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  • Binosto
    / Tzamal


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Effervescent Tablets

    4 X 70 mg

    partial basket chart

    Effervescent Tablets

    12 X 70 mg

    partial basket chart

    Effervescent Tablets

    24 x 70 mg

    partial basket chart

    Related information


    Dosage

    The recommended dose is one 70 mg effervescent tablet once weekly.
    Patients should be instructed that if they miss a dose of Binosto 70 mg, they should take one effervescent tablet on the morning after they remember.
    They should not take two effervescent tablets on the same day but should return to taking one effervescent tablet once a week, as originally scheduled on their chosen day.
    The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Binosto on an individual patient basis, particularly after 5 or more years of use.
    Use in the elderly: In clinical studies there was no age related difference in the efficacy or safety profiles of alendronate. Therefore no dosage adjustment is necessary for the elderly.
    Use in renal impairment: No dosage adjustment is necessary for patients with GFR greater than 35 ml/min. Alendronate is not recommended for patients with renal impairment where GFR is less than 35 ml/min, due to lack of experience.
    Paediatric population: Alendronate sodium is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy in conditions associated with paediatric osteoporosis.
    Method of administration:
    To permit adequate absorption of alendronate: Binosto 70 mg must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain water only. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate.
    To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences:
    – Binosto 70 mg should only be taken upon arising for the day dissolved in half a glass of plain water (not less than 120 ml or 4.2 fl.oz.). Dissolving the tablet in water yields a buffered solution of pH 4.8 – 5.4. The buffered solution should be drunk, once the fizzing has subsided and the effervescent tablet has completely dissolved to give a clear, colourless, buffered solution, followed by at least 30 ml (one sixth of a glass) of plain water. Additional plain water may be taken.
    – Patients should not swallow the undissolved effervescent tablet, should not chew the effervescent tablet or allow the effervescent tablet to dissolve in their mouths because of the risk for oropharyngeal irritation.
    – If the tablet does not dissolve completely, the buffered solution may be stirred until it is clear and colourless.
    – Patients should not lie down until after their first food of the day, which should be at least 30 minutes after drinking the oral solution.
    – Patients should not lie down for at least 30 minutes after taking Binosto 70 mg.
    – Binosto 70 mg should not be taken at bedtime or before arising for the day.
    – Binosto 70 mg can be given to patients who are unable or unwilling to swallow tablets.
    Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
    Binosto 70 mg has not been investigated in the treatment of glucocorticoid-induced osteoporosis.


    Indications

    Treatment of osteoporosis in postmenopausal women to prevent fractures, including those of the hip and spine (vertebral compression fractures).
    Treatment to increase bone mass in men with osteoporosis.


    Contra-Indications

    Hypersensitivity to alendronate or to any of the excipients.
    Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia.
    Inability to stand or sit upright for at least 30 minutes.
    Hypocalcaemia.


    Special Precautions

    Alendronate can cause local irritation of the upper gastro-intestinal mucosa. Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastro-intestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (1 year) of major gastro-intestinal disease such as peptic ulcer, or active gastro-intestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty. In patients with known Barrett’s oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis.
    Oesophageal reactions (sometimes severe and requiring hospitalisation), such as oesophagitis, oesophageal erosions and oesophageal ulcers, rarely followed by oesophageal stricture, have been reported in patients receiving alendronate. Physicians should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing or retrosternal pain, new or worsening heartburn.
    The risk of severe oesophageal adverse experiences appears to be greater in patients who fail to take alendronate properly and/or who continue to take alendronate after developing symptoms suggestive of oesophageal irritation. It is very important that the full dosing instructions are provided to, and understood by the patient. Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems.
    While no increased risk was observed in extensive clinical trials conducted with alendronate tablets, there have been rare (post-marketing) reports of gastric and duodenal ulcers, some severe and with complications.
    Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis), has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
    The following risk factors should be considered when evaluating an individual’s risk of developing osteonecrosis of the jaw:
    – potency of the bisphosphonate (highest for zoledronic acid), route of administration (see above) and cumulative dose.
    – cancer, chemotherapy, radiotherapy, corticosteroids, smoking.
    – a history of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures and poorly fitting dentures.
    A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with poor dental status.
    While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
    Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
    During bisphosphonate treatment, all patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain or swelling.
    Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. In postmarketing experience, these symptoms have rarely been severe and/or incapacitating. The time to onset of symptoms varied from one day to several months after starting treatment. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when re-challenged with the same drug or another bisphosphonate.
    Atypical fractures of the femur: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
    These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare. These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture.
    Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures has also been reported. Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
    During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
    In post-marketing experience of alendronate, there have been rare reports of severe skin reactions including Steven Johnson syndrome and toxic epidermal necrolysis.
    Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
    The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
    Alendronate is not recommended for patients with renal impairment where GFR is less than 35 ml/min.
    Paediatric population: Alendronate sodium is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy in conditions associated with paediatric osteoporosis.
    Causes of osteoporosis other than oestrogen deficiency and ageing or glucocorticoid use should be considered.
    Hypocalcaemia must be corrected before initiating therapy with alendronate.
    Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting Binosto treatment. In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with Binosto 70 mg.
    Due to the positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur especially in patients taking glucocorticoids in whom calcium absorption may be decreased. These are usually small and asymptomatic. However, there have been rare reports of symptomatic hypocalcaemia, which have occasionally been severe and often occurred in patients with predisposing conditions (e.g. hypoparathyroidism, vitamin D deficiency and calcium malabsorption).
    Ensuring adequate calcium and vitamin D intake is particularly important in patients receiving glucocorticoids.
    Excipients: This medicinal product contains 26.2 mmol (or 602.54 mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.


    Side Effects

    Very Common (≥ 1/10): musculoskel etal (bone, muscle or joint) pain, which is sometimes severe.
    Common (≥ 1/100,< 1/10): headache, dizziness, vertigo, abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer, dysphagia, abdominal distension, acid regurgitation, alopecia, pruritus, joint swelling, asthenia, peripheral oedema.
    See prescribing information for full details.


    Drug interactions

    If taken at the same time, it is likely that food and beverages (including mineral water), calcium supplements, antacids, and some oral medicinal products will interfere with absorption of alendronate. Therefore, patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product.
    In healthy subjects, oral prednisone (20 mg three times daily for five days) did not produce a clinically meaningful change in oral bioavailability of alendronate (a mean increase ranging from 20% to 44%).
    No other interactions with medicinal products of clinical significance are anticipated. A number of patients in the clinical trials received oestrogen (intravaginal, transdermal, or oral) while taking alendronate. No adverse experiences attributable to their concomitant use were identified.
    Since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate.
    Although otherwise specific interaction studies were not performed, in clinical studies alendronate was used concomitantly with a wide range of commonly prescribed medicinal products without evidence of clinical adverse interactions.


    Pregnancy and Lactation

    Pregnancy: Alendronate should not be used during pregnancy. There are no adequate data from the use of alendronate in pregnant women. Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, or postnatal development. Alendronate given during pregnancy in rats caused dystocia related to hypocalcemia.
    Lactation: It is unknown whether alendronate is excreted into human breast milk. Given the indication, alendronate should not be used by breast-feeding women.


    Overdose

    Hypocalcaemia, hypophosphataemia and upper gastro-intestinal adverse events, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdosage.
    No specific information is available on the treatment of overdosage with alendronate. Milk or antacids should be given to bind alendronate. Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.


    Important notes

    Shelf life: 4 years.
    Storage: Store below 30°C. Store in the original package in order to protect from moisture.


    Manufacturer
    SwissCo Services AG, Switzerland
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