Application Information

This drug has been submitted to the FDA under the reference 019157/001.

Names and composition

"PEDIAPRED" is the commercial name of a drug composed of PREDNISOLONE SODIUM PHOSPHATE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
019157/001 PEDIAPRED PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 5MG BASE per 5ML

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
011028/001 HYDELTRASOL PREDNISOLONE SODIUM PHOSPHATE OINTMENT/OPHTHALMIC, OTIC EQ 0.25% PHOSPHATE
011583/002 HYDELTRASOL PREDNISOLONE SODIUM PHOSPHATE INJECTABLE/INJECTION EQ 20MG PHOSPHATE per ML
019157/001 PEDIAPRED PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 5MG BASE per 5ML
021959/001 ORAPRED ODT PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING/ORAL EQ 10MG BASE
021959/002 ORAPRED ODT PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING/ORAL EQ 15MG BASE
021959/003 ORAPRED ODT PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING/ORAL EQ 30MG BASE
040065/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.11% PHOSPHATE
040070/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.9% PHOSPHATE
075099/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 5MG BASE per 5ML
075117/001 ORAPRED PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 15MG BASE per 5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
075181/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 5MG BASE per 5ML
075183/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 5MG BASE per 5ML
075250/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 15MG BASE per 5ML
075988/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 5MG BASE per 5ML
076123/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 5MG BASE per 5ML
076895/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 15MG BASE per 5ML
076913/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 15MG BASE per 5ML
076982/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 5MG BASE per 5ML
076988/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 15MG BASE per 5ML
078345/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 15MG BASE per 5ML
078416/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 5MG BASE per 5ML
078465/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 10MG BASE per 5ML
078988/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 20MG BASE per 5ML
079010/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 15MG BASE per 5ML
080517/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE INJECTABLE/INJECTION EQ 20MG PHOSPHATE per ML
080751/001 INFLAMASE MILD PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.11% PHOSPHATE
080751/002 INFLAMASE FORTE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.9% PHOSPHATE
081043/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.11% PHOSPHATE
081044/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.9% PHOSPHATE
083358/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.11% PHOSPHATE
083358/002 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.9% PHOSPHATE
083834/001 METRETON PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.5% PHOSPHATE
084168/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.9% PHOSPHATE
084169/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.9% PHOSPHATE
084171/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.11% PHOSPHATE
084172/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.9% PHOSPHATE
088165/001 PREDAIR FORTE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.9% PHOSPHATE
088415/001 PREDAIR PREDNISOLONE SODIUM PHOSPHATE SOLUTION/DROPS/OPHTHALMIC EQ 0.11% PHOSPHATE
091396/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 25MG BASE per 5ML
202179/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING/ORAL EQ 10MG BASE
202179/002 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING/ORAL EQ 15MG BASE
202179/003 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING/ORAL EQ 30MG BASE
203559/001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 10MG BASE per 5ML
203559/002 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ORAL EQ 20MG BASE per 5ML

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Answered questions

What is the oral medicen pediapred ?
Asked by Celine Kroninger 1 year ago.

Its basically prednisone, an anti inflammatory steroid. Answered by Nieves Reagin 1 year ago.


Prednisolone side effects...?
okay, i took maybe 4 prednisolone seroids (sp?) once a day about 3 or 4 weeks ago (i was sick). i was supposed to start my period on the 30th and didnt. could taking that med cause this???? I also feel really bloated and having some cramping but it doesnt feel like the same period cramps..?? Asked by Susanne Diosdado 1 year ago.

