Deltra

Each 5-mg MR tablet also contains the following excipients: Lactose 36.9 mg. Tablet Core: Anhydrous colloidal silica, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone K 29/32 and red ferric oxide E 172. Tablet Shell: Anhydrous colloidal silica, calcium hydrogen phosphate dihydrate, glyceryl behenate, magnesium stearate, povidone K 29/32 and yellow ferric oxide E 172.

Deltra modified-release tablet is consist of a Deltra-containing core and an inert coating. Delayed release of Deltra is dependent on an intact coating.

Deltra (Deltra) Tablets are indicated in the following conditions:

1. Endocrine Disorders

   Primary or secondary adrenocortical insufficiency

   (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)

   Congenital adrenal hyperplasia

   Hypercalcernia associated with cancer

   Nonsuppurative thyroiditis

2. Rheumatic Disorders

   As adjunctive therapy for short-term administration

   (to tide the patient over an acute episode or exacerbation) in:

   Psoriatic arthritis

   Rheumatoid arthritis, including juvenile rheumatoid arthritis

   (selected cases may require low-dose maintenance therapy)

   Ankylosing spondylitis

   Acute and subacute bursitis

   Acute nonspecific tenosynovitis

   Acute gouty arthritis

   Post-traumatic osteoarthritis

   Synovitis of osteoarthritis

   Epicondylitis

3. Collagen Diseases

   During an exacerbation or as maintenance therapy in selected cases of:

   Systemic lupus erythematosus

   Systemic-dermatomyositis (polymyositis)

   Acute rheumatic carditis

4. Dermatologic Diseases

   Pemphigus

   Bullous dermatitis herpetiformis

   Severe erythema multiforme

   (Stevens-Johnson syndrome)

   Exfoliative dermatitis

   Mycosis fungoides

   Severe psoriasis

   Severe seborrheic dermatitis

5. Allergic States

   Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:

   Seasonal or perennial allergic rhinitis

   Bronchial asthma

   Contact dermatitis

   Atopic dermatitis

   Serum sickness

   Drug hypersensitivity reactions

6. Ophthalmic Diseases

   Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:

   Allergic cornea marginal ulcers

   Herpes zoster ophthalmicus

   Anterior segment inflammation

   Diffuse posterior uveitis and choroiditis

   Sympathetic ophthalmia

   Allergic conjunctivitis

   Keratitis

   Chorioretinitis

   Optic neuritis

   Iritis and iridocyclitis

7. Respiratory Diseases

   Symptomatic sarcoidosis

   Loeffler's syndrome not manageable by other means

   Berylliosis

   Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy

   Aspiration pneumonitis

8. Hematologic Disorders

   Idiopathic thrombocytopenic purpura in adults

   Secondary thrombocytopenia in adults

   Acquired (autoimmune) hemolytic anemia

   Erythroblastopenia (RBC anemia)

   Congenital (erythroid) hypoplastic anemia

9. Neoplastic Diseases For palliative management of:

   Leukemias and lymphomas in adults

   Acute leukemia of childhood

10. Edematous States

    To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus

11. Gastrointestinal Diseases

    To tide the patient over a critical period of the disease in:

    Ulcerative colitis

    Regional enteritis

12. Nervous System

    Acute exacerbations of multiple sclerosis

13. Miscellaneous

    Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy

    Trichinosis with neurologic or myocardial involvement

Deltra is a steroid. Deltra prevents the release of substances in the body that cause inflammation. Deltra also suppresses the immune system.

Deltra is used as an anti-inflammatory or an immunosuppressant medication. Deltra treats many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

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

Recommended Dosing

Dosage of Deltra should be individualized according to the severity of the disease and the response of the patient. For pediatric patients, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight.

The maximal activity of the adrenal cortex is between 2 am and 8 am and is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity. Deltra is a delayed-release formulation of Deltra which releases the active substance beginning approximately 4 hours after intake. The timing of Deltra administration should take into account the delayed-release pharmacokinetics and the disease or condition being treated.

