Generic drug of Fosamax
Therapeutic class: Rheumatology
active ingredients: Alendronic acid
laboratory: Ranbaxy Pharma Generic
Box of 4
Treatment of postmenopausal osteoporosis. Alendronic acid reduces the risk of vertebral and hip fractures.
Dosage ALENDRONIC ACID RANBAXY 70 mg Tablet Box of 4
- The recommended dose is one 70 mg tablet once a week.
- To allow adequate absorption of alendronic acid :
Alendronic acid should be taken at least 30 minutes before ingestion of the first food, the first drink or the first medication of the day, only with still water. Other drinks (including mineral water), foods, and certain medications may reduce the absorption of alendronic acid (see section on interactions).
- To facilitate the arrival in the stomach and thus reduce the risk of local and oesophageal irritation as well as the risk of adverse events (see section on warnings and precautions for use) :
. Alendronic acid should only be taken in the morning with a large glass of water (at least 200 ml).
. Patients should not chew the tablet or let it melt in the mouth due to the risk of oropharyngeal ulceration.
. Patients should not lie down until they have had their first meal, which should not be done until 30 minutes after ingestion of the tablet.
. Patients should not lie down for at least 30 minutes after taking alendronic acid.
. Alendronic acid should not be taken at bedtime or before getting up in the morning.
. Patients should be supplemented with calcium and vitamin D if their dietary intake is inadequate (see section on warnings and precautions for use).
- Use in the elderly:
In clinical studies, no differences in age, efficacy or safety profiles of alendronic acid were observed. It is therefore not necessary to adjust the dosage in the elderly.
- Use in patients with renal insufficiency:
No dose adjustment is necessary in patients with a glomerular filtration rate greater than 35 ml / min. Alendronic acid is not recommended for patients with renal impairment associated with a glomerular filtration rate of less than 35 ml / min due to lack of follow-up.
- Use in children:
Alendronic acid has not been studied in children and should not be given to them.
- ALENDRONIC ACID RANBAXY has not been studied for the treatment of osteoporosis caused by glucocorticoids.
Hypersensitivity to alendronic acid or to any of the excipients.
- Abnormalities of the esophagus and other factors delaying the emptying of the esophagus (eg stenosis or achalasia).
- Inability to stand or sit for at least 30 minutes.
See also section warnings and precautions for use.
- Alendronic acid is not recommended for patients with renal impairment associated with a glomerular filtration rate below 35 ml / min (see section titration and method of administration).
- Alendronic acid has not been studied in children and should not be given to them.
- Use during pregnancy: no adequate data are available on the use of alendronic acid in pregnant women. Animal studies do not indicate any direct adverse effects with respect to pregnancy, embryonal / fetal development, or postnatal development. Alendronic acid administered to pregnant rats caused obstructed labor due to hypocalcemia. Given the indication, alendronic acid should not be used during pregnancy.
- Use during breastfeeding: It is not known if alendronic acid is excreted in breast milk. Given the indication, alendronic acid should not be used during breastfeeding.
Ranbaxy Alendronic Acid Effects
- In a one-year study in postmenopausal women with osteoporosis, the overall safety profile of "Fosamax" Once Weekly 70 mg (n = 519) and alendronic acid 10 mg / day (n = 370) were similar.
- In two three-year studies with virtually identical study design, in postmenopausal women (alendronic acid 10 mg: n = 196, placebo: n = 397), the overall safety profiles of alendronic acid 10 mg / day and placebo were similar.
- Adverse events reported by the investigators as possibly, probably, or certainly related to the drug are presented below when they reached 1% or more of the patients in one of the treatment groups for the one-year study or 1% or more of the patients treated with alendronic acid 10 mg / day and at a frequency greater than that observed for placebo-treated patients for the three-year studies.
1-year study: FOSAMAX 70 mg (n = 519) / alendronate 10 mg / day (n = 370) //
3-year study: alendronate 10 mg / day (n = 196) / placebo (n = 397).
