Fosamax plus - Ingredients, uses, doses and notes when using

Article written by Pharmacist Quang Anh Nguyet - Faculty of Pharmacy - Vinmec Central Park International General Hospital

Ingredients Each tablet contains:
91.37 mg sodium alendronate trihydrate, equivalent to 70mg alendronic acid. 70 mcg cholecalciferol equivalent to 2800 units of Vitamin D3 (for Fosamax Plus tablets 70mg/2800IU) or 140 mcg of cholecalciferol equivalent to 5600 units of Vitamin D3 (for Fosamax Plus tablets 70mg/5600 IU)
Uses of Sodium alendronate Sodium alendronate is a bisphosphonate, a potent and specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic pyrophosphate analogues that are bound to hydroxyapatite found in bone. Colecalciferol Cholecalciferol (vitamin D3) is a secosterol, which is a natural precursor of the calcium-regulating hormone calcitriol (1,25-dihydroxyvitamin D3).
Indications Treatment of postmenopausal osteoporosis in women at risk of vitamin D deficiency. (Fosamax Plus reduces the risk of spine and hip fractures).
Treatment of osteoporosis in men to prevent fractures and to help ensure adequate vitamin D.

Dosage The recommended dose is 1 Fosamax Plus 70mg/2800IU tablet or 1 Fosamax Plus 70mg/5600IU tablet once per week. For most patients with osteoporosis, the appropriate dose is 1 tablet of Fosamax Plus 70mg/5600IU once weekly.
The optimal duration of dosing is not well established. All patients receiving bisphosphonate therapy should require continued use and periodic reevaluation.
How to use, note when using Take medicine before eating, drinking or taking other drugs for the first time in the day at least 30 minutes, drink with boiled water to cool. Other beverages (including mineral water), food, and some medications can reduce the absorption of alendronate.
To make it easier to get the medicine into the stomach to reduce the possibility of esophageal irritation, follow these instructions:
Take the medicine with a full glass of water (200 mL or more) when you first wake up for the day. Patients should not lie down until after eating the first meal of the day and this meal must be at least 30 minutes after taking Fosamax Plus. Patients should not chew or allow the tablet to dissolve in the mouth because of the risk of causing oropharyngeal ulcers.

Very common (≥ 1/10)
Bone, muscle, joint pain, sometimes severe.

Common (≥ 1/100 to < 1/10)
Abdominal pain, dyspepsia, esophageal ulceration, dysphagia, abdominal distension, heartburn. + Headache, dizziness.
+ Hair loss, itching.
+ Weakness.
+ Peripheral edema.
Uncommon (≥ 1/1000 to < 1/100)
Taste disturbance. Inflammation of the eye (uveitis, scleritis, episcleritis). Nausea, vomiting, gastritis, esophagitis, esophageal erosion, black stools. Rash, erythema. Transient symptoms (myalgia, malaise, rarely fever), typical at the start of treatment. Rare (≥ 1/10,000 to < 1/100)
Hypersensitivity reactions including urticaria and angioedema. Low blood calcium. Esophageal stricture, oropharyngeal ulceration, bleeding ulcers in the upper gastrointestinal tract. Photosensitive rash, severe skin reactions including Stevens-Johnson and toxic epidermal necrolysis. Mandibular necrosis, fracture below the trochanter and femoral shaft. Very rare (< 1/10,000)
Necrosis of the outer ear canal (mainly associated with long-term treatment).

There are no or limited data on the use of alendronate in pregnant women. Animal studies have shown reproductive toxicity. Administration of alendronate to pregnant rats caused labor difficulties related to hypocalcaemia. Animal studies have shown that high doses of vitamin D cause hypercalcemia and reproductive toxicity.

It is not known whether alendronate/its metabolite is excreted in human milk. A risk to infants/children cannot be excluded. Colecalciferol and some of its active metabolites pass into breast milk.
Fosamax Plus should not be used by pregnant or lactating women.

Management of overdose Taking an overdose can cause hypocalcemia, hypophosphataemia, and side effects in the upper gastrointestinal tract such as digestive disorders, heartburn, esophagitis, inflammation or gastric ulcer. Milk or antacids need to be given to combine with alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should be kept fully upright.
Contraindications Esophageal anomalies leading to delayed esophageal emptying such as stricture or spasm of the esophageal sphincter. Inability to stand or sit upright for at least 30 minutes. Hypersensitivity to any of the ingredients in this product. Decreased blood calcium. Caution People with digestive problems such as dysphagia, esophageal disease, peptic ulcer disease or a history of peptic ulcer, gastrointestinal bleeding. Patients with cancer, chemotherapy, radiation therapy, corticosteroids, angiogenesis inhibitors, smoking, periodontal disease, invasive dental procedures. Patients with severe renal impairment (creatinine clearance <35ml/min). Diphtheria, lymphoma, sarcoid disease. People with fructose and galactose intolerance. Persons under 18 years old.