Low-Dose Phentermine (Lomaira) Wins FDA Nod for Weight Loss

Anorectic drug is administered three times daily

The FDA has approved phentermine hydrochloride USP 8-mg tablets CIV (Lomaira, KVK Tech, Inc.), a low-dose prescription medication used for a short period (a few weeks) for weight reduction in adults whose initial body mass index (BMI) is 30 or more (obese) or whose initial BMI is 27 or more (overweight) with at least one weight-related condition, such as controlled hypertension, diabetes, or hypercholesterolemia. The product should be used with regular exercise and a reduced-calorie diet.

Lomaira is the only strength of phentermine hydrochloride that can be taken up to three times a day before meals. The limited usefulness of agents in this drug class (anorectics), including Lomaira, should be measured against possible risk factors inherent in their use.

Phentermine hydrochloride, an appetite suppressant, is the most commonly prescribed drug for weight loss. More than seven million prescriptions are written for phentermine yearly by obesity medicine specialists, family practitioners, endocrinologists, internists, and cardiologists.

Phentermine hydrochloride is typically prescribed in doses ranging from 15.0 mg to 37.5 mg and is taken before or within a few hours after breakfast. The usual adult dosage of Lomaira is one 8-mg tablet three times daily 30 minutes before meals. The butterfly-shaped tablet is scored to facilitate administering one-half of the usual dose for patients that do not require the full dose, thus allowing doctors and patients to work together to customize a weight-loss treatment plan. The dosage should be individualized to obtain an adequate response with the lowest effective dose. Phentermine is not recommended for use in pediatric patients (16 years of age or younger). Late-evening use should be avoided because of the possibility of resulting insomnia.

The most common adverse events associated with phentermine include pulmonary hypertension, valvular heart disease, palpitations, increased heart rate or blood pressure, insomnia, restlessness, dry mouth, diarrhea, constipation, and changes in sexual drive.

Lomaira is expected to be available by the end of September.

Source: KVK Tech, Inc.; September 20, 2016.