Millipred DP

Name: Millipred DP

What is Millipred DP (prednisolone)?

Prednisolone is a steroid. It prevents the release of substances in the body that cause inflammation.

Prednisolone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

Prednisolone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Millipred DP (prednisolone)?

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

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

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

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

What should I discuss with my healthcare provider before taking Millipred DP (prednisolone)?

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

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

To make sure prednisolone is safe for you, tell your doctor about your other medical conditions, especially:

  • liver disease (such as cirrhosis);

  • kidney disease;

  • a thyroid disorder;

  • diabetes;

  • a history of malaria;

  • tuberculosis;

  • osteoporosis;

  • a muscle disorder such as myasthenia gravis;

  • glaucoma or cataracts;

  • herpes infection of the eyes;

  • stomach ulcers, ulcerative colitis, or diverticulitis;

  • depression or mental illness;

  • congestive heart failure; or

  • high blood pressure

FDA pregnancy category C. It is not known whether prednisolone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Prednisolone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

What should I avoid while taking Millipred DP (prednisolone)?

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 prednisolone. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid drinking alcohol while you are taking prednisolone.

What other drugs will affect Millipred DP (prednisolone)?

Many drugs can interact with prednisolone. Below is just a partial list. Tell your doctor if you are using:

  • aspirin (taken on a daily basis or at high doses);

  • a diuretic (water pill);

  • a blood thinner such as warfarin (Coumadin, Jantoven);

  • cyclosporine (Gengraf, Neoral, Sandimmune);

  • insulin or diabetes medications you take by mouth;

  • ketoconazole (Nizoral);

  • rifampin (Rifadin, Rifater, Rifamate, Rimactane); or

  • seizure medications such as phenytoin (Dilantin) or phenobarbital (Solfoton).

This list is not complete and other drugs may interact with prednisolone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Commonly used brand name(s)

In the U.S.

  • Bubbli-Pred
  • Cotolone
  • Flo-Pred
  • Millipred
  • Millipred DP
  • Orapred
  • Orapred ODT
  • Pediapred
  • Prelone
  • Veripred 20

In Canada

  • Pms-prednisoLONE

Available Dosage Forms:

  • Solution
  • Tablet
  • Syrup
  • Suspension
  • Liquid
  • Tablet, Disintegrating

