Medication Overview: Alli

Generic Name

Orlistat.

Drug Classification

Lipase inhibitor.

Mechanism of Action

Alli inhibits gastrointestinal lipases, reducing the absorption of dietary fats by approximately 25%. It acts locally within the gastrointestinal tract to block the breakdown and absorption of about one-third of the fat consumed in a meal. Unabsorbed fat is then excreted in the stool.

Indications for Use

Alli is indicated for overweight adults with a Body Mass Index (BMI) of 25 or greater. It is recommended as an adjunct to a reduced-calorie, low-fat diet and increased physical activity for weight management.

Dosage and Administration

The recommended dose of Alli is one 60 mg capsule taken with each main meal containing fat. It should be taken during or up to one hour after the meal. If a meal is missed or contains no fat, the dose of Alli can be skipped. Avoid exceeding the dosing frequency of three times per day.

Contraindications

Alli is contraindicated in patients with chronic malabsorption syndrome or cholestasis. It should not be used in individuals with known hypersensitivity to Orlistat or any component of the product.

Possible Drug Interactions

Co-administration with cyclosporine significantly reduces cyclosporine plasma levels. Alli may also affect the absorption of fat-soluble vitamins (A, D, E, K) and beta carotene. Patients on oral contraceptives may experience reduced effectiveness if gastrointestinal effects occur.

Storage Conditions

Store Alli at controlled room temperature, between 20°C to 25°C (68°F to 77°F). Protect from moisture and keep the bottle tightly closed. The desiccant in the bottle should remain in place for optimal product stability.

Special Populations

Pregnancy and Lactation

The use of Alli is not recommended during pregnancy. There is no sufficient data on the use of Orlistat in pregnant or breastfeeding women. Breastfeeding mothers should avoid using this medication due to the potential risk of affecting the infant’s nutritional intake.

Pediatric Use

The safety and efficacy of Alli in pediatric patients below the age of 18 have not been established. It should not be administered to children due to the lack of clinical data supporting its use in this population.

Elderly Use

Clinical studies of Alli did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Caution should be exercised when prescribing to elderly patients, especially those with underlying health conditions.

Renal Impairment

There are no specific dosage adjustments provided in the product labeling for patients with renal impairment. However, patients with severe renal insufficiency should consult a healthcare provider before starting Alli due to potential risk factors.

Hepatic Impairment

Alli has not been studied in patients with hepatic impairment. No specific dosage adjustments are provided, but caution is advised when using the medication in this population.

Adverse Reactions

Gastrointestinal Effects

Common adverse reactions include oily spotting, flatulence with discharge, fecal urgency, fatty/oily stool, and increased defecation. These symptoms generally decrease with continued use and adherence to a low-fat diet.

Hepatic Events

Rare cases of severe liver injury have been reported in post-marketing surveillance. Symptoms include jaundice, dark urine, pruritus, and upper right quadrant pain. These warrant immediate medical attention.

Dermatological Reactions

Rare instances of hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. Patients should be monitored for signs of severe skin reactions, rash, or itching.

Patient Counseling Information

Patients should be advised to adhere to a nutritionally balanced, reduced-calorie diet that contains approximately 30% of calories from fat. They should distribute daily intake of fat, carbohydrates, and protein over three main meals. Encourage patients to take a multivitamin supplement once daily, at least two hours before or after taking Alli.

Use with Diabetes

Patients with type 2 diabetes receiving treatment with medications such as metformin or insulin should consult their healthcare provider before starting Alli. Weight loss can improve glycemic control, potentially necessitating adjustments in antidiabetic medication dosages.

Monitoring Parameters

Routine monitoring may include checking liver function tests, renal function, and assessing vitamin levels, especially fat-soluble vitamins. Attention should be paid to any new or worsening symptoms of gastrointestinal discomfort or hepatic dysfunction.