Norsol Forte Uses

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What is Norsol Forte?

Norsol Forte 0.12% (Pred Mild®) eye drops is used to treat mild to moderate non-infectious eye allergies and inflammation, including damage caused by chemical and thermal burns.

Norsol Forte 1% (Pred Forte®) eye drops is used to treat inflammation of the eyes caused by certain conditions.

Norsol Forte is a steroid medicine that is used to relieve the redness, itching, and swelling caused by eye infections and other conditions.

Norsol Forte 0.12% and 1% are available only with your doctor's prescription.

Norsol Forte indications

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Norsol Forte (Norsol Forte (syrup)) Syrup is 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 mineralo-corticoid supplementation is of particular importance).

2. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
3. Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of:

4. Dermatologic Diseases:

5. Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
6. Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:

7. Respiratory Diseases:

8. Hematologic Disorders:

9. Neoplastic Diseases: For palliative management of:
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:

12. Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.

In addition to the above indications Norsol Forte (Norsol Forte (syrup)) Syrup is indicated for systemic dermatomyositis (polymyositis).

How should I use Norsol Forte?

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

Ask your health care provider any questions you may have about how to use Norsol Forte.

Uses of Norsol Forte in details

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Use: Labeled Indications

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

Dermatologic diseases: Bullous dermatitis herpetiformis; contact dermatitis; exfoliative erythroderma; exfoliative dermatitis; mycosis fungoides; pemphigus; severe erythema multiforme (Stevens-Johnson syndrome); severe psoriasis; severe seborrheic dermatitis.

Endocrine disorders: Congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis; primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable).

GI diseases: During acute episodes of Crohn disease or ulcerative colitis.

Hematologic disorders: Acquired (autoimmune) hemolytic anemia; congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia); erythroblastopenia (RBC anemia); immune thrombocytopenia (formerly known as idiopathic thrombocytopenic purpura), pure red cell aplasia; secondary thrombocytopenia.

Neoplastic diseases: Treatment of acute leukemia and aggressive lymphomas.

Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Note: Treatment guidelines recommend the use of high dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis (AAN [Scott 2011]; NICE 2014).

Ophthalmic diseases:

Allergic conjunctivitis; allergic corneal marginal ulcers; anterior segment inflammation; chorioretinitis; diffuse posterior uveitis and choroiditis; herpes zoster ophthalmicus; iritis and iridocyclitises; keratitis; optic neuritis; sympathetic ophthalmia; uveitis and other ocular inflammatory conditions unresponsive to topical corticosteroids.

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

Respiratory diseases: Acute exacerbations of chronic obstructive pulmonary disease (COPD); allergic bronchopulmonary aspergillosis; aspiration pneumonitis; asthma; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; hypersensitivity pneumonitis; idiopathic bronchiolitis obliterans with organizing pneumonia; idiopathic eosinophilic pneumonias; idiopathic pulmonary fibrosis; Loeffler syndrome (not manageable by other means); Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV-positive individual who is also under treatment with appropriate anti-PCP antibiotics; symptomatic sarcoidosis.

Rheumatic disorders: As adjunctive therapy for short-term administration in acute and subacute bursitis, acute gout flares, acute nonspecific tenosynovitis, ankylosing spondylitis, epicondylitis, polymyalgia rheumatica/temporal arteritis, posttraumatic osteoarthritis, psoriatic arthritis, relapsing polychondritis, rheumatoid arthritis (including juvenile rheumatoid arthritis), synovitis of osteoarthritis, acute rheumatic carditis, systemic lupus erythematosus, dermatomyositis/polymyositis, Sjogren syndrome, and certain cases of vasculitis.

Miscellaneous: Acute or chronic solid organ rejection; trichinosis with neurologic or myocardial involvement; tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, tuberculosis with pleural or pericardial effusion (use appropriate antituberculous chemotherapy concurrently when treating any tuberculosis complications).

Off Label Uses

Alcoholic hepatitis (severe)

Based on the American College of Gastroenterology (ACG) for Alcoholic Liver Disease and American Association for the Study of Liver Diseases (AASLD) guidelines, Norsol Forte (systemic) given for severe alcoholic hepatitis is effective and recommended in the management of this condition.

