Generics Name Hydroxyurea
500mg Capsules / Brand Tharolax®
Composition
Packing
Expiry
Hydroxyurea 500mg Capsules, USP
10
3 Yrs
*** 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).
What is hydroxyurea (Tharolax)?
Hydroxyurea affects certain cells in the body, such as
cancer cells or sickled red blood cells. Hydroxyurea is used
to treat chronic myelocytic leukemia, ovarian cancer, and
certain types of skin cancer (melanoma and primary squamous
cell cancer of the head and neck). Hydroxyurea is also used
to reduce pain episodes and the need for blood transfusions
in people with sickle cell anemia. Hydroxyurea will not cure
sickle cell anemia. Hydroxyurea may also be used for
purposes not listed in this medication guide
Tharolax® (hydroxyurea capsules, USP)
500 mg per capsule
Rx only
Hydroxycarbamide (Tharolax®)
Hydroxycarbamide, also
known as hydroxyurea, is a chemotherapy drug usually
given to treat chronic myeloid leukaemia(CML), cervical
cancer and some pre-cancerous conditions.
What is hydroxyurea (Tharolax)?
Hydroxyurea affects certain cells in the
body, such as cancer cells or sickled red blood cells.
Hydroxyurea is used to treat chronic
myelocytic leukemia, ovarian cancer, and certain types of
skin cancer (melanoma and primary squamous cell cancer of
the head and neck).
Hydroxyurea is also used to reduce pain
episodes and the need for blood transfusions in people with
sickle cell anemia. Hydroxyurea will not cure sickle cell
anemia.
Hydroxyurea may also be used for purposes not
listed in this medication guide.
What are the possible side effects of
hydroxyurea (Tharolax)?
Get emergency medical help if you have any of
these signs of an allergic reaction: hives;
difficulty breathing; swelling of your face, lips, tongue,
or throat.
Call your doctor at once if you have a
serious side effect such as:
fever, chills, body aches, flu symptoms,
sores in your mouth and throat;
easy bruising, unusual bleeding (nose,
mouth, vagina, or rectum), purple or red pinpoint spots
under your skin;
pale skin, feeling light-headed or short
of breath, rapid heart rate, trouble concentrating;
skin redness, skin ulcers, or open sores;
painful or difficult urination;
confusion, hallucinations, seizure; or
nausea, pain in your upper stomach,
itching, loss of appetite, dark urine, clay-colored
stools, jaundice (yellowing of your skin or eyes).
Less serious side effects may include:
hair loss;
skin peeling or discoloration, mild rash;
upset stomach, constipation, diarrhea;
headache, dizziness; or
weight gain.
This is not a complete list of side effects
and others may occur. Call your doctor for medical advice
about side effects. You may report side effects to FDA at
1-800-FDA-1088.
Read the
Tharolax (hydroxyurea capsules) Side Effects Center for a
complete guide to possible side effects.
What is the most important
information I should know about hydroxyurea (Tharolax)?
You should not use
hydroxyurea if you are allergic to it, or if you have severe
bone marrow suppression, severe anemia, or low levels of
platelets in your blood.
Before using hydroxyurea,
tell your doctor if you have bone marrow suppression, HIV or
AIDS, liver or kidney disease, or if you are receiving
chemotherapy or radiation.
Wash your hands before and
after you handle a hydroxyurea capsule or the bottle that
contains the pills. For best protection, wear disposable
gloves when handling the pills.
Do not open the hydroxyurea
capsule. Do not use a pill that has been accidentally opened
or broken. The medicine from an open capsule can be
dangerous if it gets in your eyes, mouth, or nose, or on
your skin. If this occurs, wash your skin with soap and
water or rinse your eyes with water.
If any powder from an open
capsule is spilled, wipe it up at once with a damp paper
towel and throw the towel away in a sealed plastic bag where
children and pets cannot get to it.
Hydroxyurea can lower blood
cells that help your body fight infections. This can make it
easier for you to bleed from an injury or get sick from
being around others who are ill. Your blood may need to be
tested often. Your kidney or liver function may also need to
be tested. Visit your doctor regularly.
WARNING
Treatment of patients with
THAROLAX may be complicated by severe, sometimes
lifethreatening, adverse effects. THAROLAX should be
administered under the supervision of a physician
experienced in the use of this medication for the treatment
of sickle cell anemia.
