Home › NDC Lookup › Ingredients › Phentermine And Topiramate Extended-Rele... › 43598-0625-30
💊image loading
(from DailyMed)

Phentermine and Topiramate Extended-Release 7.5 mg; 46 mg Capsule, 30-count — NDC 43598-625-30 (Billing 43598-0625-30)

by Dr.Reddys Laboratories Inc · 30 CAPSULE in 1 BOTTLE

This is a package of 30 capsules of Phentermine and Topiramate Extended-Release 7.5 mg; 46 mg Capsule from Dr.Reddys Laboratories Inc, marketed since Jun 2025 and currently FDA-listed; retail pharmacies pay about $3.06 per capsule (NADAC). It is this product's only package size.

NDC 43598-0625-30
🏷️ FDA NDC (as labeled) 43598-625-30 billing pads the product segment with a zero
Rx only Generic On market CIV 🛡 REMS ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 43598-625-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
43598 labeler · 625 product · 30 package
Package marketed since
Jun 12, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
30 EA per package
Barcode (UPC)
0343598626307, 0343598624303, 0343598625300
Medicaid fills, this package
335 prescriptions in the last four reported quarters
FDA record last changed
Sep 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43598-625-30
Product NDC 43598-625
11-digit billing NDC 43598062530
NCPDP billing unit EA — each (per item)
RxCUI 1302827, 1302839, 1302850, 1313059
UNII 0K2I505OTV, 0H73WJJ391
UPC 0343598626307, 0343598624303, 0343598625300
Application # ANDA208175
SPL Set ID 260c3f90-163d-0bdd-1099-55d18a900e68
Mechanism of action Cytochrome P450 3A4 Inducers; Cytochrome P450 2C19 Inhibitors
Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-12
Route ORAL
Dosage form CAPSULE
Substance PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 61209902307030
GCN Seq No 069618
GCN 32744
HICL code 039347
Ingredient (HICL) Phentermine/Topiramate
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J8
Therapeutic class — intermediate (HIC2) Anti-Obesity - Anorexics
HIC3 code J8A
Therapeutic class — specific (HIC3) Anti-Obesity - Anorexic Agents
AHFS code 28:20.08.00
AHFS class Anorexigenic Agents
FDB label name PHENTERMINE-TOPIR ER 7.5-46 MG
FDB brand name Phentermine-Topiramate Er
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 069618
  • GCN: 32744
  • GPI-14 (Medi-Span): 61209902307030
  • HICL (First Databank): 039347
  • AHFS class code: 28:20.08.00
  • RxCUI (RxNorm): 1302827
Why two NDCs? The FDA registers this code as 43598-625-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43598-0625-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Centrally acting antiobesity products class.

Drug family (ATC) Centrally acting antiobesity products, Other antiepileptics
How it works Cytochrome P450 2C19 Inhibitors, Cytochrome P450 3A4 Inducers
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PHENTERMINE-TOPIR ER 7.5-46 MG Ingredient Phentermine/Topiramate
📗 Our plain-language guide HelloPharmacist
  • It helps adults with obesity, or overweight plus a weight-related condition, lose weight and keep it off. You use it along with a reduced-calorie diet and more physical activity. Q...
  • Take one capsule by mouth every morning, with or without food. Avoid evening doses because they can keep you awake. Follow your prescriber’s step-up schedule, and never stop the hi...
  • Common ones are tingling in the hands, feet or face, dry mouth, constipation, dizziness, a metallic taste and trouble sleeping. Many people notice them more at higher strengths. Le...
  • Call right away for sudden vision changes or eye pain, new or worse depression, thoughts of suicide, a serious rash or swelling, or a seizure. Also report trouble with memory or co...
📖 Read our full Phentermine and Topiramate guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $3.056 $91.69 / 30 capsules
Medicaid paysCMS SDUD · 12 mo $3.85 $115.36 / 30 capsules
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $3.643 $3.056
▼ Down 16% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
43598-0625-30 You're viewing this Main listing 30 CAPSULE in 1 BOTTLE 2025-06-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phentermine and Topiramate Extended-Release 7.5 mg/1; 46 mgthis 43598-0625-30 Dr.Reddys 30 capsules $3.056 AB Availability likely —
phentermine and topiramate 7.5 mg/1; 46 mg 66993-0781-30 Prasco 30 capsules $3.056 AB Availability likely —
Qsymia 7.5 mg/1; 46 mg 62541-0202-30 Vivus 30 capsules $5.958 AB FDA listed +95%
Phentermine and topiramate 7.5 mg/1; 46 mg 00480-3296-99 Teva 14719 capsules — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Phentermine and Topiramate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerDr.Reddys Laboratories Inc
Application holderDR REDDYS LABORATORIES SA
FDA applicationANDA208175 (ANDA)
Labeler code43598
First marketedJun 2025
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio74 products on file

More NDCs from Dr.Reddys Laboratories Inc labeler code 43598

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 219 words ▾

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: Adult patients 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: Adult patients with obesity ( 1 ) 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 ( 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 ).

⏱️ Dosage and Administration ~3 min read ▾

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. 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 ).

2.1Recommended 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 )].

2.2Recommended 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. If an adult patient has not lost at least 3% of baseline body weight, 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.

If an adult patient has not lost at least 5% of baseline body weight, 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.

2.3Discontinuation 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 )].

2.4Recommended 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 impai… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS Phentermine and topiramate extended-release capsules are available in four strengths (phentermine mg/topiramate mg): • Phentermine and topiramate extended-release capsules, 3.75 mg/23 mg are two-piece hard gelatin capsule with white opaque cap and white opaque body, filled with white to pale yellow pellets, imprinted in black ink with DRL on cap and 624 on body. Free from physical defects. • Phentermine and topiramate extended-release capsules, 7.5 mg/46 mg are two-piece hard gelatin capsule with red opaque cap and white opaque body, filled with white to pale yellow pellets, imprinted in black ink with DRL on cap and 625 on body.

Free from physical defects. • Phentermine and topiramate extended-release capsules, 11.25 mg/69 mg are two-piece hard gelatin capsule with green opaque cap and white opaque body, filled with white to pale yellow pellets, imprinted in black ink with DRL on cap and 626 on body. Free from physical defects. • Phentermine and topiramate extended-release capsules, 15 mg/92 mg are elongated two-piece hard gelatin capsule with orange opaque cap and white opaque body, filled with white to pale yellow pellets, imprinted in black ink with DRL on cap and 627 on body.

Free from physical defects. Extended-release capsules: (phentermine mg/topiramate mg) • 3.75 mg/23 mg ( 3 ) • 7.5 mg/46 mg ( 3 ) • 11.25 mg/69 mg ( 3 ) • 15 mg/92 mg ( 3 )

⛔ Contraindications 148 words ▾

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 )] • Wjith 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 amine.

