Cruzz-35 Davi Pharm prevention and treatment of osteoporosis (1 blister x 4 tablets)

Precautions when using

Do not use it with the same active ingredient.

other foods and drinks are not water and drugs containing multi -chemotherapy cations (such as calcium, magnesium, iron and aluminum) interfere with bisphosphonate absorption process, should not be used at the same time as sodium Riseadronate. To achieve the effectiveness of treatment, it is necessary to strictly comply with the recommended dose.

The effect of bisphosphonate in the treatment of osteoporosis after menopause is related to the presence of low bone mineral density (BMD T -Score in the hips and lumbar spine

Only high age or clinical risk factors of fractures are not enough to start osteoporosis with bisphosphonate.

There is very little evidence of the effectiveness of bisphosphonate treatment, including riseadronate in very elderly women (> 80 years old).

bisphosphonate is related to esophagitis, gastritis, esophagitis and peptic ulcer. Therefore, it is necessary to be cautious when using Riseadronate for patients who are experiencing or recently encountered esophageal or gastrointestinal problems (such as diagnosis of esophageal barret, difficulty swallowing, other esophageal diseases, gastrointestinal ulcers).

Unwanted effects on esophagus such as esophagitis, esophageal ulcer and esophageal corrosion, often accompanied by bleeding and then rarely are stenosis or perforation of the esophagus that has been reported in patients using oral bisphosphonate.

In some cases, these unwanted effects are heavy and need to be hospitalized. Therefore, pay attention to any signs of typical symptoms for unwanted effects in the esophagus, and should emphasize patients with the importance of paying attention to the instructions for drug use and alert to any signs or symptoms of the reaction in the esophagus. The patient should be instructed to medical centers at any time if there is symptom of esophageal irritation such as difficulty swallowing, pain when swallowing, pain or appearance/severe heartburn.

The risk of unwanted effects in the esophagus occurs more in patients right after taking bisphosphonate or people who cannot take medicine with a cup of water as recommended, the person who continues to use the oral bisphosphonate when there are signs of unpleasant esophagus. In patients who cannot comply with the drug's use, the use of RISDEDRONATE should be performed under the supervision of medical staff.

Hypacentia should be treated before starting treatment with sodium Riseadronate. Bone and mineral metabolic disorders (for example, hyperpigmentation dysfunction, vitamin D deficiency) should be treated at the time of starting treatment with sodium ridedronate.

Jaw bone necrosis, mainly related to tooth extraction and/or local infection (including bone mystitis), has been reported in cancer patients in the treatment regimen with bishosphonate used injected. Including many patients who are chemotherapy and corticosteroids. Jaw bone necrosis has also been reported in patients with osteoporosis using oral bisphosphonate.

Dental test with appropriate dental prevention should be considered before treatment with bisphosphonate in patients with many risk factors simultaneously (such as cancer, chemotherapy, radiation, corticosteroid, poor dental hygiene).

During treatment, the patient should avoid dental invasive measures if possible. In patients with jaw bone necrosis when using bisphosphonate, dental surgery may make the condition worse. In patients, dental measures need to be taken, no information proves whether or not to stop using bisphosphonate reduces the risk of jaw bone necrosis.

Clinical evaluation should be assessed to set a suitable treatment plan for each patient based on benefits/risk assessments for each object.

Bone necrosis in the external ear canal has been reported when using bisphosphonate, mainly in the case of long -term use. Risk factors of bone necrosis in the outer ear canal include using steroids and chemotherapy or local risk factors such as bacterial infections or wounds. Bone necrosis in the external ear canal should be considered in patients using bisphosphonate with symptoms in the ear including chronic ear infections.

There are reports on symptoms of bone pain, joints and severe muscles and sometimes causing loss of movement in patients using bisphosphonate. The onset of diverse symptoms from 1 day to months after taking the drug. Symptoms decrease after stopping the drug in most patients. Some patients recur symptoms when reused riseadronate or other bisphosphonate. Consider stopping riseadronate if there are severe symptoms.

Not typical femoral fractures

Not typical femoral fractures in the long bone and under the transferred shift have been reported when using bisphosphonate, mainly in patients treating osteoporosis for a long time. The horizontal or short cross -bone can occur at any point along the femur from the bottom of the burning to the above convex. This bone stretch marks after a small or no shock and a few patients feel the thigh pain and groin, accompanied by the image of a fracture, a few weeks to a few months before the thigh fracture completely.

The fracture usually occurs on either side, so the other femur should be tested in patients using bisphosphonate that have a thigh bone. The recovery of poor fractures has also been reported. Consider to stop using bisphosphonate in patients suspected of not typical females based on the evaluation of benefits and risks in each patient.

During the treatment with bisphosphonate, patients should advise patients to notify any symptoms of pain in the thigh, hip or groin and any patient with these pain symptoms should be tested for the thigh bone.

Patients with severe renal failure (Creatinine clearance

The bisphosphonate group is known to affect the use of drugs used in bone photography. There is no separate research for sodium riseadronate.

Treatment of glucocorticoid induction osteoporosis: Before starting to use Crugz-35 to treat and prevent osteoporosis due to glucocorticoid induction, sex steroid hormone in both men and women should be determined and consider appropriate replacement.

The drug contains polysorbate 80 can cause allergies and castor oil can cause nausea, vomiting, abdominal pain, diarrhea.

The ability to drive and operate machinery

Riseadronate sodium does not have or have negligible impact on the ability to drive and operate machinery.

Pregnancy

There is no adequate information about the use of sodium riseadronate in pregnant women. Animal research shows toxicity on fertility.

RISDEDRONATE Sodium is not used for pregnant women.

Breastfeeding period

The risk in humans is still unknown. Animal research shows a small amount of sodium -secreted Riseadronate.

Riseadronate sodium must not be used for nursing women.

Drug interaction

No official interactive studies have been done. However, in clinical trials, no clinical interaction is not seen with other drugs.

In phase III osteoporosis study, using daily sodium risesronate, patients use acetyl salicylic and NSAID acids reported 33% and 45%. In the study of phase III 1 time/week in postmenopausal women, patients using acetyl salicylic and NSAID acid are reported 57% and 40%. Among patients using acetyl salicylic and NSAID acid regularly (from 3 days or more for 1 week), the rate of unwanted effects on the above digestive tract in the patient group treated with sodium Riseadronate similar to the control group.

If appropriate, sodium Riseadronate can be used with estrogen supplements (only for women).

Uống chung risedronate natri với antacid, thuốc chứa calci, magnesi, sắt và nhôm có thể cản trở sự hấp thu risedronate natri. These drugs should be taken at another time during the day without coinciding with the sodium Riseadronate.

Anti -histamine H2 and proton pump inhibitors: In the study of osteoporosis, the incidence of unwanted effects in patients using sodium Riseadronate with antihistamine H2 and proton pump inhibitors similar to those who use sodium Riseadronate without using antihistamine H2 and proton pump inhibitors.

Riseadronate sodium is not metabolized, does not cause P450 enzyme induction and is less attached to protein.