Planning a pregnancy after taking the pill identifier,precautions taken during pregnancy 5th month,can you get pregnant just starting the pill,pregnancy 25 weeks in hindi - Tips For You

Plan B will be available in pharmacies but will be kept behind the pharmacist’s counter and not on store shelves.
You missed taking two or more birth control pills or you are two or more days late starting your pack.
Emergency contraception is not the abortion pill (which is also known as RU-486 or Mifeprex).
If you had unprotected sex or your contraceptive method failed, it is important to get tested for sexually transmitted infections, too. If you very recently had unprotected sex or your birth control method failed, you should strongly consider taking emergency contraception if you want to prevent a pregnancy.
EC, when used within five days of unprotected sex, can significantly reduce the risk of unintended pregnancy. EC is less effective than regular birth control, like condoms or birth control pills used before or during sex, so you should not use EC as your regular form of birth control. EC is effective up to five days (120 hours) after unprotected sex but is most effective within three days. Anti-choice activists often falsely assert that contraceptive methods work as abortifacients. But baby-led weaning offers an easy alternative to spoon-feeding which lets your baby take the lead, using food you cook for the whole family.
Ideal first foods include big pieces of pasta, strips of tender meat, fruit, veg, and toast or flatbread. Recent research has suggested that 1 in 5 two-year-olds never eat their vegetables, and 30,000 two-year-olds have NEVER tried a vegetable.
By working out what it is that your child finds off-putting about food, you can understand why she’s being picky. The Nipper Single is an excellent solution for parents who require a multipurpose pushchair for use in both urban environments as well as scenic off-road routes.
WIN an Exclusive Super Soft Comfort Pure Ultra Concentrated Hamper PLUS £50 Shopping Voucher! This websites uses cookies to improve access and the service provided during your visit.By continuing you accept these cookies.
Your reproductive system is made up of a vulva, vagina, cervix, womb, fallopian tubes, ovaries and breasts.
Health information within this website is provided for educational purposes only and is not intended to replace discussions with healthcare professionals.
Females of reproductive potential must be counseled regarding pregnancy prevention and planning.
Increased risk of development of lymphoma a)nd other malignancies, particularly of the skin, due to immunosuppression. Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections.
Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe mycophenolic acid.
Mycophenolate sodium is an immunosuppressant that is FDA approved for the prophylaxis of organ rejection in patients receiving a kidney transplant.. Mycophenolic acid is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. Mycophenolic acid delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
The recommended dose of mycophenolic acid delayed-release tablets is 720 mg administered twice daily (1440 mg total daily dose). There is limited information regarding Off-Label Guideline-Supported Use of Mycophenolic acid in adult patients. There is limited information regarding Off-Label Non–Guideline-Supported Use of Mycophenolic acid in adult patients. Mycophenolic acid 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. There is limited information regarding Off-Label Guideline-Supported Use of Mycophenolic acid in pediatric patients.
There is limited information regarding Off-Label Non–Guideline-Supported Use of Mycophenolic acid in pediatric patients. Mycophenolic acid delayed-release tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, or to any of its excipients.
Use of mycophenolic acid delayed-release tablets 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, and kidney.
Females of reproductive potential must be aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe mycophenolic acid delayed-release tablets.
Patients receiving immunosuppressants, including mycophenolic acid delayed-release tablets, are at increased risk of developing lymphomas and other malignancies, particularly of the skin. As usual for patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Post-transplant lymphoproliferative disorder (PTLD) has been reported in immunosuppressed organ transplant recipients.
Patients receiving immunosuppressants, including mycophenolic acid delayed-release tablets, are at increased risk of developing bacterial, viral, fungal, and protozoal infections, and new or reactivated viral infections including opportunistic infections.
Polyomavirus associated nephropathy (PVAN), JC virus associated progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV) infections, reactivation of hepatitis B (HBV) or hepatitis C (HCV) have been reported in patients treated with immunosuppressants, including the mycophenolic acid (MPA) derivatives mycophenolic acid delayed-release tablets and MMF. PVAN, especially due to BK virus infection, is associated with serious outcomes, including deteriorating renal function and renal graft loss.
PML, which is sometimes fatal, commonly presents with hemiparesis, apathy, confusion, cognitive deficiencies, and ataxia.
