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Introduction About CERTICAN 0.25MG TABLET

CERTICAN 0.25MG TABLET contains Everolimus which belongs to the group of medicines called Immunosuppressants. It is used for the management of organ rejection in transplant patients (organs like kidney or liver). It is also used together with other medicines, such as ciclosporin for the transplantation of kidney, tacrolimus for liver transplantation, and corticosteroids. Organ transplant rejection is when a new organ is transplanted into the body, our body recognizes it as a foreign element and tries to attack and reject it because it is not originally part of the body.

Before taking CERTICAN 0.25MG TABLET, inform your doctor if you have or ever had recent major surgery, or if you still have an unhealed wound following surgery, skin cancer, high cholesterol, or triglycerides, Lapp lactase deficiency or glucose-galactose malabsorption, angioedema, heart problems, liver problems, and kidney problems.

CERTICAN 0.25MG TABLET is not recommended for use in children and adolescents (below 18 years of age) and elders (65 years and above). CERTICAN 0.25MG TABLET is generally not recommended for use among pregnant and breastfeeding women. The most common side effects of taking CERTICAN 0.25MG TABLET are nausea, swelling of the lower legs, ankles, and feet, vomiting, diarrhea, stomach pain, infections, anemia, headache, anxiety. Contact your physician for advice if any of the symptoms worsen.

Uses Of CERTICAN 0.25MG TABLET

It is used:

for the management of organ rejection in transplant patients (organs like kidney or liver)
together with other medicines, such as ciclosporin for the transplantation of kidney, tacrolimus for liver transplantation, and corticosteroids

How CERTICAN 0.25MG TABLET Works

CERTICAN 0.25MG TABLET works by suppressing the activity of the body's immune system and managing the rejection of the transplanted organ.

How to use CERTICAN 0.25MG TABLET

Take CERTICAN 0.25MG TABLET as advised by your physician. Swallow the medicine with enough water. Do not crush or chew the CERTICAN 0.25MG TABLET. The correct dose and duration will be decided by your physician for you depending on your age, body weight, and disease condition.

Side Effects Of CERTICAN 0.25MG TABLET

Common

infections (viral, bacterial, and fungal infections, urinary tract infections, upper and lower respiratory tract infections, lung infections, including pneumonia, inflammation of the pharynx, and the common cold)
anemia (reduced red blood cell count)
low levels of white blood cells (infection, reduced blood platelet count can lead to bleeding and/or bruising underneath the skin)
increased level of fats in the blood
the onset of diabetes (high level of sugar in the blood)
decreased potassium level in the blood
anxiety
problems falling asleep (insomnia)
headache
fluid collection in the sac around the heart (if severe it can decrease the heart's ability to pump blood)
high blood pressure
venous thrombosis (due to blood clot blockage of a major vein)
collection of fluid on the lungs and in the chest cavity
coughing
breathlessness
diarrhea
nausea
vomiting
stomach pain
fever
accumulation of fluid in the tissues
abnormal wound healing
blood poisoning
cancers and benign tumors
thrombocytopenic purpura/hemolytic uremic syndrome (kidney damage with low blood platelets and low red blood cell counts, with or without a rash)
fast heartbeat
nose bleeds
decreased numbers of blood cells (symptoms may include weakness, bruising and frequent infections)
clotting of the blood vessels in the kidney (which may result in graft loss mostly within the first 30 days after kidney transplantation)
bleeding disorders
cyst containing lymph fluid
pain in the mouth or throat
inflammation of the pancreas
mouth sores
acne
hives (urticaria) and other allergic symptoms (like swelling of the face or throat)
joint pain, muscle pain
protein in the urine
kidney disorders
impotence
hernia at the site of surgery

Uncommon

lymph tissue cancer (lymphoma/post-transplant lymphoproliferative disorder)
low levels of testosterone
inflammation of the lungs or liver
jaundice
ovarian cysts

Stop taking CERTICAN 0.25MG TABLET and contact your doctor immediately if you experience any of the following side effects:

infections
inflammation of the lungs
allergic reactions
fever and bruising under the skin (red dots, with or without unexplained tiredness, confusion, yellowing of the skin or eyes, and reduced urine output)
lung or breathing problems (new or worsening cough, shortness of breath, difficulty breathing or wheezing)
fever, usually feeling unwell, abdominal or chest pain, chills, burning sensation when urinating
swelling of tongue, lips, face, or throat
difficulty swallowing
spontaneous bruising or bleeding
pain, unusual warmness, swelling, or oozing from the site of surgery

How To Manage Side Effects

Diarrhea

Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your physician.

