Hydrocortisone Rectal Suspension (retention)

Hydrocortisone


Chartwell Rx Llc
Human Prescription Drug
NDC 62135-020
Hydrocortisone Rectal Suspension (retention) also known as Hydrocortisone is a human prescription drug labeled by 'Chartwell Rx Llc'. National Drug Code (NDC) number for Hydrocortisone Rectal Suspension (retention) is 62135-020. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Hydrocortisone Rectal Suspension (retention) drug includes Hydrocortisone - 100 mg/60mL . The currest status of Hydrocortisone Rectal Suspension (retention) drug is Active.

Drug Information:

Drug NDC: 62135-020
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Hydrocortisone Rectal Suspension (retention)
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Hydrocortisone
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Chartwell Rx Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Suspension
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:HYDROCORTISONE - 100 mg/60mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:RECTAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 03 Dec, 1999
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 25 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA075172
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Chartwell RX LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:310878
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0362135020460
0362135020071
0362135020217
UPC stands for Universal Product Code.
NUI:N0000175576
N0000175450
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:WI4X0X7BPJ
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:Corticosteroid Hormone Receptor Agonists [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:Corticosteroid [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
62135-020-077 BOTTLE in 1 CARTON (62135-020-07) / 60 mL in 1 BOTTLE06 Sep, 2021N/ANo
62135-020-213 CARTON in 1 BOX (62135-020-21) / 7 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE18 Nov, 2021N/ANo
62135-020-461 BOTTLE in 1 CARTON (62135-020-46) / 60 mL in 1 BOTTLE06 Sep, 2021N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Hydrocortisone rectal suspension (retention) hydrocortisone carbomer homopolymer type b (allyl sucrose crosslinked) polysorbate 80 water sodium hydroxide methylparaben hydrocortisone hydrocortisone

Indications and Usage:

Indications and usage hydrocortisone rectal suspension, usp is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. it has proved useful also in some cases involving the transverse and ascending colons.

Warnings:

Warnings in severe ulcerative colitis, it is hazardous to delay needed surgery while awaiting response to medical treatment. damage to the rectal wall can result from careless or improper insertion of an enema tip. in patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. corticosteroids may mask some signs of infection, and new infections may appear during their use. there may be decreased resistance and inability to localize infection when corticosteroids are used. prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. usage in pregnancy: since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of child-bearing pot
ential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. neonates born of mothers who have received substantial doses of corticosteroid during pregnancy should be carefully observed for signs of hypoadrenalism. average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. these effects are less likely to occur with the synthetic derivatives except when used in large doses. dietary salt restriction and potassium supplementation may be necessary. all corticosteroids increase calcium excretion. while on corticosteroid therapy, patients should not be vaccinated against smallpox. other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response. persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. chicken pox and measles, for example, can have a more serious or even fatal course in non-immune pediatric patients or adults on corticosteroids. in such pediatric patients or adults who have not had these diseases, particular care should be taken to avoid exposure. how the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. the contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. if exposed to chicken pox, prophylaxis with varicella zoster immune globulin (vzig) may be indicated. if exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (ig) may be indicated. (see the respective package inserts for complete vzig and ig prescribing information.) if chicken pox develops, treatment with antiviral agents may be considered. if corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. during prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

General Precautions:

General: hydrocortisone rectal suspension, usp should be used with caution where there is a probability of impending perforation, abscess or other pyogenic infection; fresh intestinal anastomoses; obstruction; or extensive fistulas and sinus tracts. use with caution in presence of active or latent peptic ulcer; diverticulitis; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis. steroid therapy might impair prognosis in surgery by increasing the hazard of infection. if infection is suspected, appropriate antibiotic therapy must be administered, usually in larger than ordinary doses. drug-induced secondary adrenocortical insufficiency may occur with prolonged hydrocortisone rectal suspension, usp therapy. this is minimized by gradual reduction of dosage. this type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. since mineraloco
rticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. there is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. corticosteroid should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. the lowest possible dose of corticosteroid should be used to control the conditions under treatment, and when reduction in dosage is possible, the reduction should be gradual. psychic derangement may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Dosage and Administration:

Dosage and administration the use of hydrocortisone rectal suspension, usp hydrocortisone retention enema is predicated upon the concomitant use of modern supportive measures such as rational dietary control, sedatives, antidiarrheal agents, antibacterial therapy, blood replacement if necessary, etc. the usual course of therapy is one hydrocortisone rectal suspension, usp nightly for 21 days, or until the patient comes into remission both clinically and proctologically. clinical symptoms usually subside promptly within 3 to 5 days. improvement in the appearance of the mucosa, as seen by sigmoidoscopic examination, may lag somewhat behind clinical improvement. difficult cases may require as long as 2 or 3 months of hydrocortisone rectal suspension, usp treatment. where the course of therapy extends beyond 21 days, hydrocortisone rectal suspension, usp should be discontinued gradually by reducing administration to every other night for 2 or 3 weeks. if clinical or proctologic improvement
fails to occur within 2 or 3 weeks after starting hydrocortisone rectal suspension, usp, discontinue its use. symptomatic improvement, evidenced by decreased diarrhea and bleeding; weight gain; improved appetite; lessened fever; and decrease in leukocytosis, may be misleading and should not be used as the sole criterion in judging efficacy. sigmoidoscopic examination and x-ray visualization are essential for adequate monitoring of ulcerative colitis. biopsy is useful for differential diagnosis. patient instructions for administering hydrocortisone rectal suspension, usp are enclosed in each box. it is recommended that the patient lie on their left side during administration and for 30 minutes thereafter, so that the fluid will distribute throughout the left colon. every effort should be made to retain the enema for at least an hour and preferably, all night. this may be facilitated by prior sedation and/or antidiarrheal medication, especially early in therapy when the urge to evacuate is great.

