Oysco 500/d Tablets

Manufacturer RUGBY Active Ingredient Calcium and Vitamin D Capsules and Tablets(KAL see um & VYE ta min dee) Pronunciation OY-skoh five-hundred-dee (for Oysco 500/d); KAL-see-um and VYE-tuh-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.
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Drug Class
Mineral and Vitamin Supplement; Bone Health Agent
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Pharmacologic Class
Calcium Salt; Cholecalciferol (Vitamin D3)
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Pregnancy Category
Category A (when taken within recommended daily allowances); Category C (when taken in doses exceeding recommended daily allowances)
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Oysco 500/d Tablets are a dietary supplement containing calcium and vitamin D. Calcium is essential for strong bones and teeth, and for proper functioning of muscles and nerves. Vitamin D helps your body absorb calcium and is also important for bone health and immune function. This supplement helps ensure you get enough of these vital nutrients, especially if your diet is lacking.
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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 to ensure proper absorption.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding bathrooms and areas where children and pets can access it. Keep all medications in a safe location. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method or inquire about potential 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 the missed one.
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Lifestyle & Tips

  • Take with food to improve absorption, especially calcium carbonate.
  • Do not take calcium supplements at the same time as iron, zinc, or thyroid hormone medications; separate by at least 2-4 hours.
  • Maintain a balanced diet rich in calcium (dairy, leafy greens) and vitamin D (fatty fish, fortified foods).
  • Engage in regular weight-bearing exercise to support bone health.
  • Limit excessive alcohol and caffeine intake, which can interfere with calcium absorption.
  • Avoid smoking, as it negatively impacts bone density.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 1-2 tablets daily, typically providing 500-1000 mg elemental calcium and 200-800 IU Vitamin D
Dose Range: 500 - 1200 mg

Condition-Specific Dosing:

osteoporosisPrevention: 1000-1200 mg elemental calcium and 600-800 IU Vitamin D daily
osteoporosisTreatment: Often higher doses in conjunction with other therapies, as directed by physician
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Pediatric Dosing

Neonatal: Not established (specific formulations/doses for infants)
Infant: Not established (specific formulations/doses for infants, typically liquid drops)
Child: 4-8 years: 800-1000 mg elemental calcium, 600 IU Vitamin D daily; 9-18 years: 1300 mg elemental calcium, 600 IU Vitamin D daily
Adolescent: 1300 mg elemental calcium, 600 IU Vitamin D daily
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum calcium and phosphate.
Moderate: Use with caution; monitor serum calcium and phosphate closely. May require dose adjustment or use of active vitamin D metabolites.
Severe: Contraindicated in severe hypercalcemia. Use with extreme caution; monitor serum calcium, phosphate, and PTH. May require active vitamin D metabolites and phosphate binders.
Dialysis: Use with extreme caution; monitor serum calcium, phosphate, and PTH. Calcium-containing binders may be preferred over calcium supplements. Vitamin D supplementation should be with active forms.

Hepatic Impairment:

Mild: No specific adjustment typically needed.
Moderate: No specific adjustment typically needed.
Severe: No specific adjustment typically needed, as liver metabolism of Vitamin D is the first step, but renal activation is critical.

Pharmacology

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Mechanism of Action

Calcium is an essential mineral necessary for bone formation, maintenance, and strength. It also plays crucial roles in nerve impulse transmission, muscle contraction, blood coagulation, and cellular signaling. Vitamin D (cholecalciferol) is a fat-soluble vitamin that is metabolized in the liver to 25-hydroxyvitamin D (calcifediol) and then in the kidneys to 1,25-dihydroxyvitamin D (calcitriol), its active form. Calcitriol promotes calcium absorption from the gut, regulates serum calcium and phosphate levels, and facilitates bone mineralization and remodeling.
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Pharmacokinetics

Absorption:

Bioavailability: Calcium: Varies (20-40% for calcium carbonate); Vitamin D: Highly variable (50-80% from diet/supplements)
Tmax: Calcium: 1-4 hours; Vitamin D: 10-24 hours (for 25-OH D)
FoodEffect: Calcium absorption is enhanced by food, especially calcium carbonate. Vitamin D absorption is enhanced by dietary fat.