Hydroxyurea is mutagenic and
clastogenic, and causes cellular transformation to a
tumorigenic phenotype. Hydroxyurea is thus unequivocally
genotoxic and a presumed
transspecies carcinogen which implies a carcinogenic risk to
humans. In patients receiving long-term hydroxyurea for
myeloproliferative disorders, such as polycythemia vera and
thrombocythemia, secondary leukemias have been reported. It
is unknown whether this leukemogenic effect is secondary to
hydroxyurea or is associated with the patient's underlying
disease. The physician and patient must very carefully
consider the potential benefits of THAROLAX relative to the
undefined risk of developing secondary malignancies.
Tharolax is used to treat
chronic myeloid leukaemia or cervical cancer.
Your medical team will
discuss with you the options for treating your cancer. They
will take into account factors such as the type of cancer,
where it is, which stage it is at and whether you have had
treatment before. The results of blood tests and other
investigations will also be considered.
How well you feel and how you
are likely to cope with treatment is also important.
Your cancer treatment will
usually consist of a treatment session with Tharolax
followed by a break of a number of days before the next
treatment session with Tharolax. This cycle may be repeated
many times as part of your cancer treatment.
Tharolax works by damaging
cancer cells in the body. Tharolax also affects healthy
cells and treatment with Tharolax may damage your immune
system. Your medical team may arrange for you to have some
blood tests to check how well your immune system is working.
Do not share your medicine
with other people. It may not be suitable for them and may
harm them.
The pharmacy label on your
medicine tells you how much medicine you should take. It
also tells you how often you should take your medicine. This
is the dose that you and your prescriber have agreed you
should take. You should not change the dose of your medicine
unless you are told to do so by your prescriber.
If you feel that the medicine
is making you unwell or you do not think it is working, then
talk to your prescriber.
WARNING:
Along with its benefits, hydroxyurea
treatment may cause severe, sometimes fatal side effects
(see also Side Effects section). Your doctor will follow you
closely while you are taking this medication. Keep all
medical and laboratory appointments.
Cancers have been reported
with the use of this medication but it is not known if these
cancers are due to the drug or the disease being treated.
Consult your doctor for more details.
USES:
This medication is used in people with sickle
cell anemia to reduce the number of painful crises caused by
the disease and to reduce the need for blood transfusions.
It is
also used to treat several types of cancer (such as
melanoma, chronic myelogenous leukemia, squamous cell
carcinomas).OTHER This section contains uses of this drug
that are not listed in the approved professional labeling
for the drug but that may be prescribed by your health care
professional. Use this drug for a condition that is listed
in this section only if it has been so prescribed by your
health care professional. This drug may also be used to
treat polycythemia vera and thrombocythemia.
Generic Manufacturer – Taj Pharmaceuticals
Our number one priority at Generic Manufacturing is to build
innovative and useful packaging, quality and manufacturing
drugs according to the customer's specifications. We can
customize one batch of Generic Medicine or an entire set of
products.
Taj
Pharmaceuticals Ltd. is a Pharmaceutical Generic manufacturer
of Hydroxyurea and manufacturer of various pharmaceutical
formulations in India. Taj Pharmaceuticals Ltd. provide
different pharmaceutical brands and Generic Medicines
The generic
manufacturing strategies of New Drug (Hydroxyurea) and the
product-process of Taj Pharmaceuticals Ltd. are compared and
collaborated using data from global Pharmaceuticals
manufacturing plants in the UK(Newcastle), US, Korea, Italy,
Germany and Japan.
We are an
eminent manufacturer, supplier and exporter of Hydroxyurea and
various pharmaceuticals generics medicines in Tablets,
capsules, Vial (injections), ampule, Strips and schedule packs
etc.
Hydroxyurea
and different pharma Tablet & Capsule formulations are also
available in different drug delivery forms. We also have large
volume manufacturing facilities for these Products.
With over two
decades of experience, we, Taj Pharmaceuticals Ltd., are one
of the leading generic pharmaceutical companies. We believe
that access to quality healthcare is a right, and not a
privilege. Therefore, we endeavor to ensure the availability
of world class, quality medicines at affordable prices across
the globe.
We are
committed to work towards a healthier and happier world. The
company is an integrated, research based international
pharmaceutical company, producing a wide range of quality,
affordable generic (Hydroxyurea) medicines, trusted by
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We offer you
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Hydroxycarbamide can cause a
rash, which may be itchy. Your doctor can prescribe medicine to help
with this. You may also develop leg sores or ulcers. Let your doctor
know if you develop a leg ulcer, as your treatment may need to be
adjusted. Areas of skin that have previously been treated with
radiotherapy may become red and sore. Let your doctor know if this
happens. Rarely, your skin may darken. If it does, it usually
returns to normal a few months after the treatment has finished.
