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Predixa 4mg

Tablet
Methyl Prednisolone
Unimed Unihealth MFG. Ltd

Other Strength:
- Predixa 8mg
- Predixa 16mg

Alternative:
- Methsolon 4mg
- Solupred 4mg
- Methigic 4mg



Predixa
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 toStrongyloides 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
Antibiotic, Antitubercular
– Rifampin
– Rifabutin
Anticonvulsants
– Phenobarbital
– Phenytoin
– Primidone
Adrenocortical Steroid
Synthesis Inhibitor
– Aminoglutethimide
Anticonvulsant
– Carbamazepine
Anticonvulsant
– Carbamazepine
Macrolide Antibacterial
– Troleandomycin
-Grapefruit Juice
Calcium Antagonist
– Mibefradil
H2 Receptor Antagonist
– Cimetidine
Antiemetic- Aprepitant- Fosaprepitant
Antifungal- Itraconazole- Ketoconazole
Calcium Channel Blocker- Diltiazem
Contraceptives (Oral)- Ethinylestradiol/Norethindrone
mImmunosuppressant- Ciclosporin (1)
Macrolide Antibacterial- Clarithromycin- Erythromycin
Antivirals- Hiv-Protease Inhibitors (2) (3)
Immunosuppressant- Cyclophosphamide- Tacrolimus

Interaction
CYP3A4InducerCYP3A4 Inducer(and Substrate)
CYP3A4 Inhibitor
CYP3A4Inhibitor(andSubstrate)
CYP3A4Substrate
Non-CYP3A4-mediatedeffects

Effect
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.
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.
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
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.
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 pressu 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.


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