Nausea And Vomiting

Take this medicine with, or just after meals. Stick to simple meals. Avoid eating oil-rich or spicy foods.

Stomach Pain

Try to rest and relax. Eat and drink gradually or try to have lesser and more frequent meals. Keep a heating pad on your stomach. Contact your physician for advice if the symptom does not improve.

Warning & Precautions

Pregnancy

Risky

CERTICAN 0.25MG TABLET should not be given to pregnant women unless the potential benefit outweighs the potential risk to the fetus. Consult your doctor before taking it.

Breastfeeding

Contraindicated

CERTICAN 0.25MG TABLET is not recommended for use in breastfeeding women as it may pass through breast milk. Consult your doctor before taking it.

Kidney

Use with Caution

CERTICAN 0.25MG TABLET should be taken with caution in patients with kidney problems. Consult your doctor before taking.

Liver

Use with Caution

CERTICAN 0.25MG TABLET should be taken with caution in patients with liver problems. Consult your doctor before taking.

Allergy

Contraindicated

Do not take CERTICAN 0.25MG TABLET if you are allergic to Everolimus or any of the other ingredients of this medicine.

Heart Disease

Use with Caution

CERTICAN 0.25MG TABLET should be taken with caution in patients with heart problems. Consult your doctor before taking [GBNKEYWROD].

Use In Pediatrics

Consult your doctor

There are no adequate data of the use of [GBNKEYWROD] in children and adolescents to support its use in patients in these age groups. Consult your doctor before taking [GBNKEYWROD].

Use In Geriatrics

Contraindicated

CERTICAN 0.25MG TABLET is generally not recommended for use in elderly patients (above 65 years of age). Consult your doctor before taking CERTICAN 0.25MG TABLET.

Others

Before taking CERTICAN 0.25MG TABLET, inform your physician if you:

have or ever had recent major surgery
have an unhealed wound following surgery
need to have vaccination

Interactions

A. Drug-Drug interactions:

Before taking CERTICAN 0.25MG TABLET, inform your doctor if you are taking any of the following medicine:

medicines used as antibiotics (Ex. rifampicin, rifabutin, clarithromycin, erythromycin, or telithromycin)
medicines used to manage viral infections (Ex. ritonavir, efavirenz, nevirapine, nelfinavir, indinavir or amprenavir)
medicines used to manage fungal infections (Ex. voriconazole, fluconazole, ketoconazole or itraconazole)
medicines used to manage epilepsy (Ex. phenytoin, phenobarbital, or carbamazepine)
medicines used to manage high blood pressure or heart problems (Ex. verapamil, nicardipine, or diltiazem)
medicine used to regulate heartbeat (Ex. dronedarone)
medicines used for lower blood cholesterol (Ex. atorvastatin, pravastatin, or fibrates)
medicines used to manage acute seizures
medicines used as a sedative before or during surgery or other medical procedures (Ex. midazolam)
medicine used to manage acromegaly (Ex. octreotide)
medicine used to inhibit the growth of abnormal cells (Ex. imatinib)
herbal medicine used to manage depression (Hypericum perforatum)

B. Drug-Food interactions:

Avoid having grapefruit or grapefruit juice while taking CERTICAN 0.25MG TABLET as it may increase the risk of side effects.

Overdosage:

If you or anyone else accidentally takes too much of CERTICAN 0.25MG TABLET, consult your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Everolimus
Pharmacological Category	:	Immunosuppressants
Therapeutic Indication	:	Prevention of organ rejection in transplant patients
Dosage Forms	:	Tablet

More Information

Keep CERTICAN 0.25MG TABLET out of reach of children
Store at a room temperature

FAQs About CERTICAN 0.25MG TABLET

Q: What for CERTICAN 0.25MG TABLET used?

