Medicinal Products

ALENDRONIC ACID TEVA 70 mg

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

Compressed
Box of 4
All forms

Indication

Treatment of postmenopausal osteoporosis.

Alendronic acid reduces the risk of vertebral and hip fractures.

Dosage ALENDRONIC ACID TEVA 70 mg Tablet Box of 4

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

To allow adequate absorption of alendronate:

Alendronic acid should be taken at least 30 minutes before the first food, drink or medication of the day is drunk with a large glass of tap water. Other beverages (including mineral water), foods or certain medications may decrease the absorption of alendronic acid (see section 4.5. Interactions with other medicinal products and other forms of interaction ).

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

· Alendronic acid should be taken exactly when rising, with a large glass of tap water (200 ml minimum).

· Tablets should not be chewed or sucked because of the potential risk of oropharyngeal ulceration.

· Patients should not lie down until the first meal of the day is reached at least 30 minutes after taking 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 morning sunrise.

Supplementation with calcium and vitamin D is recommended in case of insufficient dietary intake (see Warnings and Precautions for Use section ).

Use in the elderly

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 the elderly person .

Use in case of renal failure

No dose adjustment is required in patients with glomerular filtration rate (GFR)> 35 ml / min. In the absence of experimental data, alendronic acid should not be administered to patients with renal impairment characterized by GFR <35 ml / min.

Use in children and adolescents (under 18 years)

Alendronic acid has been studied in a small number of patients under 18 years of age with osteogenesis imperfecta. The results are not sufficient to recommend this treatment in children and adolescents.

Against indications

· Abnormalities of the esophagus and other factors that may delay esophageal transit, such as stenosis or achalasia.

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

Hypersensitivity to alendronic acid or to any of the excipients.

· Hypocalcemia.

See also Warnings and precautions for use .

Adverse effects Alendronic acid Teva

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

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

1 year study (%)

Study over 3 years (%)

alendronic acid

alendronic acid

alendronic acid

Placebo

70 mg

10 mg / day

10 mg / day

(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

oesophageal 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 been reported in clinical and / or post-marketing studies with alendronate:

Frequent (> 1/100, <1/10)

Uncommon (> 1/1000, <1/100)

Rare (> 1/10 000, <1/1 000)

Very rare (<1 / 10, 000), unknown (not estimable from available data).

Immune system disorders

Rare

Hypersensitivity reaction including urticaria and angioedema.

Metabolic and nutritional disorders

Rare

Symptomatic hypocalcemia, usually on predisposed terrain (see Warnings and Precautions for Use section ).

Neurological disorders

Frequent

headaches

Ophthalmological disorders

Rare

Uveitis, scleritis, episcleritis

Gastrointestinal disorders

Frequent

Abdominal pain, dyspepsia, constipation, diarrhea, flatulence, oesophageal ulceration *, abdominal distension, acid regurgitation.

Rare

Nausea, vomiting, gastritis, oesophagitis *, oesophageal erosions *, melena.

Rare

Oesophageal stenosis *, oropharyngeal ulcerations *, PUS (perforations, ulcers, bleeding) of the upper gastrointestinal tract (see Warnings and Precautions for Use section ).

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

Skin and subcutaneous tissue disorders

Rare

Rash, pruritus, erythema

Rare

Rash with photosensitivity.

Very rare

Isolated cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Musculoskeletal and connective tissue disorders

Frequent

Osteoarticular or muscular pains (bone, muscle or joint).

Rare

Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates. The majority of cases involve cancer patients, but similar cases 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).

A diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also considered as risk factors (see Warnings and precautions for use ).

General disorders and administration site reactions

Rare

Hypersensitivity reactions including urticaria and angioedema. Transient symptoms such as acute myalgia, malaise and, rarely, fever, usually seen at the beginning of treatment.

Biological data:

In clinical studies, discrete, transient and asymptomatic decreases in serum calcium and phosphate were observed in 18% and 10% of patients receiving alendronate 10 mg / day versus approximately 12% and 3% of patients receiving placebo respectively. . Nevertheless, the incidence of decreased serum calcium at <8.0 mg / dl (2.0 mmol / l) and phosphatemia at <2.0 mg / dl (0.65 mmol / l) ) were similar in both treatment groups.

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