Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..
PHARMACHOLOGIC EFFECT
Inhibitor of bone resorption. Risedronate binds to hydroxyapatite at the cellular level and suppresses the function of osteoclasts, reduces bone resorption. Time to achieve maximum therapeutic effect - 3 months, duration of therapeutic action - 16 months.
PHARMACOKINETICS
Absorption from the gastrointestinal tract is rapid, does not depend on the dose. Admission 30 minutes before breakfast or 2 hours after lunch reduces absorption by 55%, and taking 1 hour before breakfast reduces absorption by 30% compared with taking on an empty stomach (no food or liquid intake for 10 hours before meals or 4 h after eating). Binding to plasma proteins - 24%. C max - 1 h. V d - 6.3 l / kg. 60% of the dose is accumulated in the bone tissue. It is not metabolized. T 1/2 in the initial phase - 1.5 h, in the final phase - 220 h. It is excreted with feces in unchanged form or kidneys (within 24 hours - 50% of the absorbed dose, 28 days - 85% of the absorbed dose). Kidney clearance - 105 ml / min, total clearance - 122 ml / min. Kidney clearance is independent of the concentration of the drug, there is a linear relationship between renal clearance and CC.
INDICATIONS
Postmenopausal osteoporosis (prevention and treatment), osteoporosis in patients receiving SCS (prevention and treatment in men and women).
DOSING MODE
Inside, 30 minutes before breakfast or 2 hours after eating, squeezed 200 ml of water. With deforming osteitis adults - 30 mg / day once for 2 months. In the case of recurrence of the disease or a decrease in the activity of AP, it is possible to repeat the course of treatment after 2 months. For osteoporosis (postmenopauznom or on the background of taking GCS), the recommended dose for adults is 5 mg / day.
SIDE EFFECT
From the digestive system: abdominal pain (including gastralgia), dysphagia, belching, glossitis, esophagitis, duodenitis, ulcers of the esophagus and stomach, colitis, diarrhea or constipation, nausea; sometimes - a violation of the liver.
On the part of the nervous system: headache, dizziness, asthenia, unusual fatigue, cramps calf muscles, myasthenia gravis.
On the part of the sense organs: acute iritis (flushing of the sclera, pain in the eyes), amblyopia, blurred vision, dryness of the mucous membrane of the eyes, ringing in the ears.
Allergic reactions: skin rash.
Other: bone pain, arthralgia, bronchitis (cough), sinusitis, chest pain, peripheral edema, minor transient hypocalcemia and hypophosphatemia.
CONTRAINDICATIONS
Renal insufficiency (decrease in QC less than 30 ml / min), hypocalcemia, age under 18 years (efficacy and safety of application not established).
PREGNANCY AND LACTATION
Use in pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.
During breastfeeding, the drug should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in renal failure (lower QC less than 30 ml / min).
APPLICATION FOR CHILDREN
Contraindicated at the age of 18 years (efficacy and safety of use not established).
SPECIAL INSTRUCTIONS
Use with caution in erosive and ulcerative lesions of the gastrointestinal mucosa.
To determine the effectiveness of treatment, it is recommended to determine the activity of AP. To increase the speed of passage in the gastrointestinal tract and reduce the undesirable effects on the mucous membrane of the gastrointestinal tract, patients are not recommended to lie down for 30 minutes after taking risedronic acid.
During treatment, it is recommended that an adequate diet with sufficient calcium and vitamin D. It is possible to supplement calcium and vitamin D supplementation if necessary. During treatment, a slight asymptomatic decrease in plasma concentrations of calcium and phosphorus is possible.
Do not eat foods, beverages and medicines containing calcium, magnesium, aluminum, iron while taking risedron acid.
The cases of osteonecrosis of the lower jaw in the treatment of patients with malignant neoplasms with the use of bisphosphonates have been reported. Risk factors are malignant neoplasms, chemotherapy, use of GCS, inadequate oral hygiene.
DRUG INTERACTION
Medicines containing calcium, magnesium, aluminum, iron, can reduce the absorption of the active substance.
Compatible with the means for HRT.