The risk of CMV viremia and CMV disease is highest among transplant recipients seronegative for CMV at time of transplant who receive a graft from a CMV seropositive donor.
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with MPA derivatives in combination with other immunosuppressive agents. Gastrointestinal bleeding (requiring hospitalization), intestinal perforations, gastric ulcers, and duodenal ulcers have been reported in patients treated with mycophenolic acid delayed-release tablets. The following adverse reactions are discussed in greater detail in other sections of the label. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below derive from two randomized, comparative, active-controlled, double-blind, double-dummy trials in prevention of acute rejection in de novo and converted stable kidney transplant patients. In the de novo trial, patients were administered either mycophenolic acid delayed-release tablets 1.44 grams per day (N=213) or MMF 2 grams per day (N=210) within 48 hours post-transplant for 12 months in combination with cyclosporine, USP MODIFIED and corticosteroids. The average age of patients in both studies was 47 years and 48 years (de novo study and conversion study, respectively), ranging from 22 to 75 years.
The most common adverse reactions (?20%) associated with the administration of mycophenolic acid delayed-release tablets were anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia and postoperative pain. The adverse reactions reported in ?10% of patients in the de novo trial are presented in Table 2 below.
The trial was not designed to support comparative claims for mycophenolic acid for the adverse reactions reported in this table. Table 3 summarizes the incidence of opportunistic infections in de novo transplant patients. Lymphoma developed in 2 de novo patients (1%), (1 diagnosed 9 days after treatment initiation) and in 2 conversion patients (1%) receiving mycophenolic acid delayed-release tablets with other immunosuppressive agents in the 12-month controlled clinical trials. The adverse reactions reported in <10% of de novo or conversion patients treated with mycophenolic acid delayed-release tablets in combination with cyclosporine and corticosteroids are listed in Table 4.
Gastrointestinal: Intestinal perforation, gastrointestinal hemorrhage, gastric ulcers, duodenal ulcers, colitis (including CMV colitis), pancreatitis, esophagitis, and ileus. Infections: Serious life-threatening infections such as meningitis and infectious endocarditis, tuberculosis, and atypical mycobacterial infection.
The following adverse reactions have been identified during post-approval use of mycophenolic acid or other MPA derivatives. Congenital malformations and an increased incidence of first trimester pregnancy loss have been reported following exposure to MMF during pregnancy. Polyomavirus associated nephropathy (PVAN), especially due to BK virus infection, associated with serious outcomes, including deteriorating renal function and renal graft loss.
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with MPA derivatives in combination with other immunosuppressive agents .
The following additional adverse reactions have been identified during postapproval use of mycophenolic acid: agranulocytosis, asthenia, osteomyelitis, lymphadenopathy, lymphopenia, wheezing, dry mouth, gastritis, peritonitis, anorexia, alopecia, pulmonary edema, Kaposi’s sarcoma. Concomitant use of mycophenolic acid delayed-release tablets and antacids decreased plasma concentrations of mycophenolic acid (MPA).
Given that azathioprine and MMF inhibit purine metabolism, it is recommended that mycophenolic acid delayed-release tablets not be administered concomitantly with azathioprine or MMF. Drugs that interrupt enterohepatic recirculation may decrease MPA plasma concentrations when coadministered with MMF. Cyclosporine inhibits the enterohepatic recirculation of MPA, and therefore, MPA plasma concentrations may be decreased when mycophenolic acid delayed-release tablets are coadministered with cyclosporine. MPA plasma concentrations may be decreased when MMF is administrated with norfloxacin and metronidazole.
In a drug interaction study, mean levonorgestrel AUC was decreased by 15% when coadministered with MMF. Drugs that alter the gastrointestinal flora such as ciprofloxacin or amoxicillin plus clavulanic acid may interact with MMF by disrupting enterohepatic recirculation. Administration of a pantoprazole at a dose of 40 mg twice daily for 4 days to healthy volunteers did not alter the pharmacokinetics of a single dose of mycophenolic acid delayed-release tablets. For those females using mycophenolic acid at any time during pregnancy and those becoming pregnant within 6 weeks of discontinuing therapy, the healthcare practitioner should report the pregnancy to the Mycophenolate Pregnancy Registry (1-800-617-8191). Following oral or intravenous (IV) administration, MMF is metabolized to mycophenolic acid (MPA), the active ingredient in mycophenolic acid delayed-release tablets and the active form of the drug.