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 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Embryo-Fetal Toxicity: Can cause fetal harm. Inpatients who can become pregnant, a negative pregnancy test is recommended before initiating phentermine and topiramate extended-release capsules and monthly during therapy; advise use of effective contraception. Phentermine and topiramate extended-release capsules are available through a limited program under a Risk Evaluation and Mitigation Strategy (REMS) ( 5.1 ). • Suicidal Behavior and Ideation : Monitor for depression or suicidal thoughts.

Discontinue phentermine and topiramate extended-release capsules if symptoms develop ( 5.2 ). • Risk of Ophthalmologic Adverse Reactions : Acute myopia and secondary angle closure glaucoma have been reported. Immediately discontinue phentermine and topiramate extended-release capsules if symptoms develop. Consider phentermine and topiramate extended-release capsules discontinuation if visual field defects occur.

( 5.3 ). • Mood and Sleep Disorders : Consider dosage reduction or discontinuation for clinically significant or persistent mood or sleep disorder symptoms ( 5.4 ). • Cognitive Impairment: May cause disturbances in attention or memory, or speech/language problems. Caution patients about operating automobiles or hazardous machinery when starting treatment ( 5.5 ). • Slowing of Linear Growth : Consider dosage reduction or discontinuation if pediatric patients are not growing or gaining height as expected ( 5.6 ). • Metabolic Acidosis: Measure electrolytes before and during treatment.

If persistent metabolic acidosis develops, reduce dosage or discontinue phentermine and topiramate extended-release capsules ( 5.7 ). • Decrease in Renal Function: Measure creatinine before and during treatment. For persistent creatinine elevations, reduce dosage or discontinue phentermine and topiramate extended-release capsules ( 5.8 ). • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity, serious skin reactions (SJS or TEN), anaphylaxis, and angioedema: Discontinue phentermine and topiramate extended-release capsules if an alternative etiology cannot be established ( 5.13 , 5.14, 5.15 ).

5.1Embryo-Fetal Toxicity Phentermine and topiramate extended-release capsules can cause fetal harm. Data from pregnancy registries and epidemiologic studies indicate that a fetus exposed to topiramate in the first trimester of pregnancy has an increased risk of major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), and of being small for gestational age (SGA). When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring.

A negative pregnancy test is recommended before initiating phentermine and topiramate extended-release capsules treatment in patients who can become pregnant and monthly during phentermine and topiramate extended-release capsules therapy. Advise patients who can become pregnant of the potential risk to a fetus and to use effective contraception during phentermine and topiramate extended-release capsules therapy [see Use in Specific Populations ( 8.1 , 8.3 )] . Phentermine and Topiramate Extended-Release Capsules Risk Evaluation and Mitigation Strategy (REMS) Because of the teratogenic risk associated with phentermine and topiramate extended-release capsules therapy, phentermine and topiramate extended-release capsules are available through a limited program under the REMS.

Under the phentermine and topiramate extended-release capsules REMS, only certified pharmacies may distribute phentermine and topiramate extended-release capsules. Further information is available at www.PhenTopREMS.com or by telephone at 1‐800‐269‐6816.

5.2Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including topiramate, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indi… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

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). To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories, Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 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 [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-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-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 3.75 mg/23 mg (N = 240) % Phentermine and topiramate extended-release 7.5 mg/46 mg (N = 498) % Phentermine and topiramate extended-release 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… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 5 displays clinically significant drug interactions with phentermine and topiramate extended-release capsules. Table 5. Clinically Significant Drug Interactions with Phentermine and Topiramate Extended-Release Capsules Monoamine Oxidase Inhibitors Clinical Impact Concomitant use of phentermine with monoamine oxidase inhibitors (MAOIs) increases the risk of hypertensive crisis.

Intervention Concomitant use of phentermine and topiramate extended-release capsules are contraindicated during MAOI treatment and within 14 days of stopping an MAOI. Oral Contraceptives Clinical Impact Co-administration of multiple-dose phentermine and topiramate extended-release 15 mg/92 mg once daily with a single dose of oral contraceptive containing 35 mcg ethinyl estradiol (estrogen component) and 1 mg norethindrone (progestin component), in obese otherwise healthy volunteers, decreased the exposure of ethinyl estradiol by 16% and increased the exposure of norethindrone by 22% [see Clinical Pharmacology ( 12.3 )].

Although this interaction is not anticipated to increase the risk of pregnancy, irregular bleeding (spotting) may occur more frequently due to both the increased exposure to the progestin and lower exposure to the estrogen, which tends to stabilize the endometrium. Intervention Inform patients not to discontinue their combination oral contraceptive if spotting occurs, but to notify their health care provider if the spotting is troubling to them. CNS Depressants Including Alcohol Clinical Impact The concomitant use of alcohol or CNS depressant drugs (e.g., barbiturates, benzodiazepines, and sleep medications) with phentermine or topiramate may potentiate CNS depression such as dizziness or cognitive adverse reactions, or other centrally mediated effects of these agents.

Intervention Advise patients not to drive or operate machinery until they have gained sufficient experience on phentermine and topiramate extended-release capsules to gauge whether it adversely affects their mental performance, motor performance, and/or vision. Caution patients against excessive alcohol intake when taking phentermine and topiramate extended-release capsules. Consider phentermine and topiramate extended-release capsules dosage reduction or discontinuation if cognitive dysfunction persists. [see Warnings and Precautions ( 5.5 )] .

Non-Potassium Sparing Diuretics Clinical Impact Concurrent use of phentermine and topiramate extended-release with non-potassium sparing diuretics may potentiate the potassium-wasting action of these diuretics. Concomitant administration of hydrochlorothiazide alone with topiramate alone has been shown to increase the C max and AUC of topiramate by 27% and 29%, respectively. Intervention When phentermine and topiramate extended-release capsules are used concomitantly with non-potassium-sparing diuretics, measure potassium before and during phentermine and topiramate extended-release capsules treatment [see Warnings and Precautions ( 5.12 ) and Clinical Pharmacology ( 12.3 )].

Antiepileptic Drugs Clinical Impact Concomitant administration of phenytoin or carbamazepine with topiramate in patients with epilepsy, decreased plasma concentrations of topiramate by 48% and 40%, respectively, when compared to topiramate given alone [see Clinical Pharmacology ( 12.3 )]. Concomitant administration of valproic acid and topiramate has been associated with hyperammonemia with and without encephalopathy. Concomitant administration of topiramate with valproic acid in patients has also been associated with hypothermia (with and without hyperammonemia).

