Alprazolam Intensol

Name: Alprazolam Intensol

What do I need to tell my doctor BEFORE I take Alprazolam Intensol?

  • If you have an allergy to alprazolam or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have glaucoma.
  • If you are taking any of these drugs: Itraconazole or ketoconazole.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with Alprazolam Intensol.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Alprazolam Intensol Description

Alprazolam Intensol™ contains alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds.

The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo[4,3-α][1,4]benzodiazepine.

The structural formula is represented below:

Alprazolam is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH.

Each mL, for oral administration, contains 1 mg of alprazolam USP and the following inactive ingredients: propylene glycol, succinic acid disodium salt and water.

Clinical Studies

Anxiety Disorders

Alprazolam was compared to placebo in double blind clinical studies (doses up to 4 mg/day) in patients with a diagnosis of anxiety or anxiety with associated depressive symptomatology. Alprazolam was significantly better than placebo at each of the evaluation periods of these 4-week studies as judged by the following psychometric instruments: Physician’s Global Impressions, Hamilton Anxiety Rating Scale, Target Symptoms, Patient’s Global Impressions and Self-Rating Symptom Scale.

Panic Disorder

Support for the effectiveness of alprazolam in the treatment of panic disorder came from three short-term, placebo-controlled studies (up to 10 weeks) in patients with diagnoses closely corresponding to DSM-III-R criteria for panic disorder.

The average dose of alprazolam was 5 to 6 mg/day in two of the studies, and the doses of alprazolam were fixed at 2 and 6 mg/day in the third study. In all three studies, alprazolam was superior to placebo on a variable defined as "the number of patients with zero panic attacks" (range, 37 to 83% met this criterion), as well as on a global improvement score. In two of the three studies, alprazolam was superior to placebo on a variable defined as "change from baseline on the number of panic attacks per week" (range, 3.3 to 5.2), and also on a phobia rating scale. A subgroup of patients who were improved on alprazolam during short-term treatment in one of these trials was continued on an open basis up to 8 months, without apparent loss of benefit.

For the Consumer

Applies to alprazolam: oral solution, oral tablet, oral tablet disintegrating, oral tablet extended release

Along with its needed effects, alprazolam (the active ingredient contained in Alprazolam Intensol) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking alprazolam:

More common
  • Being forgetful
  • changes in patterns and rhythms of speech
  • clumsiness or unsteadiness
  • difficulty with coordination
  • discouragement
  • drowsiness
  • feeling sad or empty
  • irritability
  • lack of appetite
  • lightheadedness
  • loss of interest or pleasure
  • relaxed and calm
  • shakiness and unsteady walk
  • sleepiness or unusual drowsiness
  • slurred speech
  • tiredness
  • trouble concentrating
  • trouble performing routine tasks
  • trouble sleeping
  • trouble speaking
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach pain
  • blurred vision
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles, or tingling feelings
  • changes in behavior
  • chills
  • clay-colored stools
  • confusion about identity, place, and time
  • cough
  • dark urine
  • decrease in frequency of urination
  • decrease in urine volume
  • diarrhea
  • difficult or labored breathing
  • difficulty in passing urine (dribbling)
  • difficulty with concentration
  • difficulty with moving
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • ear congestion
  • environment seems unreal
  • fainting
  • fear or nervousness
  • feeling of unreality
  • feeling warm
  • fever
  • general feeling of discomfort or illness
  • headache
  • hyperventilation
  • inability to move the eyes
  • inability to sit still
  • increased blinking or spasms of the eyelid
  • irregular heartbeats
  • itching or rash
  • joint pain
  • lack or loss of self-control
  • loss of bladder control
  • loss of coordination
  • loss of memory
  • loss of voice
  • mood or mental changes
  • muscle aching or cramping
  • muscle pain or stiffness
  • muscle weakness
  • nasal congestion
  • nausea
  • need to keep moving
  • painful urination
  • problems with memory
  • restlessness
  • runny nose
  • seeing, hearing, or feeling things that are not there
  • seizures
  • sense of detachment from self or body
  • shaking
  • shivering
  • sneezing
  • sore throat
  • sticking out of the tongue
  • sweating
  • swollen joints
  • talkativeness
  • tightness in the chest
  • trouble with balance
  • twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unpleasant breath odor
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • unusual facial expressions
  • unusually deep sleep
  • unusually long duration of sleep
  • vomiting of blood
  • yellow eyes or skin
Rare
  • Actions that are out of control
  • attack, assault, or force
  • chest pain
  • continuing ringing or buzzing or other unexplained noise in the ears
  • decreased awareness or responsiveness
  • deep or fast breathing with dizziness
  • ear pain
  • false or unusual sense of well-being
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling jittery
  • feeling unusually cold
  • generalized slowing of mental and physical activity
  • hearing loss
  • hoarseness
  • lack of feeling or emotion
  • loss of control of the legs
  • loss of strength or energy
  • nightmares
  • numbness of the feet, hands, and around mouth
  • severe sleepiness
  • shakiness in the legs, arms, hands, or feet
  • sleep talking
  • swelling
  • talking, feeling, and acting with excitement
  • thoughts of killing oneself
  • uncaring
  • unusual weak feeling
  • voice changes
Incidence not known
  • General tiredness and weakness
  • light-colored stools
  • stomach pain, continuing
  • upper right abdominal or stomach pain