ENERIC NAME: prednisolone BRAND NAMES: Prednisolone, Pediapred Oral Liquid Medrol DRUG CLASS AND MECHANISM: Prednisolone is a synthetic adrenal corticosteroid. Corticosteroids are natural substances produced by the adrenal glands located adjacent to the kidneys. Corticosteroids have potent anti-inflammatory properties, and are used in a wide variety of inflammatory conditions such as arthritis, colitis, asthma, bronchitis, certain skin rashes, and allergic or inflammatory conditions of the nose and eyes. There are numerous preparations of corticosteroids including oral tablets, capsules, liquids, topical creams and gels, inhalers and eye drops, and injectable and intravenous solutions. Prednisolone that is prescribed in oral tablet and liquid forms is addressed in this article. Dosage requirements of corticosteroids vary among individuals and the diseases being treated. In general, the lowest possible effective dose is used. Corticosteroids given in multiple doses throughout the day are more effective, but also more toxic, than if the same total dose is given once daily, or every other day. PRESCRIPTION: yes GENERIC AVAILABLE: yes PREPARATIONS: tablets: 2mg, 4mg, 8mg, 12mg, 16mg, 24mg, 32mg; Pediapred is an oral liquid: 5mg/5ml (teaspoon); Prelone Syrup is an oral liquid: 15mg/5ml (teaspoon) STORAGE: Store at room temperature, sealed container. Store Pediapred at 39-77 degrees F. PRESCRIBED FOR: Prednisolone is used to achieve prompt suppression of inflammation in many inflammatory and allergic conditions. Examples of inflammatory conditions include rheumatoid arthritis, systemic lupus, acute gouty arthritis, psoriatic arthritis, ulcerative colitis, and Crohn's disease. Severe allergic conditions that fail conventional treatment may also respond to prednisolone. Examples include bronchial asthma, allergic rhinitis, drug-induced dermatitis, and contact and atopic dermatitis. Chronic skin conditions treated with prednisolone include dermatitis herpetiformis, pemphigus, severe psoriasis and severe seborrheic dermatitis. Chronic allergic and inflammatory conditions of the uvea, iris, conjunctiva and optic nerves of the eyes are also treated with prednisolone. Prednisolone is also used in the treatment of blood cell cancers (leukemias), and lymph gland cancers (lymphomas). Blood diseases involving destruction of platelets by the body's own immune cells (idiopathic thrombocytopenia purpura), and destruction of red blood cells by immune cells (autoimmune hemolytic anemia) can also be treated with prednisolone. Other miscellaneous conditions treated with this medication includethyroiditis and sarcoidosis. Finally, prednisolone is used as a hormone replacement in patients whose adrenal glands are unable to produce sufficient amounts of corticosteroids. DOSING: Should be taken with food. DRUG INTERACTIONS: Prolonged use of prednisolone can depress the ability of body's adrenal glands to produce corticosteroids. Abruptly stopping prednisolone in these individuals can cause symptoms of corticosteroid insufficiency, with accompanying nausea, vomiting and even shock. Therefore, withdrawal of prednisolone is usually accomplished by gradual tapering. Gradually tapering prednisolone not only minimizes the symptoms of corticosteroid insufficiency, it also reduces the risk of an abrupt flare of the disease under treatment. Prednisolone and other corticosteroids can mask signs of infection and impair the body's natural immune response to infection. Patients on corticosteroids are more susceptible to infections, and can develop more serious infections than healthy individuals. For instance, chicken pox and measles viruses can produce serious and even fatal illnesses in patients on high doses of prednisolone. Live virus vaccines, such as small pox vaccine, should be avoided in patients taking high doses of prednisolone, since even vaccine viruses may cause disease in these patients. Some infectious organisms, such as tuberculosis (TB) and malaria, can remain dormant in a patient for years. Prednisolone and other corticosteroids can reactivate dormant infections in these patients and cause serious illnesses. Patients with dormant TB may require anti-TB medications while undergoing prolonged corticosteroid treatment. By interfering with the patient's immune response, prednisolone can impede the effectiveness of vaccinations. Prednisolone can also interfere with the tuberculin skin test and cause false negative results in patients with tuberculosis infection. Prednisolone impairs calcium absorption and new bone formation. Patients on prolonged treatment with prednisolone and other corticosteroids can develop osteoporosis and an increased risk of bone fractures. Supplemental calcium and vitamin D are encouraged to slow this process of bone thinning. In rare individuals, destruction of large joints can occur while undergoing treatment with prednisolone or other corticosteroids. These patients experience severe pain in the involved joints, and can require joints replacements. The reason behind such destruction is not clear. SIDE EFFECTS: Prednisolone side effects depend on the dose, the duration and the frequency of administration. Short courses of prednisolone are usually well tolerated with few and mild side effects. Long term, high doses of prednisolone will usually produce predictable, and potentially serious side effects. Whenever possible, the lowest effective doses of prednisolone should be used for the shortest possible length of time to minimize side effects. Alternate day dosing can also help reduce side effects. Side effects of prednisolone and other corticosteroids range from mild annoyances to serious irreversible bodily damages. Side effects include fluid retention, weight gain, high blood pressure, potassium loss, headache, muscle weakness, puffiness of and hair growth on the face, thinning and easy bruising of the skin, glaucoma, cataracts, peptic ulceration, worsening of diabetes, irregular menses, growth retardation in children, convulsions, and psychic disturbances. Psychic disturbances can include depression, euphoria, insomnia, mood swings, personality changes, and even psychotic behavior. The bone and joint complications of corticosteroids are discussed above in Drug Interactions. Answered by Misty Matusek 1 year ago.

