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Generic Name: methylprednisolone sodium succinate
Dosage Form: injection, powder, lyophilized, for solution

Drug Description:

A-Methapred is a sterile powder which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate looks pale white in color, is odorless, absorbs moisture and is in undefined solid shape or form.

The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxo-propoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6a, 11ß), and has molecular weight 496.53.

Methylprednisolone sodium succinate is highly soluble in water (H2O) and hence can be used as a diluent in small volume. This is suitable to use in veins where high blood levels of methylprednisolone are required instantly.

A-Methapred (methylprednisolone sodium succinate) is available in varied quantities and packages (40 mg Single – Dose Vital & 125 mg Single – Dose Vital) applied by injecting it within veins or within muscles.

40 mg Single-Dose Vial – Each mL (when infused) contains methylprednisolone sodium succinate proportionate to 40 mg of methylprednisolone; 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate anhydrous; 25 mg lactose anhydrous; and 8.8 mg benzyl alcohol supplemented as preserver.

125 mg Single-Dose Vial – Each 2 mL (when infused) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; 1.6 mg monobasic sodium phosphate anhydrous; 17.4 mg dibasic sodium phosphate anhydrous; and 17.6 mg benzyl alcohol supplemented as preserver.

Composition:

Name (Active Moiety)

Type

Strength

Methylprednisolone Sodium Succinate (Methylprednisolone)

Active

40 MILLIGRAM In 1 MILLILITER

Monobasic Sodium Phosphate Anhydrous

Inactive

1.6 MILLIGRAM In 1 MILLILITER

Dibasic Sodium Phosphate Anhydrous

Inactive

17.46 MILLIGRAM In 1 MILLILITER

Lactose Anhydrous

Inactive

25 MILLIGRAM In 1 MILLILITER

Benzyl Alcohol

Inactive

8.8 MILLIGRAM In 1 MILLILITER

Sodium Hydroxide

Inactive

 

Mandatorily, the Potential of Hydrogen (pH) of each formula is adjusted with sodium hydroxide so that pH of the restructured solution is within the specified range of 7 to 8 and the well-being are, for the 40 mg per mL solution, 0.50 osmolar; for the 125 mg per 2 mL, 0.40 osmolar; (Isotonic saline = 0.28 osmolar).

Uses of A-Methapred:

It is also used for severe infection caused by conditions like serious asthma, relentless allergies, rheumatoid arthritis, ulcerative colitis, certain blood huddles, lupus, multiple sclerosis, and certain eye & skin conditions. A- Methapred solution is a substance used for treating inflammatory and allergic diseases. It works by reshaping the body's immune response to various difficulties and decrease pain.

Dosage:

For high dosage therapy, the suggested dose of A-Methapred (methylprednisolone sodium succinate) antiseptic powder is (30 mg/kg) injected in the veins for at least 30 minutes. This dose can be repeated every 4 to 6 hours for the next 48 hours. Generally, high dose for inflammatory and allergic disease therapies should be continued till the stability of the patient is achieved; usually not beyond 48 to 72 hours.

In other symptoms cases, initial dosage will vary from 10 to 40 mg of methylprednisolone depending on the clinical problem being treated. Heavy doses may be required for short-term supervising of severe and acute conditions. The basic dose usually should be injected to the veins over a period of several minutes. Successive doses may be injected within veins or within muscles at intervals required by the patient's response and clinical condition. Devaluation in swelling therapy is associated to, and not replacement for regular therapy.

Dosage should be reduced for infants and children depending on the strictness of the condition and response of the patient by age or size. Dosage should be more than 0.5 mg/kg every 24 hours.

Using guide for A- Methapred:

  • A-Methapred solution is usually found in injection form at doctor's clinic or hospital. A health care provider or guide is must to follow the procedure for implementing or using A-Methapred solution at home. In case of difficulties or queries contact your health care provider.
  • Avoid usage of A-Methapred solution if it contains extra undefined particles, is fade or pale, is in unidentified color, or if the package is cracked or damaged.
  • This products, as well as syringes and needles, should be kept away from children and pets. Local rules should be followed as guided by your health care for disposal of used needles, syringes, or other materials.
  • Retain the missed dose of A-Methapred solution, as soon as possible. Supposing, time for your next dose is near, skip the missed dose and move to your regular dosage cycle. Avoid using 2 doses at a time.

Storage Conditions:

The solution should be protected from direct contact with light.

Unreconstituted product to be kept at 20 to 25°C (68 to 77°F).

Solution to be kept at 20 to 25°C (68 to 77°F).

Solution should be utilized within 48 hours after mixing or diluting.

A-Methapred (methylprednisolone sodium succinate) sterile powder is available in the following packages:

LIST

CONTAINER

CONCENTRATION

3217

Single-Dose Vial

40 mg/vial

3218

Single-Dose Vial

125 mg/vial

 
Side Effects:

Below are some of the Side effects one may suffer after consuming the solution:Dizziness; facial flushing; headache; increased sweating; mild nausea; pain, swelling, or redness at the injection site; stomach pain or swelling; vomiting.

SEVERE side effects:

Severe allergic reactions (rash over body; itching welts; itching; difficulty breathing; tightness or contraction in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; changes in body fat; changes in menstrual period; chest pain; fainting; fever, chills, or sore throat; increased hunger, thirst, or urination; mental or mood changes (eg, depression, personality or behavioral changes); muscle pain, weakness, or wasting; seizures; severe nausea or vomiting; shortness of breath; slow, fast, or irregular heartbeat; slow wound healing; stomach pain; sudden, severe dizziness or headache; swelling of the feet or legs; tendon, bone, or joint pain; thinning or discoloration of the skin; unusual bruising or bleeding; unusual skin sensation; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee brown.

PACKAGING

#

NDC

Package Description

Multilevel Packaging

1

0409-3218-05

10 CARTON In 1 CASE

contains a CARTON

1

 

10 VIAL In 1 CARTON

This package is contained within the CASE (0409-3218-05) and contains a VIAL, SINGLE-DOSE ()

1

 

2 MILLILITER In 1 VIAL, SINGLE-DOSE

This package is contained within a CARTON and a CASE (0409-3218-05)

A-Methapred (Methylprednisolone Sodium Succinate)

It should be accentuate that Dosage Requirements are Variable and Must Be Individualized on the Basis of the Disease under Treatment and the Response of the Patient.