Risedronate Sodium

Registered South African indications: 

• Osteoporosis in postmenopausal women
  - In combination with calcium and/or vitamin D
• Primary osteoporosis in males

Contraindications

Registered contraindications in South Africa & other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Advanced renal impairment: CrCl<30ml/min
• Hypocalcaemia

Cautions

• Hepatic impairment
• Elderly (>80 years)
• History of oesophageal disorders which delay oesophageal transit or emptying
• Patients who are unable to stay in the upright position for at least 30 minutes after taking the tablet
• Active or recent oesophageal or upper gastrointestinal problems
• Parathyroid dysfunction
• Hypovitaminosis D
• Poor oral hygiene
• Chronic ear infections
• Cancer patients
• Invasive dental procedures 
• Patients receiving long-term treatment for osteoporosis
• Prolonged use
• Galactose intolerance
• Lapp lactase deficiency 
• Glucose-galactose malabsorption

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

South African registered indications and dosages

Osteoporosis in postmenopausal women (Additional agent(s) required)
- In combination with calcium 500-1000mg per day, additional admin. of vitamin D should be considered, when vitamin D deficiency is expected
Primary osteoporosis in males

• Oral (fct): 35mg, once a week on the same day each week

Risedronate sodium 35mg must be taken at least 30 minutes before the first food, liquid, or any other medicine of the day other than water, at least 2 hours before or after food or liquid at any other time of the day, and at least 30 minutes before going to bed. Food, beverages, and medicines containing calcium, magnesium, iron, and aluminium may interfere with the absorption of risedronate sodium and should not be taken at the same time

Patients should take risedronate sodium while in an upright position with a glass of plain water (≥120ml) to aid delivery to the stomach. Patients should not lie down for 30 minutes after taking the tablet

Risedronate sodium should not be taken at bedtime or before getting up in the morning

The tablets must be swallowed whole and not sucked or chewed

Missed doses: One risedronate sodium tablet should be taken on the day that the tablet is remembered if a dose is missed. Patients should then return to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day

Not established for use in children and growing adolescents

Pregnancy

South African recommendations

• Contraindicated
• The safety of risedronate sodium in pregnancy has not been established and its use is contraindicated

Recommendations in other jurisdictions

• Contraindicated
• There are no adequate data from the use of risedronate sodium in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown
• Risedronate sodium must not be used during pregnancy

Breastfeeding

South African recommendations

• Contraindicated
• The safety of risedronate sodium in breastfeeding women has not been established and its use is contraindicated

Recommendations in other jurisdictions

• Contraindicated
• Studies in animal indicate that small amounts of risedronate sodium pass into breast milk
• Risedronate sodium must not be used by breastfeeding women

Renal Impairment

Recommendations below are applicable to South Africa and other jurisdictions

• Mild to moderate (CrCl≥30ml/min): No dose adjustment recommended
• Severe (Advanced) (CrCl<30ml/min): Contraindicated

Hepatic Impairment

Recommendations below are applicable to South Africa and other jurisdictions

• Caution; no information available

Elderly

Recommendations below are applicable to South Africa and other jurisdictions

• ≤80 years: No dose adjustment recommended
  No dosage adjustment is necessary since bioavailability and disposition were similar in elderly (>60 years of age) compared to younger subjects
• >80 years: Caution; no dose adjustment recommended
  The evidence to support efficacy of bisphosphonates including risedronate sodium in the very elderly (>80 years) is limited

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache

Gastrointestinal Disorders

• Constipation
• Dyspepsia 
• Nausea 
• Abdominal pain
• Diarrhoea 
• Gastritis 
• Oesophagitis
• Dysphagia 
• Duodenitis
• Oesophageal ulcer 
• Glossitis
• Oesophageal stricture

Hepatobiliary Disorders

• Abnormal hepatic function tests

Musculoskeletal Disorders

• Musculoskeletal pain 
• Atypical subtrochanteric and diaphyseal femoral fractures 
• Osteonecrosis of the jaw

Skin and Subcutaneous Tissue Disorders

• Angioedema
• Generalised rash
• Urticaria
• Bullous skin reaction
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis 
• Leukocytoclastic vasculitis
• Hair loss

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Anaphylactic reaction

Sensory Disorders

• Iritis
• Uveitis

• Products containing polyvalent cations

• Height
• Weight
• Serum calcium
• Serum calcifediol
• Biochemical markers of bone turnover
• Alkaline phosphatase 

Risedronate sodium is a pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption, while bone formation is preserved. In preclinical studies, risedronate demonstrated potent anti-osteoclast and antiresorptive activity, dose-dependently.

Tablet 35mg

• Actamax (Pharma Dynamics)
• Actonel Once-a-week (Watson) (Discontinued: 06/12/2021)
• Risedronate 35 Biotech (Biotech)

Tablet 150mg

• Actonel Once-a-month fct (Watson) originator (Discontinued: 06/12/2021)