Brand name: FLORICOT
(FLORICOT (Fludrocortisone, Florinef), Florinef)
US Brand Names : Florinef
Canadian Brand Names Florinef :
Description
FLORICOT (Fludrocortisone, Florinef) (floo-droe-KOR-tis-sone) is a corticosteroid(kor-ti-koe-STE-roid)(cortisone-like
medicine). It belongs to the family of medicines called steroids. Your
body naturally produces similar corticosteroids, which are necessary
to maintain the balance of certain minerals and water for good health.
If your body does not produce enough corticosteroids, your doctor may
have prescribed this medicine to help make up the difference.
FLORICOT (Fludrocortisone, Florinef) may also be used to treat other medical conditions
as determined by your doctor.FLORICOT (Fludrocortisone, Florinef) is available only with
your doctor's prescription, in the following dosage form:
Oral : Tablets (U.S. and Canada)
Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine must
be weighed against the good it will do. This is a decision you and
your doctor will make. For FLORICOT (Fludrocortisone, Florinef), the following should be
considered:
Allergies:
Tell your doctor if you have ever had any unusual or allergic reaction
to FLORICOT (Fludrocortisone, Florinef). Also tell your health care professional if you
are allergic to any other substances, such as foods, preservatives,
or dyes.
Pregnancy :Studies on birth defects in humans have not been done with
FLORICOT (Fludrocortisone, Florinef). Adequate studies have not been done with FLORICOT (Fludrocortisone, Florinef)
in animals,
however many corticosteroids have been shown to cause birth defects.
Before taking this medicine, make sure your doctor knows if you are
pregnant or if you may become pregnant.
Breast-feeding :FLORICOT (Fludrocortisone, Florinef) passes into the breast milk and may
cause problems with growth or other unwanted effects in the nursing
baby.
Children :FLORICOT (Fludrocortisone, Florinef) may slow or stop growth in children or growing
adolescents when used for a long time. The natural production of corticosteroids
by the body may also be decreased by the use of this medicine. Before
this medicine is given to a child or adolescent, you and your child's
doctor should talk about the good this medicine will do as well as
the risks of using it. Follow the doctor's directions very carefully
to lessen the chance that these unwanted effects will occur.Older adults:Many
medicines have not been studied specifically in older people. Therefore,
it may not be known whether they work exactly
the same way
they do in younger adults or if they cause different side effects or
problems in older people. There is no specific information comparing
the use of FLORICOT (Fludrocortisone, Florinef) in the elderly with its use in other age
groups.Other medicines :Although certain medicines should not be used
together at all, in other cases two different medicines may be used
together
even if an
interaction might occur. In these cases, your doctor may want to change
the dose, or other precautions may be necessary. When you are taking
FLORICOT (Fludrocortisone, Florinef), it is especially important that your health care professional
know if you are taking any of the following:
Rifapentine (e.g., Priftin)—Using these medicines may make
FLORICOT (Fludrocortisone, Florinef) less effective because they cause the body to get rid
of it fasterDigitalis glycosides (heart medicine)—FLORICOT (Fludrocortisone, Florinef)
decreases the amount of potassium in the blood, which may increase the
chance
of irregular heartbeatOther corticosteroids (cortisone-like medicine)—Using
any corticosteroid medicine with FLORICOT (Fludrocortisone, Florinef) will cause the body
to get rid of both
medicines faster. This may make either or both medicines less effective.
Also, FLORICOT (Fludrocortisone, Florinef) and other corticosteroids decrease the amount
of potassium in the blood, which may increase the chance of severe
low blood potassium
Sodium-containing medicine—When using FLORICOT (Fludrocortisone, Florinef) to treat
certain types of kidney diseases, too much sodium may cause high blood
sodium, high blood pressure, and excess body water
Other medical problems
The presence of other medical problems may affect the use of FLORICOT (Fludrocortisone, Florinef).
Make sure you tell your doctor if you have any other medical problems,
especially:Bleeding problems—Using FLORICOT (Fludrocortisone, Florinef) and also using
aspirin may cause bleeding problems to become worse.Bone disease—FLORICOT (Fludrocortisone, Florinef)
may make bone disease worse because it causes more calcium to pass
into the urine
Edema (swelling of feet or lower legs) or Heart disease or High
blood pressure or Kidney disease—FLORICOT (Fludrocortisone, Florinef) causes the body
to retain (keep) more salt and water. These conditions may be made
worse by this extra
body water
Herpes infection of the eye—may cause a hole in the cornea
of the eye.
Ulcers in the stomach or intestines—FLORICOT (Fludrocortisone, Florinef) suppresses
the immune system. Infections with these conditions may be made worse
by this suppression.Thyroid disease—The body may not get FLORICOT (Fludrocortisone, Florinef)
out of the bloodstream at the usual rate, which may increase the effect
of
FLORICOT (Fludrocortisone, Florinef) or cause more side effects .