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Before Using Millipred DP

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of prednisolone in children. However, pediatric patients are more likely to have slower growth and bone problems if prednisolone is used for a long time. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prednisolone in the elderly. However, elderly patients are more likely to have age-related kidney and bone problems, which may require caution and an adjustment in the dose for elderly patients receiving prednisolone.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Desmopressin
  • Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Aldesleukin
  • Amtolmetin Guacil
  • Asparaginase
  • Bemiparin
  • Bromfenac
  • Bufexamac
  • Bupropion
  • Celecoxib
  • Ceritinib
  • Choline Salicylate
  • Clonixin
  • Darunavir
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Droxicam
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Ibuprofen
  • Idelalisib
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Morniflumate
  • Nabumetone
  • Nadroparin
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Olaparib
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Pixantrone
  • Pranoprofen
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Ritonavir
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Sorafenib
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Valdecoxib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alcuronium
  • Amobarbital
  • Aspirin
  • Atracurium
  • Desogestrel
  • Dienogest
  • Drospirenone
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Fosphenytoin
  • Gallamine
  • Hexafluorenium
  • Levonorgestrel
  • Licorice
  • Medroxyprogesterone Acetate
  • Mestranol
  • Metocurine
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Phenytoin
  • Primidone
  • Rifampin
  • Saiboku-To
  • Vecuronium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Cataracts or
  • Congestive heart failure or
  • Cushing's syndrome (adrenal gland problem) or
  • Diabetes or
  • Eye infection or
  • Glaucoma or
  • Hyperglycemia (high blood sugar) or
  • Hypertension (high blood pressure) or
  • Infection (e.g., bacterial, virus, or fungus) or
  • Mood changes, including depression or
  • Myasthenia gravis (severe muscle weakness) or
  • Osteoporosis (weak bones) or
  • Peptic ulcer, active or history of or
  • Personality changes or
  • Stomach or intestinal problems (e.g., diverticulitis, ulcerative colitis) or
  • Tuberculosis, inactive—Use with caution. May make these conditions worse.
  • Fungal infections or
  • Herpes simplex eye infection—Should not be used in patients with these conditions.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Millipred DP Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Aggression
  • agitation
  • anxiety
  • blurred vision
  • decrease in the amount of urine
  • dizziness
  • fast, slow, pounding, or irregular heartbeat or pulse
  • headache
  • irritability
  • mental depression
  • mood changes
  • nervousness
  • noisy, rattling breathing
  • numbness or tingling in the arms or legs
  • pounding in the ears
  • shortness of breath
  • swelling of the fingers, hands, feet, or lower legs
  • trouble thinking, speaking, or walking
  • troubled breathing at rest
  • weight gain
Incidence not known
  • Abdominal cramping and/or burning (severe)
  • abdominal pain
  • backache
  • bloody, black, or tarry stools
  • cough or hoarseness
  • darkening of skin
  • decrease in height
  • decreased vision
  • diarrhea
  • dry mouth
  • eye pain
  • eye tearing
  • facial hair growth in females
  • fainting
  • fatigue
  • fever or chills
  • flushed, dry skin
  • fractures
  • fruit-like breath odor
  • full or round face, neck, or trunk
  • heartburn and/or indigestion (severe and continuous)
  • increased hunger
  • increased thirst
  • increased urination
  • loss of appetite
  • loss of sexual desire or ability
  • lower back or side pain
  • menstrual irregularities
  • muscle pain or tenderness
  • muscle wasting or weakness
  • nausea
  • pain in back, ribs, arms, or legs
  • painful or difficult urination
  • skin rash
  • sleeplessness
  • sweating
  • trouble healing
  • trouble sleeping
  • unexplained weight loss
  • unusual tiredness or weakness
  • vision changes
  • vomiting
  • vomiting of material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Increased appetite
Incidence not known
  • Abnormal fat deposits on the face, neck, and trunk
  • acne
  • dry scalp
  • lightening of normal skin color
  • red face
  • reddish purple lines on the arms, face, legs, trunk, or groin
  • swelling of the stomach area
  • thinning of the scalp hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

For Healthcare Professionals

Applies to prednisolone: compounding powder, injectable solution, injectable suspension, oral liquid, oral suspension, oral syrup, oral tablet, oral tablet disintegrating

General

The most commonly occurring side effects have included fluid retention, alteration in glucose tolerance, increased blood pressure, behavioral and mood changes, increased appetite, and weight gain; the incidence often correlates with dosage, timing of administration, and duration of treatment.[Ref]

Metabolic

Calciphylaxis has been reported rarely with corticosteroid use, most commonly in patients with ESRD; although some patients have had minimal or no renal impairment with normal calcium, phosphate, and parathyroid hormone levels.[Ref]

Common (1% to 10%): Alteration in glucose tolerance, increased appetite, weight gain
Rare (0.01% to 0.1%): Calciphylaxis
Frequency not reported: Potassium losses, hypokalemia alkalosis, sodium retention, negative nitrogen balance due to protein catabolism, manifestation of latent diabetes mellitus, increases in total cholesterol, low density lipoproteins, and triglycerides, obesity, dyslipidemia, calciphylaxis[Ref]

Cardiovascular

Common (1% to 10%): Fluid retention, blood pressure elevations
Frequency not reported: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis, edema[Ref]

Endocrine

Frequency not reported: Hirsutism, development of cushingoid state, hyperthyroidism, hypothyroidism, moon face, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress as in trauma, surgery, or illness)[Ref]

Gastrointestinal

Frequency not reported: Abdominal distention, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, ulcerative esophagitis, esophageal candidiasis, dyspepsia, abdominal pain, diarrhea, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), vomiting[Ref]

Immunologic

Frequency not reported: Opportunistic infections (bacterial, viral, fungal and parasitic infections), recurrence of dormant tuberculosis, suppressed response to skin tests[Ref]

Musculoskeletal

Corticosteroid myopathy presents as weakness and wasting of the proximal limb and girdle muscles and is generally reversible following cessation of therapy.

