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INTRODUCTION
ZEMPRED contains Methylprednisolone which is a corticosteroid medicine. It is used to treat various inflammatory and allergic conditions affecting the adrenal glands (Ex. adrenocortical insufficiency), bones and joints (Ex. arthritis), collagen (Ex. systemic lupus erythematosus), skin (Ex. psoriasis and dermatitis), lungs (Ex. asthma, pulmonary tuberculosis), eyes (Ex. uveitis, keratitis, neuritis, iritis), blood and lymph (Ex. anemia, leukemia and lymphomas), bowel (Ex. Crohn’s disease and ulcerative colitis), brain (Ex. tuberculous meningitis) and muscles (Ex. dermatomyositis and polymyositis).
Methylprednisolone acts by changing the expression of various genes and proinflammatory cytokines that results in inflammation. It also decreases the number of circulating lymphocytes and induces apoptosis in sensitive tumor cells.
Do not eat grapes or drink grapefruit juice while taking ZEMPRED. While taking ZEMPRED, inform your doctor immediately if you experience any signs of mental problems such as depression, anxiety, difficulty in thinking, confusion, memory loss, hallucinations, or suicidal thoughts. ZEMPRED is contraindicated for use in patients having any serious fungal infection. It should be used with caution among pregnant and breastfeeding women.
USES OF ZEMPRED
Treats various inflammatory and allergic conditions affecting the:
- adrenal glands (Ex. adrenocortical insufficiency, nonsuppurative thyroiditis, congenital adrenal hyperplasia and hypercalcemia associated with cancer)
- bones and joints (Ex. arthritis, ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, and epicondylitis)
- collagen (Ex. systemic lupus erythematosus, systemic dermatomyositis, acute rheumatic carditis)
- skin (Ex. dermatitis, Stevens-Johnson syndrome, mycosis fungoides, severe psoriasis)
- lungs (Ex. allergic rhinitis, bronchial asthma, sarcoidosis, pulmonary tuberculosis, aspiration pneumonitis)
- eyes (Ex. eye inflammation, Herpes zoster ophthalmicus, uveitis, choroiditis, keratitis, optic neuritis, allergic conjunctivitis, chorioretinitis, iritis and iridocyclitis)
- blood and lymph (Ex. autoimmune hemolytic anemia, thrombocytopenia, leukemias and lymphomas)
- kidneys (Ex. remission of proteinuria in the nephrotic syndrome)
- GI tract (Ex. Crohn’s disease and ulcerative colitis)
- brain (Ex. multiple sclerosis and tuberculous meningitis)
- muscles (Ex. dermatomyositis and polymyositis)
HOW ZEMPRED WORKS
ZEMPRED binds to the specific glucocorticoid receptors and alters the expression of various genes and proinflammatory cytokines which produces inflammation. It also acts an immunosuppressant by decreasing the number of circulating lymphocytes and by inducing apoptosis in sensitive tumor cells. It also regulates the functions of adrenal glands and can help your body in conditions associated with adrenal insufficiency.
DIRECTIONS FOR USE
Take ZEMPRED as directed by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of therapy depending upon your age, weight, and health condition. Do not stop taking ZEMPRED unless your doctor tells you.
SIDE EFFECTS OF ZEMPRED
SERIOUS
- signs of bleeding from ulcers (such as stomach pain, bleeding from the anus, black or bloodstained stools and/or vomiting of blood)
- signs of infections (such as fever, feeling unwell, coughing blood or chest pain)
- mental health problems (Ex. depression, mania, suicidal thoughts, anxiety, difficulty in thinking, confusion, memory loss, hallucinations)
COMMON
- high blood pressure
- headache
- swelling of the hands, feet, and ankles
- muscle weakness, cramps, or spasms
- visual disturbances
- slowing of growth in infants and children
- Cushingoid facies (round or moon-shaped face)
- acne
- poor wound healing
- skin thinning
HOW TO MANAGE SIDE EFFECTS
Acne:
Avoid hot showers because hot water can irritate the skin. Do not rub or scratch the affected area. Use sunscreen and protective clothing when outdoors. Regularly use moisturizers to soothe and hydrate the affected area. If it does not get better, speak to your doctor.
