Drugplain

Hydrocortisone Acetate 25 mg/1

Hydrocortisone Acetate · SUPPOSITORY · NuCare Pharmaceuticals,Inc.

6 Recalls on RecordCurrently in Shortage
Plain English

Hydrocortisone Acetate is a suppository containing hydrocortisone acetate at 25 mg/1, taken rectal. Manufactured by NuCare Pharmaceuticals,Inc..

Key Facts

Brand Name
Hydrocortisone Acetate
Generic Name
Hydrocortisone Acetate
NDC Code (Product)
68071-2259
Manufacturer
NuCare Pharmaceuticals,Inc.
Strength
25 mg/1
Dosage Form
SUPPOSITORY
Route
RECTAL
Marketing Status
Marketing Start
02/05/2020

Recall History

6 Recalls on Record
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II10/27/2015

Geritrex Corp

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class III12/07/2016

Novum Pharma, LLC

Subpotent Drug: Out of specification result for pramoxine hydrochloride

TerminatedVoluntary: Firm initiated
Class II01/21/2022

Mylan Pharmaceuticals Inc

cGMP deficiencies

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,100 reports
fatigue1,948 reports
pain1,948 reports
abdominal discomfort1,942 reports
systemic lupus erythematosus1,895 reports
rash1,880 reports
alopecia1,871 reports
rheumatoid arthritis1,803 reports
swelling1,778 reports
glossodynia1,772 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani.

Dosage & Administration

DOSAGE AND ADMINISTRATION FOR RECTAL ADMINISTRATION Detach one suppository from strip of suppositories. Hold suppository upright and carefully separate tabs at top opening and pull downward from the pointed end to expose the suppository. Remove the suppository from the pocket. Avoid excessive handling of suppository which is designed to melt at body temperature. Insert one suppository rectally, pointed end first. Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times a day or two suppositories twice daily. In factitial proctitis, the recommended duration of therapy is six to eight weeks or less, according to the response of the individual case.

Contraindications

CONTRAINDICATIONS Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.

Adverse Reactions

ADVERSE REACTIONS The following local adverse reactions have been reported with hydrocortisone acetate suppositories; burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection. To report an adverse event, please contact Westminster Pharmaceuticals, LLC at 1-844-221-7294.

Frequently Asked Questions

What is Hydrocortisone Acetate used for?

Hydrocortisone Acetate contains Hydrocortisone Acetate. It is a suppository taken rectal. Consult your doctor for specific uses.

Is Hydrocortisone Acetate a controlled substance?

Hydrocortisone Acetate is not classified as a controlled substance by the DEA.

What is the generic name for Hydrocortisone Acetate?

The generic name for Hydrocortisone Acetate is Hydrocortisone Acetate. There are 10 other brand versions of Hydrocortisone Acetate.

What is the NDC code for Hydrocortisone Acetate 25 mg/1?

The NDC (National Drug Code) for Hydrocortisone Acetate 25 mg/1 is 68071-2259, listed by NuCare Pharmaceuticals,Inc..

Product NDC

68071-2259

Package NDC

68071-2259-2

Other Hydrocortisone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)