Get your patient on Lomaira - Phentermine Hydrochloride tablet (Phentermine Hydrochloride)

LOMAIRA™ tablets are indicated as 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 in patients with an initial body mass index greater than or equal to 30 kg/m ² , or greater than or equal to 27 kg/m ² in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

Below is a chart of body mass index (BMI) based on various heights and weights.

BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

BODY MASS INDEX (BMI), kg/m ²

The limited usefulness of agents of this class, including phentermine (see Clinical Pharmacology ), should be measured against possible risk factors inherent in their use such as those described below.

Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is one tablet three times a day ½ hour before meals. This tablet is scored to facilitate administering one half of the usual dosage for patients not requiring the full dose. Phentermine hydrochloride is not recommended for use in pediatric patients less than or equal to 16 years of age.

Late evening medication should be avoided because of the possibility of resulting insomnia.

• History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension)
• During or within 14 days following the administration of monoamine oxidase inhibitors
• Hyperthyroidism
• Glaucoma
• Agitated states
• History of drug abuse
• Pregnancy (see Precautions )
• Nursing (see Precautions )
• Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines

The following adverse reactions are described, or described in greater detail, in other sections:

- Primary pulmonary hypertension (see Warnings )

- Valvular heart disease (see Warnings )

- Effect on the ability to engage in potentially hazardous tasks (see Warnings )

- Withdrawal effects following prolonged high dosage administration (see Drug Abuse and
Dependence )

The following adverse reactions to phentermine have been identified:

Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows:

Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.

LOMAIRA™ tablet is available as an oral tablet containing 8 mg of phentermine hydrochloride (equivalent to 6.4 mg of phentermine base). Each LOMAIRA™ tablet also contains the following inactive ingredients: Corn Starch, Magnesium Stearate, NF, Microcrystalline Cellulose 102, NF, Stearic Acid, NF, FD&C Blue #1 and Sucrose.

In relatively short-term clinical trials, adult obese subjects 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 placebo-treated patients 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 subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an “anorectic” drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

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™ is available as follows:

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

Bottles of 30, NDC 10702-001-03

Bottles of 60, NDC 10702-001-06

Bottles of 90, NDC 10702-001-09

Bottles of 250, NDC 10702-001-25

Bottles of 500, NDC 10702-001-50

Bottles of 1000, NDC 10702-001-10

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Keep out of the reach of children.

Manufactured by:
KVK-Tech, Inc.
110 Terry Drive
Newtown, PA 18940

Item ID# 006178/09

Manufacturer’s Code: 10702 12/23

Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics.” It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.