ALENDRO 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.

Off-Label Uses

Off-label examples with some clinical use: glucocorticoid-induced osteoporosis (treatment/prevention in some settings), osteopenia in high-fracture-risk patients, and Paget disease of bone (other bisphosphonates often preferred).

Dosage & Administration

Dosing by Condition

Treatment of postmenopausal osteoporosis: 70mg once weekly or 10mg once daily. Treatment of osteoporosis in men: 70mg once weekly or 10mg once daily. Prevention of postmenopausal osteoporosis: 35mg once weekly or 5mg once daily. Treatment of glucocorticoid-induced osteoporosis: 5mg once daily (or 10mg once daily for postmenopausal women not on estrogen). Treatment of Paget's disease of bone: 40mg once daily for 6 months.

Initial Dose

70mg once weekly (for osteoporosis treatment)

Maintenance Dose

For osteoporosis treatment: 70mg once weekly.

Maximum Dose

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

Children's Dosage

Not approved for children.

Dose Adjustment Notes

No dose adjustment is needed for mild-to-moderate renal impairment; do not use/not recommended if creatinine clearance <35 mL/min.

How to Take

Once weekly: take 70 mg on the same day each week, first thing in the morning after getting up, on an empty stomach. Swallow the film‑coated tablet whole with a full glass of plain water only (≈180-240 mL); do not chew, crush, or suck. Do not eat, drink (other than water), or take other oral medicines for at least 30 minutes after the dose, and remain upright (sitting/standing) for at least 30 minutes and until after the first food of the day.

Side Effects

Side Effect Frequency

Common (1-10%): abdominal pain, dyspepsia, nausea, constipation, diarrhea, flatulence, musculoskeletal pain (bone/muscle/joint), headache. Uncommon (0.1-1%): gastritis, esophagitis, esophageal erosions/ulceration, dysphagia. Rare (<0.1%): osteonecrosis of the jaw, atypical femoral fractures, severe musculoskeletal pain.

Safety & Warnings

Contraindications

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

Warnings & Precautions

Take with plain water on waking; remain upright ≥30 minutes and until after first food; avoid in active significant upper-GI disease and stop/evaluate if dysphagia/odynophagia/heartburn occurs; correct hypocalcemia and ensure adequate calcium/vitamin D; dental evaluation/avoid invasive dental procedures when possible (ONJ risk); monitor for thigh/groin pain (atypical fracture) and severe bone/joint/muscle pain.

Age Restriction

Not indicated/approved for patients <18 years; pediatric use is not recommended.

Drug Interactions

Drug Interactions

Multivalent cations (calcium/iron/magnesium, antacids) and food reduce absorption-separate dosing; NSAIDs/aspirin increase GI irritation risk; other oral meds should be taken after the waiting period.

Interaction Severity

Absorption-reducing (separate administration): calcium supplements, antacids, iron/magnesium/aluminum-containing products and other oral medications/food-clinically significant reduction in absorption (avoid coadministration; give alendronate first, then wait ≥30 minutes before anything else). GI risk: NSAIDs/aspirin-additive upper GI irritation/ulcer risk (use caution, especially in high-risk patients).

Food Interaction

Take on an empty stomach with plain water only, at least 30 minutes before the first food, beverage, or other oral medication of the day; food and most drinks markedly reduce absorption.

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Caution

Children

Not approved for children.

Elderly

Standard adult dosing; no dose adjustment required based on age alone, but monitor renal function

Kidney Impairment

CrCl ≥35 mL/min: no adjustment; CrCl <35 mL/min: not recommended.

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Missed Dose

Once-weekly regimen: if you miss a dose, take one tablet the morning after you remember; then return to your original chosen day the following week. Do not take two tablets on the same day.

Stopping the Medicine

Reassess after 3-5 years; consider a bisphosphonate 'drug holiday' in low-to-moderate fracture risk, continue longer in high-risk patients-do not stop without prescriber review.

Patient Counseling

Key counseling: take once weekly on the same day, first thing in the morning with a full glass of plain water only; swallow whole (do not chew/suck/crush); no food/drink/other meds for ≥30 minutes; stay upright for ≥30 minutes and until after first meal. Ensure adequate calcium/vitamin D but separate from the dose. Seek care for trouble/pain swallowing, chest pain, new/worsening heartburn; report jaw symptoms (especially with dental work) and new thigh/groin pain (possible atypical fracture).

Monitoring Requirements

Monitor: baseline and periodic bone mineral density (DXA, typically every 1-2 years initially), serum calcium (and correct hypocalcemia before starting), renal function (especially if at risk), and ensure adequate vitamin D/calcium status; consider dental evaluation prior to therapy in patients with risk factors for osteonecrosis of the jaw.

Pharmacology

Mechanism of Action

Binds to bone hydroxyapatite and is taken up by osteoclasts; inhibits farnesyl pyrophosphate synthase (mevalonate pathway) leading to impaired osteoclast function and apoptosis, reducing bone resorption and turnover.

Onset of Action

Biochemical markers of bone resorption decrease within weeks to a few months; measurable BMD improvement is typically seen by ~6-12 months, with fracture-risk reduction emerging over the first year in responders.

Duration of Effect

Long residual effect: alendronate binds to bone and can continue to be released with antiresorptive effects for years after discontinuation.

Half-Life

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

Bioavailability

Oral bioavailability is very low: approximately 0.6-0.7% when taken after an overnight fast with water; it is reduced to near zero when taken with food or many beverages/medications.

Metabolism

Not metabolized (no hepatic metabolism); eliminated unchanged.

Excretion

After absorption, ~50% is excreted unchanged in urine; the remainder rapidly distributes to bone (or is not absorbed and is eliminated unchanged in feces).

Product Information

Available Dosage Forms

For this SFDA-registered product: film-coated tablet (oral), 70 mg, blister pack of 4 tablets.

Composition per Dose

Each film-coated tablet: 70mg alendronate as alendronate sodium

Generic Availability

Yes

OTC Alternatives

No OTC alternative for osteoporosis treatment. Calcium and Vitamin D supplements are recommended as adjuncts.

Primary Use

Treatment and prevention of osteoporosis and Paget's disease of bone by reducing bone resorption

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.