Flonida Cream (Generic Fluorouracil Cream)

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

2. 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. © The Swiss Pharmacy

3. Flonida Cream (Generic Fluorouracil Cream) 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%. © The Swiss Pharmacy

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

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

6. Flonida Cream (Generic Fluorouracil Cream) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html © The Swiss Pharmacy

7. Flonida Cream (Generic Fluorouracil Cream) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html © The Swiss Pharmacy

8. Flonida Cream (Generic Fluorouracil Cream) Recommended Adult Dosage The dosing instructions for Flonida Cream 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. Flonida Cream (Generic URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html © The Swiss Pharmacy

9. Flonida Cream (Generic Fluorouracil Cream) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html © The Swiss Pharmacy

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

11. Flonida Cream (Generic Fluorouracil Cream) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html © The Swiss Pharmacy

12. Flonida Cream (Generic Fluorouracil Cream) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html © The Swiss Pharmacy

13. Flonida Cream (Generic Fluorouracil Cream) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html © The Swiss Pharmacy

14. Flonida Cream (Generic Fluorouracil Cream) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html © The Swiss Pharmacy

15. Flonida Cream (Generic Fluorouracil Cream) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html © The Swiss Pharmacy

16. Flonida Cream (Generic Fluorouracil Cream) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html © The Swiss Pharmacy

17. Flonida Cream (Generic Fluorouracil Cream) 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)]. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html © The Swiss Pharmacy

18. Flonida Cream (Generic Fluorouracil Cream) Flonida Cream 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html https://www.theswisspharmacy.com/product_info.php?info=p9777_Flonida-cream.html © The Swiss Pharmacy