INN monograph
Betamethasone eye/ear/nose drops
Corticosteroid · POM
Verified · Updated 01 Aug 2026 · Source: Local active-ingredient clinical extract; Component monographs (multi-source pipeline); Professional class pharmacology (Corticosteroid)
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- Systemic fungal infections (untreated) for systemic steroids.
- Live vaccines with significant immunosuppression.
- Hypersensitivity.
- Topical: untreated skin infection at site (relative).
Precautions
- Shortest course, lowest dose.
- Taper after prolonged systemic use.
- Infection risk, hyperglycaemia, BP rise, mood changes, osteoporosis, avascular necrosis, glaucoma/cataract.
- Adrenal insufficiency on withdrawal.
- Stress-dose cover if indicated.
Point of care
Dosing
Adult
Eye: Adults and Children: 2 or 3 drops two or three hourly. Nose: Adults and children: 2-3 drops in each nostril two to three times daily.
Paediatric
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Renal
Fluid retention/hypertension — care in renal disease.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Prednisone needs hepatic activation to prednisolone.
Safety
Drug interactions
- The indiscriminate prescription of steroid for undiagnosed Red eye should be avoided as this may be caused by Herpes Simplex virus.
- The condition is aggravated by steroids.
- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Betamethasone.
- Confirm combination SmPC for exact dosing.
Safety
Adverse effects
- Secondary glaucoma, defects in visual acuity and visual field, cataract formation after prolonged use, coneal ulceration on prolonged use, coneal perforation in presence of diseases that causes corneal thinning, delay wound healing, development and spreading of bacterial/ viral / bacterial infections.
Use
Indications
- Therapeutic use is agent- and indication-specific within the class (Corticosteroid).
- Use according to culture results, national guidelines (Kenya STG/EML where applicable) and the current product SmPC.
- Steroid responsive ocular inflammation
Pharmacology
Mode of action
Combination product.
Full mechanism text
Combination product. Component mechanism (Betamethasone): It diffuses across cell membranes and forms a complex with specific cytoplasmic re-ceptors. These complexes then enter the cell nucleus, binds to DNA, and stimulate transcription of messen-ger RNA [mRNA]. Messenger RNA leads to protein synthesis of various enzymes that are responsible for the effects of systemic corticosteroids. Betamethasone may suppress transcription of mRNA in some cells like lymphocytes.
ADME
Pharmacokinetics & PD
| Onset | Hours–days |
|---|---|
| Duration | Agent and route dependent |
| Route | ORAL / IV / IM / INHALED / TOPICAL / NASAL / OPHTHALMIC |
Full PK/PD text
Systemic agents: good absorption, hepatic metabolism, variable half-lives (dexamethasone long). Inhaled/topical: designed to minimise systemic exposure but high-dose/long duration still risks adrenal suppression.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| Ivybetaneocin Eye/Ear Drops | Ivee Aqua EPZ Ltd. | Standard Commercial Pack | — |
| PROBETA -N EYE/EAR/NOSE | DAIMA BIASHARA / Wholesale Import | DROPS 7.5ML | 108.84 |
| Probeta eye drops | ATCO Laboratories (Pvt) Ltd | Standard Commercial Pack | — |
| X Beta | Abacus Pharma | Standard Commercial Pack | — |
Special populations
Pregnancy & lactation
Pregnancy
[From component Betamethasone] 8.1 Pregnancy Risk Summary There are no available data on betamethasone dipropionate cream (augmented) use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that betamethasone dipropionate cream (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate cream (augmented) on the smallest area of skin and for the shortest duration possible. In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate cream (augmented) (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Betamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.
Lactation
Low-dose systemic often compatible; time feeds if high dose — agent-specific.
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; Component monographs (multi-source pipeline); Professional class pharmacology (Corticosteroid)
Last reviewed: 01 Aug 2026
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.