RENODAPT-S
Manufacturer DetailsBIOCON
Biocon Limited 20th KM Hosur Road Electronic City P.O. Bangalore 560 100
us@biocon.com
Compositions:
Mycophenolate 180mg/360mg tablets,
Mycophenolate 180mg/360mg tablets,
| Strength | Rate | Packing Style |
|---|---|---|
| 180mg | 531.36 | 10s tablets |
| 360mg | 1059.76 | 10s tablets |
List of Related Indications:
- Renal Graft Rejection
List Of Drugs:
- Mycophenolate Mofetil-( *** ) @ Immunosuppressive drug- (May 1995)
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Interaction with Food
Pregnancy and lactation
Drug Interaction:
Interacting drugs -summary
+Mycophenolate -
Acyclovir / Ganciclovir or Mycophenolate + Acyclovir
plasma concentrations are increased in presence of renal
impairment as are acyclovir and Ganciclovir. Potential exists for the
two drugs to compete for tubular secretion, further increasing
the concentrations of both drugs
Antacids
absorption decreased when coadministered with aluminium/magnesium
hydrox antacid. Avoid simultaneous administration
Azathioprine
recommended to avoid concomittant use due to lack of clinical studies
Cholestyramine
mycophenolate should not be given with cholestyramine or other agents
that may interfere with enterohepatic recirculation.
Probenecid
in animals, coadministration resulted in threefold increase in plasma
levels
Salicylates
coadministration increased free fraction of MPA
Mycophenate +
Phenytoin
MPA decreased the binding of phenytoin from 90% to 87%
Theophylline
MPA decreased the binding of theophylline from 53% to 45%
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
24. Mycophenolate Mofetil Capsule 250mg/500mg 23-01-08
& oral suspension 200mg/ml
For the prophylaxis of acute organ rejection in patients
receiving allogenic hepatic transplantation
Immunosuppressant drugs include-
Azathioprine, Tacrolimus (FK 506 ), Mycophenolate Mofetil, Cyclosporine, Muromonab -CD3,
Organ rejection
Approved by FDA on May 9, 1995
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Mycophenolate Mofetil 0702-1999
Immuno suppressive agent
2.Mycophenolate mofetil capsules 23-01-2008
250mg, 500mg and
Oral suspension 200mg/ml
(Addl.Indn.)
For the prophylaxis of acute organ rejection in patients receiving
allogenic hepatic transplatation
3.Mycophenolate Mofetil capsules 23-01-2009
250mg
Tablets 500mg
Oral Suspension 200mg/ml
(Addl.Indn.)
For the prophylaxis of acute organ rejection in patients receiving
allogenic heaptic rejection
4.Mycophenolate Mofetil Tablets 31-03-2009
750mg
(Addl.Indn.)
Same as aproved
5.Mycophenolate Sodium 29-10-2009
Enteric coated tablet 540mg
(Addl.Stgth.)
Same as approved
Adverse Reaction:
Body as whole- Pain, abdominal pain, fever, headache, infection, sepsis, asthenia, chest pain, back pain, hypertension.
Hemic/Lymphatic- Anemia, leukopenia, thrombocytopenia, hypochromic anemia, leukocytosis.
GU- Urinary tract infection, hematuria, kidney tubular necrosis, urinary tract disorder .
Metabolic/Nutritional - Peripheral edema, hypercholesteremia,hypophosphatemia, edema, hypokalemia, hyperkalemia,hyperglycemia.
GI- Diarrhea, constipation, nausea, dyspepsia, vomiting, oral moniliasis
Respiratory- Infection, dyspnea, cough increased,pharyngitis, bronchitis, pneumonia
Dermatologic- acne,rash
CNS- Tremor, insomnia, dizziness
Contra-Indications:
Allergic reactions to mycophenolate
Special precautions:
Monitoring- perform complete blood counts wekly during the first month, twice monthyly forsecond and third months, then monthly for the first year. GI haemorrhage.
