Acid Alendronique Mylan – Indications, Posology, Against indications, Undesirable effects

Acid Alendronique Mylan – Indications, Posology, Against indications, Undesirable effects
Source RESIP-BCB
ACID ALENDRONIQUE MYLAN 70 Compressed Mg Box of 4
Generic medicine of:   FOSAMAX 70 Compressed Mg Box of 4
Therapeutic class:   Rhumatology
Active ingredients:   Acid alendronic
Statute:   Drug subjected to medical regulation

Rate of refunding S:   65%
Laboratory:   Mylan

Indications

Treatment of the post-menopausic osteoporosis. ACID ALENDRONIQUE MYLAN reduces the risk of vertebral fractures and the hip.
ONT>

Posology

The posology recommended of 1 compressed is proportioned to 70 Mg once per week.
- To allow an adequate absorption of the alendronate:
The tablet must be taken at least half an hour before the absorption of first food, drinks or drugs of the day with large tap water glass. The other drinks (including mineral water), the food or certain drugs are likely to decrease the absorption of the alendronate (see heading interactions).
- To facilitate the passage in the stomach, and thus to reduce the possible hazard of irritation or local undesirable effects and oesophagiens (see heading warning statements and precautions for use):
. The tablet must be taken strictly with the rising, with large tap water glass (minimum 200 ml).
. The patients should not crunch the tablet or let it dissolve in their mouth because of the possible hazard of oropharyngées ulcerations.
. The patients should not lie until the absorption of the first food of the day which will have to be taken at least thirty minutes after the catch of the tablet.
. The patients should not lie during at least 30 minutes after the catch of the tablet.
. The tablet should not be taken with sleeping or before the rising.
- The treated patients must be supplemented out of calcium and vitamin D if their food supplies are insufficient (see heading warning statements and precautions for use).
- Use in the old patients:
The clinical studies did not reveal any difference related to the age in the profiles of effectiveness and job security of the alendronate. Consequently no modification of posology is necessary in the old patients.
- Use in the event of impaired renal function:
No modification of posology is necessary in the patients having a glomerular rate of filtration > 35 ml/min. Because of a lack of experience, the alendronate should not be managed in the patients presenting an impaired renal function characterized by a glomerular rate of filtration < 35 ml/min.
- Use in the child:
The alendronate was not studied in the child and does not have to be to him managed.
- The alendronate was not studied in the treatment of the osteoporosis induced by corticoids.

Against indications

- Over-sensitiveness with the alendronate or the one of the excipients.
- Diseases of the esophagus and other factors which delay the transit oesophagien such as sténose and achalasy.
- Incapacity to put themselves in driving position or to be held sitted in driving position during at least 30 minutes.
- Hypocalcémie.
See also heading warning statements and precautions for use.
- The alendronate should not be managed in the patients who present an impaired renal function when the glomerular rate of filtration is < 35 ml/min (see heading posology and mode of administration).
- Because of the presence of lactose, this drug is contra-indicated in the event of congenital galactosemy, of syndrome of malabsorption of glucose and galactose or of lactase deficit.
- Use in the child: the alendronate was not studied in the child and does not have to be to him managed.
- Use during the pregnancy: there do not exist adequate data on the administration of the alendronate in the expectant mother. The studies in the animal do not indicate directly harmful effects on the pregnancy, the fetal development embryo/, or the postnatal development. The alendronate managed during the pregnancy in the rat caused a dystocie dependant on a hypocalcemy. Because of its indication, the use of the alendronate should not be under consideration during the pregnancy.
- Use during breast feeding: there are no data on the passage of the alendronate in the mother’s milk. Because of its indication, the use of the alendronate should not be under consideration at the woman who nurses.