Some side effects of alprazolam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Absent, missed, or irregular menstrual periods
  • decreased appetite
  • decreased interest in sexual intercourse
  • decreased sexual performance or desire abnormal ejaculation
  • difficulty having a bowel movement (stool)
  • inability to have or keep an erection
  • increased appetite
  • increased in sexual ability, desire, drive, or performance
  • increased interest in sexual intercourse
  • increased weight
  • loss in sexual ability, desire, drive, or performance
  • stopping of menstrual bleeding
  • watering of the mouth
  • weight loss
Less common
  • Abdominal or bloating and cramping
  • blistering, crusting, irritation, itching, or reddening of the skin
  • change in taste bad unusual or unpleasant (after) taste
  • cracked, dry, or scaly skin
  • cramps
  • double vision
  • feeling of warmth
  • heavy bleeding
  • menstrual changes
  • pain
  • pelvic pain
  • redness of the face, neck, arms, and occasionally, upper chest
  • seeing double
  • sudden sweating
  • unexplained runny nose or sneezing
Rare
  • Acid or sour stomach
  • belching
  • bigger, dilated, or enlarged pupils (black part of the eye)
  • change in color vision
  • difficulty seeing at night
  • feeling of constant movement of self or surroundings
  • feeling of relaxation
  • heartburn
  • hives or welts
  • increased sensitivity of the eyes to sunlight
  • indigestion
  • redness of the skin
  • runny nose
  • sensation of spinning
  • stomach discomfort, upset, or pain
  • stuffy nose
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • sores, ulcers, or white spots in the mouth or on the lips
  • swelling of the breasts or breast soreness in both females and males
  • unexpected or excess milk flow from the breasts

For Healthcare Professionals

Applies to alprazolam: compounding powder, oral concentrate, oral solution, oral tablet, oral tablet disintegrating, oral tablet extended release

General

The most commonly reported side effects were fatigue, tiredness, drowsiness, impaired coordination, and memory impairment.[Ref]

Psychiatric

Very common (10% or more): Irritability (33.1%), anxiety (19.2%), depression (13.9%), confusional state (10.4%),
Common (1% to 10%): Disinhibition, talkativeness, derealization, dream abnormalities, fear
Uncommon (0.1% to 1%): Anger
Frequency not reported: Hallucinations, depersonalization, aggression, hostility, abnormal thinking, withdrawal symptoms
Postmarketing reports: Hypomania, mania[Ref]

Nervous system

Very common (10% or more): Drowsiness (up to 76.8%), impaired coordination (40.1%), memory impairment (33.1%), light-headedness/dizziness (29.8%), insomnia (29.5%). headache (29.2%), cognitive disorder (28.8%), dysarthria (23.3%), abnormal involuntary movement (17.3%), somnolence, ataxia, balance disorder
Common (1% to 10%): Nervousness, syncope, akathisia, agitation, paresthesia, tinnitus, disturbance in attention, hypersomnia, lethargy
Frequency not reported: Dystonia, transient amnesia, loss of coordination, seizures, sedation, slurred speech, taste alterations, psychomotor hyperactivity, autonomic nervous system imbalance, autonomic manifestations, concentration difficulties[Ref]

Hepatic

Frequency not reported: Jaundice, elevated bilirubin, elevated hepatic enzymes, abnormal hepatic function
Postmarketing reports: Hepatitis, hepatic failure[Ref]

Respiratory

Very common (10% or more): Nasal congestion (17.4%)
Common (1% to 10%): Hyperventilation, upper respiratory infection[Ref]

Other

Very common (10% or more): Fatigue/tiredness (48.6%)
Common (1% to 10%): Weakness, felling warm, edema
Frequency not reported: Sleepiness, peripheral edema[Ref]

Ocular

Very common (10% or more): Blurred vision (21%)
Frequency not reported: Diplopia, increased intraocular pressure[Ref]

Genitourinary

Very common (10% or more): Decreased libido (14.4%), micturition difficulties (12.2%), menstrual disorders (10.4%)
Common (1% to 10%): Increased libido, change in libido, sexual dysfunction, incontinence
Uncommon (0.1% to 1%): Irregular menstruation
Frequency not reported: Urinary retention[Ref]

Gastrointestinal

Very common (10% or more): Decreased salivation (32.8%), constipation (26.2%), nausea/vomiting (22%), diarrhea (20.6%), abdominal distress (18.3%), dry mouth (14.7%)
Common (1% to 10%): Increased salivation
Frequency not reported: Gastrointestinal disorder[Ref]

Dermatologic

Very common (10% or more): Sweating (15.1%), rash (10.8%)
Common (1% to 10%): Dermatitis/allergy
Frequency not reported: Pruritus, photosensitivity reaction
Postmarketing reports: Stevens-Johnson syndrome, angioedema[Ref]

Endocrine

Postmarketing reports: Hyperprolactinemia, gynecomastia, galactorrhea[Ref]

Cardiovascular

Very common (10% or more): Tachycardia (15.4%), chest pain (10.6%)
Common (1% to 10%): Palpitations, hypotension[Ref]

Musculoskeletal

Common (1% to 10%): Rigidity, tremor, muscular twitching, muscle tone disorders, vasomotor disturbances, muscular cramps, muscular stiffness
Frequency not reported: Musculoskeletal weakness[Ref]

Metabolic

Very common (10% or more): Increased appetite (32.7%), decreased appetite (27.8%), weight gain (27.2%), weight loss (22.6%)
Frequency not reported: Anorexia[Ref]

Some side effects of Alprazolam Intensol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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