Risks and benefits of mycophenolic acid delayed-release tablets should be discussed with the patient. In the National Transplantation Pregnancy Registry (NTPR), there were data on 33 MMF-exposed pregnancies in 24 transplant patients; there were 15 spontaneous abortions (45%) and 18 live-born infants. In a teratology study performed with mycophenolate sodium in rats, at a dose as low as 1 mg per kg, malformations in the offspring were observed, including anophthalmia, exencephaly, and umbilical hernia. There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mycophenolate sodium in women who are pregnant. The safety and effectiveness of mycophenolic acid delayed-release tablets have been established in pediatric kidney transplant patients 5 to 16 years of age who were initiated on mycophenolic acid delayed-release tablets at least 6 months post-transplant.
Clinical studies of mycophenolic acid delayed-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning. Females of reproductive potential include girls who have entered puberty and all women who have a uterus and have not passed through menopause.
In the event of a positive pregnancy test, females should be counseled with regard to whether the maternal benefits of mycophenolate treatment may outweigh the risks to the fetus in certain situations. Females of reproductive potential taking mycophenolic acid delayed-release tablets must receive contraceptive counseling and use acceptable contraception (see Table 5 for Acceptable Contraception Methods). Patients should be aware that mycophenolic acid delayed-release tablets reduce blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness.
For patients who are considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity. There is no FDA guidance on the use of Mycophenolate sodium with respect to specific racial populations. There is no FDA guidance on the use of Mycophenolate sodium in patients with renal impairment. There is no FDA guidance on the use of Mycophenolate sodium in patients with hepatic impairment. There is no FDA guidance on the use of Mycophenolate sodium in women of reproductive potentials and males.


There is no FDA guidance one the use of Mycophenolate sodium in patients who are immunocompromised.
Mycophenolic acid delayed-release tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake.
Mycophenolic acid delayed-release tablets should not be crushed, chewed, or cut prior to ingesting.
There is limited information regarding the compatibility of Mycophenolate sodium and IV administrations. There have been anecdotal reports of deliberate or accidental overdoses with mycophenolic acid delayed-release tablets, 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. 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. General supportive measures and symptomatic treatment should be followed in all cases of overdosage.
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.
Mycophenolate sodium has been shown to prevent the occurrence of acute rejection in rat models of kidney and heart allotransplantation. There is limited information regarding Mycophenolate sodium Pharmacodynamics in the drug label. Mycophenolic acid delayed-release tablets exhibit linear and dose-proportional pharmacokinetics over the dose-range (360 to 2160 mg) evaluated. In vitro studies demonstrated that the enteric-coated mycophenolic acid tablet does not release MPA under acidic conditions (pH <5) as in the stomach but is highly soluble in neutral pH conditions as in the intestine.
The mean (± SD) volume of distribution at steady state and elimination phase for MPA is 54 (± 25) L and 112 (± 48) L, respectively. The majority of MPA dose administered is eliminated in the urine primarily as MPAG (>60%) and approximately 3% as unchanged MPA following mycophenolic acid administration to stable renal transplant patients. Compared to the fasting state, administration of mycophenolic acid delayed-release tablets 720 mg with a high-fat meal (55 g fat, 1000 calories) had no effect on the systemic exposure (AUC) of MPA. The mean pharmacokinetic parameters for MPA following the administration of mycophenolic acid in renal transplant patients on cyclosporine, USP MODIFIED based immunosuppression are shown in Table 6.
After near equimolar dosing of mycophenolic acid 720 mg twice daily and MMF 1000 mg twice daily (739 mg as MPA) in both the single- and multiple-dose cross-over trials, mean systemic MPA exposure (AUC) was similar.
Renal Insufficiency: No specific pharmacokinetic studies in individuals with renal impairment were conducted with mycophenolic acid delayed-release tablets.
In contrast, MPAG exposure would be increased markedly with decreased renal function; MPAG exposure being approximately 8-fold higher in the setting of anuria.
Hepatic Insufficiency: No specific pharmacokinetic studies in individuals with hepatic impairment were conducted with mycophenolic acid delayed-release tablets. Gender: There are no significant gender differences in mycophenolic acid delayed-release tablets pharmacokinetics. Ethnicity: Following a single dose administration of 720 mg of mycophenolic acid delayed-release tablets to 18 Japanese and 18 Caucasian healthy subjects, the exposure (AUCinf) for MPA and MPAG were 15% and 22% lower in Japanese subjects compared to Caucasians.
