Registered Kenya · PPB

BONDIT TABLETS

IBANDRONIC ACID

CTD3821 150MG GENERIC/BIOSIMILARS musculo-skeletal system

What it does

Ibandronic is a medication used to help strengthen bones and reduce the risk of fractures, especially in people with bone conditions.

Commonly used for: bone loss due to menopause (osteoporosis), bone loss related to certain cancers

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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.
CTD3821
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
IBANDRONIC ACID
Dosage form
150MG
Strength
-
Pack size
FILM COATED TABLET PACKED IN A CLEAR BLISTER OF ONE TABLET. SUCH SINGLE BLISTER OF ONE TABLET EACH PACKED IN A PRINTED MONO CARTON ALONG WITH INSERT. 10 MONO CARTONS ARE PACKED IN A PRINTED OUTER CARTON
Therapeutic class
GENERIC/BIOSIMILARS
ATC class (WHO)
M05BA - Bisphosphonates
RxNorm RxCUI
115264
Manufacturer / MAH
Dawa
Applicant / LTR
MEDISEL KENYA LIMITED
Country of origin
FOREIGN
Manufacturer location
Baba Dogo Rd, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:21:27 · updated 2026-07-26 09:20:39

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

About this medicine

Ibandronic is a medication used to help strengthen bones and reduce the risk of fractures, especially in people with bone conditions.

What it treats

  • bone loss due to menopause (osteoporosis)
  • bone loss related to certain cancers

How it works

Ibandronic works by slowing down the process of bone loss, helping to keep bones strong and healthy.

Who it's for

This medication is for adults, particularly postmenopausal women and those at risk of bone loss from cancer.

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

Clinical monograph: ibandronic

Ibandronic acid is a bisphosphonate medication primarily used to prevent and treat osteoporosis in postmenopausal women. It works by inhibiting bone resorption through its action on osteoclasts, leading to an increase in bone mineral density and a reduction in the risk of fractures. Ibandronic acid is administered orally or as an intravenous injection, depending on the clinical scenario.

Indications

  • Osteoporosis in postmenopausal women
  • Prevention of osteoporosis in women at high risk
  • Paget's disease of bone
  • Bone metastases from breast cancer

Dosage

Children: Not established; refer to BNF for Children for guidance.

Adults: Refer to BNF for specific dosing information based on condition and formulation.

Mechanism of action

Ibandronic acid inhibits the activity of osteoclasts, the cells responsible for bone resorption. It binds to hydroxyapatite in bone, leading to a decrease in osteoclast recruitment and activity. This results in reduced bone turnover and an increase in bone mass. The drug's action also involves the inhibition of farnesyl pyrophosphate synthase, an enzyme involved in the mevalonate pathway, which is crucial for osteoclast function.

Pharmacodynamics

The pharmacodynamics of ibandronic acid involve its ability to alter bone remodeling processes. By inhibiting osteoclast-mediated bone resorption, ibandronic acid leads to an increase in bone mineral density over time. Clinically, this translates to a lower incidence of vertebral and non-vertebral fractures in patients with osteoporosis. Its effects are dose-dependent, with higher doses providing greater efficacy in bone density improvement.

Pharmacokinetics

Ibandronic acid has a low oral bioavailability of approximately 0.6% due to poor absorption from the gastrointestinal tract. It is predominantly eliminated via the kidneys, with a half-life of approximately 10 to 60 hours depending on the formulation and route of administration. The drug is primarily distributed to bone and has a high affinity for mineralized tissues, where it remains for extended periods, contributing to its long-term effects on bone health. Renal function should be monitored, as impaired renal function can affect drug clearance.

Contra-indications

  • Hypersensitivity to ibandronic acid or any component of the formulation
  • Hypocalcemia
  • Severe renal impairment (creatinine clearance < 30 mL/min)

Adverse effects

  • Gastrointestinal disturbances (nausea, abdominal pain, dyspepsia)
  • Musculoskeletal pain
  • Osteonecrosis of the jaw
  • Esophageal irritation or ulceration
  • Hypocalcemia
  • Flu-like symptoms
  • Dermatological reactions (rash, itching)

Interactions

  • Antacids containing aluminum, calcium, or magnesium may reduce ibandronic acid absorption
  • Other bisphosphonates may have additive effects
  • NSAIDs may increase the risk of gastrointestinal adverse effects

Precautions

  • Use with caution in patients with a history of gastrointestinal disease
  • Ensure adequate calcium and vitamin D levels before initiation
  • Monitor renal function periodically during treatment
  • Consider dental examination prior to initiation, especially in patients with risk factors for osteonecrosis of the jaw

Pregnancy

Ibandronic acid is not recommended during pregnancy due to potential harm to the fetus. It should only be used if the potential benefit justifies the risk.

Breast-feeding

Ibandronic acid is excreted in breast milk; however, the effects on a nursing infant are unknown. Caution is advised.

Storage

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

Formulations

  • Tablets (150 mg)
  • Intravenous injection (3 mg/3 mL)

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

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.