Guanfacine Er
Generic Name: guanfacine er
Brand Names:
Guanfacine Er
Guanfacine extended-release tablets, USP are a once-daily, extended-release formulation of guanfacine hydrochloride in a matrix tablet formulation for oral administration only. The chemical designation is N-amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride. The molecular formula is C9H9Cl2N3O·HCl corresponding to a molecular weight of 282.55 g/mol.
Overview
Guanfacine extended-release tablets, USP are a once-daily, extended-release formulation of guanfacine hydrochloride in a matrix tablet formulation for oral administration only. The chemical designation is N-amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride. The molecular formula is C9H9Cl2N3O·HCl corresponding to a molecular weight of 282.55 g/mol.
Uses
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
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).
Side Effects
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 extended-release tablets in 2,825 patients.
Warnings
5.1 Hypotension, Bradycardia, and Syncope Treatment with guanfacine extended-release tablets can cause dose-dependent decreases in blood pressure and heart rate. Decreases were less pronounced over time of treatment. Orthostatic hypotension and syncope have been reported [see ADVERSE REACTIONS (6.1)]. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Titrate guanfacine extended-release tablets slowly in patients with a history of hypotension, and those with underlying conditions that may be worsened by hypotension and bradycardia; e.g., heart block, bradycardia, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. Guanfacine extended-release tablets are 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.
Storage
Storage - Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Frequently Asked Questions
What is Guanfacine Er used for?▼
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)].
What are the side effects of Guanfacine Er?▼
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 extended-release tablets in 2,825 patients.
What are the important warnings for Guanfacine Er?▼
5.1 Hypotension, Bradycardia, and Syncope Treatment with guanfacine extended-release tablets can cause dose-dependent decreases in blood pressure and heart rate. Decreases were less pronounced over time of treatment. Orthostatic hypotension and syncope have been reported [see ADVERSE REACTIONS (6.1)]. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Titrate guanfacine extended-release tablets slowly in patients with a history of hypotension, and those with underlying conditions that may be worsened by hypotension and bradycardia; e.g., heart block, bradycardia, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. Guanfacine extended-release tablets are 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.
Related Medications
Boldo Leaf, Cynara Scolymus, Hamamelis Virginiana, Lycopodium Clavatum, Sepia Inky Juice
boldo leaf, cynara scolymus, hamamelis virginiana, lycopodium clavatum, sepia inky juice
Non-Standardized Plant Allergenic Extract [EPC]
Uses For the temporary relief of symptoms associated with low energy and fatigue
Berberis Vulgaris Root Bark, Bryonia Alba Root, Phenol, Milk Thistle, Chelidonium Majus, Juniper Berry, Lycopodium Clavatum Spore, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, Strychnos Nux-vomica Seed, Phosphorus, Lactic Acid, L-, Taraxacum Officinale, Viscum Album Fruiting Top, And Yucca Filamentosa
berberis vulgaris root bark, bryonia alba root, phenol, milk thistle, chelidonium majus, juniper berry, lycopodium clavatum spore, sodium phosphate, dibasic, heptahydrate, sodium sulfate, strychnos nux-vomica seed, phosphorus, lactic acid, l-, taraxacum officinale, viscum album fruiting top, and yucca filamentosa
Non-Standardized Food Allergenic Extract [EPC]
For temporary relief of minor: fatigue* headache* muscle ache* nervous irritability* restlessness* difficulty sleeping* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Hydrocortisone, Iodoquinol
hydrocortisone, iodoquinol
Corticosteroid [EPC]
DESCRIPTION: Each gram contains 10 mg of hydrocortisone and 10 mg of iodoquinol in a vehicle consisting of: aloe vera powder, aminomethyl propanol 95%, benzyl alcohol, carbomer, citric acid anhydrous, D&C Yellow #10, FD&C Blue #1, glycerin, glyceryl polymethacrylate, magnesium aluminum silicate, palmitoyl oligopeptide, PPG-20 methyl glucose ether, propylene glycol, purified water and SD 40B alcohol.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.