Usage
This combination medication is primarily prescribed for the prevention and treatment of postmenopausal osteoporosis. It addresses calcium deficiency and supports bone health in perimenopausal and postmenopausal women. This time period is marked by reduced estrogen production, which contributes to bone loss. It’s classified as a dietary supplement, combining vitamins, minerals, and nutrients. It works by increasing Vitamin D and calcium levels, improving calcium absorption, and promoting bone formation. Soya isoflavones contribute by mimicking estrogen’s beneficial effects on bone health and potentially reducing menopausal symptoms. Vitamin K2-7 plays a vital role in directing calcium into bones, ensuring bone mineralization and maintaining bone density. Magnesium aids in normal muscle function.
Alternate Names
While this specific combination might not have a distinct international nonproprietary name (INN), its individual components do. Variations in the name may occur due to regional differences. Some brand names under which similar formulations are marketed include: Bio-D3 Fem, SOYA-K27, and Sagecal-K27.
How It Works
Pharmacodynamics: Calcitriol, the active form of vitamin D3, acts on the intestines to increase calcium and phosphate absorption. It also stimulates bone resorption by osteoclasts (releasing calcium into the bloodstream) and increases renal calcium reabsorption. Calcium carbonate provides a source of elemental calcium, supporting bone mineralization. Soya isoflavones, as phytoestrogens, bind to estrogen receptors, exerting weak estrogenic effects beneficial for bone health and potentially reducing menopausal symptoms. Vitamin K2-7 (menaquinone-7) activates osteocalcin and matrix Gla protein, promoting calcium deposition in bone and inhibiting vascular calcification. Magnesium is vital for muscle and nerve function, bone formation, and energy metabolism.
Pharmacokinetics: Calcitriol is absorbed from the gut. Calcium carbonate’s absorption is influenced by various factors, including vitamin D status and the presence of other food components. Soya isoflavones are metabolized by gut bacteria. Vitamin K2-7 is absorbed and transported with lipoproteins. Magnesium is absorbed in the small intestine. The combined components are metabolized and excreted through various pathways, primarily renal and hepatic.
Dosage
Dosage information for this specific combination is limited in the provided sources. Dosage should always be personalized based on patient-specific factors.
Standard Dosage
Children: This combination is generally not recommended for children below 18 years of age, as safety and efficacy have not been established.
Special Cases:
- Elderly Patients: Dosage adjustment may be needed due to potential age-related changes in renal function.
- Patients with Renal Impairment: Caution and dosage adjustments are crucial for patients with renal dysfunction due to the risk of hypercalcemia.
- Patients with Hepatic Dysfunction: Use with caution in patients with liver disease.
- Patients with Comorbid Conditions: Consider dosage adjustments for conditions such as hypercalcemia, hyperparathyroidism, kidney stones, hypercalciuria, and vitamin D toxicity.
Clinical Use Cases
Dosage recommendations for clinical scenarios like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations are not available for this specific combination.
Dosage Adjustments
Dose modification is essential based on factors like renal function, existing calcium levels, and potential drug interactions.
Side Effects
Common Side Effects
- Constipation
- Flatulence
- Upset stomach
- Nausea
- Diarrhoea
Rare but Serious Side Effects
- Hypercalcemia (high calcium levels)
- Kidney stones
- Metabolic alkalosis
Long-Term Effects
Information regarding long-term effects is limited. Regular monitoring of calcium and vitamin D levels is advisable.
Adverse Drug Reactions (ADR)
Hypercalcemia requires immediate medical attention.
Contraindications
- Hypercalcemia
- Hypervitaminosis D
- Vitamin D toxicity
- Kidney stones
- Severe renal impairment
- Hypersensitivity to any component
- Low-sodium diet
Drug Interactions
- Antibiotics (e.g., doxycycline, minocycline, ciprofloxacin, levofloxacin)
- Drugs for bone loss (e.g., alendronate)
- Anticancer drugs (e.g., estramustine)
- Thyroid drugs (e.g., levothyroxine)
- Cholesterol-lowering drugs (e.g., cholestyramine, colestipol)
- Weight-loss drugs (e.g., orlistat)
- Iron supplements (e.g., ferrous sulfate)
- Calcium supplements (e.g., ergocalciferol, cholecalciferol)
- Painkillers (e.g., aspirin)
- Antidepressants (e.g., duloxetine)
- Alcohol
- Caffeine
- Soft drinks
- Foods high in phytic or oxalic acid
Pregnancy and Breastfeeding
Use with caution during pregnancy and breastfeeding. Consult a doctor before use. If used during breastfeeding, monitor serum calcium levels in both mother and infant.
Drug Profile Summary
- Mechanism of Action: Increases calcium and phosphate absorption, supports bone mineralization, exerts weak estrogenic effects, promotes calcium deposition in bone.
- Side Effects: Constipation, flatulence, upset stomach, nausea, hypercalcemia (rare).
- Contraindications: Hypercalcemia, vitamin D toxicity, kidney stones, severe renal impairment.
- Drug Interactions: Numerous drug interactions, including antibiotics, thyroid drugs, cholesterol-lowering medications.
- Pregnancy & Breastfeeding: Use with caution; consult a doctor.
- Dosage: Determined by a physician based on individual patient needs.
- Monitoring Parameters: Calcium and vitamin D levels.
Popular Combinations
The combination itself is a popular formulation for managing bone health, particularly in postmenopausal women.
Precautions
- Assess for allergies, renal function, calcium levels, and vitamin D levels before initiating therapy.
- Use cautiously in patients with kidney disease, liver disease, or during pregnancy/breastfeeding.
- Consider age-specific precautions for children and the elderly.
- Limit alcohol, caffeine, and soft drink intake.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Calcitriol + Calcium Carbonate + Magnesium Oxide + Soya Isoflavones + Vitamin K2-7?
A: The recommended dosage is determined by a physician based on individual patient needs and factors such as age, renal function, and existing calcium levels.
Q2: What are the primary uses of this combination medication?
A: Primarily used for the prevention and treatment of postmenopausal osteoporosis and to address calcium deficiency in perimenopausal and postmenopausal women.
Q3: Can this combination be used during pregnancy or breastfeeding?
A: Use with caution during pregnancy and breastfeeding. Consult a doctor before use. Monitor the infant’s calcium levels if used during breastfeeding.
Q4: What are the common side effects?
A: Common side effects include constipation, flatulence, upset stomach, nausea, and diarrhea.
Q5: Are there any serious side effects I should be aware of?
A: Hypercalcemia (high calcium levels) is a rare but serious side effect requiring medical attention. Kidney stones are also a potential concern.
Q6: What are the contraindications for this medication?
A: Contraindications include hypercalcemia, hypervitaminosis D, vitamin D toxicity, kidney stones, and severe renal impairment.
Q7: Does this medication interact with other drugs?
A: Yes, it interacts with various medications, including certain antibiotics, thyroid drugs, cholesterol-lowering medications, and more. Consult a doctor or pharmacist about potential drug interactions.
Q8: Are there any dietary restrictions while taking this medication?
A: Limit alcohol, caffeine, and soft drink intake as they can affect calcium absorption. Foods rich in phytic or oxalic acid may also reduce calcium absorption.
Q9: What should I do if I miss a dose?
A: If a dose is missed, take it as soon as remembered. However, if it’s close to the time for the next dose, skip the missed dose and continue with the regular schedule. Do not double the dose to catch up.
Q10: How should this medication be stored?
A: Store at room temperature in a cool, dry place away from direct sunlight and heat. Keep out of reach of children.
