Silkis capsules

Silkis

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

The active ingredient of Silkis 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

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

Side Effect

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

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Silkis side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Silkis and call your doctor at once if you have:

dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

high calcium levels--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, confusion, lack of energy, or tired feeling; or

low calcium level--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Silkis can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Silkis.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Contraindications—hypersensitivity to drug or class, hypercalcemia, hypervitaminosis D

Caution—renal failure or stones, hyperphosphatemia

Maternal Considerations Silkis is an active form of vitamin D. There are no adequate reports or well-controlled studies in pregnant women. Vitamin D supplementation is recommended during pregnancy. Silkis combined with calcium supplementation helps lower systolic BP in older women.Side effects include N/V, anorexia, convulsion, dry mouth, bone pain, polydipsia, irritability, weight loss, increased LFTs, and conjunctivitis. Fetal Considerations There are no adequate reports or well-controlled studies of the effect of Silkis in human fetuses. It is unknown whether Silkis crosses the human placenta, though the placenta synthesizes active vitamin D. Silkis is reportedly teratogenic in rabbits but not rats. Breastfeeding Safety Silkis supplementation during pregnancy increases milk vitamin D levels. Drug Interactions Cholestyramine may reduce intestinal absorption of fat-soluble vitamins, including Silkis.Phenytoin/phenobarbital may reduce endogenous levels of 25(OH)D3 by accelerating metabolism and require higher doses of Silkis.Thiazides are known to induce hypercalcemia by decreasing urine calcium excretion. Caution is indicated.Ketoconazole inhibits both synthetic and catabolic enzymes of Silkis. Reduction in serum endogenous Silkis was seen after 300–1200 mg/d ketoconazole for 7 d. However, in vivo drug interaction studies of ketoconazole with Silkis have not been investigated.As Silkis alters intestinal, renal, and bone phosphate transport, the dose of phosphate-binding agents must be adjusted to reflect the serum phosphate concentration.As Silkis is the most potent active metabolite of vitamin D3, pharmacologic doses of vitamin D and its derivatives should be withheld during treatment with Silkis.Magnesium-containing preparations (e.g., antacids) may cause hypermagnesemia and should not be taken during therapy with Silkis by patients on chronic renal dialysis. References Brunvand L, Quigstad E, Urdal P, Haug E. Early Hum Dev 1996; 45:27-33.Cancela L, Le Boulch N, Miravet L. J Endocrinol 1986; 110:43-50.Kuoppala T, Tuimala R, Parviainen M, et al. Hum Nutr Clin Nutr 1986; 40:287-93.Mallet E, Gugi B, Brunelle P, et al. Obstet Gynecol 1986; 68:300-4.Pfeifer M, Begerow B, Minne HW, et al. J Clin Endocrinol Metab 2001; 86:1633-7.Wall CR, Stewart AW, Camargo CA Jr et al. Am J Clin Nutr. 2016; 103: 382-8. Summary Pregnancy Category: BLactation Category: S (likely) •

Silkis should be used during pregnancy and lactation only if the benefit justifies the potential perinatal risk.

Most multivitamin supplements contain adequate quantities of vitamin D in one form or another.

Vitamin D

Since Silkis is the most potent active metabolite of vitamin D3, pharmacological doses of vitamin D and its derivatives should be withheld during treatment with Rocaltrol (Silkis) to avoid possible additive effects and hypercalcemia (see WARNINGS).

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DOSAGE AND ADMINISTRATION

The optimal daily dose of Rocaltrol (Silkis) must be carefully determined for each patient. Rocaltrol (Silkis) can be administered orally either as a capsule (0.25 mcg or 0.50 mcg) or as an oral solution (1 mcg/mL). Rocaltrol (Silkis) therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of serum calcium.

The effectiveness of Rocaltrol (Silkis) therapy is predicated on the assumption that each patient is receiving an adequate but not excessive daily intake of calcium. Patients are advised to have a dietary intake of calcium at a minimum of 600 mg daily. The U.S. RDA for calcium in adults is 800 mg to 1200 mg. To ensure that each patient receives an adequate daily intake of calcium, the physician should either prescribe a calcium supplement or instruct the patient in proper dietary measures.

