Predixa Tablet 16mg
10 tabletsProduct Information
PREDIXA
Predixa Tablet®(Methylprednisolone)
Presentation
Predixa 4mg tablet: Light pink, caplet shaped tablet, having engraved on one side and scored on the other side; each tablet
contains Methylprednisolone BP 4mg.
Predixa 8mg tablet: Light yellow, caplet shaped tablet, having engraved on one side and scored on the other side; each tablet
contains Methylprednisolone BP 8mg.
Predixa 16mg tablet: Light blue, caplet shaped tablet, having engraved on one side and scored on the other side; each tablet
contains Methylprednisolone BP 16mg.
Indications
Methylprednisolone is indicated for conditions requiring glucocorticoid activity such as:- Endocrine disorders : Primary and
secondary adrenal insufficiency, Congenital adrenal hyperplasia, Rheumatic disorders: Rheumatoid arthritis, Juvenile chronic
arthritis, Ankylosing spondylitis, Collagen diseases/arteritis: Systemic lupus erythematosus, Systemic
dermatomyositis (polymyositis), Rheumatic fever with severe carditis, Giant cell arteritis/polymyalgia rheumatica, Dermatological
diseases: Pemphigus vulgaris, Allergic states: Severe seasonal and perennial allergic rhinitis, Drug hypersensitivity reactions,
Serum sickness, Allergic contact dermatitis, Bronchial asthma, Ophthalmic diseases: Anterior uveitis (iritis, iridocyclitis),
Posterior uveitis, Optic neuritis Respiratory diseases: Pulmonary sarcoid, Fulminating or disseminated tuberculosis (with
appropriate anti-tuberculous chemotherapy), Aspiration of gastric contents, Haematological disorders: Idiopathic thrombocytopenic
purpura, Haemolytic anaemia (autoimmune), Neoplastic diseases: Leukaemia (acute and lymphatic), Malignant lymphoma,
Gastro-intestinal diseases: Ulcerative colitis, Crohn’s disease, Miscellaneous: Tuberculous meningitis (with appropriate
antituberculous chemotherapy), Transplantation.
Dosage Recommendations
Indications Recommended initial daily dosage Rheumatoid arthritis Severe 12 – 16 mg moderately severe 8 – 12 mg Moderate
4 – 8 mg Children 4 – 8 mg Systemic dermatomyositis 48 mg Systemic lupus erythematosus 20 – 100 mg Acute rheumatic fever
48 mg until ESR normal for one week. Allergic diseases 12 – 40 mg Bronchial asthma up to 64 mg single dose/alternate day up
to 100 mg maximum. Ophthalmic diseases 12 – 40 mg Haematological disorders and leukaemias 16 – 100 mg Malignant lymphoma 16 –
100 mg Ulcerative colitis 16 – 60 mg Crohn’s disease up to 48 mg per day in acute episodes Organ transplantation up to 3.6
mg/kg/day Pulmonary sarcoid 32 – 48 mg on alternate days. Giant cell arteritis/polymyalgia rheumatic 64 mg Pemphigus vulgaris
80 – 360 mg
Contra-indications, warnings, etc.
Contra-indications: Methylprednisolone tablets are contraindicated in patients who have: systemic fungal infections, systemic
infections unless specific anti-infective therapy is employed, hypersensitivity to the active substance or to any of the
excipients.
Precautions: Immunosuppressant Effects/Increased Susceptibility to Infections: Corticosteroids may mask some signs of infection,
and new infections may appear during their use. Suppression of the inflammatory response and immune function increases the
susceptibility to fungal, viral and bacterial infections and their severity. The clinical presentation may often be atypical and
may reach an advanced stage before being recognised. Persons who are on drugs which suppress the immune system are more
susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal
course in non-immune children or adults on corticosteroids. Chickenpox is of serious concern since this normally minor illness may
be fatal in immunosuppressed patients. Patients (or parents of children) without a definite history of chickenpox should be
advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention.