Absorption of a single dose of mycophenolic acid delayed-release tablets was decreased when administered to 12 stable kidney transplant patients also taking magnesium-aluminum-containing antacids (30 mL): the mean Cmax and AUC(0 to t) values for MPA were 25% and 37% lower, respectively, than when mycophenolic acid delayed-release tablets were administered alone under fasting conditions. In a trial conducted in 12 healthy volunteers, the pharmacokinetics of MPA were observed to be similar when a single dose of 720 mg of mycophenolic acid delayed-release tablets was administered alone and following concomitant administration of mycophenolic acid delayed-release tablets and pantoprazole, which was administered at a dose of 40 mg twice daily for 4 days. Following single-dose oral administration of 1.5 grams MMF to 12 healthy volunteers pretreated with 4 grams three times daily of cholestyramine for 4 days, MPA AUC decreased approximately 40%. Concomitant administration of sevelamer and MMF in stable adult and pediatric kidney transplant patients decreased the mean MPA Cmax and AUC(0 to 12h) by 36% and 26% respectively.
Cyclosporine inhibits multidrug-resistance-associated protein 2 (MRP-2) transporter in the biliary tract, thereby preventing the excretion of MPAG into the bile that would lead to enterohepatic recirculation of MPA [see Drug Interactions (7.5)]. In a single heart-lung transplant patient on MMF therapy (1 gram twice daily), a 67% decrease in MPA exposure (AUC(0 to12h)) was observed with concomitant administration of MMF and 600 mg rifampin daily. In 8 kidney transplant patients on stable MMF therapy (1 gram twice daily), administration of 300 mg rifampin twice daily resulted in a 17.5% decrease in MPA AUC(0 to 12h) due to inhibition of enterohepatic recirculation of MPAG by rifampin. In a drug-drug interaction trial, mean AUCs were similar for ethinyl estradiol and norethindrone, when coadministered with MMF as compared to administration of the oral contraceptives alone. Coadministration of MMF (1 gram) and acyclovir (800 mg) to 12 healthy volunteers resulted in no significant change in MPA AUC and Cmax.
Following single-dose administration to 12 stable kidney transplant patients, no pharmacokinetic interaction was observed between MMF (1.5 grams) and intravenous ganciclovir (5 mg per kg). Because MPAG plasma concentrations are increased in the presence of renal impairment, as are ganciclovir concentrations, the two drugs will compete for tubular secretion and thus further increases in concentrations of both drugs may occur. A total of 64 MMF treated kidney transplant recipients received either oral ciprofloxacin 500 mg twice daily or amoxicillin plus clavulanic acid 375 mg three times daily for 7 or at least 14 days.
In a 104-week oral carcinogenicity study in rats, mycophenolate sodium was not tumorigenic at daily doses up to 9 mg per kg, the highest dose tested.
Mycophenolate sodium had no effect on male rat fertility at daily oral doses as high as 18 mg per kg and exhibited no testicular or spermatogenic effects at daily oral doses of 20 mg per kg for 13 weeks (approximately 2 times the systemic exposure of MPA at the recommended therapeutic dose).
The safety and efficacy of mycophenolic acid delayed-release tablets in combination with cyclosporine, USP MODIFIED and corticosteroids for the prevention of organ rejection was assessed in two multicenter, randomized, double-blind active-controlled trials in de novo and conversion renal transplant patients compared to MMF.
The de novo trial was conducted in 423 renal transplant patients (ages 18 to 75 years) in Austria, Canada, Germany, Hungary, Italy, Norway, Spain, UK, and USA.
The incidence of treatment failure was similar in mycophenolic acid delayed-release tablets - and MMF-treated patients at 6 and 12 months (Table 7).
Patients received 2 grams per day MMF in combination with cyclosporine USP MODIFIED, with or without corticosteroids for at least two weeks prior to entry in the trial. The incidences of treatment failure at 6 and 12 months were similar between mycophenolic acid delayed- release tablets - and MMF-treated patients (Table 8). 180 mg tablet: Light green, round, slightly biconvex beveled edge enteric coated tablet, engraved “MYC” over “180” on one side, “APO” on the other side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium. 360 mg tablet: Light pink, oval, biconvex enteric coated tablet, engraved “APO” on one side, “MYC 360” on the other side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium. Inform pregnant women and females of reproductive potential that use of mycophenolic acid delayed-release tablets in pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations.