Undesirable effects

- In a one duration clinical study of 1 year at ménopausées women having an osteoporosis, the total profiles of job security with the alendronate 70 Mg (N = 519) and the alendronate 10 mg/jour (N = 370) was similar.
- In two one 3 years duration clinical studies among ménopausées women (alendronate 10 Mg: N = 196, placebo: N = 397) with a practically identical protocol, the total profiles of job security with the alendronate 10 mg/jour and a placebo were similar.
The undesirable events reported by the investigators like possibly, probably or definitively related to the drug are presented below if they occurred at > = 1% of the patients treated in one or the other of the therapeutic groups of the study of 1 year, or at > = 1% of the patients treated by the alendronate 10 mg/jour with an incidence higher than that of the patients under placebo in the 3 years studies:
Study on 1 year: Alendronate 70 Mg once per week (N = 519)/Alendronate 10 mg/jour (N = 370) //
Study over 3 years: Alendronate 10 mg/jour (N = 196)/Placebo (N = 397).
- Gastro-intestinal:
. abdominal pains: 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%.
. nauseas: 1,9%/2,4% // 3,6%/4,0%.
. abdominal distension: 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%.
. dysphagie: 0,4%/0,5% // 1,0%/0,0%.
. flatulence: 0,4%/1,6% // 2,6%/0,5%.
. gastrite: 0,2%/1,1% // 0,5%/1,3%.
. gastric ulcer: 0,0%/1,1% // 0,0%/0,0%.
. ulcerate oesophagien: 0,0%/0,0% // 1,5%/0,0%.
- Musculosquelettiques:
. ostéo-articular or muscular pains: 2,9%/3,2% // 4,1%/2,5%.
. muscular cramps: 0,2%/1,1% // 0,0%/1,0%.
- Neurological:
cephalgias: 0,4%/0,3% // 2,6%/1,5%.
THE FOLLOWING UNDESIRABLE EVENTS ALSO WERE PAY DURING CLINICAL STUDIES AND/OR SINCE MARKETING:
- Frequent (> = 1/100, < 1/10):
. Gastro-intestinal:
abdominal pains, dyspepsia, constipation, diarrheas, flatulence, ulcer oesophagien (*), dysphagie (*), abdominal distension, acid regurgitation.
. Neurological:
cephalgias.
- Not very frequent (> = 1/1000, < 1/100):
. Generals:
rash, erythema, prurit.
. Gastro-intestinal:
nausea, vomiting, gastrite, oesophagite (*), erosions oesophagiennes (*), méléna.
- Rare (> = 1/10000, < 1/1000):
. Generals:
* reactions of over-sensitiveness of which urticaria and angio-edema,
* transitory symptoms of acute reactions type (myalgias, faintness and seldom fever) generally observed at the beginning of treatment,
* rash with photosensitivity,
* symptomatic hypocalcemy, in general on a predisposed ground (see heading warning statements and precautions for use).
. Gastro-intestinal:
sténose oesophagienne (*), oropharyngées ulcerations (*), PUS of the high part of the gastro-intestinal tract (perforation, ulcers, bleeding), although a relation of cause and effect cannot be isolated.
. Bodies of the directions:
uvéite, sclérite, épisclérite.
. Hoop nets musculosquelettic of conjunctive fabric and the bones:
* Rare: cases of ostéonécroses of the jaw were reported among patients treated by bisphosphonates. The majority of these cases concerns cancer patients, but some of them were also brought back among patients treated for osteoporosis. The ostéonécrose of the jaw is generally associated with a dental extraction and/or a local infection (including an osteomyelitis). A cancer, a chemotherapy, a radiotherapy, corticoids and a bad oral hygiene are also regarded as risk factors.
* Frequent: ostéo-articular or muscular pains severe (see heading warning statements and precautions for use).
. Affections of the skin and subcutaneous fabric:
Very rare: cases isolated from severe cutaneous reactions, including Syndrome of Stevens-Johnson and nécrolyse épidermique poison, were reported.
(*) See headings warning statements and precautions for use and posology and mode of administration.
. Biological effects:
During clinical studies, asymptomatic, light reductions and transients of the calcemy and phosphoremy were respectively observed at approximately 18 and 10% of the patients taking of the alendronate 10 mg/jour compared to approximately 12 and 3% of the patients taking of the placebo. However, the incidences of the reductions in the calcemy ata rate < 8,0 mg/dl (2,0 mmol/L) and phosphoremy ata rate < = with 2,0 mg/dl (0,65 mmol/L) were similar in the two groups of treatment.