Meridia Review - Reductil Review - Meridia Reductil Diet Pills Review

Meridia  Review - Reductil Review

Sibutramine, Meridia & Reductil, what relation?

Sibutramine (marketed as Meridia Diet Pill in the USA, Reductil Diet Pill in Europe), is an orally administered agent used to treat very overweight (obese) patients who have not been able to lose weight using a low calorie diet and exercise. It is a centrally acting stimulant chemically related to amphetamines. Sibutramine is classified as a Schedule IV controlled substance in the United States.

Sibutramine Manufacturer:

Sibutramine's manufacturer is Abbott Laboratories.

Sibutramine (Meridia & Reductil) Pharmacological aspects

Sibutramine (Meridia & Reductil) acts by increasing serotonin and norepinephrine levels in the brain. The serotonergic action, in particular, is thought to influence appetite. Despite its actions upon the neurotransmitters, sibutramine has never demonstrated any antidepressant properties. It was approved by the U.S. Food and Drug Administration (FDA) in November 1997 for the treatment of obesity.

Meridia / Reductil Contraindications

Meridia and Reductil are contraindicated in:

• Psychiatric conditions as bulimia nervosa, anorexia nervosa, serious depression or preexisting mania
  
• Patients with a history of or a predisposition to drug or alcohol abuse
  Hypersensitivity to the drug
  
• Patients below 18 years of age
  
• Concomitant treatment with a MAO inhibitor, antidepressant or other centrally active drugs, particular other anoretics
  
• Hypertension that is not sufficiently controlled (caution in controlled hypertension)
  
• Existing pulmonary hypertension
  
• Existing damage on heart valves, coronary heart disease, congestive heart failure, serious arrhythmias, previous myocardial infarction
  
• Stroke or transient ischemic attack (TIA)
  
• Hyperthyroidism (overactive thyroid gland)
  
• Closed angle glaucoma
  
• Seizure disorders
  
• Enlargement of the prostate gland with urinary retention
  
• Pheochromocytoma
  
• Pregnant and lactating women
  

Meridia - Reductil  Side effects

Reductil and Meridia frequently encountered side effects are: dry mouth, paradoxically increased appetite, nausea, strange taste in the mouth, anorgasmia and delayed ejaculation, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing, or joint/muscle pain.
Sibutramine (Meridia & Reductil ) can substantially increase blood pressure and pulse in some patients. Therefore all patients treated with sibutramine should have regular monitoring of blood pressure and pulse.
The following Reductil and Meridia side effects are infrequent but serious and require immediate medical attention: cardiac arrhythmias, paresthesia, mental/mood changes (e.g., excitement, restlessness, confusion, depression, rare thoughts of suicide).
Reductil and Meridia symptoms that require urgent medical attention are seizures, problems urinating, abnormal bruising or bleeding, melena, hematemesis, jaundice, fever and rigors, chest pain, hemiplegia, abnormal vision, dyspnea and edema.
Currently, no Reductil or Meridia case of pulmonary hypertension has been noted, although related compounds (such as Fen-Phen) have shown this rare but clinically significant problem.

Sibutramine (Meridia & Reductil) Interactions

Reductil / Meridia has a number of clinically significant interactions. The concomitant use of sibutramine (Reductil and Meridia) and monoamine oxidase inhibitors (MAOIs, such as selegiline) is not indicated, as it may increase the risk of serotonin syndrome, a somewhat rare but serious adverse drug reaction. Sibutramine (Reductil and Meridia) should not be taken less than two weeks after stopping or before starting use of an MAOI. Taking both sibutramine and certain medications used in the treatment of migraines—such as ergolines and triptans—, as well as opioids, may also increase the risk for serotonin syndrome, as may the use of more than one serotonin reuptake inhibitor at the same time.
The concomitant use of sibutramine (Reductil and Meridia) and drugs which inhibit CYP3A4, such as ketoconazole and erythromycin, may increase plasma levels of sibutramine. Sibutramine has no effect on the efficacy of oral contraceptives.

