Analpram E label

Analpram E

Analpram E Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

History

There is currently no drug history available for this drug.

Other Information

Analpram E® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1 % w/w in a hydrolipid base containing cetostearyl alcohol, ceteth 20, mineral oil, white petrolatum, propylparaben, triethanolamine lauryl sulfate, citric acid, sodium citrate, and purified water.

Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below.

Hydrocortisone Acetate

hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11-beta)-C23H32O6; mol. wt.: 404.50

Pramoxine Hydrochloride

pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C17H27NO3.HCl; mol.wt.: 329.87

Analpram E Manufacturers

  • Sebela Pharmaceuticals Inc.
    Analpram E | Marathon Pharmaceuticals, Llc
    No Recall

    Analpram E | Marathon Pharmaceuticals, Llc

    Analpram E | Marathon Pharmaceuticals, Llc

    Start ISUPREL injection at the lowest recommended dose and increase the rate of administration gradually if necessary while carefully monitoring the patient. The usual route of administration is by intravenous infusion or bolus intravenous injection. In dire emergencies, the drug may be administered by intracardiac injection. If time is not of the utmost importance, initial therapy by intramuscular or subcutaneous injection is preferred.

    Recommended dosage for adults with heart block, Adams-Stokes attacks, and cardiac arrest:

    Route of

    Administration

    Preparation of Dilution

    Initial Dose

    Subsequent

    Dose Range*

    Bolus

    intravenous injection

    Dilute 1 mL (0.2 mg) in 9 mL of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP

    0.02 mg to 0.06 mg

    (1 mL to 3 mL of diluted solution)

    0.01 mg to 0.2 mg

    (0.5 mL to 10 mL of diluted solution)

    Intravenous

    infusion

    Dilute 10 mL (2 mg) in 500 mL of 5% Dextrose Injection, USP

    5 mcg/min.

    (1.25 mL of diluted solution per minute)

     

    Intramuscular

    Use Solution undiluted

    0.2 mg (1 mL)

    0.02 mg to 1 mg

    (0.1 mL to 5 mL)

    Subcutaneous

    Use Solution undiluted

    0.2 mg (1 mL)

    0.15 mg to 0.2 mg
    (0.75 mL to 1 mL)

    Intracardiac

    Use Solution undiluted

    0.02 mg (0.1 mL)

     

    *    Subsequent dosage and method of administration depend on the ventricular rate and the rapidity with which the cardiac pacemaker can take over when the drug is gradually withdrawn.

    There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min.

    Recommended dosage for adults with shock and hypoperfusion states:

    Route of Administration

    Preparation of Dilution†

    Infusion Rate††

    Intravenous infusion

     

    Dilute 5 mL (1 mg) in 500 mL of 5% Dextrose Injection, USP

    0.5 mcg to 5 mcg per minute

    (0.25 mL to 2.5 mL of diluted solution)

    †          Concentrations up to 10 times greater have been used when limitation of volume is essential.

    ††        Rates over 30 mcg per minute have been used in advanced stages of shock. The rate of infusion should be adjusted on the basis of heart rate, central venous pressure, systemic blood pressure, and urine   flow. If the heart rate exceeds 110 beats per minute, it may be advisable to decrease or temporarily discontinue the infusion.

        Recommended dosage for adults with bronchospasm occurring during anesthesia:

    Route of

    Administration

    Preparation of Dilution

    Initial Dose

    Subsequent

    Dose

    Bolus

    intravenous

    injection

     

    Dilute 1 mL (0.2 mg) in 9 mL of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP

    0.01 mg to 0.02 mg

    (0.5 mL to 1 mL of diluted solution)

    The initial dose may be repeated when necessary

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Such solution should not be used.

  • Ferndale Laboratories, Inc.
    Analpram E | Ferndale Laboratories, Inc.
    No Recall

    Analpram E | Ferndale Laboratories, Inc.

    Analpram E | Ferndale Laboratories, Inc.

    Topical corticosteroids are generally applied to the affected area as a thin film three to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

  • Ferndale Laboratories, Inc.
    Analpram E | Ferndale Laboratories, Inc.
    No Recall

    Analpram E | Ferndale Laboratories, Inc.

    Analpram E | Ferndale Laboratories, Inc.

    Topical corticosteroids are generally applied to the affected area as a thin film three to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.