Asthma exacerbation

Based on the Global Initiative for Asthma (GINA): Global Strategy for Asthma Management and Prevention guidelines and the National Heart, Lung, and Blood Institute (NHLBI) and National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3 guidelines for the diagnosis and management of asthma, Norsol Forte is effective and recommended in the management of severe asthma exacerbations.

Bell palsy

Data from a randomized, double-blind, placebo-controlled, factorial study supports the use of Norsol Forte (systemic) in the treatment of Bell palsy. Early treatment with Norsol Forte (systemic) significantly improved the changes of complete recovery at 3 and 9 months.

Based on the American Academy of Otolaryngology, Head and Neck Surgery, Clinical Practice Guideline: Bell's Palsy, Norsol Forte (systemic) given for Bell's palsy is effective and recommended in the management of this condition.

Chronic obstructive pulmonary disease (COPD) (acute exacerbation)

Based on the Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) guidelines, Norsol Forte (systemic) given for acute exacerbation of COPD is effective and recommended in the management of this condition. Short-term treatment with systemic corticosteroids has been shown to reduce recovery time, risk of early relapse, treatment failure, and length of hospital stay, as well as to improve lung function. However, long-term use is associated with significant adverse effects.

Norsol Forte description

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A synthetic anti-inflammatory glucocorticoid derived from cortisone. It is biologically inert and converted to Norsol Forte in the liver.

Norsol Forte dosage

Recommended Dosing

Dosage of Norsol Forte (Norsol Forte sodium phosphate) 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.

Do not break or use partial Norsol Forte (Norsol Forte sodium phosphate) tablets. Use an appropriate formulation of Norsol Forte if indicated dose cannot be obtained using Norsol Forte. This may become important in the treatment of conditions that require tapering doses that cannot be adequately accommodated by Norsol Forte (Norsol Forte sodium phosphate), e.g., tapering the dose below 10 mg.

The initial dose of Norsol Forte (Norsol Forte sodium phosphate) may vary from 10 to 60 mg (Norsol Forte base) 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, Norsol Forte should be discontinued and the patient placed on 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 that 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 Norsol Forte (Norsol Forte sodium phosphate) 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.

Norsol Forte (Norsol Forte sodium phosphate) are packaged in a blister. Patients should be instructed not to remove the tablet from the blister until just prior to dosing. The blister pack should then be peeled open, and the orally disintegrating tablet placed on the tongue, where tablets may be swallowed whole as any conventional tablet, or allowed to dissolve in the mouth, with or without the assistance of water.

Orally disintegrating tablet dosage forms are friable and are not intended to be cut, split, or broken.

Multiple Sclerosis

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of Norsol Forte for a week followed by 80 mg every other day for one month have been shown to be effective.

Pediatric

In pediatric patients, the initial dose of Norsol Forte may vary depending on the specific disease entity being treated. The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/m/day.

Asthma

The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic prednisone, Norsol Forte or methylprednisolone in children whose asthma is uncontrolled by inhaled corricosteroids and long-acting bronchodilators is 1-2 mg/kg/day in single or divided doses.

It is further recommended that short course, or "burst" therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.

Recommended Monitoring

Blood pressure, body weight, routine laboratory studies, including serum potassium and fasting blood glucose, should be obtained at regular intervals during prolonged therapy. Appropriate diagnostic studies should be performed in patients with known or suspected peptic ulcer disease and in patients at risk for reactivation of latent tuberculosis infections.

