Prednisolone

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Prednisolone uses


DESCRIPTION

Prednisolone ® 1% is a sterile, topical anti-inflammatory agent for ophthalmic use. Its chemical name is 11ß,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate and it has the following structure:

Structural Formula:


Each mL of Prednisolone ® contains:

Active: Prednisolone acetate (microfine suspension) 1%

Inactives: benzalkonium chloride as preservative; boric acid; edetate disodium; hypromellose; polysorbate 80; purified water; sodium bisulfite; sodium chloride; and sodium citrate.

The pH during its shelf life ranges from 5.0 - 6.0.

Structural Formula

CLINICAL PHARMACOLOGY

Prednisolone acetate is a glucocorticoid that, on the basis of weight, has 3 to 5 times the anti-inflammatory potency of hydrocortisone. Glucocorticoids inhibit the edema, fibrin deposition, capillary dilation, and phagocytic migration of the acute inflammatory response, as well as capillary proliferation, deposition of collagen, and scar formation.

INDICATIONS AND USAGE

Prednisolone ® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

CONTRAINDICATIONS

Prednisolone ® suspension is contraindicated in acute untreated purulent ocular infections, in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis, vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Prednisolone ® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

WARNINGS

Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.

Prednisolone ® suspension contains sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

PRECAUTIONS

General

The initial prescription and renewal of the medication order beyond 20 milliliters of Prednisolone ® suspension should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.

Information for Patients

Advise patients that if eye inflammation or pain persists longer than 48 hours or becomes aggravated, they should consult a physician.

Advise patients that to prevent eye injury or contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children.

Advise patients that Prednisolone ® suspension contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of Prednisolone ® and may be reinserted 15 minutes following its administration.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted in animals or in humans to evaluate the potential of these effects.

Pregnancy

Prednisolone has been shown to be teratogenic in mice when given in doses 1-10 times the human dose. Dexamethasone, hydrocortisone, and Prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate well-controlled studies in pregnant women. Prednisolone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from Prednisolone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness in pediatric patients have been established. Use in pediatric patients is supported by evidence from adequate and well-controlled studies of Prednisolone acetate ophthalmic suspension in adults with additional data in pediatric patients.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS

The following adverse reactions have been identified during use of Prednisolone ® . Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions include elevation of intraocular pressure with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.

The development of secondary ocular infection (bacterial, fungal, and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (see PRECAUTIONS).

Other adverse reactions reported with the use of Prednisolone acetate ophthalmic suspension include: allergic reactions; dysgeusia; foreign body sensation; headache; pruritus; rash; transient burning and stinging upon instillation and other minor symptoms of ocular irritation; urticaria; and visual disturbance (blurry vision).

Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids. Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe.

OVERDOSAGE

Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.

DOSAGE AND ADMINISTRATION

Shake well before using. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely.

If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

HOW SUPPLIED

Prednisolone ® (prednisolone acetate ophthalmic suspension, USP) 1% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows:

1 mL in 5 mL bottle - NDC 11980-180-01

5 mL in 10 mL bottle - NDC 11980-180-05

10 mL in 15 mL bottle - NDC 11980-180-10

15 mL in 15 mL bottle - NDC 11980-180-15


Storage: Store at up to 25°C (77°F). Protect from freezing. Store in an upright position.

Revised: 05/2017

© 2017 Allergan. All rights reserved.

All trademarks are the property of their respective owners.

Irvine, CA 92612

Made in the U.S.A.


71592US12

Allergan Logo

ALLERGAN

NDC 11980-180-10

Rx only

Prednisolone ®

(prednisolone

acetate

ophthalmic

suspension,

USP) 1%

sterile

10 mL

Carton

Prednisolone pharmaceutical active ingredients containing related brand and generic drugs:


Prednisolone available forms, composition, doses:

