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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 reduces the risk of vertebral and hip fractures. • Treatment of osteoporosis in men at increased risk of fracture. A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated. • Prophylaxis of glucocorticoid-induced…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology 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 10 mg Tablets on an individual patient basis, particularly after 5 or more years of use.
Treatment of post-menopausal osteoporosis:
The recommended dosage is 10 mg once daily.
Treatment of osteoporosis in men:
The recommended dosage is 10 mg once daily.
Treatment and Prevention of glucocorticoid-induced osteoporosis:
For post-menopausal women who are not receiving oestrogen treatment the recommended dose is one 10 mg tablet daily. For other populations, see summary of product characteristics for preparations that contain 5 mg alendronate Elderly In clinical trials there was no age-related difference with regard to efficacy or safety profiles of alendronate.
Therefore no adjustment of the dose is necessary for elderly patients. Renal impairment No dose adjustment is necessary in patients with a glomerular filtration rate (GFR) greater than 35 ml/min. Alendronate is not recommended for patients with impaired renal function if the GFR is less than 35 ml/min, as there is no experience of this.
Use in impaired hepatic function No dose adjustment is necessary. 1). Method of administration Oral use. To obtain satisfactory absorption of alendronate Alendronic acid tablets must be taken on an empty stomach immediately on rising in the morning, with plain water only, at least 30 minutes before the first food, drink or other medication of the day.
5). 4) • Alendronic acid tablets should only be swallowed on rising for the day with a whole glass of water (not less than 200 ml). • Alendronic acid tablets should be swallowed whole. The tablets should not be chewed, sucked or allowed to dissolve in the mouth on account of the risk of oropharyngeal ulceration.
• Patients should not lie down until after the first meal of the day, which must be at least 30 minutes after taking the tablet. • Patients should not lie down within 30 minutes of taking Alendronic acid tablets • Alendronic acid tablets should not be taken at bedtime or before arising for the day.
Summary of the safety profile Alendronic Acid has been studied in nine major clinical studies (n=5,886). In the longest running trials in post-menopausal women up to five years experience has been collected. Two years safety data are available in both men with osteoporosis and men and women on glucocorticoids.
In a one-year study in post-menopausal women with osteoporosis the overall safety profiles of Alendronic acid Once weekly 70 mg (n=519) and alendronate 10mg/day (n=370) were similar. In two three-year studies of virtually identical design, in post-menopausal women (alendronate 10mg: n=196, placebo: n-397) the overall safety profiles of alendronate 10mg/day and placebo were similar.
5 Tabulated list of adverse reactions The following adverse experiences have also been reported during clinical studies and/or post- marketing use: Frequencies are defined as: Very common (≥1/10), Common (≥1/100, < 1/10), Uncommon (≥1/1,000, < 1/100), Rare (≥1/10,000, < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data).
System Organ Class Frequency Adverse Experience Term Immune system disorders:
Rare hypersensitivity reactions including urticaria and angioedema Metabolism and nutrition disorders: Rare symptomatic hypocalcaemia, often in association with predisposing conditions§.
Common headache, dizziness† Nervous system disorders:
Uncommon dysgeusia† Eye disorders: Uncommon eye inflammation (uveitis, scleritis or episcleritis) Common vertigo† Ear and labyrinth disorders: Very rare osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) Common: abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer*, dysphagia*, abdominal distension, acid regurgitation Gastro-intestinal disorders: Uncommon: nausea, vomiting, gastritis, oesophagitis*, oesophageal erosions*, melena† Rare: oesophageal stricture*, oropharyngeal ulceration*, upper gastro-intestinal PUBs (perforation, ulcers, bleeding)§ Common: alopecia†, pruritus† Uncommon: rash, erythema Skin and subcutaneous tissue disorders: Rare: rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis‡ Very common: musculoskeletal (bone, muscle or joint) pain which is sometimes severe†§ Common: joint swelling† Rare: osteonecrosis of the jaw‡§; atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction) Musculoskeletal and connective tissue disorders: Not known atypical fracture of other bones Common: asthenia†, peripheral oedema† General disorders and administration site conditions: Uncommon: transient symptoms as in an acute-phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment†.
Upper gastrointestinal adverse reactions Alendronic acid 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 or perforation, have been reported in patients receiving alendronic acid.
8). The risk of severe oesophageal adverse experiences appears to be greater in patients who fail to take alendronic acid tablet properly and/or who continue to take alendronic acid tablet after developing symptoms suggestive of oesophageal irritation.
2). Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems. 8). 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 who are receiving treatment regimens including primarily intravenously administered bisphosphonates.
Many of these patients were also receiving chemotherapy and 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.
Alendronic acid Tablet is contraindicated in: • 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. 1. • Hypocalcaemia.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4).
4 †Frequency in Clinical Trials was similar in the medicinal product 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 authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients 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.
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 such as pain or discharge, or chronic ear infections. 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 stopping treatment. A subset had recurrence of symptoms when rechallenged with the same medicinal product or another bisphosphonate.
Atypical fractures of the femur Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a complete femoral fracture. Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate- treated patients who have sustained a femoral shaft fracture.
Poor healing of these fractures has also been reported. Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
During bisphosphonate treatment patients should be […]