Label: DICYCLOMINE - dicyclomine hydrochloride tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 10/09

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  • SPL UNCLASSIFIED SECTION

    Revised 03/04
    Rx Only

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  • DESCRIPTION

    Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following form:

    Each tablet, for oral administration, contains 20 mg of dicyclomine hydrochloride. They also contain the following inactive ingredients: Anhydrous Lactose, FDandC Blue No. 1 Lake, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose.

    Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethylester, hydrochloride with the structural formula:

    dicyclomine structure     DICYCLOMINE 20MG STRUCTURE IMAGE

    Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether

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  • CLINICAL PHARMACOLOGY

    Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism: (1) a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine (in vitro, guinea pig ileum); and (2) a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine's antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum. Atropine did not affect responses to these two agonists. In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl2)-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl2. Tests for mydriatic effects in mice showed that dicyclomine was approximately 1/500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1/300 as potent as atropine.

    In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60-90 minutes. The principal route of elimination is via the urine (79.5% of the dose). Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life. Mean volume of distribution for a 20 mg oral dose is approximately 3.65 L/kg suggesting extensive distribution in tissues.

    In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg q.i.d.) demonstrated a favorable clinical response compared with 55% treated with placebo. (P less than .05). In these trials, most of the side effects were typically anticholinergic in nature (see table) and were reported by 61% of the patients.
        Dicyclomine Hydrochloride    
    Side    (40 mg q.i.d.)    Placebo
    Effect    %    %
    Dry Mouth    33    5
    Dizziness    29    2
    Blurred Vision    27    2
    Nausea    14    6
    Light-Headedness    11    3
    Drowsiness    9    1
    Weakness    7    1
    Nervousness    6    2

    Nine percent (9%) of patients were discontinued from the drug because of one or more of these side effects (compared with 2% in the placebo group). In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction. A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated. (See  ADVERSE REACTIONS.)

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  • INDICATIONS AND USAGE

    For the treatment of functional bowel/irritable bowel syndrome.

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  • CONTRAINDICATIONS

    1. Obstructive uropathy
    2. Obstructive disease of the gastrointestinal tract
    3. Severe ulcerative colitis (See  PRECAUTIONS)
    4. Reflux esophagitis
    5. Unstable cardiovascular status in acute hemorrhage
    6. Glaucoma
    7. Myasthenia gravis
    8. Evidence of prior hypersensitivity to dicyclomine hydrochloride or other ingredients of these formulations
    9. Infants less than 6 months of age (See  WARNINGS and  PRECAUTIONS: Information for Patients.)
    10. Nursing Mothers (See  WARNINGS and  PRECAUTIONS: Information for Patients.)

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  • WARNINGS

    In the presence of a high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and supportive measures instituted.

    Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.

    Dicyclomine hydrochloride may produce drowsiness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.

    Psychosis has been reported in sensitive individuals given anticholinergic drugs. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, decreased anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug.

    DICYCLOMINE IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE AND IN NURSING MOTHERS. (See  CONTRAINDICATIONS and  PRECAUTIONS: Nursing Mothers and  Pediatric Use).

    Safety and efficacy of dicyclomine hydrochloride in children have not been established.

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  • HOW SUPPLIED

    Dicyclomine Hydrochloride Tablets USP, 20 mg are supplied as blue, round, unscored tablets; embossed “WW 27” and are available in:

     
        Bottles of 100 tablets.
     
        Bottles of 1000 tablets.
     
        Unit Dose Boxes of 100 tablets.

    To prevent fading, avoid exposure to direct sunlight. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

    Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

    Manufactured By:
    West-ward Pharmaceutical Corp.
    Eatontown, NJ 07724
    Revised March 200

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  • PRINCIPAL DISPLAY PANEL

    DICYCLOMINE 20MG LABEL IMAGE     DICYCLOMINE 20MG LABEL IMAGE

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  • INGREDIENTS AND APPEARANCE
    DICYCLOMINE 
    dicyclomine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16590-324(NDC:0143-1227)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE) DICYCLOMINE HYDROCHLORIDE 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE  
    FD&C BLUE NO. 1  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    Product Characteristics
    Color blue Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code WW;27
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16590-324-30 30 in 1 BOTTLE, PLASTIC
    2 NDC:16590-324-60 60 in 1 BOTTLE, PLASTIC
    3 NDC:16590-324-90 90 in 1 BOTTLE, PLASTIC
    4 NDC:16590-324-72 120 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040161 10/01/1996
    Labeler - STAT RX USA LLC (786036330)
    Establishment
    Name Address ID/FEI Business Operations
    STAT RX USA LLC 786036330 repack, relabel
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