Buy Fotil forte eye drops 40 mg/ml + 5 mg/ml 5 ml
  • Buy Fotil forte eye drops 40 mg/ml + 5 mg/ml 5 ml

Fotil®

Santen
716 Items
2019-09-19
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$28.31
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Clinical Pharmacology

Combined antiglaucoma drug.

Pilocarpine - m-cholinomimetic. When instilled into the eye, pilocarpine causes miosis, accommodation spasm and reduces intraocular pressure. The reduction in intraocular pressure is due to the contraction of the ciliary muscle and the muscles of the iris, which leads to an increase in the angle of the anterior chamber of the eye and changes the physical structure of the trabecular meshwork, facilitating the outflow of aqueous humor. This effect lasts from 4 hours to 14 hours.

Timolol, as a beta-blocker, prevents the binding of sympathomimetic neurotransmitters with β1- and β2-adrenoreceptors in the ciliary body. Reduces intraocular pressure, reducing the production of aqueous humor. The hypotensive effect occurs 20 minutes after instillation, reaches a maximum after 2 hours and lasts about 24 hours.

Indications

Glaucoma or increased intraocular pressure when a combination of timolol and pilocarpine is needed:

  • open-angle glaucoma;
  • angle-closure glaucoma;
  • secondary glaucoma;
  • increased intraocular pressure after ophthalmic surgery.

Composition

1 ml of eye drops contains:

Active ingredients: timolol maleate 6.84 mg, pilocarpine hydrochloride 40 mg.

Excipients: benzalkonium chloride - 0.1 mg, citric acid - 0.88 mg, sodium citrate - 6.13 mg, hypromellose - 5 mg, water d / and - up to 1 ml.

Fotil® is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Fotil forte Santen France eye drops
Fotil® Santen France eye drops

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Fotil®

Dosage and Administration

Treatment should begin at the first manifestations of the disease to prevent the sharp development of its exacerbation.
1% cream Elidel 2 times a day, apply a thin layer on the affected surface and gently rub until completely absorbed.
Elidel 1% cream can be applied to the skin of any parts of the body, including the head, face, neck, as well as diaper areas.
Cream Elidel should be applied 2 times a day, until the complete disappearance of symptoms of the disease. If the severity of symptoms persists after 6 weeks of use of the drug, it is necessary to re-examine the patient to confirm the diagnosis of atopic dermatitis. After cessation of treatment, in order to avoid subsequent exacerbations, therapy should be resumed at the first sign of atopic dermatitis recurrence.
Emollients can be applied immediately after applying 1% Elidel cream. However, after water treatments, emollients should be applied before applying Elidel cream.
Given the very slight systemic absorption of pimecrolimus, there are no limitations to the total daily dose of the applied preparation, the area of ​​the treated skin surface or the duration of treatment.
If Elidel gets into eyes, mucous membranes (oral or nasal cavities), immediately remove the cream and rinse eyes and mucous membranes with running water.

Adverse reactions

Applying 1% Elidel Cream can cause minor transient reactions at the site of application, such as a feeling of warmth and / or burning. At considerable severity of these reactions, patients should consult a doctor.
The most common adverse events were reactions at the site of application of the drug in 19% of patients treated with 1% Elidel cream and in 16% of patients from the control group. These reactions mainly occurred at an early stage of treatment, were minor / moderate and short. The following adverse events are listed in frequency, starting with the most frequent. The frequency of occurrence of undesirable reactions was estimated as follows: arising “very often” - ≥1 / 10, “often” - ≥1 / 100 <1/10, “sometimes” - ≥1 / 1000 <1/100, “rarely” - ≥ 1/10 000 <1/1000, “very rarely” - <1/10 000, including individual messages.

  • Very often: a burning sensation at the site of application of the cream. Often: local reactions (irritation, itching and redness of the skin), skin infections (folliculitis). Sometimes: suppuration; worsening disease; herpes simplex; dermatitis due to herpes simplex virus (herpes eczema); molluscum contagiosum, local reactions such as rashes, pain, paresthesias, desquamation, dryness, swelling, skin papillomas, boils.

The undesirable reactions presented below were noted in the post-marketing use of the drug (an estimate of the frequency by the number of cases of AE in an unspecified population).

