Predixa Tablet 16mg

Product 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.