Passive immunization with treatment. Corticosteroids should not be stopped and the dose may need to be increased. Exposure to
measles should be avoided. Medical advice must be sought immediately if exposure occurs. Prophylaxis with normal intramuscular
immunoglobulin may be needed. Similarly corticosteroids should be used with great care in patients with known or suspected
parasitic infections such as Strongyloides (threadworm) infestation, which may lead to Strongyloides hyperinfection and
dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative
septicemia. The role of corticosteroids in septic shock has been controversial, with early studies reporting both beneficial and
detrimental effects. More recently, supplemental corticosteroids have been suggested to be beneficial in patients with
established septic shock who exhibit adrenal insufficiency. However, their routine use in septic shock is not recommended. A
systematic review of short-course high-dose corticosteroids did not support their use. However, meta-analyses, and a review have
suggested that longer courses (5-11 days) of low-dose corticosteroids might reduce mortality. Live vaccines should not be given to
individuals with impaired immune responsiveness. The antibody response
to other vaccines may be diminished. The use of corticosteroids in active tuberculosis should be restricted to those cases of
fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with
an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin
reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy,
these patients should receive chemoprophylaxis. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid
therapy. Discontinuation
of corticosteroids may result in clinical remission. Blood and Lymphatic System: Aspirin and nonsteroidal anti-inflammatory agents
should be used cautiously in conjunction with corticosteroids.
Endocrine Effects: Adrenal cortical atrophy develops during prolonged therapy and may persist for months after stopping treatment.
In patients who have received more than physiological doses of systemic corticosteroids (approximately 6 mg methylprednisolone)
for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the
disease is likely to relapse as the dose of systemic corticosteroids is reduced. Clinical assessment of disease activity may be
needed during withdrawal. If the disease is unlikely to relapse on withdrawal of systemic corticosteroids, but there is
uncertainty about HPA suppression, the dose of systemic corticosteroid may be reduced rapidly to physiological doses. Once a daily
dose of 6 mg methylprednisolone is reached, dose reduction should be slower to allow the HPA-axis to recover. Abrupt withdrawal of
systemic corticosteroid treatment, which has continued up to 3 weeks is appropriate if it considered that the disease is unlikely
to relapse. Abrupt withdrawal of doses up to 32 mg daily of for 3 weeks is unlikely to lead to clinically relevant HPA-axis
suppression, in the majority of patients. In the following patient groups, gradual withdrawal of systemic corticosteroid therapy
should be considered even after courses lasting 3 weeks or less: Patients who have had repeated courses of systemic
corticosteroids, particularly if taken for greater than 3 weeks. When a short course has been prescribed within one year of
cessation of long-term therapy (months or years). Patients who may have reasons for adrenocortical insufficiency other than
exogenous corticosteroid therapy. In addition, acute adrenal insufficiency leading to a fatal outcome may occur if glucocorticoids
are withdrawn abruptly. Patients receiving doses of systemic corticosteroid greater than 32 mg daily of methylprednisolone.
Patients repeatedly taking doses in the evening. Patients repeatedly taking doses in the evening. In drug-induced adrenocorticol
insufficiency mineralocorticoid secretion may be impaired, therefore salt and/or a mineralocorticoid should be administered
concurrently. Glucocorticoids can produce or aggravate Cushing’s syndrome,
therefore glucocorticoids should be avoided in patients with Cushing’s disease. Particular care is equired when considering the
use of systemic corticosteroids in patients with hypothyroidism and frequent patient monitoring is necessary.
Metabolism and Nutrition Disorders: Corticosteroids, including methylprednisolone, can increase blood glucose, worsen pre-existing
diabetes, and predispose those on long-term corticosteroid therapy to diabetes mellitus. Particular care is required when
considering the use of systemic corticosteroids in patients with Diabetes mellitus (or a family history of diabetes) and frequent
patient monitoring is necessary.
Psychiatric Effects: Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with
systemic steroids. Symptoms typically emerge within a few days or weeks of starting treatment. Risks may be higher with high
doses/systemic exposure,
although dose levels do not allow prediction of the onset, type, severity or duration of reactions.Most reactions recover after
either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek
medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected.
