Trade Name: PredniSONE

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 10 mg/1

Storage and handling

PREDNISONE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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  1. These products are not for sale in US territories. We offer them for exports outside US territories to trade professionals or patients with a valid prescription.
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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of PredniSONE (PredniSONE) which is also known as PredniSONE and Manufactured by PD-Rx Pharmaceuticals, Inc.. It is available in strength of 10 mg/1.

PredniSONE (PredniSONE) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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  • Prednisone Tablets USP are available for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and stearic acid (1 mg, 2.5 mg, and 5 mg only).
  • Prednisone Oral Solution USP is formulated for oral administration containing 5 mg per 5 mL of prednisone USP and alcohol 5%. The oral solution contains the following inactive ingredients: anhydrous citric acid, edetate disodium, fructose, hydrochloric acid, maltol, peppermint oil, polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate, vanilla flavor and purified water.
  • Prednisone n n n Oral Solution (Concentrate) is formulated for oral administration containing 5 mg per mL of prednisone USP and alcohol 30%. In addition, the oral solution contains the following inactive ingredients: anhydrous citric acid, poloxamer 188, propylene glycol and purified water.n nn
  • Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:
  • Cn n n Hn n n On n n M.W. 358.44n nn
  • Prednisone is a white to partially white, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol.
  • 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 bodyu2019s immune responses to diverse stimuli.
  • Prednisone tablets and solutions are indicated in the following conditions:
  • Prednisone tablets and oral solutions are contraindicated in systemic fungal infections and known hypersensitivity to components.
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  • (listed alphabetically, under each subsection)
  • The following adverse reactions have been reported with prednisone or other corticosteroids:
  • anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema.
  • Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk.
  • 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 adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day.
  • Dietary salt restriction may be advisable in patients.
  • Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy.
  • The initial dosage of prednisone may vary from 5 mg to 60 mg 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. n n n After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments 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 patientu2019s 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 patientu2019s condition. If after long-term therapy the drug is to be stopped, it recommended that it be withdrawn gradually rather than abruptly.n nn
  • PredniSONE Tablets USP
  • 10 mg u2013 White to off-white, round, biconvex tablet; scored on one side and product identification u201c54 [above] 899u201d debossed on the other side.
  • NDC 55289-330-05: Bottle of 5 Tablets
  • NDC 55289-330-07: Bottle of 7 Tablets
  • NDC 55289-330-10: Bottle of 10 Tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Distr. by: n n n n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • Revised January 2017
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