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Prednisone (prednisone 10 mg) Dailymed

  1. Human Prescription
  2. Corticosteroid
  3. JUBILANT CADISTA PHARMACEUTICALS INC.

Generic: prednisone is used for the treatment of Adrenal Insufficiency Anemia, Hemolytic, Autoimmune Arthritis, Rheumatoid Asthma Berylliosis Bursitis Chickenpox Colitis, Ulcerative Collagen Diseases Conjunctivitis, Allergic Dermatitis Herpetiformis Dermatitis, Atopic Dermatitis, Contact Dermatomyositis Erythema Multiforme Graft vs Host Disease Hypercalcemia Infections Inflammation Iritis Leukemia Lupus Erythematosus, Systemic Lymphoma Multiple Sclerosis Mycoses Nephrotic Syndrome Neuralgia Pemphigus Rheumatic Diseases Sarcoidosis Dermatitis, Seborrheic Serum Sickness Spondylitis, Ankylosing Synovitis Thyroiditis Tuberculosis, Pulmonary Arthritis, Gouty Arthritis, Psoriatic Purpura, Thrombocytopenic, Idiopathic Rhinitis, Allergic

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Description


Prednisone, USP is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is a white to practically white, odorless, crystalline powder.  It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol.The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy- and its molecular weight is 358.43 The structural formula is represented below:

Prednisone Tablets, USP are available in 5 strengths: 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg. In addition, each tablet contains the following inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD & C yellow # 6, aluminum lake, HT 15-18%.

Clinical Pharmacology Section


ACTIONS

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

Indications


Prednisone Tablets, USP 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 hyperplasiaHypercalcemia 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 arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis.

3. Collagen Diseases

During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis

4. Dermatologic Diseases PemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis

5. Allergic States

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

Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic 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 corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis

7. Respiratory Diseases

Symptomatic sarcoidosisLoeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis

8. Hematologic Disorders

Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia

9. Neoplastic Diseases

For palliative management of:

Leukemias and lymphomas in adultsAcute 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 colitisRegional 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

Contraindications


Systemic fungal infections and known hypersensitivity to components.

Warnings


In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.

Immunosuppression and Increased Risk of Infection. Corticosteroids, including prednisone tablets, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can:
  • Reduce resistance to new infections
  • Exacerbate existing infections
  • Increase the risk of disseminated infections
  • Increase the risk of reactivation or exacerbation of latent infections
  • Mask some signs of infection

Corticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages.

Monitor for the development of infection and consider prednisone tablets withdrawal or dosage reduction as needed.

Tuberculosis If prednisone tablet is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur. Closely monitor such patients for reactivation. During prolonged prednisone tablets therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis.

Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including prednisone tablets. In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles:
  • If a prednisone tablets-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered.
  • If a prednisone tablets-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.

Hepatitis B Virus Reactivation Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including prednisone tablets. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection.

Screen patients for hepatitis B infection before initiating immunosuppressive (e.g., prolonged) treatment with prednisone tablets. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.

Fungal Infections Corticosteroids, including prednisone tablets, may exacerbate systemic fungal infections; therefore, avoid prednisone tablets use in the presence of such infections unless prednisone tablet is needed to control drug reactions. For patients on chronic prednisone tablets therapy who develop systemic fungal infections, prednisone tablets withdrawal or dosage reduction is recommended.

Amebiasis Corticosteroids, including prednisone tablets, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating prednisone tablets in patients who have spent time in the tropics or patients with unexplained diarrhea.

Strongyloides Infestation Corticosteroids, including prednisone tablets, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Cerebral Malaria Avoid corticosteroids, including prednisone tablets, in patients with cerebral malaria.

Kaposi’s Sarcoma Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma.

Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

Usage in pregnancy Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism.

Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response.

Precautions


General Precautions


Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.

The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that corticosteroids affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION.)

Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

Convulsions have been reported with concurrent use of methylprednisolone and cyclosporine. Since concurrent use of these agents results in a mutual inhibition of metabolism, it is possible that adverse events associated with the individual use of either drug may be more apt to occur.

Information for the Patient


Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Adverse Reactions


Fluid and Electrolyte Disturbances

Sodium retention    Fluid retention    Congestive heart failure in susceptible patients    Potassium loss    Hypokalemic alkalosis            Hypertension

Musculoskeletal

Muscle weakness    Steroid myopathy    Loss of muscle mass    Osteoporosis    Vertebral compression fractures    Aseptic necrosis of femoral and humeral heads            Pathologic fracture of long bones

Gastrointestinal

Peptic ulcer with possible perforation and hemorrhage    Pancreatitis    Abdominal distention            Ulcerative esophagitis

Dermatologic

Impaired wound healing    Thin fragile skin    Petechiae and ecchymoses    Facial erythema    Increased sweating    May suppress reactions to skin tests

Metabolic

Negative nitrogen balance due to protein catabolism

Neurological

Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment   Convulsions    Vertigo            Headache

Endocrine

Menstrual irregularities    Development of Cushingoid state    Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illnessSuppression of growth in children    Decreased carbohydrate tolerance    Manifestations of latent diabetes mellitus            Increased requirements for insulin or oral hypoglycemic agents in diabetics

Ophthalmic

Posterior subcapsular cataracts     Increased intraocular pressure     Glaucoma            Exophthalmos

Additional Reactions

Urticaria and other allergic, anaphylactic or hypersensitivity reactions.

