MethySol Injection Info: Indications, Adverse Reactions, Skin, rash

Index

A. Key Information A.1. Ingredients A.2. Indications A.3. Side Effects A.4. Dosage Instructions
B. Additional Information B.1. Adverse Reactions B.2. Precautions for Chickenpox and Measles B.3. Administration to Pregnant and Nursing Women
C. Drug Interactions C.1. CYP Enzyme Inhibitors C.2. CYP Enzyme Inducers C.3. Antitubercular Drugs C.4. Anticoagulants C.5. Other Drug Interactions

A. Key Information

This drug is primarily used to suppress inflammation and modulate immune responses. As a corticosteroid, it is effective in treating various endocrine disorders, particularly adrenal insufficiency. It is administered through intravenous or intramuscular injection, and in cases of acute adrenal insufficiency, drugs like hydrocortisone or cortisone are the first choice. Additionally, this medication can be used in combination with synthetic corticosteroids in specific situations, and special caution is needed for newborns and pregnant women.
Since this drug can reduce immunity to infections, it should be used cautiously in patients at high risk of infections. It may also exacerbate symptoms in patients with peptic ulcers, so caution is needed in such cases. The use of this drug should be carried out under consultation with a healthcare professional, and long-term use requires monitoring for side effects.

Category	Details
Product Name	MethySol Injection 125mg
Ingredients	Methylprednisolone Sodium Succinate 125mg
Form	Injection (lyophilized powder)
Company	Alvogen
ATC Code	H02AB04 (Corticosteroids for systemic use)
Dosage & Administration	Intravenous or intramuscular injection as directed by a professional
Method of Administration	Administered by injection
Packaging Unit	10 vials (125mg/vial) with 10 ampoules of diluent (2ml/ampoule)

A.1. Ingredients

• Methylprednisolone

- Role -
The main ingredient of this medication is methylprednisolone. This compound has potent anti-inflammatory properties, playing a crucial role in suppressing inflammation and modulating immune responses. Methylprednisolone is used in the treatment of various inflammatory diseases, allergic reactions, and autoimmune disorders. It is particularly essential in managing endocrine disorders such as adrenal insufficiency. The medication is administered via intravenous or intramuscular injection, allowing for rapid efficacy.

- Characteristics -
Methylprednisolone is a synthetic corticosteroid that offers stronger anti-inflammatory effects compared to naturally occurring corticosteroids. It inhibits the production of substances in the body that cause inflammation and regulates the activity of immune cells to reduce excessive immune responses. Additionally, this drug is available in various formulations, allowing for dosage adjustments to provide tailored treatment based on the patient's condition. However, long-term use may lead to side effects, so careful monitoring is necessary.

A.2. Indications

Methylprednisolone is used for the treatment of various conditions, especially for effective treatment in severe acute situations. The dosage for pediatric patients should be reduced and determined based on the severity of symptoms and response.

• Contraindications

- Patients with infections without effective antimicrobial therapy and systemic fungal infections
- Patients receiving live or live-attenuated vaccines
- Patients with herpes simplex, herpes zoster, or chickenpox
- Neonates and premature infants

This medication is administered via intravenous or intramuscular injection when oral therapy is uncertain, and based on dosage, formulation, and administration route, it is considered appropriate for the following conditions:

1. Skin Diseases

- Pemphigus
- Severe erythema multiforme (Stevens-Johnson syndrome)
- Exfoliative dermatitis
- Bullous dermatitis herpetiformis
- Severe seborrheic dermatitis
- Severe psoriasis
- Mycosis fungoides

2. Allergic Diseases

Severe or incapacitating allergic conditions unresponsive to conventional treatments, including:

- Bronchial asthma
- Contact dermatitis
- Atopic dermatitis
- Serum sickness
- Seasonal or perennial allergic rhinitis
- Drug hypersensitivity reactions
- Urticaria(hives) related to blood transfusions
- Acute non-infectious laryngeal edema

3. Respiratory Diseases

- Symptomatic sarcoidosis
- Berylliosis
- Fulminating or disseminated pulmonary tuberculosis
(in conjunction with appropriate antituberculous chemotherapy)
- Loeffler's syndrome not manageable by other means
- Aspiration pneumonitise Effects

A.3. Side Effects

Long-term use may cause growth retardation, increased intracranial pressure symptoms, and tissue atrophy when injected intramuscularly, intradermally, or subcutaneously.

• Patients Requiring Caution

- Patients with renal impairment or chronic renal failure
- Patients with a history of acute myocardial infarction
- Patients with active or latent peptic ulcer disease
- Patients with a history of hypertension, diabetes, tuberculosis, or liver disorders

A.4. Dosage Instructions

Methylprednisolone is administered via intravenous or intramuscular injection, with an initial dose ranging from 10-40 mg. If administered for several days, the dosage should be gradually reduced or discontinued.

