Medicinal Products

ALENDRONIC ACID ACTAVIS 70 mg

Generic drug of Fosamax
Therapeutic class: Rheumatology
active ingredients: Alendronic acid
laboratory: Actavis Group Ptc Ehf

Compressed
Box of 4
All forms

Indication

Treatment of postmenopausal osteoporosis. ALENDRONIC ACTAVIS ACID reduces the risk of vertebral and hip fractures.

Dosage ACID ALENDRONIC ACTAVIS 70 mg Tablet Box of 4

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

To allow adequate absorption of alendronate:

ALENDRONIC ACTAVIS ACID should be taken at least half an hour before taking the first food, drink or medication of the day 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 therefore reduce the potential risk of irritation or local and esophageal side effects (see section Warnings and precautions for use .)

· ALENDRONIC ACID ACTAVIS must be taken strictly at sunrise, with a large glass of tap water (minimum 200 ml).

· Patients must swallow the ACENDED ALENDRONIC ACID tablet in its entirety. Patients should not crush or chew the tablet or allow it to dissolve in their mouths because of 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 ACID ALENDRONIC ACID.

· ALENDRONIC ACID ACTAVIS 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 for Use section ).

Use in elderly patients:

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

Use in case of renal failure:

No dosage modification is necessary in patients with a glomerular filtration rate> 35 ml / min. Due to a lack of experience, alendronate is not recommended in patients with renal impairment characterized by a glomerular filtration rate <35 ml / min.

Use in children (under 18 years):

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 ACTAVIS 70 mg has not been studied in the treatment of osteoporosis induced by corticosteroids.

Against indications

· Esophageal diseases 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 alendronate or any of the excipients

· Hypocalcemia.

See also Warnings and precautions for use .

Adverse effects Alendronic acid Actavis

In a 1-year clinical trial in postmenopausal women with osteoporosis, overall safety profiles with alendronate 70 mg (n = 519) and alendronate 10 mg / day (n = 370) have been similar.

In two 3-year clinical studies in postmenopausal women (alendronate 10 mg: n = 196, placebo: n = 397) with a nearly identical protocol, overall safety profiles with alendronate 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 ³ 1% of patients treated in any of the therapeutic groups in the study. 1 year, or in 1% of patients treated with alendronate 10 mg / day with an incidence greater than that of placebo-treated patients in 3-year studies:

1 year study

Study over 3 years

alendronate

70 mg

(n = 519)

%

alendronate

10 mg / day

(n = 370)

%

alendronate

10 mg / day

(n = 196)

%

Placebo

(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 pain

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), common (≥1 / 100, <1/10), infrequent (≥1 / 1, 000, <1/100), uncommon (≥1 / 10, 000, <1/1) 000), very rare (≤1 / 10, 000 including isolated cases)]

Immune system disorders

Rare: Hypersensitivity reactions including urticaria and angioedema.

Metabolism and nutrition disorders

Rare : symptomatic hypocalcemia, usually on predisposed terrain § .

Nervous system disorders

Common : headache, dizziness .

Uncommon: dysgeusia .

Eye disorders

Uncommon: inflammation of the eye (uveitis, scleritis, episcleritis).

Affections of the ear and labyrinth

Frequent: vertigo .

Gastrointestinal disorders

Common : abdominal pain, dyspepsia, constipation, diarrhea, flatulence, oesophageal ulcer *, dysphagia *, abdominal bloating, acid regurgitation

Uncommon : nausea, vomiting, gastritis, oesophagitis *, oesophageal erosions *, melena .

Rare : esophageal stenosis *, oropharyngeal ulcerations *, PUS (perforation, ulcers, bleeding) of the upper part of the gastrointestinal tract § .

Skin and subcutaneous tissue disorders

Common: alopecia , pruritus .

Uncommon : rash, erythema.

Rare : photosensitive rash, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis .

Musculoskeletal, systemic and bone disorders

Very common: osteoarticular or muscular pain sometimes severe § .

Common : joint swelling .

Rare : osteonecrosis of the jaw §, stress fractures of the proximal end of the femoral diaphysis § .

General disorders and administration site conditions

Common: asthenia , peripheral edema .

Uncommon : Transient symptoms of the acute reaction type (myalgia, malaise and rarely fever), usually seen at the beginning of treatment .

§ See warnings and precautions for use

† The frequency was similar in clinical studies between the drug group and the placebo group.

* See section Posology and method of administration and Warnings and precautions for use

‡ This adverse event has been identified by pharmacovigilance since marketing. The rare frequency has been estimated from appropriate clinical trials.

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