Dexamethasone

DRUG DESCRIPTION

Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration.

Each tablet contains:

Dexamethasone . . . . . . . . . . . . . . . . . . . .0.5, 0.75, 1, 1.5, 2, 4, or 6 mg

Each 5 mL of Oral Solution contains:

Dexamethasone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0.5 mg

Each mL of Intensol Oral Solution (Concentrate) contains:

Dexamethasone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 mg
Alcohol30%

Inactive Ingredients

The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No.10 (0.5, 4 mg), FD&C Blue No.1(0.75, 1.5 mg), FD&C Green No.3 (4, 6 mg), FD&C Red No.3 (1.5 mg), FD&C Red No.40 (1.5 mg), and FD&C Yellow No.6 (0.5, 4 mg).

The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water.

The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water.

Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11?, 17, 21-trihydroxy-16?-methylpregna-1, 4-diene, 3, 20-dione and the structural formula is:

Dexamethasone Structural Formula Illustration

What are the possible side effects of dexamethasone (Dexamethasone Intensol, Dexpak Jr. Taperpak, Dexpak Taperpak)?

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;
  • ...

Read All Potential Side Effects and See Pictures of Dexamethasone

What are the precautions when taking dexamethasone (Dexamethasone)?

Before taking dexamethasone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., 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 if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active fungal infections.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other infections (e.g., tuberculosis, herpes), kidney disease, liver disease, mental/mood conditions (e.g., psychosis, anxiety, depression), low blood minerals (e.g., low potassium/calcium),...

Read All Potential Precautions of Dexamethasone


Dexamethasone Consumer (continued)

SIDE EFFECTS: Stomach upset, headache, dizziness, menstrual changes, trouble sleeping, increased appetite, or weight gain 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: signs of infection (e.g., fever, persistent sore throat), bone/joint pain, increased thirst/urination, fast/slow/irregular heartbeat, eye pain/pressure, vision problems, heartburn, black stools, vomit that looks like coffee grounds, puffy face, swelling of the ankles/feet, stomach/abdominal pain, pain/redness/swelling of arms/legs, tiredness, mental/mood changes (e.g., depression, mood swings, agitation), unusual hair/skin growth, muscle pain/cramps, weakness, easy bruising/bleeding, slow wound healing, thinning skin, 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 taking dexamethasone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., 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 if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active fungal infections.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other infections (e.g., tuberculosis, herpes), kidney disease, liver disease, mental/mood conditions (e.g., psychosis, anxiety, depression), low blood minerals (e.g., low potassium/calcium), thyroid disease, stomach/intestinal problems (e.g., ulcer, ulcerative colitis, diverticulitis, unexplained diarrhea), high blood pressure, heart problems (e.g., congestive heart failure, recent heart attack), diabetes, eye diseases (e.g., cataracts, glaucoma, herpes infection of the eye), brittle bones (osteoporosis), history of blood clots.

This medication may mask signs of infection or put you at greater risk of developing very serious infections. Report any injuries or signs of infection (e.g., persistent sore throat/fever/cough, pain during urination, muscle aches) that occur during treatment.

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 right away 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 unless specifically directed by your doctor. Live vaccines may cause serious complications (e.g., infection) if given while you are taking this medication. Avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Avoid contact with people who have chickenpox or measles unless you have previously had these diseases (e.g., in childhood). If you are exposed to one of these infections and you have not previously had it, seek immediate medical attention.

If you have a history of ulcers or take large doses of aspirin or other arthritis medication, limit alcoholic beverages while taking this medication to decrease the risk of stomach/intestinal bleeding. Consult your doctor or pharmacist for more details.

If you have diabetes, this drug may make it harder to control your blood sugar levels. Monitor your blood sugar levels regularly and inform your doctor of the results. Your medicine, exercise plan, or diet may need to be adjusted.

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.

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. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time and/or at high doses may have low levels of corticosteroid hormone. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast- feeding.


Dexamethasone Patient Information Including Side Effects

Brand Names: Dexamethasone Intensol, Dexpak Jr. Taperpak, Dexpak Taperpak

Generic Name: dexamethasone (oral) (Pronunciation: dex a METH a sone)

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

What is dexamethasone (Dexamethasone)?

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

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

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

What are the possible side effects of dexamethasone (Dexamethasone)?

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;
  • muscle weakness; 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 dexamethasone (Dexamethasone)?

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

Before taking dexamethasone, 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 dexamethasone. Vaccines may not work as well while you are taking a steroid.

Do not stop using dexamethasone 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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