Drugplain

phentermine and topiramate 11.25 mg/1

phentermine and topiramate · CAPSULE, EXTENDED RELEASE · Prasco Laboratories

No Recall History
Plain English

phentermine and topiramate is a capsule, extended release containing phentermine and topiramate at 11.25 mg/1, taken oral. Manufactured by Prasco Laboratories.

Key Facts

Brand Name
phentermine and topiramate
Generic Name
phentermine and topiramate
NDC Code (Product)
66993-782
Manufacturer
Prasco Laboratories
Strength
11.25 mg/1
Dosage Form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing Status
DEA Schedule
Schedule IV (Controlled)
Application #
NDA022580
Drug Class
Cytochrome P450 3A4 Inducers [MoA]; Cytochrome P450 2C19 Inhibitors [MoA]
Marketing Start
06/01/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dizziness2 reports
treatment failure2 reports
fatigue1 reports
gastrointestinal toxicity1 reports
gingival bleeding1 reports
off label use1 reports
stevens-johnson syndrome1 reports
trismus1 reports
weight decreased1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 U…

Dosage & Administration

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 ). 2.1 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 ext…

Contraindications

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 )

Drug Interactions

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 expo…

Adverse Reactions

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 )] …

Frequently Asked Questions

What is phentermine and topiramate used for?

phentermine and topiramate contains phentermine and topiramate. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is phentermine and topiramate a controlled substance?

Yes, phentermine and topiramate is classified as CIV under the DEA Controlled Substances Act.

What is the generic name for phentermine and topiramate?

The generic name for phentermine and topiramate is phentermine and topiramate. There are 8 other brand versions of phentermine and topiramate.

What is the NDC code for phentermine and topiramate 11.25 mg/1?

The NDC (National Drug Code) for phentermine and topiramate 11.25 mg/1 is 66993-782, listed by Prasco Laboratories.

Product NDC

66993-782

Package NDC

66993-782-30

Other Phentermine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)