BUSPIRONE HYDROCHLORIDE tablet

Buspirone Hydrochloride by

Drug Labeling and Warnings

Buspirone Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by NCS HealthCare of KY, LLC dba Vangard Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Other Events Observed During the Entire Premarketing Evaluation of Buspirone Hydrochloride Tablets

During its premarketing assessment, buspirone hydrochloride tablets were evaluated in over 3500 subjects. This section reports event frequencies for adverse events occurring in approximately 3000 subjects from this group who took multiple doses of buspirone hydrochloride tablets in the dose range for which buspirone is being recommended (i.e., the modal daily dose of buspirone hydrochloride tablets fell between 10 and 30 mg for 70% of the patients studied) and for whom safety data were systematically collected. The conditions and duration of exposure to buspirone hydrochloride tablets varied greatly, involving well-controlled studies as well as experience in open and uncontrolled clinical settings. As part of the total experience gained in clinical studies, various adverse events were reported. In the absence of appropriate controls in some of the studies, a causal relationship to buspirone hydrochloride treatment cannot be determined. The list includes all undesirable events reasonably associated with the use of the drug.

The following enumeration by organ system describes events in terms of their relative frequency of reporting in this data base. Events of major clinical importance are also described in the PRECAUTIONS section.

The following definitions of frequency are used: Frequent adverse events are defined as those occurring in at least 1/100 patients. Infrequent adverse events are those occurring in 1/100 to 1/1000 patients, while rare events are those occurring in less than 1/1000 patients.

Cardiovascular

Frequent was nonspecific chest pain; infrequent were syncope, hypotension, and hypertension; rare were cerebrovascular accident, congestive heart failure, myocardial infarction, cardiomyopathy, and bradycardia.

Central Nervous System

Frequent were dream disturbances; infrequent were depersonalization, dysphoria, noise intolerance, euphoria, akathisia, fearfulness, loss of interest, dissociative reaction, hallucinations, involuntary movements, slowed reaction time, suicidal ideation, and seizures; rare were feelings of claustrophobia, cold intolerance, stupor, and slurred speech and psychosis.

EENT

Frequent were tinnitus, sore throat, and nasal congestion; infrequent were redness and itching of the eyes, altered taste, altered smell, and conjunctivitis; rare were inner ear abnormality, eye pain, photophobia, and pressure on eyes.

Endocrine

Rare were galactorrhea and thyroid abnormality.

Gastrointestinal

Infrequent were flatulence, anorexia, increased appetite, salivation, irritable colon, and rectal bleeding; rare was burning of the tongue.

Genitourinary

Infrequent were urinary frequency, urinary hesitancy, menstrual irregularity and spotting, and dysuria; rare were amenorrhea, pelvic inflammatory disease, enuresis, and nocturia.

Musculoskeletal

Infrequent were muscle cramps, muscle spasms, rigid/stiff muscles, and arthralgias; rare was muscle weakness.

Respiratory

Infrequent were hyperventilation, shortness of breath, and chest congestion; rare was epistaxis.

Sexual Function

Infrequent were decreased or increased libido; rare were delayed ejaculation and impotence.

Skin

Infrequent were edema, pruritus, flushing, easy bruising, hair loss, dry skin, facial edema, and blisters; rare were acne and thinning of nails.

Clinical Laboratory

Infrequent were increases in hepatic aminotransferases (SGOT, SGPT); rare were eosinophilia, leukopenia, and thrombocytopenia.

Miscellaneous

Infrequent were weight gain, fever, roaring sensation in the head, weight loss, and malaise; rare were alcohol abuse, bleeding disturbance, loss of voice, and hiccoughs.

Postmarketing Experience

Postmarketing experience has shown an adverse experience profile similar to that given above. Voluntary reports since introduction have included rare occurrences of allergic reactions (including urticaria), angioedema, cogwheel rigidity, dizziness (rarely reported as vertigo), dystonic reactions (including dystonia), ataxias, extrapyramidal symptoms, dyskinesias (acute and tardive), ecchymosis, emotional lability, serotonin syndrome, transient difficulty with recall, urinary retention, visual changes (including tunnel vision), parkinsonism, akathisia, restless leg syndrome, and restlessness. Because of the uncontrolled nature of these spontaneous reports, a causal relationship to buspirone hydrochloride tablets treatment has not been determined.