Patients/carers should be alert to possible psychiatric disturbances that may occur either during or immediately after dose
tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently. Particular care is required
when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders
in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid
psychosis. Nervous System Effects: Particular care is required when considering the use of systemic corticosteroids in patients
with seizure disorders and myasthenia gravis and frequent patient methylprednisolone monitoring is necessary.
Ocular Effects: Particular care is required when considering the use of systemic corticosteroids in patients with glaucoma (or a
family history of glaucoma) and ocular herpes simplex as there is a fear of corneal perforation, nd frequent patient monitoring is
necessary. Prolonged use of corticosteroids may produce posterior subcapsular cataracts aand nuclear cataracts (particularly in
children), exophthalmos or increased intraocular pressure, which may result in glaucoma with possible damage to the optic nerves.
Secondary fungal and viral infections of the eye may also be enhanced in patients receiving glucocorticoids. Cardiac events:
Systemic corticosteroids should be used with caution, and only if strictly necessary, in cases of congestive heart failure.
Particular care is required when considering the use of systemic corticosteroids in patients with recent myocardial infarction
(myocardial rupture has been reported) and frequent patient monitoring is necessary. Care should be taken for patients receiving
cardioactive drugs such as digoxin because of steroid induced electrolyte disturbance/potassium loss.
Vascular Effects: Hypertension: redisposition to thrombophlebitis, Particular care is required when considering the use of
systemic corticosteroids in patients with the conditions and frequent patient monitoring is necessary. Gastrointestinal Effects:
Particular care is required when considering the use of systemic corticosteroids in patients with the conditions and frequent
patient monitoring is necessary.Peptic ulceration, Fresh intestinal anastomoses, Abscess or other pyogenic infections, Ulcerative
colitis, Diverticulitis. Hepatobiliary Effects: There is an enhanced effect of corticosteroids on patients with cirrhosis.
Particular care is required when considering the use of systemic corticosteroids in patients with liver failure or cirrhosis and
frequent patient monitoring is necessary. Musculoskeletal Effects: An acute myopathy has been reported with the use of high doses
of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (eg, myasthenia gravis), or in
patients receiving concomitant therapy with anticholinergics, such as neuromuscular blocking drugs (eg, pancuronium). This acute
myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevations of creatine
kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Particular care is
required when considering the use of systemic corticosteroids in patients with osteoporosis (post-menopausal females are
particularly at risk) and frequent patient monitoring is necessary. Renal and Urinary: Particular care is required when
considering the use of systemic corticosteroids in patients with renal insufficiency and frequent patient monitoring is necessary.
Injury, poisoning and procedural complications: High doses of systemic corticosteroids should not be used for the treatment of
traumatic brain injury. Other: Undesirable effects may be minimised by using the lowest effective dose for the minimum period, and
by administering the daily requirement as a single morning
dose or whenever possible as a single morning dose on alternative days. Frequent patient review is required to appropriately
titrate the dose against disease activity. Use in children: Corticosteroids cause growth retardation in infancy, childhood and
adolescence. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
Treatment should be limited to the minimum dosage for the shortest possible time. In order to minimise suppression of the
hypothalamo-pituitary -adrenal axis and growth retardation, treatment should be administered where possible as a single dose on
alternate days. Use in the elderly: The common adverse effects of systemic corticosteroids may be associated with more serious
consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning
of the skin. Close clinical supervision is required to avoid life-threatening reactions. Drug interactions: Methylprednisolone is
a cytochrome P450 enzyme (CYP) substrate and is mainly metabolized by the CYP3A4 enzyme. CYP3A4 is the dominant enzyme of the most
abundant CYP subfamily in the liver of adult humans. It catalyzes 6?-hydroxylation of steroids, the essential Phase I metabolic
step for both endogenous and synthetic corticosteroids. Many other compounds are also substrates of CYP3A4, some of which
(as well as other drugs) have been shown to alter glucocorticoid metabolism by induction (upregulation) or inhibition of the
CYP3A4 enzyme.
