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Binosto
Overview
What is Binosto?
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 CHNNaOP • 3HO and its molecular weight is 325.12. The structural
formula of alendronate sodium is
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.
Once the effervescent
tablet is dissolved in water, the alendronate sodium is present in
a citrate-buffered solution.
What does Binosto look like?
What are the available doses of Binosto?
Effervescent tablets, 70 mg ()
What should I talk to my health care provider before I take Binosto?
How should I use Binosto?
BINOSTO effervescent tablet 70 mg is indicated for the treatment
of osteoporosis in postmenopausal women. For the treatment of osteoporosis,
alendronate sodium increases bone mass and reduces the incidence of
fractures, including those of the hip and spine (vertebral compression
fractures).
The recommended dosage is one 70 mg effervescent
tablet once weekly.
What interacts with Binosto?
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What are the warnings of Binosto?
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What are the precautions of Binosto?
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What are the side effects of Binosto?
Sorry No records found
What should I look out for while using Binosto?
BINOSTO is contraindicated in
patients with the following conditions:
Do not administer BINOSTO
to patients at increased risk of aspiration
What might happen if I take too much Binosto?
Significant lethality after single oral doses
was seen in female rats and mice at 552 mg/kg (3256 mg/m) and 966 mg/kg (2898 mg/m), respectively. In males, these values were slightly higher, 626
and 1280 mg/kg, respectively. There was no lethality in dogs at oral
doses up to 200 mg/kg (4000 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.
How should I store and handle Binosto?
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:NDCStore at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F), [See USP Controlled Room Temperature.] Protect from moisture. Store tablets in original blister package until use.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:NDCStore at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F), [See USP Controlled Room Temperature.] Protect from moisture. Store tablets in original blister package until use.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:NDCStore at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F), [See USP Controlled Room Temperature.] Protect from moisture. Store tablets in original blister package until use.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Animal studies have indicated the following mode of action. At the
cellular level, alendronate shows preferential localization to sites
of bone resorption, specifically under osteoclasts. The osteoclasts
adhere normally to the bone surface but lack the ruffled border that
is indicative of active resorption. Alendronate does not interfere
with osteoclast recruitment or attachment, but it does inhibit osteoclast
activity. Studies in mice on the localization of radioactive [H]alendronate in bone showed about 10-fold higher
uptake on osteoclast surfaces than on osteoblast surfaces. Bones examined
6 and 49 days after [H]alendronate administration
in rats and mice, respectively, showed that normal bone was formed
on top of the alendronate, which was incorporated inside the matrix.
While incorporated in bone matrix, alendronate is not pharmacologically
active. Thus, alendronate must be continuously administered to suppress
osteoclasts on newly formed resorption surfaces. Histomorphometry
in baboons and rats showed that alendronate treatment reduces bone
turnover (i.e., the number of sites at which bone is remodeled). In
addition, bone formation exceeds bone resorption at these remodeling
sites, leading to progressive gains in bone mass.
Non-Clinical Toxicology
BINOSTO is contraindicated in patients with the following conditions:Do not administer BINOSTO to patients at increased risk of aspiration
Bisoprolol fumarate should not be combined with other beta-blocking agents. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added beta-adrenergic blocking action of bisoprolol fumarate may produce excessive reduction of sympathetic activity. In patients receiving concurrent therapy with clonidine, if therapy is to be discontinued, it is suggested that bisoprolol fumarate be discontinued for several days before the withdrawal of clonidine.
Bisoprolol fumarate should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Concurrent use of rifampin increases the metabolic clearance of bisoprolol fumarate, resulting in a shortened elimination half-life of bisoprolol fumarate. However, initial dose modification is generally not necessary. Pharmacokinetic studies document no clinically relevant interactions with other agents given concomitantly, including thiazide diuretics and cimetidine. There was no effect of bisoprolol fumarate on prothrombin time in patients on stable doses of warfarin.
Risk of Anaphylactic Reaction
While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
BINOSTO, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when BINOSTO is given to patients with active upper gastrointestinal problems (such as known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers).
Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates including alendronate sodium. In some cases these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue BINOSTO and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates including alendronate sodium, and/or who continue to take oral bisphosphonates including alendronate sodium after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient . In patients who cannot comply with dosing instructions due to mental disability, therapy with BINOSTO should be used under appropriate supervision.
There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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