cortenema
Pharmaranks rates Cortenema 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Cortenema (Hydrocortisone) is a corticosteroid used to treat Adrenal Insufficiency, Congenital Adrenal Hyperplasia, Ulcerative Colitis, Contact Dermatitis.
Hydrocortisone · by Ani Pharms
Available as a generic: Nutracort
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Hydrocortisone
- Drug class
- Corticosteroid
- Form
- Enema
- Strength
- Hydrocortisone 100MG/60ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Ani Pharms
- Half-life
- about 1.5 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.15 per gm — not your price
- FDA application
- NDA016199
What is Cortenema?
From the FDA label: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-trihydroxy-,(11β)- and the following structural formula: 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
How to use
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…
Side effects
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. Neurological: 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;…
Warnings
Important safety information
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 potential 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.
Who should not take Cortenema
Systemic fungal infections; and ileocolostomy during the immediate or early post-operative period.
How long does Hydrocortisone stay in your body?
The elimination half-life of hydrocortisone is about 1.5 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the plasma (terminal) elimination half-life; the FDA label states "The terminal half-life of hydrocortisone is about 1.5 hours following intravenous and oral dosing of hydrocortisone tablets" in healthy adults, so roughly 90% of a dose clears within about 8 hours and nearly all within ~12 hours. Hydrocortisone is not a prodrug, but its half-life measures how fast the drug leaves the blood, not how long its effects last: as a short-acting glucocorticoid its biological (tissue) effect on the body persists well beyond blood clearance, and this short plasma half-life is why oral replacement is usually dosed 2-3 times a day. Because hydrocortisone is metabolized in the liver, significant liver impairment can slow clearance; the label does not give a specific half-life adjustment for age, kidney, or liver function. Half-life is not the same as a drug-test detection window.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: ALKINDI SPRINKLE (hydrocortisone) oral granules — FDA prescribing information, DailyMed.
Drug class
How this class works, per Corticosteroids - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- adrenal insufficiency
- congenital adrenal hyperplasia
- ulcerative colitis
- contact dermatitis
- facial dermatoses
- foot dermatoses
See how Cortenema ranks — best-rated corticosteroid for:
Dosage forms
Enema
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Cortenema treat?
- Cortenema (Hydrocortisone) may be used to treat adrenal insufficiency, congenital adrenal hyperplasia, ulcerative colitis, contact dermatitis, facial dermatoses, foot dermatoses, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Cortenema work?
- Cortenema is a corticosteroid. Corticosteroids mimic the body's natural stress hormone cortisol: they enter cells and bind a glucocorticoid receptor that switches off genes for inflammatory chemicals, calming swelling, redness, and an overactive immune response.
- How is Cortenema rated?
- pharmaranks gives Cortenema a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Cortenema cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.15 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Cortenema?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cortenema. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cortenema?
- Cortenema is marketed by Ani Pharms. You can see Ani Pharms's full profile, rating, and other products on pharmaranks.
- Is Cortenema a brand-name or generic drug?
- Cortenema is a brand-name product with the active ingredient Hydrocortisone. Lower-cost generic equivalents containing Hydrocortisone are available — ask your pharmacist.
- Is Cortenema available over the counter?
- No. Cortenema is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cortenema come in?
- Cortenema is currently marketed as enema, per the FDA's National Drug Code Directory.
- What class of drug is Cortenema?
- Cortenema is classified as corticosteroid, per the FDA's Established Pharmacologic Class.
- Is Cortenema FDA-registered?
- Cortenema is on record with the U.S. FDA under application number NDA016199. You can verify this on its official FDA label.
- Has Cortenema been recalled by the FDA?
- Cortenema has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Cortenema safe?
- There's no single safe-or-not verdict. pharmaranks gives Cortenema a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Cortenema?
- Cortenema's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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cortenema
70/100