Rocaltrol 0.25mcg Catalent treatment for osteoporosis after menopause (30 tablets)

Dosage form Box of 30 tablets
Specifications Calcitriol

Ingredient

Composition information	Content
Calcitriol	0.25mcg

Uses

indications

Rocaltrol drugs are indicated in the following cases:

Treatment of osteoporosis after menopause. Depending on vitamin D.

Calcitriol's biological effects are via Vitamin D receptor, a hormone receptor in the nucleus expressed in most cell types and act as a transcription factor activated by molecules associated with specific DNA positions to change the expression of the target gene.

A receptor binding protein of Calcitriol is found in the human intestine. There are additional evidence that Calcitriol may also work in the kidneys and parathyroid membranes.

The benefit of Rocaltrol in bone dysplasia caused by renal disease is to improve the loss of blood calcium and, secondary hyperthyroidism. There is no sure evidence of whether Rocaltrol has other beneficial independent impacts.

Pharmacokinetics

absorption

Peak concentration in plasma is achieved within 2 - 6 hours after taking a single dose of 0.25-1.0 µg Rocaltrol.

Distribution

While transporting in the blood, Calcitriol and other metabolites of vitamin D will combine with the specific proteins of plasma.

Metabolism

Calcitriol is hydroxy and oxidized in the kidneys and liver by a specialized isenzyme p450 cytochrome; CYP24A1.

Elimination

Calcitriol's waste sale time in plasma is about 5 to 8 hours. The pharmacological effect of the Calcitriol solo doses lasts about 4 days. Calcitriol is excreted through bile and perhaps according to the liver cycle.

Before taking Rocaltrol 0.25mcg Catalent treatment for osteoporosis after menopause (30 tablets)

How to use

The drug is prepared in the form of soft tablets for oral.

Dosage

Dosage Rocaltrol optimizes daily should be carefully identified for each patient based on serum calcium content.

It is necessary to start Rocaltrol treatment as low as possible and should not increase, the dose when not carefully monitoring serum calcium.

The prerequisite for the optimal validity of Rocaltrol is that the amount of calcium put in must be sufficient but not too much at the beginning of treatment.

Due to improving the absorption of calcium in the stomach, some patients using Rocaltrol can maintain a lower amount of calcium. Any patient who is at risk of increasing calcium-should use low-dose calcium and do not use calcium supplements.

Monitoring patients:

The process of stable treatment with Rocaltrol, need to check the amount of calcium in serum at least two weeks. Once the optimal dose of Rocaltrol is determined, the monthly serum calcium content is still required.

As soon as the serum calcium content increases to 1mg/100ml (250µmol/l) above the normal level (9-11 mg/100ml or 2250 - 2750µmol/l) or the serum creatinine increases to> i20µmol/l, it is necessary to reduce the dose of rocaltrol or stop completely stop treatment until the amount of blood calcium returns to normal.

During a period of calcium-increased calcium, it is necessary to determine the content of calcium and phosphate in daily serum.

Once the normal content has been reached, Rocaltrol may continue to use with a daily dose of 0.25µg lower than the previous dose. It is also necessary to determine the amount of calcium daily in the food and adjust the amount of calcium introduced when necessary.

Special dose instructions:

Osteoporosis after menopause:

Rocaltrol recommended dose is 0.25 µg each time, use 2 times in a day.

Need to determine the content of calcium and creatinine Thanh Thanh after 1 week, 3 and 6 months and then 6 months of checking once.

Kidney dysplasia (in patients with hemolysis):

Daily daily dosage dose is 0.25 µg in patients who only reduce blood calcium or still have normal blood calcium content, the dose of 0.25 µg in every day is sufficient. If there is no good response to the biochemical parameters and the clinical manifestations of the disease remain after 2-4 weeks of taking the drug, the dose of 0.25 µg/ 24 hours can be increased by 2 - 4 weeks apart.

During that time, the serum calcium content is needed at least twice a week. Many patients have a good response to the dose of 0.5 - 10 µg / day.

Initial treatment with Rocaltrol with oral dose 0.1 µg/kg/week, divided into two or three doses of tape to drink at night is seen as effective even for patients who do not treat continuously. Do not exceed the maximum total dosage of 12 µg a week.

