Oleofin 60 blocks some of the fat that you eat, keeping it from being absorbed by your body.
Oleofin 60 is used together with a reduced-calorie diet and weight maintenance to treat obesity in people with certain risk factors (such as diabetes, high blood pressure, and high cholesterol or triglycerides).
Oleofin 60 may also be used for purposes not listed in this medication guide.
It is dangerous to purchase Oleofin 60 on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of "alli" purchased on the Internet have been found to contain sibutramine (Meridia), a prescription weight loss medication that can have dangerous side effects in certain people. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.
Oleofin 60 indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Oleofin 60 is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. Oleofin 60 is also indicated to reduce the risk for weight regain after prior weight loss. Oleofin 60 is indicated for obese patients with an initial body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (eg, hypertension, diabetes, dyslipidemia).
Table 1 illustrates body mass index (BMI) according to a variety of weights and heights. The BMI is calculated by dividing weight in kilograms by height in meters squared. For example, a person who weighs 180 lbs and is 5'5" would have a BMI of 30.
Table 1 Body Mass Index (BMI), kg/m2*
*
Conversion Factors:
Weight in lbs ÷ 2.2 = weight in kilograms (kg)
Height in inches × 0.0254 = height in meters (m)
1 foot = 12 inches
How should I use Oleofin 60?
Use Oleofin 60 as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Oleofin 60. Talk to your pharmacist if you have questions about this information.
Take Oleofin 60 by mouth with or up to 1 hour after each main meal that contains fat (up to 3 per day).
If a meal is missed or contains no fat, do not take a dose of Oleofin 60.
You should take a multivitamin supplement containing vitamins A, D, E, and K to ensure good nutrition. The supplement should be taken at least 2 hours before or after you take Oleofin 60, such as at bedtime.
If you also take a thyroid hormone (eg, levothyroxine), do not take it within 4 hours before or after taking Oleofin 60. Check with your doctor if you have questions.
If you also take cyclosporine, do not take it within 3 hours before or after taking Oleofin 60. Check with your doctor if you have questions.
If you miss a dose of Oleofin 60, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Oleofin 60.
Uses of Oleofin 60 in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Obesity management:
OTC: Weight loss in overweight adults when used along with a reduced-calorie and low-fat diet.
Rx: Obesity management, including weight loss and weight maintenance, when used in conjunction with a reduced-calorie diet; to reduce the risk for weight regain after prior weight loss.
Limitations of use: Oleofin 60 is indicated for obese patients with an initial body mass index of ≥30 kg/m in the presence of other risk factors (eg, hypertension, diabetes, dyslipidemia).
Oleofin 60 description
Oleofin 60 is a drug designed to treat obesity. Its primary function is preventing the absorption of fats from the human diet, thereby reducing caloric intake. Oleofin 60 works by inhibiting pancreatic lipase, an enzyme that breaks down triglycerides in the intestine. Without this enzyme, triglycerides from the diet are prevented from being hydrolyzed into absorbable free fatty acids and are excreted undigested.
Oleofin 60 dosage
Oleofin 60 Dosage
Generic name: Oleofin 60 120mg
Dosage form: capsule
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Recommended Dosing
The recommended dose of Oleofin 60 is one 120-mg capsule three times a day with each main meal containing fat (during or up to 1 hour after the meal).
The patient should be on a nutritionally balanced, reduced-calorie diet that contains approximately 30% of calories from fat. The daily intake of fat, carbohydrate, and protein should be distributed over three main meals. If a meal is occasionally missed or contains no fat, the dose of Oleofin 60 can be omitted.
Because Oleofin 60 has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene, patients should be counseled to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition. The vitamin supplement should be taken at least 2 hours before or after the administration of Oleofin 60, such as at bedtime.
For patients receiving both Oleofin 60 and cyclosporine therapy, administer cyclosporine 3 hours after Oleofin 60.
For patients receiving both Oleofin 60 and levothyroxine therapy, administer levothyroxine and Oleofin 60 at least 4 hours apart. Patients treated concomitantly with Oleofin 60 and levothyroxine should be monitored for changes in thyroid function.
