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

Acid Alendronique Ranbaxy – Indications, Posology, Against indications, Undesirable effects
Source RESIP-BCB
ACID ALENDRONIQUE RANBAXY 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:   Ranbaxy Pharma Credits

Indications

Treatment of the post-menopausic osteoporosis. Acid alendronic reduced the risk of fracture of the vertebrae and the hip.

Posology

- The amount recommended is of a tablet of 70 Mg once per week.
- To allow an adequate absorption of the acid alendronic:
The acid alendronic must be taken at least 30 minutes before ingestion of first food, first drink or the first drug of the day, only with plain water. The other drinks (including mineral water), the food and certain drugs can reduce the alendronic absorption of the acid (see heading interactions).
- To facilitate the arrival in the stomach and thus to reduce the risk of local irritation and oesophagienne as well as the risk of undesirable events (see heading warning statements and precautions for use):
. The acid alendronic should be taken only the morning with the rising, with large water glass (at least 200 ml).
. The patients should not crunch the tablet, nor to let it melt in the mouth because of a risk of oropharyngée ulceration.
. The patients should not lie before to have taken a first meal, which should not intervene before 30 minutes after ingestion of the tablet.
. The patients should not lie during at least thirty minutes after having taken the acid alendronic.
. The acid alendronic should not be taken with sleeping, nor before rising the morning.
. The patients must receive a supplement out of calcium and vitamin D if their food supply is inadequate (see heading warning statements and precautions for use).
- Use at the old subject:
During clinical studies, no difference related to the age, neither of the effectiveness, nor profiles of alendronic safety of the acid was observed. It is thus not necessary to adapt posology at the old subject.
- Use at the insufficient renal ones:
No posological adaptation is necessary among patients having a rate of glomerular filtration higher than 35 ml/min. The acid alendronic is not recommended to the patients presenting a renal disorder associated witha rate of glomerular filtration lower than 35 ml/min because of the lack of retreat.
- Use in the child:
The acid alendronic was not studied in the child and it should not be to him managed.
- ACID ALENDRONIQUE RANBAXY was not studied for the treatment of the osteoporosis caused by the glucocorticoïdes.

Against indications

- Alendronic Over-sensitiveness with the acid or the one of the excipients.
- Anomalies of the esophagus and other factors delaying the draining of the esophagus (for example sténose or achalasy).
- Incapacity to hold upright or sitted during at least 30 minutes.
- Hypocalcémie.
See also heading warning statements and precautions for use.
- The acid alendronic is not recommended to the patients presenting a renal disorder associated witha rate of glomerular filtration lower than 35 ml/min (see heading posology and mode of administration).
- The acid alendronic was not studied in the child and it should not be to him managed.
- Use during the pregnancy: no adequate data is available concerning the alendronic use of the acid in the expectant mother. The studies relating to animals do not indicate any direct harmful effect relating to the pregnancy, the embryonic/fetal development nor the postnatal development. The acid alendronic managed with pregnant spleens caused a dystocie dependant on the hypocalcemy. Being given the indication, the acid alendronic should not be used during the pregnancy.
- Use during breast feeding: it is not known if the acid alendronic is excreted in the mother’s milk. Being given the indication, the acid alendronic should not be used during breast feeding.

Undesirable effects

- During a one year study at ménopausées women reached of osteoporosis, the total profiles of safety of “Fosamax” Ounce Weekly 70 Mg (N = 519) and acid alendronic 10 mg/jour (N = 370) were similar.
- During two three years studies having a practically identical study plan, at ménopausées women (acid alendronic 10 Mg: N = 196, placebo: N = 397), the total profiles of alendronic safety of the acid 10 mg/jour and the placebo were similar.
- The undesirable events reported by the investigators as being perhaps, probably or certainly related to the drug are presented below when they touched 1% of the patients or more in one of the groups of treatment for the one year study or 1% of the patients or more treated by the acid alendronic 10 mg/jour and with a frequency higher than that observed for the patients under placebo for the three years studies.
Study on 1 year: FOSAMAX 70 Mg (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), not very frequent (> = 1/1000, < 1/100), rare (> = 1/10000, < 1/1000), very rare (< 1/10000) including the isolated cases.
- Disorders of the immune system:
Rare: reactions of over-sensitiveness including urticaria and angio-edema.
- Disorders of the metabolism and the nutrition:
Rare: symptomatic hypocalcemy, often associated with predisposing diseases (see heading warning statements and precautions for use).
- Disorders of the nervous system:
Frequent: cephalgias.
- Ocular Disorders:
Rare: uvéite, sclérite, épisclérite.
- Digestive disorders:
. Frequent: abdominal pain, dyspepsia, constipation, diarrhea, flatulences, ulcer oesophagien*, dysphagie*, abdominal distension, acid régurgitations.
. Not very frequent: nauseas, vomiting, gastrite, oesophagite*, erosions oesophagiennes*, méléna.
. Rare: sténose oesophagienne*, ulceration oropharyngée*, perforations, ulcers, hemorrhages of the upper part of the digestive system (see heading warning statements and precautions for use).
to *Voir headings posology and mode of administration and warning statements and precautions for use.
- Hoop nets cutaneous and of subcutaneous fabrics:
. Not very frequent: eruption, prurit, erythema.
. Rare: eruption with photosensitivity.
. Very rare and isolated cases: cases isolated from severe cutaneous reactions including syndrome of Stevens-Johnson and nécrolyse épidermique poison.
- Hoop nets musculosquelettic, osseous and of conjunctive fabric:
. Frequent: musculosquelettic pain (osseous, muscular or articular).
. Rare: ostéonécrose of the jaw brought back among patients treated by bisphosphonates. The majority of the brought back cases concern cancer patients, but cases of this type were also reported for treated patients of an 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, the catch of corticoids and a bad oral hygiene are also regarded as risk factors; severe musculosquelettic pains (bone, muscle or articulation) (see heading warning statements and precautions for use).
- General Disorders and concerning the site of administration:
Rare: transitory symptoms as in answer of acute phase (myalgia, faintness and, seldom, fever), classically in partnership with the beginning of the treatment.
RESULTS OF THE BIOLOGICAL TESTS:
During clinical studies, asymptomatic, light reductions and transients of serum calcium and phosphate were observed at approximately 18 and 10%, respectively, of the patients taking of the acid alendronic 10 mg/jour against approximately 12 and 3% of the patients taking the placebo. However, the incidence of the reductions in serum calcium on a level lower than 8,0 mg/dl (2,0 mmol/L) and serum phosphate on a level lower or equal to 2,0 mg/dl (0,65 mmol/L) were similar in the two groups of treatment.