Oyster Shell Ca 500mg W/vit D Tabs

Manufacturer MAJOR PHARMACEUTICALS Active Ingredient Calcium and Vitamin D Capsules and Tablets(KAL see um & VYE ta min dee) Pronunciation KAL-see-um & VYE-ta-min dee
It is used to help growth and good health.It is used to prevent or treat soft, brittle bones (osteoporosis).It is used to treat or prevent low calcium levels.It may be given to you for other reasons. Talk with the doctor.
đŸˇī¸
Drug Class
Mineral and Vitamin Supplement
đŸ§Ŧ
Pharmacologic Class
Mineral (Calcium), Vitamin (Vitamin D)
🤰
Pregnancy Category
Not assigned by FDA for supplements. Generally considered safe within recommended daily allowances.
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

This product is a dietary supplement containing calcium and vitamin D. Calcium is a mineral essential for strong bones and teeth, and for proper functioning of muscles and nerves. Vitamin D helps your body absorb calcium and is important for bone health and immune function. It's often used to prevent or treat calcium and vitamin D deficiencies, especially in people at risk for osteoporosis.
📋

How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take this medication with food as directed.

Storing and Disposing of Your Medication

Keep your medication at room temperature in a dry place, avoiding storage in a bathroom. Store all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on proper disposal. You may also have access to drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
💡

Lifestyle & Tips

  • Take with food to enhance absorption, especially for calcium carbonate.
  • Do not take more than the recommended dose unless advised by your doctor.
  • Ensure adequate dietary intake of calcium-rich foods (dairy, leafy greens) and vitamin D (fatty fish, fortified foods).
  • Regular weight-bearing exercise (e.g., walking, jogging) is important for bone health.
  • Avoid excessive alcohol and smoking, which can negatively impact bone density.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 1-2 tablets daily, typically with food, or as directed by a healthcare professional. Each tablet provides 500mg elemental calcium and typically 200-400 IU Vitamin D.
Dose Range: 500 - 1200 mg

Condition-Specific Dosing:

osteoporosisPrevention: 1000-1200 mg elemental calcium daily (from diet and supplements) with 600-800 IU Vitamin D.
calciumDeficiency: Doses may be higher based on severity and physician recommendation.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established (consult pediatrician for specific calcium/Vit D needs)
Infant: Not established (consult pediatrician for specific calcium/Vit D needs)
Child: Not established for this specific product; general recommendations for elemental calcium vary by age (e.g., 700-1000 mg/day for 4-8 years) with appropriate Vitamin D (600 IU/day). Consult pediatrician.
Adolescent: Not established for this specific product; general recommendations for elemental calcium are 1300 mg/day with 600 IU Vitamin D. Consult pediatrician.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: Use with caution. Monitor serum calcium and phosphate levels.
Moderate: Use with caution. Monitor serum calcium, phosphate, and parathyroid hormone (PTH) levels. Dosage adjustment may be necessary.
Severe: Contraindicated in severe hypercalcemia or hypercalciuria. Use with extreme caution and under strict medical supervision due to risk of hypercalcemia and calcification. Vitamin D metabolism is impaired.
Dialysis: Specific formulations of calcium and vitamin D (e.g., active vitamin D metabolites) are often preferred and dosed under strict medical supervision for patients on dialysis. This product is generally not recommended without physician guidance.

Hepatic Impairment:

Mild: No specific adjustment typically required.
Moderate: No specific adjustment typically required, but monitor Vitamin D levels as hepatic activation of Vitamin D can be affected in severe cases.
Severe: No specific adjustment typically required, but monitor Vitamin D levels as hepatic activation of Vitamin D can be affected in severe cases.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Calcium is an essential mineral primarily involved in bone formation and maintenance, muscle contraction, nerve transmission, and blood coagulation. Vitamin D (cholecalciferol or ergocalciferol) is a fat-soluble vitamin that plays a crucial role in calcium homeostasis by promoting calcium absorption from the gut, regulating serum calcium and phosphate concentrations, and facilitating bone mineralization. Vitamin D is converted in the liver to 25-hydroxyvitamin D (calcifediol) and then in the kidneys to the active form, 1,25-dihydroxyvitamin D (calcitriol).
📊

Pharmacokinetics

Absorption:

Bioavailability: Calcium: Varies (25-35% for calcium carbonate, higher for citrate). Vitamin D: Readily absorbed from the small intestine (approximately 50-80%).
Tmax: Calcium: 1-2 hours. Vitamin D: 4-12 hours.
FoodEffect: Calcium absorption is enhanced by food, especially for calcium carbonate. Vitamin D absorption is enhanced by dietary fat.

Distribution:

Vd: Calcium: Approximately 0.35 L/kg (extracellular fluid). Vitamin D: Extensively distributed to adipose tissue and muscle.
ProteinBinding: Calcium: Approximately 40-45% bound to plasma proteins (primarily albumin). Vitamin D: Primarily bound to vitamin D-binding protein (DBP) and albumin.
CnssPenetration: Limited for calcium. Limited for Vitamin D (active metabolites can cross, but primary distribution is peripheral).

