phentermine and topiramate

phentermine and topiramate is an FDA-registered drug product whose active ingredient is PHENTERMINE AND TOPIRAMATE. It is labelled by Prasco Laboratories taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 66993-780, application NDA022580, label effective 20260518. It is one of 2 FDA drug label records sharing the active ingredient PHENTERMINE AND TOPIRAMATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PHENTERMINE AND TOPIRAMATE are most often described in connection with: topiramate extended-release, indicated combination, reduced-calorie diet, increased physical, activity reduce, excess body, maintain weight, reduction long. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity Adults with overweight in the presence of at least one weight-related comorbid condition Limitations of Use The effect of phentermine and topiramate extended-release capsules on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of phentermine and topiramate extended-release capsules in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. Phentermine and topiramate extended-release capsules are a combination of phentermine, a sympathomimetic amine anorectic, and topiramate, indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity ( 1 ). Adults with overweight in the presence of at least one weight-related comorbid condition ( 1 ). Limitations of Use: The effect of phentermine and topiramate extended-release capsules on cardiovascular morbidity and mortality has not been established ( 1 ). The safety and effectiveness of phentermine and topiramate extended-release capsules in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established ( 1 ).

2 DOSAGE AND ADMINISTRATION Take orally once daily in morning. Avoid administration in evening to prevent insomnia ( 2.2 ). Recommended starting dosage is 3.75 mg/23 mg (phentermine mg/topiramate mg) daily for 14 days; then increase to 7.5 mg/46 mg daily ( 2.2 ). Escalate dosage based on weight loss in adults or BMI reduction in pediatric patients. See the Full Prescribing Information for details regarding discontinuation or dosage escalation ( 2.2 ). Gradually discontinue 15 mg/92 mg dosage to prevent possible seizure ( 2.3 ). Do not exceed 7.5 mg/46 mg dosage for patients with moderate or severe renal impairment or patients with moderate hepatic impairment ( 2.4 , 2.5 ). 2.1 Recommended Testing Prior to and During Treatment with Phentermine and Topiramate Extended-Release Capsules Prior to phentermine and topiramate extended-release capsules initiation and during treatment with phentermine and topiramate extended-release capsules, the following is recommended: Obtain a negative pregnancy test before initiating phentermine and topiramate extended-release capsules in patients who can become pregnant and monthly during phentermine and topiramate extended-release capsules therapy. Phentermine and topiramate extended-release capsules are contraindicated during pregnancy [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.3) ] . Obtain a blood chemistry profile that includes bicarbonate, creatinine, and potassium in all patients, and glucose in patients with type 2 diabetes mellitus on antidiabetic medication prior to initiating phentermine and topiramate extended-release capsules treatment and periodically during treatment [see Warnings and Precautions (5.7 , 5.8 , 5.12) ] . 2.2 Recommended Dosage and Administration The recommended dosage, titration, and administration of phentermine and topiramate extended-release capsules are as follows: Take phentermine and topiramate extended-release capsules orally once daily in the morning with or without food. Avoid administration of phentermine and topiramate extended-release capsules in the evening due to the possibility of insomnia. The recommended starting dosage of phentermine and topiramate extended-release capsules is one capsule (containing 3.75 mg of phentermine and 23 mg of topiramate) (3.75 mg/23 mg) taken orally once daily for 14 days; after 14 days increase to the recommended dosage of phentermine and topiramate extended-release capsules 7.5 mg/46 mg orally once daily. After 12 weeks of treatment with phentermine and topiramate extended-release capsules 7.5 mg/46 mg, evaluate weight loss for adults or BMI reduction for pediatric patients aged 12 years and older. If an adult patient has not lost at least 3% of baseline body weight or a pediatric patient has not experienced a reduction of at least 3% of baseline BMI, increase the dosage to phentermine and topiramate extended-release capsules 11.25 mg/69 mg orally once daily for 