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DIDRONEL PMO
2013-12-03 18:25:03 来源: 作者: 【 】 浏览:505次 评论:0

Drug Class Description

Bisphosphonates / calcium supplements (Ca++ supplements).

Generic Name

Etidronate disodium/calcium - endocrine

Drug Description

A two component therapy consisting of 14 Didronel 400mg tablets and 76 Cacit 500mg effervescent tablets (equivalent to 500mg elemental calcium). Each Didronel tablet contains 400mg of etidronate disodium, USP. Each Cacit 500mg effervescent tablet contains 1250mg of calcium carbonate, Ph.Eur, which when dispersed in water provides 500mg of elemental calcium as calcium citrate.

Presentation

Each Didronel 400mg tablet is white, capsule-shaped and marked with "NE" on one face and "406" on the other. The Cacit 500mg effervescent tablet is round, flat, white with pink speckles and has a distinctive orange flavour.

Indications

Treatment of osteoporosis, and prevention of bone loss in postmenopausal women considered at risk of developing osteoporosis. Didronel PMO is particularly indicated in patients who are unable or unwilling to take oestrogen replacement therapy. Didronel PMO is also indicated for the prevention and treatment of corticosteroid - induced osteoporosis.

Adult Dosage

Didronel PMO therapy is a long-term cyclical regimen administered in 90-day cycles. Each cycle consists of Didronel 400mg tablets for the first 14 days, followed by Cacit 500mg tablets for the remaining 76 days.

The majority of patients have been treated for 3 years, with a small number of patients treated for up to 7 years, with no clinical safety concerns. The optimum duration of treatment has not been established.

*Didronel 400mg component:

One tablet should be taken each day for 14 consecutive days on an empty stomach. It is recommended that patients take the tablet with water at the midpoint of a four hour fast (ie. two hours before and two hours after food).

*Cacit 500mg component:

Following 14 days treatment with Didronel 400mg tablets, one Cacit tablet should be taken on a daily basis. The Cacit tablet should be dissolved in water and drunk immediately after complete dissolution.

Adults and Elderly

The patient should adhere to the prescribed regimen above. Modification of the dosage for the elderly is not required.

Children

No data exists in the use of this therapy in juvenile osteoporosis.

Child Dosage

Not recommended.

Contra Indications

Known hypersensitivity to any of the ingredients. Treatment of patients with severe renal impairment. Patients with hypercalcaemia or hypercalciuria. Clinically overt osteomalacia. Use in pregnancy and lactation.

Special Precautions

Clinicians should advise patients to adhere to the recommended treatment regimen, and compliance pack.

In long-term trials no clinical osteomalacia was observed in patients receiving cyclical etidronate. Following long-term therapy in excess of 4 years, analysis of bone biopsies showed an increased preva lence of peritrabecular fibrosis and histologically defined atypical and focal osteomalacia (not to be confused with the syndrome associated with "clinical osteomalacia" due to vitamin D deficiency). In addition, these laboratory findings were not associated with any clinical consequences. Osteoid, which may accumulate at high doses of continuous etidronate therapy (10-20mg/kg/day) mineralises normally after discontinuation of therapy. Continuous administration of etidronate should be avoided.

Patients with significant chronic diarrhoeal disease may experience increased frequency of bowel movements and diarrhoea. Therapy should be withheld from patients with enterocolitis because of increased frequency of bowel movements.

Caution should be taken in patients with impaired renal function, or a history of renal stone formation. In these patients, serum and urinary calcium should be monitored regularly.

Etidronate disodium does not adversely effect serum levels of parathyroid hormone or calcium.

Hyperphosphataemia has been observed in patients receiving etidronate disodium, usually in association with doses of 10-20mg/kg/day. No adverse effects have been traced to this, and it does not constitute grounds for discontinuing therapy. It is apparently due to a drug-related increase in renal tubular re absorption of phosphate. Serum phosphate levels generally return to normal 2-4 weeks post therapy.

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 bisphosphonates.

A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patient with concominant 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 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.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Interactions

Food in the stomach or upper gastrointestinal tract, particularly materials with a high calcium content such as milk, may reduce absorption of etidronate disodium. Vitamins with mineral supplements such as iron, calcium supplements, laxatives containing magnesium, or antacids containing calcium or aluminium should not be taken within two hours of dosing etidronate disodium.

A small number of patients in clinical trials (involving more than 600 patients) received either thiazide diuretics or intravaginal oestrogen while on this treatment. The concomitant use of either of these agents did not interfere with the positive effects of the therapy on vertebral bone mass or fracture rates.

Calcium salts may reduce the absorption of some drugs, eg. tetracyclines. It is therefore suggested that administration of Cacit tablets be separated from these products by at least three hours.

Vitamin D causes an increase in calcium absorption and plasma calcium levels may continue to rise after stopping vitamin D therapy. Concomitant administration of Cacit tablets and vitamin D should therefore be carried out with caution.

The effects of digoxin and other cardiac glycosides may be accentuated by calcium and toxicity may be produced, especially in combination with vitamin D therapy.

There have been isolated reports of patients experiencing changes in their prothrombin times when etidronate was added to warfarin therapy. The majority of these reports concerned variable elevations in prothrombin times without clinically significant sequelae. Although the relevance of these reports and any mechanism of coagulation alterations is unclear, patients on warfarin should have their prothrombin time monitored.

Adverse Reactions

Gastro-intestinal

In clinical studies of 2-3 years duration, the incidence of these events were comparable to placebo. The most common effects reported in order of incidence were diarrhoea, nausea, flatulence, dyspepsia, abdominal pain, gastritis, constipation and vomiting. Reports of exacerbation of peptic ulcer with complications in a few patients.

Dermatological/hypersensitivity

Hypersensitivity reactions including angio-oedema, urticaria, rash and/or pruritus have been reported rarely. The colouring agent E110 can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

Nervous System

Headache, and rarely paresthesia, peripheral neuropathy and confusion.

Haematological

There have been rare reports of leucopenia, agranulocytosis and pancytopenia

Other

Less common effects believed to be related to therapy include arthropathies (arthralgia and arthritis), and rarely burning of the tongue, alopecia, erythema multiforme and exacerbation of asthma.

Occasional mild leg cramps have been reported in less than 5% of patients on the Didronel PMO regimen. These cramps were transient, often nocturnal and generally associated with other underlying conditions.

Manufacturer

Procter & Gamble Pharmaceuticals UK Limited

Drug Availability

(POM)

Updated

03 March 2010 
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