Meridia / Reductil Dosage

10 mg once daily (usually in the morning), if this proves insufficient the dose may be increased to 15 mg daily after 4 weeks.

Meridia / Reductil Safety concerns

Studies are ongoing into reports of sudden death, heart failure, renal failure and gastrointestinal problems. Despite a petition by Ralph Nader-founded NGO Public Citizen, the FDA made no attempts to withdraw the drug, but was part of a Senate hearing in 2005. Similarly, Dr. David Graham, FDA "whistleblower", testified before a Senate Finance Committee hearing that sibutramine may be more dangerous than the conditions it is used for.

Sibutramine (Reductil and Meridia) Interference With Cognitive and Motor Performance

Although sibutramine (Reductil and Meridia) did not affect psychomotor or cognitive performance in healthy volunteers, any CNS active drug has the potential to impair judgment, thinking or motor skills.

MERIDIA Diet Pill Information For Patients

Physicians should instruct their patients to read the patient package insert before starting therapy with MERIDIA and to reread it each time the prescription is renewed.
Physicians should also discuss with their patients any part of the package insert that is relevant to them. In particular, the importance of keeping appointments for follow-up visits should be emphasized.

• Patients should be advised to notify their physician if they develop a rash, hives, or other allergic reactions.
• Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, especially weight-reducing agents, decongestants, antidepressants, cough suppressants, lithium, dihydroergotamine, sumatriptan (Imitrex®), or tryptophan, since there is a potential for interactions.
• Patients should be reminded of the importance of having their blood pressure and pulse monitored at regular intervals.

MERIDIA Diet Pill and Pregnancy

No adequate and well controlled studies with MERIDIA® (sibutramine hydrochloride monohydrate) Capsules have been conducted in pregnant women. The use of MERIDIA during pregnancy is not recommended. Women of child-bearing potential should employ adequate contraception while taking MERIDIA. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.

MERIDIA Diet Pill and Nursing Mothers

It is not known whether sibutramine or its metabolites are excreted in human milk. MERIDIA is not recommended for use in nursing mothers. Patients should be advised to notify their physician if they are breast-feeding.

MERIDIA Diet Pill Pediatric Use

The safety and effectiveness of MERIDIA in pediatric patients under 16 years of age have not been established.

MERIDIA Diet Pill DOSAGE AND ADMINISTRATION

The recommended starting dose of MERIDIA® (sibutramine hydrochloride monohydrate) Capsules is 10 mg administered once daily with or without food. If there is inadequate weight loss, the dose may be titrated after four weeks to a total of 15 mg once daily. The 5 mg dose should be reserved for patients who do not tolerate the 10 mg dose. Blood pressure and heart rate changes should be taken into account when making decisions regarding dose titration.
Doses above 15 mg daily are not recommended. In most of the clinical trials, MERIDIA was given in the morning.
Analysis of numerous variables has indicated that approximately 60% of patients who lose at least 4 pounds in the first 4 weeks of treatment with a given dose of MERIDIA in combination with a reduced-calorie diet lose at least 5% (placebo-subtracted) of their initial body weight by the end of 6 months to 1 year of treatment on that dose of MERIDIA. Conversely, approximately, 80% of patients who do not lose at least 4 pounds in the first 4 weeks of treatment with a given dose of MERIDIA do not lose at least 5% (placebo-subtracted) of their initial body weight by the end of 6 months to 1 year of treatment on that dose. If a patient has not lost at least 4 pounds in the first 4 weeks of treatment, the physician should consider reevaluation of therapy which may include increasing the dose or discontinuation of MERIDIA.

