Guanfacine ER 1 mg/1
Guanfacine ER · TABLET, EXTENDED RELEASE · Direct_rx
Guanfacine ER is a tablet, extended release containing guanfacine er at 1 mg/1, taken oral. Manufactured by Direct_rx.
Key Facts
- Brand Name
- Guanfacine ER
- Generic Name
- Guanfacine ER
- NDC Code (Product)
72189-597- Manufacturer
- Direct_rx
- Strength
- 1 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA217269
- Marketing Start
- 12/03/2024
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
Guanfacine extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)].
Dosage & Administration
2.1 General Instruction for Use Swallow tablets whole. Do not crush, chew, or break tablets because this will increase the rate of guanfacine release. Do not administer with high fat meals, due to increased exposure. 2.2 Dose Selection Take guanfacine extended-release tablets orally once daily, either in the morning or evening, at approximately the same time each day. Begin at a dose of 1 mg/day, and adjust in increments of no more than 1 mg/week. In monotherapy clinical trials, there was dose-and exposure-related clinical improvement as well as risks for several clinically significant adverse reactions (hypotension, bradycardia, sedative events). To balance the exposure-related potential benefits and risks, the recommended target dose range depending on clinical response and tolerability for guanfacine extended-release tablet is 0.05 to 0.12 mg/kg/day (total daily dose between 1 to 7 mg) (See Table 1). Table 1: Recommended Target Dose Range for Therapy with Guanfacine Extended-Release Tablets Weight Target dose range (0.05 to 0.12 mg/kg/day) 25 to 33.9 kg 2 to 3 mg/day 34 to 41.4 kg 2 to 4 mg/day 41.5 to 49.4 kg 3 to 5 mg/day 49.5 to 58.4 kg 3 to 6 mg/day 58.5 to 91 kg 4 to 7 mg/d…
Contraindications
Guanfacine is contraindicated in patients with a history of a hypersensitivity reaction to guanfacine extended-release tablets or its inactive ingredients, or other products containing guanfacine. Rash and pruritus have been reported.
Drug Interactions
Table 14 contains clinically important drug interactions with guanfacine [see Clinical Pharmacology (12.3)]. Table 14: Clinically Important Drug Interactions: Effect of other Drugs on Guanfacine Concomitant Drug Name or Drug Class Clinical Rationale and Magnitude of Drug Interaction Clinical Recommendation Strong and moderate CYP3A4 inhibitors, e.g., ketoconazole, fluconazole Guanfacine is primarily metabolized by CYP3A4 and its plasma concentrations can be significantly affected resulting in an increase in exposure Consider dose reduction [see Dosage and administration (2.7)] Strong and moderate CYP3A4 inducers, e.g., rifampin, efavirenz Guanfacine is primarily metabolized by CYP3A4 and its plasma concentrations can be significantly affected resulting in a decrease in exposure Consider dose increase [see Dosage and administration (2.7)]
Adverse Reactions
The following serious adverse reactions are described elsewhere in the labeling: Hypotension, bradycardia, and syncope [see Warnings and Precautions (5.1)] Sedation and somnolence [see Warnings and Precautions (5.2)] Cardiac conduction abnormalities [see Warnings and Precautions (5.3)] Rebound Hypertension [see Warnings and Precautions (5.4)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect clinical trial exposure to guanfacine in 2,825 patients. This includes 2,330 patients from completed studies in children and adolescents, ages 6 to 17 years and 495 patients in completed studies in adult healthy volunteers. The mean duration of exposure of 446 patients that previously participated in two 2-year, open-label long-term studies was approximately 10 months. Fixed Dose Trials Table 3: Percentage of Patients Experiencing Most Common (≥5% and at least twice the rate for placebo) Adverse Reactions in Fixed Dose St…
Frequently Asked Questions
What is Guanfacine ER used for?
Guanfacine ER contains Guanfacine ER. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Guanfacine ER a controlled substance?
Guanfacine ER is not classified as a controlled substance by the DEA.
What is the generic name for Guanfacine ER?
The generic name for Guanfacine ER is Guanfacine ER. There are no other listed brand versions of Guanfacine ER.
What is the NDC code for Guanfacine ER 1 mg/1?
The NDC (National Drug Code) for Guanfacine ER 1 mg/1 is 72189-597, listed by Direct_rx.
Other Guanfacine ER Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)