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Friday, July 20, 2012

QSYMIA (phentermine / topiramate) SIDE EFFECTS

Qsymia side effects: Paresthesia (tingling in hands, feet, or face,) in 14% to 20% of patients

Paresthesia (tingling in hands, feet, or face,) occurred in approximately 14% of subjects given the lower doses of Qsymia (7.5 mg phentermine / 46 mg topiramate), and in 20% of patients given the higher dose of Qsymia (15 mg phentermine / 92 mg topiramate) according to the prescribing information for the drug.

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Posted by Larry Hobbs on Fri, Jul 20, 2012 1:05 pm | [0] comments

QSYMIA (phentermine / topiramate) SIDE EFFECTS

Qsymia side effects: Dry Mouth in 14% to 19% of patients

Dry Mouth occurred in approximately 14% of subjects given the lower doses of Qsymia (7.5 mg phentermine / 46 mg topiramate), and in 19% of patients given the higher dose of Qsymia (15 mg phentermine / 92 mg topiramate) according to the prescribing information for the drug.

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Posted by Larry Hobbs on Fri, Jul 20, 2012 1:03 pm | [0] comments

QSYMIA (phentermine / topiramate) SIDE EFFECTS

Qsymia side effects: Constipation in 15% to 16% of patients

Constipation occurred in approximately 15% of subjects given the lower doses of Qsymia (7.5 mg phentermine / 46 mg topiramate), and in 16% of patients given the higher dose of Qsymia (15 mg phentermine / 92 mg topiramate) according to the prescribing information for the drug.

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Posted by Larry Hobbs on Fri, Jul 20, 2012 1:00 pm | [0] comments

QSYMIA (phentermine / topiramate) SIDE EFFECTS

Qsymia side effects: Dizziness in 7% to 9% of patients

Dizziness occurred in approximately 7% of subjects given the lower doses of Qsymia (7.5 mg phentermine / 46 mg topiramate), and in 9% of patients given the higher dose of Qsymia (15 mg phentermine / 92 mg topiramate) according to the prescribing information for the drug.

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Posted by Larry Hobbs on Fri, Jul 20, 2012 12:50 pm | [0] comments

QSYMIA (phentermine / topiramate) SIDE EFFECTS

Qsymia side effects: Altered taste or bad taste (dysgeusia) in 7% to 9% of patients

Altered taste or bad taste (dysgeusia) occurred in approximately 7% of subjects given the lower doses of Qsymia (7.5 mg phentermine / 46 mg topiramate), and in 9% of patients given the higher dose of Qsymia (15 mg phentermine / 92 mg topiramate) according to the prescribing information for the drug.

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Posted by Larry Hobbs on Fri, Jul 20, 2012 12:40 pm | [0] comments

QSYMIA (phentermine / topiramate) SIDE EFFECTS

Qsymia side effects: Cognitive disorders (problems with concentration, memory) in 7.6% of patients

Cognitive disorders (problems with attention / concentration, memory, and language (word finding)) occurred in 7.6% of subjects given the higher dose of Qsymia (15 mg phentermine / 92 mg topiramate) versus 1.5% of people given a placebo according to the prescribing information for the drug.

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Posted by Larry Hobbs on Fri, Jul 20, 2012 12:35 pm | [0] comments

QSYMIA (phentermine / topiramate) SIDE EFFECTS

Qsymia side effects: Anxiety in 4% of patients

Anxiety occurred in approximately 4% of subjects given the higher dose of Qsymia (15 mg phentermine / 92 mg topiramate) versus 2% of people given a placebo according to the prescribing information for the drug.

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Posted by Larry Hobbs on Fri, Jul 20, 2012 12:30 pm | [0] comments

QSYMIA (phentermine / topiramate) SIDE EFFECTS

Qsymia side effects: Depression in 4% of patients

Depression occurred in approximately 4% of subjects given the higher dose of Qsymia (15 mg phentermine / 92 mg topiramate) versus 2% of people given a placebo according to the prescribing information for the drug.

