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• Management of Paget’s disease of the bone in patients with:
  • Serum alkaline phosphatase 2 times the upper limit of normal,
  • Symptoms,
  • Risk for complications.

• Inhibits resorption of bone by inhibiting osteoclast activity.

• Decreased progression of Paget’s disease.

Absorption: Rapidly but poorly absorbed following oral administration (6% bioavailability).

Distribution: Distributes to bone and soft tissue; subsequently is slowly released from bone.

Protein Binding: 90% protein binding.

Metabolism/Excretion: Excreted mostly in urine.

Half-life: 150 hr.

Contraindicated in:

• Hypersensitivity
• Inability to stand/sit upright for at least 30 min
• Severe renal impairment (CCr <30 mL/min).

Use Cautiously in:

• History of upper GI disorders
• Invasive dental procedures, cancer, receiving chemotherapy or corticosteroids, poor oral hygeine, periodontal disease, dental disease, anemia, coagulopathy, infection, or poorly-fitting dentures (may ↑ risk of jaw osteonecrosis)
• OB: Lactation: Pedi: Safety not established.

CNS: anxiety, drowsiness, fatigue, insomnia, nervousness, syncope, vertigo, weakness,.

EENT: cataracts, conjunctivitis, glaucoma, pharyngitis, rhinitis, sinusitis.

Resp: bronchitis.

CV: chest pain, dependent edema, hypertension, peripheral edema.

GI: abdominal pain, anorexia, constipation, diarrhea, dry mouth, dysphagia, esophageal ulcer, esophagitis, flatulence, gastric ulcer, gastritis, nausea, tooth disorder, vomiting.

GU: urinary tract infection.

Derm: flushing, increased sweating, pruritus, rash, skin disorder.

Endo: hyperparathyroidism.

F and E: hypocalcemia.

MS: musculoskeletal pain, arthrosis, involuntary muscle contractions, osteonecrosis (primarily of jaw), pathological fractures.

Neuro: paresthesia.

Misc: infection.

Drug-Drug:

• Absorption is decreased by concurrent administration of calcium supplements, aspirin, or aluminum- or magnesium-containing antacids.
• Bioavailability is ↑ by concurrent administration of indomethacin.

Drug-Food:

• Food↓ absorption.

• PO (Adults): 400 mg/day taken with 8 oz of plain water only, for 3 mo.

• PO: Administer first thing in the morning with 6–8 oz plain water 30 min prior to other medications, beverages, or food.
  • Calcium supplements, aspirin, or indomethacin should not be taken for 2 hr before or 2 hr after tiludronate; antacids should not be taken for at least 2 hr following tiludronate.

Skelid

Therapeutic Classification: bone resorption inhibitors

Pharmacologic Classification: biphosphonates

• Tablets: 400 mg;

(blood levels)

• Paget’s Disease: Assess for symptoms of Paget’s disease (bone pain, headache, decreased visual and auditory acuity, increased skull size).

• Monitor alkaline phosphatase prior to and periodically during therapy. Tiluronate is indicated for patients with alkaline phosphatase 2 times the upper limit of normal.

• Risk for injury (Indications).

• Instruct patient on the importance of taking exactly as directed, first thing in the morning, 30 min prior to other medications, beverages, or food. Waiting longer than 30 min will improve absorption. Tiluronate should be taken with 6–8 oz plain water (mineral water, orange juice, coffee, and other beverages decrease absorption). If a dose is missed, skip dose and resume the next morning; do not double doses or take later in the day. Do not discontinue without consulting health care professional.
  • Caution patients to remain upright for 30 min following dose to facilitate passage to stomach and minimize risk of esophageal irritation.
  • Advise patient to eat a balanced diet and consult health care professional about the need for supplemental calcium and vitamin D.
  • Encourage patient to participate in regular exercise and to modify behaviors that increase the risk of osteoporosis (stop smoking, reduce alcohol consumption).
  • Advise patient to inform health care professional of tiludronate therapy prior to dental surgery.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if she is nursing.

• Decrease in the progression of Paget’s disease.