Clinical medicine profile
Vit C 1000mg+Cal 250mg+Vit D 300 IU +Vit B6 15mg
Therapeutic agent (verify pharmacological class)
- Route
- See product SmPC
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
This profile needs source confirmation
Some sections contain general class guidance rather than medicine-specific evidence. Confirm prescribing decisions against the current SmPC and Kenya STG/EML.
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- [From component Calcitriol 0.25mcg, Calcium Carbonate 500mg, Methylcobalamin 1500mcg plus others] CONTRAINDICATIONS Calcitriol Oral Solution should not be given to patients with hypercalcemia or evidence of vitamin D toxicity.
- Use of Calcitriol Oral Solution in patients with known hypersensitivity to Calcitriol Oral Solution (or drugs of the same class) or any of the inactive ingredients is contraindicated.
Precautions
- [From component Calcitriol 0.25mcg, Calcium Carbonate 500mg, Methylcobalamin 1500mcg plus others] 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.
- Calcitriol Oral Solution is the most potent metabolite of vitamin D available.
- The administration of Calcitriol Oral Solution 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 Calcitriol Oral Solution treatment to avoid possible additive effects and hypercalcemia.
- If treatment is switched from ergocalciferol (vitamin D 2 ) to calcitriol, it may take several months for the ergocalciferol level in the blood to return to the baseline value (see OVERDOSAGE ).
- Calcitriol 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 nonaluminum phosphate-binding compound and a low-phosphate diet should be used to control serum phosphorus levels in patients undergoing dialysis.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
Above 9 yrs old: 1 Tab OD. Children 4-8 yrs: 1/2 Tab OD.
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Use, effects & interactions
Indications
- Vitamin/mineral supplements.
- Label claim: Promoting or supporting the functioning of the immune system and adjuvant therapy for
- pressure sores, common col,d and allergies.
- Clinical selection for Vit C 1000mg+Cal 250mg+Vit D 300 IU +Vit B6 15mg should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Therapeutic agent (verify pharmacological class).
- Confirm site-specific dose, duration and monitoring before prescribing.
Adverse effects
- [From component Calcitriol 0.25mcg, Calcium Carbonate 500mg, Methylcobalamin 1500mcg plus others] ADVERSE REACTIONS Since Calcitriol Oral Solution is believed to be the active hormone which exerts vitamin D activity in the body, adverse effects are, in general, similar to those encountered with excessive vitamin D intake, ie, hypercalcemia syndrome or calcium intoxication (depending on the severity and duration of hypercalcemia) (see WARNINGS ).
- Because of the short biological half-life of calcitriol, pharmacokinetic investigations have shown normalization of elevated serum calcium within a few days of treatment withdrawal, ie, much faster than in treatment with vitamin D 3 preparations.
- The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include: Early : weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia, abdominal pain or stomach ache.
- Late : polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated SGOT (AST) and SGPT (ALT), ectopic calcification, nephrocalcinosis, hypertension, cardiac arrhythmias, dystrophy, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and, rarely, overt psychosis.
- In clinical studies on hypoparathyroidism and pseudohypoparathyroidism, hypercalcemia was noted on at least one occasion in about 1 in 3 patients and hypercalciuria in about 1 in 7 patients.
- Elevated serum creatinine levels were observed in about 1 in 6 patients (approximately one half of whom had normal levels at baseline).
- In concurrent hypercalcemia and hyperphosphatemia, soft-tissue calcification may occur
- this can be seen radiographically (see WARNINGS ).
- In patients with normal renal function, chronic hypercalcemia may be associated with an increase in serum creatinine (see PRECAUTIONS: GENERAL ).
- Hypersensitivity reactions (pruritus, rash, urticaria, and very rarely severe erythematous skin disorders) may occur in susceptible individuals.
- One case of erythema multiforme and one case of allergic reaction (swelling of lips and hives all over the body) were confirmed by rechallenge.
- To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug interactions
Open multi-drug checker ↗- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Calcitriol 0.25mcg, Calcium Carbonate 500mg, Methylcobalamin 1500mcg plus others.
- Confirm combination SmPC for exact dosing.
Mechanism & disposition
Mechanism is agent-specific.
Read complete mechanism
Mechanism is agent-specific. At receptor, enzyme, ion channel, transporter or microbial target level, the drug alters a physiological or pathological pathway to produce its therapeutic effect. Confirm precise molecular mechanism in current SmPC / pharmacology reference for this INN before high-stakes decisions.
Product-specific
Product-specific
See product SmPC
are product-specific. Consider food effects, protein binding, hepatic CYP/UGT
when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC.
Pregnancy, lactation & diet
[From component Calcitriol 0.25mcg, Calcium Carbonate 500mg, Methylcobalamin 1500mcg plus others] See FDA/DailyMed label section on pregnancy; use only if potential benefit justifies potential risk.
Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| No reviewed brand listings are linked yet. | |||
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.