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Posted by Larry Hobbs on Fri, Jul 20, 2012 12:25 pm | [0] comments

QSYMIA (phentermine / topiramate) SIDE EFFECTS

Qsymia side effects: Reduced sense of touch (hypoesthesia) in 4% of patients

Reduced sense of touch (hypoesthesia) occurred in approximately 4% of subjects given the lower doses of Qsymia (7.5 mg phentermine / 46 mg topiramate), and in 4% of patients given the higher dose of Qsymia (15 mg phentermine / 92 mg topiramate) according to the prescribing information for the drug.

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Posted by Larry Hobbs on Fri, Jul 20, 2012 12:20 pm | [0] comments

QSYMIA (phentermine / topiramate) SIDE EFFECTS

Qsymia side effects: Irritability in 3% to 4% of patients

Irritability occurred in approximately 3% of subjects given the lower doses of Qsymia (7.5 mg phentermine / 46 mg topiramate), and in 4% of patients given the higher dose of Qsymia (15 mg phentermine / 92 mg topiramate) according to the prescribing information for the drug.

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Posted by Larry Hobbs on Fri, Jul 20, 2012 12:10 pm | [0] comments

QSYMIA (phentermine / topiramate) SIDE EFFECTS

Qsymia side effects: Hair loss (alopecia) in 3% to 4% of patients

Hair loss (alopecia) occurred in approximately 3% of subjects given the lower doses of Qsymia (7.5 mg phentermine / 46 mg topiramate), and in 4% of patients given the higher dose of Qsymia (15 mg phentermine / 92 mg topiramate) according to the prescribing information for the drug.

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Posted by Larry Hobbs on Fri, Jul 20, 2012 12:05 pm | [0] comments

QSYMIA (phentermine / topiramate) SIDE EFFECTS

Qsymia side effects: Disturbance in attention in 2% to 4% of patients

Disturbance in attention occurred in approximately 2% of subjects given the lower doses of Qsymia (7.5 mg phentermine / 46 mg topiramate), and in 4% of patients given the higher dose of Qsymia (15 mg phentermine / 92 mg topiramate) according to the prescribing information for the drug.

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Posted by Larry Hobbs on Fri, Jul 20, 2012 12:00 pm | [0] comments

QSYMIA (phentermine / topiramate) SIDE EFFECTS

Qsymia side effects: Low potassium levels (hypokalemia) in 2% to 3% of patients

Low potassium levels (hypokalemia) occurred in 1.4% of subjects given the lower doses of Qsymia (7.5 mg phentermine / 46 mg topiramate), and in 2.5% of patients given the higher dose of Qsymia (15 mg phentermine / 92 mg topiramate) according to the prescribing information for the drug.

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Posted by Larry Hobbs on Fri, Jul 20, 2012 11:39 am | [0] comments

Thursday, July 19, 2012

QYSEMIA

Qsymia (phentermine / topiramate) dosage and administration

​Here are the dosage and administration instructions for Qsymia (phentermine / topirimate) as shown in the prescribing information.

In adults with an initial BMI of 30 kg/m2 or greater or 27 kg/m2 or greater when accompanied by weight-related co-morbidities such as hypertension, type 2 diabetes mellitus, or dyslipidemia prescribe Qsymia as follows: 

  • Take Qsymia once daily in the morning with or without food. 
  • Avoid dosing with Qsymia in the evening due to the possibility of insomnia.
  • Start treatment with Qsymia 3.75 mg/23 mg (phentermine 3.75 mg/topiramate 23 mg extended-release) daily for 14 days; after 14 days increase to the recommended dose of Qsymia 7.5 mg/46 mg (phentermine 7.5 mg/topiramate 46 mg extended-release) once daily.
  • Evaluate weight loss after 12 weeks of treatment with Qsymia 7.5 mg/46 mg.
  • If a patient has not lost at least 3% of baseline body weight on Qsymia 7.5 mg/46 mg, discontinue Qsymia or escalate the dose, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss at the Qsymia 7.5 mg/46 mg dose.
  • To escalate the dose: Increase to Qsymia 11.25 mg/69 mg (phentermine 11.25 mg/topiramate 69 mg extended-release) daily for 14 days; followed by dosing Qsymia 15 mg/92 mg (phentermine
  • 15 mg/topiramate 92 mg extended-release) daily.
  • Evaluate weight loss following dose escalation to Qsymia 15 mg/92 mg after an additional 12 weeks of treatment.
  • If a patient has not lost at least 5% of baseline body weight on Qsymia 15 mg/92 mg, discontinue Qsymia as directed, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
  • Qsymia 3.75 mg/23 mg and Qsymia 11.25 mg/69 mg are for titration purposes only.

