Weight loss diets

Didrex Tablets contain the anorectic agent benzphetamine hydrochloride.
Benzphetamine is an anti-obesity drug marketed under brand name: Didrex in the USA by Pharmacia.

Benzphetamine has been approved by the FDA in 1960, for treating obesity on a short term use.

Benzphetamine is a sympathomimetic amine, which is similar to an amphetamine. It is also known as an “anorectic” or “anorexigenic” drug.
Didrex works by suppressing your appetite .

Although the mechanism of action of the sympathomimetic appetite suppressants in the treatment of obesity is not fully known, these medications have pharmacological effects similar to those of amphetamines. Amphetamine and related sympathomimetic medications (such as benzphetamine) are thought to stimulate the release of norepinephrine and/or dopamine from storage sites in nerve terminals in the lateral hypothalamic feeding center, thereby producing a decrease in appetite. This release is mediated by the binding of benzphetamine to centrally located adrenergic receptors. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Benzphetamine is contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyper-thyroidism, known hypersensitivity or idiosyncrasy to sympathomimetic amines, and glaucoma. Benzphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse.

Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol.
Each Didrex tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride.
Inactive Ingredients: Calcium Stearate, Corn Starch. Ervthrosine Sodium. FD 8 C Yellow No.61 Lactose, Povidone, Sorbitol.
Didrex tablets are supplied as follows:

50 mg (peach, round, imprinted with Didrex 50, scored)

• Bottles of 100 NDC 0009-0024-01
• Bottles of 500 NDC 0009-0024-02

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make.
It is best to take Didrex in the mid-morning or mid-afternoon. Because Didrex may cause sleeplessness, do not take a dose late in the day unless directed to do so by your doctor.
Carefully follow your doctor’s instructions about a special diet plan that will help you lose weight .
For weight loss:
Dosage should be individualized according to the response of the patient. The suggested dosage ranges from 25 to 50 mg one to three times daily. Treatment should begin with 25 to 50 mg once daily with subsequent increase in individual dose or frequency according to response. A single daily dose is preferably given in mid-morning or mid-afternoon, according to the patient’s eating habits. In an occasional patient it may be desirable to avoid late afternoon administration. Use of benzphetamine hydrochloride is not recom-mended in children under 12 years of age.

It is very important that your doctor check your progress at regular visits to make sure that Didrex is working properly .

Didrex may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions .

If you will be taking Didrex for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely .

Check with your doctor right away if you think that you may be pregnant. Benzphetamine may cause birth defects or other problems in the baby if taken during pregnancy. Use an effective form of birth control to keep from getting pregnant .

You should not use Didrex if you have used an MAO inhibitor (MAOI) such as Eldepryl, Marplan, Nardil, or Parnate within the past 14 days .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, and herbal or vitamin supplements .

Didrex may cause some people to feel a false sense of well-being or to become dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to Didrex before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Didrex is available only with your doctor’s prescription .

Appetite suppressants are not a substitute for proper diet. For maximum effects, this must be used in combination with diet and exercise programs.

ACOMPLIA ( active ingredient in Acomplia is rimonabant) approved in the European Union as an adjunct to diet and exercise for the treatment of obese patients.
If approved in the United States, it is intended to be marketed under the name Zimulti.

Rimonabant, discovered and developed by French pharmaceutical company Sanofi-Synthelabo.

In Europe, it is indicated for use in conjunction with diet and exercise for patients with a body mass index
greater than 30 kg/m2, or patients wih a BMI greater than 27 kg/m2 with associated risk factors, such as type 2
diabetes or dyslipidaemia.

Rimonabant acts by selectively blocking CB1 receptors found in the brain and in peripheral organs important in glucose and lipid (or fat) metabolism, including adipose tissue, the liver, gastrointestinal tract and muscle.
CB1 receptor blockade with ACOMPLIAН acts to decrease the overactivity of the endocannabinoid system (EC system). The EC system is a recently characterised physiological system that includes receptors such as the CB1 receptor and it has been shown to play an important role in regulating body weight and in controlling energy balance, as well as glucose and lipid (or fat) metabolism.

In total more than 6800 patients were included in the Phase 2 and Phase 3 clinical studies. The patients included in the phase 3 trials followed a restrictive diet during the trial prescribed by a dietician and they were advised to increase their physical activity. Patients had a BMI GREATER-THAN OR EQUAL TO 30 kg/m2 or BMI >27 kg/m2 with hypertension and/or dyslipidemia at inclusion. Approximately 80% of the population were women, 87% Caucasian and 9% Black. Experience in patients over 75 years and Orientals/Asians was limited.
In clinical trials, over one year 33% of patients lost more than 10% of their initial bodyweight, with nearly two thirds of patients losing over 5%.
Most of the observed weight reduction was obtained within the first nine months of treatment. ACOMPLIA 20 mg was effective in maintaining weight loss up to two years. Weight loss at two years was 5.1 kg for patients who received ACOMPLIA 20 mg and 1.2 kg for placebo.
The effects on body weight appeared to be consistent among men and women. In the limited number of Black patients weight loss was less pronounced.

Method of administration
In adults, the recommended dosage is one 20 mg tablet daily to be taken in
the morning before breakfast.
The treatment should be introduced with a mildly reduced calorie diet.
The safety and efficacy of rimonabant have not been evaluated beyond 2 years.

Side Effects of Acomplia
Nausea, vomitting and other gastrointestinal disorders were relatively common side effects of taking Acomplia.
Disorders of the nervous system includes: headaches, faintness and feeling dizzy.
Psychiatric disorders Including: mood swings, anxiety, depression, irritability, sleep disorders and other similar disorders. If you already have a history of mental health disorders, it would be highly adviseable to mention this to your doctor before obtaining Acomplia.

Warnings and precautions
ACOMPLIA should be used with caution in patients over 75 years of age.
ACOMPLIA should be used with caution in patients with moderate hepatic impairment. ACOMPLIA should not be used in patients with severe hepatic impairment.
No dosage adjustment is required for patients with mild and moderate renal impairment. ACOMPLIA should not be used in patients with severe renal impairment.
ACOMPLIA is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.

Rimonabant should be used with caution in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone)
Since ACOMPLIA tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take ACOMPLIA.

ACOMPLIA Overdose
Experience with rimonabant in overdosage is limited. In a single-dose tolerability study, doses up to 300 mg were administered to a limited number of subjects with only minor symptoms reported. These included headache, euphoria, fatigue and insomnia. The pharmacokinetic profile demonstrates that a plateau in exposures is reached at 180 mg. There is no specific antidote for rimonabant; therefore, appropriate supportive measures should be initiated in case of overdose. Treatment should consist of the general measures employed in the management of overdoses, such as keeping airways unobstructed, monitoring cardiovascular function and general symptomatic and supportive measures.

Rimonabant may also be found to be effective in assisting some smokers to quit smoking. Sanofi-Aventis is
currently conducting studies to determine the possible value of rimonabant in smoking-cessation therapy.