Dexagalen tablets

Dexagalen

  • Active Ingredient: Dexamethasone
  • 1 mg, 0.5 mg
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What is Dexagalen?

The active ingredient of Dexagalen brand is dexamethasone. Dexamethasone is a steroid that prevents the release of substances in the body that cause inflammation.

Used for

Dexagalen is used to treat diseases such as: Addison's Disease, Adrenal Insufficiency, Adrenocortical Insufficiency, Adrenogenital Syndrome, Allergic Rhinitis, Ankylosing Spondylitis, Aphthous Ulcer, Aspiration Pneumonia, Asthma, Asthma, acute, Atopic Dermatitis, Bronchopulmonary Dysplasia, Bursitis, Cerebral Edema, Chorioretinitis, Croup, Cushing's Syndrome, Dermatitis Herpetiformis, Eczema, Epicondylitis, Tennis Elbow, Erythroblastopenia, Evan's Syndrome, Gouty Arthritis, Hemolytic Anemia, Hypercalcemia of Malignancy, Idiopathic Thrombocytopenic Purpura, Inflammatory Bowel Disease, Inflammatory Conditions, Iridocyclitis, Iritis, Juvenile Rheumatoid Arthritis, Keratitis, Leukemia, Loeffler's Syndrome, Lymphoma, Meningitis, Haemophilus influenzae, Meningitis, Listeriosis, Meningitis, Meningococcal, Meningitis, Pneumococcal, Mountain Sickness / Altitude Sickness, Multiple Myeloma, Multiple Sclerosis, Mycosis Fungoides, Nausea/Vomiting, Chemotherapy Induced, Neurosarcoidosis, Pemphigus, Plaque Psoriasis, Psoriasis, Psoriatic Arthritis, Pulmonary Tuberculosis, Rheumatoid Arthritis, Sarcoidosis, Seborrheic Dermatitis, Shock, Synovitis, Systemic Lupus Erythematosus, Thrombocytopenia, Toxic Epidermal Necrolysis, Transverse Myelitis, Tuberculous Meningitis, Ulcerative Colitis, Uveitis, Posterior.

Side Effect

Possible side effects of Dexagalen include: eye tearing; decreased vision; pain in back, ribs, arms, or legs; fruit-like breath odor; Abnormal fat deposits on the face, neck, and trunk; reddish purple lines on the arms, face, legs, trunk, or groin.

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25.12.1.4 Other agents

Dexagalen (FDA category C) also has been used and normalizes serum concentration of bile acids in ICP. No adverse effects have been seen in long-term follow-up evaluations in children exposed to Dexagalen in utero .

Rifampicin (FDA category C) and phenobarbital (FDA category D) have been used after first-line agents have failed to relieve pruritus. Rifampicin eliminates bile acids through conjugation. In animal models it has been found to be teratogenic when administered at high doses. Studies in humans have not found it to be teratogenic; however, it has been associated with hemorrhagic disease of the newborn . Phenobarbital works similarly to rifampicin. Third trimester exposure did not find it to be associated with fetal complications in two observational studies .

What are the possible side effects of Dexagalen?

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

Call your doctor at once if you have:

  • muscle tightness, weakness, or limp feeling;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;
  • shortness of breath (even with mild exertion), swelling, rapid weight gain;
  • severe depression, unusual thoughts or behavior;
  • a seizure (convulsions);
  • bloody or tarry stools, coughing up blood;
  • fast or slow heart rate, weak pulse;
  • pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling; or
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Dexagalen can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

  • fluid retention (swelling in your hands or ankles);
  • increased appetite;
  • mood changes, trouble sleeping;
  • skin rash, bruising or discoloration;
  • acne, increased sweating, increased hair growth;
  • headache, dizziness;
  • nausea, vomiting, upset stomach;
  • changes in your menstrual periods; 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.

Can Dexagalen cause problems?

Along with its useful effects, Dexagalen can cause unwanted side-effects which your doctor will discuss with you. The benefits of taking an oral steroid usually outweigh the side-effects; however, they can sometimes be troublesome. The table below contains some of the most common ones associated with Dexagalen. The best place to find a full list of the side-effects which can be associated with your medicine, is from the manufacturer's printed information leaflet supplied with the medicine. Alternatively, you can find an example of a manufacturer's information leaflet in the reference section below.

Although not everyone experiences side-effects, and some will improve as your body adjusts to the new medicine, speak with your doctor or pharmacist if you become concerned about any of the following:

Before taking Dexagalen,

  • tell your doctor and pharmacist if you are allergic to Dexagalen, aspirin, tartrazine (a yellow dye in some processed foods and drugs), or any other drugs.
  • tell your doctor and pharmacist what prescription and nonprescription medications you are taking especially anticoagulants ('blood thinners') such as warfarin (Coumadin), arthritis medications, aspirin, cyclosporine (Neoral, Sandimmune), digoxin (Lanoxin), diuretics ('water pills'), ephedrine, estrogen (Premarin), ketoconazole (Nizoral), oral contraceptives, phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), theophylline (Theo-Dur), and vitamins.
  • if you have a fungal infection (other than on your skin), do not take Dexagalen without talking to your doctor.
  • tell your doctor if you have or have ever had liver, kidney, intestinal, or heart disease; diabetes; an underactive thyroid gland; high blood pressure; mental illness; myasthenia gravis; osteoporosis; herpes eye infection; seizures; tuberculosis (TB); or ulcers.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Dexagalen, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Dexagalen.
  • if you have a history of ulcers or take large doses of aspirin or other arthritis medication, limit your consumption of alcoholic beverages while taking this drug. Dexagalen makes your stomach and intestines more susceptible to the irritating effects of alcohol, aspirin, and certain arthritis medications: this effect increases your risk of ulcers.