Elimination:

HalfLife: Calcium: Not applicable (homeostatically regulated). Vitamin D (cholecalciferol): Approximately 24 hours (initial), 2-3 weeks (terminal for 25-hydroxyvitamin D).
Clearance: Not applicable for calcium (excreted via kidneys/feces). Vitamin D: Primarily hepatic and renal clearance of metabolites.
ExcretionRoute: Calcium: Primarily renal (urine) and fecal. Vitamin D: Primarily biliary/fecal, with some renal excretion of metabolites.
Unchanged: Calcium: Not applicable. Vitamin D: Minimal unchanged drug excreted.
âąī¸

Pharmacodynamics

OnsetOfAction: Calcium: Immediate (for systemic effects), weeks to months for bone density changes. Vitamin D: Days to weeks for significant changes in calcium absorption and serum levels.
PeakEffect: Calcium: Hours (for serum levels), months to years for bone density. Vitamin D: Weeks to months.
DurationOfAction: Calcium: Dependent on intake and physiological needs. Vitamin D: Weeks to months (due to storage in adipose tissue and long half-life of 25-hydroxyvitamin D).

Safety & Warnings

âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
- Signs of an allergic reaction, such as:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin with or without fever
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
- Signs of high calcium levels, including:
- Weakness
- Confusion
- Feeling tired
- Headache
- Upset stomach and vomiting
- Constipation
- Bone pain

Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
- Upset stomach or vomiting
- Constipation
Please note that this list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor.

Reporting Side Effects
For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe nausea or vomiting
  • Constipation that is severe or persistent
  • Unusual thirst or frequent urination
  • Muscle weakness or fatigue
  • Confusion or changes in mental status
  • Bone pain
  • Symptoms of kidney stones (e.g., severe back or side pain, blood in urine)
📋

Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ High calcium levels
+ High vitamin D levels
+ Kidney stones
+ Low phosphate levels

This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.

Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins

It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
âš ī¸

Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a known allergy to tartrazine (FD&C Yellow No. 5), consult your doctor, as some formulations of this drug may contain this ingredient.

When taking this medication, be aware that it may interfere with the absorption of other oral medications. To minimize potential interactions, your doctor may advise you to take other oral drugs at a different time than this medication. Discuss your medication schedule with your doctor to ensure safe and effective treatment.

Adhere to the dietary plan recommended by your doctor to maximize the benefits of this medication. If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision about treatment.
🆘

Overdose Information

Overdose Symptoms:

  • Hypercalcemia (excessively high calcium levels)
  • Nausea, vomiting, constipation
  • Loss of appetite
  • Increased thirst and urination
  • Muscle weakness, fatigue
  • Confusion, lethargy
  • Kidney stones
  • In severe cases: cardiac arrhythmias, coma, kidney failure

What to Do:

If you suspect an overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Management typically involves discontinuing the supplement, hydration, and potentially medications to lower calcium levels.

Drug Interactions

🔴

Major Interactions

  • Digitalis glycosides (e.g., Digoxin): Concomitant use with high doses of calcium or vitamin D can increase risk of hypercalcemia, leading to digitalis toxicity (arrhythmias).
  • Thiazide diuretics (e.g., Hydrochlorothiazide): Reduce urinary calcium excretion, increasing risk of hypercalcemia.
🟡

Moderate Interactions

  • Bisphosphonates (e.g., Alendronate): Calcium can interfere with absorption. Administer calcium at least 30-60 minutes after bisphosphonate.
  • Thyroid hormones (e.g., Levothyroxine): Calcium can interfere with absorption. Administer calcium at least 4 hours after thyroid hormone.
  • Tetracycline antibiotics (e.g., Doxycycline): Calcium can chelate tetracyclines, reducing absorption. Separate administration by at least 2-4 hours.
  • Fluoroquinolone antibiotics (e.g., Ciprofloxacin): Calcium can chelate fluoroquinolones, reducing absorption. Separate administration by at least 2-4 hours.
  • Corticosteroids (e.g., Prednisone): Can decrease calcium absorption and increase calcium excretion, potentially increasing calcium and vitamin D requirements.
  • Orlistat, Cholestyramine, Mineral oil: Can reduce absorption of fat-soluble vitamins, including Vitamin D.
  • Phenytoin, Barbiturates (e.g., Phenobarbital): Can increase vitamin D metabolism, potentially leading to vitamin D deficiency.
đŸŸĸ

Minor Interactions

  • Oxalic acid (found in spinach, rhubarb) and Phytic acid (found in whole grains, beans): Can reduce calcium absorption.
  • Caffeine, Alcohol: May slightly increase calcium excretion.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Serum Calcium (total and ionized)

Rationale: To establish baseline levels and identify pre-existing hypercalcemia or hypocalcemia.

Timing: Before initiating therapy, especially if high doses are planned or patient has renal impairment.

Serum 25-hydroxyvitamin D (25(OH)D)

Rationale: To assess baseline vitamin D status and guide dosing.