HOW is MERIDIA® Diet Pill  SUPPLIED

MERIDIA® (sibutramine hydrochloride monohydrate) Capsules contain 5 mg, 10 mg, or 15 mg sibutramine hydrochloride monohydrate and are supplied as follows:

• 5 mg, NDC 0048-0605-01, blue/yellow capsules imprinted with “MERIDIA” on the cap and “-5-” on the body, in bottles of 100 capsules.
• 10 mg, NDC 0048-0610-01, blue/white capsules imprinted with “MERIDIA” on the cap and “-10-” on the body, in bottles of 100 capsules.
• 15 mg, NDC 0048-0615-01, yellow/white capsules imprinted with “MERIDIA” on the cap and “-15-” on the body, in bottles of 100 capsules.

Storage: Store at 25C (77 F); excursions permitted to 15-30C (59-86F). Protect capsules from heat and moisture. Dispense in a tight, light-resistant container as defined in USP.

MERIDIA Diet Pill Manufacturer

MERIDIA is a registered trademark of Knoll Pharmaceutical Company.
Knoll Pharmaceutical Company
3000 Continental Drive – North
Mount Olive, New Jersey 07828-1234
1-800-526-0221

Alli Review - Xenical Review - Orlistat Diet Pills Review

Alli Review -   Xenical  Review  - Orlistat  Diet  Pills Review

Orlistat, Xenical & alli diet pills, what relation?

Orlistat (Alli and Xenical diet pills), also known as tetrahydrolipstatin, is a white to off-white crystalline powder. Orlistat is practically insoluble in water, freely soluble in chloroform, and very soluble in methanol and ethanol. Orlistat has no pKa within the physiological pH range.

Orlistat(Alli and Xenical diet pills) is a drug designed to treat obesity. Orlistat is marketed by Roche under the trade name Xenical, and as an over-the-counter under the name alli by GlaxoSmithKline.

Orlistat (Alli and Xenical diet pills) is primarily used to prevent the absorption of fats from the human diet, hence reducing caloric intake and should be used in combination with a physician-supervised reduced-calorie diet.

How alli / Xenical works

Alli and Xenical diet pills are a reversible inhibitor of lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine residue site of gastric and pancreatic lipases. The inactivated enzymes are thus unavailable to
hydrolyze dietary fat in the form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides are not absorbed, the resulting caloric deficit may have a positive effect on weight control. Systemic absorption of the drug is therefore not needed for activity. At the recommended therapeutic dose of 120 mg three times a day, Orlistat(Alli and Xenical diet pills) inhibits dietary fat absorption by approximately 30%.

In other words: Orlistat (Alli and Xenical diet pills) inhibits the absorption of about 30% of dietary fat using the recommended dosage of 120 mg three times a day, the fat which is not absorbed by the body is excreted undigested.
Note: At the standard prescription dose of 120 mg three times daily before meals, Orlistat (Alli and Xenical diet pills) prevents approximately 30% of dietary fat from being absorbed. Higher doses do not produce more potent effects.

What special dietary instructions should I follow?

Follow the diet program your doctor has given you. You should evenly divide the amount of daily fat, carbohydrates, and protein you eat over three main meals. If orlistat is taken with a diet high in fat (a diet with more than 30% of the total daily calories from fat), or with one meal very high in fat, it is more likely you will experience side effects from the medication.

Orlistat (Alli and Xenical diet pills) blocks your body's absorption of some fat-soluble vitamins and beta carotene. Therefore, when you use orlistat you should take a daily multivitamin that contains vitamins A, D, E, K, and beta-carotene. Read the label to find a multivitamin product that contains these vitamins. Take the multivitamin once a day, 2 hours before or 2 hours after taking orlistat, or take the multivitamin at bedtime. Ask your doctor or pharmacist any questions you might have about taking a multivitamin while you are taking orlistat.

