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ORGALOX is
A PRESCRIPTION MEDICINE USED WITH OTHER MEDICINES TO HELP
PREVENT ORGAN REJECTION IN PEOPLE WHO HAVE HAD A KIDNEY,
LIVER, OR HEART TRANSPLANT.
ORGALOX IS A PRESCRIPTION MEDICINE USED WITH OTHER MEDICINES
TO HELP PREVENT ORGAN REJECTION IN PEOPLE WHO HAVE HAD A KIDNEY,
LIVER, OR HEART TRANSPLANT. ORGALOX IS NOT FOR USE WITH
MEDICINES CALLED CYCLOSPORINES (GENGRAF®, NEORAL®, AND
SANDIMMUNE®) AND IS NOT FOR USE WITH A MEDICINE CALLED SIROLIMUS
(RAPAMUNE®) IN PEOPLE WHO HAVE HAD A LIVER OR HEART TRANSPLANT.
IT IS NOT KNOWN IF ORGALOX IS SAFE AND EFFECTIVE WHEN USED WITH
SIROLIMUS IN PEOPLE WHO HAVE HAD KIDNEY TRANSPLANTS. IT IS
NOT KNOWN IF ORGALOX IS SAFE AND EFFECTIVE IN CHILDREN WHO HAVE
HAD KIDNEY OR HEART TRANSPLANTS.
What is the most important information I should know about
ORGALOX?
ORGALOX can cause serious side effects, including:
1. Increased risk of cancer. People who take ORGALOX have an
increased risk of getting some kinds of cancer, including skin
and lymph gland cancer (lymphoma).
2. Increased risk of infection. ORGALOX is a medicine that
affects your immune system. ORGALOX can lower the ability of
your immune system to fight infections. Serious infections can
happen in people receiving ORGALOX that can cause death. Call
your doctor right away if you have symptoms of an infection such
as fever, sweats or chills, cough or flu‐like symptoms, muscle
aches, and/or warm, red, or painful areas on your skin.
Do not take ORGALOX if you are allergic to tacrolimus or any of
the ingredients in ORGALOX.
What should I tell my doctor before taking ORGALOX?
Before you take ORGALOX, tell your doctor if you: plan to
receive any live vaccines, have or have had liver, kidney or
heart problems, are pregnant or plan to become pregnant Talk to
your doctor if you are pregnant or plan to become pregnant. Tell
your doctor if you are breastfeeding or plan to breastfeed.
ORGALOX can pass into your breast milk. You and your doctor
should decide if you will take ORGALOX or breastfeed. You should
not do both.
Tell your doctor about all the medicines you take, including
prescription and non-prescription medicines, vitamins, and
herbal supplements. Especially tell your doctor if you take:
cyclosporine (Gengraf®, Neoral®, and Sandimmune®), sirolimus (Rapamune®),
nelfinavir (Viracept®), telaprevir (Incivek®), boceprevir (Victrelis®)
or amiodarone (Cordarone®, Nexterone®, Pacerone®). ORGALOX may
affect the way other medicines work, and other medicines may
affect how ORGALOX works. Know the medicines you take. Keep a
list of your medicines and show it to your doctor and pharmacist
when you get a new medicine.
How Should I Take ORGALOX?
Do not eat grapefruit or drink grapefruit juice while taking
ORGALOX. Take ORGALOX exactly as your doctor tells you to take
it. Take ORGALOX with or without food and the same way and time
every day. If you take too much ORGALOX, call your doctor or go
to the nearest hospital emergency room right away.
ORGALOX may cause serious side effects, including:
• high blood sugar (diabetes). Your doctor may do certain tests
to check for diabetes.
• kidney problems. Your doctor may do certain tests to check
your kidney function.
• nervous system problems
• high levels of potassium in your blood. Your doctor may do
certain tests to check your potassium level.
• high blood pressure. Your doctor will monitor your blood
pressure.
• heart problems (myocardial hypertrophy)
Call your doctor right away if you have any of these symptoms:
frequent urination, increased thirst or hunger, blurred vision,
confusion, drowsiness, loss of appetite, fruity smell on your
breath, nausea, vomiting, stomach pain, muscle tremors, numbness
and tingling, headache, seizures, coma, vision changes,
shortness of breath, chest pain, feel lightheaded, or feel
faint.
Orgalox is an immunosuppressive drug used mainly after
allogeneic organ transplant to lower the risk of organ
rejection. It achieves this by inhibiting the production of
interleukin-2, a molecule that promotes the development and
proliferation of T cells, which are vital to the body's learned
(or adaptive) immune response. Tacrolimus is also used in the
treatment of other T cell-mediated diseases such as eczema (for
which it is applied to the skin in a medicated ointment), severe
refractory uveitis after bone marrow transplants, exacerbations
of minimal change disease, Kimura's disease, and the skin
condition vitiligo.
The most common side effects of ORGALOX are: tremors (shaking of
the body); high blood pressure; kidney problems; diarrhea;
headache; stomach pain; trouble sleeping; nausea; pain; weakness
or low red blood cell count (anemia); infection; constipation;
low levels of phosphate in your blood; swelling of the hands,
ankles, or legs; high levels of fat or potassium in your blood;
numbness or tingling in your hands or feet; fever; or low levels
of magnesium in the blood.
Tell your doctor if you have any side effect that bothers you or
that does not go away. These are not all the possible side
effects of ORGALOX. For more information, ask your doctor or
pharmacist. Call your doctor for medical advice about side
effects.
orgalox is available for oral administration as capsules (tacrolimus
capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg
of anhydrous tacrolimus USP.
PACKING: 10 CAPSULES PER ALU - ALU BLISTER / 500 CAPSULES
Sterile solution (tacrolimus injection) - 5 mL
SPECIAL DISCOUNTED PRICES FOR NGO / HOSPITALS .
Note : This product information is intended only
for residents of the India. Taj Pharmaceuticals Limited,
medicines help to treat and prevent a range of conditions—from the
most common to the most challenging—for people around the world.
Information for Health Care Professionals *** Please consult local Prescribing
Information for any product before use. This website is an
international information resource for healthcare professionals
with an interest in disease management. This website is not
intended to replace the advice of a qualified healthcare
professional. Above brand is a trademark of the Taj group of
companies (Taj Pharmaceuticals Limited).
Prescription medicine
used with other medicines to help prevent organ rejection .