What are the patient information details for alendronate?

Alendronate Patient Information

How to Take Alendronate Correctly

Take alendronate first thing in the morning on an empty stomach with a full glass (6-8 ounces) of plain water only—not mineral water, coffee, tea, soda, or juice—and remain upright (sitting, standing, or walking) for at least 30 minutes before eating, drinking anything else, or taking other medications. 1

Critical Administration Instructions

• Swallow the tablet whole with plain water—do not chew or suck on it, as this can cause mouth or throat ulcers 1
• Wait at least 30 minutes after taking alendronate before:
  • Lying down 1
  • Eating your first food of the day 1
  • Taking any other medications, including antacids, calcium supplements, or vitamins 1
• Taking alendronate with orange juice or coffee markedly reduces absorption and effectiveness 1
• Never take alendronate at bedtime or before getting up for the day 1

Dosing Schedules

• For osteoporosis treatment: 70 mg once weekly (choose one day per week that fits your schedule) 2
• For osteoporosis prevention: 35 mg once weekly OR 5 mg daily 2
• If you miss a weekly dose: Take one dose the morning after you remember, then return to your regular weekly schedule—never take two doses on the same day 1

Essential Supplements

You must take adequate calcium (1,000-1,200 mg daily) and vitamin D (800-1,000 IU daily) while on alendronate therapy to optimize bone health and prevent low calcium levels. 2, 1

• Most clinical trials included 500-1,000 mg calcium and 400-800 IU vitamin D supplementation daily 2
• Vitamin D deficiency should be corrected before starting alendronate, particularly for intravenous bisphosphonate therapy 3

Who Should NOT Take Alendronate

Alendronate is contraindicated in patients with: 2, 1

• Abnormalities of the esophagus that delay emptying
• Inability to stand or sit upright for at least 30 minutes
• Low blood calcium (hypocalcemia)
• Severe kidney disease (creatinine clearance <35 mL/min/1.73 m²) 2
• Allergy to any component of the product

Expected Benefits

• Vertebral fracture reduction: 47-53% reduction in spine fractures 4
• Hip fracture reduction: 33-53% reduction 4
• Bone density improvement: Progressive increases of 2-5% at spine and hip sites 4
• Benefits become statistically significant within 12 months of starting treatment 5

Duration of Treatment

The standard treatment duration is 5 years for most patients. 2, 3

• After 5 years, your doctor will reassess your fracture risk to determine whether to continue, take a drug holiday, or switch medications 2, 3
• Patients at very high risk (previous hip/spine fractures, age >80, ongoing steroid use) may need treatment beyond 5 years 2, 3
• Patients at lower risk may safely stop after 5 years with continued monitoring 3

Potential Side Effects

Common Side Effects (Generally Mild and Transient)

• Stomach pain, heartburn, nausea 1, 6
• Constipation or diarrhea 1
• Bone, joint, or muscle pain 1
• Upset stomach 1

Serious Side Effects (Rare but Important)

Stop taking alendronate and contact your doctor immediately if you develop: 1

• Difficulty or pain when swallowing
• New or worsening heartburn
• Chest pain behind the breastbone

Very Rare Long-Term Risks (Mainly with Use Beyond 5 Years)

• Osteonecrosis of the jaw (ONJ): Less than 1 case per 100,000 person-years with standard osteoporosis dosing 4, 3
  • Risk increases with dental surgery or tooth extraction 3
  • Complete any needed dental work before starting therapy 3
• Atypical femoral fractures: 3.0-9.8 cases per 100,000 patient-years 4, 3
  • Risk increases significantly after 5-8 years of continuous use 3
• Atrial fibrillation: Evidence is conflicting; some studies show increased risk while others do not 4

Lifestyle Modifications

In addition to medication, you should: 1

• Engage in weight-bearing exercise
• Stop smoking if you smoke
• Limit alcohol consumption if excessive
• Ensure adequate dietary calcium and vitamin D intake

Storage

• Store at room temperature 68-77°F (20-25°C) 1
• Keep in a tightly closed container 1
• Keep out of reach of children 1

What to Do in Case of Overdose

• Call your doctor immediately 1
• Do NOT try to vomit 1
• Do NOT lie down 1

Important Reminders

• Alendronate only works when taken on an empty stomach with plain water 1
• Failure to follow dosing instructions increases your risk of esophageal problems 1
• Keep all appointments for bone density monitoring and fracture risk assessment 2
• Report any new bone, joint, or thigh pain to your doctor, as this may signal an atypical fracture 3