Intuniv ( Guanfacine ) Extended Release
INTUNIV™ is a once-daily, extended-release formulation of guanfacine hydrochloride (HCl) 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 C9H9Cl2 N3O•HCl corresponding to a molecular weight of 282.55.
INTUNIV ( Guanfacine ) Structural Formula
Guanfacine HCl is a white to off-white crystalline powder, sparingly soluble in water (approximately 1 mg/mL) and alcohol and slightly soluble in acetone. The only organic solvent in which it has relatively high solubility is methanol ( > 30 mg/mL). Each tablet contains guanfacine HCl equivalent to 1 mg, 2 mg, 3 mg, or 4 mg of guanfacine base. The tablets also contain hypromellose, methacrylic acid copolymer, lactose, povidone, crospovidone, microcrystalline cellulose, fumaric acid, and glyceryl behenate. In addition, the 3mg and 4mg tablets also contain green pigment blend PB-1763.
Why INTUNIV?
INTUNIV may help to treat the symptoms and behaviors associated with ADHD. In order to gain the most benefit from INTUNIV, it should be used as part of a total treatment plan, which may include individual or family counseling, skills training, or other therapies. Look below to learn more about why INTUNIV may be right for your child.
INTUNIV treats a range of ADHD symptoms and behaviors
INTUNIV has been shown to improve a range of ADHD symptoms and behaviors, including:
* not being able to focus
* being easily distracted
* arguing with adults
* irritability
* temper outbursts
* deliberately annoying others
* impulsiveness or overexcitement
INTUNIV is not a controlled substance
Unlike many other ADHD medications, INTUNIV is not a controlled substance. That means that it's not likely to cause dependence or be abused and it can be refilled—over the phone, at the pharmacy, or through mail order.
Parents and teachers reported that INTUNIV improved symptoms day and night
INTUNIV is extended release, which means that your child will only have to take it once a day. In a clinical study, parents of children taking INTUNIV reported:
* symptom improvement at home
* symptom improvement with INTUNIV over a full day as
reported at 6 PM, 8 PM, and 6 AM the next morning
In the same study:
* teachers reported that children taking INTUNIV had significantly fewer ADHD symptoms than children taking a sugar pill
How do you take Intuniv ?
INTUNIV comes in 4 doses: 1 mg, 2 mg, 3 mg, and 4 mg. Your child should take INTUNIV exactly as prescribed by the doctor. Your child's doctor may start with a low dose and adjust the dose over time to manage your child's ADHD symptoms and side effects. This process may take a couple of weeks and is likely to occur at the beginning of treatment.
In 2 clinical studies with INTUNIV lasting 8 and 9 weeks, ADHD symptoms started to improve within
2 weeks. For most patients, symptom improvement continued over the course of the studies.
Your child should continue to take INTUNIV exactly as prescribed by your child's doctor—do not change your child's dose without consulting your child's doctor first.
Look below for more important information about how to give INTUNIV to your child.
Whare are the side effects ?
Your child may have some side effects when taking INTUNIV
Some important notes about sleepiness, tiredness, and drowsiness:
* In clinical studies, these side effects were the most commonly reported and were generally mild to moderate
* Side effects were seen most often at the start of treatment in these studies
* In a clinical study, when INTUNIV was taken in the morning, sleepiness occurred mainly in the evening
Other side effects may include:
* Low blood pressure and low heart rate. The doctor may regularly check your child's blood pressure and heart rate
* Dizziness, light-headedness, and fainting have also been reported. If your child experiences any of these, tell the doctor
* Fainting episodes (syncope) have been reported in some patients taking INTUNIV. Your child should avoid becoming dehydrated or overheated while taking INTUNIV
* Nausea, stomach pain, irritability, headaches, dry mouth, constipation, and decreased appetite
Tell the doctor about side effects that bother your child or that do not go away. The doctor may change your child's dose of INTUNIV. Your child may not always let you know about side effects, so be sure to ask how he or she is feeling. Try keeping a log of side effects to take to your next appointment with your child's doctor.
Sleepiness and drowsiness may increase if INTUNIV is used with alcohol or other medicines that cause sleepiness. If you or your child notices drowsiness as a result of taking other medications, you should tell this to the doctor before beginning treatment with INTUNIV.
Children of driving age should not drive, operate heavy machinery, or do other dangerous activities until they know how INTUNIV may affect them. INTUNIV can slow thinking and motor skills.
Do not give INTUNIV to your child if your child is allergic to guanfacine or anything else in INTUNIV.
Unless directed by the doctor, do not take other medicines containing guanfacine along with, or in place of, INTUNIV.
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