Retained Kenya · PPB

Predni-POS 1 % Eye Drops

Prednisoloine acetate

H2003/235/14671/R1 Eye Drops

What it does

Prednisolone is a steroid medication that helps reduce inflammation and suppress the immune system.

Commonly used for: inflammation, allergic reactions, autoimmune diseases, skin conditions …

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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.
H2003/235/14671/R1
Registration date
2026 May 19
Expiry date
2031 May 19
Status
Retained
Active ingredient
Prednisoloine acetate
Dosage form
Eye Drops
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Ursapharm Arzneimittel GMBH
Applicant / LTR
GLOBE PHARMACY LTD
Country of origin
Germany

Source: Pharmacy and Poisons Board · fetched 2026-08-27 13:05:35 · updated 2026-10-20 02:03:20

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Prednisolone is a steroid medication that helps reduce inflammation and suppress the immune system.

What it treats

  • inflammation
  • allergic reactions
  • autoimmune diseases
  • skin conditions
  • asthma
  • certain blood disorders

How it works

It works by blocking substances in the body that cause inflammation and by suppressing the immune response.

Who it's for

It is prescribed for people with conditions that involve inflammation or an overactive immune system.

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

Clinical monograph: prednisoloine

Prednisolone is a synthetic glucocorticoid that is widely used for its anti-inflammatory and immunosuppressive properties. It is indicated for a variety of conditions, including autoimmune disorders, allergic reactions, and certain types of cancer. It mimics the effects of cortisol, a hormone produced by the adrenal glands, and is effective in reducing inflammation and modulating the immune response.

Indications

  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Rheumatoid arthritis
  • Systemic lupus erythematosus
  • Dermatitis
  • Allergic reactions
  • Certain types of cancer
  • Adrenal insufficiency
  • Ulcerative colitis

Dosage

Children: Paediatric dosing of prednisolone is dependent on the condition being treated and the child's weight.

Adults: Dosing of prednisolone varies based on the specific condition being treated. It is essential to refer to clinical guidelines or the BNF for specific adult dosing recommendations.

Mechanism of action

Prednisolone exerts its effects by binding to the glucocorticoid receptor, leading to the regulation of gene expression. This results in the inhibition of pro-inflammatory cytokines and chemokines, as well as the suppression of the immune system's response. The drug also influences metabolic processes, such as glucose metabolism and protein synthesis.

Pharmacodynamics

The pharmacodynamic effects of prednisolone include reduced inflammation, decreased immune response, and altered metabolism. Its anti-inflammatory action is achieved through the inhibition of the synthesis of inflammatory mediators such as prostaglandins and leukotrienes. Additionally, it has effects on carbohydrate, protein, and fat metabolism, which can lead to increased blood glucose levels and potential weight gain with prolonged use.

Pharmacokinetics

Prednisolone is well absorbed after oral administration, with peak plasma concentrations occurring within 1 to 2 hours. It has a high volume of distribution and is extensively bound to plasma proteins. The drug undergoes hepatic metabolism, primarily through the cytochrome P450 system, resulting in active metabolites. The elimination half-life varies, typically ranging from 3 to 4 hours, but can be prolonged in patients with liver impairment. Prednisolone is excreted mainly in urine, both as unchanged drug and metabolites.

Contra-indications

  • Systemic fungal infections
  • Hypersensitivity to prednisolone or any excipients in the formulation
  • Active tuberculosis (unless under adequate treatment)

Adverse effects

  • Increased risk of infections
  • Hyperglycemia
  • Hypertension
  • Osteoporosis
  • Weight gain
  • Mood changes
  • Gastrointestinal disturbances
  • Adrenal suppression
  • Cushing's syndrome
  • Skin changes (e.g., thinning of skin, acne)

Interactions

  • Non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of gastrointestinal side effects
  • Anticoagulants may have altered effects
  • Antidiabetic agents may have reduced efficacy
  • Live vaccines may be less effective
  • CYP3A4 inducers or inhibitors may alter prednisolone metabolism

Precautions

  • Use with caution in patients with a history of peptic ulcer disease
  • Monitor for signs of infection
  • Gradual withdrawal is necessary after prolonged therapy
  • Use with caution in patients with diabetes or hypertension

Pregnancy

Prednisolone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It may cause adverse effects on fetal development.

Breast-feeding

Prednisolone is excreted in breast milk, and caution should be exercised when administering to nursing mothers.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Tablets
  • Oral solution
  • Injection (intravenous, intramuscular)
  • Topical formulations (cream, ointment)

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