Intervention Consider measuring blood ammonia in patients in whom the onset of hypothermia or encephalopathy has been reported [see Clinical Pharmacology ( 12.3 )]. Carbonic Anhydrase Inhibitors Clinical Impact Concomitant use of topiramate with any other carbonic anhydrase inhibitor may increase the severity of metabolic acidosis and may also increase the risk of kidney ston… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Lactation : Breastfeeding not recommended ( 8.2 ).

8.1Pregnancy Risk Summary Phentermine and topiramate extended-release capsules are contraindicated in pregnant patients. The use of phentermine and topiramate extended-release capsules can cause fetal harm and weight loss offers no clear clinical benefit to a pregnant patient (see Clinical Considerations) . Available data from pregnancy registries and epidemiologic studies indicate an increased risk of major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), and of being SGA in infants exposed in utero to topiramate (see Data) .

When phentermine and topiramate were co-administered to rats at doses of 3.75 and 25 mg/kg, respectively [approximately 2 times the maximum recommended human dose (MRHD) based on area under the curve (AUC)], or at the same dose to rabbits (approximately 0.1 times and 1 time, respectively, the clinical exposures at the MRHD based on AUC), there were no drug-related malformations. However, structural malformations, including craniofacial defects and reduced fetal weights occurred in offspring of multiple species of pregnant animals administered topiramate at clinically relevant doses (see Data) .

Advise pregnant women of the potential risk to a fetus. Clinical Considerations Disease Associated Maternal and/or Embryo/Fetal Risk Weight loss during pregnancy may result in fetal harm. Appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy.

Maternal obesity increases the risk for congenital malformations, including neural tube defects, cardiac malformations, oral clefts, and limb reduction defects. Fetal/Neonatal Adverse Reactions Phentermine and topiramate extended-release capsules can cause metabolic acidosis [see Warnings and Precautions ( 5.7 )] . The effect of topiramate-induced metabolic acidosis has not been studied in pregnancy; however, metabolic acidosis in pregnancy (due to other causes) can cause decreased fetal growth, decreased fetal oxygenation, and fetal death, and may affect the fetus’ ability to tolerate labor.

Data Human Data Data evaluating the risk of major congenital malformations, oral clefts, and being SGA with topiramate exposure during pregnancy is available from the North American Antiepileptic Drug (NAAED) Pregnancy Registry and from several larger retrospective epidemiologic studies. Major Congenital Malformations The NAAED Pregnancy Registry indicates an increased risk of major congenital malformations, including but not limited to oral clefts in infants exposed to topiramate during the first trimester of pregnancy.

Other than oral clefts, no specific pattern of major congenital malformations or grouping of major congenital malformation types were observed. In the NAAED pregnancy registry, when topiramate-exposed infants with only oral clefts were excluded, the prevalence of major congenital malformations (4.1%) was higher than that in infants exposed to a reference antiepileptic drug (AED) (1.8%) or in infants with mothers without epilepsy and without exposure to AEDs (1.1%). Oral Clefts In the NAAED Pregnancy Registry, the prevalence of oral clefts among topiramate-exposed infants (1.4%) was higher than the prevalence in infants exposed to a reference AED (0.3%) or the prevalence in infants with mothers without epilepsy and without exposure to AEDs (0.11%).

It was also higher than the background prevalence in United States (0.17%) as estimated by the Centers for Disease Control and Prevention (CDC). The relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 12.5 (95% Confidence Interval [CI] 5.9-26.37) as compared to the risk in a background population of untreated women. The UK Epilepsy and Pregnancy Register reported a… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Phentermine and topiramate extended-release capsules are contraindicated in pregnant patients. The use of phentermine and topiramate extended-release capsules can cause fetal harm and weight loss offers no clear clinical benefit to a pregnant patient (see Clinical Considerations) . Available data from pregnancy registries and epidemiologic studies indicate an increased risk of major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), and of being SGA in infants exposed in utero to topiramate (see Data) .

When phentermine and topiramate were co-administered to rats at doses of 3.75 and 25 mg/kg, respectively [approximately 2 times the maximum recommended human dose (MRHD) based on area under the curve (AUC)], or at the same dose to rabbits (approximately 0.1 times and 1 time, respectively, the clinical exposures at the MRHD based on AUC), there were no drug-related malformations. However, structural malformations, including craniofacial defects and reduced fetal weights occurred in offspring of multiple species of pregnant animals administered topiramate at clinically relevant doses (see Data) .

Advise pregnant women of the potential risk to a fetus. Clinical Considerations Disease Associated Maternal and/or Embryo/Fetal Risk Weight loss during pregnancy may result in fetal harm. Appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy.

Maternal obesity increases the risk for congenital malformations, including neural tube defects, cardiac malformations, oral clefts, and limb reduction defects. Fetal/Neonatal Adverse Reactions Phentermine and topiramate extended-release capsules can cause metabolic acidosis [see Warnings and Precautions ( 5.7 )] . The effect of topiramate-induced metabolic acidosis has not been studied in pregnancy; however, metabolic acidosis in pregnancy (due to other causes) can cause decreased fetal growth, decreased fetal oxygenation, and fetal death, and may affect the fetus’ ability to tolerate labor.

Data Human Data Data evaluating the risk of major congenital malformations, oral clefts, and being SGA with topiramate exposure during pregnancy is available from the North American Antiepileptic Drug (NAAED) Pregnancy Registry and from several larger retrospective epidemiologic studies. Major Congenital Malformations The NAAED Pregnancy Registry indicates an increased risk of major congenital malformations, including but not limited to oral clefts in infants exposed to topiramate during the first trimester of pregnancy.

Other than oral clefts, no specific pattern of major congenital malformations or grouping of major congenital malformation types were observed. In the NAAED pregnancy registry, when topiramate-exposed infants with only oral clefts were excluded, the prevalence of major congenital malformations (4.1%) was higher than that in infants exposed to a reference antiepileptic drug (AED) (1.8%) or in infants with mothers without epilepsy and without exposure to AEDs (1.1%). Oral Clefts In the NAAED Pregnancy Registry, the prevalence of oral clefts among topiramate-exposed infants (1.4%) was higher than the prevalence in infants exposed to a reference AED (0.3%) or the prevalence in infants with mothers without epilepsy and without exposure to AEDs (0.11%).

