Precautions and warnings

Use the smallest effective dose of corticosteroids for treatment. If you need to lower the dose, do so slowly and gradually.

The risks of side effects from glucocorticosteroids increase with higher doses and longer treatment times. Each patient’s dose and length of treatment should be decided based on a careful weighing of risks and benefits, and the doctor should also consider whether the medicine is given every day or just occasionally.

Kaposi’s sarcoma has been reported in people using corticosteroids, usually for long-term conditions. Stopping corticosteroid treatment may lead to an improvement in this condition.

Drug Interactions

This medicine can reduce the effectiveness of anticholinesterase drugs used for myasthenia gravis. It may also lower the blood sugar-lowering effects of diabetes medications and decrease the amount of salicylates in the blood. There is a higher risk of low potassium levels (hypokalemia) if taken with certain diuretics (like thiazides or furosemide), amphotericin B, or some bronchodilators (xanthines or beta-2 agonists). Using it with NSAIDs can increase the chance of stomach bleeding or ulcers. It may also increase the blood-thinning effects of warfarin.

Certain drugs (called CYP3A4 inducers, such as carbamazepine, phenytoin, and rifamycins) can lower its levels or effects, while others (CYP3A4 inhibitors, like azole antifungals and some antibiotics) can increase its levels or effects. It could make vaccines work less effectively (dead vaccines), or raise the risk of infection from live vaccines.

Taking antacids or bile sequestrants may reduce how much of this medicine your body absorbs, so take them at least 2 hours apart. There's also an increased risk of muscle problems if taken with neuromuscular-blocking drugs, or a risk of tendon problems if taken with fluoroquinolones (a type of antibiotic).

Contraindications

You should not use methylprednisolone acetate if you are allergic to it or any of its ingredients.

People with idiopathic thrombocytopenic purpura (a bleeding disorder) should not get corticosteroid injections in their muscles.

Methylprednisolone acetate injection should never be given into the space around the spinal cord (intrathecal injection). Doing this has caused serious medical problems.

People with widespread fungal infections should not use methylprednisolone acetate, unless it is injected directly into a joint to treat a localized problem there.

Mode of actions

Methylprednisolone is an artificial corticosteroid that mostly works as a glucocorticoid, with very little effect as a mineralocorticoid. It reduces inflammation by stopping certain white blood cells from moving to the affected area and by making blood vessels less leaky.

Dosage & Administration

The initial dosage of parenterally administered Methyl Prednisolone Acetate will vary from 4 to 120 mg, depending on the specific disease entity being treated. However, in certain overwhelming, acute, life-threatening situations, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.

It Should Be Emphasized that Dosage Requirements Are Variable and Must Be Individualized on the Basis of the Disease Under Treatment and the Response of the Patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

A. Administration for Local Effect

1. Rheumatoid Arthritis and Osteoarthritis. The dose for intra-articular administration depends upon the size of the joint and varies with the severity of the condition in the individual patient. In chronic cases, injections may be repeated at intervals ranging from one to five or more weeks, depending upon the degree of relief obtained from the initial injection. The doses in the following table are given as a general guide:

Large Joint: Knees, Ankles & Shoulders: 20 to 80 mg
Medium joint: Elbows & Wrists: 10 to 40 mg
Small joint: Metacarpophalangeal, Interphalangeal, Sternoclavicular & Acromioclavicular: 4 to 10 mg

2. The dose in the treatment of the various conditions of the tendinous or bursal structures varies with the condition being treated and ranges from 4 to 30 mg. In recurrent or chronic conditions, repeated injections may be necessary.

3. Injections for Local Effect in Dermatologic Conditions. Following cleansing with an appropriate antiseptic such as 70% alcohol, 20 to 60 mg of the suspension is injected into the lesion. It may be necessary to distribute doses ranging from 20 to 40 mg by repeated local injections in the case of large lesions.

B. Administration for Systemic Effect

The intramuscular dosage will vary with the condition being treated. When employed as a temporary substitute for oral therapy, a single injection during each 24-hour period of a dose of the suspension equal to the total daily oral dose of methylprednisolone tablets is usually sufficient. When a prolonged effect is desired, the weekly dose may be calculated by multiplying the daily oral dose by 7 and given as a single intramuscular injection.

In pediatric patients, the initial dose of methylprednisolone may vary depending on the specific disease entity being treated. Dosage must be individualized according to the severity of the disease and response of the patient. The recommended dosage may be reduced for pediatric patients, but dosage should be governed by the severity of the condition rather than by strict adherence to the ratio indicated by age or body weight.

In patients with the adrenogenital syndrome, a single intramuscular injection of 40 mg every two weeks may be adequate. For maintenance of patients with rheumatoid arthritis, the weekly intramuscular dose will vary from 40 to 120 mg. The usual dosage for patients with dermatologic lesions benefited by systemic corticoid therapy is 40 to 120 mg of methylprednisolone acetate administered intramuscularly at weekly intervals for one to four weeks. In acute severe dermatitis due to poison ivy, relief may result within 8 to 12 hours following intramuscular administration of a single dose of 80 to 120 mg. In chronic contact dermatitis, repeated injections at 5 to 10 day intervals may be necessary. In seborrheic dermatitis, a weekly dose of 80 mg may be adequate to control the condition.

Following intramuscular administration of 80 to 120 mg to asthmatic patients, relief may result within 6 to 48 hours and persist for several days to two weeks. Similarly, in patients with allergic rhinitis (hay fever), an intramuscular dose of 80 to 120 mg may be followed by relief of coryzal symptoms within six hours persisting for several days to three weeks.

If signs of stress are associated with the condition being treated, the dosage of the suspension should be increased. If a rapid hormonal effect of maximum intensity is required, the intravenous administration of highly soluble methylprednisolone sodium succinate is indicated.

In treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.

Pregnancy & Lactation

Although animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in pregnant women, but during pregnancy, this medicine can be used just when definitely required despite potential risks.

Mothers with a newborn baby who have used this drug during the last 3 months of pregnancy may seldom create symptoms including drowsiness, muscle stiffness or shakiness, feeding or breathing troubles, constant crying. If you notice any of these symptoms of your baby's particularly during their first month, tell the doctor immediately.

This medicine passes into breast milk. Talk to your doctor before breastfeeding.

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