Alendroic Acid

Medication

The recommended dosage is one 70 mg tablet once weekly.

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.Calcium and Vitamin D supplements have been prescribed.

Reasses necessity

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.

Usage

To permit adequate absorption of alendronate:
Alendronic Acid must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain water only. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate .
To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal (gullet) irritation/adverse experiences

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.

• Alendronic Acid should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml).
• Patients should only swallow Alendronic Acid whole. Patients should not crush or 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.
Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems.

• Alendronic Acid should not be taken at bedtime or before arising for the day.

Dental

If you have dental problems, you should see your dentist prior to starting them advising them that you need to potentially start alendronic acid.

maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain, or swelling.
While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis (bone death) of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition

Contraindications / Reasons not to use this medicine
– 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.
– Hypersensitivity to alendronate or to any of the excipients.
– Hypocalcaemia.
– See also section ‘Special warnings and precautions for use’.

Special warnings and precautions for use
Alendronate can cause local irritation of the upper gastro-intestinal mucosa. Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastro-intestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastro- intestinal disease such as peptic ulcer, or active gastro-intestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty (see section 4.3). 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.

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