It was also higher than the background prevalence in United States (0.17%) as estimated by the Centers for Disease Control and Prevention (CDC). The relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 12.5 (95% Confidence Interval [CI] 5.9-26.37) as compared to the risk in a background population of untreated women. The UK Epilepsy and Pregnancy Register reported a prevalence of oral clefts among infants exposed to topiramate monotherapy (3.2%) t… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 75 words ▾

8.4Pediatric Use Increases in linear growth were attenuated in phentermine and topiramate extended-release- versus placebo-treated patients [see Warnings and Precautions ( 5.6 )] . Serious adverse reactions seen in pediatric patients using topiramate include acute angle glaucoma, oligohidrosis and hyperthermia, metabolic acidosis, cognitive and neuropsychiatric reactions, hyperammonemia and encephalopathy, and kidney stones. The safety and effectiveness of phentermine and topiramate extended-release in pediatric patients below the age of 12 years have not been established.

🧓 Geriatric Use 103 words ▾

8.5Geriatric Use In the phentermine and topiramate extended-release clinical trials, a total of 254 (7%) of the patients were 65 to 69 years of age; no patients 70 years of age or older were enrolled. Clinical studies of phentermine and topiramate extended-release did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE In the event of a significant overdose with phentermine and topiramate extended-release capsules, if the ingestion is recent, the stomach should be emptied immediately by gastric lavage or by induction of emesis. Appropriate supportive treatment should be provided according to the patient’s clinical signs and symptoms. In the event of an overdose of phentermine and topiramate extended-release capsules, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

Acute overdose of phentermine may be associated with restlessness, tremor, hyperreflexia, rapid respiration, confusion, aggressiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse.

Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning usually terminates in convulsions and coma. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes.

A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. Management of acute phentermine intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Acidification of the urine increases phentermine excretion.

Intravenous phentolamine has been suggested for possible acute, severe hypertension, if this complicates phentermine overdosage. Topiramate overdose has resulted in severe metabolic acidosis. Other signs and symptoms include convulsions, drowsiness, speech disturbance, blurred vision, diplopia, impaired mentation, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness, and depression.

The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving topiramate. A patient who ingested a dose between 96 and 110 grams topiramate was admitted to hospital with coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days. Hemodialysis is an effective means of removing topiramate from the body.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and d/l-amphetamine). Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." The effect of phentermine on weight reduction and long-term maintenance of body weight is likely mediated by release of catecholamines in the hypothalamus, resulting in reduced appetite and decreased food consumption, but other metabolic effects may also be involved.

The exact mechanism of action is not known. The precise mechanism of action of topiramate on weight reduction and long-term maintenance of body weight is not known. Topiramate’s effect on weight reduction and long-term maintenance of body weight may be due to its effects on both appetite suppression and satiety enhancement, induced by a combination of pharmacologic effects including augmenting the activity of the neurotransmitter gamma-aminobutyrate, modulation of voltage-gated ion channels, inhibition of AMPA/kainite excitatory glutamate receptors, or inhibition of carbonic anhydrase.

12.2Pharmacodynamics Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with drugs in this class. Cardiac Electrophysiology The effect of phentermine and topiramate extended-release on the QTc interval was evaluated in a randomized, double-blind, placebo-and active-controlled (400 mg moxifloxacin), and parallel group/crossover thorough QT/QTc study.

A total of 54 healthy subjects were administered phentermine and topiramate extended-release 7.5 mg/46 mg at steady state and then titrated to phentermine and topiramate extended-release 22.5 mg/138 mg at steady state. Phentermine and topiramate extended-release 22.5 mg/138 mg [a supra-therapeutic dose resulting in a phentermine and topiramate maximum concentration (C max ) of 4-and 3-times higher than those at phentermine and topiramate extended-release 7.5 mg/46 mg, respectively] did not affect cardiac repolarization as measured by the change from baseline in QTc.

Glomerular Filtration Rate (GFR) Healthy obese males and females received phentermine and topiramate extended-release capsules daily for 4 weeks (3.75 mg/23 mg on Days 1 to 3, 7.5 mg/46 mg on Days 4 to 6, 11.25 mg/69 mg on Days 7 to 9, and 15 mg/92 mg on Days 10 to 28). The glomerular filtration rate (GFR) of these participants was assessed via iohexol clearance. On average, GFR decreased during phentermine and topiramate extended-release treatment and returned to baseline within 4 weeks after discontinuing phentermine and topiramate extended-release capsules [see Warnings and Precautions ( 5.8 )].

12.3Pharmacokinetics Absorption Phentermine Upon oral administration of a single phentermine and topiramate extended-release capsule 15 mg/92 mg, the resulting mean plasma phentermine maximum concentration (C max ), time to C max (T max ), area under the concentration curve from time zero to the last time with measurable concentration (AUC 0-t ), and area under the concentration curve from time zero to infinity (AUC 0‑∞ ) are 49.1 ng/mL, 6 hr, 1,990 ng⋅hr/mL, and 2,000 ng⋅hr/mL, respectively. A high fat meal does not affect phentermine pharmacokinetics for phentermine and topiramate extended-release 15 mg/92 mg.

Phentermine pharmacokinetics are approximately dose-proportional from phentermine and topiramate extended-release 3.75 mg/23 mg to phentermine 15 mg/topiramate 100 mg. Upon dosing phentermine 15 mg/topiramate 100 mg fixed dose combination capsule to steady state, the mean phentermine accumulation ratios for AUC and C max are both approximately 2.5. Topiramate Upon oral administration of a single phentermine and topiramate extended-release capsule 15 mg/92 mg, the resulting mean plasma topiramate C max , T max , AUC 0-t , and AUC 0-∞ , are 1,020 ng/mL, 9 hr, 61,600… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 162 words ▾

12.1Mechanism of Action Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and d/l-amphetamine). Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." The effect of phentermine on weight reduction and long-term maintenance of body weight is likely mediated by release of catecholamines in the hypothalamus, resulting in reduced appetite and decreased food consumption, but other metabolic effects may also be involved.

The exact mechanism of action is not known. The precise mechanism of action of topiramate on weight reduction and long-term maintenance of body weight is not known. Topiramate’s effect on weight reduction and long-term maintenance of body weight may be due to its effects on both appetite suppression and satiety enhancement, induced by a combination of pharmacologic effects including augmenting the activity of the neurotransmitter gamma-aminobutyrate, modulation of voltage-gated ion channels, inhibition of AMPA/kainite excitatory glutamate receptors, or inhibition of carbonic anhydrase.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Phentermine and topiramate extended-release capsules are available as follows: • Phentermine and topiramate extended-release capsules, 3.75 mg/23 mg are two-piece hard gelatin capsule with white opaque cap and white opaque body, filled with white to pale yellow pellets, imprinted in black ink with DRL on cap and 624 on body. Free from physical defects. They are supplied in: Bottles of 14 43598-624-13 Bottles of 30 43598-624-30 Bottles of 100 43598-624-01 • Phentermine and topiramate extended-release capsules 7.5 mg/46 mg are two-piece hard gelatin capsule with red opaque cap and white opaque body, filled with white to pale yellow pellets, imprinted in black ink with DRL on cap and 625 on body.