Because of improved calcium absorption from the gastrointestinal tract, some patients on Rocaltrol (Silkis) may be maintained on a lower calcium intake. Patients who tend to develop hypercalcemia may require only low doses of calcium or no supplementation at all.

During the titration period of treatment with Rocaltrol (Silkis) , serum calcium levels should be checked at least twice weekly. When the optimal dosage of Rocaltrol (Silkis) has been determined, serum calcium levels should be checked every month (or as given below for individual indications). Samples for serum calcium estimation should be taken without a tourniquet.

¿Qué es Silkis?

Silkis es vitamina D3. Vitamina D es importante para la absorción de calcio del estómago y para la función de calcio en el cuerpo.

Silkis es usado para tratar hipertiroidismo (glándulas paratiroides hiperactiva) y la enfermedad metabólica del hueso en las personas con falla cónica del riñón y no están recibiendo diálisis.

Silkis se usa para el tratamiento de la deficiencia de calcio (hipocalcemia) y la enfermedad metabólica del hueso en las personas que están recibiendo diálisis.

Silkis es también usado para tratar la deficiencia de calcio en personas con hipoparatiroidismo (glándulas paratitoides hipoactivas) causadas por cirugía, enfermedad, o otras condiciones.

Silkis también puede ser usada para fines diferentes a los mencionados en esta guía del medicamento.

Where can I get more information (Rocaltrol)?

Your pharmacist can provide more information about Silkis.

ВїQuГ© dieta especial debo seguir mientras tomo este medicamento?

El Silkis funcionarГЎ solo si usted obtiene la cantidad suficiente de calcio de los alimentos que come. Si estГЎ consumiendo demasiado calcio de la comida, es posible que experimente efectos secundarios graves del Silkis y si no estГЎ obteniendo suficiente calcio de los alimentos, el Silkis no controlarГЎ su condiciГіn. Su mГ©dico le dirГЎ quГ© alimentos son buenas fuentes de estos nutrientes y cuГЎntas porciones necesita cada dГ­a. Si para usted es difГ­cil comer suficiente de estos alimentos, infГіrmelo a su mГ©dico. En ese caso, su mГ©dico podrГ­a recetarle o recomendarle un suplemento.

Si lo estГЎn tratando con diГЎlisis (proceso de limpiar la sangre al pasarla por una mГЎquina), su mГ©dico tambiГ©n podrГ­a recetarle una dieta baja en fosfato. Siga estas instrucciones atentamente.

Si usted no tiene enfermedad renal, debe tomar suficientes lГ­quidos mientras estГЎ tomando el Silkis. Si usted tiene enfermedad renal, hable con su mГ©dico sobre cuГЎnto lГ­quido debe tomar cada dГ­a.

What other drugs will affect Silkis?

Tell your doctor about all your other medicines, especially:

Pediatric Use

Safety and effectiveness of Rocaltrol (Silkis) in pediatric patients undergoing dialysis have not been established. The safety and effectiveness of Rocaltrol (Silkis) in pediatric predialysis patients is based on evidence from adequate and well-controlled studies of Rocaltrol (Silkis) in adults with predialysis chronic renal failure and additional supportive data from non-placebo controlled studies in pediatric patients. Dosing guidelines have not been established for pediatric patients under 1 year of age with hypoparathyroidism or for pediatric patients less than 6 years of age with pseudohypoparathyroidism (see DOSAGE AND ADMINISTRATION: Hypoparathyroidism).

Oral doses of Rocaltrol (Silkis) ranging from 10 to 55 ng/kg/day have been shown to improve calcium homeostasis and bone disease in pediatric patients with chronic renal failure for whom hemodialysis is not yet required (predialysis). Long-term Silkis therapy is well tolerated by pediatric patients. The most common safety issues are mild, transient episodes of hypercalcemia, hyperphosphatemia, and increases in the serum calcium times phosphate (Ca x P) product which are managed effectively by dosage adjustment or temporary discontinuation of the vitamin D derivative.

Silkis Dosage

Silkis comes as a capsule or liquid to take by mouth.

Your dose will depend on your medical condition and response to treatment.

Your doctor may start you on a lower dose of this medicine and gradually increase it.