The initial dosage of Deltra may vary from 5 to 60 mg per day depending on the specific disease entity being treated. Patients currently on immediate release Deltra, prednisolone, or methylprednisolone should be switched to Deltra at an equivalent dose based on relative potency (2.4).

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 there is a lack of satisfactory clinical response, Deltra 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 Deltra for a period of time consistent with the patient's condition. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Recommended Monitoring

Blood pressure, body weight, routine laboratory studies (including 2-hour postprandial blood glucose and serum potassium), and chest X-ray should be obtained at regular intervals during prolonged therapy with Deltra. Upper GI X-rays are desirable in patients with known or suspected peptic ulcer disease.

Method of Administration

Deltra is for oral administration.

Deltra should be taken daily with food.

Deltra tablets should not be broken, divided, or chewed because the delayed release of Deltra is dependent on an intact coating.

Corticosteroid Comparison Chart

For the purpose of comparison, one 5 mg Deltra tablet is the equivalent milligram dosage of the following 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.

How supplied

Dosage Forms And Strengths

Delayed-release Tablets

• Deltra 1 mg Deltra: Pale yellowish-white, round, unscored delayed-release tablet embossed with “NP 1” on one side.
• Deltra 2 mg Deltra: Yellowish-white, round, unscored delayed-release tablet embossed with “NP 2” on one side.
• Deltra 5 mg Deltra: Light yellow, round, unscored delayed-release tablet embossed with “NP 5” on one side.

Storage And Handling

Deltra delayed-release tablets (1 mg Deltra) are pale yellowish-white, round, unscored tablets embossed with “NP 1” on one side and supplied as:

Deltra delayed-release tablets (2 mg Deltra) are yellowish-white, round, unscored tablets embossed with “NP 2” on one side and supplied as:

Deltra delayed-release tablets (5 mg Deltra) are light yellow, round, unscored tablets embossed with “NP 5” on one side and supplied as:

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)..

Protect Deltra tablets from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Distributed by: Horizon Pharma USA, Inc. 520 Lake Cook Road, Suite 520 Deerfield, IL 60015. Revised: June 2013

See also:
What is the most important information I should know about Deltra?

Hypersensitivity to Deltra or any component of the formulation; administration of live or live attenuated vaccines with immunosuppressive doses of Deltra; systemic fungal infections

Canadian labeling: Additional contraindications (not in US labeling): Herpes simplex of the eye, measles, or chickenpox (except when being used for short-term or emergency therapy); peptic ulcer; nonspecific ulcerative colitis; diverticulitis; viral or bacterial infection not controlled by anti-infectives

Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Use Deltra delayed-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Deltra delayed-release tablets by mouth with food.
• Swallow Deltra delayed-release tablets whole. Do not break, crush, chew, or divide before swallowing.
• Do not suddenly stop taking Deltra delayed-release tablets without checking with your doctor. You may have an increased risk of side effects. If you need to stop Deltra delayed-release tablets, your doctor may gradually lower your dose.
• If you miss a dose of Deltra delayed-release tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Deltra delayed-release tablets.

Deltra is used to treat conditions such as arthritis, blood disorders, breathing problems, severe allergies, skin diseases, cancer, eye problems, and immune system disorders. Deltra belongs to a class of drugs known as corticosteroids. It decreases your immune system's response to various diseases to reduce symptoms such as swelling and allergic-type reactions.

How to use Deltra

Take this medication by mouth, with food or milk to prevent stomach upset, as directed by your doctor. Take the tablet form of this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. If you are prescribed only one dose per day, take it in the morning before 9 A.M.

Take this medication exactly as directed by your doctor. Follow the dosing schedule carefully. The dosage and length of treatment are based on your medical condition and response to treatment. If you are taking this medication on a different schedule than a daily one (such as every other day), it may help to mark your calendar with a reminder.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.