Discontinuing Qsymia

  • Discontinue Qsymia 15 mg/92 mg gradually by taking a dose every other day for at least 1 week prior to stopping treatment altogether, due to the possibility of precipitating a seizure [see Warnings and Precautions.
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Posted by Larry Hobbs on Thu, Jul 19, 2012 12:08 pm | [0] comments

QYSEMIA

Qsymia (phentermine / topiramate) contraindications

​Here are the contraindications for Qsymia (phentermine / topirimate) as shown in the prescribing information.

  • Pregnancy
  • Glaucoma 
  • Hyperthyroidism 
  • During or within 14 days of taking monoamine oxidase inhibitors (MAO inhibitors) 
  • Known hypersensitivity or idiosyncrasy to sympathomimetic amines
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Posted by Larry Hobbs on Thu, Jul 19, 2012 12:03 pm | [0] comments

QYSEMIA

Qsymia (phentermine / topiramate) warnings and precautions

Here are the warnings and precautions for Qsymia (phentermine / topirimate) as shown in the prescribing information.

  • Fetal Toxicity: Females of reproductive potential: Obtain negative pregnancy test before treatment and monthly thereafter; use effective contraception. 
  • Qsymia is available through a limited program under a Risk Evaluation and Mitigation Strategy (REMS)
  • Increase in Heart Rate: Monitor heart rate in all patients, especially those with cardiac or cerebrovascular disease.
  • Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue Qysmia if symptoms develop.
  • Acute Myopia and Secondary Angle Closure Glaucoma: Discontinue Qsymia.
  • Mood and Sleep Disorders: Consider dose reduction or withdrawal for clinically significant or persistent symptoms.
  • Cognitive Impairment: May cause disturbances in attention or  memory. 
  • Caution patients about operating automobiles or hazardous machinery when starting treatment.
  • Metabolic Acidosis: Measure electrolytes before/during treatment 
  • Creatinine: Measure creatinine before/during treatment 
  • Use of Antidiabetic Medications: Weight loss may cause hypoglycemia. 
  • Measure serum glucose before/during treatment 
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Posted by Larry Hobbs on Thu, Jul 19, 2012 11:50 am | [0] comments

QYSEMIA

Qsymia (phentermine / topiramate) drug interactions

Here are the potential drug interactions for Qsymia (phentermine / topirimate) as shown in the prescribing information.

  • Oral contraceptives: Altered exposure may cause irregular bleeding but not increased risk of pregnancy. 
  • Advise patients not to discontinue oral contraceptives if spotting occurs.
  • CNS depressants including alcohol: Potentiate CNS depressant effects. 
  • Avoid concomitant use of alcohol
  • Non-potassium sparing diuretics: May potentiate hypokalemia [low potassium].
  • Measure potassium before/during treatment 
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Posted by Larry Hobbs on Thu, Jul 19, 2012 11:35 am | [0] comments

QYSEMIA

Qsymia (phentermine / topiramate), possibility of Suicidal Behavior and Ideation

Here is information about Suicidal Behavior and Ideation regarding Qsymia (phentermine / topirimate) as shown in the prescribing information.

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including topiramate, a component of Qsymia, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. 

Patients treated with Qsymia should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. 

Discontinue Qsymia in patients who experience suicidal thoughts or behaviors.

Avoid Qsymia in patients with a history of suicidal attempts or active suicidal ideation.

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Posted by Larry Hobbs on Thu, Jul 19, 2012 11:30 am | [0] comments

QYSEMIA

Qsymia (phentermine / topiramate), possibility of Myopia (nearsightedness) and Glaucoma

Here is information about the possibility of Myopia [nearsightedness] and glaucoma with the use of Qsymia (phentermine / topirimate) as shown in the prescribing information.

Acute Myopia [nearsightedness] and Secondary Angle Closure Glaucoma

A syndrome consisting of acute myopia [nearsightedness] associated with secondary angle closure glaucoma has been reported in patients treated with topiramate, a component of Qsymia. 

