Use
Therapeutic indications
ORLISTAT EG is indicated in combination with a moderately low calorie diet, in the treatment of obesity (body mass index [BMI] greater than or equal to 30 kg / m²), or overweight (BMI greater than or equal to 28 kg / m² ) associated with risk factors.
Orlistat treatment should be discontinued after 12 weeks if patients have not lost at least 5% of the initial measured weight at the start of treatment.
Dosage and method of administration
Adults
The recommended dose for orlistat is a 120 mg capsule, taken with water, immediately before, during or up to one hour after each of the main meals. If you skip a meal or do not contain fat, you should stop taking orlistat.
The patient should follow a moderately low calorie diet, well balanced in nutrition and containing approximately 30% of the caloric intake in the form of fat. It is recommended that the diet be rich in fruits and vegetables. The daily intake of lipids, carbohydrates and proteins should be distributed in the three main meals.
Doses greater than 120 mg three times a day do not provide any additional benefit.
Orlistat increases the amount of fat in the stool 24 to 48 hours after taking it. When treatment is stopped, the fat content of the stool generally returns to baseline within 48 to 72 hours.
Special populations:
Pediatric population
The effects of orlistat have not been studied in children.
There are no relevant indications for the use of ORLISTAT EG in children.
Elderly (over 65 years old)
The effects of orlistat have not been studied in the elderly.
Liver and kidney failure.
The effects of orlistat have not been studied in patients with hepatic and / or renal impairment.
Prescription and delivery conditions
List I.
Duration and special precautions for conservation
Shelf life: 2 years.
Special precautions for storage: Store at a temperature not exceeding + 25 ° C.
Store in the original package in order to protect from light and moisture.
Preclinical safety data
Non-clinical data from conventional studies of safety pharmacology, repeated-dose toxicology, genotoxicity, carcinogenesis, and reproductive functions did not reveal any particular risk to humans.
No teratogenic effects have been observed in animal reproduction studies. In the absence of a teratogenic effect in animals, no malformation is expected in humans. In general, the active substances responsible for malformation in humans have also been shown to be teratogenic in animals, in appropriate tests carried out on two animal species.
Incompatibilities
Aimlessly.
Employment precautions
Contraindications
- Hypersensitivity to the active substance or to any of the excipients included in the Composition section.
- Chronic malabsorption syndrome.
- Cholestasis
- Breastfeeding
Pregnancy and lactation
Pregnancy
There are no data on the use of orlistat in pregnant women.
Animal studies have not shown any direct or indirect adverse effects on pregnancy, embryonic or fetal development, delivery or postnatal development (see section Preclinical safety data).
ORLISTAT EG should be prescribed with caution in pregnant women.
Breastfeeding
Since the passage to breast milk is not known, orlistat is contraindicated during lactation.
Warnings and precautions for use
Antidiabetic medications
The weight loss with orlistat observed in clinical studies was less in patients with type 2 diabetes than in non-diabetic patients. Antidiabetic medical treatments may require close monitoring when combined with orlistat.
Cyclosporine
The combination of orlistat with cyclosporine is not recommended (see section Interactions with other medicinal products and other forms of interaction).
Gastrointestinal symptoms
Patients are advised to follow the dietary recommendations given to them (see section 4.2).
The possibility of developing gastrointestinal side effects (see section Side effects) can be increased if orlistat is taken with a high fat diet (example: in the case of a 2,000 kCal / day diet, plus 30% calories of lipid origin equivalent to more than 67 g of fat). The daily fat intake should be extended to the three main meals. If orlistat is taken with a high fat meal, it may increase the possibility of gastrointestinal side effects.
Rectal bleeding
Rectal bleeding has been reported with ORLISTAT EG. Prescribers should perform more in-depth examinations in case of severe and / or persistent symptoms.
Oral contraceptives
To avoid possible failure of oral contraception, which could occur in severe diarrhea, the use of an additional contraceptive method is recommended (see section Drug interactions and other forms of interaction).
Oral anticoagulants
Coagulation parameters should be monitored in patients receiving concomitant oral anticoagulants (see sections Interaction with other medicinal products and other forms of interaction and adverse reactions).
Hyperoxaluria and oxalate nephropathy
The use of orlistat may be associated with hyperoxaluria and oxalate nephropathy that can lead to kidney failure. This risk increases in patients with underlying chronic kidney disease and / or decreased plasma volume (see section 4.8).