For Oral Administration

The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated.

It Should Be Emphasized That Dosage Requirements Are Variable And Must Be Individualized On The Basis Of The Disease Under Treatment And The Response Of The Patient.

After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that maintains an adequate clinical response is reached.

Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of Dexagalen for a week followed by 4 to 12 mg every other day for one month have been shown to be effective (see PRECAUTIONS: Neuro-Psychiatric).

In pediatric patients, the initial dose of Dexagalen may vary depending on the specific disease entity being treated. The range of initial doses is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m²bsa/day).

For the purpose of comparison, the following is the equivalent milligram dosage of the various corticosteroids:

These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested:

Dexagalen sodium phosphate injection, 4 mg per mL

First Day: 1 or 2 mL, intramuscularly Dexagalen tablets, 0.75 mg Second Day: 4 tablets in two divided doses Third Day: 4 tablets in two divided doses Fourth Day: 2 tablets in two divided doses Fifth Day: 1 tablet Sixth Day: 1 tablet Seventh Day: No treatment Eighth Day: Follow-up visit

This schedule is designed to ensure adequate therapy during acute episodes, while minimizing the risk of overdosage in chronic cases.

In cerebral edema, Dexagalen sodium phosphate injection is generally administered initially in a dosage of 10 mg intravenously followed by 4 mg every six hours intramuscularly until the symptoms of cerebral edema subside. Response is usually noted within 12 to 24 hours and dosage may be reduced after two to four days and gradually discontinued over a period of five to seven days. For palliative management of patients with recurrent or inoperable brain tumors, maintenance therapy with either Dexagalen sodium phosphate injection or Dexagalen tablets in a dosage of 2 mg two or three times daily may be effective.

How should this medicine be used?

Dexagalen comes as a tablet and a solution to take by mouth. Your doctor will prescribe a dosing schedule that is best for you. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Dexagalen exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not stop taking Dexagalen without talking to your doctor. Stopping the drug abruptly can cause loss of appetite, upset stomach, vomiting, drowsiness, confusion, headache, fever, joint and muscle pain, peeling skin, and weight loss. If you take large doses for a long time, your doctor probably will decrease your dose gradually to allow your body to adjust before stopping the drug completely. Watch for these side effects if you are gradually decreasing your dose and after you stop taking the tablets or oral liquid, even if you switch to an inhalation corticosteroid medication. If these problems occur, call your doctor immediately. You may need to increase your dose of tablets or liquid temporarily or start taking them again.

Dexagalen Overdose

If you think you have taken too much Dexagalen, contact your doctor or go to the nearest emergency room.

Important Information

You should not use Dexagalen if you have a fungal infection anywhere in your body.

Tell your doctor about all your medical conditions, and all the 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 dosage 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.

Dexagalen 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.

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.

All vaccines may not work as well while you are taking a steroid. Do not receive a "live" vaccine while you are taking this medicine.

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

Dexagalen belongs to a group of medicines called corticosteroids. It is sometimes referred to simply as an oral steroid. Corticosteroids are produced naturally in your body. They help to keep you healthy. By boosting your body with extra corticosteroid, it can help treat conditions involving inflammation.

What should I discuss with my healthcare provider before taking Dexagalen?

You should not use Dexagalen if you are allergic to it, or if you have:

  • a fungal infection anywhere in your body.

Tell your doctor if you have ever had:

Steroid medication affects your immune system. You may get infections more easily. Steroids can also worsen or reactivate an infection you've already had. Tell your doctor about any illness or infection you have had within the past several weeks.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breast-feed while using Dexagalen.

What should I do if I forget a dose?

When you start to take Dexagalen, ask your doctor what to do if you forget a dose. Write down these instructions so that you can refer to them later.

If you take Dexagalen once a day, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Use in diagnosis

Dexagalen suppression test. Dexagalen acts on the hypothalamus to reduce output of corticotropin releasing hormone (CRH), but it does not interfere with measurement of cortisol in blood or urine. Normal suppression of cortisol production after administering low Dexagalen (0.5 mg 6-hourly) indicates that the HPA axis is intact. Failure of suppression implies pathological hypersecretion of ACTH by the pituitary, ectopic ACTH or autonomous secretion of cortisol by the adrenal. Dexagalen is used because its action is prolonged (24 h). There are several ways of carrying out the test.

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.

Dexagalen, 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-11β, 17, 21-trihydroxy-16α-methylpregna-1, 4-diene, 3, 20-dione and the structural formula is:

Other drugs

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID). It’s often used to treat pain, as well as thin the blood to reduce your risk of heart attack. Dexagalen can decrease your aspirin levels. This can make aspirin less effective and increase your risk of heart attack. Also, aspirin can increase your risk of bleeding from stomach ulceration (sores) when used with Dexagalen. If you take aspirin, talk with your doctor about whether Dexagalen is safe for you.

Thalidomide is used to treat skin lesions and multiple myeloma. Combining it with Dexagalen can cause toxic epidermal necrolysis. This skin condition can be life-threatening. If your doctor prescribes both of these drugs for you, they will be cautious about effects the combination can cause.

Cyclosporine is used to prevent organ rejection in transplant patients, as well as to treat rheumatoid arthritis or psoriasis. Taking this drug with Dexagalen could increase the risk that your immune system will be suppressed (won’t work well). This would raise your risk of infection. Seizures have also been reported when these drugs are used together.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of Dexagalen.


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