Corticosteroid Comparison Chart

For the purpose of comparison, one 10 mg Norsol Forte tablet (13.4 mg Norsol Forte sodium phosphate) is equivalent to the following milligram dosage of the various glucocorricoids:

Betamethasone 1.75 mg Paramethasone 4 mg
Cortisone 50 mg Norsol Forte 10 mg
Dexamethasone 1.75 mg Prednisone lOmg
Hydrocortisone 40 mg Triamcinolone 8 mg
Methylprednisolone 8 mg

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

Orally disintegrating tablets:

Norsol Forte (Norsol Forte sodium phosphate orally disintegrating tablets) 13.4 mg Norsol Forte sodium phosphate (equivalent to 10 mg Norsol Forte base) are white, flat faced, bevelled tablet, debossed with ORA on one side and 10 on the other. Supplied as:

Norsol Forte (Norsol Forte sodium phosphate orally disintegrating tablets) 20.2 mg Norsol Forte sodium phosphate (equivalent to 15 mg Norsol Forte base) are white, flat faced, bevelled tablet, debossed with ORA on one side and 15 on the other. Supplied as:

Norsol Forte: (Norsol Forte sodium phosphate orally disintegrating tablets) 40.3 mg Norsol Forte sodium phosphate (equivalent to 30 mg Norsol Forte base) are white, flat faced, beveled tablets, debossed with ORA on one side and 30 on the other. Supplied as:

Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F).. Protect from moisture.

Do not break or use partial Norsol Forte (Norsol Forte sodium phosphate) tablets. Keep out of the reach of children.

Manufactured for: Shionogi Pharma, Inc. Atlanta, GA 30328. Manufactured by: CIMA® LABS INC., Eden Prairie, MN 55344. Revised 07/2010

Norsol Forte interactions

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What other drugs will affect Norsol Forte?

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Aminoglutethimide

May lead to loss of Norsol Forte-induced adrenal suppression.

Amphotericin B

Coadministration may be followed by cardiac enlargement and CHF.

Anticholinesterase agents

Coadministration may produce severe weakness in patients with myasthenia gravis. If possible, withdraw anticholinesterase agent 24 h prior to starting Norsol Forte.

Antidiabetic agents

Because Norsol Forte may increase blood glucose concentrations, dose adjustments of antidiabetic agents may be required.

Aspirin and other salicylates, NSAIDs

Risk of GI bleeding may be increased. Salicylate clearance may be increased.

CYP3A4 inducers (eg, barbiturates, carbamazepine, phenytoin, rifampin)

Norsol Forte metabolism may be increased, reducing Norsol Forte plasma levels and necessitating an increase in dosage.

CYP3A4 inhibitors (eg, estrogens [eg, hormonal contraceptives], ketoconazole, macrolide antibiotics [eg, erythromycin])

Norsol Forte metabolism may be decreased, increasing Norsol Forte plasma levels and increasing the risk of adverse reactions.

Cholestyramine

Norsol Forte clearance may be increased, reducing plasma levels and decreasing the efficacy.

Cyclosporine

Increased activity of cyclosporine and Norsol Forte may occur. Convulsions have been reported with coadministration of corticosteroids and cyclosporine.

Digitalis glycosides

Because of possible hypokalemia, the risk of arrhythmias may be increased.

Isoniazid

Isoniazid serum levels may be reduced, decreasing the efficacy.

Potassium-depleting agents (eg, amphotericin B, diuretics)

Risk of hypokalemia may be increased.

Toxoids and live or inactivated vaccines

Because of inhibition of antibody response, patients on prolonged Norsol Forte therapy may exhibit a diminished response to toxoids and live or inactivated vaccines. Replication of some organisms contained in live attenuated vaccines may be potentiated.

Warfarin

Because data are conflicting, monitor coagulation indices frequently.

Norsol Forte side effects

See also:
What are the possible side effects of Norsol Forte?

Applies to Norsol Forte: oral liquid, oral solution, oral suspension, oral syrup, oral tablet, oral tablet disintegrating

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

Major Side Effects

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

More common:

Incidence not known:

Minor Side Effects

Some Norsol Forte 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:

Incidence not known:

Norsol Forte contraindications

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What is the most important information I should know about Norsol Forte?

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

Before taking Norsol Forte, 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 using Norsol Forte. The vaccine may not work as well during this time, and may not fully protect you from disease.

Do not stop using Norsol Forte suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using Norsol Forte.

Wear a medical alert tag or carry an ID card stating that you take Norsol Forte. Any medical care provider who treats you should know that you take steroid medication.



Active ingredient matches for Norsol Forte:

Prednisolone in Turkey.


