LATEST NEWS AND FACTS ABOUT MEDICINES YOU TAKE

Intuniv (guanfacine) may increase depression.

Report the development of any tendency to emotional depression.

ABOVE: Stanford University School of Medicine, Psychiatric Medications: whatmeds.stanford.edu/medications/guanfacine.html (copyright date: 2014; captured 7/14/2014). Rybacki, J., et al. The Essential Guide to Prescription Drugs, HarperCollins Publishers Inc., NY (1996).

The safety and efficacy of INTUNIV in children patients less than 6 years of age have not been established. For children and adolescents 6 years and older, efficacy beyond 9 weeks and safety beyond 2 years of treatment have not been established.

ABOVE: Intuniv Prescribing Information, rev. 2/2011.
Kapvay (clonidine)

“Guanfacine [INTUNIV] may increase depression.” (3)

Intuniv Side Effects and Warnings

  • Brand Names: INTUNIV, INTUNIV ER (see also, TENEX)
  • Generic Names: guanfacine hydrochloride, guanfacine
  • Categories: selective alpha2A-adrenergic receptor agonist
  • and ANTI-HYPERTENSIVE

How Intuniv Works

Intuniv decreases certain nerve signals from the brain to the blood vessels and the heart. This causes the blood vessels to relax so that blood flows more easily and slows the heart rate. These effects help to lower blood pressure. (4) The drug lowers blood pressure and heart rate, thereby supressing the body's “fight or flight response” by decreasing that activity of part of the brain known as vasomotor center. Many users of Intuniv experience sedation or drowsiness. (5)

INTUNIV can make your child sleepy. One of the most common side effects of INTUNIV is sleepiness.

ABOVE: Safety Information for INTUNIV, Shire US Inc., captured 7/18/2014: www.intuniv.com/non-stimulant-adhd-medication/intuniv-side-effects.aspx

Used For

  • High blood pressure (hypertension)
  • Attention deficit disorder in children ages 6-17
  • Oppositional defiant disorder
  • Conduct disorder
  • Pervasive development disorders

Intuniv Dosage Forms and Strengths

Guanfacine hydrochloride in 1 mg, 2 mg, 3 mg, and 4 mg extended-release tablets.

1 mg 2 mg 3 mg 4 mg
Color White/off-white White/off-white Green Green
Shape Round Caplet Round Caplet
Debossment
(top/bottom)
503 / 1mg 503 / 2mg 503 / 3mg 503 / 4mg

Let Your Doctor Know Before Taking This Drug If (2)

  • you have or have had serious emotional depression
  • you are taking any antidepressant
  • you are taking a tricyclic antidepressant
  • you are taking any sedative
  • you are taking any hypnotic drugs
  • you have a circulatory disorder of the brain
  • you have angina or coronary heart disease
  • you have impaired liver or kidney function
  • you are a diabetic
  • you have a history of orthostatic hypotension
  • you have a very slow heart rate
  • you plan to have surgery under general anesthesia in the near future

Like other antihypertensive agents, Intuniv should be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease, or chronic renal or hepatic failure.

ABOVE: National Institute of Mental Health. "GUANFACINE HYDROCHLORIDE tablet," Daily Med. Bethesda, MD: National Institute of Mental Health, National Institutes of Health, US Department of Health and Human Services; Revised 2/2011 (captured 7/15/2014): dailymed.nlm.nih.gov/dailymed/lookup.cfm?~.

Common (Expected) Adverse Side Effects (4)

  • Dry mouth (xerostomia) (10-60%)
  • Drowsiness and sleepiness (somnolence) (5-39%)
  • Sedation (5-30%)
  • Headache (0.2-26%)
  • Dizziness (2-15%)
  • Constipation (2-16%)
  • Fatigue (2-15%)
  • Abdominal pain (11%)

Less Possible (1-10%) Adverse Effects (4)

If any of the following develop, consult your physician promptly for guidance.

