Alendronic Acid

Registered South African indications:

• Osteoporosis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• End-stage renal impairment (eGFR ≤10ml/min)
• Abnormalities of the oesophagus and other factors which delay oesophageal emptying  
• Inability to stand or sit upright for at least 30 minutes
• Hypocalcaemia

Cautions

• Pregnancy
• Breastfeeding
• Severe renal impairment (eGFR ≥11-29ml/min)
• Active upper gastrointestinal problems
• Recent history of major gastrointestinal disease or surgery
• Known Barrett's oesophagus
• Cancer
• Poor dental status
• Invasive dental procedure
• Osteonecrosis of the external auditory canal
• Infection or ear trauma
• Long-term treatment
• Hypocalcaemia
• Conditions predisposing to hypocalcaemia
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption
• History of Stevens-Johnson syndrome and toxic epidermal necrolysis

Forms avail. in SA and covered in this monograph: tab

Treatment of osteoporosis in men and post-menopausal females

• Oral (tab): 10mg, dly
• Oral (tab): 70mg, weekly

To be taken with a glass of plain water at least 30min before any food, beverages or other medication is taken

Patients should remain in an upright position for at least 30min after taking dosage

Patients should take calcium and vitamin D supplements 30min before taking alendronic acid

Prophylaxis of glucocorticoid-induced osteoperosis

• Oral (tab): 10mg, dly

Not recommended for use in children below 18 years

Pregnancy 

• Caution
• There are no or limited amount of data from the use of alendronic acid in pregnant women. Studies in animals have shown reproductive toxicity. Alendronic acid given during pregnancy in rats caused dystocia related to hypocalcaemia. Alendronic acid should not be used during pregnancy

Breastfeeding

• Caution; not recommended
• It is unknown whether alendronic acid/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Alendronic acid should not be used during breastfeeding

Renal Impairment 

• Mild to moderate: No dose adjustment recommended  
• Severe: Caution; dose adjustment recommended
• End-stage renal disease: Contraindicated

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness
• Asthenia
• Dysgeusia

Gastrointestinal Disorders

• Abdominal pain
• Dyspepsia
• Constipation
• Diarrhoea
• Flatulence
• Oesophageal ulcer
• Dysphagia
• Abdominal distension
• Acid regurgitation
• Nausea and vomiting
• Gastritis
• Oesophagitis
• Melaena
• Oesophageal stricture
• Oropharyngeal ulceration
• Upper gastrointestinal perforation, ulcers and/or bleeding 

Endocrine and Metabolic Disorders

• Hypocalcaemia

Musculoskeletal Disorders

• Musculoskeletal pain 
• Joint swelling
• Osteonecrosis of the jaw
• Stress fractures of the proximal femoral shaft

Skin and Subcutaneous Tissue Disorders

• Alopecia
• Pruritus
• Rash
• Erythema
• Photosensitivity
• Stevens-Johnson syndrome 
• Toxic epidermal necrolysis
• Peripheral oedema

Immune, Blood and Lymphatic System Disorders

• Urticaria
• Angioedema

Sensory Disorders

• Uveitis
• Scleritis
• Episcleritis
• Vertigo

• Any food or beverages
• Chemotherapy
• Radiotherapy
• Angiogenesis inhibitors
• Smoking
• Non-steroidal anti-inflammatory drugs
• Calcium supplements
• Antacids

• Bone mineral density
• Serum calcium 
• Height 
• Weight

10mg tablet - EML (Hospital)

Alendronic Acid has not been investigated in the treatment of drug-induced (glucocorticoid-induced) osteoporosis

Alendronic acid is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. Preferential localisation of alendronic acid to sites of active resorption has been shown in preclinical studies.  The activity of osteoclasts is inhibited, but recruitment or attachment of osteoclasts is not affected. The bone formed during treatment with alendronic acid is of normal quality.

Tablet 10mg

• Accord alendronate (Accord)
• Ostena (Accord)

Tablet 70mg

• Accord Alendronate (Accord)
• Alendronate unicorn (Pharma Dynamics)
• Aldren (Zydus)
• Boniran 70 (Ranbaxy)
• Densate (Novagen)
• Femax (Arrow)
• Fosamax once weekly 70mg (Organon) originator
• Fosagen (Pharmacare)
• Osteobon (Cipla Medpro)
• Osteonate (Pharma Dynamics)
• Ran-Alendronate (Ranbaxy)
• Sandoz Alendronate (Sandoz)
• Ostena (Accord)
• Alendronate 70 Oethmaan (Oethmaan Biosims)

COMBINATION PREPARATIONS

Alendronic acid/ Colecalciferol

Tablet 70mg/2800mg

• Fosavance (MSD) originator