Proper Use of This Medicine
Your doctor may want you to control the amount of sodium in your diet.
When FLORICOT (Fludrocortisone, Florinef) is used to treat certain types of kidney diseases,
too much sodium may cause high blood sodium, high blood pressure, and
excess body water.
Take this medicine only as directed by your doctor . Do not take more
or less of it, do not take it more often, and do not take it for a
longer time than your doctor ordered. To do so may increase the chance
of side effects.
Dosing
The dose of FLORICOT (Fludrocortisone, Florinef) will be different for different patients.
Follow your doctor's orders or the directions on the label . The following
information includes only the average doses of FLORICOT (Fludrocortisone, Florinef). If
your dose is different, do not change it unless your doctor tells you
to do so.
Missed dose FLORICOT (FLORICOT (Fludrocortisone, Florinef), Florinef)
If you miss a dose of this medicine, take it as soon as you remember.
However, if it is almost time for your next dose, skip the missed dose
and go back to your regular dosing schedule. Do not double doses.
Storage FLORICOT (FLORICOT (Fludrocortisone, Florinef), Florinef)
To store this medicine: Keep out of the reach of children. Store
away from heat and direct light. Do not store in the bathroom, near the
kitchen sink, or in other damp places. Heat or moisture may cause the
medicine to break down.Do not keep outdated medicine or medicine no longer
needed. Be sure that any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
Your doctor should check your progress at regular visits to make sure
this medicine does not cause unwanted effects.If you will be using
this medicine for a long time, your doctor may want you to carry a
medical identification card stating that you are
using this medicine.While you are taking FLORICOT (Fludrocortisone,
Florinef), be careful to limit the amount of alcohol you drink.
Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted
effects. Although not all of these side effects may occur, if they
do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects
occur:
Less common or rare
Abdominal pain; agitation or combativeness; anxiety; back or rib pain;
blindness; bloating; bloody or black, sticky stools; blurred vision;
burning in stomach; changes in skin color; chest pain or tightness;
chills; confusion; constipation; convulsions; cough; coughing up blood;
darkened urine; decrease in height; decreased range of motion; decreased
urine output; decreased vision; depression; difficulty swallowing;
dry mouth; expressed fear of impending death; eye pain; eyeballs bulge
out of eye sockets; fainting or lightheadedness when getting up from
a lying or sitting position; fast or slow heartbeat; fever; flushed
dry skin; fractures in arms or legs without any injury; fractures in
the neck or back; fruit-like breath odor; hallucinations; headache;
heartburn; hives; increased fat deposits on face, neck, and trunk;
increased hunger; increased thirst; increased urination; indigestion;
irregular breathing or shortness of breath; irregular heartbeat; joint
pain; lack or slowing of normal growth in children; walking with a
limp; loss of appetite; loss of consciousness; muscle cramps or pain;
nausea or vomiting; nervousness; pain, tenderness, or swelling of foot
or leg; pains in stomach or side, possibly radiating to the back; patients
taking oral medicines or insulin for diabetes may need to increase
the amount they take; pounding in the ears; problems with wound healing;
redness and itching of skin; redness of eyes; redness of face; severe
or continuing dizziness; severe weakness of arms and legs; skin rash;
sweating; swelling of face, fingers, feet, or lower legs; swelling
of nasal passages, face, or eyelids; swollen neck veins; tearing of
eyes; unexplained weight loss; unusual tiredness or weakness; vision
changes; weight gain; wheezing; yellow eyes or skin.
Other side effects may occur that usually do not need medical attention.
These side effects may go away during treatment as your body adjusts
to the medicine. However, check with your doctor if any of the following
side effects continue or are bothersome.
Less common or rare
Acne, pimples; bruising, large, flat, blue or purplish patches in
the skin; change in color of skin or nails; increased sweating; loss
of muscle mass; menstrual changes; muscle weakness; reddish purple
lines on arms, face, legs, trunk, or groin; sleeplessness, trouble
sleeping, unable to sleep; small, red, or purple spots on skin; swelling
of abdominal or stomach area, full or bloated feeling or pressure in
the stomach; thin, fragile skin; unusual increase in hair growth.
Other side effects not listed above may also occur in some patients.
If you notice any other effects, check with your doctor.
Additional Information
Once a medicine has been approved for marketing for a certain use,
experience may show that it is also useful for other medical problems.
Although these uses are not included in product labeling, FLORICOT (Fludrocortisone, Florinef)
is used in certain patients with the following medical conditions:
Idiopathic orthostatic hypotension (a certain type of low blood pressure)
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