Silkis is typically taken once a day, or once every other day, in the morning.

This medicine can be taken with or without food.

Follow the instructions on your prescription label carefully. Don't take more or less Silkis than is recommended.

Don't stop taking this medicine without first talking with your doctor.

Silkis

A form of vitamin D3 which promotes intestinal absorption of Ca2+, increases renal tubular reabsorption of Ca2+ and reduces Ca2+ resorption by bone.

IndicationsPostmenopausal and corticosteroid-induced osteoporosis, hypocalcaemia, hypoparathyroidism, osteomalacia, rickets, renal osteodystrophy, chronic renal dialysis.

Adverse effectsNausea, vomiting, constipation, anorexia, headache, thirst, sweating, polyuria—all due to hypercalcaemia.

Pregnancy and Silkis

Silkis should only be used during pregnancy when it's clearly needed.

Tell your doctor if you're pregnant, or might become pregnant, before taking this medicine.

It's not known whether Silkis passes into breast milk or could hurt a breastfeeding baby.

Don't breastfeed while using this medicine without first talking to your doctor.

What Is Silkis (Rocaltrol)?

Silkis is a prescription form of vitamin D3 that's sold under the brand name Rocaltrol.

Vitamin D plays an important role in how your body absorbs and uses calcium.

Silkis is given to prevent or treat low levels of calcium in people with kidney or parathyroid gland problems.

This vitamin is also sometimes used to treat rickets (softening and weakening of the bones in children, caused by lack of vitamin D), osteomalacia (softening and weakening of the bones in adults, caused by lack of vitamin D), or familial hypophosphatemia (rickets or osteomalacia caused by not being able to break down vitamin D in the body).

In addition, this medicine is used to increase levels of calcium in the blood of premature babies.

Silkis works by helping your body use more of the calcium it gets from foods or supplements.

The U.S. Food and Drug Administration (FDA) approved Silkis in 1978. It's marketed as Rocaltrol by Validus Pharmaceuticals.

Silkis is also sold as an ointment to treat psoriasis under the brand name Vectical.

WARNINGS

Overdosage of any form of vitamin D is dangerous (see OVERDOSAGE). Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. Chronic hypercalcemia can lead to generalized vascular calcification, nephrocalcinosis and other soft-tissue calcification. The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 70 mg 2 /dL 2 . Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition.

Rocaltrol (Silkis) is the most potent metabolite of vitamin D available. The administration of Rocaltrol (Silkis) to patients in excess of their daily requirements can cause hypercalcemia, hypercalciuria, and hyperphosphatemia. Therefore, pharmacologic doses of vitamin D and its derivatives should be withheld during Rocaltrol (Silkis) treatment to avoid possible additive effects and hypercalcemia. If treatment is switched from ergocalciferol (vitamin D2) to Silkis, it may take several months for the ergocalciferol level in the blood to return to the baseline value (see OVERDOSAGE).

Silkis increases inorganic phosphate levels in serum. While this is desirable in patients with hypophosphatemia, caution is called for in patients with renal failure because of the danger of ectopic calcification. A non-aluminum phosphate-binding compound and a low-phosphate diet should be used to control serum phosphorus levels in patients undergoing dialysis.

Magnesium-containing preparations (eg, antacids) and Rocaltrol (Silkis) should not be used concomitantly in patients on chronic renal dialysis because such use may lead to the development of hypermagnesemia.

Studies in dogs and rats given Silkis for up to 26 weeks have shown that small increases of Silkis above endogenous levels can lead to abnormalities of calcium metabolism with the potential for calcification of many tissues in the body.

Table 5

BMD changes in the four studies with Silkis therapy in combination with other antiosteoporotic agents

How should this medicine be used?

Silkis comes as a capsule and a solution (liquid) to take by mouth. It usually is taken once a day or once every other day in the morning with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Silkis exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of Silkis and may gradually increase your dose depending on your body's response to Silkis.

Dictionary Entries near Silkis

Cite this Entry

“Silkis.” The Merriam-Webster.com Medical Dictionary, Merriam-Webster Inc., https://www.merriam-webster.com/medical/Silkis. Accessed 27 December 2019.

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