Alendronic Acid (Alendronate)

Indications

Alendronic Acid (Alendronate) is used for: Osteopetrosis, postmenopausal osteoporosis, Paget's disease of bone.

Adult Dose

Adult: PO Osteoporosis 10 mg/day or 70 mg once wkly. Prevention of postmenopausal osteoporosis 5 mg/day or 35 mg once wkly. Corticosteroid-induced osteoporosis 5 mg/day; up to 10 mg/day in women not on HRT treatment. Paget's disease of bone 40 mg/day for 6 mth. May repeat after an interval of 6 mth if needed.

Child Dose

Renal Dose

Renal impairment: CrCl (ml/min) <35 Not recommended.

Administration

Administration Take only in morning, not at bedtime or before arising Take tablet with full glass of water (6-8 oz) at least 30 minutes before first food or drink of day, in upright position Administer oral solution with at least 2 ounces of water Swallow with plain water only; mineral water, coffee, juice or other beverages severely reduces bioavailability Swallow tablet whole; do not suck or chew Do not lie down for 30 minutes after taking drug; sit or stand upright

Contra Indications

Hypocalcaemia; oesophageal abnormalities and factors which delay oesophageal emptying; severe renal impairment; hypersensitivity; inability to stand or sit upright for ?30 min. Pregnancy, lactation.

Precautions

Upper GI disorders (discontinue if symptoms worsen); history of ulcers, active GI bleeding. Correct vitamin D and calcium deficiency before starting therapy. To be taken half an hr before breakfast and remain upright for at least 30 minutes after admin. Not recommended for use in patients with CrCl <35 ml/min. Lactation: Unknown whether drug is excreted in milk; use with caution.

Pregnancy-Lactation

Pregnancy Available data on use in pregnant women insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes; discontinue when pregnancy recognized. Lactation Not known whether drug present in human breast mild, affects milk production or has effects on infants Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential effects on breastfed child from drug or underlying maternal condition

Interactions

Concomitant iron, calcium supplements and antacids hinder alendronate absorption. Concomitant aspirin or NSAIDs may increase the incidence of adverse GI effects.

Adverse Effects

Side effects of Alendronic Acid (Alendronate) : >10% Hypocalcemia, transient and mild (18%) 1-10% Hypophosphatemia, transient and mild (10%), Abdominal pain (7%), Musculoskeletal pain (4.1%), Dyspepsia (3.6%), Nausea (3.6%), Constipation (3.1%), Diarrhea (3.1%), Flatulence (2.6%), Headache (2.6%), Acid regurgitation (2%), Esophagitis (1.5%), Abdominal distention (1%) <1% Alopecia, Diaphyseal femur fracture, Esophageal cancer, Flu like syndrome, Gastritis, Myalgia, Oropharyngeal ulceration, Pruritus, Rash, Taste perversion, Toxic epidermal necrolysis, Uveitis, Vertigo, Weakness

Mechanism of Action

Alendronic acid reduces bone resorption by inhibiting the action of osteoclasts.