Oscal capsules

Oscal

  • Active Ingredient: Calcitriol
  • 0.25mcg
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What is Oscal?

The active ingredient of Oscal brand is calcitriol. Calcitriol is vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body. The other names frequently used for Calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC.

Used for

Oscal is used to treat diseases such as: Hypocalcemia, Hypoparathyroidism, Renal Osteodystrophy, Rickets, Secondary Hyperparathyroidism.

Side Effect

Possible side effects of Oscal include: ; ; ; ; .

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Oscal Overdose

Symptoms of a Oscal overdose may include:

  • Dizziness
  • Headache
  • Loss of appetite
  • Irregular heartbeat
  • Nausea
  • Stomach pain or cramps
  • Vomiting
  • Weakness
  • Mental or mood changes such as confusion

If you suspect an overdose, contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at 800-222-1222.

Abstract

Osteoporosis, a skeletal disorder characterized by a reduction in bone strength, is becoming a major public health problem in the People’s Republic of China, with a rapid increase observed among the population. Chinese guidelines particularly recommend use of active vitamin D in managing osteoporosis. 1,25-(OH)2D3 (Oscal) is an active vitamin D metabolite. It plays a role in many biological processes, especially in bone metabolism and muscle function, and is mediated by vitamin D receptors. Osteoporosis in elderly men and women is characterized by uncoupled bone remodeling, which is induced by sex hormone deficiencies, somatopause, vitamin D deficiency, reduced synthesis of D hormone, and lack of receptors or receptor affinity for D hormone in target organs. Reviewed here are six randomized controlled trials on Oscal monotherapy and five on Oscal therapy combined with other antiosteoporotic agents. Evidence from these trials shows that Oscal monotherapy can improve bone mineral density in elderly osteoporotic Chinese patients but may be insufficient for long-term treatment. Oscal can also decrease bone turnover markers and bring about significant improvements in muscle strength. Further, Oscal in combination with other therapeutic bone agents was shown to be well tolerated and capable of additional bone-preserving effects compared with use of Oscal alone in areas including bone mineral density, bone turnover markers, bone pain improvement, and fracture incidence. Hypercalcemia and hypercalciuria, the most common side effects of Oscal therapy, were not documented in the trials reviewed, and might have been the result of the low dosages used. One study showed that treatment with Oscal can improve quality of life in patients with osteoporosis, although not to the same extent as bisphosphonates.

Effect of Oscal on BMD

We searched PubMed, EMBASE, and WanFang (http://www.wanfangdata.com.cn, a Chinese database) with article type restricted to clinical trials and publication time restricted to October 1, 2013 or earlier, using the following keywords: “Oscal”, “active vitamin D”, “1,25(OH)2-vitamin D”, “China”, “Chinese”, and “osteoporosis”. Studies were included for review if the following conditions were met: they were randomized controlled trials; participants were patients with osteoporosis or bone loss; intervention consisted of use of Oscal in the trial group and placebo or calcium in the control group; BMD as measured by dual-energy X-ray absorptiometry at the lumbar spine and femoral neck were collected as the primary outcome; and bone turnover markers were the secondary outcome. We excluded trials that enrolled participants with coexisting medical conditions (eg, diabetes). Statistical analyses were performed in Review Manager 5.2 (RevMan, version 5.2; The Cochrane Collaboration, Copenhagen, Denmark).

Phosphate-Binding Agents

Since Rocaltrol (Oscal) also has an effect on phosphate transport in the intestine, kidneys and bones, the dosage of phosphate-binding agents must be adjusted in accordance with the serum phosphate concentration.

Q: I take Oscal three times per week. Now my doctor has prescribed vitamin D twice a month. Is it okay to take these together?

A: Rocaltrol (Oscal) is the hormonally active form of vitamin D, and it is usually prescribed for the treatment of hypocalcemia and osteoporosis, or to prevent corticosteroid-induced osteoporosis. To avoid possible additive effects of taking two different forms of vitamin D, it's recommended that patients not take other forms of vitamin D or its derivatives while being treated with Oscal. Patients are also advised to avoid an abrupt increase in dietary calcium intake, as it may trigger hypercalcemia. Check with your doctor about this, and ask whether you should be taking both medications together. If you are advised to take both Oscal and vitamin D, contact your doctor if you experience symptoms of vitamin D intoxication, including weakness, fatigue, headache, somnolence (sleepiness), vertigo, tinnitus, anorexia, nausea, vomiting, constipation, dry mouth, metallic taste, muscle pain, or bone pain.

¿Dónde puedo obtener más información?

Su farmacéutico le puede dar más información acerca de Oscal.

Antes de tomar el Oscal,

  • Informe a su mГ©dico y farmacГ©utico quГ© medicamentos con y sin receta, vitaminas, suplementos nutricionales y productos de hierbas estГЎ tomando, especialmente antiГЎcidos que contengan calcio o magnesio. suplementos de calcio; colestiramine (Cholybar, Prevalite, Questran); digoxina (Lanoxin); diurГ©ticos ('pГ­ldoras que provocan la eliminaciГіn de agua a travГ©s de la orina'); ketoconazol; lantano (Fosrenol); laxantes que contienen magnesio; esteroides orales como dexametasona, metilprednisolona (Medrol) y prednisona (Rayos); otras formas de vitamina D; fenobarbital; fenitoГ­na (Dilantin, Phenytek); y sevelamer (Renagel, Renvela). AdemГЎs, informe a su mГ©dico o farmacГ©utico si estГЎ tomando ergocalciferol (Deltalin, Drisdol) o si lo dejГі de tomar en los Гєltimos meses.Es posible que su mГ©dico deba cambiar las dosis de sus medicamentos o supervisarle atentamente para saber si sufre efectos secundarios.
  • Informe a su mГ©dico si tiene altos niveles de calcio. Su mГ©dico posiblemente le dirГЎ que no tome Oscal.
  • Informe a su mГ©dico si recientemente tuvo una cirugГ­a o no puede movilizarse por cualquier motivo y si tiene o alguna vez ha tenido alguna enfermedad renal o hepГЎtica.
  • Informe a su mГ©dico si estГЎ embarazada, tiene planificado quedar embarazada o estГЎ amamantando. Si queda embarazada mientras toma calcictriol, llame a su mГ©dico. No debe amamantar mientras toma Oscal.