Free from physical defects. They are supplied in: Bottles of 30 43598-625-30 Bottles of 100 43598-625-01 • Phentermine and topiramate extended-release capsules, 11.25 mg/69 mg are two-piece hard gelatin capsule with green opaque cap and white opaque body, filled with white to pale yellow pellets, imprinted in black ink with DRL on cap and 626 on body. Free from physical defects.

They are supplied in: Bottles of 30 43598-626-30 Bottles of 100 43598-626-01 • Phentermine and topiramate extended-release capsules, 15 mg/92 mg are elongated two-piece hard gelatin capsule with orange opaque cap and white opaque body, filled with white to pale yellow pellets, imprinted in black ink with DRL on cap and 627 on body. Free from physical defects. They are supplied in: Bottles of 30 43598-627-30 Bottles of 100 43598-627-01 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Keep container tightly closed and protect from moisture.

📋 Description ~2 min read ▾

11 DESCRIPTION Phentermine and topiramate extended-release capsules are comprised of immediate-release phentermine hydrochloride, USP (expressed as the weight of the free base) and extended-release topiramate, USP. Phentermine and topiramate extended-release capsules contain phentermine hydrochloride, USP, a sympathomimetic amine anorectic, and topiramate, USP, a sulfamate-substituted monosaccharide. Phentermine Hydrochloride, USP The chemical name of phentermine hydrochloride, USP is α,α-dimethylphenethylamine hydrochloride.

The molecular formula is C 10 H 16 ClN and its molecular weight is 185.69 g mol -1 (hydrochloride salt) or 149.2 (free base). Phentermine hydrochloride, USP is a white, odourless, hygroscopic, crystalline powder that is soluble in water and lower alcohols. It is also slightly soluble in chloroform and insoluble in ether.

Its structural formula is: Topiramate, USP Topiramate, USP is 2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate. The molecular formula is C 12 H 21 NO 8 S and its molecular weight is 339.36.Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane.

Its structural formula is: Phentermine and Topiramate Extended-Release Capsules Phentermine and topiramate extended-release capsules are for oral administration and available in four dosage strengths: • 3.75 mg/23 mg (phentermine 3.75 mg and topiramate USP, 23 mg) (equivalent to 4.665 mg of Phentermine Hydrochloride, USP). • 7.5 mg/46 mg (phentermine 7.5 mg and topiramate USP, 46 mg) (equivalent to 9.33 mg of Phentermine Hydrochloride, USP). • 11.25 mg/69 mg (phentermine 11.25 mg and topiramate USP, 69 mg) (equivalent to 14 mg of Phentermine Hydrochloride, USP). • 15 mg/92 mg (phentermine 15 mg and topiramate USP, 92 mg) (equivalent to 18.66 mg of Phentermine Hydrochloride, USP).

Each capsule contains the following inactive ingredients: ethocel, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, talc and titanium dioxide. In addition, the 7.5 mg/46 mg contains FD&C Red No. 40 and FD&C Yellow #6, 11.25 mg/69 mg contains FD&C Yellow #5 and FD&C Blue #1, 15 mg/92 mg contains FD&C Yellow #6 and D&C Red #28.

The imprinting ink opacode Black contains shellac, iron oxide black, propylene glycol, FD&C Blue #2, FD&C Red No. 40, D&C Yellow #10, FD&C Blue #1..

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Embryo-Fetal Toxicity Inform patients who can become pregnant that phentermine and topiramate extended-release capsules can cause fetal harm and patients should avoid getting pregnant while taking phentermine and topiramate extended-release capsules [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7 ), and Use in Specific Populations ( 8.3 )] . Advise patients who can become pregnant: that pregnancy testing is recommended before initiating phentermine and topiramate extended-release capsules and monthly during therapy; to use effective contraception during phentermine and topiramate extended-release capsules therapy; who experience spotting while taking a combined oral contraceptive to notify their health care provider; with a known or suspected pregnancy to stop phentermine and topiramate extended-release capsules immediately and notify their health care provider.

Access to Phentermine and Topiramate Extended-Release Capsules Advise patients that phentermine and topiramate extended-release capsules are only available through certified pharmacies that are enrolled in the phentermine and topiramate extended-release capsules certified pharmacy network. Advise patients on how to access phentermine and topiramate extended-release capsules through certified pharmacies. Additional information may be obtained via the website www.PhenTopREMS .com or by telephone at 1‐800‐269‐6816.

Suicidal Behavior and Ideation and Mood and Sleep Disorders Inform patients that phentermine and topiramate extended-release capsules can increase the risk of mood changes, sleep disorders, depression, and suicidal ideation. Advise patients to tell their health care provider(s) immediately if mood changes, depression, or suicidal ideation occur [see Warnings and Precautions ( 5.2 , 5.4 )]. Ophthalmologic Adverse Reactions Inform patients that phentermine and topiramate extended-release capsules can increase the risk of acute myopia, secondary angle closure glaucoma, and visual field defects.

Advise patients to immediately report symptoms of severe and persistent eye pain or significant changes in their vision to their health care provider(s) [see Warnings and Precautions ( 5.3 )]. Cognitive Impairment Inform patients that phentermine and topiramate extended-release capsules can cause confusion, concentration, and word-finding difficulties. Inform patients that the concomitant use of alcohol or central nervous system (CNS) depressant drugs with phentermine and topiramate extended-release capsules, may increase the risk of dizziness, cognitive adverse reactions, drowsiness, light-headedness, impaired coordination and somnolence.

Advise patients to tell their health care provider(s) about any changes in attention, concentration, memory, difficulty finding words, or other cognitive functions. Advise patients not to drive or operate machinery until they have gained sufficient experience on phentermine and topiramate extended-release capsules to gauge whether it adversely affects their mental performance, motor performance, and/or vision. Advise patients to avoid excessive alcohol intake while taking phentermine and topiramate extended-release capsules [see Warnings and Precautions ( 5.5 )].

Slowing of Linear Growth Discuss with the patient and caregiver that long-term phentermine and topiramate extended-release capsules treatment may attenuate growth as reflected by slower height increase in pediatric patients [see Warnings and Precautions ( 5.6 )]. Metabolic Acidosis Inform patients that phentermine and topiramate extended-release capsules can increase the risk of metabolic acidosis. Advise patients to tell their health care provider(s) about any factors that can increase the risk of acidosis (e.g. prolonged diarrhea, surgery, and high protein/low carbohydrate diet, and/or concomitant medications such as carbonic anhydrase inhibitors) [see… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Phentermine (FEN-ter-meen) and Topiramate (toe-PIE-rah-mate) Extended-Release Capsules, for oral use, CIV This Medication Guide has been approved by the U.S. Food and Drug Administration. To reorder additional Medication Guides, contact Dr.

