"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Cortenema Consumer (continued)
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.
Read the Cortenema (hydrocortisone) Side Effects Center for a complete guide to possible side effects
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.
Additional Cortenema Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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