Hypothyroidism
Rare hypothyroidism and / or decreased control of hypothyroidism may occur. The mechanism, although not clearly established, could imply a decrease in the absorption of iodized salts and / or levothyroxine (see section Interactions with other drugs and other forms of interaction).
Patients taking antiepileptics.
Orlistat may unbalance anticonvulsant therapy by decreasing the absorption of antiepileptic drugs and causing seizures (see section Interactions with other medicinal products and other forms of interaction).
Antiretrovirals for HIV
Orlistat has the potential to reduce the absorption of antiretroviral drugs used to treat HIV infection and may adversely affect their effectiveness (see section Drug interactions and other forms of interaction).
Interaction with other medicinal products and other forms of interaction
Cyclosporine
A decrease in plasma levels of cyclosporine has been observed in a drug interaction study and has also been reported in several cases when orlistat is administered in combination with cyclosporine. This can lead to decreased immunosuppressive efficacy. Accordingly, association is not recommended (see Warnings and Precautions for Use section). However, if concomitant administration is essential, more frequent monitoring of the level of cyclosporin in the blood should be performed after the addition of orlistat and until it stops. The level of cyclosporine in the blood should be monitored until stabilization.
Carbonaceous
In the absence of pharmacokinetic interaction studies, concomitant administration of orlistat with acarbose should be avoided.
Oral anticoagulants
When warfarin or other anticoagulants are combined with orlistat, an INR (International Normalized Ratio) test should be performed (see section 4.4).
Fat-soluble vitamins
Orlistat treatment can potentially decrease the absorption of fat-soluble vitamins (A, D, E and K).
In clinical trials, in most patients treated with orlistat up to four years of age, plasma concentrations of vitamins A, D, E, and K and beta-carotene were within normal limits. To achieve a proper nutritional balance, a diet rich in fruits and vegetables should be recommended for patients on a diet. Multivitamin supplementation may be considered. If multivitamin supplementation is recommended, it should be taken at least two hours after orlistat administration or at bedtime.
Amiodarone
A slight decrease in plasma amiodarone concentration has been observed in a limited number of healthy volunteers after administration of a single dose of amiodarone in combination with orlistat. In patients treated with amiodarone, the clinical relevance of this effect is unknown, but in some cases it may be clinically significant. In patients treated with amiodarone in combination with orlistat, it is advisable to strengthen clinical and electrocardiographic (ECG) monitoring.
Antiepileptic drugs
Seizures have been reported in patients treated with orlistat and antiepileptics (eg valproate, lamotrigine), for whom a causal relationship with a drug interaction cannot be excluded. Therefore, these patients should be monitored for a possible change in seizure frequency and / or severity (see section 4.4).
Levothyroxine
Rare hypothyroidism and / or decreased control of hypothyroidism may occur. The mechanism, although not clearly established, could imply a reduction in the absorption of iodized salts and / or levothyroxine (see section 4.4).
Lack of interaction
No interaction with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, nifedipine by gastrointestinal administration device, delayed-release nifedipine, sibutramine or alcohol have not been observed. Lack of interaction has been demonstrated in specific drug interaction studies.
Lack of interaction between oral contraceptives and orlistat has been demonstrated in specific drug interaction studies. However, orlistat can indirectly reduce the bioavailability of oral contraceptives and lead to unwanted pregnancies in some cases. An additional contraceptive method is recommended in severe diarrhea (see Warnings and Precautions for Use section).
Decreased efficacy of antiretrovirals indicated for the treatment of HIV infection, antidepressants, antipsychotics (including lithium), and benzodiazepines have been reported, coinciding with the initiation of orlistat treatment in previously well-stabilized patients. Therefore, treatment with orlistat should only be started after carefully evaluating the possible impact in these patients.
Caution
Undesirable effects
The side effects of orlistat are mainly gastrointestinal. The incidence of side effects decreases with long-term use of orlistat.
Adverse events are listed below by class of organ system and by frequency. Frequencies are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to minus 1/10), uncommon (≥ 1/1000 to minus 1/100), rare (≥ 1 / 10,000 at least 1/1000) and very rare (minus 1/10000) that includes isolated cases.
Within each frequency group, unwanted effects are presented in descending order of severity.