Symptoms include acute onset of decreased visual acuity and/or ocular pain.

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Posted by Larry Hobbs on Thu, Jul 19, 2012 11:19 am | [0] comments

QYSEMIA

Qsymia (phentermine / topiramate) can cause anxiety, depression and insomnia

Here is information about the possibility of anxiety, depression and insomnia with the use of Qsymia (phentermine / topirimate) as shown in the prescribing information.

Mood and Sleep Disorders

Qsymia can cause mood disorders, including depression, and anxiety, as well as insomnia. 

Patients with a history of depression may be at increased risk of recurrent depression or other mood disorders while taking Qsymia. 

The majority of these mood and sleep disorders resolved spontaneously, or resolved upon discontinuation of dosing [see Adverse Reactions].

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Posted by Larry Hobbs on Thu, Jul 19, 2012 11:10 am | [0] comments

QYSEMIA

Qsymia (phentermine / topiramate) can cause Cognitive Impairment

Here is information about the possibility of Cognitive Impairment with the use of Qsymia (phentermine / topirimate) as shown in the prescribing information.

Cognitive Impairment

Qsymia can cause cognitive dysfunction (e.g., impairment of concentration/attention, difficulty with memory, and speech or language problems, particularly word-finding difficulties).

Rapid titration or high initial doses of Qsymia may be associated with higher rates of cognitive events such as attention, memory and language/word-finding difficulties [see Adverse Reactions].

Since Qsymia has the potential to impair cognitive function, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain Qsymia therapy does not affect them adversely.

If cognitive dysfunction persists consider dose reduction or withdrawal of Qsymia for symptoms that are moderate to severe, bothersome, or those which fail to resolve with dose reduction. 

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Posted by Larry Hobbs on Thu, Jul 19, 2012 10:59 am | [0] comments

Wednesday, July 18, 2012

QSYMIA (phentermine and topiramate)

Qsymia (phentermine and topiramate) approved by US FDA on July 17, 2012

Qsymia (phentermine and topiramate extended-release) was approved as a diet pill by the U.S. Food and Drug Administration on July 17, 2012 to be used in addition to a reduced-calorie diet and exercise for chronic weight management.

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Posted by Larry Hobbs on Wed, Jul 18, 2012 4:00 pm | [0] comments

QSYMIA (phentermine and topiramate)

Qsymia (phentermine and topiramate) should NOT be used during pregnancy

Qsymia (phentermine and topiramate extended-release) "must not be used during pregnancy because it can cause harm to a fetus," notes the press release from the U.S. Food and Drug Administration.

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Posted by Larry Hobbs on Wed, Jul 18, 2012 3:50 pm | [0] comments

QSYMIA (phentermine and topiramate)

Qsymia (7.5 mg phentermine plus 46 mg topiramate) lost 6.7% more than with placebo

Subjects given the lower doses of Qsymia (7.5 mg phentermine plus 46 mg topiramate extended-release) lost 6.7% of their body weight more than those given a placebo.

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Posted by Larry Hobbs on Wed, Jul 18, 2012 3:45 pm | [0] comments

QSYMIA (phentermine and topiramate)

Qsymia (15 mg phentermine plus 92 mg topiramate) lost 8.9% more than with placebo

Subjects given the higher doses of Qsymia (15 mg phentermine plus 92 mg topiramate extended-release) lost 8.9% of their body weight more than those given a placebo.

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Posted by Larry Hobbs on Wed, Jul 18, 2012 3:40 pm | [0] comments

QSYMIA (phentermine and topiramate)

Those who don’t lose at least 3% in 3 months with Qsymia (phentermine plus topiramate)

Subjects who don't lose at least 3% of their body weight after 3 months on the lower dose of Qsymia (7.5 mg phentermine plus 46 mg topiramate extended-release) are "unlikely to achieve and sustain weight loss with continued treatment at this dose," notes the press release from the U.S. FDA.

At this point, it should be evaluated based on weight loss if the drug should be discontinued or if the dose should be increased to the higher dose.