Antiemetic- Aprepitant- FosaprepitantCYP3A4Inhibitor(andSubstrate)CYP3A4 SUBSTRATES – In the presence of anotherCYP3A4 substrate,
the hepatic clearance of methylprednisolone may be inhibited or induced, withcorresponding dosage adjustments required. It
ispossible that adverse events associated with the use of either drug alone may be more likely to occur with coadministration.(1)
Mutual inhibition of metabolism occurs with concurrent use of cyclosporine and methylprednisolone, which may increase the
plasmaconcentrations of either or both drugs. Therefore, it is possible that adverse events associated with the use of either
drugAntifungal- Itraconazole- KetoconazoleCalcium Channel Blocker- DiltiazemContraceptives (Oral)-
Ethinylestradiol/NorethindronemImmunosuppressant- Ciclosporin (1)CYP3A4Substrate2) Protease inhibitors, such as indinavir and
ritonavir, may increase plasma concentrations of corticosteroids.(3) Corticosteroids may induce the metabolism of
HIVproteaseinhibitors resulting in reduced plasma concentrations.Macrolide Antibacterial- Clarithromycin- ErythromycinAntivirals-
Hiv-Protease Inhibitors (2) (3)Immunosuppressant- Cyclophosphamide- TacrolimusNon-CYP3A4-mediatedeffectsCYP3A4 SUBSTRATES – In the
presence of anotherCYP3A4 substrate, the hepatic clearance ofmethylprednisolone may be inhibited or induced, withcorresponding
dosage adjustments required. It ispossible that adverse events associated with the useof either drug alone may be more likely to
occur with(4) There may be increased incidence ofgastrointestinal bleeding and ulceration whencorticosteroids are given with
NSAIDs.(5) Methylprednisolone may increase the clearance ofhigh-dose aspirin. This decrease in salicylate serumlevels could lead
to an increased risk of salicylatetoxicity when methylprednisolone is withdrawn.(6) An acute myopathy has been reported with
theconcomitant use of high doses of corticosteroids andanticholinergics, such as neuromuscular blocking(7) Antagonism of the
neuromuscular blocking effectsof pancuronium and vecuronium has been reported inpatients taking corticosteroids. This interaction
may beexpected with all competitive neuromuscular blockers.The efficacy of coumarin anticoagulants may beenhanced by concurrent
corticosteroid therapy andclose monitoring of the INR or prothrombin time isrequired to avoid spontaneous bleeding.NSAIDs
(nonsteroidalanti-inflammatory drugs) (4)- high-dose ASPIRIN (5)(acetylsalicylic acid)Anticholinergics (6)- NeuromuscularBlockers
(7)Anticoagulants (oral)Steroids may reduce the effects of anticholinesterases in myasthenia gravis. The desired effects
ofhypoglycaemic agents (including insulin), anti-hypertensives and diuretics are antagonised by
corticosteroids, and the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics and
carbenoxolone are enhanced. Pregnancy and lactation: Pregnancy: The ability of corticosteroids to cross the placenta varies
between individual drugs, however, methylprednisolone does cross the placenta. Administration of corticosteroids to pregnant
animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and effects on
brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital
abnormalities, such as cleft palate in man, however, when administered for long periods or repeatedly during pregnancy,
corticosteroids
Drg Class Or Type- Drug Or Substance Interaction Effect Antibiotic, Antitubercular
– Rifampin
– Rifabutin CYP3A4InducerCYP3A4 Inducer(and Substrate) CYP3A4 INDUCERS – Drugs that induce CYP3A4 activity generally increase
hepatic clearance, resulting in decreased plasma concentration of medications that are substrates for CYP3A4. Coadministration may
require an increase in methylprednisolone dosage to achieve the desired result.CYP3A4 SUBSTRATES – In the presence of another
CYP3A4 substrate, the hepatic clearance of methylprednisolone may be inhibited or induced, with corresponding dosage adjustments
required. It is possible that adverse events associated with the use
of either drug alone may be more likely to occur with coadministration. Anticonvulsants
– Phenobarbital
– Phenytoin
– Primidone Adrenocortical Steroid
Synthesis Inhibitor
– Aminoglutethimide Anticonvulsant
– Carbamazepine Anticonvulsant
– Carbamazepine CYP3A4 Inhibitor CYP3A4 INHIBITORS – Drugs that inhibit CYP3A4 activity generally decrease hepatic clearance and
increase the plasma concentration of CYP3A4 substrate medications, such as methylprednisolone. In
the presence of a CYP3A4 inhibitor, the dose of methylprednisolone may need to be titrated to avoid
steroid toxicity. Macrolide Antibacterial
– Troleandomycin -Grapefruit Juice Calcium Antagonist
– Mibefradil H2 Receptor Antagonist
– Cimetidine
Antiemetic- Aprepitant- Fosaprepitant CYP3A4Inhibitor(andSubstrate) CYP3A4 SUBSTRATES – In the presence of anotherCYP3A4
substrate, the hepatic clearance of methylprednisolone may be inhibited or induced, withcorresponding dosage adjustments required.
