Thera-M Plus Tablets

Manufacturer MAJOR Active Ingredient Vitamins (Multiple/Oral)(VYE ta mins, MUL ti pul/OR al) Pronunciation THAIR-uh-EM PLUS
WARNING: If your product has iron in it:Accidental overdose of drugs that have iron in them is a leading cause of deadly poisoning in children younger than 6 years of age. Keep away from children. If this drug is taken by accident, call a doctor or poison control center right away. @ COMMON USES: It is used to help growth and good health.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Nutritional Supplement; Vitamin/Mineral Supplement
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Pharmacologic Class
Multivitamin/Mineral
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Pregnancy Category
Not available (Dietary Supplement; consult healthcare provider for specific vitamin/mineral needs during pregnancy)
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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?

Thera-M Plus is a daily dietary supplement that contains a combination of essential vitamins and minerals. It's designed to help fill nutritional gaps in your diet and support your overall health and well-being.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions and read all the information provided. Take your medication as directed, and follow these guidelines:

You can take this medication with or without food. If it upsets your stomach, try taking it with food.
For best results, take this medication at bedtime. If you have questions about the timing, consult your doctor or pharmacist.
Extended-Release Products: Swallow the tablets whole; do not chew, break, or crush them.
Liquid Medication: Measure your dose carefully using the provided measuring device. If one is not included, ask your pharmacist for a device to measure your medication accurately.
* Chewable Tablets: Chew the tablets thoroughly before swallowing.

Storing and Disposing of Your Medication

Keep your medication in a safe place, out of the reach of children and pets. Store it at room temperature in a dry location, away from heat and light. Avoid storing it in a bathroom.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take with food to improve absorption and reduce stomach upset.
  • Do not exceed the recommended dose on the product label unless advised by a healthcare professional.
  • Store in a cool, dry place, out of reach of children.
  • Remember that supplements are not a substitute for a balanced diet and healthy lifestyle.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Refer to product label for specific formulation. Typically, one tablet daily with food.

Condition-Specific Dosing:

general_supplementation: One tablet daily
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Pediatric Dosing

Neonatal: Not established for this specific product; use pediatric-specific formulations under medical guidance.
Infant: Not established for this specific product; use pediatric-specific formulations under medical guidance.
Child: Not established for this specific product; use pediatric-specific formulations under medical guidance.
Adolescent: Refer to product label or healthcare provider for age-appropriate dosing; often similar to adult dosing for some formulations.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically required, but caution with certain minerals (e.g., potassium, phosphorus) or fat-soluble vitamins if accumulation is a concern. Consult healthcare provider.
Moderate: Caution advised; consult healthcare provider due to potential for accumulation of certain vitamins/minerals (e.g., Vitamin A, D, phosphorus, potassium).
Severe: Contraindicated or significant dose adjustment required for specific components; consult nephrologist. Risk of hypervitaminosis or mineral imbalance.
Dialysis: Specific formulations for dialysis patients are available (e.g., nephrovitamins) that exclude or limit certain components. Thera-M Plus is generally not suitable without medical guidance.

Hepatic Impairment:

Mild: No specific adjustment typically required.
Moderate: Caution advised, especially with fat-soluble vitamins (A, D, E, K) due to altered metabolism and storage. Consult healthcare provider.
Severe: Caution advised; consult healthcare provider due to altered metabolism and storage of fat-soluble vitamins and potential for iron/copper accumulation.

Pharmacology

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Mechanism of Action

Thera-M Plus Tablets provide a combination of essential vitamins and minerals that serve as cofactors for numerous enzymatic reactions, participate in metabolic pathways, support cellular growth and differentiation, maintain tissue integrity, and contribute to overall physiological function. They are intended to supplement dietary intake and prevent or correct nutritional deficiencies.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (depends on specific vitamin/mineral, formulation, and individual factors)
Tmax: Variable (e.g., water-soluble vitamins typically 1-4 hours, fat-soluble longer)
FoodEffect: Generally enhanced absorption of fat-soluble vitamins (A, D, E, K) when taken with food containing fat. Some minerals (e.g., iron) may be better absorbed on an empty stomach but often taken with food to reduce GI upset.

