Actonel

Actonel Warnings

risedronic acid

Manufacturer:

Theramex

Distributor:

Zuellig Pharma
Full Prescribing Info
Warnings
Food, drinks (other than plain water) and medicinal products containing polyvalent cations eg, calcium, magnesium, iron or aluminium that may interfere with the absorption of bisphosphonates (see Interactions) should not be taken at the same time as Actonel. In order to achieve the intended efficacy, strict adherence to dosing recommendations is necessary (see Dosage & Administration).
Some bisphosphonates have been associated with oesophagitis and oesophageal ulcerations. Therefore, patients should pay attention to the dosing instructions (see Dosage & Administration). In patients who have a history of oesophageal disorders which delay oesophageal transit or emptying (eg, stricture or achalasia), or who are unable to stay in the upright position for at least 30 min after taking the tablet, Actonel should be used with special caution because of limited clinical experience in these patients. Prescribers should emphasize the importance of the dosing instructions to these patients.
Hypocalcaemia should be treated before starting Actonel therapy. Other disturbances of bone and mineral metabolism (eg, parathyroid dysfunction, hypovitaminosis D) should be treated at the time of starting Actonel therapy. In patients who have a lack of vitamin D, or problem with the parathyroid glands, Actonel should be used with special caution. The evidence to support efficacy of bisphosphonates including Actonel in very elderly women (>80 years) is limited. In case of doubt, the patient should consult the physician or pharmacist.
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 IV-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 (eg, 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 judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Actonel contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take Actonel.
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