What other drugs will affect Oscal (Rocaltrol)?

Tell your doctor about all other medicines you use, especially:

This list is not complete and other drugs may interact with Oscal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Oscal and Other Interactions

Oscal may cause drowsiness.

Don't drive, operate machinery, or perform other tasks that require alertness until you know how this medicine affects you.

What is the most important information I should know about Oscal (Rocaltrol)?

You should not use this medication if you have high levels of calcium or vitamin D in your blood, or if you have ever had an allergic reaction to Oscal or other forms of vitamin D.

Drink plenty of fluids unless your doctor has told you to restrict your fluid intake.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to a serious electrolyte imbalance.

Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb Oscal.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Oscal is only part of a complete program of treatment that may also include a special diet. Follow your diet and medication routines very closely. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

Before taking Oscal,

  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking, especially calcium or magnesium-containing antacids; calcium supplements; cholestyramine (Cholybar, Prevalite, Questran); digoxin (Lanoxin); diuretics ('water pills'); ketoconazole; lanthanum (Fosrenol); magnesium-containing laxatives; oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); other forms of vitamin D; phenobarbital; phenytoin (Dilantin, Phenytek); and sevelamer (Renagel, Renvela). Also tell your doctor or pharmacist if you are taking ergocalciferol (Deltalin, Drisdol) or have stopped taking it in the past few months.Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have high levels of calcium. Your doctor will probably tell you not to take Oscal.
  • tell your doctor if you have recently had surgery or are unable to move around for any reason and if you have or have ever had kidney or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking Oscal, call your doctor. You should not breastfeed while you are taking Oscal.

Oscal

Oscal is commonly prescribed and relatively well-studied in the setting of CKD. It does not require renal activation for potent binding to the vitamin D receptor. As a result, it is an established therapy for the treatment of secondary hyperparathyroidism in all stages of CKD and is known to effectively lower serum PTH concentration (see Chapter 8 ). In addition, Oscal has been associated with improved survival in observational studies of CKD and ESRD (see Consequences ). Oscal can be administered intravenously with hemodialysis or orally at any stage of CKD.

Because Oscal potently activates the vitamin D receptor, one potential adverse effect is adynamic bone disease due to oversuppression of PTH (see Chapter 8 ). In addition, Oscal carries a risk of hypercalcemia and, less frequently, hyperphosphatemia. Regular monitoring is therefore required.

Digitalis

Oscal dosage must be determined with care in patients undergoing treatment with digitalis, as hypercalcemia in such patients may precipitate cardiac arrhythmias (see PRECAUTIONS: General).

Treatment of Hypercalcemia and Overdosage in Predialysis Patients

If hypercalcemia ensues (greater than 1 mg/dL above the upper limit of the normal range), adjust dosage to achieve normocalcemia by reducing Rocaltrol (Oscal) therapy from 0.5 mcg to 0.25 mcg daily. If the patient is receiving a therapy of 0.25 mcg daily, discontinue Rocaltrol (Oscal) until patient becomes normocalcemic. Calcium supplements should also be reduced or discontinued. Serum calcium levels should be determined 1 week after withdrawal of calcium supplements. If serum calcium levels have returned to normal, Rocaltrol (Oscal) therapy may be reinstituted at a dosage of 0.25 mcg/day if previous therapy was at a dosage of 0.5 mcg/day. If Rocaltrol (Oscal) therapy was previously administered at a dosage of 0.25 mcg/day, Rocaltrol (Oscal) therapy may be reinstituted at a dosage of 0.25 mcg every other day. If hypercalcemia is persistent at the reduced dosage, serum PTH should be measured. If serum PTH is normal, discontinue Rocaltrol (Oscal) therapy and monitor patient in 3 months' time.

What Other Drugs Interact with Oscal?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Oscal has no known severe interactions with other drugs.

Serious interactions of Oscal include:

Moderate interactions of Oscal include:

  • axitinib
  • crofelemer
  • dabrafenib
  • dienogest/estradiol valerate
  • efavirenz
  • elvitegravir/cobicistat/emtricitabine/tenofovir DF
  • iloperidone
  • linagliptin
  • mitotane

Oscal has no known mild interactions with other drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

What is Oscal?

Oscal is vitamin D3. Vitamin D helps your body absorb calcium from the stomach.

Oscal is used to treat hyperparathyroidism (overactive parathyroid glands) and metabolic bone disease in people who have chronic kidney failure and are not receiving dialysis.

Oscal is also used to treat calcium deficiency in people with hypoparathyroidism (underactive parathyroid glands) caused by surgery, disease, or other conditions.

Oscal is also used to treat calcium deficiency (hypocalcemia) and metabolic bone disease in people who are receiving dialysis.

Oscal may also be used for purposes not listed in this medication guide.


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