Adult Dosing

Paget's disease

• 400 mg PO qd for 3 months
• Give 2 hrs before or after meals

Pediatric Dosing

• Safety and effectiveness in pediatric population have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Paget's disease of bone (osteitis deformans)

• Hypersensitivity to tiludronate, bisphosphonates or any of the excipients
• CrCl > 30 mL/min
• Inability to remain upright for at least 30 mins

• N/A

Renal Dose Adjustment (Based on CrCl)

• < 30 mL/min: Use not recommended

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

• Biphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Use with caution in patients with active upper GI impairment. Esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding, have been reported in patients using oral bisphosphonates
• Hypocalcemia and other disturbances of bone and mineral metabolism must be corrected prior to use
• Osteonecrosis of the jaw has been reported rarely. Risk factors for osteonecrosis of the jaw include invasive dental procedures, diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids), poor oral hygiene, and co-morbid disorders
• Severe bone, joint, or muscle pain may occur. Severe and occasionally incapacitating pain have been reported in postmarketing experience. Discontinue use if severe symptoms develop
• Patients should maintain an adequate intake of calcium and vitamin D

Cautions: Use cautiously in

• Renal impairment
• Upper GI disease
• Dental surgery, invasive
• Pregnancy
• Lactation

Pregnancy Category:C

Breastfeeding: Tiludronate is poorly absorbed after oral administration, it would not be expected to adversely affect the breastfed infant. However, no published experience exists with tiludronate during breastfeeding; an alternate drug may be preferred. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 30 July 2010).

• GI: Diarrhea, nausea, dyspepsia, vomiting, abdominal pain, flatulence, tooth disorder, anorexia, constipation, dry mouth, dysphagia, esophageal ulcer, esophageal erosion, esophagitis, gastric ulcer, gastritis
• MUSC: Musculoskeletal pain, arthrosis, arthralgia, osteonecrosis (primarily of jaw), pathological fractures
• CNS: Anxiety, headache, dizziness, fatigue, paresthesias
• NEURO: Paresthesias
• EENT: Cataracts, conjunctivitis, glaucoma, pharyngitis, rhinitis, sinusitis
• RESP: URTI, bronchitis
• CV: Chest pain, edema, hypertension
• GU: Urinary tract infections
• DERM: Flushing, increased sweating, pruritus, rash, skin disorder
• ENDO: Hyperparathyroidism
• METABOLIC: Hypocalcemia

• Biphosphonate; inhibits osteoclasts, reducing bone resorption and turnover. Disrupts cytoskeletal ring structure by inhibition of protein-tyrosine phosphatase and inhibits the osteoclast proton pump
• Absorption is rapid; Delayed onset of action
• Not metabolized significantly; CYP450: unknown
• Renally excreted: Primarily; 60%
• Bioavailability: 2-11%; reduced by 90% when given with food
• Half-life:
• single dose: 50 hrs
• repeated dose: 150 hrs
• single dose [CrCl 11-18 (mL/min)]: 205 hrs

US Trade Name(s)

• Skelid

US Availability

Skelid

• TABS: 200 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Skelid

UK Availability

Skelid

• TABS: 200 mg

Australian Trade Name(s)

• Skelid

Australian Availability

Skelid

• TABS: 200 mg

[Outline]

Endocrine/Metabolic

Bisphosphonates

Drug Name: Skelid 200 MG (as tiludronate disodium 240 MG) Oral Tablet

Ingredient(s): Tiludronic acid

Imprint: S.W;200

Color(s): White

Shape: Round

Size (mm): 9.00

Score: 1

Inactive Ingredient(s): sodium lauryl sulfate / hydroxypropyl methylcellulose 2910 / crospovidone / magnesium stearate / lactose monohydrate

Drug Label Author:
sanofi-aventis U.S. LLC

DEA Schedule:
Non-Scheduled