Distribution:

Vd: Calcium: Not well-defined (primarily in bone); Vitamin D: Highly lipophilic, widely distributed to adipose tissue, muscle, and liver.
ProteinBinding: Calcium: Approximately 40-50% bound to albumin and globulins; Vitamin D: >99% bound to vitamin D binding protein (DBP) and albumin.
CnssPenetration: Limited for both, but active metabolites of Vitamin D can cross.

Elimination:

HalfLife: Calcium: Not applicable (homeostatically regulated); Vitamin D: Parent compound (cholecalciferol) ~24 hours; 25-OH D ~2-3 weeks; 1,25-OH D ~4-6 hours
Clearance: Calcium: Renal excretion; Vitamin D: Biliary/fecal excretion (primary), minor renal excretion.
ExcretionRoute: Calcium: Renal, fecal; Vitamin D: Fecal (primary), renal (minor)
Unchanged: Calcium: Varies; Vitamin D: Minimal unchanged excretion
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Pharmacodynamics

OnsetOfAction: Calcium: Immediate (for systemic effects, but bone deposition is gradual); Vitamin D: Days to weeks (for significant changes in serum 25-OH D levels and calcium absorption)
PeakEffect: Calcium: Hours; Vitamin D: Weeks to months (for optimal bone health effects)
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-OH D)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

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 have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:

Upset stomach or vomiting
Constipation

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe constipation
  • Nausea or vomiting that doesn't go away
  • Extreme thirst or frequent urination
  • Unusual tiredness or muscle weakness
  • Confusion or changes in mental status
  • Bone pain
  • Signs of kidney stones (e.g., severe back pain, blood in urine)
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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 symptoms you experienced.
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 prescription and over-the-counter (OTC) medications you are taking
Natural products
* Vitamins

Carefully review your medications and health problems to ensure it is safe to take this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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 (also referred to as FD&C Yellow No. 5), consult with 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 use.

Adhere to the dietary plan recommended by your doctor to optimize the benefits of this medication. If you are pregnant, planning to become pregnant, or are breast-feeding, notify 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.
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Overdose Information

Overdose Symptoms:

  • Severe hypercalcemia (calcium levels >12 mg/dL)
  • Nausea, vomiting, constipation
  • Polyuria (frequent urination), polydipsia (increased thirst)
  • Muscle weakness, fatigue, lethargy
  • Confusion, stupor, coma
  • Cardiac arrhythmias
  • Kidney damage, kidney stones

What to Do:

Discontinue supplement immediately. Seek emergency medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment may involve IV fluids, diuretics, calcitonin, or bisphosphonates to lower calcium levels.

Drug Interactions

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Major Interactions

  • Thiazide diuretics (risk of hypercalcemia)
  • Digoxin (risk of arrhythmias with hypercalcemia)
  • Certain antibiotics (e.g., tetracyclines, fluoroquinolones - reduced absorption of antibiotics)
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Moderate Interactions

  • Levothyroxine (reduced absorption of levothyroxine)
  • Bisphosphonates (reduced absorption of bisphosphonates)
  • Iron supplements (reduced absorption of iron)
  • Zinc supplements (reduced absorption of zinc)
  • Proton pump inhibitors (may reduce calcium absorption)
  • Corticosteroids (may reduce calcium absorption and vitamin D metabolism)
  • Anticonvulsants (e.g., phenytoin, carbamazepine - may increase vitamin D metabolism)
  • Orlistat (may reduce absorption of fat-soluble vitamins, including Vitamin D)
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Minor Interactions

  • Dietary fiber (may reduce calcium absorption)
  • Oxalic acid (in spinach, rhubarb) and phytic acid (in whole grains) (may reduce calcium absorption)

Monitoring

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Baseline Monitoring

Serum Calcium (total and ionized)

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

Timing: Before initiation of therapy

Serum 25-hydroxyvitamin D (25-OH D)

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

Timing: Before initiation of therapy

Renal Function (BUN, Creatinine, eGFR)

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

Timing: Before initiation of therapy

Serum Phosphate

Rationale: To assess phosphate levels, which are interrelated with calcium and vitamin D metabolism.

