Diprolene label

Diprolene

Diprolene Recall

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Side Effects & Adverse Reactions

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FDA Safety Alerts

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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

DIPROLENE® Lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.

History

There is currently no drug history available for this drug.

Other Information

DIPROLENE (augmented betamethasone dipropionate) Lotion contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone.

Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21- trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:

Chemical Structure

It is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol.

Each gram of DIPROLENE Lotion 0.05% contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone), in a colorless, clear to translucent lotion base of hydroxypropyl cellulose; isopropyl alcohol (30%); phosphoric acid used to adjust the pH; propylene glycol; purified water; and sodium phosphate monobasic monohydrate.

Diprolene Manufacturers

  • Merck Sharp & Dohme Corp.
    Diprolene | Merck Sharp & Dohme Corp.
    No Recall

    Diprolene | Merck Sharp & Dohme Corp.

    Diprolene | Merck Sharp & Dohme Corp.

    Apply a few drops of DIPROLENE Lotion to the affected skin areas once or twice daily and massage lightly until the lotion disappears.

    Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. DIPROLENE Lotion is a super-high-potency topical corticosteroid. Treatment with DIPROLENE Lotion should be limited to 2 consecutive weeks and amounts should not exceed 50 mL per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

    DIPROLENE Lotion should not be used with occlusive dressings unless directed by a physician.

    DIPROLENE Lotion is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

    Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.

  • Merck Sharp & Dohme Corp.
    Diprolene | Hospira, Inc.
    No Recall

    Diprolene | Hospira, Inc.

    Diprolene | Hospira, Inc.

    Ampicillin and Sulbactam for Injection may be administered by either the IV or the IM routes.

    For IV administration, the dose can be given by slow intravenous injection over at least 10 to 15 minutes or can also be delivered in greater dilutions with 50 to 100 mL of a compatible diluent as an intravenous infusion over 15 to 30 minutes.

    Ampicillin and Sulbactam for Injection may be administered by deep intramuscular injection (see DIRECTIONS FOR USE-Preparation for Intramuscular Injection section).

    The recommended adult dosage of ampicillin and sulbactam for injection is 1.5 g (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection, and corresponds to a range of 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total dose of sulbactam should not exceed 4 grams per day.

    Pediatric Patients 1 Year of Age or Older: The recommended daily dose of ampicillin and sulbactam for injection in pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours. This 300 mg/kg/day dosage represents the total ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy of ampicillin and sulbactam for injection administered via intramuscular injection in pediatric patients have not been established. Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 grams per day. The course of intravenous therapy should not routinely exceed 14 days. In clinical trials, most children received a course of oral antimicrobials following initial treatment with intravenous ampicillin and sulbactam for injection. (see CLINICAL STUDIES section).

    Impaired Renal Function

    In patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of ampicillin and sulbactam in such patients should be administered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations:

    Table 5
    Ampicillin and Sulbactam for Injection Dosage Guide for Patients
    with Renal Impairment

    Creatinine Clearance
    (mL/min/1.73 m2)

    Ampicillin/Sulbactam
    Half-Life (Hours)

    Recommended
    Ampicillin and Sulbactam Dosage 

    ≥30

    1

    1.5 g to 3 g q 6h - q 8h

    15 to 29

    5

    1.5 g to 3 g q 12h

    5 to 14

    9

    1.5 g to h3 g q 24h

    When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

                 Males         weight (kg) × (140 – age)
                                       72 × serum creatinine

                 Females         0.85 × above value