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Orlistat online in Australia

  • 4.38
Orlistat

Payment methods: VISA, Mastercard, American Express, Jcb card

Availability: In stock

Prescription required for Generic Orlistat?: No Prescription

Active ingredient: Orlistat

Medical form: Pills

Delivery time: EMS Trackable (5-9 days), Airmail (10 - 21 days)

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.

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