Millipred

Name: Millipred

What should I discuss with my healthcare provider before taking Millipred (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 happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of prednisolone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Millipred (prednisolone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • problems with your vision;

  • swelling, rapid weight gain, feeling short of breath;

  • severe depression, unusual thoughts or behavior, seizure (convulsions);

  • bloody or tarry stools, coughing up blood;

  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);

  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • sleep problems (insomnia), mood changes;

  • acne, dry skin, thinning skin, bruising or discoloration;

  • slow wound healing;

  • increased sweating;

  • headache, dizziness, spinning sensation;

  • nausea, stomach pain, bloating; or

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

How is this medicine (Millipred) best taken?

Use Millipred as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take in the morning if taking once a day.
  • Take with food.
  • To gain the most benefit, do not miss doses.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Millipred?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Millipred Description

Millipred Oral Solution (10 mg Prednisolone per 5 mL) is a dye free, pale to light yellow solution. Each 5 mL (teaspoonful) of Millipred Oral Solution contains 13.4 mg prednisolone sodium phosphate (10 mg prednisolone base) in a palatable, aqueous vehicle. Inactive Ingredients: Millipred Oral Solution (10 mg Prednisolone per 5 mL) contains the following inactive ingredients: anti-bitter mask, corn syrup, edetate disodium, glycerin, grape flavor, hydroxyethylcellulose, methylparaben, potassium phosphate dibasic,  potassium phosphate monobasic, purified water, and sodium saccharin.

Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble  in  alcohol  and  in  chloroform;  and  very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is pregna-1,4-diene-3,20-dione,11,17- dihydroxy-21- (phosphonooxy)- disodium salt, (11β)-. The empirical formula is C21H27Na2O8P; the molecular weight is 484.39. Its chemical structure is:

Pharmacological Category: Glucocorticoid

ADVERSE REACTIONS (listed alphabetically under each subsection)

Cardiovascular: Hypertrophic cardiomyopathy in premature infants.

Dermatologic: Facial erythema; increased sweating; impaired wound healing; may suppress reactions to skin tests; petechiae and ecchymoses; thin fragile skin; urticaria; edema.

Endocrine: Decreased carbohydrate tolerance; development of cushingoid state; hirsutism; increased requirements for insulin or oral hypoglycemic agents in diabetic patients; manifestations of latent diabetes mellitus; menstrual irregularities; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness; suppression of growth in children.

Fluid and Electrolyte Disturbances:
Congestive heart failure in susceptible patients; fluid retention; hypertension; hypokalemic alkalosis; potassium loss; sodium retention.

Gastrointestinal: Abdominal distention; elevation in serum liver enzyme levels (usually reversible upon discontinuation); pancreatitis; peptic ulcer with possible perforation and hemorrhage; ulcerative esophagitis.

Metabolic: Negative nitrogen balance due to protein catabolism.

Musculoskeletal: Aseptic necrosis of femoral and humeral heads; loss of muscle mass; muscle weakness; osteoporosis; pathologic fracture of long bones; steroid myopathy; tendon rupture; vertebral compression fractures.

Neurological: Convulsions; headache; increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment; psychic disorders; vertigo.

Ophthalmic: Exophthalmos; glaucoma; increased intraocular pressure; posterior subcapsular cataracts.

Other: Increased appetite; malaise; nausea; weight gain.

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

(web3)