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Posted by Larry Hobbs on Wed, Jul 18, 2012 3:30 pm | [0] comments

QSYMIA (phentermine and topiramate)

Qsymia (phentermine plus topiramate) must not be used in patients with glaucoma

Qsymia must not be used in patients with glaucoma notes the press release from the U.S. FDA.

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Posted by Larry Hobbs on Wed, Jul 18, 2012 3:20 pm | [0] comments

QSYMIA (phentermine and topiramate)

Qsymia (phentermine plus topiramate) must not be used in patients with hyperthyroidism

Qsymia must not be used in patients with hyperthyroidism notes the press release from the U.S. FDA.

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Posted by Larry Hobbs on Wed, Jul 18, 2012 3:10 pm | [0] comments

QSYMIA (phentermine and topiramate)

Qsymia (phentermine / topiramate) can increase heart rate; risk of heart attack and stroke not known

Qsymia (phentermine plus topiramate) "can increase heart rate; this drug’s effect on heart rate in patients at high risk for heart attack or stroke" is not known notes the FDA press release.

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Posted by Larry Hobbs on Wed, Jul 18, 2012 2:50 pm | [0] comments

QSYMIA (phentermine and topiramate)

Qsymia (phentermine/topiramate) most common side effects: tingling of hands and feet, dizziness, etc

Qsymia's (phentermine plus topiramate) most common side effects are:

  • tingling of hands and feet (paresthesia)
  • dizziness
  • altered taste sensation
  • insomnia
  • constipation
  • dry mouth

according to the FDA press release.

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Posted by Larry Hobbs on Wed, Jul 18, 2012 2:30 pm | [0] comments

Saturday, November 05, 2011

PHENTERMINE + TOPAMAX

3.75 mg of phentermine plus 23 mg of topiramate caused weight loss of 5.1% vs 1.6% with placebo

Obese men and women given 3.75 mg of controlled-release phentermine plus 23 mg of controlled-release topiramate (Topamax) -- the trade name of this drug combination is Qnexa -- lost an average of 5.1% of body weight after one-year compared to an average weight loss of 1.6% for those given a placebo according to a study from the researchers at the University of Alabama at Birmingham. Read the entire article | Email this article
Posted by Larry Hobbs on Sat, Nov 05, 2011 1:27 pm | [0] comments

PHENTERMINE + TOPAMAX

15 mg of phentermine plus 92 mg of topiramate caused weight loss of 10.9% vs 1.6% with placebo

Obese men and women given 15 mg of controlled-release phentermine plus 92 mg of controlled-release topiramate (Topamax)—the trade name of this drug combination is Qnexa— lost an average of 10.9% of body weight after one-year compared to an average weight loss of 1.6% for those given a placebo according to a study from the researchers at the University of Alabama at Birmingham. Read the entire article | Email this article
Posted by Larry Hobbs on Sat, Nov 05, 2011 1:20 pm | [0] comments

PHENTERMINE + TOPAMAX

Most common side effects with phentermine plus topiramate: paresthesia, dry mouth, constipation

The most common side effects in people given controlled-release phentermine plus controlled-release topiramate (Topamax) -- the trade name of this drug combination is Qnexa -- according to a study from the researchers at the University of Alabama at Birmingham, were:
  • paresthesia (tingling or pricking of a person's skin, a feeling of "pins and needles"

  • dry mouth

  • constipation

  • altered taste (dysgeusia), and

  • insomnia.
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Posted by Larry Hobbs on Sat, Nov 05, 2011 10:24 am | [0] comments

Tuesday, April 26, 2011

PHENTERMINE + TOPAMAX

Depression-related events more common in those given 15 mg phentermine + 92 mg Topamax: 7.3% vs 3.8%

"Depression-related adverse events (excluding sleep disorders)" occurred in 7.3 percent of patients given 15 mg of phentermine plus 92 mg of Topamax (topiramate) versus 3.8 percent in those given 7.5 mg of phentermine plus 46 mg of Topamax (topiramate) versus 3.8 percent in those given a placeboaccording to a new study from Duke University in Durham, North Carolina, USA.

