Medicinal Products

ALENDRONIC ACID SANDOZ 70 mg

Generic drug of Fosamax
Therapeutic class: Rheumatology
active ingredients: Alendronic acid
laboratory: Sandoz

Compressed
Box of 4
All forms

Indication

Treatment of postmenopausal osteoporosis.

Alendronic acid reduces the risk of vertebral and hip fractures.

Dosage ALENDRONIC ACID SANDOZ 70 mg Tablet Box of 4

Oral way.

The recommended dosage is 1 70 mg tablet once a week.

The optimal duration of bisphosphonate therapy for osteoporosis has not been established. The need for further treatment should be reassessed periodically on a case-by-case basis depending on the benefits and potential risks of alendronic acid, particularly after 5 or more years of treatment.

To allow adequate absorption of alendronate

ALENDRONIC ACID SANDOZ 70 mg tablet should be taken on an empty stomach immediately upon waking, at least half an hour before the first food, drink or medication of the day is taken with a large glass of tap water. Other drinks (including mineral water), foods or certain medications may decrease the absorption of alendronate (see section 4.5 ).

To facilitate the passage in the stomach, and thus reduce the potential risk of irritation or local and esophageal side effects (see Warnings and precautions for use )

· ALENDRONIC ACID SANDOZ 70 mg, tablet should be taken strictly at sunrise, with a large glass of tap water (minimum 200 ml).

· ALENDRONIC ACID SANDOZ 70 mg, tablet should be swallowed whole. Patients should not crush or chew the tablet or allow it to dissolve in their mouth due to the potential risk of oropharyngeal ulcers.

· Patients should not lie down until the first foods of the day are absorbed and should be taken at least 30 minutes after taking the tablet.

· Patients should not lie down for at least 30 minutes after taking ALENDRONIC ACID SANDOZ 70 mg tablets.

· ALENDRONIC ACID SANDOZ 70 mg tablet should not be taken at bedtime or before sunrise.

Patients treated should be supplemented with calcium and vitamin D if their dietary intake is inadequate (see Warnings and Precautions ).

Use in elderly patients

Clinical studies have not revealed any age-related differences in the efficacy and safety profiles of alendronic acid. Therefore, no dosage adjustment is necessary in elderly patients.

Use in case of renal failure

No dosage adjustment is necessary in patients with a glomerular filtration rate> 35 ml / min. Due to a lack of experience, alendronic acid should not be administered in patients with renal impairment characterized by a glomerular filtration rate <35 ml / min.

Use in case of liver failure

No dosage adjustment is necessary.

Use in children

Alendronate has been studied in a small number of patients under 18 years of age with osteogenesis imperfecta. The results are insufficient to allow its use in children.

ALENDRONIC ACID SANDOZ 70 mg tablet has not been studied in the treatment of glucocorticoid-induced osteoporosis.

Against indications

· Diseases of the esophagus and other factors that delay esophageal transit such as stenosis and achalasia.

· Unable to stand upright or sit upright for at least 30 minutes.

Hypersensitivity to alendronic acid, other bisphosphonates or any of the excipients.

· Hypocalcemia.

See Warnings and precautions for use .

Adverse effects Alendronic acid Sandoz

In a 1-year clinical study in postmenopausal women with osteoporosis, overall safety profiles with alendronic acid 70 mg tablets once a week (n = 519) and acid alendronic 10 mg / day (n = 370) were similar.

In two 3-year clinical studies in postmenopausal women (alendronic acid 10 mg: n = 196, placebo: n = 397) with a nearly identical protocol, overall safety profiles with alendronic acid 10 mg / day and placebo were similar.

Adverse events reported by the investigators as possibly, probably, or definitely related to the drug are presented below if they occurred in ≥ 1% of patients treated in any of the therapeutic groups in the study. 1 year, or ≥ 1% of patients treated with alendronic acid 10 mg / day with an incidence greater than that of placebo-treated patients in 3-year studies:

1 year study (%)

Study on 3 (%)

alendronic acid 70 mg

alendronic acid 10 mg / day

alendronic acid 10 mg / day

Placebo

(n = 519)

(n = 370)

(n = 196)

(n = 397)

Gastrointestinal

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

Esophageal ulcer

0.0

0.0

1.5

0.0

musculoskeletal

Osteoarticular or muscular pains

2.9

3.2

4.1

2.5

Muscle cramps

0.2

1.1

0.0

1.0

neurological

headaches

0.4

0.3

2.6

1.5

The following adverse events have also been reported in clinical trials and / or post-marketing:

· Very common: ≥ 1/10

· Frequent: ≥ 1/100 to <1/10

· Infrequent: ≥ 1/1000 to <1/100

· Rare: ≥ 1/10 000 to <1/1000

· Very few ≤ 1/10 000

· Unknown (not estimable from available data).

Nervous system disorders

Frequent (≥ 1/100, <1/10): headache.

Unknown: dizziness, dysgeusia.

Eye disorders

Rare (≥ 1/10 000, <1/1000): uveitis, scleritis, episcleritis.

Affections of the ear and labyrinth

Unknown: vertigo.

Gastrointestinal disorders

Frequent (≥ 1/100, <1/10): abdominal pain, dyspepsia, constipation, diarrhea, flatulence, oesophageal ulceration *, dysphagia *, abdominal bloating, acid regurgitation.

Uncommon (≥ 1/1000, <1/100): nausea, vomiting, gastritis, oesophagitis *, oesophageal erosions *, melena.

Rare (≥ 1/10 000, <1/1000): oesophageal stenosis *, oropharyngeal ulceration *, upper gastrointestinal tract PUSA (perforations, ulcers, bleeding) (see Warnings and Precautions section) employment ).

Skin and subcutaneous tissue disorders

Uncommon (≥ 1/1000, <1/100): rash, pruritus, erythema, alopecia.

Rare (≥ 1/10 000, <1/1000): rash with photosensitivity.

Very rare (≤ 1/10 000): isolated cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.

Musculoskeletal disorders of connective tissue and bones

Frequent: musculoskeletal pain (bone, muscle and joints).

Unknown frequency: osteonecrosis.

During post-marketing studies, the following effects have been reported (rare frequency): atypical femoral fractures under trochanteric and diaphyseal (class-related adverse effects of bisphosphonates).

Cases of osteonecrosis of the jaw have been reported in patients treated with bisphosphonates. The majority of these cases involve cancer patients, but some of them 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 (see Warnings and Precautions ).

Metabolism and nutrition disorders

Rare (≥ 1/10 000 to <1/1000): symptomatic hypocalcemia, often associated with risk factors (see Warnings and Precautions section ).

General disorders and administration site conditions

Uncommon (≥ 1/1000, <1/100): rash, erythema, pruritus.

Rare (≥ 1/10 000, <1/1000): transient symptoms such as acute myalgia, malaise and, rarely, fever, usually seen at the start of treatment.

Unknown: asthenia, peripheral edema.

Immune system disorders

Rare (≥ 1/10 000, <1/1000): Hypersensitivity reactions including urticaria and angioedema.

* (see sections Posology and method of administration and Warnings and precautions for use ).

Biological effects

In clinical trials, asymptomatic, mild and transient decreases in serum calcium and phosphorus levels were observed in approximately 18% and 10%, patients taking alendronate 10 mg / day compared to approximately 12% and 3%, respectively. patients taking placebo. However, the incidences of decreases in serum calcium <2.0 mmol / l and phosphoremia <0.65 mmol / l were similar in both treatment groups.

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