Doses above 120 mg three times a day have not been shown to provide additional benefit.
Based on fecal fat measurements, the effect of Oleofin 60 is seen as soon as 24 to 48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48 to 72 hours.
Amiodarone: Oleofin 60 may decrease the serum concentration of Amiodarone. Monitor therapy
Anticonvulsants: Oleofin 60 may decrease the serum concentration of Anticonvulsants. Exceptions: Fosphenytoin; PENTobarbital; Thiopental. Monitor therapy
Antiretroviral Agents: Oleofin 60 may decrease the serum concentration of Antiretroviral Agents. Monitor therapy
CycloSPORINE (Systemic): Oleofin 60 may decrease the serum concentration of CycloSPORINE (Systemic). Management: Administer Oleofin 60 at least 3 hours before or after oral cyclosporine. Monitor for decreased serum concentrations of oral cyclosporine, even with the recommended dose separation. Consider therapy modification
Levothyroxine: Oleofin 60 may decrease the serum concentration of Levothyroxine. Management: Separate administration of oral levothyroxine and Oleofin 60 by a least 4 hours. Monitor patients closely for signs and symptoms of hypothyroidism. Consider therapy modification
Multivitamins/Fluoride (with ADE): Oleofin 60 may decrease the serum concentration of Multivitamins/Fluoride (with ADE). Specifically, Oleofin 60 may impair absorption of fat-solube vitamins. Management: Administer oral fat soluble vitamins (such as vitamins A, D, E, and/or K that are contained in many multivitamin products) at least 2 hours before or after the administration of Oleofin 60. Consider therapy modification
Multivitamins/Minerals (with ADEK, Folate, Iron): Oleofin 60 may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, Oleofin 60 may impair the absorption of fat-soluble vitamins. Management: Administer oral fat soluble vitamins (such as vitamins A, D, E, and/or K that are contained in many multivitamin products) at least 2 hours before or after the administration of Oleofin 60. Consider therapy modification
Multivitamins/Minerals (with AE, No Iron): Oleofin 60 may decrease the serum concentration of Multivitamins/Minerals (with AE, No Iron). Specifically, Oleofin 60 may impair absorption of fat-solube vitamins. Management: Administer oral fat soluble vitamins (such as vitamins A, D, E, and/or K that are contained in many multivitamin products) at least 2 hours before or after the administration of Oleofin 60. Consider therapy modification
Paricalcitol: Oleofin 60 may decrease the serum concentration of Paricalcitol. Management: Monitor clinical response to paricalcitol closely when used with Oleofin 60. When this combination must be used, consider administering paricalcitol at least 1 hour before or 4 to 6 hours after the administration of Oleofin 60 Consider therapy modification
Propafenone: Oleofin 60 may decrease the serum concentration of Propafenone. Monitor therapy
Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Consider therapy modification
Vitamin D Analogs: Oleofin 60 may decrease the serum concentration of Vitamin D Analogs. More specifically, Oleofin 60 may impair absorption of Vitamin D Analogs. Management: Monitor clinical response (including serum calcium) to oral vitamin D analogs closely if used with Oleofin 60. If this combination must be used, consider giving the vitamin D analog at least 2 hrs before or after Oleofin 60. Exceptions: Calcipotriene; Calcitriol (Topical); Tacalcitol. Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Oleofin 60 may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy
Vitamins (Fat Soluble): Oleofin 60 may decrease the serum concentration of Vitamins (Fat Soluble). Management: Administer oral fat soluble vitamins at least 2 hours before or after the administration of Oleofin 60. Similar precautions do not apply to parenterally administered fat soluble vitamins. Exceptions: Calcipotriene. Consider therapy modification
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in patients.
Commonly Observed (based on first year and second year data)
Gastrointestinal (GI) symptoms were the most commonly observed treatment-emergent adverse events associated with the use of Oleofin 60 in the seven double-blind, placebo-controlled clinical trials and are primarily a manifestation of the mechanism of action. (Commonly observed is defined as an incidence of ≥ 5% and an incidence in the Oleofin 60 120 mg group that is at least twice that of placebo.)