  • On the part of the immune system: very rarely - anaphylactic reactions.
  • On the part of the metabolism (metabolic disorders): rarely intolerance to alcohol.
  • From the skin and its appendages: rarely allergic reactions (rash, urticaria, angioedema); skin color changes (hypopigmentation, hyperpigmentation).
  • In most cases, immediately after ingestion of alcohol, a reddening of the face, rash, burning, itching or swelling developed.
  • With the use of Elidel cream, the development of malignant neoplasms, including cutaneous and other types of lymphomas, skin cancer was rarely observed. The causal relationship between these adverse events and the use of the drug has not been established.

Contraindications

Carefully

  • There are no data on the safety of using Elidel cream in patients with Netherton syndrome and generalized erythroderma. Given the possible risk of increasing systemic absorption of the drug, Elidel cream is not recommended for use in patients with Netherton syndrome or in severe forms of inflammation or skin lesions (for example, erythroderma).
  • Since the efficacy and safety of using Elidel cream in immunocompromised patients has not been studied, the drug is not recommended for use in this category of patients.
  • Safety data for long-term use of Elidel cream are not available.
  • Since the effect of long-term use of the drug on the immune protection of the skin and the incidence of malignant tumors has not been studied, Elidel Cream should not be applied to the damaged areas of the skin with possible malignancy or dysplastic changes.
  • In the case of bacterial or fungal skin lesions, the use of Elidel cream on the affected areas is possible only after the infection has been cured.

Drug interactions

Potential interactions of 1% Elidel cream with other drugs have not been studied. Given that the systemic absorption of pimecrolimus is very small, any interaction of Elidel cream with drugs for systemic use is unlikely.
When applying Elidel cream in children aged 2 years and older, the drug did not affect the effectiveness of vaccination.
It is not recommended to apply the cream on the vaccine injection area until the local manifestations of the post-vaccination reaction completely disappear.
Incompatibility. Since compatibility studies have not been conducted, it is not recommended to use the drug in conjunction with other local means.

Pregnancy and Lactation

  • Pregnancy. Data on the use of 1% Elidel cream in pregnant women do not. In experimental studies with local use of the drug direct or indirect damaging effect of Elidel on the course of pregnancy, the development of the embryo / fetus, the course of labor and the postnatal development of the offspring were not detected. Care should be taken when prescribing 1% Elidel cream to pregnant women. However, given the minimum degree of absorption of pimecrolimus when applied topically, the potential risk in humans is considered negligible.
  • Lactation. The excretion of the drug with breast milk after topical application in experimental models has not been studied. Data on the content of pimecrolimus in breast milk in nursing women is not. Since many drugs are excreted in breast milk, care should be taken when prescribing 1% Elidel cream to nursing women. However, given the minimal degree of systemic absorption of pimecrolimus when applied topically, the potential risk to humans is considered negligible.
  • Nursing women should not apply 1% Elidel cream on the breast area.
  • The effect of Elidel cream on fertility in men and women has not been established.

Special instructions

In the treatment with topical calcineurin inhibitors, including Elidel, in rare cases, malignant neoplasms have been observed (for example, skin tumors and lymphomas). The causal relationship between these adverse events and the use of the drug has not been established.
In clinical studies with the use of Elidel cream, 0.9% of patients (14 out of 1544) developed lymphadenopathy. Typically, lymphadenopathy was due to infectious diseases and disappeared after a course of appropriate antibiotic therapy. In all patients, either it was possible to identify the cause of the development of lymphadenopathy or the disappearance of this adverse event was noted. In patients receiving treatment by Elidel with the development of lymphadenopathy, it is necessary to establish the etiology of the process and ensure that patients are monitored until this undesirable phenomenon completely disappears. If the etiology of lymphadenopathy is unknown or the patient has acute mononucleosis, the drug should be discontinued.
When treating with Elidel cream, patients are advised to minimize artificial or natural skin insolation or to completely avoid ultraviolet radiation.The possible effect of the use of the drug in skin lesions caused by ultraviolet irradiation is unknown.

Influence on ability to drive motor transport or work with mechanisms:
The impact of the use of Elidel cream on the ability to drive vehicles or work with mechanisms has not been established.

Overdosage

Cases of overdose or accidental use of 1% Elidel cream orally were not observed.

Studies and clinical trials of Fotil (Click to expand)

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