tiludronate

[ti-loo´drah-nāt] an inhibitor of bone resorption, administered orally as the disodium salt in treatment of Paget's disease of bone.

tiludronate

(tye-loo-droe-nate) tiludronate,

Skelid

(trade name)

Classification

Therapeutic: bone resorption inhibitors
Pharmacologic: biphosphonates
Pregnancy Category: C

Indications

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.

Action

Inhibits resorption of bone by inhibiting osteoclast activity.

Therapeutic effects

Decreased progression of Paget’s disease.

Pharmacokinetics

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 and Excretion: Excreted mostly in urine.Half-life: 150 hr.

Time/action profile (blood levels)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	within 2 hr	unknown

Contraindications/Precautions

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); Obstetric / Lactation / Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

anxiety
drowsiness
fatigue
insomnia
nervousness
syncope
vertigo
weakness

Ear, Eye, Nose, Throat

cataracts
conjunctivitis
glaucoma
pharyngitis
rhinitis
sinusitis

Respiratory

bronchitis

Cardiovascular

chest pain
dependent edema
hypertension
peripheral edema

Gastrointestinal

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

Genitourinary

urinary tract infection

Dermatologic

flushing
increased sweating
pruritus
rash
skin disorder

Endocrinologic

hyperparathyroidism

Fluid and Electrolyte

hypocalcemia

Musculoskeletal

musculoskeletal pain (most frequent)
arthrosis
involuntary muscle contractions
osteonecrosis (primarily of jaw)
pathological fractures

Neurologic

paresthesia

Miscellaneous

infection

Interactions

Drug-Drug interaction

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

Route/Dosage

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

Availability

Tablets: 400 mg

Nursing implications

Nursing assessment

Paget’s Disease: Assess for symptoms of Paget’s disease (bone pain, headache, decreased visual and auditory acuity, increased skull size).
Lab Test Considerations: Monitor alkaline phosphatase prior to and periodically during therapy. Tiluronate is indicated for patients with alkaline phosphatase 2 times the upper limit of normal.

Potential Nursing Diagnoses

Risk for injury (Indications)

Implementation

Oral: 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.

Patient/Family Teaching

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.

Evaluation/Desired Outcomes

Decrease in the progression of Paget’s disease.