Table 2 : Commonly Observed Adverse Events
Adverse Event
Year 1
Year 2
Oleofin 60* % Patients
(N=1913)
Placebo* % Patients
(N=1466)
Oleofin 60* % Patients
(N=613)
Placebo* % Patients
(N=524)
Oily Spotting†
26.6
1.3
4.4
0.2
Flatus with Discharge
23.9
1.4
2.1
0.2
Fecal Urgency
22.1
6.7
2.8
1.7
Fatty/Oily Stool†
20.0
2.9
5.5
0.6
Oily Evacuation†
11.9
0.8
2.3
0.2
Increased Defecation
10.8
4.1
2.6
0.8
Fecal Incontinence
7.7
0.9
1.8
0.2
*Treatment designates Oleofin 60 three times a day plus diet or placebo plus diet
†Oily discharge may be clear or have a coloration such as orange or brown.
In general, the first occurrence of these events was within 3 months of starting therapy. Overall, approximately 50% of all episodes of GI adverse events associated with Oleofin 60 treatment lasted for less than 1 week, and a majority lasted for no more than 4 weeks. However, GI adverse events may occur in some individuals over a period of 6 months or longer.
Discontinuation Of Treatment
In controlled clinical trials, 8.8% of patients treated with Oleofin 60 discontinued treatment due to adverse events, compared with 5.0% of placebo-treated patients. For Oleofin 60, the most common adverse events resulting in discontinuation of treatment were gastrointestinal.
Other Adverse Clinical Events
The following table lists other treatment-emergent adverse events from seven multicenter, double-blind, placebo-controlled clinical trials that occurred at a frequency of ≥ 2% among patients treated with Oleofin 60 120 mg three times a day and with an incidence that was greater than placebo during year 1 and year 2, regardless of relationship to study medication.
Table 3 : Other Treatment-Emergent Adverse Events From Seven Placebo-Controlled Clinical Trials
Body System/
Adverse Event
Year 1
Year 2
Oleofin 60* % Patients
(N=1913)
Placebo* % Patients
(N=1466)
Oleofin 60* % Patients
(N=613)
Placebo* % Patients
(N=524)
Gastrointestinal System
Abdominal Pain/Discomfort
25.5
21.4
-
-
Nausea
8.1
7.3
3.6
2.7
Infectious Diarrhea
5.3
4.4
-
—
Rectal Pain/Discomfort
5.2
4.0
3.3
1.9
Tooth Disorder
4.3
3.1
2.9
2.3
Gingival Disorder
4.1
2.9
2.0
1.5
Vomiting
3.8
3.5
—
—
Respiratory System
Influenza
39.7
36.2
-
—
Upper Respiratory Infection
38.1
32.8
26.1
25.8
Lower Respiratory Infection
7.8
6.6
—
—
Ear, Nose & Throat Symptoms
2.0
1.6
Musculoskeletal System
Back Pain
13.9
12.1
—
—
Pain Lower Extremities
-
-
10.8
10.3
Arthritis
5.4
4.8
—
—
Myalgia
4.2
3.3
—
—
Joint Disorder
2.3
2.2
—
—
Tendonitis
—
—
2.0
1.9
Central Nervous System
Headache
30.6
27.6
—
—
Dizziness
5.2
5.0
—
—
Body as a Whole
Fatigue
7.2
6.4
3.1
1.7
Sleep Disorder
3.9
3.3
—
—
Skin & Appendages
Rash
4.3
4.0
—
—
Dry Skin
2.1
1.4
—
—
Reproductive, Female
Menstrual Irregularity
9.8
7.5
—
—
Vaginitis
3.8
3.6
2.6
1.9
Urinary System
Urinary T ract Infection
7.5
7.3
5.9
4.8
Psychiatric Disorder
Psychiatric Anxiety
4.7
2.9
2.8
2.1
Depression
—
—
3.4
2.5
Hearing & Vestibular Disorders
Otitis
4.3
3.4
2.9
2.5
Cardiovascular Disorders
Pedal Edema
—
—
2.8
1.9
- None reported at a frequency ≥ 2% and greater than placebo
* Treatment designates Oleofin 60 120 mg three times a day plus diet or placebo plus diet
Table 4 illustrates the percentage of adult patients on Oleofin 60 and placebo who developed a low vitamin level on two or more consecutive visits during 1 and 2 years of therapy in studies in which patients were not previously receiving vitamin supplementation.