Tell your doctor if your condition persists or worsens.

See also:
What other drugs will affect Deltra?

Interactions with other Medicinal Products and other Forms of Interaction: Cardiac Glycosides: The effect of the glycosides can be enhanced by potassium deficiency.

Saluretics/Laxatives: Potassium excretion is enhanced.

Antidiabetic Agents: The blood sugar lowering effect is reduced.

Coumarin Derivatives: The efficacy of coumarin anticoagulants may be reduced or enhanced.

Non-Steroidal Antiphlogistic/Antirheumatic Agents, Salicylates and Indomethacin: The risk of gastrointestinal haemorrhages is increased.

Non-Depolarising Muscle Relaxants: Muscle relaxation may be prolonged.

Atropine and Other Anticholinergics: The concurrent use of Deltra may result in additional increases in intraocular pressure.

Praziquantel: Glucocorticoids may lower the praziquantel concentrations in the blood.

Chloroquine, Hydroxychloroquine, Mefloquine: There is an increased risk of occurrence of myopathies, cardiomyopathies.

Somatropin: The efficacy of somatropin may be reduced.

Oestrogens (eg,

Oral Contraceptives): May enhance the efficacy of glucocorticoids.

Liquorice: Inhibition of the metabolism of glucocorticoids is possible.

Rifampicin, Phenytoin, Barbiturates, Bupropion and Primidone: The efficacy of glucocorticoids is reduced.

Cyclosporine: The blood levels of cyclosporine are increased. There is an increased risk of seizures.

Amphotericine B: The risk of hypokalaemia may be increased.

Cyclophosphamide: The effects of cyclophosphamide may be enhanced.

ACE inhibitors: Increased risk of occurrence of blood count changes.

Aluminium and Magnesium Antacids: The absorption of glucocorticoids is reduced. However, due to the delayed release mechanism of Deltra, an interaction between Deltra and aluminium/magnesium antacids is unlikely.

Impact on Diagnostic Methods: Skin reactions caused by allergy testing may be suppressed. The TSH increase following the administration of protirelin may be reduced.

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

Applies to Deltra: oral solution, oral syrup, oral tablet, oral tablet delayed release

As well as its needed effects, Deltra (the active ingredient contained in Deltra) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Deltra, check with your doctor immediately:

More common:

• Aggression
• agitation
• anxiety
• blurred vision
• decrease in the amount of urine
• dizziness
• fast, slow, pounding, or irregular heartbeat or pulse
• headache
• irritability
• mental depression
• mood changes
• nervousness
• noisy, rattling breathing
• numbness or tingling in the arms or legs
• pounding in the ears
• shortness of breath
• swelling of the fingers, hands, feet, or lower legs
• trouble thinking, speaking, or walking
• troubled breathing at rest
• weight gain

• Abdominal or stomach cramping or burning (severe)
• abdominal or stomach pain
• backache
• bloody, black, or tarry stools
• cough or hoarseness
• darkening of skin
• decrease in height
• decreased vision
• diarrhea
• dry mouth
• eye pain
• eye tearing
• facial hair growth in females
• fainting
• fever or chills
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• heartburn or indigestion (severe and continuous)
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• loss of sexual desire or ability
• lower back or side pain
• menstrual irregularities
• muscle pain or tenderness
• muscle wasting or weakness
• nausea
• pain in back, ribs, arms, or legs
• painful or difficult urination
• skin rash
• sleeplessness
• sweating
• trouble healing
• trouble sleeping
• unexplained weight loss
• unusual tiredness or weakness
• vision changes
• vomiting
• vomiting of material that looks like coffee grounds

Minor Side Effects

Some Deltra side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:

• Increased appetite

• Abnormal fat deposits on the face, neck, and trunk
• acne
• dry scalp
• lightening of normal skin color
• red face
• reddish purple lines on the arms, face, legs, trunk, or groin
• swelling of the stomach area
• thinning of the scalp hair