In the event of a positive pregnancy test, discuss the risks and benefits of mycophenolic acid delayed-release tablets with the patient. Discuss pregnancy testing, pregnancy prevention and planning with females of reproductive potential.
Inform females of reproductive potential must use acceptable birth control during entire mycophenolic acid delayed-release tablets therapy and for 6 weeks after stopping mycophenolic acid delayed-release tablets, unless the patient chooses to avoid heterosexual sexual intercourse completely (abstinence). For patients who are considering pregnancy, discuss appropriate alternative immunosuppressants with less potential for embryofetal toxicity. Advise patients that they should not breastfeed during mycophenolic acid delayed-release tablets therapy. Inform patients they are at increased risk of developing lymphomas and other malignancies, particularly of the skin, due to immunosuppression. Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and use a sunscreen with a high protection factor. Inform patients they are at increased risk of developing a variety of infections, including opportunistic infections, due to immunosuppression and to contact their physician if they develop any symptoms of infection. Inform patients that mycophenolic acid delayed-release tablets can cause gastrointestinal tract complications including bleeding, intestinal perforations, and gastric or duodenal ulcers. Inform patients that mycophenolic acid delayed-release tablets can interfere with the usual response to immunizations and that they should avoid live vaccines. Advise patients to swallow mycophenolic acid delayed-release tablets whole, and not crush, chew, or cut the tablets.
Patients should be advised to report to their doctor the use of any other medications while taking mycophenolic acid delayed-release tablets. There is limited information regarding Mycophenolate sodium Look-Alike Drug Names in the drug label. You can get tested at your doctor’s office or at a county health department, STI clinic or family planning clinic. EC is a safe method of pregnancy prevention, even for women who have been advised not to take birth control pills on an ongoing basis.
All of the birth control methods listed above work by either preventing fertilization or ovulation, not by causing an abortion. When you think of starting your baby on solid foods, you might imagine it will involve a lot of scouring recipe books for the best blends of fruit and veg for your baby, then steaming and puréeing.
Cutting meat and veg into long strips and stick-shapes makes it easier for babies to pick them up and have a go at eating them. Work out when you're most fertile to increase your chances of getting pregnant with our easy-to-use ovulation calculator. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider.
Patients receiving mycophenolic acid should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. Reduction in immunosuppression should be considered for patients who develop evidence of new or reactivated viral infections. Risk factors for PML include treatment with immunosuppressant therapies and impairment of immune function. Monitoring infected patients for clinical and laboratory signs of active HBV or HCV infection is recommended. The mechanism for MPA derivatives induced PRCA is unknown; the relative contribution of other immunosuppressants and their combinations in an immunosuppressive regimen is also unknown.
The development of neutropenia may be related to mycophenolic acid itself, concomitant medications, viral infections, or some combination of these reactions.
Mycophenolic acid delayed-release tablets should be administered with caution in patients with active serious digestive system disease. Mycophenolic acid should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch- Nyhan and Kelley-Seegmiller syndromes because it may cause an exacerbation of disease symptoms characterized by the overproduction and accumulation of uric acid leading to symptoms associated with gout such as acute arthritis, tophi, nephrolithiasis or urolithiasis and renal disease including renal failure. The most common adverse reactions leading to discontinuation in the mycophenolic acid arm were graft loss (2%), diarrhea (2%), vomiting (1%), renal impairment (1%), CMV infection (1%), and leukopenia (1%). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. It is recommended that mycophenolic acid delayed-release tablets and antacids not be administered simultaneously.
Sevelamer and other calcium free phosphate binders should not be administered simultaneously with mycophenolic acid delayed-release tablets. Clinicians should be aware that there is also a potential change of MPA plasma concentrations after switching from cyclosporine to other immunosuppressive drugs or from other immunosuppressive drugs to cyclosporine in patients concomitantly receiving mycophenolic acid delayed-release tablets. Therefore, mycophenolic acid delayed-release tablets are not recommended to be given with the combination of norfloxacin and metronidazole. Therefore, mycophenolic acid delayed-release tablets are not recommended to be given with rifampin concomitantly unless the benefit outweighs the risk. Interference of MPAG hydrolysis may lead to less MPA available for absorption when mycophenolic acid delayed-release tablet is concomitantly administered with ciprofloxacin or amoxicillin plus clavulanic acid.
