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Fosamax Oral Solution (Alendronate)

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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

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    Description

    Fosamax Oral Solution is a bisphosphonate medication indicated for the treatment and prevention of osteoporosis in postmenopausal women, and for the treatment of osteoporosis in men. It is also approved for the treatment of glucocorticoid-induced osteoporosis, and Paget’s disease of bone in men and women. The active ingredient, alendronate sodium, works by inhibiting osteoclast-mediated bone resorption, leading to increased bone mineral density (BMD) and reduced fracture risk. The oral solution formulation offers an alternative to tablets for patients with difficulty swallowing.

    Fact Table

    Formula

    C4H13NO7P2Na

    License

    US FDA, EMA

    Bioavailability

    ~0.6% (oral, fasting)

    Legal status

    Rx-only

    Chemical Name

    Alendronate sodium

    Elimination half-life

    >10 years (in bone)

    Dosage (Strength)

    70 mg/75 mL oral solution, once weekly

    Pregnancy

    Category C – consult physician

    Brands

    Fosamax, Binosto (effervescent), generics

    Protein binding

    ~78%

    PubChem CID

    2088

    MedlinePlus

    a601011

    ChEBI

    2953

    ATC code

    M05BA04

    DrugBank

    DB00630

    KEGG

    D00845

    Routes of administration

    Oral (solution or tablet)

    Directions

    The recommended dosage is:

    • Postmenopausal osteoporosis (treatment or prevention): 70 mg once weekly
    • Osteoporosis in men: 70 mg once weekly
    • Glucocorticoid-induced osteoporosis: 5 or 10 mg once daily (based on risk profile)
    • Paget’s disease: 40 mg once daily for 6 months

    Administration instructions:

    • Take the oral solution first thing in the morning on an empty stomach, at least 30 minutes before food, beverages, or other medications.
    • Swallow the entire 70 mL dose (containing 70 mg alendronate) while upright (sitting or standing).
    • Follow with at least 200 mL (6–8 oz) of plain water.
    • Remain upright for at least 30 minutes after dosing to reduce the risk of esophageal irritation.

    Ingredients

    Each 70 mL unit-dose bottle contains:

    • Alendronate sodium 70 mg
    • Sodium benzoate (preservative)
    • Sodium citrate dihydrate
    • Citric acid anhydrous
    • Artificial raspberry flavor
    • Purified water
    • Hydrochloric acid and/or sodium hydroxide (for pH adjustment)

    Contraindications

    Fosamax Oral Solution is contraindicated in patients with:

    • Abnormalities of the esophagus that delay emptying (e.g., stricture or achalasia)
    • Inability to stand or sit upright for at least 30 minutes
    • Hypocalcemia
    • Known hypersensitivity to alendronate or any component of the formulation

    Cautions

    • Correct hypocalcemia and other mineral imbalances (e.g., vitamin D deficiency) before starting therapy.
    • Use with caution in patients with upper gastrointestinal disorders such as Barrett’s esophagus, gastritis, or ulcers.
    • Monitor renal function in patients with renal impairment; use is not recommended if creatinine clearance is <35 mL/min.
    • Rare but serious complications include osteonecrosis of the jaw, atypical femur fractures, and esophageal ulceration.
    • Ensure adequate calcium and vitamin D intake during treatment.

    Side Effects

    Common side effects include:

    • Abdominal pain
    • Dyspepsia
    • Esophageal irritation or reflux
    • Musculoskeletal pain
    • Constipation or diarrhea
    • Nausea

    Serious but rare adverse effects may include:

    • Esophageal ulcers or strictures
    • Osteonecrosis of the jaw
    • Atypical subtrochanteric or femoral shaft fractures
    • Hypocalcemia (especially in patients with risk factors)

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 5994

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