It ispossible that adverse events associated with the use of either drug alone may be more likely to occur with
coadministration.(1) Mutual inhibition of metabolism occurs with concurrent use of cyclosporine and methylprednisolone, which may
increase the plasmaconcentrations of either or both drugs. Therefore, it is possible that adverse events associated with the use
of either drug Antifungal- Itraconazole- Ketoconazole Calcium Channel Blocker- Diltiazem Contraceptives (Oral)-
Ethinylestradiol/Norethindrone mImmunosuppressant- Ciclosporin (1) CYP3A4Substrate 2) Protease inhibitors, such as indinavir and
ritonavir, may increase plasma concentrations of corticosteroids.(3) Corticosteroids may induce the metabolism of
HIVproteaseinhibitors resulting in reduced plasma concentrations. Macrolide Antibacterial- Clarithromycin- Erythromycin
Antivirals- Hiv-Protease Inhibitors (2) (3) Immunosuppressant- Cyclophosphamide- Tacrolimus Non-CYP3A4-mediatedeffects CYP3A4
SUBSTRATES – In the presence of anotherCYP3A4 substrate, the hepatic clearance ofmethylprednisolone may be inhibited or induced,
withcorresponding dosage adjustments required. It ispossible that adverse events associated with the useof either drug alone may
be more likely to occur with(4) There may be increased incidence ofgastrointestinal bleeding and ulceration whencorticosteroids
are given with NSAIDs.(5) Methylprednisolone may increase the clearance ofhigh-dose aspirin. This decrease in salicylate
serumlevels could lead to an increased risk of salicylatetoxicity when methylprednisolone is withdrawn.
(6) An acute myopathy has been reported with the concomitant use of high doses of corticosteroids and anticholinergics, such as
neuromuscular blocking
(7) Antagonism of the neuromuscular blocking effects of pancuronium and vecuronium has been reported in patients taking
corticosteroids. This interaction may be expected with all competitive neuromuscular blockers. The efficacy of coumarin
anticoagulants may be enhanced by concurrent corticosteroid therapy and close monitoring of the INR or prothrombin time is
required to avoid spontaneous bleeding.NSAIDs (nonsteroidalanti-inflammatory drugs) (4)- high-dose ASPIRIN (5)(acetylsalicylic
acid)Anticholinergics (6)- NeuromuscularBlockers (7)Anticoagulants (oral)Steroids may reduce the effects of anticholinesterases in
myasthenia gravis. The desired effects of hypoglycaemic agents (including insulin), anti-hypertensives and diuretics are
antagonised by corticosteroids, and the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics and
carbenoxolone are enhanced.
Pregnancy and lactation: Pregnancy: The ability of corticosteroids to cross the placenta varies between individual drugs, however,
methylprednisolone does cross the placenta. Administration of corticosteroids to pregnant animals can cause abnormalities of
foetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is
no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate in man,
however, when
administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine
intrauterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to
corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. As with all drugs,
corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are
essential, however, patients with normal pregnancies may be treated as though they were in the non-gravid state. Lactation:
Corticosteroids are excreted in small amounts in breast milk, however, doses of up to 40 mg daily of methylprednisolone are
unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal
suppression. Since adequate reproductive studies have not been performed in humans with glucocorticoids, these drugs should be
administered to nursing mothers only if the benefits of therapy are
judged to outweigh the potential risks to the infant.
