Alli

Product Name and Description

Brand Name: Alli (orlistat 60 mg)
Type: Over-the-counter medication for weight loss
Description: Alli is an over-the-counter weight loss aid designed to help individuals lose weight when combined with a reduced-calorie, low-fat diet. It works by blocking about 25% of the fat from being absorbed in the gastrointestinal tract. The unabsorbed fat is then eliminated from the body in stools.

Active Ingredient and Strength

Alli contains the active ingredient orlistat at a 60 mg strength per capsule. Orlistat is an inhibitor of gastrointestinal lipases.

Indications for Use

Alli is indicated for use in adults 18 years and older who are overweight with a body mass index (BMI) of 25 kg/m2 or higher. It should be used in conjunction with a reduced-calorie, low-fat diet and exercise program.

Dosing Instructions

Recommended Dose: Take one 60 mg capsule with water at mealtimes, up to three times a day. Doses should coincide with meals containing fat, up to a maximum of 15 grams of fat per meal. Taking more than the recommended dose will not provide an additional benefit and may increase the risk of side effects.

Dosing Limitations

Do not exceed three 60 mg capsules in 24 hours. Alli should not be taken for longer than six months without consulting a healthcare provider.

Administration Instructions

Take Alli during or up to one hour after a fat-containing meal. If a meal is missed or contains no fat, skip the dose of Alli.

Mechanism of Action

Alli works by inhibiting the enzyme lipase, which is essential for the hydrolysis of triglycerides in the intestines. This results in a reduction of fat absorption from the diet by approximately 25%.

Expected Weight Loss

When used in conjunction with a reduced-calorie, low-fat diet and exercise, Alli can lead to an additional 5% to 10% weight loss over diet and exercise alone within a year.

Pharmacokinetic Profile

Minimal systemic absorption occurs with orlistat. Plasma concentrations of intact orlistat are generally below 5 ng/mL within 8 hours of ingestion. The primary route of elimination is through feces.

Drug Interactions

Alli may interact with fat-soluble vitamins and medications such as warfarin, antiepileptic drugs, and antiretroviral drugs. A multivitamin containing vitamins A, D, E, K, and beta-carotene should be taken once a day, at least 2 hours before or after taking Alli. Monitor INR levels closely in patients taking concomitant oral anticoagulants.

Precautions in Special Populations

Pregnancy: Not recommended for use during pregnancy.
Nursing Mothers: It is not known if Alli is excreted in human breast milk; therefore, a decision should be made to discontinue nursing or discontinue the drug.
Pediatric Use: Not approved for use in pediatric patients under 18 years of age.
Geriatric Use: Clinical studies did not include a significant number of individuals aged 65 and over to determine whether they respond differently from younger individuals.

Side Effects and Adverse Reactions

Common side effects include gastrointestinal symptoms related to undigested fats passing through the digestive system, such as oily or fatty stools, flatulence with discharge, urgent bowel movements, and increased defecation. Rarely, patients may experience liver injury, kidney stones, or hypo or hyperthyroidism.

Overdosage Information

In cases of overdosage, standard supportive measures should be performed. Single doses of 800 mg of Alli and multiple doses of up to 400 mg three times a day have been studied without significant adverse findings.

Storage Requirements

Store at 20-25°C (68-77°F). Protect from excessive heat and humidity. Keep the container tightly closed.

Handling and Disposal

Handle accordant to the guidelines for non-hazardous pharmaceuticals. For disposal, Alli capsules should be disposed of in accordance with local regulations for medications.

Packaging and Manufacturer Information

Packaging: Alli is available in various packages, including bottles and starter packs.
Manufacturer: Alli is manufactured by GlaxoSmithKline Consumer Healthcare, L.P.