Withdrawn Voluntarily by MAH Kenya · PPB

ZOLENDRONIC ACID AMRING

Zolendronic Acid

What it does

Zolendronic is a medicine used to treat conditions related to bone health, particularly in patients with weakened bones.

Commonly used for: osteoporosis, bone loss due to hormone therapy for breast or prostate cancer, Paget's disease of bone

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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.
-
Registration date
-
Expiry date
-
Status
Withdrawn Voluntarily by MAH
Active ingredient
Zolendronic Acid
Dosage form
Solution For Infusion
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Amring Farma
Applicant / LTR
-
Country of origin
Foreign
Manufacturer location
1205 Westlakes Dr #275, Berwyn, PA 19312, USA

Source: Pharmacy and Poisons Board · fetched 2026-03-01 02:03:28 · updated 2026-08-09 02:04:21

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

About this medicine

Zolendronic is a medicine used to treat conditions related to bone health, particularly in patients with weakened bones.

What it treats

  • osteoporosis
  • bone loss due to hormone therapy for breast or prostate cancer
  • Paget's disease of bone

How it works

Zolendronic helps to strengthen bones by slowing down the process that leads to bone loss.

Who it's for

It is for adults, especially those at risk of bone fractures or loss due to certain medical conditions.

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

Clinical monograph: zolendronic

Zolendronic acid is a bisphosphonate used primarily in the treatment and prevention of osteoporosis, as well as in managing conditions associated with high bone turnover, such as Paget's disease and malignancy-related bone disorders. It works by inhibiting osteoclast-mediated bone resorption, thereby increasing bone mineral density and reducing the risk of fractures.

Indications

  • Osteoporosis in postmenopausal women
  • Osteoporosis in men
  • Paget's disease of bone
  • Prevention of skeletal-related events in patients with bone metastases from solid tumors
  • Hypercalcemia of malignancy

Dosage

Children: Refer to the BNF for Children for dosing information.

Adults: Refer to the BNF for specific dosing guidelines.

Mechanism of action

Zolendronic acid binds to hydroxyapatite in bone, inhibiting the activity of osteoclasts, the cells responsible for bone resorption. This action leads to a reduction in the turnover of bone tissue and helps in maintaining or increasing bone density. It also induces apoptosis in osteoclasts, further decreasing bone resorption.

Pharmacodynamics

The pharmacodynamic effects of zolendronic acid include a significant decrease in the biochemical markers of bone turnover, such as serum calcium and alkaline phosphatase levels. Its effects on bone density can be observed within months of initiation of therapy, with long-term treatment showing sustained benefits in bone mass and fracture reduction.

Pharmacokinetics

Zolendronic acid has a bioavailability of approximately 5% when administered intravenously. It has a volume of distribution of about 100 L, indicating extensive distribution in the bone. The elimination half-life is relatively long, as it is predominantly retained in the bone matrix, with renal clearance being the primary route of elimination. Adjustments may be necessary in patients with renal impairment due to its accumulation in the kidneys.

Contra-indications

  • Hypocalcemia
  • Hypersensitivity to zoledronic acid or any of the excipients
  • Severe renal impairment (creatinine clearance < 35 mL/min)
  • Pregnancy

Adverse effects

  • Fever
  • Chills
  • Myalgia
  • Arthralgia
  • Nausea
  • Vomiting
  • Diarrhea
  • Atypical femoral fractures
  • Osteonecrosis of the jaw
  • Renal impairment
  • Hypocalcemia

Interactions

  • Aminoglycosides may enhance the risk of hypocalcemia
  • Other bisphosphonates may increase the risk of adverse effects
  • Non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of renal toxicity

Precautions

  • Assess renal function prior to administration and periodically during treatment
  • Ensure adequate calcium and vitamin D intake
  • Monitor for signs of osteonecrosis of the jaw, especially in patients with cancer
  • Use caution in patients with a history of gastrointestinal disease

Pregnancy

Zoledronic acid should not be used during pregnancy due to potential harm to the fetus.

Breast-feeding

The drug is not recommended during breastfeeding due to potential adverse effects on the nursing infant.

Storage

Store in a refrigerator (2-8 degrees Celsius). Do not freeze. Protect from light.

Formulations

  • Intravenous solution for infusion (5 mg/100 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.