FOSAMAX 70/MG TAB 4/TAB

Indications

Approved Uses

Treatment and prevention of osteoporosis in postmenopausal women, Treatment to increase bone mass in men with osteoporosis, Treatment of glucocorticoid-induced osteoporosis, Treatment of Paget's disease of bone.

Dosage & Administration

Dosing by Condition

Postmenopausal osteoporosis treatment: 70mg once weekly or 10mg once daily. Postmenopausal osteoporosis prevention: 35mg once weekly or 5mg once daily. Osteoporosis in men: 70mg once weekly or 10mg once daily. Glucocorticoid-induced osteoporosis: 5mg once daily (10mg once daily in postmenopausal women not on estrogen). Paget's disease: 40mg once daily for 6 months

Initial Dose

For treatment of osteoporosis: 70mg once weekly.

Maintenance Dose

For treatment of osteoporosis: 70mg once weekly.

Maximum Dose

Osteoporosis: 70 mg once weekly (or 10 mg once daily); Paget’s disease: 40 mg once daily for 6 months.

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Renal: Not recommended if creatinine clearance (CrCl) <35 mL/min; no dose adjustment needed for CrCl ≥35 mL/min. Hepatic: no dose adjustment. Duration: reassess fracture risk periodically; in lower-risk patients consider a bisphosphonate ‘drug holiday’ after ~3-5 years of oral therapy.

How to Take

Take 1 tablet (alendronic acid 70 mg) once weekly on the same chosen day each week. Take first thing in the morning upon arising, on an empty stomach, with a full glass of plain water only (about 200-240 mL/6-8 oz). Swallow whole-do not chew or suck. Do not eat, drink (other than water), or take other oral medicines for at least 30 minutes after the dose. Remain upright (sitting/standing/walking) for at least 30 minutes and until after the first food of the day; do not lie down before then.

Side Effects

Common Side Effects

Common adverse effects include abdominal pain, dyspepsia/heartburn (acid regurgitation), nausea, constipation, diarrhea, flatulence, and musculoskeletal pain (bone/joint/muscle pain); headache can occur.

Side Effect Frequency

Common (≥3%): abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, nausea. Uncommon (<1%): esophagitis, esophageal ulcer/erosion, gastritis, gastric/duodenal ulcer, rash/pruritus, hypocalcemia; rare: osteonecrosis of the jaw, atypical femoral fractures

Safety & Warnings

Contraindications

Esophageal abnormalities delaying emptying (e.g., stricture/achalasia); inability to stand/sit upright for ≥30 minutes; hypocalcemia; hypersensitivity to alendronate/excipients.

Warnings & Precautions

Take first thing in the morning with a full glass of plain water on an empty stomach; remain upright ≥30 minutes and until after first food; avoid coadministration with other meds/food; correct hypocalcemia (and vitamin D deficiency) and ensure adequate Ca/Vit D; use caution in active upper GI disease; stop and evaluate if dysphagia/odynophagia/retrosternal pain occurs; consider dental evaluation and ONJ risk mitigation; monitor for atypical femur fracture symptoms with long-term use.

Age Restriction

Not indicated in pediatric patients; safety and efficacy have not been established (<18 years).

Drug Interactions

Drug Interactions

Calcium/iron/magnesium/aluminum (antacids, supplements, multivalent cations) markedly reduce absorption-separate dosing; NSAIDs/aspirin may increase upper GI irritation/ulcer risk.

Interaction Severity

MAJOR/clinically significant (absorption): calcium, iron, magnesium, aluminum-containing antacids/supplements, and other products with divalent/trivalent cations or food-separate by at least 30 minutes (often longer separation is used in practice). MODERATE: NSAIDs/aspirin-additive upper GI irritation/ulcer risk. OTHER: aminoglycosides may contribute to hypocalcemia risk in susceptible patients but this is not a typical primary interaction for alendronate.

Food Interaction

Take on an empty stomach with plain water only; administer at least 30 minutes before any food, beverage (including coffee/juice/mineral water), or other oral medications because these markedly reduce absorption.

Special Populations

Pregnancy

Category C

Children

Not approved for children.

Elderly

Standard adult dosing; no dose adjustment required based on age alone, but ensure adequate calcium and vitamin D supplementation and monitor renal function

Kidney Impairment

CrCl ≥35 mL/min: no dose adjustment; CrCl <35 mL/min: not recommended (avoid use).

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Missed Dose

If you miss the once-weekly dose, take 1 tablet the morning after you remember; do not take 2 tablets on the same day. Then return to taking 1 tablet once weekly on your originally chosen day.

Stopping the Medicine

Do not stop without clinician review; reassess fracture risk after 3-5 years and consider a drug holiday in low-to-moderate risk patients.

Overdose

Possible hypocalcemia/hypophosphatemia and upper GI injury (esophagitis/gastritis/ulcer); give milk/antacids, keep upright, do NOT induce vomiting, seek urgent medical care/supportive management.

Patient Counseling

Once weekly: take first thing in the morning on the same day each week with a full glass of plain water only; swallow whole. Do not eat/drink anything else or take other oral medicines for at least 30 minutes. Stay upright for at least 30 minutes and until after the first meal; do not lie down. Stop and seek medical advice if you develop trouble/pain swallowing, chest pain, or new/worsening heartburn. Ensure adequate calcium and vitamin D intake but separate supplements from the dose. Maintain good oral hygiene and inform your dentist; report jaw symptoms or planned invasive dental work. Report new thigh/hip/groin pain (possible atypical femur fracture).

Monitoring Requirements

Before and during therapy: correct/monitor hypocalcemia and ensure adequate vitamin D; consider checking serum calcium (and vitamin D in at-risk patients) and renal function prior to initiation; monitor for GI intolerance/esophageal symptoms. Efficacy: bone mineral density (DEXA) at baseline and periodically

Pharmacology

Mechanism of Action

Alendronate binds to hydroxyapatite at sites of active bone resorption and, when taken up by osteoclasts, inhibits farnesyl pyrophosphate synthase (mevalonate pathway), impairing osteoclast function and survival and thereby reducing bone resorption.

Duration of Effect

Effects on bone turnover and fracture-risk reduction can persist for months to years after discontinuation because alendronate binds to bone mineral and has a very long functional half-life in bone.

Half-Life

Plasma half-life is short (~1-2 hours), but the terminal half-life in bone exceeds 10 years due to skeletal binding and slow release.

Bioavailability

Oral bioavailability is very low (~0.6-0.7% in fasting conditions) and is markedly reduced when taken with food or beverages other than plain water and by concomitant calcium/other polyvalent cations.

Metabolism

Alendronate is not metabolized (no hepatic metabolism demonstrated).

Excretion

After absorption, ~50% of alendronate is excreted unchanged in urine within ~72 hours; the remainder is taken up by bone with very slow release. Unabsorbed drug is eliminated unchanged in feces.

Product Information

Available Dosage Forms

Tablet, Oral solution

Composition per Dose

Each tablet: 70mg alendronic acid (as alendronate sodium trihydrate equivalent to 91.37mg)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Primary Use

Treatment and prevention of osteoporosis by reducing bone resorption and decreasing fracture risk

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