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

Acid Alendronique Sandoz – Indications, Posology, Against indications, Undesirable effects
Source RESIP-BCB
ACID ALENDRONIQUE SANDOZ 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
Selling price including all taxes:
Rate of refunding S:   65%
Laboratory:   Sandoz

Indications

- Treatment of the post-menopausic osteoporosis.
- Acid alendronic reduced the risk of vertebral fractures and the hip.

Posology

Oral way.
- The posology recommended of 1 is compressed to 70 Mg once per week.
- To allow an adequate absorption of the alendronate:
ACID ALENDRONIQUE SANDOZ 70 Mg, compressed must be taken with the stomach empties immediately with the rising, 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):
. ACID ALENDRONIQUE SANDOZ 70 Mg, compressed must be taken strictly with the rising, with large tap water glass (minimum 200 ml).
. ACID ALENDRONIQUE SANDOZ 70 Mg, compressed must be swallowed whole. 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 ACID ALENDRONIQUE SANDOZ 70 Mg, compressed.
. ACID ALENDRONIQUE SANDOZ 70 Mg, compressed 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 alendronic job security of the acid. Consequently, no adjustment of posology is necessary in the old patients.
- Use in the event of impaired renal function:
No adjustment of posology is necessary in the patients having a glomerular rate of filtration > 35 ml/mn. Because of a lack of experience, the acid alendronic 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 event of hepatic insufficiency:
No adjustment of posology is necessary.
- Use in the child:
The acid alendronic was not studied in the child and does not have to be to him managed.
- ACID ALENDRONIQUE SANDOZ 70 Mg, compressed was not studied in the treatment of the osteoporosis induced by the glucocorticoïdes.

Against indications

- Alendronic Over-sensitiveness with the acid, the others bisphosphonates 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 heading warning statements and precautions for use.
- The acid alendronic 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).
- This drug contains lactose. The patients having a rare hereditary problem of intolerance to galactose, a congenital galactosemy, a syndrome of malabsorption of glucose and galactose should not take this drug.
- Use in the child: the acid alendronic was not studied in the child and does not have to be to him managed.
- Use during the pregnancy: there do not exist sufficient data on the alendronic administration of the acid in the expectant mother. The studies in the animal highlighted effects on the fetal osseous formation at high amounts. The acid alendronic managed during the pregnancy in the rat caused a dystocie dependant on a hypocalcemy. Because of its indication, the use of the acid alendronic should not be under consideration during the pregnancy.
- Use during breast feeding: there are no data on the passage of the acid alendronic in the mother’s milk. Because of its indication, the use of the acid alendronic should not be under consideration at the woman who nurses.

Undesirable effects

- In two one three years duration clinical studies among women ménopausées with a practically identical protocol, (10 Mg of alendronate: N = 196, placebo: N = 397), the total profiles of tolerance of the alendronate 10 mg/jour and the placebo were similar.
- The undesirable effects presented by the investigators as being in possible or probable relation with the drug or incontestably related to the drug are presented below if they appeared at > = 1% of the patients treated by 10 mg/jour of alendronate and at a frequency higher than among patients receiving the placebo in the studies over three years:
Alendronate 10 mg/jour (N = 196)/Placebo (N = 397).
- Gastro-intestinal Effects:
. abdominal pains: 6,6%/4,8%.
. dyspepsia: 3,6%/3,5%.
. acid regurgitation: 2,0%/4,3%.
. nauseas: 3,6%/4,0%.
. abdominal distension: 1,0%/0,8%.
. constipation: 3,1%/1,8%.
. diarrhea: 3,1%/1,8%.
. dysphagie: 1,0%/0,0%.
. flatulences: 2,6%/0,5%.
. gastrite: 0,5%/1,3%.
. gastric ulcer: 0,0%/0,0%.
. ulceration oesophagienne: 1,5%/0,0%.
- Effects musculosquelettic:
. musculosquelettic pains (osseous, muscular or articular pains): 4,1%/2,5%.
. muscular cramps: 0,0%/1,0%.
- Neurological Effects:
cephalgias: 2,6%/1,5%.
THE FOLLOWING UNDESIRABLE EFFECTS WERE ANNOUNCE DURING CLINICAL STUDIES AND/OR AFTER THE MARKETING OF THE ALENDRONATE:
- Frequent (> = 1/100, < 1/10):
. Gastro-intestinal: Abdominal pains, dyspepsia, constipation, diarrhea, flatulences, ulceration oesophagienne*, dysphagie*, abdominal distension, pyrosis.
. Musculosquelettiques: Osseous, muscular or articular pains.
. Neurological: Cephalgias.
- Not very frequent (> = 1/1000, < 1/100):
. General reactions: Cutaneous eruption, prurit, erythema.
. Gastro-intestinal: Nauseas, vomiting, gastrite, oesophagite*, erosion oesophagienne*, méléna.
- Rare (> = 1/10000, < 1/1000):
. General reactions: Reaction of over-sensitiveness including/understanding of the cases of urticaria and angio-edema.
Transitory symptoms such as it occurs about it in an answer in acute phase (myalgia, faintness and, seldom, fever), in a typical way in partnership with the beginning of the treatment. Cutaneous eruption due to a photosensitivity. Symptomatic Hypocalcemy, often in partnership with predisposing conditions (see heading warning statements and precautions for use).
. Gastro-intestinal: Sténose of the oesophage*, ulceration oropharyngée*, PUS (perforations, ulcers, bleeding) of the high part of the gastro-intestinal tract, although no causal relation was established.
. Sensors: Uvéite, sclérite, épisclérite.
- Unknown Frequency:
Musculosquelettique: Ostéonécrose of the jaw.
A ostéonécrose of the jaw was brought back in patients treated by the bisphosphonates. The majority of the cases concerns patients reached of cancer, but of the similar cases were also brought back in patients treated for an osteoporosis.
The ostéonécrose of the jaw is usually associated with the extraction of a tooth and/or a local infection (including osteomyelitis). A diagnosis of cancer, chemotherapy, the radiotherapy, corticoids and a bad oral hygiene are also regarded as risk factors (see heading warning statements and precautions for use).
- Cases isolated from severe cutaneous reactions, including a syndrome of Stevens-Johnson and a bulleuse erythrodermy with épidermolyse were announced.
* (see headings posology and mode of administration and warning statements and precautions for use).
BIOLOGICAL PARAMETERS:
During clinical studies, discrete, transitory and asymptomatic reductions of the calcemy and phosphatemy were observed at respectively 18% and 10% of the patients taking 10 mg/jour alendronate against approximately 12% and 3% of the patients under the placebo. Nevertheless, the incidences of a reduction in the calcemy ata rate < 8,0 mg/dl (2,0 mmol/L) and phosphatemy ata rate < = 2,0 mg/dl (0,65 mmol/L) were similar in the two therapeutic groups.