Tiludronate Disodium

Trade Names:
Skelid
- Tablets 240 mg (eq. to 200 mg tiludronic acid)

Pharmacology

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Inhibits normal and abnormal bone resorption.

Pharmacokinetics

Absorption

Tiludronate bioavailability is 6%. In clinical studies, efficacy was seen when dosed at least 2 h before or after meals. Tiludronate C _max is 3 mg/L; T _max occurs with 2 h of dose.

Distribution

Tiludronate is widely distributed in bones and soft tissue and is about 90% bound to proteins.

Elimination

The primary route of elimination is in urine. Approximately 60% of a dose is excreted in urine. Tiludronate t _½ is 150 h.

Special Populations

Tiludronate is not recommended for patients with severe renal failure (CrCl less than 30 mL/min) because of lack of clinical experience.

Indications and Usage

Treatment of Paget disease of bone.

Contraindications

Standard considerations.

Dosage and Administration

PO 400 mg every day for 3 mo.

Storage/Stability

Store at controlled room temperature. Do not remove from foil strip until ready for administration.

Drug Interactions

Decrease tiludronate bioavailability.

Increases tiludronate bioavailability.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypertension; syncope.

CNS

Paresthesia; vertigo; somnolence; anxiety; nervousness; insomnia; involuntary muscle contractions.

Dermatologic

Rash; pruritus; sweating.

EENT

Cataract; conjunctivitis; glaucoma; rhinitis; sinusitis; pharyngitis.

GI

Diarrhea; nausea; constipation; vomiting; flatulence; abdominal pain; anorexia; dry mouth; gastritis.

Metabolic

Hyperparathyroidism.

Miscellaneous

Fatigue; asthenia; chest pain; edema; arthrosis; flushing.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Renal Function

Not recommended in patients with CrCl less than 30 mL/min.

Overdosage

Symptoms

Hypocalcemia.

Patient Information

• Instruct patient to take drug with 6 to 8 oz of plain water. Advise patient to not use any other beverage (eg, mineral water).
• Instruct patient to avoid eating 2 h before and 2 h after taking medication since absorption of drug is reduced by food.
• Instruct patient to maintain adequate intake of vitamin D and calcium.
• Advise patient to take calcium or mineral supplements 2 h before or 2 h after tiludronate.
• Advise patient to take aluminum- or magnesium-containing antacids at least 2 h after tiludronate.
• Advise patients taking aspirin or indomethacin to take these 2 h before or after tiludronate.
• Advise patient to not remove medication from foil strip until just before administration.

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