The healthcare practitioner should strongly encourage the patient to enroll in the pregnancy registry. Use of MMF 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, and kidney. When appropriate, consider alternative immunosuppressants with less potential for embryofetal toxicity. The systemic exposure at this dose represents 0.05 times the clinical exposure at the dose of 1440 mg per day mycophenolic acid delayed-release tablets. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from mycophenolic acid delayed-release tablets, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Use of mycophenolic acid delayed-release tablets in this age group is supported by evidence from adequate and well-controlled studies of mycophenolic acid delayed-release tablets in a similar population of adult kidney transplant patients with additional pharmacokinetic data in pediatric kidney transplant patients.


The safety and effectiveness of mycophenolic acid delayed-release tablets in de novo pediatric kidney transplant patients and in pediatric kidney transplant patients below the age of 5 years have not been established. Of the 372 patients treated with mycophenolic acid delayed-release tablets in the clinical trials, 6% (N=21) were 65 years of age and older and 0.3% (N=1) were 75 years of age and older. Patients must use acceptable birth control during entire mycophenolic acid delayed-release tablets therapy, and for 6 weeks after stopping mycophenolic acid delayed-release tablets, unless the patient chooses abstinence (she chooses to avoid heterosexual intercourse completely). The tablets should be swallowed whole in order to maintain the integrity of the enteric coating.
Accordingly an overdose of mycophenolic acid delayed-release tablets could possibly result in over suppression of the immune system and may increase the susceptibility to infection including opportunistic infections, fatal infections and sepsis. 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. T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines, whereas other cell types can utilize salvage pathways. The absolute bioavailability of mycophenolic acid delayed-release tablets in stable renal transplant patients on cyclosporine was 72%.
The phenolic glucuronide of MPA, mycophenolic acid glucuronide (MPAG), is the predominant metabolite of MPA and does not manifest pharmacological activity.
However, based on studies of renal impairment with MMF, MPA exposure is not expected to be appreciably increased over the range of normal to severely impaired renal function following mycophenolic acid delayed-release tablets administration. Although dialysis may be used to remove the inactive metabolite MPAG, it would not be expected to remove clinically significant amounts of the active moiety MPA. In a single dose (MMF 1000 mg) trial of 18 volunteers with alcoholic cirrhosis and 6 healthy volunteers, hepatic MPA glucuronidation processes appeared to be relatively unaffected by hepatic parenchymal disease when the pharmacokinetic parameters of healthy volunteers and alcoholic cirrhosis patients within this trial were compared. The mean MPA pharmacokinetic parameters for stable pediatric renal transplant patients, 5 to 16 years, on cyclosporine, USP MODIFIED are shown in Table 6. The peak concentrations (Cmax) for MPAG were similar between the two populations, however, Japanese subjects had 9.6% higher Cmax for MPA.
This decrease is consistent with interruption of enterohepatic recirculation which may be due to binding of recirculating MPAG with cholestyramine in the intestine. At month 12 post-transplant, the mean MPA (AUC(0 to 12h)) in the cyclosporine withdrawal group was approximately 40% higher, than that of the standard dose cyclosporine group.
There was no significant effect on mean MPA AUC(0 to 48h) when MMF was concomitantly administered with norfloxacin or metronidazole separately.
However, MPAG and acyclovir plasma mean AUC(0 to 24h) were increased 10% and 18%, respectively.
Approximately 50% reductions in median trough MPA concentrations (predose) from baseline (MMF alone) were observed in 3 days following commencement of oral ciprofloxacin or amoxicillin plus clavulanic acid. The genotoxic activity of mycophenolic acid (MPA) is probably due to the depletion of the nucleotide pool required for DNA synthesis as a result of the pharmacodynamic mode of action of MPA (inhibition of nucleotide synthesis). No effects on female fertility were seen up to a daily dose of 20 mg per kg (approximately 3 times the systemic exposure of MPA at the recommended therapeutic dose).
