Cortenema

DRUG 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- trihydroxy-,(11?) and the following structural formula:

CORTENEMA (hydrocortisone) structural formula illustration

CORTENEMA* 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.

What are the possible side effects of hydrocortisone rectal foam or enema (Colocort, Cortenema, Cortifoam)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling short of breath, even with mild exertion;
  • swelling of your ankles or feet;
  • muscle weakness;
  • rapid weight gain, especially in your face and midsection;
  • severe rectal pain or burning;
  • ...

Read All Potential Side Effects and See Pictures of Cortenema

What are the precautions when taking hydrocortisone (Cortenema)?

Before using hydrocortisone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other stomach/intestinal problems (such as ulcers, blockage, bleeding, infection, recent surgery), infections (such as tuberculosis, fungal infections), certain eye conditions (cataracts, glaucoma, herpes infection of the eye), heart problems (such as congestive heart failure, recent heart attack), high blood pressure, liver disease, kidney disease, thyroid problems...

Read All Potential Precautions of Cortenema


Cortenema Consumer (continued)

SIDE EFFECTS: Pain or burning in the rectum, dizziness, menstrual period changes, trouble sleeping, unusual weight gain, increased sweating, acne, or unusual hair growth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: persistent headache, swelling ankles/feet, increased thirst/urination, vision problems, puffy face, thinning skin, unusual skin growths, slow wound healing, persistent rectal bleeding, unusual bruising/bleeding, black/tarry stools, vomit that looks like coffee grounds, severe stomach/abdominal pain, severe heartburn, bone pain, easily broken bones, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, irregular heartbeat, signs of infection (such as fever, persistent sore throat, painful urination, worsening redness/irritation near the anus), seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using hydrocortisone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other stomach/intestinal problems (such as ulcers, blockage, bleeding, infection, recent surgery), infections (such as tuberculosis, fungal infections), certain eye conditions (cataracts, glaucoma, herpes infection of the eye), heart problems (such as congestive heart failure, recent heart attack), high blood pressure, liver disease, kidney disease, thyroid problems (overactive or underactive thyroid disease), diabetes, bone loss (osteoporosis), bleeding or blood clotting problems, mental/mood conditions (such as psychosis, depression), low potassium or calcium blood levels, a certain muscle/nerve disease (myasthenia gravis).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages to decrease the risk of dizziness and also stomach/intestinal bleeding.

Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor immediately if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.

Do not have immunizations, vaccinations, or skin tests without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This drug can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

If you have diabetes, this drug may make it harder to control your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.

This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.

During pregnancy, this medication should be used only when clearly needed and not for prolonged periods. Other forms of hydrocortisone (given by mouth or by injection) may harm an unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have low levels of the natural corticosteroid hormone in their bodies and may need more monitoring. Tell your doctor immediately if you notice symptoms such as vomiting, severe diarrhea, or weakness in your newborn.

It is unknown if this drug passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Cortenema Patient Information Including Side Effects

Brand Names: Colocort, Cortenema, Cortifoam

Generic Name: hydrocortisone rectal (foam, enema) (Pronunciation: hye dro KORT i zone REK tal)

  • What is hydrocortisone rectal foam or enema (Cortenema)?
  • What are the possible side effects of hydrocortisone rectal foam or enema (Cortenema)?
  • What is the most important information I should know about hydrocortisone rectal foam or enema (Cortenema)?
  • What should I discuss with my health care provider before using hydrocortisone rectal foam or enema (Cortenema)?
  • How should I use hydrocortisone rectal foam or enema (Cortenema)?
  • What happens if I miss a dose (Cortenema)?
  • What happens if I overdose (Cortenema)?
  • What should I avoid while using hydrocortisone rectal foam or enema (Cortenema)?
  • What other drugs will affect hydrocortisone rectal foam or enema (Cortenema)?
  • Where can I get more information?

What is hydrocortisone rectal foam or enema (Cortenema)?

Hydrocortisone is a steroid medicine that reduces inflammation in the body.

The information in this medication guide is specific to hydrocortisone rectal foam or enema.

Hydrocortisone rectal is used to treat hemorrhoids and itching or swelling of the rectal area caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone rectal is also used together with other medications to treat ulcerative colitis, proctitis, and other inflammatory conditions of the lower intestines and rectal area.

Hydrocortisone rectal foam or enema may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of hydrocortisone rectal foam or enema (Cortenema)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling short of breath, even with mild exertion;
  • swelling of your ankles or feet;
  • muscle weakness;
  • rapid weight gain, especially in your face and midsection;
  • severe rectal pain or burning;
  • bleeding from your rectum;
  • severe stomach pain;
  • sudden and severe headache or pain behind your eyes; or
  • seizure (convulsions).

Less serious side effects may include:

  • mild rectal pain or burning;
  • acne;
  • changes in your menstrual periods;
  • increased sweating; or
  • increased facial or body hair growth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about hydrocortisone rectal foam or enema (Cortenema)?

The information in this medication guide is specific to hydrocortisone rectal foam or enema.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Call your doctor at once if you have any bleeding from your rectum, feeling short of breath (even with mild exertion), swelling of your ankles or feet, or rapid weight gain.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

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