Timing: Before initiating therapy, especially if deficiency is suspected or patient has risk factors.

Renal Function (BUN, Creatinine, eGFR)

Rationale: To assess kidney function, as renal impairment affects calcium and vitamin D metabolism and excretion.

Timing: Before initiating therapy, particularly in elderly or those with known renal issues.

📊

Routine Monitoring

Serum Calcium (total and ionized)

Frequency: Every 3-6 months initially, then annually, or as clinically indicated.

Target: Total: 8.5-10.2 mg/dL; Ionized: 4.5-5.6 mg/dL

Action Threshold: If consistently above upper limit of normal (e.g., >10.5 mg/dL), consider dose reduction or discontinuation and investigate cause.

Serum 25-hydroxyvitamin D (25(OH)D)

Frequency: Every 6-12 months, or as clinically indicated to ensure sufficiency (e.g., after 3 months of high-dose repletion).

Target: >30 ng/mL (sufficiency)

Action Threshold: If <20 ng/mL, consider higher dose Vitamin D supplementation. If >100 ng/mL, consider dose reduction due to potential toxicity.

Renal Function (BUN, Creatinine, eGFR)

Frequency: Annually, or more frequently in patients with pre-existing renal impairment or on high doses.

Target: Within normal limits for age/sex.

Action Threshold: Significant decline in eGFR may necessitate dose adjustment or discontinuation.

Urinary Calcium Excretion (24-hour urine calcium)

Frequency: Periodically, especially if hypercalcemia or kidney stones are a concern.

Target: <250 mg/24 hours (for women), <300 mg/24 hours (for men)

Action Threshold: Elevated levels (>250-300 mg/24 hours) may indicate hypercalciuria and increased risk of kidney stones; consider dose reduction.

đŸ‘ī¸

Symptom Monitoring

  • Nausea
  • Vomiting
  • Constipation
  • Excessive thirst (polydipsia)
  • Frequent urination (polyuria)
  • Muscle weakness
  • Fatigue
  • Confusion
  • Bone pain
  • Kidney stones (flank pain, hematuria)

Special Patient Groups

🤰

Pregnancy

Calcium and Vitamin D are essential nutrients during pregnancy. Supplementation is generally considered safe and often recommended to meet increased maternal and fetal needs, provided doses are within recommended daily allowances (RDAs) and tolerable upper intake levels (ULs). Excessive intake can be harmful.

Trimester-Specific Risks:

First Trimester: Generally safe within recommended doses. Essential for early fetal development.
Second Trimester: Generally safe within recommended doses. Continued importance for fetal bone development.
Third Trimester: Generally safe within recommended doses. Crucial for rapid fetal bone mineralization.
🤱

Lactation

Calcium and Vitamin D are excreted in breast milk. Supplementation is generally considered safe and often recommended for lactating mothers to meet their own and infant's needs, provided doses are within RDAs/ULs. Consult a healthcare provider.

Infant Risk: Low risk at recommended maternal doses. Excessive maternal intake could theoretically lead to high infant levels, but this is rare with typical supplementation.
đŸ‘ļ

Pediatric Use

Use in children should be under the guidance of a healthcare professional. Dosing varies significantly by age and specific needs. This product's dosage (500mg elemental calcium) may be too high for very young children. Ensure appropriate forms and doses for pediatric use.

👴

Geriatric Use

Elderly individuals are often at higher risk for calcium and vitamin D deficiency due to decreased dietary intake, reduced skin synthesis of vitamin D, and impaired renal activation of vitamin D. Supplementation is commonly recommended for bone health. However, monitor for hypercalcemia, especially in those with renal impairment or on concomitant medications (e.g., thiazide diuretics).

Clinical Information

💎

Clinical Pearls

  • Calcium carbonate (like oyster shell calcium) should be taken with food for optimal absorption, as it requires stomach acid. Calcium citrate can be taken with or without food.
  • Divide large doses of calcium (e.g., >500-600 mg elemental calcium) throughout the day to maximize absorption.
  • Ensure adequate fluid intake to help prevent constipation, a common side effect of calcium supplements.
  • Inform your healthcare provider about all supplements you are taking, especially if you are on medications for thyroid, osteoporosis, or certain antibiotics, due to potential interactions.
  • While beneficial for bone health, calcium and vitamin D supplements are not a substitute for a balanced diet and healthy lifestyle.
🔄

Alternative Therapies

  • Dietary sources of calcium (dairy products, fortified foods, leafy greens)
  • Dietary sources of Vitamin D (fatty fish, fortified foods, sun exposure)
  • Prescription Vitamin D (e.g., ergocalciferol, cholecalciferol in higher doses for deficiency)
  • Other osteoporosis medications (e.g., bisphosphonates, denosumab, teriparatide) for severe cases.
💰

Cost & Coverage

Average Cost: $5-$20 per 30-100 tablets
Generic Available: Yes
Insurance Coverage: Generally not covered by prescription insurance plans as it is an over-the-counter (OTC) dietary supplement. May be eligible for FSA/HSA reimbursement.
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.