Reddy’s Customer Service at 1-866-733-3952. The brands listed are trademarks of their respective owners and are not trademarks of Dr. Reddy’s Laboratories Limited.

Rx only Distributed by: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 Made in India Revised: 03/2026 What is the most important information I should know about phentermine and topiramate extended-release capsules? Phentermine and topiramate extended-release capsules can cause serious side effects, including : Birth defects.

If you take phentermine and topiramate extended-release capsules during pregnancy, your baby has a higher risk for birth defects including cleft lip and cleft palate. Your baby may also be smaller than expected at birth. The long-term effects of this are not known.

These defects can begin early in pregnancy, even before you know you are pregnant. Patients who are pregnant must not take phentermine and topiramate extended-release capsules. Patients who can become pregnant should: Have a pregnancy test before taking phentermine and topiramate extended-release capsules and every month while taking phentermine and topiramate extended-release capsules.

Use effective birth control (contraception) consistently while taking phentermine and topiramate extended-release capsules. Talk to your health care provider about how to prevent pregnancy. If you become pregnant while taking phentermine and topiramate extended-release capsules, stop taking phentermine and topiramate extended-release capsules immediately and tell your health care provider right away.

Health care providers and patients who become pregnant should report all cases of pregnancy to: FDA MedWatch at 1-800-FDA-1088 Because of the risk for birth defects (cleft lip and cleft palate), phentermine and topiramate extended-release capsules are available through a restricted program called the phentermine and topiramate extended-release capsules Risk Evaluation and Mitigation Strategy (REMS) . Phentermine and topiramate extended-release capsules are only available through certified pharmacies that participate in the phentermine and topiramate extended-release capsules REMS program.

Your health care provider can give you information about how to find a certified pharmacy. For more information, go to www.PhenTopREMS or call 1‐800‐269‐6816. Suicidal thoughts or actions.

Topiramate, an ingredient in phentermine and topiramate extended-release capsules, may cause you to have suicidal thoughts or actions. Call your health care provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood Do not stop phentermine and topiramate extended-release capsules without first talking to a health care provider.

Stopping phentermine and topiramate extended-release capsules suddenly can cause serious problems. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your health care provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your health care provider as scheduled.

Call your health care provider between visits as needed, especially if you are worried about symptoms. Serious eye problems which include: any sudden d… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Phentermine Upon oral administration of a single phentermine and topiramate extended-release capsule 15 mg/92 mg, the resulting mean plasma phentermine maximum concentration (C max ), time to C max (T max ), area under the concentration curve from time zero to the last time with measurable concentration (AUC 0-t ), and area under the concentration curve from time zero to infinity (AUC 0‑∞ ) are 49.1 ng/mL, 6 hr, 1,990 ng⋅hr/mL, and 2,000 ng⋅hr/mL, respectively. A high fat meal does not affect phentermine pharmacokinetics for phentermine and topiramate extended-release 15 mg/92 mg.

Phentermine pharmacokinetics are approximately dose-proportional from phentermine and topiramate extended-release 3.75 mg/23 mg to phentermine 15 mg/topiramate 100 mg. Upon dosing phentermine 15 mg/topiramate 100 mg fixed dose combination capsule to steady state, the mean phentermine accumulation ratios for AUC and C max are both approximately 2.5. Topiramate Upon oral administration of a single phentermine and topiramate extended-release capsule 15 mg/92 mg, the resulting mean plasma topiramate C max , T max , AUC 0-t , and AUC 0-∞ , are 1,020 ng/mL, 9 hr, 61,600 ng⋅hr/mL, and 68,000 ng⋅hr/mL, respectively.

A high fat meal does not affect topiramate pharmacokinetics for phentermine and topiramate extended-release 15 mg/92 mg. Topiramate pharmacokinetics are approximately dose-proportional from phentermine and topiramate extended-release 3.75 mg/23 mg to phentermine 15 mg/topiramate 100 mg. Upon dosing phentermine 15 mg/topiramate 100 mg fixed dose combination capsule to steady state, the mean topiramate accumulation ratios for AUC and C max are both approximately 4.

Distribution Phentermine Phentermine is 17.5% plasma protein bound. The estimated phentermine apparent volume of distribution (Vd/F) is 348 L via population pharmacokinetic analysis. Topiramate Topiramate is 15 to 41% plasma protein bound over the blood concentration range of 0.5 to 250 mcg/mL.

The fraction bound decreased as blood topiramate increased. The estimated topiramate Vc/F (volume of the central compartment), and Vp/F (volume of the peripheral compartment) are

50.8 L, and

13.1L, respectively, via population pharmacokinetic analysis. Elimination Metabolism and Excretion Phentermine Phentermine has two metabolic pathways, namely p-hydroxylation on the aromatic ring and N-oxidation on the aliphatic side chain. Cytochrome P450 (CYP) 3A4 primarily metabolizes phentermine but does not show extensive metabolism.

Monoamine oxidase (MAO)-A and MAO-B do not metabolize phentermine. Seventy to 80% of a dose exists as unchanged phentermine in urine when administered alone. The mean phentermine terminal half-life is about 20 hours.

The estimated phentermine oral clearance (CL/F) is

8.79L/h via population pharmacokinetic analysis. Topiramate Topiramate does not show extensive metabolism. Six topiramate metabolites (via hydroxylation, hydrolysis, and glucuronidation) exist, none of which constitutes more than 5% of an administered dose. About 70% of a dose exists as unchanged topiramate in urine when administered alone. The mean topiramate terminal half-life is about 65 hours. The estimated topiramate CL/F is

1.17L/h via population pharmacokinetic analysis. Specific Populations Patients with Renal Impairment A single-dose, open-label study was conducted to evaluate the pharmacokinetics of phentermine and topiramate extended-release 15 mg/92 mg in adult patients with varying degrees of chronic renal impairment compared to healthy volunteers with normal renal function. The study included patients with renal impairment classified on the basis of creatinine clearance as mild (greater or equal to 50 and less than 80 mL/min), moderate (greater than or equal to 30 and less than 50 mL/min), and severe (less than 30 mL/min).

Creatinine clearance was estimated from serum creatinine based on the Cockcroft-Gault equation. Compared to healthy volunteers, phentermine AUC… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with drugs in this class. Cardiac Electrophysiology The effect of phentermine and topiramate extended-release on the QTc interval was evaluated in a randomized, double-blind, placebo-and active-controlled (400 mg moxifloxacin), and parallel group/crossover thorough QT/QTc study.