While you are taking orlistat, you should avoid foods that have more than 30% fat. Read the labels on all the foods you buy. When eating meat, poultry (chicken) or fish, eat only 2 or 3 ounces (55 or 85 grams) (about the size of a deck of cards) for a serving. Choose lean cuts of meat and remove the skin from poultry. Fill up your meal plate with more grains, fruits, and vegetables. Replace whole-milk products with nonfat or 1% milk and reduced- or low-fat dairy items. Cook with less fat. Use vegetable oil spray when cooking. Salad dressings; many baked items; and prepackaged, processed, and fast foods are usually high in fat. Use the low- or nonfat versions of these foods and/or cut back on serving sizes. When dining out, ask how foods are prepared and request that they be prepared with little or no added fat.

Orlistat (alli & Xenical) side effects

The primary side effects of Orlistat (alli & Xenical) are gastrointestinal-related. Side effects are most severe when beginning therapy, and decrease in frequency with time; in clinical trials, nearly half of side effects lasted less than a week, but some may persist for over six months. Because orlistat's main effect is to prevent dietary fat from being absorbed, the fat is excreted unchanged in the feces and so the stool may become oily or loose (steatorrhea). Increased flatulence is also common. Bowel movements may become frequent or urgent, and rare occurrences of fecal incontinence have been seen in clinical trials. To minimize these effects, foods with high fat content should be avoided; the manufacturer advises consumers to follow a low-fat, reduced-calorie diet. Oily stools and flatulence can be controlled by reducing the dietary fat content to somewhere in the region of 15 grams per meal.

Here are some possible side effects of Xenical? (This is NOT a complete list of side effects reported with Xenical. Your health care provider can discuss with you a more complete list of side effects.)

• Oily spotting
• Gas with discharge
• Urgent need to have a bowel movement
• Oily or fatty stools
  
• Oily discharge
• Increased number of bowel movements
• Inability to control bowel movements
• oily spotting on underwear or on clothing
• gas with oily spotting
• urgent need to have a bowel movement
• loose stools
• oily or fatty stools
  
• difficulty controlling bowel movements
• pain or discomfort in the rectum (bottom)
• stomach pain
• irregular menstrual periods
• headache
• anxiety

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• hives
• rash
• itching
• difficulty breathing or swallowing
• severe or continuous abdominal pain

For more detailed information about Xenical, ask your health care provider.

Xenical Description: Color, Capsules & ingredients

XENICAL is available for oral administration in dark-blue, hard-gelatin capsules, with
light-blue imprinting. Each capsule contains 120 mg of the active ingredient, orlistat. The capsules also contain the inactive ingredients microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone, and talc. Each capsule shell contains gelatin, titanium dioxide, and FD&C Blue No.1, with printing of pharmaceutical glaze NF, titanium dioxide, and FD&C Blue No.1 aluminum lake.

Xenical Indication and Usage

Xenical is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. XENICAL is also indicated to reduce the risk for weight regain after prior weight loss. XENICAL is indicated for obese patients with an initial body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (eg, hypertension, diabetes, dyslipidemia).

What NOT to take with Orlistat (alli & Xenical)

Absorption of fat-soluble vitamins and other fat-soluble nutrients is inhibited by the use of orlistat. A multivitamin tablet containing vitamins A, D, E, K, and beta-carotene should be taken once a day, at least 2 hours before or after taking the drug.

Orlistat may reduce plasma levels of cyclosporin, an immunosuppressive drug frequently used to prevent transplant rejection; the two drugs should therefore not be administered concomitantly.

General Precautions with Orlistat (alli & Xenical)

• Your daily intake of fat should be evenly divided over 3 main meals.
• Xenical can decrease the absorption some fat-soluble vitamins and beta-carotene. Therefore when being treated with Xenical, take a multivitamin supplement that contains vitamins D, E, K, and beta-carotene. Take your multivitamin once a day at least 2 hours before or after taking Xenical, such as bedtime.
• Review all medications that you are taking with your health care provider, including those that you take without a prescription. If you are taking cyclosporine you may have to be monitored more closely.
• If you are diabetic, Xenical may affect your blood sugar control. See your doctor regularly for monitoring and treatment adjustments.

