Cortef

DRUG DESCRIPTION

CORTEF Tablets contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215 C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform.

The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11?)-. Its molecular weight is 362.46 and the structural formula is as outlined below.

CORTEF (hydrocortisone)  Structural Formula Illustration

CORTEF (hydrocortisone tablet) Tablets are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose.

What are the possible side effects of hydrocortisone (Cortef, Hydrocortone)?

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:

  • problems with your vision;
  • swelling, rapid weight gain, feeling short of breath;
  • severe depression, unusual thoughts or behavior, seizure (convulsions);
  • bloody or tarry stools, coughing up blood;
  • pancreatitis (severe pain in your upper...

Read All Potential Side Effects and See Pictures of Cortef

What are the precautions when taking hydrocortisone tablet (Cortef)?

Before using this product, tell your doctor or pharmacist if you are allergic to neomycin, bacitracin, polymyxin, or hydrocortisone; or to aminoglycoside antibiotics (e.g., gentamicin, tobramycin); or to other corticosteroids (e.g., dexamethasone, 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.

This medication should not be used to treat an infection in the outer ear canal if the eardrum is torn (perforated).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, a weakened immune system.

Children may be more sensitive to the effects of too much...

Read All Potential Precautions of Cortef


Cortef Consumer (continued)

SIDE EFFECTS: Burning, redness, irritation, or dryness of the skin may occur. If any of these effects persist or worsen, notify 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: stretch marks, skin thinning/discoloration, acne, extreme/unwanted hair growth, "hair bumps" (folliculitis).

Rarely, use of this medication for prolonged or repeated periods may result in other types of skin infections (e.g., fungal or other bacterial infections). Contact your doctor if you notice any unusual skin symptoms or if your condition does not improve.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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 this product, tell your doctor or pharmacist if you are allergic to neomycin, bacitracin, polymyxin, or hydrocortisone; or to aminoglycoside antibiotics (e.g., gentamicin, tobramycin); or to other corticosteroids (e.g., dexamethasone, 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.

This medication should not be used to treat an infection in the outer ear canal if the eardrum is torn (perforated).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, a weakened immune system.

Children may be more sensitive to the effects of too much corticosteroid medication. Consult your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.


Cortef Patient Information Including Side Effects

Brand Names: Cortef, Hydrocortone

Generic Name: hydrocortisone (oral) (Pronunciation: hye droe KOR ti sone)

  • What is hydrocortisone (Cortef)?
  • What are the possible side effects of hydrocortisone (Cortef)?
  • What is the most important information I should know about hydrocortisone (Cortef)?
  • What should I discuss with my healthcare provider before taking hydrocortisone (Cortef)?
  • How should I take hydrocortisone (Cortef)?
  • What happens if I miss a dose (Cortef)?
  • What happens if I overdose (Cortef)?
  • What should I avoid while taking hydrocortisone (Cortef)?
  • What other drugs will affect hydrocortisone (Cortef)?
  • Where can I get more information?

What is hydrocortisone (Cortef)?

Hydrocortisone is in a class of drugs called steroids. Hydrocortisone prevents the release of substances in the body that cause inflammation.

Hydrocortisone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

Hydrocortisone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of hydrocortisone (Cortef)?

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:

  • problems with your vision;
  • swelling, rapid weight gain, feeling short of breath;
  • severe depression, unusual thoughts or behavior, seizure (convulsions);
  • bloody or tarry stools, coughing up blood;
  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • sleep problems (insomnia), mood changes;
  • acne, dry skin, thinning skin, bruising or discoloration;
  • slow wound healing;
  • increased sweating;
  • headache, dizziness, spinning sensation;
  • nausea, stomach pain, bloating; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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 (Cortef)?

You should not use this medication if you are allergic to hydrocortisone, or if you have a fungal infection anywhere in your body.

Before taking hydrocortisone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are taking hydrocortisone. Vaccines may not work as well while you are taking a steroid.

Do not stop using hydrocortisone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.

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