Residron Pharmathen treatment for osteoporosis (1 blister x 4 tablets)

Dosage form Box of 1 blister x 4 tablets
Specifications Sodium Riseadronate

Ingredient

Composition information	Content
Sodium Riseadronate	35mg

Uses

Indications

Residron drug indications for treatment in the following cases:

Osteoporosis after menopause

RISDEDRONAT is indicated in treatment and preventing osteoporosis in postmenopausal women.

In postmenopausal women with osteoporosis, residronat reduces the risk of spondylosis and reduces the risk of spinal fractures.

osteoporosis in men

RISDEDRONAT is indicated for treatment to increase bone volume in men with osteoporosis.

Pharmacokic

Sodely Riseadronate is a pyridinyl bisphosphonate affinity with hydroxyapatite crystals in the bone and inhibit the cancellation of cells - intermediate agents that cause bone reabsorption. The drug reduces the bone destruction activity of the cell canvel and bone mineralization are maintained.

pharmacokinetic

absorption

After taken, the drug is absorbed relatively quickly (the time for the drug reaches the highest concentration in plasma is 1 hour) and is independent of the dose within the study of the study (single -dose research, 2.5 to 30 mg; multi -dose research, 2.5 to 5 mg/day and up to 50 mg/week). The average oral bioavailability is 0.63% and reduces when sodium Riseadronate is used with food. Birth of drugs in men and women similarly.

distribution

The average distribution volume in a state is 6.3 liters/kg. About 24% of the drug is attached to plasma proteins.

transformation

There is no evidence of the body metabolism of sodium Riseadronate,

Elimination

About half of the absorbed dose is excreted in urine within 24 hours, and 85% of intravenous dose is found in water pepper after 28 days. The average renal clearance is 105 ml/min and the average total clearance is 122 ml/min, the difference of clearance can be attributed to the absorption of the bone.

Renal clearance does not depend on concentration, and there is a linear correlation between the clearance of the kidney and the clearinine clearance. The non -absorbing drug is eliminated in the form of unchanged in feces. After drinking, the chart shows between concentration and time showing 3 stages of excretion and the final selling time of 480 hours.

Before taking Residron Pharmathen treatment for osteoporosis (1 blister x 4 tablets)

How to use

Oral drugs.

Dosage

Adults

One (01) tablet 35 mg/week. Should take medicine on a certain day of the week. The absorption of sodium Riseadronate is affected by food, so to make sure the absorption is fully, patients should take RISDEDRONAT at:

Before breakfast: at least 30 minutes before the first meal, or before taking other pharmaceuticals or other drinks (except for normal water) for the first time.

If the patient forgets to take one (01) 35 mg of Riseadronat in the morning, do not drink later the day. The next day continued to take the medication as usual and then still took one tablet (01) on a certain day of the week chosen from the beginning. Do not take two (02) capsules in the same day to compensate for the tablet forgot to drink.

Should swallow the tablet without sucking or chewing. To help the pill to the stomach are easy to take, it is advisable to take Riseadronat with plenty of water (≥ 120 ml), in a straight position (standing or sitting). Patients should not lie within 30 minutes after taking the drug.

Should supplement calcium and vitamin D if the diet is incomplete.

Elderly

No need to adjust the dose in the elderly because of bioavailability, distribution and elimination in this object (over 60 years old) and younger objects are the same. Also do not calibrate the dose in people older than 75 years old, postmenopausal women.

Patients with renal failure

No need to adjust the dose for patients with mild to moderate renal failure.

Children

The safety and effectiveness of Risedonat 35 mg has not been established in children and teenagers.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? After overdose, the weight can be reduced.

Signs and symptoms of hypocalcemia are also occurring in some of these patients. Take milk or antacids containing magnesi, calcium or aluminum to cohesion with sodium Riseadronate and reduce the absorption of the drug.

In case of serious overdose, the stomach must be removed to eliminate the unprocessed drug.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

Sodium Riseadronate has been studied in clinical trials in phase III in 15,000 patients.

Most of the unwanted effects are observed in mild to medium clinical trials and usually do not need to stop treatment.

The adverse effects are reported: Very common (≥ 1/10); Common (≥ 1/100, ≤ 1/10); rarely ≥ 1/1,000;

Nervous system disorders

Common: headache.

visual disorders

Uncommon: irisitis.

Digestive disorders

Common: constipation, indigestion, nausea, abdominal pain, diarrhea.

Common: musculoskeletal pain.

Research

Rare: Unusual liver function test.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Residron drugs are contraindicated in the following cases:

Hypersensitivity to sodium riseadronate or any ingredients of the drug.

Caution should be used

The effect of bisphosphonat in the treatment of osteoporosis is related to mineral density in low bones and/or fractures in a common way. Older people or clinical risk factors leading to fractures are not enough to treat osteoporosis with bisphosphonate. There is not much evidence of the support effect of bisphosphonat including iSedronat in the elderly (> 80 years old).

bisphosphonate causes esophagitis, gastritis, esophagitis and gastric ulcer. Therefore, be careful when used for the following patients:

Patients using esophageal transport disorders (narrowing/loss of expansion).

The prescription doctor should emphasize to patients the importance of adhering to the drug tutorial and warning the signs or symptoms of esophageal irritation. Patients should be instructed to have appropriate medical care if severe symptoms of esophageal irritation appear such as difficulty swallowing, pain when swallowing, post -sternum pain, heartburn.

Should treat blood calcium before starting treatment with rISEDRONAT.

Other disorders of bone metabolism and minerals (for example, hyperpigmentation dysfunction, vitamin D deficiency) should be treated simultaneously with Riseadronat.

Use drugs for women during pregnancy and lactation

do not have a satisfactory data for the use of sodium Riseadronate on pregnant women. Animal studies have shown toxicity on reproduction. The risk of pressing on people is not clear. Animal studies also show that a small amount of sodium Riseadronate excretes breast milk.

Do not use sodium riseadronate in, during pregnancy and nursing.

The effect of the drug on driving and operating machinery

does not affect the ability to drive and operate machinery.

Drug interaction

There has been no official interactive studies conducted, however, in clinical studies, there is no clinical interaction with other pharmaceuticals.

In the study of Phase III Riseadronat osteoporosis, with daily doses, the interaction with acetylsalicylie acid or NSAID has been reported by 33% and 45% of patients.

In the study of phase III osteoporosis in postmenopausal women, at a dose 1 time/week, the interaction with acetylsalicylic acid or NSAID has been reported by 57% and 40% of patients respectively. Among people who regularly acetylsalicylic or NSAID (≥ 3 days/week), the risk of gastrointestinal pain above the patient is treated with sodium Riseadronate similar to the control patient group.

If appropriate consideration, sodium Riseadronate can be stopped with estrogen supplements for women. Take the medication simultaneously with chemotherapy cations (such as calcium, magnesium, iron and aluminum) that hinders the rubbing of Riseadronat. Riseadronate is not metabolized, does not cause P450 enzyme and is less attached to protein.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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