The cumulative incidence of graft loss, death and lost to follow-up at 12 months is also shown in Table 7. Patients were randomized to mycophenolic acid delayed-release tablets 1.44 grams per day or MMF 2 grams per day for 12 months.
The cumulative incidence of graft loss, death and lost to follow-up at 12 months is also shown in Table 8. Advise the patient to contact their healthcare provider if they have symptoms of gastrointestinal bleeding or sudden onset or persistent abdominal pain.
Inform patients to take mycophenolic acid delayed-release tablets on an empty stomach, 1 hour before or 2 hours after food intake. A staff member at your local Planned Parenthood health center can discuss all of your birth control options with you and help you get the birth control you need. Emergency contraception will not work if you are already pregnant and will not harm a pregnancy or the fetus.
Academic medicine confirms that preventing fertilization or ovulation does not qualify as abortion.
At the clinic your urine and blood pressure will be checked and your diabetes care reviewed. The physicians responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
The risk of PTLD appears greatest in those individuals who are EBV seronegative, a population which includes many young children. Because of the danger of oversuppression of the immune system which can increase susceptibility to infection, combination immunosuppressant therapy should be used with caution. Physicians should also consider the risk that reduced immunosuppression represents to the functioning allograft.
In immunosuppressed patients, physicians should consider PML in the differential diagnosis in patients reporting neurological symptoms and consultation with a neurologist should be considered as clinically indicated.
In some cases PRCA was found to be reversible with dose reduction or cessation of therapy with MPA derivatives. Complete blood count should be performed weekly during the first month, twice monthly for the second and the third month of treatment, then monthly through the first year. In the conversion trial, renal transplant patients who were at least 6 months post-transplant and receiving 2 grams per day MMF in combination with cyclosporine USP MODIFIED, with or without corticosteroids for at least two weeks prior to entry in the trial were randomized to mycophenolic acid delayed-release tablets 1.44 grams per day (N=159) or MMF 2 grams per day (N=163) for 12 months.
The overall incidence of patients reporting dose reduction at least once during the 0 to12 month study period was 59% and 60% in the mycophenolic acid delayed-release tablets and MMF arms, respectively.
Although there will be no effect on MPA plasma concentrations when mycophenolic acid delayed-release tablets are concomitantly administered with norfloxacin or metronidazole when given separately [see Clinical Pharmacology (12.3)]. The clinical relevance of this interaction is unclear; however, no dose adjustment of mycophenolic acid delayed-release tablet is needed when coadministered with these drugs. The information provided to the registry will help the Health Care Community to better understand the effects of mycophenolate in pregnancy.
In animal studies, congenital malformations and pregnancy loss occurred when pregnant rats and rabbits received mycophenolic acid at dose multiples similar to and less than clinical doses. In certain situations, the patient and her healthcare practitioner may decide that the maternal benefits outweigh the risks to the fetus.
In postmarketing data (collected from 1995 to 2007) on 77 women exposed to systemic MMF during pregnancy, 25 had spontaneous abortions and 14 had a malformed infant or fetus.
In teratology studies in rabbits, fetal resorptions and malformations occurred at doses equal to or greater than 80 mg per kg per day, in the absence of maternal toxicity (which corresponds to about 1.1 times the recommended clinical dose, based on body surface area). Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
By interfering with enterohepatic circulation of mycophenolic acid, activated charcoal or bile sequestrates, such as cholestyramine, may reduce the systemic mycophenolic acid exposure. The acyl glucuronide is a minor metabolite and has comparable pharmacological activity to MPA. To avoid the variability in MPA absorption between doses, mycophenolic acid delayed-release tablets should be taken on an empty stomach.
However, in the early post-transplant period, mean MPA AUC and Cmax were approximately one-half of those measured 6 months post-transplant. However, it should be noted that for unexplained reasons, the healthy volunteers in this trial had about a 50% lower AUC compared to healthy volunteers in other studies, thus making comparison between volunteers with alcoholic cirrhosis and healthy volunteers difficult. At the same dose administered based on body surface area, the respective mean Cmax and AUC of MPA determined in children were higher by 33% and 18% than those determined for adults. These reductions in trough MPA concentrations tended to diminish within 14 days of antibiotic therapy and ceased within 3 days after discontinuation of antibiotics. Mycophenolate sodium was not genotoxic in the bacterial mutation assay (Salmonella typhimurium TA 1535, 97a, 98, 100, and 102) or the chromosomal aberration assay in human lymphocytes. The most frequent reasons for dose reduction in the mycophenolic acid delayed-release tablets arm were adverse reactions (44%), dose reductions according to protocol guidelines (17%), dosing errors (11%) and missing data (2%). If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Some commonly used diagnostic criteria include 1) 12 months of spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical therapy), or 2) postsurgical from a bilateral oophorectomy. The predominant metabolite of MPA is the phenolic glucuronide (MPAG) which is pharmacologically inactive.
