Rocaltrol official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more.
The safety and effectiveness of Rocaltrol in pediatric predialysis patients is based on evidence from adequate and well-controlled studies of Rocaltrol in adults with predialysis chronic renal failure and additional supportive data from nonplacebo-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 ).
Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract.
Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of Rocaltrol (calcitriol). No significant effects of Rocaltrol (calcitriol) on fertility and/or general reproductive performances were observed in a Segment I study in rats at doses of up to 0.3 mcg/kg (approximay 3 times the maximum recommended dose based on body surface area ). Rocaltrol (calcitriol) is not mutagenic in vitro in the Ames Test, nor is it genotoxic in vivo in the Mouse Micronucleus Test.
Rocaltrol (calcitriol) is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.
The dose of Rocaltrol should be carefully adjusted for each patient according to the biological response so as to avoid hypercalcaemia.
Gelatin Glycerol Karion 83 (Sorbitol, Mannitol, Hydrogenated hydrolysed starch) Titanium dioxide E171 Iron oxide red E172 Iron oxide yellow E172 6.2 Incompatibilities None. 6.4 Special precautions for storage Do not store above 25°C. 6.6 Special precautions for disposal and other handling Not applicable. Marketing authorisation holder Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom. 7. 8. Marketing authorisation number(s) Rocaltrol 0.25 microgram Capsules: PL 00031/0122 Rocaltrol 0.5 microgram Capsules: PL 00031/0123 9.
Find patient medical information for Rocaltrol Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings.
US residents can call their local poison control center at. Canada residents can call a provincial poison control center. Otherwise, call a poison control center right away. Symptoms of overdose may include: weakness, headache, loss of appetite, metallic taste, nausea, vomiting, stomach cramps, dizziness. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911.
You may report side effects to Health Canada at. In Canada - Call your doctor for medical advice about side effects.
Consult your doctor before breast -feeding.
Physician reviewed Rocaltrol patient information - includes Rocaltrol description, dosage and directions.
Seek emergency medical attention or call the Poison Help line at.
digoxin (digitalis, Lanoxin, Lanoxicaps); cholestyramine (Questran, Prevalite); ketoconazole (Nizoral); lanthanum (Fosrenol);
Overdose symptoms may include some of the serious side effects listed in this medication guide.
To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly.
You can easily become dehydrated while taking this medication, which can lead to a serious electrolyte imbalance.