Timing: Before initiation of therapy

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Routine Monitoring

Serum Calcium (total and ionized)

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

Target: 8.5-10.2 mg/dL (total); 4.6-5.3 mg/dL (ionized)

Action Threshold: >10.5 mg/dL (total) or symptoms of hypercalcemia; investigate and adjust dose.

Serum 25-hydroxyvitamin D (25-OH D)

Frequency: Every 6-12 months, or as needed to achieve target levels

Target: 30-100 ng/mL (optimal: 40-60 ng/mL)

Action Threshold: <30 ng/mL (consider dose increase); >100 ng/mL (consider dose reduction/cessation).

Renal Function (BUN, Creatinine, eGFR)

Frequency: Annually or as clinically indicated, especially in patients with pre-existing renal impairment or risk factors.

Target: Normal for age

Action Threshold: Significant decline in eGFR or rise in creatinine; reassess calcium/vitamin D dosing.

24-hour Urine Calcium (if hypercalciuria suspected)

Frequency: As clinically indicated (e.g., history of kidney stones, unexplained hypercalcemia)

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

Action Threshold: >250-300 mg/24 hours; investigate and adjust dose.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Constipation
  • Increased thirst
  • Increased urination
  • Muscle weakness
  • Fatigue
  • Confusion
  • Bone pain
  • Kidney stones

Special Patient Groups

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Pregnancy

Calcium and Vitamin D are essential nutrients during pregnancy for fetal bone development and maternal bone health. Recommended daily allowances should be met through diet and supplementation if necessary. Excessive doses should be avoided due to potential risks of hypercalcemia in the mother and fetus.

Trimester-Specific Risks:

First Trimester: Essential for early fetal development; generally safe within RDA.
Second Trimester: Increased demand for calcium for fetal skeletal growth; generally safe within RDA.
Third Trimester: Highest demand for calcium; generally safe within RDA. High doses of Vitamin D (>4000 IU/day) should be avoided unless specifically indicated and monitored.
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Lactation

Calcium and Vitamin D are excreted in breast milk in small amounts and are considered compatible with breastfeeding when taken within recommended daily allowances. They are essential for the nursing mother's health and infant's development.

Infant Risk: L1 (compatible); no known adverse effects on breastfed infants at recommended doses. High maternal doses of Vitamin D may lead to higher levels in milk, but infant toxicity is rare.
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Pediatric Use

Essential for bone growth and development. Dosing varies significantly by age and weight. Always consult a pediatrician for appropriate dosing. Risk of hypercalcemia with excessive doses.

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Geriatric Use

Increased risk of osteoporosis and vitamin D deficiency. Often require higher doses of calcium (1200 mg elemental) and vitamin D (600-800 IU or more) compared to younger adults. Monitor for hypercalcemia and renal function, especially in those with comorbidities or polypharmacy.

Clinical Information

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Clinical Pearls

  • Calcium carbonate should be taken with food for optimal absorption, while calcium citrate can be taken with or without food.
  • Divide calcium doses throughout the day (e.g., 500-600 mg per dose) as the body can only absorb a limited amount at one time.
  • Ensure adequate magnesium intake, as magnesium is important for vitamin D activation and calcium metabolism.
  • Patients with a history of kidney stones should discuss calcium and vitamin D supplementation with their physician and may require 24-hour urine calcium monitoring.
  • Regular sun exposure (10-15 minutes, 2-3 times per week) can contribute to natural vitamin D synthesis, but sunscreen blocks this process.
  • Consider the total daily intake of calcium and vitamin D from all sources (diet, other supplements, fortified foods) to avoid excessive intake.
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Alternative Therapies

  • Dietary calcium (dairy products, fortified foods, leafy greens)
  • Dietary vitamin D (fatty fish, fortified milk/cereals)
  • Prescription vitamin D (e.g., ergocalciferol, cholecalciferol at higher doses)
  • Other osteoporosis medications (e.g., bisphosphonates, denosumab, teriparatide) for treatment of osteoporosis
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Cost & Coverage

Average Cost: $5 - $25 per 60-120 tablets
Generic Available: Yes
Insurance Coverage: Often OTC, may be covered by FSA/HSA. Prescription forms may be covered by some insurance plans (Tier 1 or 2).
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more details. 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.