Prednisolone/prednisone is undesirable stuff! sure, the urge for nutrition section is a component results of the med. i'm guessing you only began it? yet another section result: moon face. consistent with probability there is yet another medical care the dr. aspects you, or a minimum of shrink the dose. it is worth asking the question simply by fact the arthritis would be with you constantly. attempt and drink as lots fluid (water) as you are able to to stave off the urge to consume. solid success and all the final alongside with your medical care. Answered by Marguerite Ahlman 1 year ago.


Should my little girl be in the hospital? help?
My 6-year-old went to the doctor today, because she had a 102F fever and a sore throat. In the waiting room she started scratching herself and I looked around her neck and saw a rash. The doctor did a swab culture of her throat and verified it was strep. They also said the rash could be scarlatina or scarlet fever.... Asked by Benjamin Whisenhunt 1 year ago.

My 6-year-old went to the doctor today, because she had a 102F fever and a sore throat. In the waiting room she started scratching herself and I looked around her neck and saw a rash. The doctor did a swab culture of her throat and verified it was strep. They also said the rash could be scarlatina or scarlet fever. They gave her a shot of Rocephin and wrote a prescription for Amoxicillin. We came home and my daughter fell asleep for about an hour and woke up scratching The rash was a little worse, so we called the doctor again. They insisted we come back to the office. During the 2nd visit, the doctor said there must have been an allergic reaction to one of the drugs. He then said disregard the previous orders and prescribed Zithromicin, Benadryl, and pediapred. All the pharmacies were close so we wasn't able to start these prescriptions today. Now she is in bed sleeping with a stuffy nose and the rash is present. We suspect she might have had strep for a week because she was coughing the week before. The Doctor at the clinic was actually a nurse practitioner. She did consult a doctor by phone the second visit. Answered by Aiko Salzer 1 year ago.

She started scratching before she stated taking anything didn't she? So it can't have been the initial drugs. She has had a positive Strep throat test, and now she is not on any medication - you need to do something. Go back to the doctor and confirm whether you can put her back on the original medication. Don't take any chances with your little girl. Answered by Sharice Lambeth 1 year ago.

I would give her a cold cloth to put on the rash and even one for her forehead to keep her fever down. Give her some tylenol and try to help her fall asleep. Go get your prescription first thing in the morning, if she seems to get worse through the night or can't fall asleep or her fever keeps rising take her to the hospital. I hope she feels better soon! I give her my best. Answered by Russell Niederhauser 1 year ago.

No, she shouldn't be in the hospital. Give her tylenol and benedryl adn wait until tomorrow to fill the prescription. Answered by Lavern Bourget 1 year ago.


Antibiotics and meds?
and they are allergic to apples. they 21 months Asked by Luigi Ramkissoon 1 year ago.

My twins are sick and they were both put on antibiotics and other medicines. its azithromycin, and pediapred. i give it to them at different times, and i usually mix it with about 2 ounces of milk so they are actually taking all of it, & since they cant drink milk right now they drink it all pretty quickly. is that ok? its the only way they will actually take the medicine, i know some people say that it will make the meds lose there health purposes but it seems like its working. and their both tired of taking so much medicine, but i cant do anything about it cause theyre so sick. i dont think it would do any harm? Answered by Hannah Graziani 1 year ago.