  • DRUG ABUSE AND DEPENDENCE

    Controlled Substance Class

    Buspirone hydrochloride is not a controlled substance.

    Physical and Psychological Dependence

    In human and animal studies, buspirone has shown no potential for abuse or diversion and there is no evidence that it causes tolerance, or either physical or psychological dependence. Human volunteers with a history of recreational drug or alcohol usage were studied in two double-blind clinical investigations. None of the subjects were able to distinguish between buspirone hydrochloride tablets and placebo. By contrast, subjects showed a statistically significant preference for methaqualone and diazepam. Studies in monkeys, mice, and rats have indicated that buspirone lacks potential for abuse.

    Following chronic administration in the rat, abrupt withdrawal of buspirone did not result in the loss of body weight commonly observed with substances that cause physical dependency.

    Although there is no direct evidence that buspirone hydrochloride tablets cause physical dependence or drug-seeking behavior, it is difficult to predict from experiments the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of buspirone hydrochloride tablets misuse or abuse (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

  • OVERDOSAGE

    Signs and Symptoms

    In clinical pharmacology trials, doses as high as 375 mg/day were administered to healthy male volunteers. As this dose was approached, the following symptoms were observed: nausea, vomiting, dizziness, drowsiness, miosis, and gastric distress. A few cases of overdosage have been reported, with complete recovery as the usual outcome. No deaths have been reported following overdosage with buspirone hydrochloride tablets alone. Rare cases of intentional overdosage with a fatal outcome were invariably associated with ingestion of multiple drugs and/or alcohol, and a causal relationship to buspirone could not be determined. Toxicology studies of buspirone yielded the following LD50 values: mice, 655 mg/kg; rats, 196 mg/kg; dogs, 586 mg/kg; and monkeys, 356 mg/kg. These dosages are 160 to 550 times the recommended human daily dose.

    Recommended Overdose Treatment

    General symptomatic and supportive measures should be used along with immediate gastric lavage. Respiration, pulse, and blood pressure should be monitored as in all cases of drug overdosage. No specific antidote is known to buspirone, and dialyzability of buspirone has not been determined.

  • DOSAGE AND ADMINISTRATION

    The recommended initial dose is 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 to 30 mg per day were commonly employed.

    The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food.

    When buspirone is to be given with a potent inhibitor of CYP3A4, the dosage recommendations described in the PRECAUTIONS, Drug Interactions section should be followed.

  • HOW SUPPLIED

    BusPIRone Hydrochloride Tablets USP, 5 mg are available as white to off-white, round, beveled-edge tablets, debossed “TV” and “53” on one side and scored on the other side and packaged in blistercards of 30 tablets and boxes of 30 tablets for unit-dose dispensing.

    BusPIRone Hydrochloride Tablets USP, 10 mg are available as white to off-white, round, beveled-edge tablets, debossed “TEVA” on one side and scored and debossed “54” on the other side and packaged in blistercards of 30 and 31 tablets.

    BusPIRone Hydrochloride Tablets USP, 15 mg are available as white to off-white, rectangular, tablets that can either be bisected or trisected, debossed “TV” and “1003” on bisect segments, and debossed “5” on each trisect segment, and packaged in blistercards of 30 and 31 tablets.

    BusPIRone Hydrochloride tablets USP, 30 mg are available as white to off-white, rectangular, tablets that can either be bisected or trisected, debossed “TV” and “5200” on bisect segments, and debossed “10” on each trisect segment.

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

    Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

  • REFERENCES

  • SPL UNCLASSIFIED SECTION

    Manufactured In Croatia By:

    PLIVA HRVATSKA d.o.o.

    Zagreb, Croatia

    Manufactured For:

    TEVA PHARMACEUTICALS USA

    Sellersville, PA 18960

    Rev. X 2/2011

  • PATIENT INFORMATION

    BUSPIRONE HYDROCHLORIDE TABLETS USP

    Rx only

    HOW TO USE:

    BUSPIRONE HYDROCHLORIDE TABLETS, 15 mg

    Response to buspirone varies among individuals. Your physician may find it necessary to adjust your dosage to obtain the proper response.