  • Hypotension (abnormally low blood pressure) (7%)
  • Fatigue and loss of energy (asthenia) (2-7%)
  • Impotence (erectile dysfunction) (0-7%)
  • Tiredness, sluggishness (lethargy) (6%)
  • Dizziness (6%)
  • Irritability (6%)
  • Nausea (3-6%)
  • Decreased appetite (5%)
  • Weakness (1-5%)
  • Insomnia (inability to obtain adequate or quality sleep) (3-4%)
  • Bradycardia (slow heart rate) (3%)
  • Palpitations (irregular, hard, or rapid heartbeats) (3%)
  • Confusion (3%)
  • Depression (3%)
  • Dyspnea (difficulty in breathing or shortness of breath) (3%)
  • Alopecia (hair loss, baldness) (3%)
  • Dermatitis (inflammation of the skin) (3%)
  • Diaphoresis (excessive perspiration, sweating) (3%)
  • Pruritus (severe itching) (3%)
  • Dyspepsia (digestion problems including stomach discomfort or vomiting) (3%)
  • Dysphagia (difficulty in swallowing or inability to swallow) (3%)
  • Hypokinesia (abnormally slow muscle activity) (3%)
  • Leg cramps (3%)

Adverse Effects (Frequency Not Defined) (4)

  • Orthostatic hypotension (head rush, dizzy spell)
  • Exfoliation
  • Rash
  • Arthralgia (joint pain)
  • Myalgia (muscle pain)

Adverse Effects Reported in Actual Patients (Postmarketing Experience) (4, 5)

  • Body as a Whole:
    • Asthenia (loss of strength and energy; weakness)
    • Chest pain
    • Edema (swelling)
    • Malaise (feeling of general discomfort, "I just don't feel good.")
    • Tremor (shakiness or trembling)
  • Cardiovascular:
    • Bradycardia (slow heart rate)
    • Palpitations (irregular, hard, or rapid heartbeats)
    • Syncope (fainting, brief loss of consciousness)
    • Tachycardia (rapid heart rate)
  • Central Nervous System (CNS):
    • Paresthesias (prickly, tingling sensation)
    • Vertigo (sensation of irregular or whirling motion, dizziness)
  • Eye Disorders:
    • Blurred vision
  • Gastrointestinal (GI):
    • Abdominal pain
    • Constipation
    • Diarrhea
    • Dyspepsia (digestion problems including stomach discomfort or vomiting)
  • Liver and Biliary System:
    • Abnormal liver function tests (LFTs)
  • Musculoskeletal:
    • Arthralgia (joint pain)
    • Leg cramps
    • Leg pain
    • Myalgia (muscle pain)
  • Psychiatric:
    • Agitation
    • Anxiety
    • Confusion
    • Depression
    • Hallucinations
    • Insomnia
    • Nervousness
  • Reproductive System:
    • Male: impotence
  • Respiratory System:
    • Dyspnea (difficulty in breathing or shortness of breath)
  • Skin and Appendages:
    • Alopecia (hair loss, baldness)
    • Dermatitis (inflammation of the skin)
    • Exfoliative dermatitis (scaling and itching of the skin, with loss of hair)
    • Pruritus (severe itching)
    • Rash
  • Special Senses:
    • Alterations in taste
  • Urinary System:
    • Nocturia (excessive urination at night)
    • Urinary frequency

Rare, serious disorders with no definitive cause and effect relationship to Intuniv have been reported spontaneously and/or in the postmarketing study. These events include acute renal failure, cardiac fibrillation, cerebrovascular accident, congestive heart failure, heart block, and myocardial infarction. (5)

Possible Effects On Sexual Functions (2)

  • Decreased libido
  • Impotence

DO NOT STOP THIS DRUG SUDDENLY

Sudden withdrawl can produce anxiety, nervousness, tremors, fast or irregular heart beat action, nausea, stomach cramps, vomiting and rebound hypertension.

