Hydrate Ii label

Hydrate Ii

Hydrate Ii Recall

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Side Effects & Adverse Reactions

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Severe Hypertriglyceridemia

Fenofibric acid tablets is indicated as adjunctive therapy to diet for treatment of severe hypertriglyceridemia (≥ 500 mg/dL). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.

Markedly elevated levels of serum triglycerides > 2000 mg/dL may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.

1.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

Fenofibric acid tablets is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.

1.3 Important Limitations of Use

Fenofibrate at a dose equivalent to 105 mg of fenofibric acid tablets was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)].

History

There is currently no drug history available for this drug.

Other Information

Fenofibric acid tablets is a lipid regulating agent available as tablets for oral administration. Each tablet contains 35 mg or 105 mg of fenofibric acid. The chemical name for fenofibric acid is 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid with the following structural formula:

Structural Formula

Fenofibric acid is a white to almost white crystalline powder that is stable under ordinary conditions, and has a melting point of 179 – 183°C. Its empirical formula is C17H15ClO4 and molecular weight 318.75. Fenofibric acid is insoluble in water; its solubility increases with pH in buffered media.

Inactive Ingredients: Each tablet contains copovidone, crospovidone, magnesium stearate and microcrystalline cellulose.

Hydrate Ii Manufacturers

  • Hydrate Ii | Halton Laboratories
    No Recall

    Hydrate Ii | Halton Laboratories

    Hydrate Ii | Halton Laboratories
    2.1 General Considerations

    Fenofibric acid tablets can be given without regard to meals. Patients should be advised to swallow fenofibric acid tablets tablets whole. Do not crush, dissolve or chew tablets.

    Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibric acid tablets and should continue this diet during treatment with fenofibric acid.

    The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

    Periodic determination of serum lipids should be obtained during initial therapy in order to establish the lowest effective dose of fenofibric acid tablets. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 105 mg per day.

    Consideration should be given to reducing the dosage of fenofibric acid tablets if lipid levels fall significantly below the targeted range.

    2.2 Severe Hypertriglyceridemia

    The initial dose is 35 to 105 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 105 mg once daily.

    2.3 Primary Hypercholesterolemia or Mixed Dyslipidemia

    The dose of fenofibric acid tablets is 105 mg per day.

    2.4 Impaired Renal Function

    In patients with mild-to-moderate renal impairment, treatment with fenofibric acid tablets should be initiated at a dose of 35 mg once daily, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibric acid tablets should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

    2.5 Geriatric Patients

    Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].

  • Bioactive Nutritional, Inc.
    Hydrate Ii | Bioactive Nutritional, Inc.
    No Recall

    Hydrate Ii | Bioactive Nutritional, Inc.

    Hydrate Ii | Bioactive Nutritional, Inc.

    Mix 3 parts water to one part juice, add 6 drops Hydrate II to 8 oz mixture or add 30 drops to a quart mixture. Drink 4 eight oz glasses daily in between meals. Drink Hydrate/water mixture for 6 days and then only water for one day. Repeat. After eight weeks begin drinking more pure water and less Hydrate/water mixture. Consult a physician for use in children under 12 years of age.

  • Maplewood Company
    Hydrate Ii | Maplewood Company
    No Recall

    Hydrate Ii | Maplewood Company

    Hydrate Ii | Maplewood Company

    Mix 3 parts water to one part juice, add 6 drops Hydrate II to 8 oz. mixture.  Drink 4 eight oz glasses daily in between meals.  Drink hydrate/water mixture for 6 days and then only water for one day. Repeat. After eight weeks begin drinking more pure water and less hydrate/water mixture.  Consult a physician for use in children under 12 years of age.