Amberin

When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramusculat use of Solu-Amberin Sterile Powder is indicated as follows:

Allergic states

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.

Dermatologic diseases

Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).

Endocrine disorders

Primary or secondary adrenocortical insufficiency (Amberin or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.

Gastrointestinal diseases

To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis.

Hematologic disorders

Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia.

Miscellaneous

Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.

Neoplastic diseases

For the palliative management of leukemias and lymphomas.

Nervous System

Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy.

Ophthalmic diseases

Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.

Renal diseases

To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus.

Respiratory diseases

Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.

Rheumatic disorders

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.

See also: Entyvio

Amberin is a steroid medicine that is used in the treatment of many different conditions, including allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, multiple sclerosis, or lung disorders.

Amberin is also used to replace steroids in people with adrenal insufficiency (decreased production of natural steroids by the adrenal glands).

Amberin affects your immune system and is often used to treat certain blood cell disorders such as anemia (low red blood cells) or thrombocytopenia (low platelets).

Amberin is also used in the treatment of certain cancers such as leukemia, lymphoma, and multiple myeloma.

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

The initial dosage of Amberin Tablets may vary from 20 mg to 240 mg of Amberin per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Amberin should be discontinued and the patient transferred to other appropriate therapy. 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 which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the 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 Amberin 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.

Multiple Sclerosis

In treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (20 mg of Amberin is equivalent to 5 mg of prednisolone).

How supplied

Amberin Tablets are available in the following strengths and package sizes:

5 mg (white, round, scored, imprinted Amberin 5) Bottles of 50 NDC 0009-0012-01

10 mg (white, round, scored, imprinted Amberin 10) Bottles of 100 NDC 0009-0031-01

20 mg (white, round, scored, imprinted Amberin 20) Bottles of 100 NDC 0009-0044-01

Store at controlled room temperature 20° to 25°C (68° to 77°F).

Distributed by: Pharmacia & Upjohn Company, Division of Pfizer Inc., NY, NY 10017. Revised: Sep 2013

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What is the most important information I should know about Amberin?

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

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

Do not stop using Amberin 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.

Use Amberin solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Amberin solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Amberin solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Amberin solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Amberin solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Amberin solution, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Amberin solution.

Amberin is a natural substance (corticosteroid hormone) made by the adrenal gland. It is used to treat conditions such as arthritis, blood/hormone/immune system disorders, skin and eye conditions, breathing problems, cancer, and severe allergies. It decreases your immune system's response to various diseases to reduce symptoms such as pain, swelling and allergic-type reactions.

Amberin is also used to treat low Amberin levels caused by diseases of the adrenal gland (such as Addison's disease, adrenocortical insufficiency). Corticosteroids are needed in many ways for the body to function well. They are important for salt and water balance and keeping blood pressure normal.

How to use Amberin

Take this medication by mouth, with food or milk to prevent stomach upset, exactly as directed by your doctor. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise.

Follow the dosing schedule carefully. The dosage and length of treatment are based on your medical condition and response to treatment. Your doctor may direct you to take Amberin 1 to 4 times a day or take a single dose every other day. It may help to mark your calendar with reminders or use a pill box.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

If you have used Amberin regularly for a long time or in high doses, you may have withdrawal symptoms if the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. See also Precautions section.

Tell your doctor if your condition persists or worsens.

See also:
What other drugs will affect Amberin?

With simultaneous use of Amberin increases the toxicity of cardiac glycosides (because of the emerging hypokalemia increases the risk of arrhythmias); with acetylsalicylic acid - accelerates its excretion and reduces its concentration in blood plasma (with the abolition of Amberin concentration of salicylates in the blood increases, and increases the risk of side effects); with paracetamol - increased risk of hepatotoxic action of paracetamol (induction of hepatic enzymes and formation of a toxic metabolite of paracetamol); with cyclosporine - increased side effects of Amberin as a result of inhibition of its metabolism; with ketoconazole - increased side effects of Amberin as a result of reduction of its clearance.

Amberin Micronised Xepa-Soul Pattinson reduces the effectiveness of hypoglycemic; intensifies the effect of indirect anticoagulants of coumarin derivatives.

Amberin reduces the effect of vitamin D on the absorption of calcium ions into the lumen of the intestine. Ergocalciferol and parathyroid hormone hinder the development of osteopathy caused by GCS.

Amberin Micronised Xepa-Soul Pattinson increases the metabolism of isoniazid, meksiletina (especially in "fast acetylators"), which leads to a decrease in their plasma concentrations; increases (with prolonged therapy) the content of folic acid reduces the concentration of praziquantel in blood.

Amberin in high doses reduces the effect somatropina.