Withdrawal reactions occur within 2 to 7 days after the last dose. Best to reduce dose gradually (over 3 to 4 days), with periodic monitoring of the blood pressure.

ABOVE: Rybacki, J., et al. The Essential Guide to Prescription Drugs, HarperCollins Publishers Inc., NY (1996).

Overdose Side Effects (2)

  • Marked drowsiness
  • Weakness
  • Dry mouth
  • Slow pulse
  • Low blood pressure
  • Vomiting
  • Stupor progressing to coma

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INTUNIV may cause serious side effects including:

  • low blood pressure
  • low heart rate
  • fainting
  • sleepiness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of INTUNIV include

  • sleepiness
  • tiredness
  • trouble sleeping (insomnia)
  • low blood pressure
  • nausea
  • stomach pain
  • dizziness

These are not all the possible side effects of INTUNIV. For more information, ask your doctor or pharmacist.

Tell the doctor if you have any side effect that bothers you or that does not go away.

ABOVE: Intuniv Prescribing Information, rev. 2/2011.

NY Times: Children's A.D.D. Drugs Don't Work Long-Term

The NY Times, in an op-ed article by L. Alan Sroufe, a professor emeritus of psychology at the University of Minnesota's Institute of Child Development:

“Attention-deficit drugs increase concentration in the short term, which is why they work so well for college students cramming for exams. But when given to children over long periods of time, they neither improve school achievement nor reduce behavior problems. The drugs can also have serious side effects...

“Many parents who take their children off the drugs find that behavior worsens, which most likely confirms their belief that the drugs work. But the behavior worsens because the children's bodies have become adapted [because the drugs are habit-forming] to the drug. Adults may have similar reactions if they suddenly cut back on coffee, or stop smoking.”

ABOVE: L. Alan Sroufe, “Ritalin Gone Wrong: Children's A.D.D. Drugs Don't Work Long-Term,” New York Times, pg SR1, NY ed, 1/28/2012.

Use of Methylphenidate (RITALIN) with Clonidine (KAPVAY, CATAPRES) is Controversial

The use of methylphenidate (RITALIN) and clonidine (KAPVAY, CATAPRES) in combination continues to be controversial. Both drugs can adversely affect an irregular heart rate or rhythm (cardiac arrhythmia) and this effect can be worsened when the drugs are combined. Four deaths of children using both drugs were reported to the FDA. [More]

Surge in ADHD Diagnoses Gets a Red Flag

Doctors sounded a warning in the British Medical Journal over a rise in ADHD diagnoses, saying some children may be needlessly taking powerful drugs intended to correct a poorly understood disorder.

The analysis found Ritalin and other drugs were meant to be used only for “severe” ADHD symptoms, which according to research data only occur among about 14 percent of children with the condition.

Yet “about 87 percent of children diagnosed with ADHD in the US in 2010 subsequently received medication,” it said, warning of “unnecessary and possibly harmful medication treatment.”

ABOVE: “Surge in ADHD diagnoses gets a red flag,” France 24 International News, Nov. 6, 2013: www.france24.com/en/20131106-surge-adhd-diagnoses-gets-red-flag.

How Safe is Ritalin?

Many think methylphenidate (Ritalin) is safe, or mild, because so many children use it. However, the government classifies the psychoactive drug with cocaine and morphine because it is highly addictive. [More]

ProCentra: Liquid “Dexedrine”

ProCentra is a new name for what used to be a popular diet drug, Dexedrine. Now sold for children in bubblegum-flavored liquid and advertised as “easier to swallow.” [More]

Vyvanse is a “Pro-Drug”

Although Vyvanse is referred to as “pro-drug” of dextroamphetamine, it is still an amphetamine, meaning that Vyvanse is easily abused and can cause insomnia, agitation, anxiety and sometimes psychotic symptoms like seeing things or becoming paranoid. [More]

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