In stable renal transplant patients on cyclosporine, USP MODIFIED based immunosuppression, gastrointestinal absorption and absolute bioavailability of MPA following the administration of mycophenolic acid delayed-release tablet was 93% and 72%, respectively. The free MPA concentration may increase under conditions of decreased protein binding (uremia, hepatic failure, and hypoalbuminemia). In stable renal transplant patients on cyclosporine, USP MODIFIED based immunosuppression, approximately 28% of the oral mycophenolic acid delayed-release tablets dose was converted to MPAG by presystemic metabolism.
MPA resulting from the deconjugation may then be reabsorbed and produce a second peak of MPA approximately 6 to 8 hours after mycophenolic acid dosing.
The postulated mechanism for this interaction is an antibiotic-induced reduction in glucuronidase-possessing enteric organisms leading to a decrease in enterohepatic recirculation of MPA. In a 104-week oral carcinogenicity study in mice, MMF was not tumorigenic at a daily dose level as high as 180 mg per kg (which corresponds to 0.6 times the recommended mycophenolate sodium therapeutic dose, based on body surface area). Patients were administered either mycophenolic acid delayed-release tablets 1.44 grams per day or MMF 2 grams per day within 48 hours post-transplant for 12 months in combination with cyclosporine, USP MODIFIED and corticosteroids. Treatment failure was defined as the first occurrence of biopsy-proven acute rejection, graft loss, death, or lost to follow-up at 6 and 12 months.
Changes to mycophenolic acid therapy should only be undertaken under appropriate supervision in transplant recipients in order to minimize the risk of graft rejection. Because these postmarketing data are reported voluntarily, it is not always possible to reliably estimate the frequency of particular adverse outcomes.
A minor metabolite AcMPAG which is an acyl glucuronide of MPAG is also formed and has pharmacological activity comparable to MPA. Mycophenolic acid delayed-release tablets pharmacokinetics is dose proportional over the dose range of 360 to 2160 mg.
The mean elimination half-life of MPA and MPAG ranged between 8 and 16 hours, and 13 and 17 hours, respectively.
Hepatic disease, such as primary biliary cirrhosis, with other etiologies may show a different effect. The change in trough level may not accurately represent changes in overall MPA exposure; therefore, clinical relevance of these observations is unclear.
Treatment failure was defined as the first occurrence of biopsy proven acute rejection, graft loss, death or lost to follow-up at 6 months. For comparison, the background rate for congenital anomalies in the United States is about 3%, and NTPR data show a rate of 4% to 5% among babies born to organ transplant patients using other immunosuppressive drugs. A fraction of MPAG also undergoes biliary excretion, followed by deconjugation by gut flora and subsequent reabsorption as MPA. There are no relevant qualitative or quantitative differences in the teratogenic potential of mycophenolate sodium and MMF. The mean elimination half-lives of MPA and MPAG ranged between 8 and 16 hours, and 13 and 17 hours, respectively. Dorset Smoke StopWell Woman ClinicPractice Nurses Buffy and Diane provide the opportunity for ladies to discuss and monitor issues relating to a healthy lifestyle.
A reminder is sent if the due date has passed.Well ManOur Practice Nurse can advise you on achieving and maintaining good health, the emphasis being on self-motivation through leaflets and advice.
This includes the elderly or frail, people with asthma or diabetes, those with long standing heart and lung problems and people on long-term steroids or immuno suppressant treatment.Disease ManagementMany long-term conditions need regular monitoring and blood tests.
Your Doctor or the Practice Nurse can advise you.Minor Surgical ProceduresWe have a well-equipped minor surgery room. Warts, verrucas and some other skin problems can be treated by freezing with Liquid Nitrogen.Ante-Natal and Post-Natal ClinicsOur attached midwives run these clinics, providing full maternity care.



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