Table 4 : Incidence of Low Vitamin Values on Two or More Consecutive Visits (Nonsupplemented Adult Patients With Normal Baseline Values - Firs t and Second Year)
Placebo*
Oleofin 60*
Vitamin A
1.0%
2.2%
Vitamin D
6.6%
12.0%
Vitamin E
1.0%
5.8%
Beta-carotene
1.7%
6.1%
* Treatment designates placebo plus diet or Oleofin 60 plus diet
Table 5 illustrates the percentage of adolescent patients on Oleofin 60 and placebo who developed a low vitamin level on two or more consecutive visits during the 1-year study.
Table 5 : Incidence of Low Vitamin Values on Two or More Consecutive Vis its (Pediatric Patients With Normal Baseline Values*)
Placebo†
Oleofin 60†
Vitamin A
0.0%
0.0%
Vitamin D
0.7%
1.4%
Vitamin E
0.0%
0.0%
Beta-carotene
0.8%
1.5%
*All patients were treated with vitamin supplementation throughout the course of the study
†Treatment designates placebo plus diet or Oleofin 60 plus diet
In the 4-year XENDOS study, the general pattern of adverse events was similar to that reported for the 1- and 2-year studies with the total incidence of gastrointestinal-related adverse events occurring in year 1 decreasing each year over the 4-year period.
In clinical trials in obese diabetic patients, hypoglycemia and abdominal distension were also observed.
Pediatric Patients
In clinical trials with Oleofin 60 in adolescent patients ages 12 to 16 years, the profile of adverse reactions was generally similar to that observed in adults.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Oleofin 60. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Oleofin 60 exposure.
Rare cases of increase in transaminases and in alkaline phosphatase and hepatitis that may be serious have been reported. There have been reports of hepatic failure observed with the use of Oleofin 60 in postmarketing surveillance, with some of these cases resulting in liver transplant or death.
Rare cases of hypersensitivity have been reported with the use of Oleofin 60. Signs and symptoms have included pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis. Very rare cases of bullous eruption have been reported.
Rare cases of leukocytoclastic vasculitis have been reported. Clinical signs include palpable purpura, maculopapular lesions, or bullous eruption.
Acute oxalate nephropathy after treatment with Oleofin 60 has been reported in patients with or at risk for renal disease.
Pancreatitis has been reported with the use of Oleofin 60 in postmarketing surveillance. No causal relationship or physiopathological mechanism between pancreatitis and obesity therapy has been definitively established.
Lower gastrointestinal bleeding has been reported in patients treated with Oleofin 60. Most reports are nonserious; severe or persistent cases should be investigated further.
Do not take Oleofin 60 if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight or obese.
You should not take this medication if you are allergic to Oleofin 60, if you are pregnant, or if you have gallbladder problems or chronic malabsorption syndrome (an inability to absorb food and nutrients properly).
Before taking Oleofin 60, tell your doctor if you have an underactive thyroid, a history of gallstones or pancreatitis, type 1 or type 2 diabetes, an eating disorder, liver or kidney disease, or if you take other weight-loss medications (prescription or over-the-counter).
Do not give over-the-counter Oleofin 60 (alli) to a child younger than 18 years old. Prescription Oleofin 60 should not be used by anyone age 12 to 18 without the advice of a doctor.
Oleofin 60 should be used only by the person for whom it was prescribed. Never share Oleofin 60 with another person, especially someone who has a history of eating disorder. Keep the medication in a place where others cannot get to it.
Oleofin 60 is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.
Avoid a diet that is high in fat. High-fat meals taken in combination with Oleofin 60 can increase your risk of unpleasant side effects on your stomach or intestines.
DailyMed. "ORLISTAT: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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