Milk does interact with some meds and make them less effective. You don't say how old they are, but maybe you could mix with applesauce or something. Check with the pharamacist. Answered by Clemmie Hoffelt 1 year ago.

You're really supposed to take medication with water only. While milk might not reduce the drug's efficiency, it's best to play it safe. Always follow the drug instructions so give it to them with water only. Answered by Emily Boppre 1 year ago.


Sick little guy:( Overreacting or true mother's instinct?
Hi! I'm a mom of four, ages 10, 8, 5 (6 in July), and 2. My 5 year old son has me worried sick:( He currently has a sinus infection. That's not necessarily what has me worried, it's what's putting me over the top. Last month it was a bladder infection and two months prior a lung infection and a... Asked by Lesia Fiallos 1 year ago.

Hi! I'm a mom of four, ages 10, 8, 5 (6 in July), and 2. My 5 year old son has me worried sick:( He currently has a sinus infection. That's not necessarily what has me worried, it's what's putting me over the top. Last month it was a bladder infection and two months prior a lung infection and a multitude of infections over his life. He has terrible asthma treated with ventolin and flovent but still requires pediapred 4+ times a year. The poor thing has had 4 abscess teeth and 14 cavities, that mystery has been solved though by our dentist suggesting GERD/acid reflux. This also explained his colic for the first 14 months of his life that my doctor said was nothing to worry about. He has two pea sized hernias that are between his naval and sternum, which Dr. says nothing concerning as well. Terrible eczema on his legs which used to cover his entire body including his face. He also gets terrible bone pain or "growing pains" in his legs that seem to come and go every couple of months. And lastly he's nearly six, and weighs 33 lbs and wears size 3 clothing, whereas his two year old sister weighs in at 29 lbs. He was born a healthy 6lbs 13oz via c-section at 38 weeks and breastfed for 13 months, if that info is of any significance. He's otherwise a very energetic, happy boy who requires little sleep (ha ha). My three other children are all average size and weights, great health and great teeth. Born via c-section and breastfed as well. I don't get it! Is he just the "runt" or the "sickly" one?? We've tried gluten free, dairy free, egg free...you name it, I feel we've tried it! I'm out of answers and am trying not to let his health terrify me. I guess my overall question is am I over reacting or should I trust my instincts that something is wrong? Thank you in advance for taking the time to read and answer! Answered by Many Monje 1 year ago.

I don't think your overreacting at all, as a mother myself I would be worried as heck too. This really sounds like there is an underlying cause that is the root to all of these problems. As to what exactly, I'm not sure, but I think I can give a few ideas about some of the issues that might help. As for the teeth and bone pain, I think I know what's going on. Have his Vitamin D levels tested. As a child my teeth literally crumbled out of my mouth, and I had awful pains in my arms that felt like someone was breaking them in slow motion and it was worsened by cold. I am now 20, and was tested for vitamin d levels by my rhuemotologist and it showed that I had a severe deficiency. Vitamin D is vital in the the bodies use of calcium, causing bones, muscles, and teeth to weaken which causes severe pain. That many infections make it seem to me like he has a compromised immune system, which is a symptom of many diseases. As for his size, it's definitely an indication he's not growing the way he should as a result of whatever is affecting him. I advise taking him to a doctor and telling them all the problems and have them run some tests to try and figure it out. I wish you both the best of luck, and I sincerely hope the problem can be identified. Answered by Melynda Mullenaux 1 year ago.

Sounds terrible. Have you tried goat's milk instead of cows milk? also, bake your own bread instead of using store bought. for the eczema and skin problems what worked for our child was a British product, Salcura Dermaspray Gentle. It was 10 times more effective than everything else we tried, plus it left no residue and was made with all natural products. It stopped the itching in seconds and healed his inflamed damaged skin rapidly. Answered by Dori Knost 1 year ago.


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