• For Pediatric Patients

The minimum effective dose should be used, with careful monitoring of growth and development. It is generally preferable to administer on alternate days.

• Dosage Adjustment

The dosage of methylprednisolone may need to be adjusted when co-administered with CYP enzyme inhibitors or inducers.

B. Additional Information

B.1. Adverse Reactions

• Skin and Subcutaneous Tissue Disorders

- Hyperpigmentation or hypopigmentation
- Hirsutism
- Rash, erythema, pruritus
- Urticaria(hives)
- Acne
- Hyperhidrosis

• Musculoskeletal and Connective Tissue Disorders

- Osteonecrosis
- Pathological fractures
- Growth retardation
- Muscle atrophy
- Myopathy
- Osteoporosis
- Neuropathic arthropathy
- Arthralgia (joint pain)
- Myalgia (muscle pain)
- Muscle weakness

• Infection-related Adverse Reactions

- Infection, opportunistic infection, peritonitis
- Liver failure due to reactivation of hepatitis B virus

• Blood and Lymphatic System Disorders

- Leukocytosis
- Aseptic abscess, drug hypersensitivity, pseudo-anaphylactic or anaphylactic reactions

• Immune System Disorders

- Increased susceptibility to infections due to immunosuppressive action
- Some signs of infection may present subclinically

• Endocrine Disorders

- Cushing's syndrome
- Hypopituitarism
- Steroid withdrawal syndrome
- Secondary adrenal insufficiency
(especially after discontinuation, in cases of trauma, surgery, or illness)

• Nervous System Disorders

- Seizures, sensory disturbances
- Acute myopathy may occur with high-dose corticosteroid therapy

• Others

- Increased incidence of scleroderma renal crisis
- Acute myopathy may occur when combined with neuromuscular blockers

B.2. Precautions for Chickenpox and Measles

• Infection Risk in Immunocompromised Patients

Patients receiving corticosteroids are at a greater risk of severe or fatal outcomes if infected with chickenpox or measles compared to healthy individuals. Therefore, special precautions are necessary for these patients.

• Medical History and Vaccination

Before administering the medication, the patient's history of chickenpox or measles and their vaccination status should be checked. For patients without a history of these diseases, measures should be taken to prevent infection as much as possible.

• Actions if Infection is Suspected

If chickenpox or measles infection is suspected, the patient should be immediately examined and receive appropriate treatment. If exposed to chickenpox, administration of Varicella-Zoster Immune Globulin (VZIG) within 3 to 10 days is necessary.

• Active and Latent Tuberculosis

In patients with active tuberculosis receiving corticosteroids, fulminant or disseminated tuberculosis can develop, and appropriate antitubercular therapy should be administered concurrently. In patients with latent tuberculosis, careful monitoring is required as corticosteroid use can reactivate the disease.

B.3. Administration to Pregnant and Nursing Women

• Administration to Pregnant Women

- Corticosteroids can cross the placenta, and animal studies have reported fetal growth retardation and the occurrence of congenital malformations (e.g., cleft palate).
- Repeated administration of corticosteroids during pregnancy increases the risk of fetal developmental delay (e.g., low birth weight, reduced height, and head circumference).

• Administration to Nursing Women

- Corticosteroids are excreted in breast milk; therefore, breastfeeding should be discontinued during the administration of this drug.
- Corticosteroids in breast milk can inhibit the growth of nursing infants and interfere with endogenous glucocorticoid production.
- When considering the use of corticosteroids in nursing women, the benefits and risks should be carefully evaluated before administration.

C. Drug Interactions

C.1. CYP Enzyme Inhibitors

Methylprednisolone is a substrate of CYP3A4, and co-administration with CYP3A4 inhibitors can decrease hepatic clearance and increase plasma concentrations. In such cases, the dosage of methylprednisolone should be adjusted to avoid steroid toxicity.

C.2. CYP Enzyme Inducers

Co-administration with CYP3A4 inducers can increase hepatic clearance and decrease plasma concentrations of methylprednisolone. In such cases, an increase in the dosage may be necessary.

C.3. Antitubercular Drugs

When co-administered with isoniazid, the plasma concentration of isoniazid may decrease, necessitating dosage adjustment.

C.4. Anticoagulants

Methylprednisolone can affect the efficacy of oral anticoagulants, potentially decreasing or enhancing their effect.

C.5. Other Drug Interactions

• Salbutamol

Co-administration can increase the effects and side effects of glucocorticoids.

• Chloroquine and Hydroxychloroquine

Co-administration can increase the risk of myopathy and cardiomyopathy.

• Antihypertensive Drugs

Co-administration can reduce the antihypertensive effect.

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