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Generic Name
Alendronate
Brand Names
Binosto, Fosamax
FDA approval date: February 06, 2008
Classification: Bisphosphonate
Form: Tablet, Solution
What is Binosto (Alendronate)?
BINOSTO is a bisphosphonate indicated for: Treatment of osteoporosis in postmenopausal women.
Approved To Treat
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Brand Information
Binosto (alendronate sodium)
1DOSAGE FORMS AND STRENGTHS
BINOSTO effervescent tablets are round, flat-faced, white to off-white tablets, 25 mm in diameter, with beveled edges, with "M" debossed on one side, containing 91.37 mg of alendronate sodium, which is equivalent to 70 mg of free alendronic acid. After dissolution the solution has a pH of 4.8-5.4.
2CONTRAINDICATIONS
BINOSTO is contraindicated in patients with the following conditions:
- Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
- Inability to stand or sit upright for at least 30 minutes
Do not administer BINOSTO to patients at increased risk of aspiration
- Hypocalcemia
- Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported
3ADVERSE REACTIONS
The following clinically significant adverse drug reactions are described elsewhere in the labeling:
- Upper Gastrointestinal Adverse Reactions
- Mineral Metabolism
- Musculoskeletal Pain
- Osteonecrosis of the Jaw
- Atypical Fractures Including Femoral Fractures
- Renal Impairment
- Patients sensitive to High Sodium Intake
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of BINOSTO (alendronate sodium) effervescent tablet 70 mg is based on clinical trial data of alendronate sodium 10 mg daily and alendronate sodium 70 mg weekly.
3.2Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of alendronate sodium or bisphosphonate products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a Whole: hypersensitivity reactions including urticaria and angioedema. Transient symptoms of myalgia, malaise, asthenia and fever have been reported with alendronate, typically in association with initiation of treatment. Symptomatic hypocalcemia has occurred, generally in association with predisposing conditions. Peripheral edema.
Gastrointestinal: esophagitis, esophageal erosions, esophageal ulcers, esophageal stricture or perforation, and oropharyngeal ulceration. Gastric or duodenal ulcers, some severe and with complications have also been reported [see .
Dental: Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection with delayed healing, has been reported [see .
Musculoskeletal: bone, joint, and/or muscle pain, occasionally severe and incapacitating [see ; joint swelling; low-energy femoral shaft and subtrochanteric fractures, and atypical fractures of other bones [see .
Nervous system: dizziness and vertigo.
Pulmonary: acute asthma exacerbations
Skin: rash (occasionally with photosensitivity), pruritus, alopecia, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Special Senses: uveitis, scleritis or episcleritis. Cholesteatoma of the external auditory canal (focal osteonecrosis).
4OVERDOSAGE
Significant lethality after single oral doses was seen in female rats and mice at 552 mg/kg (3256 mg/m
No specific information is available on the treatment of overdosage with BINOSTO. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Milk or antacids should be given to bind alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Dialysis would not be beneficial.
5DESCRIPTION
BINOSTO (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.
Alendronate sodium is chemically described as (4 amino-1-hydroxybutylidene) bisphosphonic acid, monosodium salt, trihydrate. The molecular formula of alendronate sodium is C
Alendronate sodium is a white or almost white crystalline powder that is soluble in water, very slightly soluble in methanol, and practically insoluble in methylene chloride.
BINOSTO for oral administration is an effervescent tablet formulation that must be dissolved in water before use. Each individual tablet contains 91.37 mg of alendronate sodium, which is equivalent to 70 mg of free alendronic acid. Each tablet also contains the following inactive ingredients: monosodium citrate anhydrous, citric acid anhydrous, sodium hydrogen carbonate, and sodium carbonate anhydrous as buffering agents, strawberry flavor, acesulfame potassium, and sucralose.
70 mg of BINOSTO effervescent tablet contains 603 mg of sodium and 17 mg of phosphorus.
Once the effervescent tablet is dissolved in water, the alendronate sodium is present in a citrate-buffered solution of pH 4.8 to 5.4.
6HOW SUPPLIED/STORAGE AND HANDLING
BINOSTO effervescent tablets are round, flat faced, white to off-white tablets with beveled edges and "M" debossed on one side. BINOSTO effervescent tablets, 70 mg are provided in blisters made of aluminum foil composite, as follows:
NDC 70539-400-04 carton containing 4 units of use blisters
7PATIENT COUNSELING INFORMATION
See
Instruct patients to read the Medication Guide before starting therapy with BINOSTO and to reread it each time the prescription is renewed.
7.1Osteoporosis Recommendations, Including Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium and vitamin D, if daily dietary intake is inadequate. Weight-bearing exercise should be considered along with the modification of certain behavioral factors, such as cigarette smoking and/or excessive alcohol consumption, if these factors exist.
7.2Dosing Instructions
Instruct patients that
- BINOSTO should only be taken upon arising for the day and must be taken at least 30 minutes before the first food, beverage, or medication of the day. Instruct patients not to attempt to swallow, chew, or suck on the tablet because of a potential for oropharyngeal ulceration.
- Instruct patients to dissolve the effervescent tablet in 4 ounces room temperature plain water only (not mineral water or flavored water).
- Instruct patients to wait at least 5 minutes after the effervescence stops and then stir the solution for approximately 10 seconds and then consume the contents.
- Instruct patients to avoid lying down for at least 30 minutes after taking BINOSTO
- Instruct patients not to take BINOSTO at bedtime or before arising for the day.
- Instruct patients that waiting less than 30 minutes, or taking BINOSTO with food, beverages (other than plain water) or other medications will lessen the effect of BINOSTO by decreasing its absorption into the body
- Inform patients that failure to follow these instructions may increase their risk of esophageal problems.
Instruct patients that if they develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) they should stop taking BINOSTO and consult their physician.
Instruct patients that if they miss a dose of once weekly BINOSTO, they should take one dose on the morning after they remember. They should not take 2 doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.
7.3Patients on Sodium Restriction
Inform patients who are prescribed sodium restricted diets that BINOSTO contains 603 mg of sodium which is equivalent to approximately 1532 mg NaCl per tablet.
8PRINCIPAL DISPLAY PANEL - 4 Tablet Blister Pack
Fold and tear at
NDC 70539-400-00
Binosto
Rx only
This blister contains 1 complete week of treatment
2023-BIN-0001
Manufactured for:
9PRINCIPAL DISPLAY PANEL - 4 Tablet Blister Pack Carton
NDC 70539-400-04
Binosto
* Each effervescent tablet contains 91.37 mg
4 Effervescent Tablets
ATTENTION PHARMACIST:
10PRINCIPAL DISPLAY PANEL - 4 Tablet Blister Sample Pack Carton
NDC 70539-400-94
SAMPLE—NOT FOR SALE
Binosto
* Each effervescent tablet contains 91.37 mg
4 Effervescent Tablets
ATTENTION PHARMACIST:
