Orlistat oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of orlistat.
Drugs List
Therapeutic Indications
Uses
Treatment with a hypocaloric diet for obese or overweight patients
Treatment in conjunction with a mildly hypocaloric diet for:
Obese patients (body mass index greater than or equal to 30kg per square metre)
Overweight patients (body mass index greater than or equal to 28kg per square metre) with associated risk factors such as type 2 diabetes, hypertension or hypercholesterolaemia.
Pharmacy only product: Only licensed for overweight patients with BMI greater than or equal to 28kg per square metre.
Dosage
Diet and exercise should be undertaken as part of the weight loss programme and continued once treatment with orlistat is stopped.
Pharmacy only product: Treatment should not exceed 6 months.
Adults
Prescription only product:
120mg three times a day, taken immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat, the dose is omitted. Doses above 120mg three times a day have not shown any additional benefit.
Pharmacy only product:
60mg three times a day.
The patient should be on a nutritionally balanced, mildly hypocaloric diet containing approximately 30% of calories from fat. Meals with very high fat content may increase gastrointestinal adverse effects. The diet should be rich in fruit and vegetables with a daily intake of fat, carbohydrate and protein distributed over three main meals. The use of a multivitamin supplement could be considered, which should be taken at least 2 hours after orlistat or at bedtime.
The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing. On discontinuation of treatment faecal fat content usually returns to pre-treatment levels, within 48 to 72 hours.
Children
Children aged 12 to 18 years (unlicensed)
120mg up to three times a day, taken immediately before, during, or up to 1 hour after each main meal. If a meal is missed or contains no fat, the dose is omitted.
Contraindications
Children under 12 years
Breastfeeding
Cholestasis
Malabsorption syndrome
Precautions and Warnings
Children aged 12 to 18 years
Chronic renal disorder
Diabetes mellitus
Hypercholesterolaemia
Hypertension
Hypothyroidism
Hypovolaemia
Positive HIV status
Pregnancy
Seizures
May reduce absorption of antiretroviral HIV drugs
Discontinue after 12 weeks of treatment if weight loss less than 5%
Monitor anticoagulant drug treatment
Monitor antidiabetic drug treatment
Monitor antiepileptic drug treatment
Monitor hypercholesterolaemia drug treatment
Monitor hypertension drug treatment
Advise patient to contact prescriber if rectal bleeding occurs
Supplements of fat-soluble vitamins A,D,E and K may be required
Not licensed for use in children under 18 years
Diet high in fat increases possibility of gastro-intestinal adverse effects
Dietary restrictions should be maintained
Female:Additional contraception method advised in cases of severe diarrhoea
Advise patient on AED to consult Dr before taking OTC product
Advise patient with diabetes to consult Dr before taking OTC product
Advise patient with high cholesterol to consult Dr before taking OTCproduct
Advise patient with HIV to consult Dr before taking OTC product
Advise patient with hypertension to consult Dr before taking OTC product
Advise patient with hyperthyroidism to consult Dr before taking OTC product
Advise patient with hypothyroidism to consult Dr before taking OTC product
Advise patient with renal impairment to consult Dr before taking OTCproduct
The possibility of gastrointestinal events may increase if a diet high in fat is taken, for example, above 67 g of fat equals more than 30% of the calories in a 2000 kcal/day diet. Patients should therefore be advised to adhere to dietary recommendations.
Use with caution in hypertension and/or hypercholesterolaemia as weight loss may be accompanied by improved blood pressure and cholesterol and an adjustment in treatment may be required.
Increased risk of hyperoxaluria and oxalate nephropathy in patients with chronic renal disease and or volume depletion.
Pregnancy and Lactation
Pregnancy
Use orlistat with caution during pregnancy.
The manufacturer advises caution if orlistat is used during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/foetal development. At the time of writing there is limited published information regarding the use of orlistat during pregnancy. Potential risks are unknown.
Weight-loss medications may interfere with adequate nutrition for both the mother and foetus. Orlistat may cause a deficiency of fat soluble vitamins if a daily multivitamin supplement is not taken.
Lactation
Orlistat is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking orlistat. The presence of orlistat in human breast milk is unknown.
Counselling
Advise patient to follow a diet rich in fruit and vegetables and low in fat.
If multivitamins are taken advise patients that these should be at least 2 hours after taking orlistat or at bedtime.
Advise patients that additional non oral contraceptive methods are recommended, particularly if diarrhoea is severe.
Advise patients with diabetes, hypertension or hypercholesterolaemia that weight loss may be accompanied by improved metabolic control, blood pressure and cholesterol, which may require treatment adjustment.
Advise patient to consult a doctor before purchasing orlistat over the counter if they have renal impairment, are being treated for hypothyroidism, are taking anticonvulsant medication or are taking antiretroviral medication for HIV.
Side Effects
Abdominal discomfort
Abdominal distension
Abdominal pain
Anaphylaxis
Angioedema
Anxiety
Bronchospasm
Bullous eruption
Cholelithiasis
Diverticulitis
Faecal incontinence
Faecal urgency
Fatigue
Fatty/oily stool
Flatulence
Flatus with discharge
Gingival disorder
Headache
Hepatitis
Hyperoxaluria
Hypersensitivity reactions
Hypoglycaemia
Increase in alkaline phosphatase
Increase of liver transaminases
Increased defecation
Influenza-like symptoms
Irregular menstruation
Lower respiratory tract infection
Nephropathy
Oily evacuation
Oily spotting from the rectum
Pancreatitis
Pruritus
Rash
Rectal bleeding
Rectal pain/discomfort
Soft or liquid stools
Tooth disorder
Upper respiratory tract infection
Urinary tract infections
Urticaria
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: February 2020
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Alli 60mg hard capsules. GlaxoSmithKline Consumer Healthcare. Revised November 2018.
Summary of Product Characteristics: Beacita 120mg. Actavis. Revised October 2017.
Summary of Product Characteristics: Orlos 60 mg hard capsules. Crescent Pharma Ltd. Revised February 2017.
Summary of Product Characteristics: Xenical 120mg hard capsules. Cheplapharm Arzneimittel GmbH. Revised May 2017.
MHRA Drug Safety Update March 2014
Available at: https://www.mhra.gov.uk
Last accessed: 24 February 2020
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 24 February 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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