Descrizione Clinica
Bench drugs Rosiced cream 30g 0.75%
ROSICED 7.5 MG/G CREMA
active ingredients
1 g cream contains metronidazole 7.5 mg (0.75% m/m) Excipient with known effect: 100 g cream contain: For the full list of excipients, see the paragraph 6.1.Excellent
Monolaurate glyceryl, monomiristat gliceryl, propylene glycol, anidro citric acid ( pH regulator), sodium hydroxide ( pH regulator), Carbomeres, purified water.Therapeutic indications
ROSICED 7.5 mg/g Cream is indicated in adults for the topical treatment of the papulo-pustolose inflammatory manifestations of rosacea.Contraindications
- Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1, - Hypersensitivity or medicines containing metronidazole or other 5-nitroimidazoles such as ROSICED 7.5 mg/g Cream. The only exception is cases of potentially fatal infections and if other medicines are ineffective. - During the first trimester of pregnancy. - In patients with severe liver damage, disematopoiesis and diseases of the central or peripheral nervous system, careful risk/benefit assessment is required before treatment with ROSICED 7.5 mg/g Cream.Population
Posology: Apply and gently massage a thin layer of cream on the skin sliced face twice a day, for a usual duration of treatment from 6 to 12 weeks. If necessary, the treatment may be continued (see paragraph 4.4). In the absence of clinical improvement, therapy must be interrupted. Pediatric population: The safety and effectiveness of ROSICED 7.5 mg/g cream in children has not been established; therefore ROSICED 7.5 mg/g cream should not be used in children. Method of administration: Skin use. The areas to be treated must be detergents before the application of the cream. Patients can use non-comedogenic and non-astringent cosmetics after applying the cream.Conservation
Do not store at temperature above 30°C. Do not refrigerate or freeze.Warnings
Avoid contact with eyes and mucosa. In case of contact, the cream must be removed carefully with water. If irritation occurs, you should inform the patient to use ROSICED 7.5 mg/g cream less frequently or to temporarily suspend the therapy and feel the doctor for advice if necessary. Avoid exposure to ultraviolet light (solar beds, solarium, solar lamps), during therapy with ROSICED 7.5 mg/g cream. The recommended duration of therapy should not be exceeded. If required, therapy can be repeated, but a 6 week interval between the two treatments should be held. ROSICED 7.5 mg/g Cream must be used with caution in patients with evidence or anamnesi of blood disorder. You must avoid unnecessary or prolonged use of this medicine. The evidence suggests that metronidazole is carcinogenic in some animal species. There is no evidence so far of a carcinogenic effect in man. Pediatric population: There are no adequate clinical studies on the effectiveness and safety of ROSICED 7.5 mg/g cream in children; therefore ROSICED 7.5 mg/g cream should not be used in children. Excipients with known effects: ROSICED 7.5 mg/g cream contains 400 mg of propylene glycol in 2 g (daily dose), which can cause skin irritation.Interactions
There are no known interactions with other medicines for skin use. An interaction with systemic treatments is unlikely, because the absorption of metronidazole after skin application of ROSICED 7.5 mg/g cream is low. However, it should be remembered that disulfiram-like reactions were reported in a small number of patients taking metronidazole and alcohol at the same time. It is found that the metronidazole taken orally enhances the effect of warfarin and other cumin anticoagulants, resulting in prolongation of protrombine time. It is not known the effect of metronidazole by topical way on the time of protrombine.Effects
The following spontaneous adverse reactions have been reported, according to the classification for systems and organs, according to the frequency using the following convention: very common (≥ 1/10), common (≥1/100,Overdosing
Overdose is extremely unlikely. The cream must be removed by rinsing with hot water. There is no data about overdose in man. Acute oral toxicity studies with topical gel formulation containing 0.75% of metronidazole in the rat showed no toxic action with doses of up to 5g of finished product per kg body weight, the highest dose used. This dose is equivalent to the oral administration of 12 tubes of 30 g of metronidazole cream 0.75% for an adult weighing 72 kg and 2 tubes of cream for a child weighing 12 kg.Pregnancy: The safety of use of metronidazole during pregnancy has not been sufficiently demonstrated. Contradictory reports are available, especially regarding the first phase of pregnancy. Some studies showed an increase in the rate of malformation. The risk of possible sequels, including a cancer risk, has not yet been clarified. In case of uncontrolled use of nitroimidazoles by the mother, the fetus and/or the newborn are exposed to cancer or genotoxic risk. To date, there are no evidence of damage to embryo or fetus. In experimental studies on the animal, metronidazole did not manifest teratogenic properties (see paragraph 5.3). ROSICED 7.5 mg/g Cream is contraindicated during the first trimester of pregnancy. During the central quarter and during the last trimester of pregnancy, ROSICED 7.5 mg/g Cream must be administered only in case of failure of other treatments. Breastfeeding: The metronidazole passes into breast milk. Following oral administration, 100% of the plasma value can be achieved. Following the skin application of ROSICED 7.5 mg/g Cream, plasma levels are lower than those detected after oral administration of metronidazole. However, breastfeeding must be interrupted or the treatment with ROSICED 7.5 mg/g Cream must be suspended.
Source: Farmadati
