INTUNIV , its inactive ingredients or other products containing guanfacine should not take INTUNIV . ®[ ] SEE DESCRIPTION (11)®
5 WARNINGS AND PRECAUTIONS
5.1 Hypotension, Bradycardia, and Syncope
Treatment with INTUNIV 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. Use INTUNIV with caution in patients with a history of hypotension, heart block, bradycardia, cardiovascular disease, or who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration. Use INTUNIV with caution in patients treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope. Advise patients to avoid becoming dehydrated or overheated. ®®
5.2 Sedation and Somnolence
Somnolence and sedation were commonly reported adverse reactions in clinical studies [ . Before using INTUNIV with other centrally active depressants (such as phenothiazines, barbiturates, or benzodiazepines), consider the potential for additive sedative effects. Caution patients against operating heavy equipment or driving until they know how they respond to treatment with INTUNIV Advise patients to avoid use with alcohol. ] SEE ADVERSE REACTIONS (6.1)®®.
6 ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labelling:
Hypotension, bradycardia, and syncope [ ] SEE WARNINGS AND PRECAUTIONS (5.1)
Sedation and somnolence [ ] SEE WARNINGS AND PRECAUTIONS (5.2)
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 clinical practice.
A total of 2,028 subjects have been exposed to INTUNIV while participating in clinical trials. This includes 1,533 patients from completed studies in children and adolescents, and 495 subjects 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.
Monotherapy Trials
The most commonly observed adverse reactions (incidence ≥ 5% and at least twice the rate for placebo) in the monotherapy trials (Studies 1 and 2) with INTUNIV were: somnolence, fatigue, nausea, lethargy, and hypotension. Most Common Adverse Reactions -®
Twelve percent (12%) of patients receiving INTUNIV discontinued from the monotherapy clinical studies (Studies 1 and 2) due to adverse reactions, compared to 4% in the placebo group. The most common adverse reactions leading to discontinuation of INTUNIV -treated patients from the studies were somnolence/sedation (6%) and fatigue (2%). Less common adverse reactions leading to discontinuation (occurring in approximately 1% of patients) included: hypotension, headache, and dizziness. Adverse Reactions Leading to Discontinuation -®®
Adjunctive Trial
The most commonly observ |