Table of adverse events (first year of treatment) that occur with a frequency plus 2% and an incidence ≥ 1% compared to the placebo group, during the clinical studies of 1 and 2 years duration.
CLASS OF ORGAN SYSTEMS
ADVERSE EVENT / EFFECT
Nervous system disorders
Very common
Headache
Respiratory, thoracic and mediastinal disorders.
Very common
Frequent
Upper respiratory infection
Lower respiratory infection
Gastrointestinal disorders.
Very common
Frequent
Abdominal pain / discomfort.
Trace of fat at the anal level
Filtered gas
Driving stool
Oily / oily stools
Flatulence
Liquid stool
Fat emissions
Abundant stool
Rectal pain / discomfort
Loose stool
Fecal incontinence
Abdominal bloating *
Dental problem
Gum problem
Kidney and urinary tract disorders.
Frequent
Urinary tract infection
Metabolism and nutrition disorders.
Very common
Hypoglycemia *
Infections and infestations.
Very common
Flu
General disorders and administration site conditions.
Frequent
Tired
Reproductive system and breast disorders.
Frequent
Irregular periods
Psychiatric disorders
Frequent
Anxiety
* only adverse events that occur with a frequency plus 2% and an incidence ≥ 1% compared to the placebo group in obese patients with type 2 diabetes.
In a 4-year clinical study, the overall profile of adverse events was similar to that reported in 1 and 2-year studies. The incidence of gastrointestinal events reported in the first year has decreased year after year for all four years.
Table of spontaneous post-marketing adverse reactions, the frequency of which is therefore not known.
CLASS OF ORGAN SYSTEMS
ADVERSE EFFECT
Research
Increased liver transaminases and alkaline phosphatases.
Reduced prothrombin levels, increased INR, and imbalance in anticoagulant therapy that is manifested by different hemostasis parameters have been reported in patients treated with anticoagulants in combination with orlistat (see Warnings and Precautions for Use and Interactions with Other Drugs and Other Forms of interaction)
Gastrointestinal disorders.
Rectal bleeding (see section 4.4)
Diverticulitis
Pancreatitis
Skin and subcutaneous tissue disorders.
Blistering rashes
Immune system disorders.
Hypersensitivity (eg, pruritus, rash, hives, angioedema, bronchospasm, and anaphylactic reaction)
Hepatobiliary disorders.
Cholelithiasis
Potentially serious hepatitis. Cases of fatal outcome or cases requiring liver transplantation have been reported.
Kidney and urinary tract disorders.
Oxalate nephropathy that can lead to kidney failure
Overdose
No significant adverse events were observed in normal-weight subjects and obese subjects exposed to single 800-mg doses of orlistat and multiple doses of up to 400 mg three times daily for 15 days. In addition, 240 mg doses have been administered three times a day to obese patients for 6 months. In the majority of cases of overdose with orlistat reported in the market, no adverse events, or adverse events similar to those observed at the recommended dose have been reported.
In case of overdose, it is recommended to monitor the patient for 24 hours. According to animal and human studies, any systemic effect attributable to the lipase inhibitory properties of orlistat should be rapidly reversible.
You can read our articles:
- A guide to diet pills
- Can orlistat help you lose weight here s what you need to know
- Drug safety diets while products remain on sale
- Everything you need to know to buy xenical for weight loss
- Facilitate weight loss with the slimming pill
- Health benefits of the famous weight loss pill
- How to lose weight successfully with pills and exercise
- If done correctly fasting can help you lose weight
- Make sure that weight loss medication is used correctly
- Obesity and drug addiction
- Obesity is one of the biggest problems facing people around the world
Package | Price |
---|---|
60 mg 180 pills | AUD 240.88 |
60 mg 120 pills | AUD 178.63 |
60 mg 90 pills | AUD 148.86 |
60 mg 60 pills | AUD 110.07 |
60 mg 30 pills | AUD 61.35 |
60 mg 10 pills | AUD 25.56 |
120 mg 270 pills | AUD 324.79 |
120 mg 180 pills | AUD 240.88 |
120 mg 120 pills | AUD 178.63 |
120 mg 90 pills | AUD 148.86 |
120 mg 60 pills | AUD 110.07 |
120 mg 30 pills | AUD 61.35 |
120 mg 10 pills | AUD 25.56 |