Metronidazole Same 1% Gel 30g

Metronidazole Same 1% Gel

What is Metronidazole Cream for?

METRONIDAZOLE SAME is indicated for topical application in the treatment of papules, inflammatory pustules and rosacea erythema.

Composition

100 g of gel contain: Active ingredient: METRONIDAZOLE 1.0 g. For the full list of excipients, see section 6.1

Excipients

Octyldodecanol, caprilocaproil macrogol – 8 glycerides, carbomer, methyl parahydroxybenzoate, sodium hydroxide, sodium edetate, purified water.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Contraindicated in pregnancy and lactation (see p.4.6).

Dosage

Apply a thin layer of METRONIDAZOLE SAME 1–2 times a day, according to medical indications and after cleansing the affected areas. Significant therapeutic results should be observed within three weeks of starting treatment. Clinical studies have shown progressive improvement for up to nine weeks of therapy. After the application of METRONIDAZOLE SAME it is possible to use cosmetics.

Warnings and Precautions

However, due to the minimal absorption of metronidazole applied locally and, consequently, to negligible plasma concentrations, the undesirable effects reported following oral administration of the drug were not recorded following topical application. Avoid contact with eyes and mucous membranes; Metronidazole applied to the face has been reported to cause lacrimation. In case of contact with the eyes, the gel must be carefully removed with water. The patient should be advised that if irritation occurs, he or she should use Metronidazole Same less frequently or temporarily discontinue therapy and notify the physician. Avoid exposure to ultraviolet light (sun, UV lamps, tanning equipment) during therapy with Same Metronidazole. Since the drug is a nitroimidazole derivative it should be used with caution in patients presenting with blood dyscrasias or with anamnestic data relating to them. The product must be used according to the instructions provided by the attending physician. Do not exceed the recommended dose. The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena. There are no adequate clinical data on the efficacy and safety of Metronidazole Same in children, therefore Metronidazole Same should not be used in children. Do not swallow. Keep out of reach of children.

Interactions

In consideration of the low blood levels following the topical application of Metronidazole, interactions with other drugs are unlikely. However, it should be borne in mind that disulfiram-like reactions have been reported in a small number of patients taking metronidazole and alcohol at the same time and when treating patients receiving concomitant anticoagulant therapy, it should be borne in mind that metronidazole, following oral administration, determines an enhancement of the anticoagulant effects of coumarins and warfarin which occurs by inducing a prolongation of the prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

Side effects

The following side effects have been reported following the use of topical metronidazole: Skin and subcutaneous tissue disorders: contact dermatitis, dry skin, erythema, itching, rash, skin discomfort (burning and stinging sensation), irritation skin, transient redness and worsening of rosacea. Eye disorders: lacrimation None of these side effects occurred in more than 2% of treated patients.

Pregnancy and breastfeeding

The safety of metronidazole use during pregnancy has not been sufficiently demonstrated. Contradicting reports are available, especially regarding the first stage of pregnancy. Some studies have indicated an increase in the rate of malformations. The risk of possible sequelae, including a carcinogenic risk, has not yet been clarified. Same metronidazole is contraindicated during the first trimester of pregnancy. During the middle and last trimester of pregnancy, Metronidazole Same should only be given if other treatments have failed. Following oral administration, metronidazole is secreted into breast milk in concentrations similar to those found in plasma. Following topical application, the drug reaches plasma levels significantly lower than those obtained after oral administration, therefore the treating physician will have to decide whether to stop breastfeeding or treatment with the drug by appropriately evaluating the importance of therapeutic treatment for the mother.

Format

Metronidazole Same cream is sold in packs of 30g gel with 1% concentration.