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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 post-menopausal osteoporosis. Alendronic acid reduces the risk of vertebral and hip fractures.
Verbatim from this product's MHRA label. Tap a section to expand.
Posolgy For oral administration. The recommended dosage is one 70mg unit-dose (100 ml) once weekly. 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 70 mg Oral Solution on an individual patient basis, particularly after 5 or more years of use Method of administration To permit adequate absorption of alendronic acid Alendronic Acid 70 mg Oral Solution must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain water only.
5). 4) • Patients should not lie down until after their first food of the day which should be at least 30 minutes after taking the solution • Patients should not lie down for at least 30 minutes after taking Alendronic Acid 70 mg Oral Solution • Alendronic Acid 70 mg Oral Solution should only be swallowed on arising for the day as a single 100 ml dose (entire bottle contents) followed by at least 30 ml of plain water.
” • Alendronic Acid 70 mg Oral Solution should not be taken at bedtime or before arising for the day. 4). .
Use in the elderly:
In clinical studies there was no age-related difference in the efficacy or safety profiles of Alendronic Acid. Therefore no dosage adjustment is necessary for the elderly.
Use in renal impairment:
No dosage adjustment is necessary in patients with a glomerular filtration rate (GFR) greater than 35 ml/min. Alendronic acid is not recommended for patients with impaired renal function where GFR is less than 35 ml/min, due to lack of experience.
1). Alendronic Acid has not been investigated in the treatment of glucocorticoid-induced osteoporosis.
In a one-year study in post-menopausal women with osteoporosis the overall safety profiles for alendronic acid once-weekly tablets (n=519) and alendronic acid 10 mg daily (n=370) were similar. In two three-year studies of virtually identical design, in post-menopausal women (alendronic acid 10 mg: n=196; placebo: n= 397) the overall safety profiles for alendronic acid 10 mg daily and placebo were similar.
5 The following undesirable effects 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 (≥1/1000, < 1/100), Rare (≥1/10,000, < 1/1000), Very rare ( < 1/10,000 including isolated cases)] Immune system disorders: Rare: hypersensitivity reactions including urticaria and angioedema Metabolism and nutrition disorders: Rare: symptomatic hypocalcaemia, often in association with predisposing conditions §.
4) Nervous system disorders: Common: headache, dizziness † Uncommon: dysgeusia † Eye disorders: Uncommon: Eye inflammation (uveitis, scleritis, episcleritis) Ear and labyrinth disorders: Common: vertigo † Gastrointestinal disorders: Common: abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer*, dysphagia*, abdominal distension, acid regurgitation Uncommon: nausea, vomiting, gastritis, oesophagitis*,oesophageal erosions*, melena † Rare: oesophageal stricture*, oropharyngeal ulceration*, upper gastrointestinal PUBs (perforation, ulcers, bleeding) § Skin and subcutaneous tissue disorders: Common: alopecia †, pruritus † Uncommon: rash, erythema Rare: rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis‡ Musculoskeletal, connective tissue and bone disorders: Very common: musculoskeletal (bone, muscle or joint) pain, which is sometimes severe †§ Common: Joint swelling † Rare: Osteonecrosis of the jaw ‡ § has been reported in patients treated by bisphosphonates.
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, have been reported in patients receiving alendronic acid.
Physicians should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue alendronic acid 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 alendronic acid properly and/or who continue to take alendronic acid 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.
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 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.
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. 4 ‘Special warnings and precautions for use’.
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 majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis. Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
, ; Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction) .
Very Rare:
Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) General disorders and administration site conditions: Common: asthenia †, peripheral oedema †. Uncommon: transient symptoms as in an acute-phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment†.
†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. ┴ Identified in post-marketing experience 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.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with 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 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. 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 including 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.
A subset had recurrence of symptoms when rechallenged with the same drug 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 completed 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.
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