Skelid

tiludronate

(tye-loo-droe-nate) ,

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)

ROUTEONSETPEAKDURATION
POunknownwithin 2 hrunknown

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.

Skelid®

Tiludronate, see there.

Skelid

A brand name for TILUDRONIC ACID.
References in periodicals archive ?
Table 1 First-Generation Drugs Second Generation Non-nitrogen containing BPs (NNBP) (Aminobisphosphonate Drugs) Nitrogen containing BPs (NBP) Bonefos (clodronate) Actonel (risedronate sodium) Relative potency of 10 PO and IV Relative potency of 5000 PO formulations Aredia (pamidronate disodium) Didronel (etidronate disodium) Relative potency 100 IV Relative potency of 1 PO Boniva (ibandronate sodium) Skelid (tiludronic disodium) Relative potency 10000 Relative potency of 10 PO PO and IV formulations Fosamax (alendronate sodium) Relative potency 1000 PO Reclast (zoledronic acid) Relative potency 100000 IV Formulation Infused annually for osteoporosis FDA approval pendin Zometa (zoledronic acid) Relative potency 100000 IV Table 2 Risk factors Literature Of Review 1.
1) The fractures are associated with long-term use of bisphosphonates, which are sold under the brand names Actonel, Aredia, Boniva, Didronel, Fosamax, Reclast, Skelid, and Zometa.
Bisphosphonates include Aclasta, Actonel, Aredia, Bondronat, Boniva, Didronel, Fosamax, Fosavance, Reclast, Skelid and Zometa.
Skelid [R] (tiludronate disodium) -- Tablet; 400 mg (two 200 mg tablets) once daily for 3 months; may be taken any time of day, as long as there is a period of 2 hours before and after resuming food, beverages, and medications.
In the first 6 months of 1997, the following new drugs were approved by the FDA: Agrylin, Alesse, Anzemet, Carbatrol, Fareston, Flomax, Galzin, Idamycin, Migranal, Posicor, Prelay, Prevacid, Pytest, Requip, Resulin, Serlect, Skelid, Tasmar, Uniretic, Urso, Vicoprofen, Viracept, Zyban.
This apart, products such as Skelid, which recently lost its patent in 2009, already have generic versions available in the market which are much lower priced than the original molecule.