Hypokalemia caused by GCS, may increase the severity and duration of muscle blockade on the background of muscle relaxants.

Antacids reduce the absorption of the GCS.

At simultaneous application with SCS thiazides, carbonic anhydrase inhibitors, other GCS, amphotericin B increase the risk of hypokalemia, drugs containing sodium ions - swelling and increase blood pressure.

NSAIDs and ethanol increases the risk of gastrointestinal ulcerations and bleeding, in combination with NSAIDs to treat arthritis may reduce the dose of GCS due to summation of therapeutic effect. Indomethacin displacing the SCS from its association with albumin, increases the risk of its side effects.

Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis.

The therapeutic effect of GCS is reduced under the influence of inducers of microsomal liver enzymes (including phenytoin, barbiturates, ephedrine, theophylline, rifampin) due to increased rate of metabolism of these substances.

Inhibitors of the function of the adrenal cortex (including mitotan) may necessitate higher doses of GCS.

Clearance GCS increased against the background of preparations of thyroid hormones.

Immunosuppressants increase the risk of infection and lymphoma or other lymphoproliferative disorders associated with Epstein-Barr virus.

Estrogens (including oral contraceptives containing estrogen) reduce the clearance of GKS, lengthens T1/2 and their therapeutic and toxic effects. The appearance of hirsutism and acne promotes the simultaneous use of other steroid hormone funds - androgens, estrogens, anabolic steroids, oral contraceptives.

Tricyclic antidepressants may increase the severity of depression caused by GCS (not shown for the treatment of these side effects).

The risk of developing cataracts increases with the application against other GCS antipsychotic funds (neuroleptics), carbutamide and azathioprine. Simultaneous of Amberin Micronised Xepa-Soul Pattinson with the appointment of m-cholinoblockers, as well as with means having m-anticholinergic action (including antihistamines, tricyclic antidepressants), with nitrates improves the intraocular pressure.

With simultaneous application of SCS with live vaccines and antiviral compared to other types of immunization increases the risk of activation of viruses and development of infections.

See also:
What are the possible side effects of Amberin?

Applies to Amberin topical: topical application cream, topical application ointment

Other dosage forms:

• topical application cream
• topical application cream, topical application lotion, topical application ointment, topical application solution
• topical application cream, topical application foam, topical application gel/jelly, topical application kit, topical application liquid, topical application lotion, topical application ointment, topical application pad, topical application paste, topical application solution, topical application spray, topical application stick

In addition to its needed effects, some unwanted effects may be caused by Amberin topical (the active ingredient contained in Amberin with Aloe). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Amberin topical:

More common:

• Skin rash, encrusted, scaly, and oozing
• stinging

• Burning, itching, redness, skin rash, swelling, or soreness at the application site
• cough or hoarseness
• dry skin
• fever or chills
• itching in the genital or other skin areas
• lower back or side pain
• painful or difficult urination
• rash
• rash with flat lesions or small raised lesions on the skin
• skin irritation

• Blistering, burning, crusting, dryness, or flaking of the skin
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on facial or intertriginous areas

Minor Side Effects

Some of the side effects that can occur with Amberin topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:

• Diarrhea
• indigestion
• loss of appetite
• nausea or vomiting
• passing of gas
• stomach pain, fullness, or discomfort

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

Solu-Amberin 100 mg contains Hydrocortisone sodium succinate equivalent to Amberin 100 mg, monobasic sodium phosphate 1 mg, dibasic sodium 9 mg and sodium hydroxide 10%.

Solu-Amberin 100 mg/2 mL contains Hydrocortisone sodium succinate equivalent to Amberin 100 mg/2 mL, monobasic sodium phosphate 1 mg, dibasic sodium 10 mg and sodium hydroxide 10%.

Solu-Amberin 250 mg/2 mL contains Hydrocortisone sodium succinate equivalent to Amberin 250 mg/2 mL, monobasic sodium phosphate 2 mg, dibasic sodium phosphate 25 mg and sodium hydroxide 10%.

Solu-Amberin 500 mg/4 mL contains Hydrocortisone sodium succinate equivalent to Amberin 500 mg/4 mL, monobasic sodium phosphate 5 mg, dibasic sodium phosphate 52 mg and sodium hydroxide 10%.

Amberin sodium succinate or pregn-4-ene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy; monosodium salt,(11β) is an anti-inflammatory adrenocortical steroid. This highly water-soluble sodium succinate ester of Amberin permits the immediate IV administration of high doses of Amberin in a small volume of diluent and is particularly useful where high blood levels of Amberin are required rapidly.

When necessary, the pH of Solu-Amberin was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7-8.