Dosage And Administration


The initial dosage of Prednisone Tablets, USP may vary from 5 mg to 60 mg of prednisone 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, prednisone 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 prednisone 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 the 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. (Dosage range is the same for prednisone and prednisolone).

ADT ® (Alternate Day Therapy)

ADT is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.

The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.

A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.  

The diurnal rhythm of the HPA axis is lost in Cushing’s Disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.

During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 11/4 to 11/2 days following a single dose) and thus are recommended for alternate day therapy.

The following should be kept in mind when considering alternate day therapy:

1) Basic principles and indications for corticosteroid therapy should apply. The benefits of ADT should not encourage the indiscriminate use of steroids. 2) ADT is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. 3)   In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with ADT. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to ADT and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. 4) Because of the advantages of ADT, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (eg, patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on ADT may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. 5) As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (eg; dexamethasone and betamethasone). 6) The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). 7) In using ADT it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of ADT will help the patient to understand and tolerate the possible flare-up in symptoms  which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. 8) In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. 9) Although many of the undesirable features of corticosteroid therapy can be minimized by ADT, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.

How Supplied


Prednisone Tablets, USP are available in the following strengths and package sizes:

2.5 mg - White, round tablets debossed with "C 782" on one side and scored on the other side.           Bottles of 30 tablets with Child Resistant Closure,   NDC 59746-782-30          Bottles of 100 tablets with Child Resistant Closure, NDC 59746-782-01

5 mg - White, round tablets debossed with "TL 172" on one side and scored on the other side.           Bottles of 100 tablets with Child Resistant Closure, NDC 59746-172-06          Bottles of 1000                                                          NDC 59746-172-10

10 mg - White, round tablets debossed with "TL 173" on one side and scored on the other side.           Bottles of 100 tablets with Child Resistant Closure, NDC 59746-173-06          Bottles of 500                                                            NDC 59746-173-09          Bottles of 1000                                                          NDC 59746-173-10

20 mg - Peach, round tablets debossed with "TL 175" on one side and scored on the other side.           Bottles of 100 tablets with Child Resistant Closure, NDC 59746-175-06          Bottles of 500                                                            NDC 59746-175-09          Bottles of 1000                                                          NDC 59746-175-10

50 mg - White, round tablets debossed with "C 783" on one side and scored on the other side.           Bottles of 100 tablets with Child Resistant Closure, NDC 59746-783-01          

Store at 20° to 25° C (68° to 77° F) [See USP Room Temperature].

Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA.

Revised 02/2024

Package Label.principal Display Panel


NDC 59746-782-30 PredniSONE Tablets, USP 2.5 mg CADISTA™ 30 Tablets Rx only Each tablet contains 2.5 mg prednisone USP. USUAL DOSAGE: See Prescribing Information for complete information. Dispense in tight, child-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature.] PROTECT FROM MOISTURE. Manufactured by:Jubilant Cadista Pharmaceuticals Inc.Salisbury, MD 21801, USA Rev. # 09/21

NDC 59746-172-06 PredniSONE Tablets, USP 5 mg CADISTA™ 100 Tablets   Rx only See package insert for complete product information. Dispense in tight, light-resistant container. Keep patient under close observation of a physician. Store at 20-25°C (68-77°F)[See USP Controlled Room Temperature].  Manufactured by:Jubilant Cadista Pharmaceuticals Inc.Salisbury, MD 21801, USA Rev. # 03/17 TL172

NDC 59746-173-06 PredniSONE Tablets, USP 10 mg CADISTA™ 100 Tablets Rx only See package insert for complete product information. Dispense in tight, light-resistant container. Keep patient under close observation of a physician. Store at 20-25°C (68-77°F)[See USP Controlled Room Temperature].  Manufactured by:Jubilant Cadista Pharmaceuticals Inc.Salisbury, MD 21801, USA Rev # 03/17 TL173

NDC 59746-175-06 PredniSONE Tablets, USP 20 mg CADISTA™ 100 Tablets Rx only Each tablet contains:Prednisone 20 mg. See package insert for complete product information. Dispense in tight, light-resistant container. Keep patient under close observation of a physician. Store at 20-25°C (68-77°F)[See USP Controlled Room Temperature].  Manufactured by:Jubilant Cadista Pharmaceuticals Inc.Salisbury, MD 21801, USA Rev # 03/17 TL175

NDC 59746-783-01 PredniSONE Tablets, USP 50 mg CADISTA™ 100 Tablets Rx only Each tablet contains 50 mg prednisone USP. USUAL DOSAGE: See Prescribing Information for complete information. Dispense in tight, child-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature.] PROTECT FROM MOISTURE. Manufactured by:Jubilant Cadista Pharmaceuticals Inc.Salisbury, MD 21801, USA Rev. # 09/21

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