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ALENDRONIC ACID is a brand name for Alendronate (also known as Alendronic Acid). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of postmenopausal osteoporosis. Alendronic Acid 70 mg Tablets reduce the risk of vertebral and hip fractures.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The recommended dosage is one 70 mg tablet once weekly. Missed dose Patients should be instructed that if they miss a dose of Alendronic Acid 70 mg Tablets, they should take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.
To permit adequate absorption of alendronate:
Alendronic Acid 70 mg Tablets must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain water only. 5 'Interaction with other medicinal products and other forms of interaction'). 4 'Special warnings and precautions for use'): • Alendronic Acid 70 mg Tablets should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml or 7 fl.
). • Patients should not chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration. • Patients should not lie down until after their first food of the day which should be at least 30 minutes after taking the tablet.
• Patients should not lie down for at least 30 minutes after taking Alendronic Acid 70 mg Tablets • Alendronic Acid 70 mg Tablets should not be taken at bedtime or before arising for the day. 4 'Special warnings and precautions for use').
Use in the elderly:
In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate. Therefore, no dosage adjustment is necessary for the elderly.
Use in renal impairment:
No dosage adjustment is necessary for patients with GFR greater than 35 ml/min. Alendronic Acid 70 mg Tablets are not recommended for patients with renal impairment where GFR is less than 35 ml/min, due to lack of experience.
Use in children (under 18 years):
Alendronate has been studied in a small number of patients with osteogenesis imperfecta under 18 years of age. Results are insufficient to support its use in children Alendronic Acid 70 mg Tablets have not been investigated in the treatment of glucocorticoid-induced osteoporosis.
Summary of the safety profile In a one-year study in post-menopausal women with osteoporosis the overall safety profiles of Alendronate Sodium Once Weekly 70 mg (n = 519) and alendronate 10 mg/day (n = 370) were similar. In two three-year studies of virtually identical design, in post-menopausal women (alendronate 10 mg: n=196, placebo: n = 397) the overall safety profiles of alendronate 10 mg/day and placebo were similar.
4 †Frequency in Clinical Trials was similar in the drug and placebo group. 4 ‡This adverse reaction was identified through post-marketing surveillance. The frequency of rare was estimated based on relevant clinical trials. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Upper gastrointestinal adverse reactions Alendronate can cause local irritation of the upper gastro-intestinal mucosa. 3). In patients with known Barrett’s oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis.
Oesophageal reactions (sometimes severe and requiring hospitalisation), such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophageal stricture, have been reported in patients receiving alendronate.
Physicians should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing or retrosternal pain, new or worsening heartburn.
The risk of severe oesophageal adverse experiences appears to be greater in patients who fail to take alendronate properly and/or who continue to take alendronate after developing symptoms suggestive of oesophageal irritation. 2 'Posology and method of administration').
Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems. While no increased risk was observed in extensive clinical trials, there have been rare (post-marketing) reports of gastric and duodenal ulcers, some severe and with complications.
2). Bone and mineral metabolism Causes of osteoporosis other than oestrogen deficiency and ageing should be considered. 3 Contraindications). Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting this medicinal product.
In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with Alendronate Sodium. Due to positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur especially in patients taking glucocorticoids in whom calcium absorption may be decreased.
1. • Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia. • Inability to stand or sit upright for at least 30 minutes. • Hypocalcaemia.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Alendronate in United Kingdom.
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The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of alendronic acid on an individual patient basis, particularly after 5 or more years of use.
Method of administration Oral use.
These are usually small and asymptomatic. g. hypoparathyroidism, vitamin D deficiency and calcium malabsorption). Ensuring adequate calcium and vitamin D intake is therefore particularly important in patients receiving glucocorticoids.
Osteonecrosis of the external auditory canal Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections. Osteonecrosis of the jaw Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
Many of these patients were also receiving chemotherapy with corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates. The following risk factors should be considered when evaluating an individual's risk of developing osteonecrosis of the jaw: • potency of the bisphosphonate (highest for zoledronic acid), route of administration (see above) and cumulative dose • cancer, chemotherapy, radiotherapy, corticosteroids, angiogenesis inhibitors, smoking • a history of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures and poorly fitting dentures.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with oral bisphosphonates in patients with poor dental status. While on treatment, these patients should avoid invasive dental procedures if possible.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patient requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment. During bisphosphonate treatment, all patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain, or swelling.
Musculoskeletal pain Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. 8). The time to onset of symptoms varied from one day to several months after starting treatment. Most patients had relief of symptoms after […]