Alendon Tablet
Alendronic Acid (Alendronate)
10mg
Beximco Pharmaceuticals Ltd.
| Pack size | 30's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 5.00 AED |
Available as:
Indications
Alendon Tablet is used for:
Osteopetrosis, postmenopausal osteoporosis, Paget's disease of bone.
Adult Dose
Adult: PO
Osteoporosis
Postmenopausal women
Indicated for treatment and prevention of osteoporosis in postmenopausal women
Prevention
5 mg PO once daily or 35 mg PO once weekly
Treatment
10 mg PO once daily or 70 mg tablet once weekly
Men
10 mg PO once daily or 70 mg tablet once weekly
Glucocorticoid-Induced Osteoporosis
Indicated for treatment of glucocorticoid-induced osteoporosis
Males and females: 5 mg PO once daily
Postmenopausal women not on hormone replacement therapy: 10 mg PO once daily
Paget Disease
Indicated for treatment of Paget disease of bone
40 mg PO once daily for 6 months
Child Dose
Renal Dose
Renal impairment
Mild-to-moderate renal impairment (CrCl 35-60 mL/min): Dose adjustment not necessary
Severe renal impairment (CrCl <35 mL/min): Not recommended
Administration
Administration
Take only in morning, not at bedtime or before arising
Take tablet with full glass of water (6-8 oz) at least 30 minutes before first food or drink of day, in upright position
Administer oral solution with at least 2 ounces of water
Swallow with plain water only; mineral water, coffee, juice or other beverages severely reduces bioavailability
Swallow tablet whole; do not suck or chew
Do not lie down for 30 minutes after taking drug; sit or stand upright
Contra Indications
Abnormalities of the esophagus that delay emptying such as stricture or achalasia.
Inability to stand/sit upright for at least 30 minutes.
Do not administer FOSAMAX oral solution to patients at increased risk of aspiration.
Hypocalcemia.
Hypersensitivity to any component of this product.
Precautions
Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue if new or worsening symptoms occur.
Hypocalcemia can worsen and must be corrected prior to use.
Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop.
Osteonecrosis of the Jaw has been reported.
Atypical Femur Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out an incomplete femoral fracture.
Monitoring Parameters
Correct disturbances of calcium and mineral metabolism (e.g. vitamin-D deficiency, hypocalcemia) before starting treatment.
Monitor serum-calcium concentration during treatment.
Pregnancy-Lactation
Pregnancy
Available data on use in pregnant women insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes; discontinue when pregnancy recognized.
Lactation
Not known whether drug present in human breast mild, affects milk production or has effects on infants
Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential effects on breastfed child from drug or underlying maternal condition
Interactions
Calcium supplements/antacids
Coadministration with calcium, antacids, or oral medications containing multivalent cations will interfere with absorption of alendronate
Aspirin
In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving concomitant therapy with daily doses of alendronate sodium greater than 10 mg and aspirin-containing products
Nonsteroidal anti-inflammatory drugs (NSAIDs)
Use with caution
In a clinical study which a majority of patients received concomitant NSAIDs, the incidence of upper gastrointestinal adverse events was similar in alendronate-treated group compared to placebo
Levothyroxine
Bioavailability of alendronate was slightly decreased when alendronate and levothyroxine were coadministered to healthy subjects
Contraindicated (1)
human parathyroid hormone, recombinant
Serious - Use Alternative (0)
Adverse Effects
Side effects of Alendronic Acid (Alendronate) :
>10%
Hypocalcemia, transient and mild (18%)
1-10%
Hypophosphatemia, transient and mild (10%),Abdominal pain (7%),Musculoskeletal pain (4.1%),Dyspepsia (3.6%),Nausea (3.6%),Constipation (3.1%),Diarrhea (3.1%),Flatulence (2.6%),Headache (2.6%),Acid regurgitation (2%),Esophagitis (1.5%),Abdominal distention (1%)
<1%
Alopecia,Diaphyseal femur fracture,Esophageal cancer,Flu like syndrome,Gastritis,Myalgia,Oropharyngeal ulceration,Pruritus,Rash,Taste perversion,Toxic epidermal necrolysis,Uveitis,Vertigo,Weakness
Mechanism of Action
Bisphosphonate; binds to hydroxyapatite crystals in bone and inhibits osteoclast-mediated bone resorption; decreases mineral release and collagen or matrix breakdown in bone.
Note
Alendon 10mg Tablet manufactured by Beximco Pharmaceuticals Ltd.. Its generic name is Alendronic Acid (Alendronate). Alendon is availble in Bangladesh.
Farmaco BD drug index information on Alendon Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.