Pediatric Use: The safety and efficacy of Xenical have been evaluated in obese adolescent patients aged 12 to 16 years. However, the safety and efficacy of Xenical has not been studied in pediatric patients below the age of 12 years.

Orlistat (alli & Xenical) Contraindications

You cannot take Orlistat if you:

• have problems absorbing food

• have reduced gallbladder function (e.g. after cholecystectomy)

• are pregnant, or breast-feeding a child. It is not known if orlistat is secreted in human milk. Therefore, orlistat (alli & Xenical) should not be taken by nursing women.
  

People with certain kidney problems may not be able to take Orlistat.

What other information should I know?

• Keep all appointments with your doctor.
• You should also follow a program of regular physical activity or exercise while you are taking orlistat. However, before you start any new activity or exercise program, talk with your doctor or health care professional.
• Do not let anyone else take your prescription medication. Ask your pharmacist any questions you have about refilling your prescription.
• It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
  

Orlistat Xenical Drug Interactions

Alcohol
In a multiple-dose study in 30 normal-weight subjects, coadministration of Xenical
and 40 grams of alcohol (eg, approximately 3 glasses of wine) did not result in alteration
of alcohol pharmacokinetics, orlistat pharmacodynamics (fecal fat excretion), or systemic
exposure to orlistat.

Cyclosporine
Preliminary data from a Xenical and cyclosporine drug interaction study indicate a
reduction in cyclosporine plasma levels when Xenical was coadministered with
cyclosporine.

Digoxin
In 12 normal-weight subjects receiving Xenical 120 mg three times a day for 6 days, Xenical did not alter the pharmacokinetics of a single dose of digoxin.

Fat-soluble Vitamin Supplements and Analogues
A pharmacokinetic interaction study showed a 30% reduction in beta-carotene supplement absorption when concomitantly administered with Xenical. Xenical inhibited absorption of a vitamin E acetate supplement by approximately 60%. The effect of orlistat on the absorption of supplemental vitamin D, vitamin A, and nutritionallyderived vitamin K is not known at this time.

Glyburide
In 12 normal-weight subjects receiving orlistat 80 mg three times a day for 5 days, orlistat did not alter the pharmacokinetics or pharmacodynamics (blood glucoselowering) of glyburide.

Nifedipine (extended-release tablets)
In 17 normal-weight subjects receiving Xenical 120 mg three times a day for 6 days,
Xenical did not alter the bioavailability of nifedipine (extended-release tablets).

Oral Contraceptives
In 20 normal-weight female subjects, the treatment of Xenical 120 mg three times a
day for 23 days resulted in no changes in the ovulation-suppressing action of oral
contraceptives.

Phenytoin
In 12 normal-weight subjects receiving Xenical 120 mg three times a day for 7 days, Xenical did not alter the pharmacokinetics of a single 300-mg dose of phenytoin.

Pravastatin
In a 2-way crossover study of 24 normal-weight, mildly hypercholesterolemic patients receiving Xenical 120 mg three times a day for 6 days, Xenical did not affect the pharmacokinetics of pravastatin.

Warfarin
In 12 normal-weight subjects, administration of Xenical 120 mg three times a day for 16 days did not result in any change in either warfarin pharmacokinetics (both R- and Senantiomers)
or pharmacodynamics (prothrombin time and serum Factor VII). Although undercarboxylated osteocalcin, a marker of vitamin K nutritional status, was unaltered with Xenical administration, vitamin K levels tended to decline in subjects taking Xenical. Therefore, as vitamin K absorption may be decreased with Xenical, patients on chronic stable doses of warfarin who are prescribed Xenical should be monitored closely for changes in coagulation parameters.

Xenical & Special Populations

Because the drug is minimally absorbed, studies in special populations (geriatric, different races, patients with renal and hepatic insufficiency) were not conducted.

