Phentermine and Topiramate Extended-Release 15 mg/1
Phentermine and Topiramate Extended-Release · CAPSULE · Dr.Reddys Laboratories Inc
Phentermine and Topiramate Extended-Release is a capsule containing phentermine and topiramate extended-release at 15 mg/1, taken oral. Manufactured by Dr.Reddys Laboratories Inc.
Key Facts
- Brand Name
- Phentermine and Topiramate Extended-Release
- Generic Name
- Phentermine and Topiramate Extended-Release
- NDC Code (Product)
43598-627- Manufacturer
- Dr.Reddys Laboratories Inc
- Strength
- 15 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA208175
- Drug Class
- Cytochrome P450 3A4 Inducers [MoA]; Cytochrome P450 2C19 Inhibitors [MoA]
- Marketing Start
- 06/12/2025
Recall History
No Recall HistoryFull Prescribing Information
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 Extended-Release used for?
Phentermine and Topiramate Extended-Release contains Phentermine and Topiramate Extended-Release. It is a capsule taken oral. Consult your doctor for specific uses.
Is Phentermine and Topiramate Extended-Release a controlled substance?
Yes, Phentermine and Topiramate Extended-Release is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Phentermine and Topiramate Extended-Release?
The generic name for Phentermine and Topiramate Extended-Release is Phentermine and Topiramate Extended-Release. There are no other listed brand versions of Phentermine and Topiramate Extended-Release.
What is the NDC code for Phentermine and Topiramate Extended-Release 15 mg/1?
The NDC (National Drug Code) for Phentermine and Topiramate Extended-Release 15 mg/1 is 43598-627, listed by Dr.Reddys Laboratories Inc.
Other Phentermine and Topiramate Extended-Release Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)