. Abdominal pain: 3.7% / 3.0% // 6.6% / 4.8%.
. dyspepsia: 2.7% / 2.2% // 3.6% / 3.5%.
. acid regurgitation: 1.9% / 2.4% // 2.0% / 4.3%.
. nausea: 1.9% / 2.4% // 3.6% / 4.0%.
. abdominal bloating: 1.0% / 1.4% // 1.0% / 0.8%.
. constipation: 0.8% / 1.6% // 3.1% / 1.8%.
. diarrhea: 0.6% / 0.5% // 3.1% / 1.8%.
. dysphagia: 0.4% / 0.5% // 1.0% / 0.0%.
. flatulence: 0.4% / 1.6% // 2.6% / 0.5%.
. gastritis: 0.2% / 1.1% // 0.5% / 1.3%.
. gastric ulcer: 0.0% / 1.1% // 0.0% / 0.0%.
. oesophageal ulcer: 0.0% / 0.0% // 1.5% / 0.0%.
. Osteo-articular or muscular pains: 2.9% / 3.2% // 4.1% / 2.5%.
. muscle cramps: 0.2% / 1.1% // 0.0% / 1.0%.
headache: 0.4% / 0.3% // 2.6% / 1.5%.
THE FOLLOWING UNDESIRABLE EVENTS HAVE ALSO BEEN REPORTED DURING CLINICAL STUDIES AND / OR SINCE MARKETING:
Frequent (> = 1/100, = 1/1000, = 1/10000, <1/1000), very rare (<1/10000) including isolated cases.
- Immune system disorders:
Rare : Hypersensitivity reactions including urticaria and angioedema.
- Metabolism and nutrition disorders:
Rare : symptomatic hypocalcemia, often associated with predisposing diseases (see section on warnings and precautions for use).
- Nervous system disorders:
Frequent : headache.
- Eye disorders:
Rare : uveitis, scleritis, episcleritis.
- Digestive disorders :
. Frequent : abdominal pain, dyspepsia, constipation, diarrhea, flatulence, esophageal ulcer *, dysphagia *, abdominal distension, acid regurgitation.
. Uncommon : nausea, vomiting, gastritis, oesophagitis *, oesophageal erosions *, melena.
. Rare : oesophageal stenosis *, oropharyngeal ulceration *, perforations, ulcers, bleeding from the upper part of the digestive system (see section on warnings and precautions for use).
* See Dosage and Administration Instructions and Warnings and Precautions for Use.
- Skin and subcutaneous tissue disorders:
. Uncommon : rash, pruritus, erythema.
. Rare : eruption with photosensitivity.
. Very rare and isolated cases : isolated cases of severe cutaneous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.
- Musculoskeletal, bone and connective tissue disorders:
. Frequent : musculoskeletal pain (bone, muscle or joint).
. Rare : Osteonecrosis of the jaw reported in patients treated with bisphosphonates. The majority of reported cases involve cancer patients, but cases of this type have also been reported in patients treated for osteoporosis. Osteonecrosis of the jaw is usually associated with tooth extraction and / or local infection (including osteomyelitis). Cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also considered as risk factors; severe musculoskeletal pain (bone, muscle or joint) (see section on warnings and precautions for use).
- General disorders and affecting the administration site:
Rare : transient symptoms such as acute phase response (myalgia, malaise and, rarely, fever), usually associated with the start of treatment.
RESULTS OF BIOLOGICAL TESTS:
In clinical studies, asymptomatic, mild and transient decreases in serum calcium and phosphate were observed in approximately 18% and 10%, respectively, of patients taking alendronic acid 10 mg / day versus approximately 12% and 3%, respectively. patients taking the placebo. However, the incidence of decreases in serum calcium at levels below 8.0 mg / dl (2.0 mmol / L) and serum phosphate at or below 2.0 mg / dl (0.65 mmol / L) was similar in both treatment groups.