Intuniv 1 mg/1

guanfacine · TABLET, EXTENDED RELEASE · Takeda Pharmaceuticals America, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Intuniv is a tablet, extended release containing guanfacine at 1 mg/1, taken oral. Manufactured by Takeda Pharmaceuticals America, Inc..

Key Facts

Brand Name: Intuniv
Generic Name: guanfacine
NDC Code (Product): 54092-513
Manufacturer: Takeda Pharmaceuticals America, Inc.
Strength: 1 mg/1
Dosage Form: TABLET, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: NDA022037
Marketing Start: 09/02/2009

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective697 reports

off label use568 reports

somnolence418 reports

aggression343 reports

fatigue292 reports

hypotension268 reports

dizziness253 reports

suicidal ideation248 reports

bradycardia245 reports

headache241 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE INTUNIV ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14) ]. INTUNIV is a central alpha 2A -adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications ( 1 , 14 ).

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Recommended dose: 1 mg to 7 mg (0.05 to 0.12 mg/kg target weight based dose range) once daily in the morning or evening based on clinical response and tolerability ( 2.2 ). Begin at a dose of 1 mg once daily and adjust in increments of no more than 1 mg/week ( 2.2 ). Do not crush, chew or break tablets before swallowing ( 2.1 ). Do not administer with high-fat meals, because of increased exposure ( 2.1 ). Do not substitute for immediate-release guanfacine tablets on a mg-per-mg basis, because of differing pharmacokinetic profiles ( 2.3 ). If switching from immediate-release guanfacine, discontinue that treatment and titrate with INTUNIV as directed ( 2.3 ). When discontinuing, taper the dose in decrements of no more than 1 mg every 3 to 7 days to avoid rebound hypertension ( 2.5 ). 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 INTUNIV 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 adj…

Contraindications

4 CONTRAINDICATIONS INTUNIV is contraindicated in patients with a history of a hypersensitivity reaction to INTUNIV or its inactive ingredients, or other products containing guanfacine. Rash and pruritus have been reported. History of hypersensitivity to INTUNIV , its inactive ingredients, or other products containing guanfacine ( 4 ).

Drug Interactions

7 DRUG INTERACTIONS Table 14 contains clinically important drug interactions with INTUNIV [see Clinical Pharmacology (12.3) ]. Table 14: Clinically Important Drug Interactions: Effect of other Drugs on INTUNIV 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) ] Strong and moderate CYP3A4 inhibitors increase guanfacine exposure. Decrease INTUNIV to 50% of target dosage when coadministered with strong and moderate CYP3A4 inhibitors ( 2.7 ). Strong and moderate CYP3A4 inducers decrease guanfacine exposure. Based on patient response, consider titrating INTUNIV dosage up to double the target d…

Adverse Reactions

6 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) ] Most common adverse reactions (≥5% and at least twice placebo rate) in fixed-dose monotherapy ADHD trials in children and adolescents (6 to 17 years): hypotension, somnolence, fatigue, nausea, and lethargy ( 6.1 ) Flexible dose-optimization ADHD trials in children (6 to 12 years) and adolescents (13 to 17 years): somnolence, hypotension, abdominal pain, insomnia, fatigue, dizziness, dry mouth, irritability, nausea, vomiting, and bradycardia ( 6.1 ). Adjunctive treatment to psychostimulant ADHD trial in children and adolescents (6 to 17 years): somnolence, fatigue, insomnia, dizziness, and abdominal pain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials a…

Frequently Asked Questions

What is Intuniv used for?

Intuniv contains guanfacine. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is Intuniv a controlled substance?

Intuniv is not classified as a controlled substance by the DEA.

What is the generic name for Intuniv?

The generic name for Intuniv is guanfacine. There are 12 other brand versions of guanfacine.

What is the NDC code for Intuniv 1 mg/1?

The NDC (National Drug Code) for Intuniv 1 mg/1 is 54092-513, listed by Takeda Pharmaceuticals America, Inc..

Product NDC

54092-513

Package NDC

54092-513-02

Other Guanfacine 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)