List of Norsol Forte substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
NOVACORTIL tab 5 mg x 10's (Novagen)$ 0.07
NOVACORTIL tab 10 mg x 10's (Novagen)$ 0.13
Novapred 10 mg Tablet (Kind Care Pharmaceuticals)$ 0.01
Novapred 20 mg Tablet (Kind Care Pharmaceuticals)$ 0.01
Novapred 5 mg Tablet (Kind Care Pharmaceuticals)$ 0.00
Tablet; Oral; Prednisolone 5 mg
Tablets; Oral; Prednisolone 5 mg
Nucort Forte 10 mg Tablet (Mankind Pharmaceuticals Pvt. Ltd.)$ 0.01
Nucort P 30 ml Syrup (Mankind Pharmaceuticals Pvt. Ltd.)$ 0.04
O Gesic 5 ml Drop (Calibre Pharmaceutical Pvt. Ltd.)$ 0.05
Drops; Ophthalmic; Boric Acid 5 mg; Diphenhydramine 1 mg; Zinc Sulfate 2.5 mg / ml
OMNACORTIL Capsule/ Tablet / 5mg / 10 units (Macleods Pharmaceuticals Pvt Ltd.)$ 0.05
OMNACORTIL Capsule/ Tablet / 10mg / 10 units (Macleods Pharmaceuticals Pvt Ltd.)$ 0.09
OMNACORTIL Capsule/ Tablet / 40mg / 10 units (Macleods Pharmaceuticals Pvt Ltd.)$ 0.30
OMNACORTIL Capsule/ Tablet / 20mg / 10 units (Macleods Pharmaceuticals Pvt Ltd.)$ 0.16
5 mg x 10's (Macleods Pharmaceuticals Pvt Ltd.)$ 0.05
10 mg x 10's (Macleods Pharmaceuticals Pvt Ltd.)$ 0.08
20 mg x 10's (Macleods Pharmaceuticals Pvt Ltd.)$ 0.15
40 mg x 10's (Macleods Pharmaceuticals Pvt Ltd.)$ 0.29
5 mg x 5 mL x 60ml (Macleods Pharmaceuticals Pvt Ltd.)$ 0.26
Omnacortil 20 mg Tablet (Macleods Pharmaceuticals Pvt Ltd.)$ 0.02
Omnacortil Skin 10 gm Cream (Macleods Pharmaceuticals Pvt Ltd.)$ 0.86
Omnacortil 40 mg Tablet (Macleods Pharmaceuticals Pvt Ltd.)$ 0.04
Omnacortil 10 mg Tablet (Macleods Pharmaceuticals Pvt Ltd.)$ 0.01
Omnacortil 5 mg Tablet (Macleods Pharmaceuticals Pvt Ltd.)$ 0.01
Omnacortil 60 ml Suspension (Macleods Pharmaceuticals Pvt Ltd.)$ 0.02
Omnacortil Eye 10 ml Drop (Macleods Pharmaceuticals Pvt Ltd.)$ 0.19
Omnacortil 2.5mg DT-TAB / 10 (Macleods Pharmaceuticals Pvt Ltd.)$ 0.04
Omnacortil 5mg DT-TAB / 10 (Macleods Pharmaceuticals Pvt Ltd.)$ 0.06
Omnacortil 10mg DT-TAB / 10 (Macleods Pharmaceuticals Pvt Ltd.)$ 0.11
Omnacortil 20mg DT-TAB / 10 (Macleods Pharmaceuticals Pvt Ltd.)$ 0.20
Omnacortil 30mg DT-TAB / 10 (Macleods Pharmaceuticals Pvt Ltd.)$ 0.29
Omnacortil 40mg DT-TAB / 10 (Macleods Pharmaceuticals Pvt Ltd.)$ 0.28
Omnacortil 5mg x 5mL SUSP / 60ml (Macleods Pharmaceuticals Pvt Ltd.)$ 0.28

References

  1. DailyMed. "PREDNISOLONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "prednisolone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "prednisolone". http://www.drugbank.ca/drugs/DB00860 (accessed September 17, 2018).

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The results of a survey conducted on ndrugs.com for Norsol Forte are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Norsol Forte. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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