Fever and chills
These may occur from the time your treatment is given, but they
don’t usually last long. Your doctor may prescribe medicines to
reduce these effects.
It’s important to let your doctor know straight away if you feel
unwell or have any severe side effects, even if they’re not
mentioned above.
Additional information
Conditions other than cancer
Hydroxycarbamide may be prescribed for conditions other than cancer.
The drug dosage will be much lower and so the side effects mentioned
in this fact sheet will probably not occur. You should discuss the
treatment and any possible side effects with your relevant
specialist.
Risk of developing a blood clot
Cancer can increase the risk of developing a blood clot
(thrombosis), and chemotherapy may increase this risk further.
A blood clot may cause symptoms such as pain, redness and swelling
in a leg, or breathlessness and chest pain. Blood clots can be very
serious, so it’s important to tell your doctor straight away if you
notice any of these symptoms. Most clots can be treated with drugs
that thin the blood. The doctor or nurse can give you more
information.
Other medicines
Some medicines, including those you can buy in a shop or chemist,
can be harmful to take when you are having chemotherapy. Tell your
doctor about any medicines you are taking, including
over-the-counter drugs, complementary therapies and herbal drugs.
Fertility
Your ability to become pregnant or father a child may be affected by
having this treatment. It's important to discuss fertility with your
doctor before starting treatment.
Contraception
It's not advisable to become pregnant or father a child while having
hydroxycarbamide, as it may harm the developing baby. It’s important
to use effective contraception while having this drug and for at
least a few months afterwards. You can discuss this with your
doctor.
It’s not known whether chemotherapy drugs can be present in semen or
vaginal fluids. To protect your partner, it’s safest to either avoid
sex or use a barrier form of contraception for about 48 hours after
chemotherapy.
Breastfeeding
There's a potential risk that chemotherapy drugs may be present in
breast milk. Women are advised not to breastfeed during chemotherapy
and for a few months afterwards.
Non-cancer admission
If you’re admitted to hospital for a reason not related to the
cancer, it’s important to tell the doctors and nurses looking after
you that you're having chemotherapy treatment. You should tell them
the name of your cancer specialist so that they can ask for advice.
Emergency contacts
It’s a good idea to know who you should contact if you have any
problems or troublesome side effects when you’re at home. Your
chemotherapy nurse or doctor will give you details of who to contact
for advice. This should include ‘out-of hours’ contact details if
you need to call someone at evenings, overnight or at the weekend.
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Treatment of patients with THAROLAX may be
complicated by severe, sometimes lifethreatening, adverse
effects. THAROLAX should be administered under the
supervision of a physician experienced in the use of this
medication for the treatment of sickle cell anemia.
Hydroxyurea is mutagenic and clastogenic,
and causes cellular transformation to a tumorigenic
phenotype. Hydroxyurea is thus unequivocally genotoxic and a
presumed transspecies carcinogen which implies a
carcinogenic risk to humans. In patients receiving long-term
hydroxyurea for myeloproliferative disorders, such as
polycythemia vera and thrombocythemia, secondary leukemias
have been reported. It is unknown whether this leukemogenic
effect is secondary to hydroxyurea or is associated with the
patient's underlying disease. The physician and patient must
very carefully consider the potential benefits of THAROLAX
relative to the undefined risk of developing secondary
malignancies.
Tharolax is used to treat chronic myeloid
leukaemia or cervical cancer.
Your medical team will discuss with you
the options for treating your cancer. They will take into
account factors such as the type of cancer, where it is,
which stage it is at and whether you have had treatment
before. The results of blood tests and other investigations
will also be considered.
How well you feel and how you are likely
to cope with treatment is also important.
Your cancer treatment will usually consist
of a treatment session with Tharolax followed by a break of
a number of days before the next treatment session with
Tharolax. This cycle may be repeated many times as part of
your cancer treatment.
`
How it is given
Your doctor will tell you how many capsules to take
and when to take them. You'll need to make sure you are taking the
right dose.
You should swallow the capsules whole with plenty of water. If you
have trouble swallowing them, you can empty the contents of the
capsules into a glass of water and drink it straight away. You
should avoid touching the contents of the capsules and make sure you
finish the whole drink.The glass and spoon should be washed and kept
separate from your other crockery and cooking utensils.
