Metabolism: Treatment of Obesity
Composition: Each coated tablet contains: Phentermine Hydrochloride 37.5 mg. Excipients: Lactose Monohydrate, Microcrystalline Cellulose, Sodium Glycolate Starch, Pregelatinized Starch D and C Yellow N ° 10, Aluminic Lacquer, Magnesium Stearate, Hypromellose, Macrogol, Talc, Titanium Dioxide, qs
Therapeutic Action: Treatment of obesity.
Indications: Short-term treatment of primary or common obesity, together with a dietary regimen to reduce body weight based on caloric restriction, exercise, and modification of eating habits, in patients with a body mass index (BMI). )> 30 kg / m 2 or> 27 kg / m 2 in the presence of other risk factors (eg, high blood pressure, diabetes, dyslipidemia).
Properties: Phentermine is a sympathomimetic amine similar in activity to the prototype drugs of its class used in obesity, amphetamines. Its actions also include stimulation of the central nervous system and elevation of blood pressure. Drugs of this class used in obesity are commonly known as “anorectics”. Although the mechanism of action of anorectics has not been fully established, these drugs have similar pharmacological effects to amphetamines. Amphetamines and related sympathomimetic drugs are believed to stimulate the release of norepinephrine and / or dopamine from storage sites at nerve endings in the control center for satiety and appetite in the hypothalamus, leading to decreased appetite. It has not been established that the action of these drugs in the treatment of obesity is exclusively due to decreased appetite; Other central nervous system actions and / or metabolic effects may be involved, such as decreased gastric acid secretion or increased energy expenditure.Pharmacokinetics: Absorption: After oral administration, phentermine is rapidly absorbed from the digestive tract. Peak plasma concentrations occur after 1 to 3 hours. Generally, complete absorption occurs between 4 to 6 hours. Metabolism: its metabolization is extensive, through a complex pathway of biotransformation that involves oxidative deamination and reduction of many of its metabolites that are biologically active and that can participate in the therapeutic action. Like all amphetamines, phentermine is concentrated in the kidney, lungs, cerebrospinal fluid, and brain. As it is highly soluble in lipids, it crosses the blood-brain barrier. The average volume of distribution is 5 l / kg of body weight. Excretion:Under normal conditions, about 30% of phentermine is excreted in the urine unchanged, but this excretion is highly variable and depends on urinary pH. When the urinary pH is acidic (pH 5.5 to 6.0), elimination is predominantly by urinary excretion, with approximately 60% of the phentermine dose excreted unchanged by the kidney within 48 hours. When the urinary pH is alkaline (pH 7.5 to 8.0), the predominant elimination is by deamination (less than 7% is excreted unchanged in the urine).
Dosage: Administration route: Oral. Usual dose in adults and adolescents over 16 years of age: 1 tablet a day, before or 1 to 2 hours after breakfast. The dose can be adjusted according to the patient’s need. For some patients the adequate daily dose may be 1/2 tablet (18.75 mg) a day, while in other cases it may be appropriate to administer 1/2 tablet (18.75 mg) 2 times a day. The administration of the medication in the afternoon (after 18 hrs.) Is not recommended because it can cause insomnia. Usual dose in children and adolescents under 16 years of age:The use of this medicine is not recommended in patients under 16 years of age, since safety and efficacy have not been established. Dose in patients over 60 years of age: It is recommended to reduce the dose.
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