Alendronate Hovid愛骨靈

Alendronate Hovid

alendronic acid

Manufacturer:

Hovid

Distributor:

DCH Auriga - Healthcare
/
Four Star
Full Prescribing Info
Contents
Alendronic acid.
Description
Each tablet contains Sodium Alendronate Trihydrate 91.4 mg equivalent to 70 mg Alendronic Acid.
Action
Pharmacology: The active ingredient of Alendronate Hovid 70 mg Tablet, alendronate sodium trihydrate, is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. Preclinical studies have shown preferential localisation of alendronate to sites of active resorption. Activity of osteoclasts is inhibited, but recruitment or attachment of osteoclasts is not affected. The bone formed during treatment with alendronate is of normal quality.
Alendronate is given in the management of osteoporosis either alone or with Vitamin D.
Pharmacokinetics: Absorption: Alendronate is poorly absorbed after oral doses. Absorption is decreased by food, especially by products containing calcium or other polyvalent cations.
Relative to an intravenous reference dose, the oral mean bioavailability of alendronate in women was 0.64% for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardised breakfast. Bioavailability was decreased similarly to an estimated 0.46% and 0.39% when alendronate was administered one hour or half an hour before a standardised breakfast. In osteoporosis studies, alendronate was effective when administered at least 30 minutes before the first food or beverage of the day.
Bioavailability was negligible whether alendronate was administered with, or up to two hours after, a standardised breakfast. Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approximately 60%.
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%).
Distribution: The mean steady-state volume of distribution, exclusive of bone, is at least 28 litres in humans. Concentrations of drug in plasma following therapeutic oral doses are too low for analytical detection (<5 ng/ml). Protein binding in human plasma is approximately 78%.
Metabolism: There is no evidence that alendronate is metabolised in humans.
Elimination: Following a single intravenous dose of [14C] alendronate, approximately 50% of the radioactivity was excreted in the urine within 72 hours and little or no radioactivity was recovered in the faeces.
Following a single 10 mg intravenous dose, the renal clearance of alendronate was 71 ml/min, and systemic clearance did not exceed 200 ml/min. Plasma concentrations fell by more than 95% within six hours following intravenous administration. The terminal half-life in humans is estimated to exceed ten years, reflecting release of alendronate from the skeleton.
Indications/Uses
To treat postmenopausal osteoporosis and reduces the risk of vertebral and hip fractures.
Dosage/Direction for Use
The recommended dosage is one 70 mg tablet once weekly.
To permit adequate absorption of alendronate: Alendronate Hovid 70 mg Tablet 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 or adverse experiences: (a) Alendronate Hovid 70 mg Tablet should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml or 7 fl.oz.).
(b) Patients should only swallow Alendronate Hovid 70 mg Tablet whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
(c) Patients should not lie down until after their first food of the day which should be at least 30 minutes after taking the tablet.
(d) Patients should not lie down for at least 30 minutes after taking Alendronate Hovid 70 mg Tablet.
(e) Alendronate Hovid 70 mg Tablet should not be taken at bedtime or before arising for the day.
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
Use in the elderly: 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.
Use in children (under 18 years): Not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy.
Overdosage
Symptoms: Hypocalcaemia, hypophosphataemia and upper gastro-intestinal adverse events, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdosage.
Treatment: 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.
Contraindications
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.
Hypersensitivity to alendronate.
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 (within the previous year) of major gastro-intestinal disease such as peptic ulcer, or active gastro-intestinal bleeding, or surgery of the upper gastro-intestinal 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 ulcers and oesophageal erosions, 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.
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.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with oral 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.
Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. In post-marketing 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 rechallenged with the same drug or another bisphosphonate.
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.
The fractures occurred after minimal or no trauma and some patients experienced thigh pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture. Fractures were 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 was also reported. Discontinuation of bisphosphonate therapy in patients with stress fracture is advisable pending evaluation of the patient, based on an individual benefit risk assessment.
Patients should be instructed that if they miss a dose of Alendronate Hovid 70 mg Tablet, they should take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.
Alendronate is not recommended for patients with renal impairment where GFR is less than 35 ml/min.
Causes of osteoporosis other than oestrogen deficiency and ageing 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. In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with Alendronate Hovid 70 mg Tablet.
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.
Limitation of Use: 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 on an individual patient basis, particularly after 5 or more years of use.
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.
Use In Pregnancy & Lactation
Pregnancy: Alendronate should not be used during pregnancy. There are no adequate data from the use of alendronate in pregnant women.
Lactation: It is not known whether alendronate is excreted into human breast milk. Alendronate should not be used by breast-feeding women.
Adverse Reactions
Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10000, <1/1000), Very rare (<1/10000 including isolated cases)
Very Common: Musculoskeletal (bone, muscle or joint) pain which is sometimes severe.
Common: Headache, dizziness, vertigo, abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer, dysphagia, abdominal distension, acid regurgitation, alopecia, pruritus, joint swelling, asthenia, peripheral oedema.
Uncommon: Dysgeusia, eye inflammation (uveitis, scleritis, episcleritis), nausea, vomiting, gastritis, oesophagitis, oesophageal erosions, melena, rash, erythema, transient symptoms as in an acute-phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment.
Rare: Hypersensitivity reactions including urticaria and angioedema, symptomatic hypocalcaemia, often in association with predisposing conditions, oesophageal stricture, oropharyngeal ulceration, upper gastrointestinal PUBs (perforation, ulcers, bleeding), rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, osteonecrosis of the jaw; atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).
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.
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 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.
Storage
Store below 30°C.
Protect from moisture and light.
ATC Classification
M05BA04 - alendronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Presentation/Packing
Tab 70 mg (oval, white, uncoated, shallow convex with 'HD' and break bar embossed on one face) x 4's.
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in