Chemotherapy is usually given as a course of several sessions
(cycles) of treatment over a few months. The length of your
treatment and the number of cycles you have will depend on the type
of cancer you are being treated for. Your nurse or doctor will
discuss your treatment plan with you.
Before you begin your treatment your doctor will arrange for you to
have blood tests. You will usually be given anti-sickness drugs
before and/or during your treatment.
Possible side effects
Each person’s reaction to chemotherapy is different. Some people
have very few side effects while others may experience more. The
side effects described here won't affect everyone who has
hydroxycarbamide and may be different if you are having more than
one type of chemotherapy drug.
We have outlined the most common side effects but haven't included
those that are rare and unlikely to affect you. If you notice any
effects that aren't listed here, discuss them with your doctor,
chemotherapy nurse or pharmacist.
Risk of infection
Hydroxycarbamide can reduce the number of white blood cells, which
help fight infection. White blood cells are produced by the bone
marrow. If the number of your white blood cells is low you'll be
more prone to infections. A low white blood cell count is called
neutropenia.
Neutropenia begins seven days after treatment, and your resistance
to infection is usually at its lowest 10–14 days after chemotherapy.
The number of your white blood cells will then increase steadily and
usually return to normal before your next cycle of chemotherapy is
due.
Contact your doctor or the hospital straight away if:
your temperature goes above 38ºC (100.4ºF)
you suddenly feel unwell even with a normal temperature.
You'll have a blood test before having more chemotherapy to check
the number of white blood cells. Occasionally, your treatment may
need to be delayed if the number of your blood cells (blood count)
is still low.
Bruising and bleeding
Hydroxycarbamide can reduce the production of platelets, which help
the blood to clot. Tell your doctor if you have any unexplained
bruising or bleeding, such as nosebleeds, bleeding gums, blood spots
or rashes on the skin. You may need to have a platelet transfusion
if your platelet count is low.
Anaemia
Hydroxycarbamide can reduce the number of red blood cells, which
carry oxygen around the body. A low red blood cell count is called
anaemia. This may make you feel tired and breathless. Tell your
doctor or nurse if you have these symptoms. You may need to have a
blood transfusion if the number of red blood cells becomes too low.
Raised levels of uric acid in the blood
This is more likely to happen when you first start taking
hydroxycarbamide. Too much uric acid can affect the kidneys and
result in a condition called gout, which causes inflammation of the
joints. To prevent these effects, you may be given a drug called
allopurinol (Zyloric®), and you may be asked to drink plenty of
fluids. While you're having hydroxycarbamide your uric acid levels
will be checked regularly with blood tests.
Less common side effects
Feeling sick (nausea) or being sick (vomiting)
Your doctor can prescribe very effective anti-sickness (anti-emetic)
drugs to prevent or greatly reduce nausea and vomiting. If the
sickness isn't controlled, or if it continues, tell your doctor they
can prescribe other anti-sickness drugs that may be more effective.
Some anti-sickness drugs can cause constipation. Let your doctor or
nurse know if this is a problem.
Sore mouth
Your mouth may become sore or dry, or you may notice small ulcers
during this treatment. Drinking plenty of fluids, and cleaning your
teeth regularly and gently with a soft toothbrush, can help reduce
the risk of this happening. Some people may find sucking on ice
soothing. Tell your nurse or doctor if you have any of these
problems, as they can prescribe mouthwashes and medicine to prevent
or clear mouth infections.
Taste changes
You may notice that food tastes different. Normal taste usually
comes back after treatment finishes. A dietitian or specialist nurse
at your hospital can give you advice about ways of coping with this
side effect.
Tiredness (fatigue)
Feeling tired is a common side effect of chemotherapy, especially
towards the end of treatment and for some weeks after it’s over.
It’s important to try to pace yourself and get as much rest as you
need. Try to balance this with some gentle exercise, such as short
walks, which will help. If tiredness is making you feel sleepy,
don’t operate or drive machinery.
Diarrhoea
Hydroxycarbamide can cause diarrhoea. This can usually be easily
controlled with medicine, but tell your doctor if it is severe or
continues. It's important to drink plenty of fluids if you have
diarrhoea.
Hair loss
It's very unusual to lose your hair during treatment. Some people
notice that their hair becomes a little thinner but not usually
enough to be noticeable to other people.
Skin changes
Quality
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