Maxlen Special Precautions

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 taken 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 gastro-intestinal bleeding, or surgery of the upper gastro-intestinal tract other than pyloroplasty (see Contraindications).
Oesophageal reactions (sometimes severe and requiring hospitalization), such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophagitis stricture, have been reported in patients receiving alendronate. Physicians should therefore be alert to any signs or symptoms signaling 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. It is very important that the full dosing instructions are provided to, and understood by the patient (see Dosage & Administration). Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems.
Osteonecrosis of the jaw generally associated with tooth extraction and/local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimen 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.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
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 judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates (see Adverse Reactions). 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.
Patients should be instructed that if they miss a dose of Maxlen-70 once weekly, 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.
Alendronate is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min (see Dosage & Administration).
Causes of osteoporosis other than oestrogen deficiency and ageing should be considered. Hypocalcaemia must be corrected before initiating therapy with alendronate (see Contraindications). Other disorders affecting mineral metabolism (such as Vitamin D deficiency and hypoparathyroidism) should also be effectively treated. In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with Maxlen-70. Due to positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur. These are usually small and asymptomatic. However, there have been reports of symptomatic hypocalcaemia, which occasionally have been severe and often occurred in patients with predisposing conditions (e.g. hypoparathyrodism, vitamin D deficiency and calcium malabsorption). Ensuring adequate calcium and vitamin D intake is particularly important in patients receiving glucocorticoids.
Effects on Ability to Drive and Operate Machine: No effects on ability to drive and use machines have been observed.