A total of 54 healthy subjects were administered phentermine and topiramate extended-release 7.5 mg/46 mg at steady state and then titrated to phentermine and topiramate extended-release 22.5 mg/138 mg at steady state. Phentermine and topiramate extended-release 22.5 mg/138 mg [a supra-therapeutic dose resulting in a phentermine and topiramate maximum concentration (C max ) of 4-and 3-times higher than those at phentermine and topiramate extended-release 7.5 mg/46 mg, respectively] did not affect cardiac repolarization as measured by the change from baseline in QTc.

Glomerular Filtration Rate (GFR) Healthy obese males and females received phentermine and topiramate extended-release capsules daily for 4 weeks (3.75 mg/23 mg on Days 1 to 3, 7.5 mg/46 mg on Days 4 to 6, 11.25 mg/69 mg on Days 7 to 9, and 15 mg/92 mg on Days 10 to 28). The glomerular filtration rate (GFR) of these participants was assessed via iohexol clearance. On average, GFR decreased during phentermine and topiramate extended-release treatment and returned to baseline within 4 weeks after discontinuing phentermine and topiramate extended-release capsules [see Warnings and Precautions ( 5.8 )].

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Clinical Studies in Adults The effect of phentermine and topiramate extended-release on weight loss in conjunction with reduced caloric intake and increased physical activity was studied in two randomized, double-blind, placebo-controlled studies in patients with obesity (Study 1) and patients with obesity or overweight with two or more significant co-morbidities (Study 2). Both studies had a 4-week titration period, followed by 52 weeks of treatment. There were two co-primary efficacy outcomes measured after 1 year of treatment (Week 56): 1) the percent weight loss from baseline; and 2) treatment response defined as achieving at least 5% weight loss from baseline.

In Study 1 (NCT00554216), patients with obesity (BMI greater than or equal to 35 kg/m 2 ) were randomized to receive 1 year of treatment with placebo (N=514), phentermine and topiramate extended-release 3.75 mg/23 mg (N=241), or phentermine and topiramate extended-release 15 mg/92 mg (N=512) in a 2:1:2 ratio. Patients ranged in age from 18 to 71 years old (mean age 43) and 83% were female. Approximately 80% were White, 18% were Black or African American, and 15% were Hispanic or Latino ethnicity.

At the beginning of the study the average weight and BMI of patients was 116 kg and 42 kg/m 2 , respectively. Patients with type 2 diabetes mellitus were excluded from participating in Study 1. During the study, a well-balanced, reduced-calorie diet to result in an approximate 500 kcal/day decrease in caloric intake was recommended to all patients and patients were offered nutritional and lifestyle modification counseling.

In Study 2 (NCT00553787), patients with overweight or obesity were randomized to receive 1 year of treatment with placebo (N=994), phentermine and topiramate extended-release 7.5 mg/46 mg (N=498), or phentermine and topiramate extended-release 15 mg/92 mg (N=995) in a 2:1:2 ratio. Eligible patients had to have a BMI greater than or equal to 27 kg/m 2 and less than or equal to 45 kg/m 2 (there was no lower limit on BMI for patients with type 2 diabetes mellitus) and two or more of the following obesity-related co-morbid conditions: • Elevated blood pressure (greater than or equal to 140/90 mmHg, or greater than or equal to 130/85 mmHg for diabetics) or requirement for greater than or equal to 2 antihypertensive medications; • Triglycerides greater than 200 to 400 mg/dL or were receiving treatment with 2 or more lipid-lowering agents; • Elevated fasting blood glucose (greater than 100 mg/dL) or diabetes; and/or • Waist circumference greater than or equal to 102 cm for men or greater than or equal to 88 cm for females.

Patients ranged in age from 19 to 71 years of age (mean age 51) and 70% were female. Approximately 86% were White, 12% were Black or African American, and 13% were Hispanic/ or Latino ethnicity. The average weight and BMI of patients at the start of the study was 103 kg and 36.6 kg/m 2 , respectively.

Approximately half (53%) of patients had hypertension at the start of the study. There were 388 (16%) patients with type 2 diabetes mellitus at the start of the study. During the study, a well-balanced, reduced-calorie diet to result in an approximate 500 kcal/day decrease in caloric intake was recommended to all patients and patients were offered nutritional and lifestyle modification counseling.

The percentage of randomized patients who withdrew from each study prior to week 56 was 40% in Study 1, and 31% in Study 2. Table 10 provides the results for weight loss at 1 year in Studies 1 and 2. After 1 year of treatment with phentermine and topiramate extended-release, all dose levels resulted in statistically significant weight loss compared to placebo (see Table 10, Figure 1 and Figure 2).

A statistically significant greater proportion of the patients randomized to phentermine and topiramate extended-release than placebo achieved 5% and 10% weight loss. Table 10. Weight Loss at One Year in Adult Patients in Studies 1 and 2 St… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence ~1 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Phentermine and topiramate extended-release capsules contains phentermine, a Schedule IV controlled substance, and topiramate, which is not a controlled substance.

9.2Abuse Phentermine has a known potential for abuse. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Phentermine is related chemically and pharmacologically to amphetamines.

Amphetamines and other stimulant drugs have been extensively abused. Abuse of amphetamines and related drugs (e.g., phentermine) may be associated with impaired control over drug use and severe social dysfunction. There are reports of patients who have increased the dosage of these drugs to many times higher than recommended.

Assess the risk of abuse prior to prescribing phentermine and topiramate extended-release capsules as part of a weight reduction and long-term maintenance of body weight program.

9.3Dependence Physical dependence may occur in patients treated with phentermine and topiramate extended-release capsules. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. The following adverse reactions have been associated with the abrupt discontinuation of the individual components of phentermine and topiramate extended-release capsules: • For topiramate, abrupt discontinuation has been associated with seizures in patients without a history of seizures or epilepsy [see Warnings and Precautions ( 5.9 )]. • For phentermine, abrupt discontinuation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on a sleep electroencephalogram.

Thus, in situations where rapid withdrawal of phentermine and topiramate extended-release capsules is required, appropriate medical monitoring is recommended. Patients discontinuing phentermine and topiramate extended-release capsules 15 mg/92 mg should be gradually tapered to reduce the possibility of precipitating a seizure [see Dosage and Administration ( 2.3 )] .

🔒 Controlled Substance 23 words ▾

9.1Controlled Substance Phentermine and topiramate extended-release capsules contains phentermine, a Schedule IV controlled substance, and topiramate, which is not a controlled substance.