Xenical Short-term Studies

Adults
In several studies of up to 6-weeks duration, the effects of therapeutic doses of Xenical on gastrointestinal and systemic physiological processes were assessed in normal-weight and obese subjects. Postprandial cholecystokinin plasma concentrations were lowered after multiple doses of XENICAL in two studies but not significantly different from placebo in two other experiments. There were no clinically significant changes observed in gallbladder motility, bile composition or lithogenicity, or colonic cell proliferation rate, and no clinically significant reduction of gastric emptying time or gastric acidity. In addition, no effects on plasma triglyceride levels or systemic lipases were observed with the administration of Xenical in these studies. In a 3-week study of 28 healthy male volunteers, Xenical (120 mg three times a day) did not significantly affect the balance of calcium, magnesium, phosphorus, zinc, copper, and
iron.
Pediatrics
In a 3-week study of 32 obese adolescents aged 12 to 16 years, Xenical (120 mg three times a day) did not significantly affect the balance of calcium, magnesium, phosphorus, zinc, or copper. The iron balance was decreased by 64.7 μmole/24 hours and 40.4 μmole/24 hours in orlistat and placebo treatment groups, respectively.

Orlistat (Alli and Xenical diet pills) availability

In most areas, such as the United Kingdom, France, and Canada, orlistat is available by prescription only. In Australia and the United States, certain formulations of orlistat have been approved for sale without a prescription.
United States
On January 23, 2006, a U.S. Food and Drug Administration advisory panel voted 11 to 3 to recommend the approval of an OTC formulation of orlistat, to be marketed under the name alli by GlaxoSmithKline. Approval was granted on February 7, 2007,and alli became the first weight loss drug officially sanctioned by the U.S. government for over-the-counter use. Consumer advocacy organization Public Citizen, through its Health Research Group, opposed over-the-counter approval for orlistat, calling it "the height of recklessness" and "a dangerous mistake" due to questionable benefits and possible adverse effects.
(Becoming available in the U.S. during the summer of 2007, alli will be sold as 60 mg capsules — half the dosage of prescription orlistat.)
As of 2007, no generic formulations of orlistat are legally available in the United States. U.S. patent protection for Xenical, originally to end on June 18, 2004, was extended by five years (until 2009) by the U.S. Patent and Trademark Office. The extension was granted on July 20, 2002.
Australia
In Australia, orlistat is currently available over-the-counter in 120 mg size (84 capsules to the pack). Initially available only with a prescription, it was reclassified as a "Pharmacist Only Medicine" in October 2003. In late 2006, the Australian Consumers' Association complained that Roche was inappropriately advertising the drug to teenagers, and Roche was forced to withdraw its ads. The Association filed further complaints with the Therapeutic Goods Administration — TGA, Australia's regulatory authority for healthcare products — and the TGA's Scheduling Committee agreed to convene on February 20, 2007, to discuss possible revoking of orlistat's over-the-counter status. The Committee ultimately decided to keep orlistat as a Schedule 3 drug, but withdrew its authorization of direct-to-consumer Xenical advertising, stating this "increased pressure on pharmacists to provide orlistat to consumers...this in turn had the potential to result in inappropriate patterns of use".

Some claims!

Despite claims that (Alli and Xenical diet pills) increases the risk of breast cancer amongst clinical trial participants, there is evidence to suggest that the introduction of specific varied preparations containing orlistat, namely the concurrent administration of orlistat and the monoclonal antibody trastuzumab, can actually induce cell death in tumor cells and block their growth.
A 2006 animal study addressed a connection orlistat (alli & Xenical) shares with aberrant crypt foci (ACF), lesions found in the colon which are believed to be one of the earliest precursors of colon cancer.

Some Alli and Xenical Images

alli, Orlistat 60mg. 90 capsules.(Alli 60 capsule starter pack. )

Xenical box and capsules, Orlistat 120 mg.

Alli 120 capsule refill.

The Price of Weight Loss :-)

Alli shuttle to carry the pills.

Xenical Capsules