14 days; followed by an increase in the dosage to phentermine and topiramate extended-release capsules 15 mg/92 mg orally once daily. After 12 weeks of treatment with phentermine and topiramate extended-release capsules 15 mg/92 mg, evaluate weight loss for adults or BMI reduction for pediatric patients aged 12 years and older. If an adult patient has not lost at least 5% of baseline body weight or a pediatric patient has not experienced a reduction of at least 5% of baseline BMI, discontinue phentermine and topiramate extended-release capsules [see Dosage and Administration (2.3) ] , as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment. Monitor the rate of weight loss in pediatric patients. If weight loss exceeds 2 lbs (0.9 kg)/week, consider dosage reduction. 2.3 Discontinuation of Phentermine and Topiramate Extended-Release Capsules 15 mg/92 mg Discontinue phentermine and topiramate extended-release capsules 15 mg/92 mg gradually by taking phentermine and topiramate extended-release capsules 15 mg/92 mg orally once daily 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 (5.9) and Drug Abuse and Dependence (9.3) ] . 2.4 Recommended Dosage in Patients with Renal Impairment The recommended dosage in patients with mild (CrCl greater or equal to 50 and less than 80 mL/min) renal impairment is the same as the recommended dosage for patients with normal renal function [see Warnings and Precautions (5.9) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ]. In patients with severe [creatinine clearance (CrCl) less than 30 mL/min] or moderate (CrCl greater than or equal to 30 and less than 50 mL/min) renal impairment (CrCl calculated using the Cockcroft-Gault equation with actual body weight), the maximum recommended dosage is phentermine and topiramate extended-release capsules 7.5 mg/46 mg once daily. Avoid use of phentermine and topiramate extended-release capsules in patients with end-stage renal disease on dialysis. 2.5 Recommended Dosage in Patients with Hepatic Impairment The recommended dosage of phentermine and topiramate extended-release capsules in patients with mild hepatic impairment (Child-Pugh 5 - 6) is the same as the recommended dosage in patients with normal hepatic function [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ] . In patients with moderate hepatic impairment (Child-Pugh score 7 - 9), the maximum recommended dosage is phentermine and topiramate extended-release capsules 7.5 mg/46 mg orally once daily. Avoid use of phentermine and topiramate extended-release capsules in patients with severe hepatic impairment (Child-Pugh score 10 - 15).

4 CONTRAINDICATIONS Phentermine and topiramate extended-release capsules are contraindicated in patients: Who are pregnant [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] With glaucoma [see Warnings and Precautions (5.3) ] With hyperthyroidism Taking or within 14 days of stopping a monoamine oxidase inhibitors [see Drug Interactions (7) ] With known hypersensitivity to phentermine, topiramate or any of the excipients in phentermine and topiramate extended-release capsules, or idiosyncrasy to the sympathomimetic amines. Anaphylaxis and angioedema have occurred with topiramate [ see Warnings and Precautions (5.15) ]. Pregnancy ( 4 ) Glaucoma ( 4 ) Hyperthyroidism ( 4 ) Taking or within 14 days of stopping monoamine oxidase inhibitors ( 4 ) Known hypersensitivity to any component of phentermine and topiramate extended-release capsules or idiosyncrasy to sympathomimetic amines ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Embryo-Fetal Toxicity [ see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.6) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2) ] Risk of Ophthalmologic Adverse Reactions [see Warnings and Precautions (5.3) ] Mood and Sleep Disorders [see Warnings and Precautions (5.4) ] Cognitive Impairment [see Warnings and Precautions (5.5) ] Slowing of Linear Growth [see Warnings and Precautions (5.6) ] Metabolic Acidosis [see Warnings and Precautions (5.7) ] Decrease in Renal Function [see Warnings and Precautions (5.8) ] Risk of Seizures with Abrupt Withdrawal of phentermine and topiramate extended-release capsules [see Warnings and Precautions (5.9) ] Kidney Stones [see Warnings and Precautions (5.10) ] Oligohydrosis and Hyperthermia [see Warnings and Precautions (5.11) ] Hypokalemia [see Warnings and Precautions (5.12) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [ see Warnings and Precautions (5.13) ] Serious Skin Reactions [ see Warnings and Precautions (5.14) ] Anaphylaxis and Angioedema [ see Warnings and Precautions (5.15) ] Allergic