Headache:
Rest and drink plenty of fluids. Do not drink alcohol. Ask your doctor to recommend a painkiller.
WARNING & PRECAUTIONS
PREGNANCY
ZEMPRED should be used with caution in pregnant women. Consult your doctor before taking.
BREASTFEEDING
ZEMPRED should be used with caution in breastfeeding women. Consult your doctor before taking.
DRIVING AND USING MACHINES
Do not drive or operate any machines, because this medicine may cause such as dizziness, vertigo, visual disturbances or fatigue.
ALCOHOL
Avoid consumption of alcohol while taking ZEMPRED.
KIDNEY
ZEMPRED should be taken with caution in patients with severe kidney disease. Consult your doctor for advice.
LIVER
ZEMPRED should be taken with caution in patients with severe liver disease. Consult your doctor for advice.
ALLERGY
Do not take this medicine if you are allergic to methylprednisolone.
HEART DISEASE
ZEMPRED should be taken with caution in patients with severe heart disease such as heart attack or hypertension. Consult your doctor for advice.
OTHERS
Before taking ZEMPRED, inform your doctor if you:
- have any serious fungal infection
- have worm infestation (Ex. threadworm)
- have or had severe depression in the past
- are currently having diabetes or a family history of diabetes
- have fits or seizures
- have glaucoma or cataracts
- have viral infections
- have hypothyroidism (an under-active thyroid)
- have pancreatitis (inflammation of pancreas)
- have peritonitis (inflammation of peritoneum)
- have scleroderma (an auto-immune skin disorder)
- have Kaposi’s sarcoma (a type of skin cancer)
- have myasthenia gravis (tired or weak muscles)
- have osteoporosis
- have pheochromocytoma (tumour of adrenal glands)
- have skin abscess
- have stomach ulcers or other serious stomach or intestinal problems
- have thrombophlebitis (blood clot in the veins)
- have or had tuberculosis in the past
- have Cushing’s disease (caused by an excess of cortisol hormone)
- have brain injury
- have unusual stress
- have recently had or going to have any vaccination
- have been in contact with someone who has chickenpox, measles or shingles
- are going to undergo any surgery or dental procedures
Use in Pediatrics:
ZEMPRED should be used with caution in children (under 18 years). Consult your doctor before taking.
Use in Geriatrics:
ZEMPRED should be used with caution in elderly patients (aged above 65 years). Consult your doctor before taking.
INTERACTIONS
Drug-Drug Interactions:
Before taking ZEMPRED, inform your doctor if you are taking:
- medicines used to thin blood (Ex. acenocoumarol, phenindione and warfarin)
- medicines used to treat myasthenia gravis (Ex. distigmine and neostigmine)
- medicines used to treat tuberculosis (Ex. isoniazid, rifampicin and rifabutin)
- medicines used to treat other bacterial infections (Ex. erythromycin, clarithromycin and troleandomycin)
- medicines used to treat viral infections (Ex. ritonavir, indinavir)
- medicines used to treat diabetes (Ex. insulin, metformin)
- medicines used to treat mild to moderate pain (Ex. aspirin, ibuprofen)
- medicines used to treat epilepsy (Ex. phenobarbital, carbamezipine, phenytoin and primidone)
- medicines used to treat heartburn and acid indigestion (Ex. carbenoxolone and cimetidine)
- medicines which cause depletion of potassium (such as diuretics, amphotericin B, xanthenes or salbutamol, terbutaline)
- medicines used to treat heart problems (Ex. digoxin, diltiazem or mibefradil)
- acetazolamide (used to treat glaucoma and epilepsy)
- aminoglutethimide or cyclophosphamide (used to treat cancer)
- fosaprepitant or aprepitant (used to prevent nausea and vomiting)
- ciclosporin (used to treat arthritis, psoriasis or to prevent graft rejection)
- tacrolimus (used to prevent graft rejection)
- oral contraceptives (Ex. ethinylestridiol and norethisterone)
- pharmacokinetic enhancers (Ex. cobicistat) used for HIV infections
- ketoconazole or itraconazole (used for fungal infections)
- neuromuscular blocking agents (used to prevent paralysis) Ex. pancuronium or vecuronium
- vaccines
Drug-Food Interaction:
Do not eat grapes or drink grapefruit juice while taking ZEMPRED, as it may increase the risk of side effects.
