Flonida Cream (Generic Fluorouracil Cream)

Flonida Cream (Generic Fluorouracil Cream) is used for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas, when conventional methods are impractical, such as with multiple lesions and difficult treatment sites.

1. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy

2. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Flonida Cream (Generic Fluorouracil Cream) is used for
the topical treatment of multiple actinic or solar
keratoses of the face and anterior scalp.
In the 5% strength it is also useful in the treatment of
superficial basal cell carcinomas, when conventional
methods are impractical, such as with multiple lesions
and difficult treatment sites.

3. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Fluorouracil Cream is manufactured by Aurochem Laboratories
Private Limited, India and marketed and distributed by A.
Menarini India Private Limited in the strengths of 1% and 5%.

4. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Chemical Structure

5. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
The active ingredient contained in Flonida Cream is
Fluorouracil.
Flonida Cream contains 1% or 5% w/w Fluorouracil.

6. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Uses of Flonida 5% & 1% Cream:
Flonida Cream (Generic Fluorouracil Cream) is used for
the topical treatment of superficial pre-malignant and
malignant skin lesions; keratoses including senile, actinic
and arsenical forms; keratoa canthoma; Bowen’s disease;
superficial basal-cell carcinoma.
Deep, penetrating or nodular basal cell and squamous
cell carcinomas do not usually respond to Flonida
cream therapy. It should be used only as a palliative
therapy in such cases where no other form of treatment is
possible.
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7. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Uses of Flonida 5% & 1% Cream:
Flonida Cream is recommended for the topical treatment of
multiple actinic or solar keratoses, and in the treatment of
superficial basal cell carcinoma when conventional
methods are impractical, such as with multiple lesions or
difficult treatment sites.
The diagnosis should be established prior to treatment,
since this method has not been proven effective in other
types of basal cell carcinoma.
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8. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Recommended Adult Dosage
The dosing instructions for Flonida Cream (Generic
Fluorouracil Cream) is given below:
The patient must be instructed to apply sufficient medication to
cover the entire face or other affected areas.
Apply medication twice daily with fingertips and wash hands
afterwards. A treatment period of 2 to 6 weeks is usually required.
Increasing the frequency of application and a longer period of
administration with Flonida Cream (Generic Fluorouracil Cream)
may be required on areas other than the head and neck.
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9. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Recommended Adult Dosage
When Flonida cream is applied to keratotic skin, a response
occurs with the following sequence: erythema, usually followed
by scaling, tenderness, erosion, ulceration, necrosis and re-
epithelization.
When the inflammatory reaction reaches the erosion, ulceration
and necrosis stages, the use of the medicine should be
terminated. Responses may sometimes occur in areas which
appear clinically normal. These may be sites of subclinical
actinic (solar) keratosis which the medication is affecting.
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10. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Contraindications
➔Flonida Cream is contraindicated in patients with a known
hypersensitivity to Fluorouracil or parabens or any component of
the tablet.
➔
Administration of Flonida Cream is contraindicated in women
who are or may become pregnant during therapy and in mothers
who are breast-feeding. Fluorouracil has been shown to be
teratogenic.
➔Flonida Cream should not be used in patients with
Dihydropyrimidine Dehydrogenase (DPD) enzyme deficiency.

11. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Storage Instructions
Flonida Cream (Generic Fluorouracil Cream) have to be stored at
controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F)
with excursions permitted between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away from children and
pets.
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12. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Warnings
If an occlusive dressing is used, there may be an increase in the
incidence of inflammatory reactions in the adjacent normal skin.
Prolonged exposure to ultraviolet lights should be avoided while
under treatment with Flonida Cream because the intensity of the
reaction may be increased.
Since Fluorouracil is known to have teratogenic properties, the
potential value of its use in women of child-bearing potential
should be weighed against the risks involved.
Appropriate therapy for pre-existing concomitant inflammatory
dermatoses should be instituted before using Flonida Cream.
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13. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Possible Side Effects
Side effects that have been reported include Pain, pruritus, burning,
irritation, inflammation, allergic contact dermatitis and telangiectasia .
Occasionally, hyperpigmentation and scarring have also been
reported.
Ulcerations, other local reactions, cases of miscarriage, and a birth
defect (ventricular septal defect) have been reported when
Fluorouracil Cream was applied to mucous membrane areas.
Leukocytosis is the most frequent hematological side effect.
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14. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Possible Side Effects
Although a causal relationship is remote, other side effects which have
been reported infrequently are:
Central Nervous System: Emotional upset, insomnia, irritability.
Gastrointestinal: Medicinal taste, stomatitis.
Hematological: Eosinophilia, thrombocytopenia, toxic granulation.
Integumentary: Alopecia, blistering, bullous pemphigoid, discomfort,
ichthyosis, scaling, suppuration,
swelling, telangiectasia, tenderness, urticaria, skin rash.
Special Senses: Conjunctival reaction, corneal reaction, lacrimation,
nasal irritation.
Miscellaneous: Herpes simplex.
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15. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Flonida Cream Overdosage
Ordinarily, overdosage will not cause acute problems. If Flonida
Cream (Generic Fluorouracil Cream) accidentally comes in
contact with the eye(s), flush the eyes(s) with water or normal
saline.
If Flonida cream is accidentally ingested, induce emesis and
gastric lavage. Administer symptomatic and supportive care as
needed.
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16. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Flonida Cream during Pregnancy
Fluorouracil Cream (Flonida Cream) has been classified by the
US FDA as Pregnancy Category X.
Fluorouracil may cause fetal harm when administered to a
pregnant woman. Fluorouracil is contraindicated in women who
are or may become pregnant.
If this medicine is used during pregnancy, or if the patient
becomes pregnant while taking this medicine, the patient should
be apprised of the potential hazard to the fetus.
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17. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Flonida Cream during Pregnancy
No adequate and well-controlled studies have been conducted in
pregnant women with either topical or parenteral forms of Fluorouracil.
One birth defect (ventricular septal defect) and cases of miscarriage
have been reported when fluorouracil was applied to mucous
membrane areas. Multiple birth defects have been reported in the
fetus of a patient treated with intravenous Fluorouracil.
Fluorouracil, the active ingredient, has been shown to be teratogenic in
mice, rats, and hamsters when administered parenterally at doses
greater than or equal to 10, 15 and 33 mg/kg/day, respectively,[4X, 11X
and 20X, respectively, the Maximum Recommended Human Dose
(MRHD) based onbody surface area (BSA)].
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18. Flonida Cream (Generic Fluorouracil Cream)
© The Swiss Pharmacy
Flonida Cream (Generic Fluorouracil Cream) are
manufactured by Aurochem Laboratories Private
Limited, India and marketed and distributed by A.
Menarini India Private Limited. are manufactured by
Limited, India.
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