Contraindications:

Contraindications systemic fungal infections; and ileocolostomy during the immediate or early post-operative period.

Adverse Reactions:

Adverse reactions local pain or burning, and rectal bleeding attributed to hydrocortisone rectal suspension, usp have been reported rarely. apparent exacerbations or sensitivity reactions also occur rarely. the following adverse reactions should be kept in mind whenever corticosteroids are given by rectal administration. fluid and electrolyte disturbances: sodium retention; fluid retention; congestive heart failure in susceptible patients; potassium loss; hypokalemic alkalosis; hypertension. musculoskeletal: muscle weakness; steroid myopathy; loss of muscle mass; osteoporosis; vertebral compression fractures; asceptic necrosis of femoral and humeral heads; pathologic fracture of long bones. gastrointestinal: peptic ulcer with possible perforation and hemorrhage; pancreatitis; abdominal distention; ulcerative esophagitis. dermatologic: impaired wound healing; thin fragile skin; petechiae and ecchymoses; facial erythema; increased sweating; may suppress reactions to skin tests. neurologi
cal: convulsions; increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment; vertigo; headache. endocrine: menstrual irregularities; development of cushingoid state; suppression of growth in pediatric patients; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness, decreased carbohydrate tolerance; manifestations of latent diabetes requirements for insulin or oral hypoglycemic agents in diabetics. ophthalmic: posterior subcapsular cataracts; increased intraocular pressure; glaucoma; exophthalmos. metabolic: negative nitrogen balance due to protein catabolism.

Pediatric Use:

Pediatric use: safety and effectiveness in pediatric patients have not been established. growth and development of pediatric patients on prolonged corticosteroid therapy should be carefully observed.

Description:

Description hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. it has the chemical name pregn-4-ene-3,20-dione,11,17,21-tri-hydroxy,(11β)-and the following structural formula: c 21 h 30 o 5 m.w. 362.47 hydrocortisone rectal suspension, usp is a convenient disposable single-dose hydrocortisone enema designed for ease of self-administration. each disposable unit (60 ml) contains: hydrocortisone, 100 mg in an aqueous solution containing carbomer 934p, polysorbate 80, purified water, sodium hydroxide and methylparaben, 0.18% as a preservative. chemical structure

Clinical Pharmacology:

Clinical pharmacology hydrocortisone is a naturally occurring glucocorticoid (adrenal corticosteroid), similar to its acetate and sodium hemisuccinate derivatives, is partially absorbed following rectal administration. absorption studies in ulcerative colitis patients have shown up to 50% absorption of hydrocortisone administered as hydrocortisone rectal suspension, usp and up to 30% of hydrocortisone acetate administered in an identical vehicle. hydrocortisone rectal suspension, usp provides the potent anti-inflammatory effect of hydrocortisone. because this drug is absorbed from the colon, it acts both topically and systemically. although rectal hydrocortisone, used as recommended for hydrocortisone rectal suspension, usp, has a low incidence of reported adverse reactions, prolonged use presumably may cause systemic reactions associated with oral dosage forms.

How Supplied:

How supplied hydrocortisone rectal suspension, usp (retention) 100 mg/60 ml, is supplied as disposable single-dose bottles with lubricated rectal applicator tips, in boxes of seven x 60 ml (ndc 62135-020-07), boxes of one x 60 ml (ndc 62135-020-46) and boxes of three x seven x 60 ml (ndc 62135-020-21). store at controlled room temperature 20° to 25°c (68° to 77°f). [see usp controlled room temperature] rx only manufactured for: chartwell rx, llc. congers, ny 10920 made in usa l70536 rev: 10/2021

Package Label Principal Display Panel:

Package/label principal display panel hydrocortisone rectal suspension, usp (retention) 100 mg/60 ml - ndc 62135-020-46 - carton hydrocortisone rectal suspension, usp (retention) 100 mg/60 ml - ndc 62135-020-46 - container hydrocortisone rectal suspension, usp (retention) 100 mg/60 ml - unit dose 7 x 60 ml - ndc 62135-020-07 - carton hydrocortisone rectal suspension, usp (retention) 100 mg/60 ml - 3 cartons of 7 x 60 ml - ndc 62135-020-21 - container hydrocortisone rectal suspension, usp 100 mg/60 ml - ndc 62135-020-46 - carton hydrocortisone rectal suspension, usp 100 mg/60 ml - ndc 62135-020-46 - container hydrocortisone rectal suspension, usp 100 mg/60 ml - ndc 62135-020-07 - carton hydrocortisone rectal suspension, usp 100 mg/60 ml - ndc 62135-020-21- container


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