Lack of power and rickets:

The recommended dose at the beginning is 0.25µg of Rocaltrol/ day, drinking in the morning. If there is no good response to biochemical parameters or but clinical manifestations have not been improved, the dose may be increased after 2-4 weeks.

During that time, the serum calcium content is needed at least twice a week. If you see hypercalcemia, immediately stop using Rocaltrol until the level of blood calcium returns to normal, need to consider carefully to reduce the amount of calcium absorbed into the body through the daily food.

Sometimes there is a reduction in absorption in patients with parathyroid diseases, so sometimes higher rocaltrol dose is needed.

Elderly:

There is no change in the dosage in the elderly. Need to remind the content of calcium and creatinine in serum.

Pediatric:

Efficiency and safety of Calcitriol crutches in children have not been fully surveyed for recommendations on dosage.

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? Drink paraffin oil to remove intestines.

Should determine serum calcium content regularly. If the calcium content is still high in serum, phosphate and corticosteroids can be used and used measures that lead to diuretic benefits.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using Rocaltrol, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Metabolism and nutrition: Hypertension of blood calcium.

nerve: headache. digestive: abdominal pain, nausea.

Skin and subcutaneous tissue: rash. Urinary: Urinary infection.

Uncommon, 1/1000

Metabolism and nutrition: Reduce appetite.

Digestive: vomiting.

Not determined frequency

The immune system: hypersensitivity, urticaria.

Metabolism and nutrition: Thirst, dehydration.

Psychiatric: Perseverance.

nerve: muscle weakness, sensory disorders. digestive: constipation, upper abdominal pain.

Skin and subcutaneous tissue: Red rash, itching.

muscle, bones, joints: developmental retardation.

Metabolism: Deposition of lime, sauce, thirst.

Urinary tract: urine.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

contraindicated

Rocaltrol drugs are contraindicated in the following cases:

Contraindicated using Rocaltrol in all diseases with hypercalcemia.

Contraindicated using Rocaltrol in humans has increased sensitivity to Calcitriol (or with the same drugs) and with the excipients of this drug.

Contraindicated to use Rocaltrol, if the patient has vitamin D poisoning.

Be cautious when using

Prisable when using food or preparations containing a lot of calcium during treatment with Rocaltrol.

In people with motionless illness, such as surgery, easy to increase calcium-thin.

Calcitriol increases inorganic phosphate in serum.

Be careful with people with kidney failure, due to the risk of calcification. In the above cases, it is necessary to maintain the normal plasma phosphate content (2-5mg/100ml or 0.65-1.62mmol/l) to take phosphate-mounted drugs and diets reduced phosphate.

Calcium with phosphate (Ca X P) must not exceed 70mg2 /DL2.

People with rickets due to vitamin D resistant to Rocaltrol, they need to continue taking phosphate.

Because Calcitriol is the most effective metabolic substance of vitamin D, no preparation contains vitamin D during Rocaltrol treatment.

Patients with normal kidney function and use Rocaltrol, need to avoid dehydration.

The ability to drive and operate machinery

This product is safe and almost does not affect the ability to drive and operate machinery.

Pregnancy

only use Rocaltrol in pregnant women, when considering the benefits and harm to the fetus.

The period of breastfeeding

may be exterminated with excretion of breast milk. The mother can breastfeed when using Rocaltrol, as long as it is necessary to closely monitor serum calcium in both mother and child.

Drug interaction

Nutrition instructions, especially related to calcium supplements, should be carefully monitored and avoided not controlling calcium -containing preparations.

Coordinate with thiazide diuretics to increase the risk of hypercalcemia. Calcitriol dosage should be considered in people who are being treated with digitalis, because of the risk of arrhythmias associated with hypercalcemia.

There is a correlation of antagonistic effects between vitamin D derivatives that increase calcium absorption, with corticosteroids that reduce calcium absorption.

Magnesium drugs (such as antacids) can cause increased blood magnesium and therefore do not use these drugs while being treated with Rocaltrol in people with chronic kidney disease to be fertilizer.

Using chelate complexes with phosphate needs to be adjusted the dose based on serum phosphate concentration.

Storage

Store at temperatures below 25 ° C, avoid moisture and direct light.

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