    This tablet design makes dosage adjustments easy. Each tablet is scored and can be broken accurately to provide any of the following dosages:

    If your doctor prescribed the 15 mg tablet:

    15 mg (the entire tablet)

    15 mg (the entire tablet)

    10 mg (two-thirds of a tablet)

    10 mg (two-thirds of a tablet)

    7.5 mg (one-half of a tablet)

    7.5 mg (one-half of a tablet)

    5 mg (one-third of a tablet)

    5 mg (one-third of a tablet)

    To break a tablet accurately and easily, hold the tablet between your thumbs and index fingers close to the appropriate tablet score (groove) as shown below. Then, with the tablet score facing you, apply pressure and snap the tablet segments apart (segments breaking incorrectly should not be used).

    break tablet 15 mg

    Manufactured In Croatia By:

    PLIVA HRVATSKA d.o.o.

    Zagreb, Croatia

    Manufactured For:

    TEVA PHARMACEUTICALS USA

    Sellersville, PA 18960

    Rev. F 2/2011

  • PATIENT INFORMATION

    BUSPIRONE HYDROCHLORIDE TABLETS USP

    Rx only

    HOW TO USE:

    BUSPIRONE HYDROCHLORIDE TABLETS, 30 mg

    Response to buspirone varies among individuals. Your physician may find it necessary to adjust your dosage to obtain the proper response.

    This tablet design makes dosage adjustments easy. Each tablet is scored and can be broken accurately to provide any of the following dosages:

    If your doctor prescribed the 30 mg tablet:

    30 mg (the entire tablet)

    30 mg (the entire tablet)

    20 mg (two-thirds of a tablet)

    20 mg (two-thirds of a tablet)

    15 mg (one-half of a tablet)

    15 mg (one-half of a tablet)

    10 mg (one-third of a tablet)

    10 mg (one-third of a tablet)

    To break a tablet accurately and easily, hold the tablet between your thumbs and index fingers close to the appropriate tablet score (groove) as shown below. Then, with the tablet score facing you, apply pressure and snap the tablet segments apart (segments breaking incorrectly should not be used).

    break tablet 30 mg

    Manufactured In Croatia By:

    PLIVA HRVATSKA d.o.o.

    Zagreb, Croatia

    Manufactured For:

    TEVA PHARMACEUTICALS USA

    Sellersville, PA 18960

    Rev. F 2/2011

  • PRINCIPAL DISPLAY PANEL

     Buspirone Hydrochloride Tablets, USP 15mg

    Principal Display Panel-Buspirone Hydrochloride Tablets 15mg 

  • PRINCIPAL DISPLAY PANEL

    Buspirone HCl Tab, USP 5mg 

    Buspirone Tabs 5mg Unit Dose Label
  • PRINCIPAL DISPLAY PANEL

     Buspirone Hydrochloride Tabs, USP 10mg

    Principal Display Panel-Buspirone Hydrochloride Tablets, USP 10mg
  • INGREDIENTS AND APPEARANCE
    BUSPIRONE HYDROCHLORIDE 
    buspirone hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0615-7689(NDC:0093-1003)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL) BUSPIRONE HYDROCHLORIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (white to off-white) Score3 pieces
    ShapeRECTANGLESize15mm
    FlavorImprint Code TV;1003;5;5;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0615-7689-3131 in 1 BLISTER PACK; Type 0: Not a Combination Product02/13/201204/30/2016
    2NDC: 0615-7689-3930 in 1 BLISTER PACK; Type 0: Not a Combination Product01/24/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07502212/23/2010
    BUSPIRONE HYDROCHLORIDE 
    buspirone hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0615-7714(NDC:0093-0053)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL) BUSPIRONE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (Off White) Score2 pieces
    ShapeROUNDSize6mm
    FlavorImprint Code TV;53
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0615-7714-306 in 1 BOX, UNIT-DOSE04/23/2012
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC: 0615-7714-3930 in 1 BLISTER PACK; Type 0: Not a Combination Product04/23/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07502204/23/2012
    BUSPIRONE HYDROCHLORIDE 
    buspirone hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0615-7718(NDC:0093-0054)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL) BUSPIRONE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (white to off-white) Score2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code TEVA;54
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0615-7718-3131 in 1 BLISTER PACK; Type 0: Not a Combination Product08/07/201201/31/2017
    2NDC: 0615-7718-3930 in 1 BLISTER PACK; Type 0: Not a Combination Product08/07/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07502202/28/2002
    Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
    Establishment
    NameAddressID/FEIBusiness Operations
    NCS HealthCare of KY, Inc dba Vangard Labs050052943REPACK(0615-7689, 0615-7714, 0615-7718)

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