Distribution:

Vd: Variable (water-soluble vitamins distribute in body water, fat-soluble stored in liver/adipose tissue)
ProteinBinding: Variable (e.g., Vitamin D metabolites are protein-bound)
CnssPenetration: Limited for most, but some (e.g., B vitamins) are essential for neurological function.

Elimination:

HalfLife: Variable (e.g., water-soluble vitamins hours to days, fat-soluble vitamins days to months)
Clearance: Variable (renal for water-soluble, biliary/fecal for fat-soluble)
ExcretionRoute: Renal (water-soluble vitamins, some minerals), Biliary/Fecal (fat-soluble vitamins, some minerals)
Unchanged: Variable (significant for water-soluble vitamins)
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Pharmacodynamics

OnsetOfAction: Gradual, reflecting repletion of body stores and restoration of metabolic functions. Not acutely measurable for general supplementation.
PeakEffect: Not acutely measurable for general supplementation.
DurationOfAction: Variable, depending on the specific vitamin/mineral and body stores.

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 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
If your product contains iron:
+ Black, tarry, or bloody stools
+ Fever
+ Vomiting blood or coffee ground-like material
+ Stomach cramps

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. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Common to all products:
+ Upset stomach or vomiting
If your product contains iron:
+ Diarrhea or constipation
+ Change in stool color to green
+ Stomach pain

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 nausea or vomiting
  • Persistent diarrhea or constipation
  • Severe headache
  • Unusual fatigue or weakness
  • Blurred vision
  • Bone or joint pain
  • Yellowing of skin or eyes
  • Signs of allergic reaction (rash, itching, swelling, difficulty breathing)
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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 to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as symptoms and signs.
Certain types of anemia, including pernicious anemia, which is characterized by a lack of vitamin B12 in the body.
If you are currently taking levodopa.
If you are taking mineral oil.
* If your medication contains iron:
+ If you have an excessive amount of iron in your body (iron overload).
+ If you have hemolytic anemia, a condition where red blood cells are destroyed faster than they can be made.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health issues. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
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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. This is crucial because this drug may interfere with certain laboratory tests. Therefore, be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication.

If you have a soy allergy, consult with your doctor before taking this medication, as some products may contain soy. Similarly, if you are allergic to tartrazine (also known as FD&C Yellow No. 5), discuss this with your doctor, as some products may contain this ingredient.

When administering this medication to children, note that different brands may be suitable for different age groups. Before giving this drug to a child, consult with their doctor to ensure you are using the appropriate brand and dosage.

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 taking this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Acute overdose symptoms can include severe gastrointestinal upset (nausea, vomiting, diarrhea, abdominal pain), headache, dizziness, and fatigue.
  • Chronic overdose of fat-soluble vitamins (A, D, E, K) can lead to accumulation and toxicity (e.g., hypervitaminosis A or D with symptoms like bone pain, hair loss, liver damage, kidney stones).
  • Iron overdose is particularly dangerous, especially in young children, and can cause severe gastrointestinal bleeding, shock, and organ damage.

What to Do:

If an overdose is suspected, seek immediate medical attention or call a Poison Control Center (1-800-222-1222) right away. Bring the product container with you.

Drug Interactions

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Major Interactions

  • Warfarin (Coumadin) with Vitamin K (can reduce anticoagulant effect)
  • Tetracycline antibiotics (e.g., doxycycline) and Fluoroquinolone antibiotics (e.g., ciprofloxacin) with Iron, Calcium, Magnesium, Zinc (can chelate and reduce antibiotic absorption)
  • Levodopa with high doses of Vitamin B6 (pyridoxine) (can reduce levodopa efficacy, though less common with carbidopa/levodopa)
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Moderate Interactions

  • Thyroid hormones (e.g., levothyroxine) with Calcium or Iron (can reduce thyroid hormone absorption)
  • Diuretics (e.g., thiazides, loop diuretics) with certain minerals (can alter excretion of potassium, magnesium, calcium)
  • Anticonvulsants (e.g., phenytoin, phenobarbital) with Folic Acid (can reduce anticonvulsant levels or efficacy)
  • Bile acid sequestrants (e.g., cholestyramine) with fat-soluble vitamins (can reduce absorption of A, D, E, K)
  • Orlistat with fat-soluble vitamins (can reduce absorption of A, D, E, K)
  • Proton pump inhibitors (PPIs) and H2 blockers with Vitamin B12 (can impair absorption)
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Minor Interactions

  • Alcohol with B vitamins (can increase B vitamin requirements)
  • Caffeine with Calcium (can increase calcium excretion)

Monitoring

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Baseline Monitoring

Dietary assessment

Rationale: To identify potential nutritional gaps and determine the need for supplementation.