A: CERTICAN 0.25MG TABLET is used for the management of organ rejection in transplant patients (organs like kidney, liver, or heart). It is used together with other medicines, such as ciclosporin for the transplantation of kidney and heart, tacrolimus for liver transplantation, and corticosteroids.

Q: How does CERTICAN 0.25MG TABLET works?

A: CERTICAN 0.25MG TABLET acts by suppressing the activity of the body's immune system and manages the rejection of the transplanted organ.

Q: What are the common side effects of CERTICAN 0.25MG TABLET?

A: The most common side effects of taking CERTICAN 0.25MG TABLET are nausea, vomiting, diarrhea, stomach pain, infections, anemia, headache, anxiety. Contact your physician for advice if any of the symptoms worsen.

Q: Is it safe to use CERTICAN 0.25MG TABLET in elderly patients?

A: CERTICAN 0.25MG TABLET is generally not recommended for use in elderly patients (above 65 years of age). Consult your doctor before taking CERTICAN 0.25MG TABLET.

Q: Is there any food to avoid while taking CERTICAN 0.25MG TABLET?

A: Avoid having grapefruit or grapefruit juice while taking CERTICAN 0.25MG TABLET as it may increase the risk of side effects. Consult your physician before taking CERTICAN 0.25MG TABLET.

Q: Can I take CERTICAN 0.25MG TABLET along with antiepileptics?

A: Antiepileptics like phenytoin, phenobarbital, or carbamazepine will affect the efficacy of CERTICAN 0.25MG TABLET. Consult your doctor before taking CERTICAN 0.25MG TABLET.

Q: Is it safe to use CERTICAN 0.25MG TABLET in pregnant and breastfeeding?

A: CERTICAN 0.25MG TABLET is generally not recommended for use in pregnant and breastfeeding women unless considered clearly necessary. Consult your doctor before taking CERTICAN 0.25MG TABLET.

References

1. Alan M. Krensky, Jamil R. Azzi, and David A. Hafler. Immunosuppressants and Tolerogens. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 13th Edition. New York McGraw Hill Medical 2018. Page – 638-653.

2. Mei-Ling Yee and Hui-Hui Tan. Use of everolimus in liver transplantation. World Journal of Hepatology. August 2017. [Accessed on 11th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5569278/

3. Tedesco H, Felipe C, de Sandes Freitas TV, Cristeli MP, Rodrigues C, Medina-Pestana JO. Impact of everolimus: update on immunosuppressive therapy strategies and patient outcomes after renal transplantation. Journals of Transplant Research and Risk Management. January 2011. [Accessed on 11th June 2022] https://www.dovepress.com/impact-of-everolimus-update-on-immunosuppressive-therapy-strategies-an-peer-reviewed-fulltext-article-TRRM

4. Jinyu Liu,Dong Liu,Juan Li,Lan Zhu,Chengliang Zhang,Kai Lei,Qiling Xu,Ruxu You. Efficacy and Safety of Everolimus for Maintenance Immunosuppression of Kidney Transplantation: A Meta-Analysis of Randomized Controlled Trials. Journal of Plos One. January 2017. [Accessed on 11th June 2022] https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0170246

5. Damien Vitiello, Paul-Eduard Neagoe, Martin G Sirois & Michel White. Effect of everolimus on the immunomodulation of the human neutrophil inflammatory response and activation. Journal of Cellular & Molecular Immunology. June 2014. [Accessed on 11th June 2022] https://www.nature.com/articles/cmi201424

6. Novartis Pharmaceuticals UK Limited. Electronic Medicines Compendium (EMC). [Revised in May 2021] [Accessed 11th June 2021] https://www.medicines.org.uk/emc/files/pil.1920.pdf

7. Hikma Pharmaceuticals USA. dailymed.nlm.nih.gov. [Revised in May 2021] [Accessed on 11th June 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cf2dd54b-7a1d-4401-9a01-75e68235e433

8. Novartis Pharmaceuticals Corporation. US Food and Drug Administration. [Revised on January 2018] [Accessed on 11th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560Orig1s022lbl.pdf#page=31

Useful Diagnostic Tests

Complete Blood Count

Author Details

Written By Dr. Janet.C - Pharm.D

Reviewed For Accuracy By Dr. M N Himaja - MBBS

Last updated on 23 Mar 2023 | 03:21 PM(IST)