Reactions Due to Inactive Ingredients FD&C Yellow No. 5 [see Warnings and Precautions (5.16) ] Most common adverse reactions in: Adults (incidence ≥ 5% and at least 1.5 times placebo) are: paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth ( 6.1 ). Pediatric patients aged 12 years and older (incidence ≥4% and greater than placebo) are: depression, dizziness, arthralgia, pyrexia, influenza, and ligament sprain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact VIVUS LLC, at 1-888-998-4887 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The data described herein reflect exposure to phentermine and topiramate extended-release capsules in two 1-year, randomized, double-blind, placebo-controlled, multicenter clinical trials and two supportive trials in 2,318 adult patients with overweight or obesity [936 (40%) patients with hypertension, 309 (13%) patients with type 2 diabetes mellitus, 808 (35%) patients with BMI greater than 40 kg/m 2 ] exposed for a mean duration of 298 days. Data in this section also describe adverse reactions from a 1-year, randomized, double-blind, placebo-controlled multicenter clinical trial that evaluated 223 pediatric patients (12 to 17 years old) with obesity [see Clinical Studies (14) ] . Adults Adverse reactions occurring at greater than or equal to 5% and at least 1.5 times placebo in adults include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth. Adverse reactions reported in greater than or equal to 2% of phentermine and topiramate extended-release capsule-treated adults and more frequently than in the placebo group are shown in Table 1 . Table 1. Adverse Reactions Reported in ≥2% of Phentermine and Topiramate Extended-Release Capsule-Treated Adults with Overweight or Obesity and More Frequently than Placebo in Overall Study Population of 1 Year Duration Adverse Reaction Placebo (N = 1561) % Phentermine and Topiramate Extended- Release Capsules 3.75 mg/23 mg (N = 240) % Phentermine and Topiramate Extended- Release Capsules 7.5 mg/46 mg (N = 498) % Phentermine and Topiramate Extended- Release Capsules 15 mg/92 mg (N = 1,580) % Paraesthesia 2 4 14 20 Dry Mouth 3 7 14 19 Constipation 6 8 15 16 Upper Respiratory Tract Infection 13 16 12 14 Headache 9 10 7 11 Dysgeusia 1 1 7 9 Insomnia 5 5 6 9 Nasopharyngitis 8 13 11 9 Dizziness 3 3 7 9 Sinusitis 6 8 7 8 Nausea 4 6 4 7 Back Pain 5 5 6 7 Fatigue 4 5 4 6 Diarrhea 5 5 6 6 Vision Blurred 4 6 4 5 Bronchitis 4 7 4 5 Urinary Tract Infection 4 3 5 5 Cough 4 3 4 5 Influenza 4 8 5 4 Depression 2 3 3 4 Anxiety 2 3 2 4 Hypoesthesia 1 1 4 4 Irritability 1 2 3 4 Alopecia 1 2 3 4 Disturbance in Attention 1 0 2 4 Pain in Extremity 3 2 3 3 Muscle Spasms 2 3 3 3 Dyspepsia 2 2 2 3 Gastroesophageal Reflux Disease 1 1 3 3 Rash 2 2 2 3 Hypokalemia 0 0 1 3 Dry Eye 1 1 1 3 Gastroenteritis 2 1 2 3 Pharyngolaryngeal Pain 2 3 1 2 Paraesthesia Oral 0 0 1 2 Eye Pain 1 2 2 2 Nasal Congestion 1 2 1 2 Thirst 1 2 2 2 Sinus Congestion 2 3 3 2 Procedural Pain 2 2 2 2 Palpitations 1 1 2 2 Musculoskeletal Pain 1 1 3 2 Decreased Appetite 1 2 2 2 Neck Pain 1 1 2 1 Dysmenorrhea 0 2 0 1 Chest Discomfort 0 2 0 1 Pediatric Patients Aged 12 Years and Older Adverse reactions occurring in pediatric patients treated with either phentermine and topiramate extended-release capsules 15 mg/92 mg or phentermine and topiramate extended-release capsules 7.5 mg/46 mg at greater than or equal to 4% and higher than placebo include depression, pyrexia, dizziness, arthralgia, influenza, and ligament sprain. Adverse reactions reported in greater than or equal to 2% of phentermine and topiramate extended-release capsule-treated pediatric patients and more frequently than in the placebo group from a study in pediatric patients aged 12 years and older are shown in Table 2 . Table 2. Adverse Reactions Reported in ≥2% of Phentermine and Topiramate Extended-Release Capsule-Treated Pediatric Patients Aged 12 to 17 Years and More Frequently than Placebo during 56 Weeks of Treatment Adverse Reaction Placebo (N = 56) % Phentermine and Topiramate Extended-Release Capsules 7.5 mg/46 mg (N = 54) % Phentermine and Topiramate Extended-Release Capsules 15 mg/92 mg (N = 113) % Depression 0 2 4 Nausea 4 4 4 Pyrexia 2 2 4 Dizziness 0 2 4 Arthralgia 0 2 4 Paraesthesia 0 2 3 Anxiety 0 2 3 Abdominal Pain Upper 0 0 3 Fatigue 2 0 3 Ear Infection 0 2 3 Musculoskeletal Chest Pain 0 0 3 Influenza 0 4 2 Ligament Sprain 0 4 2 Increase in Heart Rate In adult and pediatric clinical trials, there was a higher incidence of heart rate elevations observed in phentermine and topiramate extended-release capsule-treated compared to