Timing: Prior to initiating supplementation

Review of existing medical conditions and medications

Rationale: To identify potential interactions or contraindications.

Timing: Prior to initiating supplementation

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Routine Monitoring

Symptoms of deficiency or toxicity

Frequency: Ongoing, as needed

Target: Absence of symptoms

Action Threshold: Development of new or worsening symptoms; consult healthcare provider.

Specific vitamin/mineral levels (e.g., Vitamin D, B12, Iron)

Frequency: Only if deficiency is suspected or being treated, or if toxicity risk is high (e.g., iron overload)

Target: Within normal reference ranges for age/sex

Action Threshold: Levels outside target range; consult healthcare provider for dose adjustment or further investigation.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Abdominal pain
  • Headache
  • Fatigue
  • Blurred vision (Vitamin A toxicity)
  • Bone pain (Vitamin D toxicity)
  • Muscle weakness
  • Changes in urine color (e.g., bright yellow from riboflavin)
  • Allergic reactions (rash, itching, swelling)

Special Patient Groups

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Pregnancy

Consult a healthcare provider before taking any multivitamin during pregnancy. While many vitamins and minerals are crucial for fetal development (e.g., folic acid), excessive intake of certain vitamins, particularly Vitamin A (retinol form), can be harmful (teratogenic). Specific prenatal vitamins are formulated to meet the needs of pregnant women.

Trimester-Specific Risks:

First Trimester: Critical period for organ development; excessive Vitamin A (retinol) is a concern. Folic acid is essential to prevent neural tube defects.
Second Trimester: Continued need for adequate nutrition; generally safe if within recommended daily allowances.
Third Trimester: Continued need for adequate nutrition; generally safe if within recommended daily allowances.
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Lactation

Consult a healthcare provider before taking any multivitamin while breastfeeding. Most vitamins and minerals are excreted into breast milk in varying amounts. Generally, multivitamins are considered safe at recommended doses, but excessive intake should be avoided.

Infant Risk: Low risk when taken at recommended doses. High doses of certain vitamins could potentially lead to infant toxicity, though rare.
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Pediatric Use

Multivitamins should be used with caution in children. Accidental iron overdose is a leading cause of poisoning fatalities in young children. Use child-resistant packaging and keep out of reach. Pediatric-specific formulations with appropriate dosing are recommended.

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Geriatric Use

Older adults may have altered nutritional needs (e.g., increased need for Vitamin D, B12) or decreased absorption. They may also be on multiple medications, increasing the risk of drug-nutrient interactions. Consult a healthcare provider to ensure appropriate supplementation and avoid interactions.

Clinical Information

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Clinical Pearls

  • Thera-M Plus, like other multivitamins, is a dietary supplement and not a substitute for a balanced diet. Emphasize healthy eating habits.
  • Educate patients on the difference between water-soluble (B vitamins, C) and fat-soluble (A, D, E, K) vitamins regarding storage and potential for toxicity.
  • Always inquire about all supplements a patient is taking, not just prescription medications, to identify potential interactions, especially with iron, calcium, and Vitamin K.
  • Accidental iron overdose is a significant risk in young children; stress the importance of child-resistant packaging and keeping supplements out of reach.
  • Advise patients to take multivitamins with food to enhance absorption of fat-soluble vitamins and minimize gastrointestinal upset.
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Alternative Therapies

  • Dietary modifications to increase intake of nutrient-rich foods
  • Individual vitamin or mineral supplements to target specific deficiencies (e.g., Vitamin D, B12, Iron)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets
Generic Available: Yes
Insurance Coverage: Not typically covered by prescription drug insurance plans. May be eligible for reimbursement through Flexible Spending Accounts (FSA) or Health Savings Accounts (HSA) if deemed medically necessary.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 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.