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Myfortic

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Overview

What is Myfortic?

Myfortic (mycophenolic acid) delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Myfortic is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt.

Its empirical formula is CHONa. The molecular weight is 342.32 and the structural formula is:

Myfortic, as the sodium salt, is a white to off-white, crystalline powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid.

Myfortic is available for oral use as delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose anhydrous, magnesium stearate, povidone (K-30), and starch. The enteric coating of the tablet consists of hypromellose phthalate, titanium dioxide, iron oxide yellow, and indigotine (180 mg) or iron oxide red (360 mg).



What does Myfortic look like?



What are the available doses of Myfortic?

Myfortic is available as 180 mg and 360 mg tablets. ()

What should I talk to my health care provider before I take Myfortic?

How should I use Myfortic?

Myfortic (mycophenolic acid) is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.

Myfortic is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.

Myfortic is to be used in combination with cyclosporine and corticosteroids.

The recommended dose of Myfortic is 720 mg administered twice daily (1440 mg total daily dose).


What interacts with Myfortic?

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What are the warnings of Myfortic?

Sorry No Records found


What are the precautions of Myfortic?

Sorry No Records found


What are the side effects of Myfortic?

Sorry No records found


What should I look out for while using Myfortic?

Known hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, or to any of its excipients. ()


What might happen if I take too much Myfortic?

Signs and Symptoms

There have been anecdotal reports of deliberate or accidental overdoses with Myfortic, whereas not all patients experienced related adverse reactions.

In those overdose cases in which adverse reactions were reported, the reactions fall within the known safety profile of the class. Accordingly an overdose of Myfortic could possibly result in oversuppression of the immune system and may increase the susceptibility to infection including opportunistic infections, fatal infections and sepsis. If blood dyscrasias occur (e.g., neutropenia with absolute neutrophil count <1.5 x 10/mcL or anemia), it may be appropriate to interrupt or discontinue Myfortic.

Possible signs and symptoms of acute overdose could include the following: hematological abnormalities such as leukopenia and neutropenia, and gastrointestinal symptoms such as abdominal pain, diarrhea, nausea and vomiting, and dyspepsia.

Treatment and Management

General supportive measures and symptomatic treatment should be followed in all cases of overdosage. Although dialysis may be used to remove the inactive metabolite mycophenolic acid glucuronide (MPAG), it would not be expected to remove clinically significant amounts of the active moiety, mycophenolic acid, due to the 98% plasma protein binding of mycophenolic acid. By interfering with enterohepatic circulation of mycophenolic acid, activated charcoal or bile sequestrates, such as cholestyramine, may reduce the systemic mycophenolic acid exposure.


How should I store and handle Myfortic?

Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .360 mg tablet: Pale orange-red film-coated ovaloid tablet with imprint (debossing) “CT” on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0386-66180 mg tablet: Lime green film-coated round tablet with bevelled edges and the imprint (debossing) “C” on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0385-66StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) Dispense in a tight container (USP).HandlingKeep out of reach and sight of children. Myfortic tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [].Teratogenic effects have been observed with mycophenolate sodium []. If for any reason, the Myfortic tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes. 360 mg tablet: Pale orange-red film-coated ovaloid tablet with imprint (debossing) “CT” on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0386-66180 mg tablet: Lime green film-coated round tablet with bevelled edges and the imprint (debossing) “C” on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0385-66StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) Dispense in a tight container (USP).HandlingKeep out of reach and sight of children. Myfortic tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [].Teratogenic effects have been observed with mycophenolate sodium []. If for any reason, the Myfortic tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes. 360 mg tablet: Pale orange-red film-coated ovaloid tablet with imprint (debossing) “CT” on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0386-66180 mg tablet: Lime green film-coated round tablet with bevelled edges and the imprint (debossing) “C” on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0385-66StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) Dispense in a tight container (USP).HandlingKeep out of reach and sight of children. Myfortic tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [].Teratogenic effects have been observed with mycophenolate sodium []. If for any reason, the Myfortic tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes. 360 mg tablet: Pale orange-red film-coated ovaloid tablet with imprint (debossing) “CT” on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0386-66180 mg tablet: Lime green film-coated round tablet with bevelled edges and the imprint (debossing) “C” on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0385-66StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) Dispense in a tight container (USP).HandlingKeep out of reach and sight of children. Myfortic tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [].Teratogenic effects have been observed with mycophenolate sodium []. If for any reason, the Myfortic tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes. 360 mg tablet: Pale orange-red film-coated ovaloid tablet with imprint (debossing) “CT” on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0386-66180 mg tablet: Lime green film-coated round tablet with bevelled edges and the imprint (debossing) “C” on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0385-66StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) Dispense in a tight container (USP).HandlingKeep out of reach and sight of children. Myfortic tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [].Teratogenic effects have been observed with mycophenolate sodium []. If for any reason, the Myfortic tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes. 360 mg tablet: Pale orange-red film-coated ovaloid tablet with imprint (debossing) “CT” on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0386-66180 mg tablet: Lime green film-coated round tablet with bevelled edges and the imprint (debossing) “C” on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0385-66StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) Dispense in a tight container (USP).HandlingKeep out of reach and sight of children. Myfortic tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [].Teratogenic effects have been observed with mycophenolate sodium []. If for any reason, the Myfortic tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes. 360 mg tablet: Pale orange-red film-coated ovaloid tablet with imprint (debossing) “CT” on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0386-66180 mg tablet: Lime green film-coated round tablet with bevelled edges and the imprint (debossing) “C” on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0385-66StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) Dispense in a tight container (USP).HandlingKeep out of reach and sight of children. Myfortic tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [].Teratogenic effects have been observed with mycophenolate sodium []. If for any reason, the Myfortic tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes. 360 mg tablet: Pale orange-red film-coated ovaloid tablet with imprint (debossing) “CT” on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0386-66180 mg tablet: Lime green film-coated round tablet with bevelled edges and the imprint (debossing) “C” on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0385-66StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) Dispense in a tight container (USP).HandlingKeep out of reach and sight of children. Myfortic tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [].Teratogenic effects have been observed with mycophenolate sodium []. If for any reason, the Myfortic tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes. 360 mg tablet: Pale orange-red film-coated ovaloid tablet with imprint (debossing) “CT” on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0386-66180 mg tablet: Lime green film-coated round tablet with bevelled edges and the imprint (debossing) “C” on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0385-66StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) Dispense in a tight container (USP).HandlingKeep out of reach and sight of children. Myfortic tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [].Teratogenic effects have been observed with mycophenolate sodium []. If for any reason, the Myfortic tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes. 360 mg tablet: Pale orange-red film-coated ovaloid tablet with imprint (debossing) “CT” on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0386-66180 mg tablet: Lime green film-coated round tablet with bevelled edges and the imprint (debossing) “C” on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0385-66StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) Dispense in a tight container (USP).HandlingKeep out of reach and sight of children. Myfortic tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [].Teratogenic effects have been observed with mycophenolate sodium []. If for any reason, the Myfortic tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes. 360 mg tablet: Pale orange-red film-coated ovaloid tablet with imprint (debossing) “CT” on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0386-66180 mg tablet: Lime green film-coated round tablet with bevelled edges and the imprint (debossing) “C” on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0385-66StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) Dispense in a tight container (USP).HandlingKeep out of reach and sight of children. Myfortic tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [].Teratogenic effects have been observed with mycophenolate sodium []. If for any reason, the Myfortic tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes. 360 mg tablet: Pale orange-red film-coated ovaloid tablet with imprint (debossing) “CT” on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0386-66180 mg tablet: Lime green film-coated round tablet with bevelled edges and the imprint (debossing) “C” on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.Bottles of 120…………………………………………………………………NDC 0078-0385-66StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) Dispense in a tight container (USP).HandlingKeep out of reach and sight of children. Myfortic tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [].Teratogenic effects have been observed with mycophenolate sodium []. If for any reason, the Myfortic tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Mycophenolic acid (MPA), an immunosuppressant, is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation to DNA. T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines, whereas other cell types can utilize salvage pathways. MPA has cytostatic effects on lymphocytes.

Mycophenolate sodium has been shown to prevent the occurrence of acute rejection in rat models of kidney and heart allotransplantation. Mycophenolate sodium also decreases antibody production in mice.

Non-Clinical Toxicology
Known hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, or to any of its excipients. ()

Use of Myfortic during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system [see].

The following adverse reactions are discussed in greater detail in other sections of the label.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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