Corticosteroids inhibit intestinal calcium absorption and increase urinary calcium excretion leading to bone resorption and bone loss. Bone loss of 3% over one year has been demonstrated with prednisolone (the active ingredient contained in Millipred DP) 10 mg per day. Postmenopausal females are particularly at risk for loss of bone density. Sixteen percent of elderly patients treated with corticosteroids for 5 years may experience vertebral compression fractures. One author reported measurable bone loss over two years in women on concomitant therapy with prednisolone 7.5 mg per day and tamoxifen.[Ref]

Frequency not reported: Aseptic necrosis of femoral and humeral heads, Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures, growth suppression in pediatric patients (infancy, childhood and adolescence), proximal myopathy, vertebral and long bone fractures, avascular osteonecrosis, tendinopathies, myalgia[Ref]

Ocular

In renal transplant patients maintained on prednisolone (the active ingredient contained in Millipred DP) 10 mg per day, 33% developed posterior subcapsular cataracts. Mean time to cataract development is 26 months. Increased intraocular pressure has occurred in 5% of patients.[Ref]

Frequency not reported: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, nuclear cataracts (particularly in children), corneal or scleral thinning, exacerbation of ophthalmic viral or fungal disease[Ref]

Psychiatric

Common (1% to 10%): Behavioral changes, mood changes, irritability, suicidal thoughts, psychotic reactions, mania, delusions, hallucinations, aggravation of schizophrenia, anxiety, sleep disorders, amnesia
Frequency not reported: Depression, emotional instability, euphoria, insomnia, mood swings, personality changes, euphoria, psychological dependence[Ref]

A wide range of psychiatric reactions have been commonly reported in both adults and children. The frequency of severe reactions has been estimated at around 5% to 6%. Psychological effects have been reported on withdrawal of corticosteroids, the frequency of this is unknown.[Ref]

Hematologic

Frequency not reported: Leucocytosis[Ref]

Dermatologic

Frequency not reported: Acne, allergic dermatitis, cutaneous and subcutaneous fat atrophy, dry scalp, edema, facial erythema, hyper or hypo pigmentation, impaired wound healing, increased sweating, petechiae, ecchymosis, rash, sterile abscess, striae, suppressed reactions to skin tests, thinning of skin, thinning scalp hair, urticaria, hirsutism, bruising, telangiectasia, rash, perineal irritation[Ref]

Genitourinary

Frequency not reported: Amenorrhea, postmenopausal bleeding or menstrual irregularities, increased or decreased motility and number of spermatozoa[Ref]

Hepatic

Frequency not reported: Elevation in serum liver enzyme levels, hepatomegaly[Ref]

Hypersensitivity

Frequency not reported: Anaphylactoid reaction, anaphylaxis, angioedema[Ref]

Nervous system

Frequency not reported: Arachnoiditis, convulsions, headache, increased intracranial hypertension with papilledema (pseudotumour cerebri) usually following discontinuation of therapy, meningitis, neuritis, neuropathy, paraparesis/paraplegia, paraesthesia, sensory disturbances, aggravation of epilepsy, clinical signs of evolving stroke, EEG abnormalities, increased motor activity, ischemic neuropathy, severe tiredness, weakness[Ref]

Other

A steroid withdrawal syndrome unrelated to adrenocortical insufficiency has been reported following discontinuation. The syndrome includes symptoms such as anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules, weight loss, and/or hypotension. These effects may be due to the sudden change in glucocorticosteroid concentrations rather than to low corticosteroid levels.[Ref]

Frequency not reported: Malaise, vertigo, fatigue, impaired healing, steroid withdrawal syndrome[Ref]

Respiratory

Frequency not reported: Pulmonary edema, hiccups[Ref]

Oncologic

Frequency not reported: Kaposi's sarcoma[Ref]

Kaposi's sarcoma has been reported among patients receiving corticosteroid therapy; discontinuation may result in clinical remission.[Ref]

Some side effects of Millipred DP may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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