placebo-treated patients. In an 8-week ambulatory blood pressure monitoring (ABPM) study in adults, phentermine and topiramate extended-release capsules increased the 24-hr average heart rate by 3.6 beats per minute (bpm) (95% CI 2.1, 5.2) compared to the placebo group [see Clinical Pharmacology (12.2) ] . In clinical trials, a higher percentage of phentermine and topiramate extended-release capsule-treated adults and pediatric patients aged 12 years and older experienced heart rate increases from baseline of more than 5, 10, 15, and 20 bpm compared to placebo-treated patients. Table 3 and Table 4 provide the numbers and percentages of adult and pediatric patients, respectively, with elevations in heart rate in clinical studies of up to one year. Table 3. Number and Percentage of Adults with Overweight or Obesity with an Increase in Heart Rate at a Single Time Point from Baseline Placebo N=1561 n (%) Phentermine and Topiramate Extended-Release Capsules 3.75 mg/23 mg N=240 n (%) Phentermine and Topiramate Extended-Release Capsules 7.5 mg/46 mg N=498 n (%) Phentermine and Topiramate Extended-Release Capsules 15 mg/92 mg N=1580 n (%) Greater than 5 bpm 1021 (65.4) 168 (70.0) 372 (74.7) 1228 (77.7) Greater than 10 bpm 657 (42.1) 120 (50.0) 251 (50.4) 887 (56.1) Greater than 15 bpm 410 (26.3) 79 (32.9) 165 (33.1) 590 (37.3) Greater than 20 bpm 186 (11.9) 36 (15.0) 67 (13.5) 309 (19.6) Table 4. Number and Percentage of Pediatric Patients with an Increase in Heart Rate at a Single Time Point from Baseline Placebo N=56 n (%) Phentermine and Topiramate Extended-Release Capsules 7.5 mg/46 mg N=54 n (%) Phentermine and Topiramate Extended-Release Capsules 15 mg/92 mg N=113 n (%) Greater than 5 bpm 37 (66.1) 38 (70.4) 92 (81.4) Greater than 10 bpm 26 (46.4) 30 (55.6) 73 (64.6) Greater than 15 bpm 17 (30.4) 18 (33.3) 48 (42.5) Greater than 20 bpm 10 (17.9) 10 (18.5) 27 (23.9) Paraesthesia/Dysgeusia In adult clinical trials, reports of paraesthesia, characterized as tingling in hands, feet, or face, and dysgeusia, characterized as a metallic taste, occurred (see Table 1 ). Adverse reactions of paraesthesia were also reported in pediatric patients (see Table 2 ). Phentermine and topiramate extended-release capsule-treated adult patients discontinued treatment due to these adverse reactions (1% for paraesthesia and 0.6% for dysgeusia); no pediatric patients discontinued treatment due to paraesthesia or dysgeusia. Mood and Sleep Disorders The proportion of adult patients in 1-year controlled trials of phentermine and topiramate extended-release capsules reporting one or more adverse reactions related to mood and sleep disorders was 15% and 21% with phentermine and topiramate extended-release capsules 7.5 mg/46 mg and 15 mg/92 mg, respectively, compared to 10% with placebo. These events were further categorized into sleep disorders, anxiety, and depression. Reports of sleep disorders were typically characterized as insomnia and occurred in 8.1% and 11% of patients treated with phentermine and topiramate extended-release capsules 7.5 mg/46 mg and 15 mg/92 mg, respectively, compared to 5.8% of patients treated with placebo. Reports of anxiety occurred in 4.8% and 7.9% of patients treated with phentermine and topiramate extended-release capsules 7.5 mg/46 mg and 15 mg/92 mg, respectively, compared to 2.6% of patients treated with placebo. Reports of depression/mood problems occurred in 3.8% and 7.6% of patients treated with phentermine and topiramate extended-release capsules 7.5 mg/46 mg and 15 mg/92 mg, respectively, compared to 3.4% of patients treated with placebo. Mood and sleep disorder adverse reactions occurred in patients with and without a history of depression. In a pediatric clinical trial, higher proportions of phentermine and topiramate extended-release capsule-treated patients reported one or more adverse reactions related to mood (e.g., depression, anxiety) and sleep disorders (e.g., insomnia) compared to placebo-treated patients (see Table 2 ). Cognitive Disorders In the 1-year controlled trials of phentermine and topiramate extended-release capsules in adults, the proportion of patients who experienced one or more cognitive-related adverse reactions was 5.0% for phentermine and topiramate extended-release capsules 7.5 mg/46 mg and 7.6% for phentermine and topiramate extended-release capsules 15 mg/92 mg, compared to 1.5% for placebo. These adverse reactions were comprised primarily of reports of problems with attention/concentration, memory, and language (word-finding). These events occurred at any time during treatment with phentermine and