3 months to expiry Ghana · FDA Ghana

PRED FORTE STENLE SUSPENSION ( Prednisoline acetate 1%)

Prednisoline acetate

FDA/SD.233-060558 Prednisoline acetate 1%

What it does

Prednisoline is a medication used to reduce inflammation and suppress the immune system.

Commonly used for: allergic reactions, asthma, skin conditions (dermatitis), autoimmune diseases (e.g., lupus) …

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.233-060558
Registration date
2023-06-06
Expiry date
2026-07-01
Status
3 months to expiry
Active ingredient
Prednisoline acetate
Dosage form
Prednisoline acetate
Strength
1%
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Allergan
Country of origin
Ireland
Manufacturer location
ALLERGAN PHARMACEUTICALS, Carrowbeg, Westport, Co. Mayo, F28 AW83, Ireland

Source: Food and Drugs Authority · fetched 2026-04-18 08:32:59 · updated 2026-06-30 04:00:28

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Prednisoline is a medication used to reduce inflammation and suppress the immune system.

What it treats

  • allergic reactions
  • asthma
  • skin conditions (dermatitis)
  • autoimmune diseases (e.g., lupus)
  • inflammatory bowel disease (IBD)

How it works

It works by decreasing inflammation and reducing the activity of the immune system.

Who it's for

This medication is for anyone needing relief from inflammation or immune system overactivity, as advised by a healthcare provider.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: prednisoline

Prednisolone is a synthetic glucocorticoid, which is a type of steroid. It is commonly used to treat conditions involving inflammation, immune responses, and certain types of cancer. Prednisolone works by mimicking the effects of cortisol, a natural hormone produced by the adrenal glands, and it has potent anti-inflammatory and immunosuppressive properties.

Indications

  • Allergic conditions
  • Asthma
  • Rheumatoid arthritis
  • Systemic lupus erythematosus
  • Inflammatory bowel disease
  • Certain types of cancer
  • Dermatologic conditions
  • Multiple sclerosis exacerbations

Dosage

Children: Refer to the BNF for Children for appropriate dosing information in pediatric patients, as dosing is age and weight-dependent.

Adults: Refer to the BNF for specific indications and dosing recommendations, as doses can vary widely depending on the condition being treated.

Mechanism of action

Prednisolone binds to the glucocorticoid receptor in the cytoplasm of target cells. This complex then translocates to the nucleus, where it influences gene expression by binding to specific DNA sequences, leading to the upregulation of anti-inflammatory proteins and downregulation of pro-inflammatory cytokines. This results in reduced inflammation and suppression of the immune response.

Pharmacodynamics

The pharmacodynamic effects of prednisolone include decreased migration of leukocytes and reduced production of inflammatory mediators such as prostaglandins and leukotrienes. It also inhibits the function of various immune cells, including T lymphocytes and macrophages, which contributes to its immunosuppressive effects. The onset of action can vary depending on the condition treated but generally occurs within hours.

Pharmacokinetics

Prednisolone is administered orally or intravenously and is well absorbed from the gastrointestinal tract. Its bioavailability is affected by food, with higher absorption noted when taken on an empty stomach. The drug is extensively metabolized in the liver, primarily by the cytochrome P450 enzyme system, and has a half-life ranging from 3 to 4 hours. It is excreted mainly in the urine as metabolites. Its effects can last longer than its half-life due to the duration of action of its metabolites.

Contra-indications

  • Systemic fungal infections
  • Hypersensitivity to prednisolone or any component of the formulation
  • Administration of live vaccines in immunocompromised patients

Adverse effects

  • Increased risk of infections
  • Gastrointestinal disturbances including peptic ulcers
  • Mood changes such as euphoria or depression
  • Weight gain and fluid retention
  • Hyperglycemia and potential development of diabetes mellitus
  • Osteoporosis with prolonged use
  • Adrenal suppression

Interactions

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of gastrointestinal ulceration
  • Anticoagulants may have altered effects due to changes in protein binding
  • Diuretics can lead to increased potassium loss
  • Vaccines may have reduced effectiveness, particularly live vaccines

Precautions

  • Use with caution in patients with a history of peptic ulcer disease
  • Monitor for signs of infection due to immunosuppressive effects
  • Consider dose adjustments in patients with renal or hepatic impairment
  • Gradual withdrawal is recommended after prolonged therapy to prevent adrenal insufficiency

Pregnancy

Use during pregnancy only if potential benefit justifies the potential risk to the fetus. Corticosteroids can cross the placenta.

Breast-feeding

Prednisolone is excreted in breast milk; caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

  • Tablets
  • Oral solution
  • Injectable form
  • Topical preparations

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.