Didronel Information
Didronel (Etodolac) Description:
Didronel (Etodolac) Indications And Usage:
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In addition, reductions in pagetically elevated cardiac output and skin temperature have been observed in some patients.
In many patients, the disease process will be suppressed for a period of at least 1 year following cessation of therapy. The upper limit of this period has not been determined.
The effects of the treatment in patients with asymptomatic Paget's disease have not been studied. However, treatment of such patients may be warranted if extensive involvement threatens irreversible neurologic damage, major joints, or major weight-bearing bones.
Didronel (Etodolac)
Among those patients who form heterotopic bone, retards the progression of immature lesions and reduces the severity by at least half. Follow-up data (at least 9 months posttherapy) suggest these benefits persist.
Didronel (Etodolac) Warnings:
Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6-8 oz) of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient [see ]. In patients who cannot comply with dosing instructions due to mental disability, therapy with should be used under appropriate supervision.
There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials.
Paget's Disease:
Didronel (Etodolac)
Heterotopic Ossification:
Didronel (Etodolac) Precautions:
General:
Therapy has been withheld from some patients with enterocolitis since diarrhea may be experienced, particularly at higher doses.
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Didronel (Etodolac)
For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment.
Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment.
Musculoskeletal Pain:
Long bones predominantly affected by lytic lesions, particularly in those patients unresponsive to therapy, may be especially prone to fracture.
Patients with predominantly lytic lesions should be monitored radiographically and biochemically to permit termination of in those patients unresponsive to treatment.
Drug Interactions:
Carcinogenesis:
Didronel (Etodolac)
Pregnancy: Teratogenic Effects:
Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over periods of weeks to years. The amount of bisphosphonate incorporation into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the dose and duration of bisphosphonate use. There are no data on fetal risk in humans. However, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been studied.
There are no adequate and well-controlled studies in pregnant women. (etidronate disodium) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers:
Didronel (Etodolac)
Pediatric Use:
Didronel (Etodolac)
Geriatric Use:
Didronel (Etodolac)
Didronel (Etodolac)
Didronel (Etodolac) Adverse Reactions:
The incidence of gastrointestinal complaints (diarrhea, nausea) is the same for at 5 mg/kg/day as for placebo, about 1 patient in 15. At 10 to 20 mg/kg/day the incidence may increase to 2 or 3 in 10. These complaints are often alleviated by dividing the total daily dose.
Paget's Disease:
Heterotopic Ossification:
Worldwide Postmarketing Experience:
In patients receiving etidronate disodium, there have been rare reports of agranulocytosis, pancytopenia, and a report of leukopenia with recurrence on rechallenge. In addition, there have been rare reports of exacerbation of asthma. Exacerbation of existing peptic ulcer disease including perforation has been reported rarely.
In osteoporosis clinical trials, headache, gastritis, leg cramps, and arthralgia occurred at a significantly greater incidence in patients who received etidronate as compared with those who received placebo.
Didronel (Etodolac) Overdosage:
Clinical experience with acute overdosage is extremely limited. Decreases in serum calcium following substantial overdosage may be expected in some patients. Signs and symptoms of hypocalcemia also may occur in some of these patients. Some patients may develop vomiting. In one event, an 18-year-old female who ingested an estimated single dose of 4000 to 6000 mg (67 to 100 mg/kg) of was reported to be mildly hypocalcemic (7.52 mg/dl) and experienced paresthesia of the fingers. Hypocalcemia resolved 6 hours after lavage and treatment with intravenous calcium gluconate. A 92-year-old female who accidentally received 1600 mg of etidronate disodium per day for 3.5 days experienced marked diarrhea and required treatment for electrolyte imbalance. Orally administered etidronate disodium may cause hematologic abnormalities in some patients (see ).
Etidronate disodium suppresses bone turnover and may retard mineralization of osteoid laid down during the bone accretion process. These effects are dose and time dependent. Osteoid which may accumulate noticeably at doses of 10 to 20 mg/kg/day of chronic, continuous dosing mineralizes normally posttherapy.
Prolonged continuous treatment (chronic overdosage) has been reported to cause nephrotic syndrome and fracture.
Gastric lavage may remove unabsorbed drug. Standard procedures for treating hypocalcemia, including the administration of Ca intravenously, would be expected to restore physiologic amounts of ionized calcium and relieve signs and symptoms of hypocalcemia. Such treatment has been effective.
Didronel (Etodolac) Dosage And Administration:
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The recommended initial dose is 5 mg/kg/day for a period not to exceed 6 months. Doses above 10 mg/kg/day should be reserved for when 1) lower doses are ineffective or 2) there is an overriding need to suppress rapid bone turnover (especially when irreversible neurologic damage is possible) or reduce elevated cardiac output. Doses in excess of 20 mg/kg/day are not recommended.
Retreatment Guidelines:
Didronel (Etodolac)
Heterotopic Ossification:
Retreatment has not been studied.
Didronel (Etodolac) How Supplied:
0149-0406-60 bottle of 60
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
[see USP Controlled Room Temperature]
Mfg. by: Norwich Pharmaceuticals, Inc.North Norwich, NY 13814Dist. by: TM Owner, Cincinnati, OH 45202
REVISED DECEMBER 2009
Didronel (Etodolac) Principal Display Panel - Mg Tablet Label
Didronel (Etodolac) Principal Display Panel - Mg Tablet Label
Rx Only
FPO 2D Data Matrix & Human Readable
