Alli


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Related to Alli: Xenical

orlistat

Alli, Xenical

Pharmacologic class: GI lipase inhibitor

Therapeutic class: Weight control drug

Pregnancy risk category X

Action

Inhibits absorption of dietary fats in stomach and small intestine

Availability

Capsules: 60 mg (over-the-counter drug), 120 mg

Indications and dosages

Obesity management (in conjunction with reduced-calorie diet); to reduce risk of regaining after weight loss

Adults: 120 mg (Xenical) P.O. t.i.d. with each main meal containing fat (during or up to 1 hour after the meal)

Weight loss in overweight adults (in conjunction with reduced-calorie and low-fat diet)

Adults ages 18 and older: 60 mg (Alli) P.O. t.i.d. with each meal containing fat

Contraindications

• Hypersensitivity to drug or its components
• Chronic malabsorption syndrome or cholestasis
• Patients who have had organ transplant or are taking drugs to reduce organ rejection (such as cyclosporine), patients with known problems absorbing food (Alli)
• Pregnancy

Precautions

Use cautiously in:
• hypothyroidism, nephrolithiasis, diabetes mellitus, clinically significant GI disease, fat-soluble vitamin deficiencies
• history of bulimia or anorexia nervosa
• breastfeeding patients
• children.

Administration

• Know that organic causes of obesity should be ruled out before therapy starts.
• Give three times daily with meal containing fat (Alli) or up to 1 hour after a meal (Xenical).
• If patient misses a meal or eats a fat-free meal, omit dose.
• Know that orlistat therapy is frequently combined with psychotherapy.

Adverse reactions

CNS:Xenical: dizziness, headache, fatigue, insomnia, depression, anxiety

EENT:Xenical: ear, nose, and throat symptoms

GI: fecal urgency, flatus with discharge, oily or increased bowel movements, oily spotting, fecal incontinence

GU:Xenical: urinary tract infection (UTI), vaginitis, menstrual irregularities

Hepatic: severe liver injury (rare)

Musculoskeletal:Xenical: back pain, arthritis, myalgia, tendinitis

Respiratory:Xenical: upper or lower respiratory infection

Skin:Xenical: dry skin, rash

Other:Xenical: dental pain, tooth disorder, influenza

Interactions

Drug-drug.Beta-carotene, fat-soluble vitamins: reduced vitamin absorption

Cyclosporine: reduced cyclosporine blood level (Xenical)

Pravastatin: increased lipid-lowering effects (Xenical)

Warfarin: altered coagulation parameters

Patient monitoring

Monitor hepatic function closely. If liver injury is suspected, discontinue drug immediately and continue to monitor liver function tests.
• Watch for signs and symptoms of UTI, respiratory infection, and EENT disorders.
• Monitor patient for weight loss.
• Evaluate patient's diet for appropriate caloric intake.
• Be aware that patient may develop an elevated urinary oxalate level. Monitor renal function in patients at risk for renal insufficiency.

Patient teaching

• Instruct patient to take with meals as directed. Tell him he may omit a dose if he misses a meal or eats a fat-free meal.
• Advise patient to consume reduced-calorie diet and to spread daily fat intake over three main meals.
• Inform patient that drug predisposes him to EENT, respiratory, and urinary infections. Instruct him to promptly report signs and symptoms.

Instruct patient to report signs or symptoms of hepatic dysfunction (anorexia, pruritus, jaundice, dark urine, light-colored stools, or right upper quadrant pain).
• Tell patient about common adverse GI reactions, including problems controlling bowel movements. If significant GI upset occurs, encourage him to consult prescriber about taking psyllium at bedtime or with each dose.
• Advise patient to ask prescriber if he should take a daily multivitamin containing vitamins A, D, E, K, and beta-carotene at least 2 hours before or after taking drug.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs mentioned above.

orlistat

(or-li-stat) ,

Alli

(trade name),

Xenical

(trade name)

Classification

Therapeutic: weight control agents
Pharmacologic: lipase inhibitors
Pregnancy Category: X

Indications

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, hyperlipidemia).Reduces the risk of weight regain after prior loss.May delay onset of type 2 diabetes in prediabetic patients.

Action

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

Therapeutic effects

Weight loss and maintenance in obese patients.
Delayed onset of type 2 diabetes.

Pharmacokinetics

Absorption: Minimal systemic absorption.
Distribution: Action is local, within the GI 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 hr.

Time/action profile (effects on fecal fat)

ROUTEONSETPEAKDURATION
PO24–48 hrunknown48–72 hr†
†Following discontinuation

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Chronic malabsorption syndrome or cholestasis; Obstetric: Pregnancy (weight loss not recommended during pregnancy)
Use Cautiously in: Lactation: Breast feeding Pediatric: Children <12 yr (safety not established).

Adverse Reactions/Side Effects

With initial use; incidence decreases with prolonged use

Gastrointestinal

  • hepatotoxicity (life-threatening)
  • fecal urgency (most frequent)
  • flatus with discharge (most frequent)
  • ↑ defecation (most frequent)
  • oily evacuation (most frequent)
  • oily spotting (most frequent)
  • fecal incontinence

Genitourinary

  • nephrolithiasis
  • renal impairment

Interactions

Drug-Drug interaction

↓ absorption of some fat-solublevitamins, beta-carotene, levothyroxine (separate orlistat and levothyroxine by ≥4 hr), and cyclosporine (give cyclosporine 3 hr after orlistat).May ↓ effectiveness of anticonvulsants

Route/Dosage

Oral (Adults and children ≥12 yr) 60–120 mg 3 times daily with each meal containing fat.

Availability

Capsules: 60 mgOTC, 120 mg

Nursing implications

Nursing assessment

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

Potential Nursing Diagnoses

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

Implementation

  • Do not confuse Xenical (orlistat) with Xeloda (capecitabine).
  • Oral: Administer one capsule 3 times daily with or up to 1 hr after a meal. If a meal is missed or contains no fat, dose of orlistat can be omitted.
    • A supplemental multivitamin containing vitamins A, D, E, K, and beta-carotene should be taken daily, at least 2 hr before or after orlistat dose.
  • Psyllium 6 g with each dose or 12 g at bedtime may decrease GI side effects.

Patient/Family Teaching

  • 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 GI 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 GI 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. GI 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 mo or longer.
  • Advise patient to notify health care professional if signs and symptoms of hepatotoxicity (weakness, fatigue, fever, jaundice, brown urine, abdominal pain, nausea, vomiting, light-colored stools, itching, loss of appetite) occur.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise patient to notify health care professional if pregnancy is planned or suspected.

Evaluation/Desired Outcomes

  • Slow, consistent weight loss when combined with a reduced-calorie diet.
  • Delayed onset of type 2 diabetes.

Alli

(ăl′ī)
A trademark for a preparation of the drug orlistat that is sold over-the-counter.
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