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Phentermine/Topiramate No animal studies have been conducted with the combination of phentermine/topiramate to evaluate carcinogenesis, mutagenesis, or impairment of fertility. The following data are based on findings in studies performed individually with phentermine or topiramate, phentermine and topiramate extended-release capsule's two active ingredients. Phentermine Phentermine was not mutagenic or clastogenic with or without metabolic activation in the Ames bacterial mutagenicity assay, a chromosomal aberration test in Chinese hamster lung (CHL-K1) cells, or an in vivo micronucleus assay.

Rats were administered oral doses of 3, 10, and 30 mg/kg/day phentermine for 2 years. There was no evidence of carcinogenicity at the highest dose of phentermine (30 mg/kg) which is approximately 11 to 15 times the maximum recommended clinical dose of phentermine and topiramate extended-release 15 mg/92 mg based on AUC exposure. No animal studies have been conducted with phentermine to determine the potential for impairment of fertility.

Topiramate Topiramate did not demonstrate genotoxic potential when tested in a battery of in vitro and in vivo assays. Topiramate was not mutagenic in the Ames test or the in vitro mouse lymphoma assay; it did not increase unscheduled DNA synthesis in rat hepatocytes in vitro ; and it did not increase chromosomal aberrations in human lymphocytes in vitro or in rat bone marrow in vivo. An increase in urinary bladder tumors was observed in mice given topiramate (20, 75, and 300 mg/kg) in the diet for 21 months.

The elevated bladder tumor incidence, which was statistically significant in males and females receiving 300 mg/kg, was primarily due to the increased occurrence of a smooth muscle tumor considered histomorphologically unique to mice. Plasma exposures in mice receiving 300 mg/kg were approximately 2 to 4 times steady-state exposures measured in patients receiving topiramate monotherapy at the MRHD of phentermine and topiramate extended-release 15 mg/92 mg. The relevance of this finding to human carcinogenic risk is uncertain.

No evidence of carcinogenicity was seen in rats following oral administration of topiramate for 2 years at doses up to 120 mg/kg (approximately 4 to 10 times the MRHD of phentermine and topiramate extended-release based on AUC estimates). No adverse effects on male or female fertility were observed in rats at doses up to 100 mg/kg (approximately 4 to 8 times male and female MRHD exposures of phentermine and topiramate extended-release based on AUC).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Phentermine/Topiramate No animal studies have been conducted with the combination of phentermine/topiramate to evaluate carcinogenesis, mutagenesis, or impairment of fertility. The following data are based on findings in studies performed individually with phentermine or topiramate, phentermine and topiramate extended-release capsule's two active ingredients. Phentermine Phentermine was not mutagenic or clastogenic with or without metabolic activation in the Ames bacterial mutagenicity assay, a chromosomal aberration test in Chinese hamster lung (CHL-K1) cells, or an in vivo micronucleus assay.

Rats were administered oral doses of 3, 10, and 30 mg/kg/day phentermine for 2 years. There was no evidence of carcinogenicity at the highest dose of phentermine (30 mg/kg) which is approximately 11 to 15 times the maximum recommended clinical dose of phentermine and topiramate extended-release 15 mg/92 mg based on AUC exposure. No animal studies have been conducted with phentermine to determine the potential for impairment of fertility.

Topiramate Topiramate did not demonstrate genotoxic potential when tested in a battery of in vitro and in vivo assays. Topiramate was not mutagenic in the Ames test or the in vitro mouse lymphoma assay; it did not increase unscheduled DNA synthesis in rat hepatocytes in vitro ; and it did not increase chromosomal aberrations in human lymphocytes in vitro or in rat bone marrow in vivo. An increase in urinary bladder tumors was observed in mice given topiramate (20, 75, and 300 mg/kg) in the diet for 21 months.

The elevated bladder tumor incidence, which was statistically significant in males and females receiving 300 mg/kg, was primarily due to the increased occurrence of a smooth muscle tumor considered histomorphologically unique to mice. Plasma exposures in mice receiving 300 mg/kg were approximately 2 to 4 times steady-state exposures measured in patients receiving topiramate monotherapy at the MRHD of phentermine and topiramate extended-release 15 mg/92 mg. The relevance of this finding to human carcinogenic risk is uncertain.

No evidence of carcinogenicity was seen in rats following oral administration of topiramate for 2 years at doses up to 120 mg/kg (approximately 4 to 10 times the MRHD of phentermine and topiramate extended-release based on AUC estimates). No adverse effects on male or female fertility were observed in rats at doses up to 100 mg/kg (approximately 4 to 8 times male and female MRHD exposures of phentermine and topiramate extended-release based on AUC).

📄 Recent Major Changes 9 words ▾

Contraindications (4) 03/2026 Warnings and Precautions (5.13, 5.15) 03/2026

📄 Package Label / Principal Display Panel 58 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION Phentermine and Topiramate Extended-Release Capsules, 3.75 mg/23 mg - 30’s Count Container Label

Phentermine and Topiramate Extended-Release Capsules, 7.5 mg/46 mg - 30’s Count Container Label

Phentermine and Topiramate Extended-Release Capsules, 11.25 mg/69 mg - 30’s Count Container Label

Phentermine and Topiramate Extended-Release Capsules, 15 mg/92 mg - 30’s Count Container Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q3 2025 – Q1 2026 · 3 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
335
Units reimbursed last 4 qtrs
9.9K
Gross reimbursed last 4 qtrs
$38.1K
Avg / prescription
$113.73
Avg / unit
$3.8452
Latest quarter Q1 2026
215Rx
Medicaid pays / ea
$3.8452
gross reimbursed
vs
NADAC / ea
$3.0564
acquisition cost
=
Spread
+$0.7888
+26% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
70% FFS 30% MCO
Fee-for-service · 236 Rx Managed care · 99 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 492 units · 8.3 per 100k residents WI Michigan: 1,230 units · 12.3 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 330 units · 7.8 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 4,186 units · 10.7 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 714 units · 19.7 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 1,560 units · 21.9 per 100k residents TN North Carolina: 1,396 units · 12.9 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
7.821.9
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Tennessee 21.9 /100k
2 Connecticut 19.7 /100k
3 North Carolina 12.9 /100k
4 Michigan 12.3 /100k
5 California 10.7 /100k
6 Wisconsin 8.3 /100k
7 Oregon 7.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
🛡
This drug has a REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It may require enrollment, counseling, or monitoring to manage a serious risk. See the boxed warning & full label below, and REMS@FDA ↗.
← 43598-0624-30 · Dr.Reddys 43598-0626-30 · Dr.Reddys →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.