Fozanate Tablets
Alendronic Acid (Alendronate)
70mg
Globalpharma Co. L.L.C.
| Pack size | 4's Blister |
|---|---|
| Dispensing mode | POM |
| Source | UAE |
| Agent | GlobalPharma Co. L.L.C. |
| Retail Price | 116.50 AED |
Indications
Fozanate Tablets is used for:
Osteopetrosis, postmenopausal osteoporosis, Paget's disease of bone.
Adult Dose
Adult: PO Osteoporosis 10 mg/day or 70 mg once wkly.
Prevention of postmenopausal osteoporosis 5 mg/day or 35 mg once wkly.
Corticosteroid-induced osteoporosis 5 mg/day; up to 10 mg/day in women not on HRT treatment.
Paget's disease of bone 40 mg/day for 6 mth. May repeat after an interval of 6 mth if needed.
Child Dose
Renal Dose
Renal impairment:
CrCl (ml/min)
<35 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
Hypocalcaemia; oesophageal abnormalities and factors which delay oesophageal emptying; severe renal impairment; hypersensitivity; inability to stand or sit upright for ?30 min. Pregnancy, lactation.
Precautions
Upper GI disorders (discontinue if symptoms worsen); history of ulcers, active GI bleeding. Correct vitamin D and calcium deficiency before starting therapy. To be taken half an hr before breakfast and remain upright for at least 30 minutes after admin. Not recommended for use in patients with CrCl <35 ml/min.
Lactation: Unknown whether drug is excreted in milk; use with caution.
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
Concomitant iron, calcium supplements and antacids hinder alendronate absorption. Concomitant aspirin or NSAIDs may increase the incidence of adverse GI effects.
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
Alendronic acid reduces bone resorption by inhibiting the action of osteoclasts.
Note
Fozanate 70mg Tablets manufactured by Globalpharma Co. L.L.C.. Its generic name is Alendronic Acid (Alendronate). Fozanate is availble in United Arab Emirates.
Farmaco UAE drug index information on Fozanate Tablets is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.