GI hemorrhage- GI tract hemorrhage has been observed in ablout 3 % of patients treated with mycophenolate.GI tract perforations have rarely been observed.
Most patients receiving mycophenolate were also receiving other drugs known to be associated with these complications.
Because mycophenolate has been associated with an increased incidence of adverse events, including infrequent cases of GI tract ulceration, hemorrhage and perforation, administer with caution in patients with active serious digestive system disease.
Delayed graft function- although patients with delayed graft function have a greater incidence of certain adverse events (eg, anemia, thrombocytopenia, hyperkalemia ) than patients without delayed graft function,these events were not more frequent in patients receiving mycophenolate than azathioprine or placebo.
Warnings-
Lymphomas/malignancies-patients receiving immunosuppressive regimens involving combination of drugs, including mycophenolate, as part of immunosuppresive regimen are at increased risk of developing lymphomas and other malignancies particuarly of the skin.
Oversuppression of the immune system can also increase susceptibility to infection.
Neutropenia- up to 2% of patients receiving mycophenolate developed severe neutropenia.
Monitor patients receiving mycophenolate for neutropenia. Neutropenia has been observed most frequently in the period from 31 to 180 days post-transplant in patients treated for prevention of rejection.
Renal function impairment- subjects with severe chronic renal impairment who have received single doses of mycophenolate showed higher plasma MPA and MPAG AUCs relative to subjects with lesser degree of renal impairment or normal healthy volunteers.
Pregnancy- do not use in pregnant women unless the potential benefits justifies potential risk to the fetus.
Lactation- because of the paotentail for serious advese reactions in nursing infants from
mycophenolate, decide whether to discontunue nursing or todiscontunue the drug takling into account the importance of the drug to the mother.
Children- safety and efficay have not been established.
Dosages/ Overdosage Etc:
Approved by FDA on May 9, 1995
Indications:
Organ rejection
Dosage:
Give initial dose within 72 hrs following transplantation. A dose of 1g administered twice a day (daily dose of 2g) is recommended for use in combination with corticosteroids and cyclosporine in renal transplant patients.
Overdosage-
Symptoms
Nausea, vomiting or diarrhea and occassional hemotologic
abnormalities,principally neutropenia, leading to a need to
reduce or discontinue dosing.
Treatment
1. MPA and MPAGare usually not removed by hemodialysis
2. However, at higher MPAG plasma concentration (. 100mcg/ml) small amounts of MPAG are removed .
3. MPA can be removed by bile acid sequestrants, such as cholestyramine.
Missed dose-
------------------
1. If you miss a dose of this medicine, take it as soon as possible.
2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing
schedule.
3. Do not double doses.
Patient Information:
1. Inform patients of the need for repeated appropiate lab tests while they are receiving mycophenolate
2. Give patients complete dosage instructions and inform them of the increased risk of lymphoproliferative disease and certain other malignancies.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Mycophenolate prolongs the survival of allogeneic transplant in animals. The drug inhibits immunologically medicated inflammatory responses in animal models.
Pharmacokinetics:
Following oral administration, mycophenolate undergoes rapid and extensive absorption and complete presystemic metabolism to MPA, the active metabolite. Negligable amount of the drug is excreted as MPA in the urine. Oral admin resulted in complete recovery of the administered dose, 93% was recovered in the urine and 6% recovered in feces.
Interaction with Food:
Food had no effect on the extent of absorption of mycophenolate when administered at doses of 1.5g twice a daily to renal transplant patients.
Pregnancy and lactation:
Pregnancy-
Do not use in pregnant women unless the potential benefits justifies potential risk to the fetus.
Lactation-
Because of the paotentail for serious advese reactions in nursing infants from mycophenolate, decide whether to discontunue nursing or todiscontunue the drug takling into account the importance of the drug to the mother.
Children-
Safety and efficacy have not been established.
