Orlistat (or-li-stat)

US Brand Name: Xenical

Orlistat Classification

(The therapeutic classification, which categorizes drugs by the disease state they are used to treat, appears first, followed by the pharmacologic classification, which is based on the drug’s mechanism of action.)

Therapeutic class: weight control agents

Pharmacologic class of Orlistat: lipase inhibitors

Pregnancy Category (pregnancy categories (A, B, C, D, and X) provide a basis for determining a drug’s potential for fetal harm): B

Orlistat Indications

(Medications are approved by the FDA for specific disease states. This section identifies the diseases or conditions for which the drug is commonly used and includes significant unlabeled uses as well.)

Obesity management (weight loss and maintenance) when used in conjunction with a reduced-calorie diet in patients with an initial BMI >30 kg/m2 or >27 kg/m2 in the presence of additional risk factors (diabetes, hypertension, hy-perlipidemia). Reduces the risk of weight regain after prior loss. May delay onset of type 2 diabetes in prediabetic patients.

Orlistat Action

(This section contains a concise description of how the Orlistat produces the desired therapeutic effect.)

Decreases the absorption of dietary fat by re-versibly inhibiting enzymes (lipases), which are necessary for the breakdown and subsequent absorption of fat.

Therapeutic Effects of Orlistat: Weight loss and maintenance in obese patients. Delayed onset of type 2 diabetes.

Pharmacokinetics

(Pharmacokinetics refers to the way the body processes a medication by absorption, distribution, metabolism, and excretion. Also includes information on the drug’s half-life.)

Absorption: Minimal systemic absorption.

Distribution: Action is local, within the gastrointestinal tract.

Protein Binding: Minimally absorbed drug is >99% bound to plasma proteins.

Metabolism and Excretion: Major route is fecal elimination of unabsorbed drug.

Half-life: 1-2 hours.

Time/Action Profile (the table provides the onset of Orlistat action, its peak effect, and its duration of activity) (effects on fecal fat)

Route Onset Peak Duration
PO 24-48 hours unknown 48-72 hours*

* Following discontinuation

Contraindications/Precautions

(Situations in which Orlistat use should be avoided or alternatives strongly considered are listed as contraindications. In general, most drugs are contraindicated in pregnancy or lactation. The precautions portion includes disease states or clinical situations in which drug use involves particular risks or in which dosage modification may be necessary.)

Contraindicated in: Hypersensitivity; Chronic malabsorption syndrome or cholestasis; Obstetric Pregnancy or lactation.

Use Cautiously in: Pediatric: Children

Adverse Reactions/Side Effects of Orlistat

(Although it is not possible to include all reported reactions, major side effects for all drugs are included.)

With initial use; incidence decreases with prolonged use.

Gastrointestinal (GI): fecal urgency, flatus with discharge, increased defecation, oily evacuation, oily spotting, fecal incontinence.

Interactions

(Orlistat interactions are a significant risk for patients. As the number of medications a patient receives increases, so does the likelihood of drug-drug interactions. This section provides the most important drug-drug interactions and their physiological effects.)

Orlistat-Drugs: Reduces the absorption of some fat-soluble vitamins and beta-carotene.

Orlistat Dosage / Route

(Routes of administration are grouped together and include recommended doses for adults, children, and other. Dosage units are expressed in the terms in which they are usually prescribed. Dosing intervals also are provided in the manner in which they are frequently ordered.)

PO (by mouth, orally) (Adults and adolescents >16 year): 60-120 mg three times daily with each meal containing fat.

Package & Price of Orlistat in Pharmacies of the US

(This lists the strengths and concentrations of available dose forms. Such information is useful in planning more convenient regimens (fewer tablets / capsules, less injection volume). General availability and average wholesale prices of commonly prescribed drugs have also been added as an aid to nurses with prescriptive authority.)

Capsules: 120 mg, 60 mg (OTC).

Nursing Implications for Orlistat

(This section helps the nurse apply the nursing process to pharmacotherapeutics. The subsections provide a step-by-step guide to clinical assessment, implementation (Orlistat administration), and evaluation of the outcomes of pharmacologic therapy.)

Assessment

(This section includes guidelines for assessing patient history and physical data before and during drug therapy. Assessments specific to the drug’s various indications are also included.)

• Monitor patients for weight loss and adjust concurrent medications (antihypertensives, antidiabetics, lipid-lowering agents) as needed.

Potential Nursing Diagnoses

(The two or three most pertinent NANDA diagnoses that potentially apply to a patient receiving the Orlistat are listed. Each diagnosis includes the pharmacologic effect from which the diagnosis has been derived.)

Disturbed body image (Indications) Imbalanced nutrition: more than body requirements (Indications)

Orlistat Implementation

(Guidelines specific for Orlistat administration)

Per Os/By Mouth: Administer one capsule 3 times daily with or up to 1 hour after a meal. If a meal is missed or contains no fat, dose of orlistat can be omitted.

• A supplemental multivitamin containing vitamins D, E, K, and beta-carotene should be taken daily, at least 2 hours before or after orlistat dose.

• Psyllium 6 g with each dose or 12 g at bedtime may decrease gastrointestinal side effects.

Orlistat: Patient/Family Teaching

(This section includes information that should be taught to patients. Side effects that should be reported, information on minimizing and managing side effects of Orlistat, details on administration, and follow-up requirements are presented. Home Care Issues discusses aspects to be considered for medications taken in the home setting.)

• Instruct patient to take orlistat with meals as directed. If a meal is missed or contains no fat, orlistat dose can be omitted. Do not take more than recommended dose; does not improve benefit.

• Instruct patient to adhere to a reduced-calorie diet. Daily intake of fat should be distributed over three main meals. Meals should contain no more than 30% fat. Taking orlistat with a meal high in fat may increase the gastrointestinal side effects.

• Advise patient that regular physical activity, approved by a health care professional, should be used in conjunction with orlistat and diet.

• Inform patient of common gastrointestinal side effects (oily spotting, gas with discharge, urgent need to go to the bathroom, oily or fatty stools, an oily discharge, increased number of bowel movements, inability to control bowel movements). Oil in bowel movement may be clear or have orange or brown colorations. gastrointestinal side effects usually occur in first weeks of treatment and are more increased following a meal high in fat. May lessen or disappear, or may continue for 6 month or longer.

• Advise patient to notify health care professional prior to taking any Rx (prescription), OTC, or herbal product.

• Advise patient to notify health care professional if pregnancy is planned or suspected.

Orlistat: Evaluation / Desired Outcomes

(Outcome criteria for determination of the effectiveness of Orlistat are provided.)

• Slow, consistent weight loss when combined with a reduced-calorie diet.

• Delayed onset of type 2 diabetes.

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