Price
Depo-Medrol (Preserved) 40 mg/ml5.75 USD
Depo-Medrol (Preserved) 80 mg/ml8.89 USD
Depo-Medrol 20 mg/ml2.63 USD
Depo-Medrol 40 mg/ml6.01 USD
Depo-Medrol 80 mg/ml11.51 USD
Depo-medrol 20 mg/ml vial3.78 USD
Depo-medrol 40 mg/ml vial6.41 USD
Depo-medrol 80 mg/ml vial11.67 USD
Econopred Plus 1% Suspension 10ml Bottle63.44 USD
Econopred Plus 1% Suspension 5ml Bottle40.99 USD
Econopred plus 1% eye drops3.93 USD
Medrol (Pak) 21 4 mg tablet Disp Pack39.3 USD
Medrol 16 mg tablet3.5 USD
Medrol 2 mg tablet0.84 USD
Medrol 32 mg tablet5.13 USD
Medrol 4 mg dosepak1.59 USD
Medrol 4 mg tablet1.69 USD
Medrol 8 mg tablet2.3 USD
Methylprednisolone Acetate (P) 40 mg/ml4.5 USD
Methylprednisolone Acetate (P) 80 mg/ml6.97 USD
Methylprednisolone Acetate 40 mg/ml4.71 USD
Methylprednisolone Acetate 80 mg/ml9.01 USD
Methylprednisolone Sod Succin. 1 g/vial32.47 USD
Methylprednisolone Sod Succin. 125 mg/vial8.9 USD
Methylprednisolone Sod Succin. 40 mg/vial3.77 USD
Methylprednisolone Sod Succin. 500 mg/vial19.48 USD
Millipred 5 mg tablet0.59 USD
Millipred dp 5 mg dose pack tablet1.18 USD
Omnipred 1% eye drops6.78 USD
Orapred 15 mg/5 ml solution0.74 USD
Orapred ODT 48 15 mg Dispersible Tablet Box289.42 USD
Orapred odt 10 mg tablet3.89 USD
Orapred odt 15 mg tablet7.97 USD
Orapred odt 30 mg tablet8.34 USD
Pediapred 1 mg/ml Liquid0.14 USD
Pediapred 6.7 mg/5ml Solution 120ml Bottle57.77 USD
Pms-Prednisolone 1 mg/ml Liquid0.07 USD
Pred Forte 1 % Suspension5.95 USD
Pred Forte 1% Suspension 10ml Bottle68.06 USD
Pred Forte 1% Suspension 15ml Bottle97.79 USD
Pred Forte 1% Suspension 5ml Bottle37.12 USD
Pred Mild 0.12 % Suspension2.02 USD
Pred Mild 0.12% Suspension 10ml Bottle44.33 USD
Pred Mild 0.12% Suspension 5ml Bottle33.98 USD
Pred forte 1% eye drops10.32 USD
Pred mild 0.12% eye drops5.14 USD
PrednisoLONE Acetate 1% Suspension 10ml Bottle24.02 USD
PrednisoLONE Acetate 1% Suspension 15ml Bottle35.46 USD
PrednisoLONE Acetate 1% Suspension 5ml Bottle15.99 USD
PrednisoLONE Sodium Phosphate 1% Solution 10ml Bottle72.82 USD
PrednisoLONE Sodium Phosphate 1% Solution 15ml Bottle34.41 USD
PrednisoLONE Sodium Phosphate 1% Solution 5ml Bottle19.99 USD
PrednisoLONE Sodium Phosphate 15 mg/5ml Solution0.33 USD
PrednisoLONE Sodium Phosphate 5 mg/5ml Solution0.23 USD
Prednisol 1% eye drops5.69 USD
Prednisolone 5 mg tablet0.14 USD
Prednisolone ac 1% eye drop5.75 USD
Prednisolone acetate powder3.36 USD
Prednisolone powder3.36 USD
Prednisolone sod 1% eye drops3.7 USD
Prednisolone sod ph powder36.11 USD
Prelone 15 mg/5 ml syrup0.54 USD
Prelone 15 mg/5ml Syrup0.47 USD
Ratio-Prednisolone 1 % Suspension2.03 USD
Sandoz Prednisolone Acetate 0.12 % Suspension1.33 USD
Sandoz Prednisolone Acetate 1 % Suspension2.03 USD
Solu-Medrol 1 g/vial60.04 USD
Solu-Medrol 500 mg/vial39.17 USD
Solu-Medrol Act-O-Vial 1 g/vial61.25 USD
Solu-Medrol Act-O-Vial 125 mg/vial15.94 USD
Solu-Medrol Act-O-Vial 40 mg/vial6.72 USD
Solu-Medrol Act-O-Vial 500 mg/vial39.96 USD
Solu-medrol (pf) 125 mg vial5.83 USD
Solu-medrol (pf) 500 mg vial20.9 USD
Solu-medrol 1 gm vial24.43 USD
Solu-medrol 500 mg vial12.9 USD
Tablets, Dispersible; Oral; Prednisolone Metasulfobenzoate Sodium 20 mg
Tablets, Effervescent; Oral; Prednisolone Metasulfobenzoate Sodium 20 mg

Prednisolone destination | category:


Prednisolone Anatomical Therapeutic Chemical codes:


Prednisolone pharmaceutical companies:


References

  1. Dailymed."PREDNISTAB (PREDNISOLONE) TABLET [LLOYD, INC. OF IOWA]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. 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/dailym... (accessed August 28, 2018).
  3. "prednisolone". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Prednisolone?

Depending on the reaction of the Prednisolone after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Prednisolone not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Prednisolone addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Prednisolone, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Prednisolone consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported useful

How is the drug Prednisolone useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sdrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
Visitors%
Useful1
100.0%

Visitor reported side effects

No survey data has been collected yet

One visitor reported price estimates

What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Prednisolone is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitors%
Not expensive1
100.0%

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Prednisolone drug as prescribed by the doctor?

Few medications can be taken Twice in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Prednisolone is mentioned below.
Visitors%
Twice in a day1
100.0%

Eight visitors reported doses

What is the dose of Prednisolone drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 1-5mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
1-5mg5
62.5%
11-50mg1
12.5%
6-10mg1
12.5%
51-100mg1
12.5%

Three visitors reported time for results

What is the time duration Prednisolone drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed 3 days to notice the result from using Prednisolone drug. The time needed to show improvement in health condition after using the medicine Prednisolone need not be same for all the users. It varies based on other factors.
Visitors%
3 days1
33.3%
2 days1
33.3%
2 weeks1
33.3%

Two visitors reported administration

The drugs are administered in various routes, like oral or injection form. They are administered before food or after food. How are you taking Prednisolone drug, before food or after food?
Click here to find out how other users of our website are taking it. For any doubts or queries on how and when the medicine is administered, contact your health care provider immediately.
Visitors%
After food1
50.0%
With a meal1
50.0%

Four visitors reported age

Visitors%
> 603
75.0%
6-151
25.0%

Visitor reviews


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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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