topiramate extended-release capsules. Slowing of Linear Growth Phentermine and topiramate extended-release capsules are associated with a reduction in height velocity (centimeters of height gained per year) in obese pediatric patients 12 to 17 years of age. In a 56-week study, average height increased from baseline in both phentermine and topiramate extended-release capsules and placebo-treated patients; however, a lower height velocity of -1.3 to -1.4 cm/year was observed in phentermine and topiramate extended-release capsule-treated compared to placebo-treated patients. Decrease in Bone Mineral Density Phentermine and topiramate extended-release capsules are associated with less bone mineral acquisition in pediatric patients 12 to 17 years of age. In a substudy (n=66) evaluating bone mineralization via dual-energy X-ray absorptiometry (DEXA), increases in bone mineral density (BMD) at the lumbar spine and total body less head (TBLH) were smaller in pediatric patients treated with phentermine and topiramate extended-release capsules compared to those treated with placebo after 1 year of treatment. Declines in BMD Z-scores of -0.5 or greater from baseline for TBLH were observed in 9% of phentermine and topiramate extended-release capsules 7.5 mg/46 mg-treated patients and 30% of phentermine and topiramate extended-release capsules 15 mg/92 mg-treated patients, compared to 0% of placebo-treated patients. The sample size and study duration were too small to determine if fracture risk is increased. Decreased BMD was not correlated with decreased serum bicarbonate, which commonly occurs with phentermine and topiramate extended-release capsules treatment, or changes in body weight. No patient had a BMD Z-score that went below -2.0 during the trial. Similar findings were observed in a 1 year, active-controlled trial of topiramate in pediatric patients with another condition. Nephrolithiasis In the 1-year controlled trials of phentermine and topiramate extended-release capsules in adults, the incidence of nephrolithiasis was 0.2% for phentermine and topiramate extended-release capsules 7.5 mg/46 mg and 1.2% for phentermine and topiramate extended-release capsules 15 mg/92 mg, compared to 0.3% for placebo. Laboratory Abnormalities Serum Bicarbonate In the 1-year controlled trials of phentermine and topiramate extended-release capsules in adults, the incidence of persistent decreases in serum bicarbonate below the normal range (levels of less than 21 mEq/L at 2 consecutive visits or at the final visit) was 6.4% for phentermine and topiramate extended-release capsules 7.5 mg/46 mg and 12.8% for phentermine and topiramate extended-release capsules 15 mg/92 mg, compared to 2.1% for placebo. The incidence of persistent, markedly low serum bicarbonate values (levels of less than 17 mEq/L on 2 consecutive visits or at the final visit) was 0.2% for phentermine and topiramate extended-release capsules 7.5 mg/46 mg dose and 0.7% for phentermine and topiramate extended-release capsules 15 mg/92 mg dose, compared to 0.1% for placebo. In a pediatric clinical trial, 60 to 70% phentermine and topiramate extended-release capsule-treated patients had a persistent bicarbonate level below the normal range (<21 mEq/L) compared to 43% of placebo-treated patients. Serum Potassium In the 1-year controlled trials of phentermine and topiramate extended-release capsules in adults, the incidence of persistent low serum potassium values (less than 3.5 mEq/L at two consecutive visits or at the final visit) during the trial was 3.6% for phentermine and topiramate extended-release capsules 7.5 mg/46 mg dose and 4.9% for phentermine and topiramate extended-release capsules 15 mg/92 mg, compared to 1.1% for placebo. Of the subjects who experienced persistent low serum potassium, 88% were receiving treatment with a non-potassium sparing diuretic. The incidence of markedly low serum potassium (less than 3 mEq/L, and a reduction from pre-treatment of greater than 0.5 mEq/L) at any time during the trial was 0.2% for phentermine and topiramate extended-release capsules 7.5 mg/46 mg dose and 0.7% for phentermine and topiramate extended-release capsules 15 mg/92 mg dose, compared to 0.0% for placebo. Persistent markedly low serum potassium (less than 3 mEq/L, and a reduction from pre-treatment of greater than 0.5 mEq/L at two consecutive visits or at the final visit) occurred in 0.2% receiving phentermine and topiramate extended-release capsules 7.5 mg/46 mg dose and 0.1% receiving phentermine and topiramate extended-release capsules 15 mg/92 mg dose, compared to 0.0% receiving placebo. Low