Berlex

Berlex

  • Active Ingredient: Alendronate
  • 70 mg, 35 mg, 5 mg
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What is Berlex?

The active ingredient of Berlex brand is alendronate. Alendronate is a bisphosphonate (bis FOS fo nayt) medicine that slows bone loss while increasing bone mass, which may prevent bone fractures. Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Alendronate sodium tablets, USP, for oral administration contain 45.68 mg or 91.37 mg of Alendronate monosodium salt trihydrate, which is the molar equivalent of 35 mg and 70 mg, respectively, of free acid, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. This product meets USP Dissolution Test 2.

Used for

Berlex is used to treat diseases such as: Aseptic Necrosis, Osteoporosis, Paget's Disease, Prevention of Osteoporosis.

Side Effect

Possible side effects of Berlex include: muscle cramps in the hands, arms, feet, legs, or face; sensitivity of the eye to light; chest pain; Abdominal or stomach pain; tearing.

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* Number evaluable for vertebral fractures: Berlex sodium, n=984; placebo, n=966 † p ‡ p=0.007, § p ¶ p Figure 1: Cumulative Incidence of Hip Fractures in the Three-Year Study of FIT (patients with radiographic vertebral fracture at baseline)

What are the side effects of Berlex (Fosamax)?

The most common side effect of Berlex is stomach pain.,

Other important side effects are:

What should I discuss with my healthcare provider before taking Berlex (Binosto, Fosamax)?

You should not take Berlex if you are allergic to it, or if you have:

  • low levels of calcium in your blood (hypocalcemia); or
  • problems with the muscles in your esophagus (the tube that connects your mouth and stomach).

Do not take Berlex if you cannot sit upright or stand for at least 30 minutes. Berlex can cause serious problems in the stomach or esophagus. You must stay upright for at least 30 minutes after taking this medicine.

To make sure Berlex is safe for you, tell your doctor if you have ever had:

  • trouble swallowing;
  • problems with your stomach or digestion;
  • hypocalcemia;
  • a dental problem (you may need a dental exam before you begin taking Berlex);
  • kidney disease; or
  • any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

The effervescent tablet contains a lot of sodium. Tell your doctor if you are on a low-salt diet before using this form of Berlex.

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use Berlex, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.

Talk with your doctor about the risks and benefits of using this medication.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Berlex passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Renal Impairment

Berlex sodium is not recommended for patients with creatinine clearance less than 35 mL/min. No dosage adjustment is necessary in patients with creatinine clearance values between 35 to 60 mL/min .

Q: My gynecologist has me on Fosamax Plus D for osteopenia. Can I take calcium with vitamin D? I know that the calcium needs the vitamin D to be absorbed. Is it possible to take too much vitamin D? What amount would you recommend?

A: Fosamax Plus D is a prescription medicine that contains Berlex sodium and vitamin D3 (cholecalciferol) as the active ingredients. Fosamax Plus D provides a week's worth of vitamin D3 (2800 IU). The Daily Value is 400 IU. Fosamax Plus D is used for the treatment of osteoporosis (thinning of bone) in women after menopause. It reduces the chance of having a hip or spinal fracture (break). Treatment to increase bone mass in men with osteoporosis. Fosamax Plus D (Berlex cholecalciferol), a single once weekly tablet containing 70 mg Fosamax (Berlex) and 2,800 IU vitamin D3, representing seven days worth of 400 IU of vitamin D. (The recommended intake of vitamin D is 400 to 800 IU daily). Maintaining adequate levels of vitamin D is necessary for the development of strong bones because it helps increase the intestinal absorption of calcium. Vitamin D insufficiency is associated with reduced calcium absorption, bone loss and increased risk of fracture. Patients at increased risk for vitamin D insufficiency (e.g., those who are nursing-home bound, chronically ill, over the age of 70 years) and with gastrointestinal malabsorption syndromes should receive vitamin D supplementation in addition to that provided in Fosamax Plus D. For more detailed information, consult with your physician or pharmacist for guidance based on your specific condition and current medications. Shereen A. Gharbia, PharmD

Treatment of Paget's Disease of Bone

Berlex sodium tablets are indicated for the treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.


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