Myfortic Tablets / Gastro-Resistant
Mycophenolic Acid (Mycophenolate sodium)
180mg
Novartis Pharma AG
| Pack size | 120's (10's Blister x 12) |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 1254.00 AED |
Available as:
Indications
Myfortic Tablets / Gastro-Resistant is used for:
Kindey transplant rejection
Adult Dose
Oral
Adult
Kidney transplant patients
As Mycophenolic Acid (MPA) (As Mycophenolate sodium): 720 mg twice daily.
Child Dose
Oral
Child
Kidney transplant patients
As Mycophenolic Acid (MPA) (As Mycophenolate sodium):
5 years or above: 400 mg/m2 twice daily.
Renal Dose
Renal impairment
No dosage adjustment needed in renal transplant patients experiencing delayed graft function post-operatively.
Administration
Drug is taken on empty stomach 1 hour before or 2 hours after meals
Contra Indications
Contraindicated to patients with hypersensitivity to mycophenolic acid or any of its excipients.
Precautions
Can cause embryofetal toxicity
Increases new or reactive viral infection
Cause blood dyscrasias
Can cause serious GI tract complication
Use of live vaccine should be avoided
Active peptic ulcer disease.
Severe renal impairment.
Lactation: Unknown whether drug is excreted in breast milk; avoid using, or do not nurse
Pregnancy-Lactation
Pregnancy
Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems
Consider alternative immunosuppressants with less potential for embryofetal toxicity; risks and benefits of therapy should be discussed with the pregnant woman; the estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear
Animal data
Oral administration of mycophenolate to rats and rabbits during period of organogenesis produced congenital malformations and pregnancy loss at doses less than recommended clinical dose (0.02 to 0.1 times the recommended clinical doses in kidney and heart transplant patients)
Lactation
There are no data on presence of drug in human milk, or effects on milk production; there are limited data in the National Transplantation Pregnancy Registry on effects of mycophenolate on a breastfed child; studies in rats treated with MMF have shown mycophenolic acid (MPA) to be present in milk
Because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from the underlying maternal condition
Interactions
Increased plasma levels of both drugs when combined with aciclovir, valaciclovir, ganciclovir and valganciclovir. Reduced absorption with colestyramine, magnesium- and aluminium hydroxide-containing products, sevelamer and other calcium-free phosphate binders. Reduced plasma levels with ciclosporin, metronidazole, quinolones, rifamycins. May reduce plasma levels of progestins; may reduce efficacy of oral contraceptives. Increased plasma levels with probenecid. May reduce efficacy of live vaccines.
Adverse Effects
Side effects of Mycophenolic Acid (Mycophenolate sodium) :
>10%
Hyperglycemia (44%), Hypercholesterolemia (41%), Hypomagnesemia (39%), Dyspnea (37%), Back pain (35%), Increased blood urea nitrogen (BUN) (35%), Leukopenia (34%), Pleural effusion (34%), Urinary tract infection (34%), Increasing frequency of cough (31%), Hypocalcemia (30%), Hypertension (28%), Abdominal pain (27%), Peripheral edema (27%), Anemia (26%), Fever (23%), Nausea (23%), Hyperkalemia (22%), Diarrhea (21%), Infection (21%), Headache (16%)
1-10%
Melanoma (1.6-4.2%), Other malignancies (0.7-2.1%), Lymphoma (0.4-1%), Opportunistic infection (including herpes), Neutropenia, GI bleeding, Pulmonary fibrosis, Progressive multifocal leukoencephalopathy
Potentially Fatal: Angioedema, anaphylaxis, fatal pulmonary fibrosis.
Mechanism of Action
Mycophenolic acid acts by blocking purine synthesis of human lymphocytes through reversible inhibition of inosine monophosphate dehydrogenase. It also inhibits proliferation of both T- and B- lymphocytes.
Note
Myfortic 180mg Tablets / Gastro-Resistant manufactured by Novartis Pharma AG. Its generic name is Mycophenolic Acid (Mycophenolate sodium). Myfortic is availble in United Arab Emirates.
Farmaco UAE drug index information on Myfortic Tablets / Gastro-Resistant is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.