetine, sertraline, fluvoxamine, paroxetine): not recommended. Caution with alcohol. Insulin or oral hypoglycemics: requirements may be altered. May decrease hypotensive effect of adrenergic neuron blockers.

    Lomaira Adverse Reactions

    Adverse Reactions

    Cardiovascular (eg, PPH, regurgitant cardiac valvular disease, palpitation, tachycardia, elevated blood pressure, ischemic events, CNS (eg, overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis), dry mouth, unpleasant taste, GI upset, constipation, urticaria, impotence, changes in libido.

    Lomaira Clinical Trials

    Clinical Trials

    In relatively short-term clinical trials, adult obese patients instructed in dietary management and treated with anorectic drugs lost more weight on the average than those treated with placebo and diet.

    The magnitude of increased weight loss of drug-treated patients over patients given placebo is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo patients and tends to decrease in succeeding weeks. 

    The natural history of obesity is measured over several years, whereas the studies cited are restricted to a few weeks’ duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

    Lomaira Note

    Not Applicable

    Lomaira Patient Counseling

    Patient Counseling

    Inform patients that phentermine should be used only for a short period of time (a few weeks) as an adjunct to a weight reduction program based on exercise, behavioral modification, and caloric restriction.

    Caution patients about engaging in potentially hazardous tasks as phentermine may impair the ability to operate machinery or drive a motor vehicle.

    Inform patients of the risks associated with phentermine use (eg, PPH, valvular heart disease, increased BP, drug interactions); the potential for developing tolerance, and the risk of dependence.

    Phentermine should be kept in a safe place to prevent theft, accidental overdose, misuse or abuse.

    Cost Savings Program

    Lomaira Lo-Cost Access Program

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