Overdosage:
If you or anyone accidentally took too much of ZEMPRED, contact your doctor immediately.
SYNOPSIS
| Drug | : | Methylprednisolone |
| Pharmacological Category | : | Corticosteroids |
| Therapeutic Indication | : | Allergic and inflammatory conditions, Cancer |
| Dosage Forms | : | Tablet, Injection |
MORE INFORMATION
Store below 20-25°C and keep out of reach of children.
FAQs ABOUT ZEMPRED
Can I stop taking ZEMPRED abruptly?
No. Do not stop taking ZEMPRED abruptly without consulting your doctor, as it may result in withdrawal symptoms such as itchy skin, fever, muscle and joint pains, runny nose, sticky eyes, loss of appetite, nausea, vomiting, headache, feeling tired, peeling skin and weight loss.
Can ZEMPRED cause headache?
Yes. ZEMPRED may cause headache in some individuals. Rest and drink plenty of fluids. Do not drink too much alcohol. Ask your pharmacist to recommend a painkiller. If it does not get better, contact your doctor.
Can ZEMPRED cause suicidal thoughts?
Yes. ZEMPRED may cause mental problems such as depression, anxiety, hallucinations, or suicidal thoughts which could be serious. Contact your doctor immediately in such cases. Your doctor might lower your dose or think of an alternative treatment.
Is ZEMPRED a steroid?
Yes. ZEMPRED is a corticosteroid. Supplying your body with extra corticosteroid such as methylprednisolone can help your body in conditions associated with adrenal insufficiency.
Can ZEMPRED be used in children?
Yes. ZEMPRED should be used with caution in children (under 18 years). Consult your doctor before taking
Can ZEMPRED cause weight gain?
ZEMPRED can cause weight gain especially when high doses are taken for a long time or when repeated short courses are taken. Please consult your doctor if this bothers you.
REFERENCES
1. KD. Tripathi. Corticosteroids. Essentials of medical pharmacology. Seventh edition. 2013. Page – 288-295.
2. Bernard P. Schimmer and John W. Funder. ACTH, Adrenal steroids and Pharmacology of adrenal glands. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1215-1233.
3. Pfizer. A Study Comparing Drug Availability of Methylprednisolone in Liquid Form Versus Methylprednisolone in Tablet Form. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on June 2012] [Accessed 11th December 2020]. https://clinicaltrials.gov/ct2/show/NCT01267201
4. Nathan Evaniew, Emilie P. Belley-Côté, Nader Fallah, Vanessa K. Noonan, Carly S. Rivers and Marcel F. Dvorak. Methylprednisolone for the Treatment of Patients with Acute Spinal Cord Injuries: A Systematic Review and Meta-Analysis. NCBI; PMC US National Library of Medicine, National Institute of Health. March 2016. [Accessed 11th December 2020]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4779323/
5. Pfizer Italia S.r.l. Electronic Medicines Compendium (EMC); [Revised on November 2018] [Accessed 11th December 2020] https://www.medicines.org.uk/emc/files/pil.1086.pdf
6. Pfizer Italia S.r.l. Electronic Medicines Compendium (EMC); [Revised on November 2018] [Accessed 11th December 2020]. https://www.medicines.org.uk/emc/files/pil.1085.pdf
7. Pfizer Inc. U.S. Food & Drug Administration. [Revised on July 2018] [Accessed 11th December 2020] https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011153s075lbl.pdf
USEFUL DIAGNOSTIC TESTS
- Absolute Eosinophil Count
- Anti-Nuclear Antibody
- Anti-ds-DNA Antibody
- Anti-ds-DNA Antibody-IFA
- Complete Blood Count
- Peripheral Smear Examination
- Total IgE
PRODUCT DETAILS
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