It took an average of approximately one-month for these symptoms to occur. Read the entire article | Email this article
Posted by Larry Hobbs on Tue, Apr 26, 2011 2:33 pm | [0] comments

PHENTERMINE + TOPAMAX

Anxiety-related events more common in those given 15 mg phentermine + 92 mg Topamax: 7.7% vs 2.8%

"Anxiety-related adverse events (including irritability)" occurred in 7.7 percent of patients given 15 mg of phentermine plus 92 mg of Topamax (topiramate) versus 4.9 percent in those given 7.5 mg of phentermine plus 46 mg of Topamax (topiramate) versus 2.8 percent in those given a placeboaccording to a new study from Duke University in Durham, North Carolina, USA.

It took an average of approximately one-month for these symptoms to occur. Read the entire article | Email this article
Posted by Larry Hobbs on Tue, Apr 26, 2011 2:20 pm | [0] comments

PHENTERMINE + TOPAMAX

Attention problems more common in those given 15 mg phentermine + 92 mg Topamax: 3.5% vs 0.7%

"Anxiety-related adverse events (including irritability)" occurred in 3.5 percent of patients given 15 mg of phentermine plus 92 mg of Topamax (topiramate) versus 2 percent in those given 7.5 mg of phentermine plus 46 mg of Topamax (topiramate) versus 0.7 percent in those given a placeboaccording to a new study from Duke University in Durham, North Carolina, USA. Read the entire article | Email this article
Posted by Larry Hobbs on Tue, Apr 26, 2011 2:04 pm | [0] comments

PHENTERMINE + TOPAMAX

Kidney stones 5 times more common in those given 15 mg of phentermine plus 92 mg of Topamax

Kidney stones were 5 times more common in people given 15 mg of phentermine plus 92 mg of Topamax (topiramate) than those given either a placebo or 7.5 mg of phentermine plus 46 mg of Topamax (topiramate) according to a new study from Duke University in Durham, North Carolina, USA. Read the entire article | Email this article
Posted by Larry Hobbs on Tue, Apr 26, 2011 11:03 am | [0] comments

Monday, April 25, 2011

PHENTERMINE + TOPAMAX

7.5 mg of phentermine plus 46 mg of Topamax caused weight loss of 17.8 lbs vs 3.1 lbs with placebo

People given 7.5 mg of phentermine plus 46 mg of Topamax (topiramate) lost an average of 17.8 pounds in one year versus a weight loss of 3.1 pounds in those given a placebo according to a new study from Duke University in Durham, North Carolina, USA.

The weight loss represented 7.8 percent of body weight for the drug group versus 1.2 percent for the placebo group. Read the entire article | Email this article
Posted by Larry Hobbs on Mon, Apr 25, 2011 11:02 am | [0] comments

PHENTERMINE + TOPAMAX

15 mg of phentermine plus 92 mg of Topamax caused weight loss of 22.4 lbs vs 3.1 lbs with placebo

People given 15 mg of phentermine plus 92 mg of Topamax (topiramate) lost an average of 22.4 pounds in one year versus a weight loss of 3.1 pounds in those given a placebo according to a new study from Duke University in Durham, North Carolina, USA.

The weight loss represented 9.8 percent of body weight for the drug group versus 1.2 percent for the placebo group.

Note: This is the average weight loss for people regardless of whether they completed the one-year study or if they dropped out early. Read the entire article | Email this article
Posted by Larry Hobbs on Mon, Apr 25, 2011 10:46 am | [0] comments

PHENTERMINE + TOPAMAX

Most common side effects of phentermine plus Topamax were paraesthesia, dry mouth, constipation

The most common adverse events in people given phentermine plus Topamax (topiramate) were as follows.

The percentages shown are for those give 15 mg of phentermine plus 92 mg of Topamax (topiramate) versus those give 7.5 mg of phentermine plus 46 mg of Topamax (topiramate) versus placebo.
  • Paraesthesia (tingling, pricking, or numbness of the skin) in 21% vs 14% vs 2%

  • Dry Mouth in 21% vs 13% vs 2%

  • Constipation in 17% vs 6% vs 5%

  • Insomnia in 10% vs 7% vs 3%

  • Dizziness in 10% vs 7% vs 3%

  • Dysgeusia (altered taste) in 10% vs 7% vs 1%
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Posted by Larry Hobbs on Mon, Apr 25, 2011 10:31 am | [0] comments

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