MedDRA SystemOrgan Class Frequency* Undesirable Effects Infections and infestationsNeoplasms benign, malignantand unspecified
(includingcysts and polyps) Common Infection (including increased susceptibility and severity of infections with suppression of
clinical symptoms andsigns) Not Known Kaposi’s sarcoma Blood and lymphatic systemdisorders Not Known Leucocytosis Immune system
disorders Not Known Drug hypersensitivity (including Anaphylactic reaction and Anaphylactoid reaction); Suppression of reactions
to skin tests Endocrine disorders Endocrine disorders Cushingoi Not Known Hypopituitarism Metabolism and nutritiondisorders Common
Sodium retention; Fluid retention Not Known Alkalosis hypokalaemic; Metabolic acidosis; Glucose tolerance impaired; increased
requirements for insulin or oral hypoglycemic agents in diabetics; Increased appetite (which may result in Weight increase).
Psychiatric disorders Common Affective disorder (including Depressed mood and Euphoric mood) Not Known Psychotic disorder
(including Mania, Delusion, Hallucination, and Schizophrenia [aggravation of]); Psychotic behaviour; Affective disorder (including
Affect lability, Psychological dependence, Suicidal ideation); Mental disorder; Personality change; Mood swings; Confusional
state; Abnormal behaviour; Anxiety; Insomnia; Irritibility. Nervous system disorders Not Known Convulsions; Intracranial pressure
increased (with Papilloedema [Benign intracranial hypertension]); Amnesia Cognitive disorder; Dizziness; Headache. Eye disorders
Common Cataract subcapsular Not Known Glaucoma, Exophthalmos, Corneal thinning; Scleral thinning Ear and labyrinth disorders Not
Known Vertigo Cardiac disorders Not Known Cardiac failure congestive (in susceptible patients), Myocardial rupture following
myocardial infarction Vascular disorders Common Hypertension Not Known Hypotension, Embolism arterial Respiratory, thoracic
andmediastinal disorders Not Known Hiccups Gastrointestinal disorders Common Peptic ulcer (with possible Peptic ulcer perforation
and Peptic ulcer haemorrhage) Not Known Intestinal perforation; Gastric haemorrhage; Pancreatitis; Oesophagitis ulcerative;
Abdominal distension; Oesophagitis; Abdominal pain; Diarrhoea; Dyspepsia, Nausea. Skin and subcutaneous tissue disorders Common
Erythema; Angioedema; Pruritus; Urticaria Ecchymosis, Petechiae; Rash; Hirsutism, Hyperhidrosis; Skin striae, Telangiectasia Not
Known Musculoskeletal and connective tissue Common Muscular weakness; Growth retardation Not Known Pathologic fracture;
Osteonecrosis; Muscle atrophy; Neuropathic Reproductive system and breast disorders Not Known Menstruation irregular General
disorders andadministration siteconditions Common Impaired healing Not Known Fatigue; Malaise Investigations Common Blood
potassium decreased Not Known Intraocular pressure increased; Carbohydrate tolerance decreased; Alanine aminotransferase
increased; Aspartate aminotransferaseincreased; Injury, poisoning andprocedural complications Not Known Tendon rupture
(particularly of the Achilles tendon); Spinal compression
Overdose: Administration of methylprednisolone should not be discontinued abruptly but tailed off over a period of time.
Appropriate action should be taken to alleviate the symptoms produced by any side-effect that may become apparent. It may be
necessary to support the patient with corticosteroids during any further period of trauma occurring within two years of
overdosage. There is no clinical syndrome of acute overdose with methylprednisolone. Reports of acute toxicity and/or death
following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available; treatment is
supportive and symptomatic. Methylprednisolone is haemodialysable
Pharmaceutical precautions
Store in a cool and dry place, protected from light.
Packaging quantities
Predixa 4mg tablet: Each box contains 30 tablets in alu-alu blister.
Predixa 8mg tablet: Each box contains 20 tablets in alu-alu blister.
Predixa 16mg tablet: Each box contains 10 tablets in alu-alu blister.