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Tacrolimus
API (DMF ready) |
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Haorui supplies high quality Tacrolimus API produced by our
GMP facility that has been successfully inspected by the
FDA.
We offer
competitive prices and support our products with reliable technical and
regulatory services. Tacrolimus API is available from R&D to
commercial quantities. Please contact us for more details. |
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The following
information is provided for general information purposes
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What is
Tacrolimus?
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Tacrolimus
belongs to a group of drugs called macrolide lactones or
calcineurin inhibitors. It has similar immunosuppressant
activity to cyclosporin
and is given orally or by injection to prevent organ
transplantation rejection. Tacrolimus is available as
capsules and concentrated injection.
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Clinical trials
have shown tacrolimus (given orally or applied
topically) is often an effective treatment for
inflammatory skin diseases such as atopic
dermatitis and psoriasis.
The topical form of tacrolimus called Protopic? is now
available in many countries.
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How does
Tacrolimus work?
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Tacrolimus works on the immune system and
directly on skin cells. Its mechanism of
action is similar to pimecrolimus
cream.
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It binds to a
receptor within the cell called the FK binding
proteins. This resulting drug-protein complex
inhibits calcineurin (a calcium-dependent phosphatase
transmitting chemical) that in turn reduces the activity
of T-lymphocytes in the immune system.
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In addition, tacrolimus may also have direct
effects on skin cells (keratinocytes). It appears to
reduce the number of IL-8 cytokine receptors on the
keratinocyte, hence reducing
inflammation.
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| What is
tacrolimus used for?
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Tacrolimus ointment is mainly indicated for the
treatment of moderate to severe atopic dermatitis in
adults and children who are: responding
poorly to conventional therapy (emollients, topical and
oral steroids, antibiotics, phototherapy) and/or
suffering
side effects from conventional therapy. |
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Children should only be treated with tacrolimus
ointment 0.03%. A stronger ointment (0.1%) is also
available for adults. Studies have shown that treatment
with topical tacrolimus show benefits after about one
week and maximum improvement at about 3
months. |
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There is no cure for atopic dermatitis, but
tacrolimus provides a steroid-free treatment for
controlling the symptoms. It frequently relieves the
itch and inflammation caused by atopic
dermatitis. Topical tacrolimus may also
be useful for lichen
planus, discoid
lupus and many other inflammatory skin
diseases.
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| Why is tacrolimus
prescribed? |
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Tacrolimus is
used to prevent rejection of liver transplants.
Sometimes it is used to prevent rejection of other types
of transplants.
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This medication
is sometimes prescribed for other uses; ask your doctor
or pharmacist for more
information.
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What special precautions should I
follow?
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tacrolimus:
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1. tell your
doctor and pharmacist if you are allergic to tacrolimus
or any other drugs.
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2. tell your
doctor if you are pregnant, plan to become pregnant, or
are breast-feeding. If you become pregnant while taking
tacrolimus, call your doctor.
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3. if you are
having surgery, including dental surgery, tell the
doctor or dentist that you are taking
tacrolimus.
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| How to use
tacrolimus? |
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Tacrolimus
ointment is a prescription medicine and should be used
only as directed by your doctor. Initial treatment will
be for a short period to assess the response. If it is
effective it may be continued long-term (6-12 months) if
required. A thin layer of ointment should be rubbed in
gently and completely onto the affected area(s) twice
daily.
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| Tacrolimus side
effects: |
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Most patients
tolerate tacrolimus ointment well. The most common side
effect that can be experienced around the site of
application is a feeling of warmth or a sensation of
burning. This is usually mild to moderate in severity
and goes away within a few days after starting
treatment. However, if this reaction persists for more
than one week you should see your doctor. Other less
common side effects include headache, cough, fever,
flu-like symptoms, muscle aches, infection of the hair
follicle (folliculitis)
and acne.
Unlike
topical
corticosteroids, topical tacrolimus has not been
shown to cause skin thinning, hence it is suitable for
application to areas of skin that are thin such as the
face, neck and flexures.There are concerns however that
topical tacrolimus may aggravate herpes
simplex and other viral infections. Long term use
of oral tacrolimus, like other immune suppressive
agents, is known to increase the risk of skin
cancer. |
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| How should
tacrolimus be used? |
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Tacrolimus comes
as a capsule to take by mouth and in an injectable form.
It usually is taken twice a day. Follow the directions
on your prescription label carefully, and ask your
doctor or pharmacist to explain any part you do not
understand. Take tacrolimus exactly as directed. Do not
take more or less of it or take it more often than
prescribed by your doctor. Continue to take
tacrolimus even if you feel well. Do not stop taking
tacrolimus without talking to your doctor. You will
probably take tacrolimus for a long time.
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| What
special dietary instructions should I follow?
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| Avoid drinking
grapefruit juice while taking tacrolimus.
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| What
should I do if I forget a Tacrolimus dose?
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Take the missed
dose as soon as you remember it. However, if it is
almost time for the next dose, skip the missed dose and
continue your regular dosing schedule. Do not take a
double dose to make up for a missed one.
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| What
side effects can tacrolimus cause?
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Although side
effects from tacrolimus are not common, they can occur.
Tell your doctor if any of these symptoms are severe or
do not go away: diarrhea, upset stomach, vomiting,
stomach pain, loss of appetite, insomnia
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| What storage
conditions are needed for tacrolimus?
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Keep this
medication in the container it came in, tightly closed,
and out of reach of children. Store it at room
temperature and away from excess heat and moisture (not
in the bathroom). Throw away any medication that is
outdated or no longer needed. Talk to your pharmacist
about the proper disposal of your medication.
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| What
other tacrolimus information should I know?
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Keep all
appointments with your doctor and the laboratory. Your
doctor will order certain lab tests to check your
response to tacrolimus and do blood tests to see how
your liver and kidneys are working.
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Tacrolimus can
raise your blood pressure. Talk to your doctor about
checking your blood pressure regularly.
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Before receiving
any vaccinations, tell your doctor that you are taking
tacrolimus.
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Disclaimer:
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Information on
this page is provided for general information
purposes. You should not make a clinical treatment
decision based on information contained in this page
without consulting other references including the
package insert of the drug, textbooks and where
relevant, expert opinion. We cannot be held
responsible for any errors you make in administering
drugs mentioned on this page, nor for use of any
erroneous information contained on this page.
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