serum potassium levels (<3.5 mEq/L) were not observed in a 56-week clinical trial of pediatric patients with obesity. Serum Creatinine In the 1-year controlled trials of phentermine and topiramate extended-release capsules in adults and pediatric patients, there was an increase in serum creatinine from baseline, peaking between Week 4 to 8 in adults and at Week 16 in pediatric patients. Serum creatinine values declined but remained elevated over baseline over 1 year of treatment. The incidence of increases in serum creatinine of greater than or equal to 0.3 mg/dL at any time during treatment in adults was 7.2% for phentermine and topiramate extended-release capsules 7.5 mg/46 mg and 8.4% for phentermine and topiramate extended-release capsules 15 mg/92 mg, compared to 2.0% for placebo; 17% of pediatric patients treated with phentermine and topiramate extended-release capsules 7.5 mg/46 mg or phentermine and topiramate extended-release capsules 15 mg/92 mg and 0% of patients treated with placebo had a serum creatinine ≥0.3 mg/dL at any time post-randomization. Increases in serum creatinine of greater than or equal to 50% over baseline occurred in 2.0% of adult subjects receiving phentermine and topiramate extended-release capsules 7.5 mg/46 mg and 2.8% receiving phentermine and topiramate extended-release capsules 15 mg/92 mg, compared to 0.6% receiving placebo. Serum Ammonia Hyperammonemia with or without encephalopathy has been reported with topiramate. The risk for hyperammonemia with topiramate appears dose related and has been reported more frequently when concomitantly used with valproic acid [see Drug Interactions (7) ] . The incidence of hyperammonemia in pediatric patients 12 to 17 years of age in clinical trials of another condition was 26% in patients taking topiramate at 100 mg/day (1.1 times the maximum recommended dosage of phentermine and topiramate extended-release capsules) and 14% in patients taking topiramate at 50 mg/day (0.6 times the maximum recommended dosage of phentermine and topiramate extended-release capsules), compared to 9% in patients taking placebo. There was also an increased incidence of markedly increased hyperammonemia (defined as 50% above the upper limit of normal reference range) at the 100 mg dose. 6.2 Postmarketing Experience The following adverse reactions have been reported during post approval use of phentermine and topiramate extended-release capsules, phentermine, and topiramate. Because these reactions are reported voluntarily from a population of uncertain size it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Phentermine and Topiramate Extended-Release Capsules Psychiatric: suicidal ideation, suicidal behavior Ophthalmic: acute angle closure glaucoma, increased intraocular pressure Phentermine Allergic Reactions: urticaria Cardiovascular: elevation of blood pressure, ischemic events Central Nervous System: euphoria, psychosis, tremor Reproductive: changes in libido, impotence Topiramate Hypersensitivity: immediate hypersensitivity reactions (including anaphylaxis and angioedema, delayed hypersensitivity reactions (including facial swelling, lip swelling, periorbital swelling, tongue swelling) anaphylaxis, angioedema, facial swelling, lip swelling, tongue swelling, periorbital edema Dermatologic: bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), pemphigus, urticaria Gastrointestinal: pancreatitis Hepatic: hepatic failure (including fatalities), hepatitis Metabolic: hyperammonemia with or without encephalopathy has been reported with concomitant valproic acid [see Drug Interactions (7) ] , hypothermia Ophthalmic: maculopathy

FDA lists 2 drug label records with PHENTERMINE AND TOPIRAMATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is phentermine and topiramate used for?
1 INDICATIONS AND USAGE Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity Adults with overweight in the presence of at least one weight-related comorbid condition …

Who makes phentermine and topiramate?
Prasco Laboratories is the labeler of record for phentermine and topiramate. 2 FDA label records share the active ingredient PHENTERMINE AND TOPIRAMATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does phentermine and topiramate come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is phentermine and topiramate prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing PHENTERMINE AND TOPIRAMATE?
Yes. 2 FDA drug label records list PHENTERMINE AND TOPIRAMATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has phentermine and topiramate been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.