drugs

BETABIOPTAL ® Chloramphenicol and Betamethasone

BETABIOPTAL ® is a drug based on chloramphenicol and betamethasone.

THERAPEUTIC GROUP: Ophthalmology - anti-inflammatory and antimicrobial in association.

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications BETABIOPTAL ® Chloramphenicol and Betamethasone

BETABIOPTAL® is indicated in the treatment of eye infections sustained by micro-organisms sensitive to chloramphenicol and characterized by an evident inflammatory component.

Mechanism of action BETABIOPTAL ® Chloramphenicol and Betamethasone

BETABIOPTAL ® is a medicinal specialty consisting of two important active ingredients with different but complementary biological activity, whose synergy is particularly useful for therapeutic purposes.

More precisely, Chloramphenicol is an antibiotic with bacteriostatic activity guaranteed by the ability to bind and inhibit the 50S ribosomal subunit, blocking protein synthesis and thus preventing the performance of normal biological activities of the microorganism, while Betamethasone is a powerful corticosteroid useful to block a upstream the molecular events involved in the synthesis of inflammatory mediators.

Evidently the use of this drug guarantees both a regression of the phlogistic symptomatology present in the course of ophthalmologic affections and the block of the possible bacterial proliferation often cause of comorbidity and lengthening of the healing times.

Studies carried out and clinical efficacy

POST-OPERATIVE PROPHYLAXIS WITH CHLORAMPHENICLE

Acta Ophthalmol. 2013 Mar; 91 (2): 118-22. doi: 10.1111 / j.1755-3768.2011.02324.x. Epub 2011 Dec 13.

Study demonstrating the usefulness of chloramphenicol eye drops in the post-operative phase of cataract surgery in reducing the risk of endophthalmitis.

CHLORAMPHENICLE PHARMACOCINETICS

Clin Experiment Ophthalmol. 2013 Sep; 41 (7): 644-647. doi: 10.1111 / ceo.12087. Epub 2013 Apr 11.

Italian pharmacokinetic study that seeks to characterize the penetration profile of chloramphenicol in the aqueous humor and in the anterior chamber of the eye, thus characterizing the possible biological efficacy against pathogenic microorganisms such as Neisseria, Streptocococcus pneumoniae and others.

THE RISKS OF OTC COLLIRES BASED ON CHLORAMPHENICOL

Int J Pharm Pract. 2013 Apr 17. doi: 10.1111 / ijpp.12033. [Epub ahead of print]

Interesting study that in light of the free marketing of Chloramphenicol based eye drops seeks to characterize any side effects related to the abuse of this product, such as to require a revision of the common guidelines.

Method of use and dosage

BETABIOPTAL ®

Suspension or ophthalmic ointment of 0.5 g of chloramphenicol and 0.2 g of betamethasone per 100 ml or gr of product.

Dosages and timing of intake should be defined by the physician based on the patient's health status and the severity of the present clinical picture.

In principle it is recommended to apply 1 or 2 drops of eye drops or the appropriate amount of ointment 3 to 6 times a day directly into the conjunctival sac.

Warnings BETABIOPTAL ® Chloramphenicol and Betamethasone

BETABIOPTAL ® therapy should be preceded and supervised by your doctor to ensure the safety and effectiveness of the treatment.

It should be remembered that prolonged use of BETABIOPTAL ® could determine:

- increase in ocular tone with possible damage to eyesight and associated structures;

- hypersensitivity reactions with possible irritation of the eye structures;

-selection of multi-drug resistant microbial strains.

The patient should immediately inform his doctor following the appearance of the above side effects.

It is recommended to keep the medicine out of the reach of children.

PREGNANCY AND BREASTFEEDING

The absence of studies able to fully characterize the safety profile of BETABIOPTAL ® for the health of the fetus and the suckling greatly limits the use of this drug during pregnancy and lactation, restricting cases of real need and always under the supervision of your doctor.

Interactions

Drug interactions worthy of clinical note are currently unknown.

Contraindications BETABIOPTAL ® Chloramphenicol and Betamethasone

The use of BETABIOPTAL ® is contraindicated in patients with hypersensitivity to the active ingredient or to one of its excipients and in patients suffering from endocular hypertension, from viral, fungal or purulent infections of the eye and from stye.

Undesirable effects - Side effects

BETABIOPTAL ® therapy, especially when prolonged over time, could lead to the appearance of local side effects such as burning, edema, urticaria, and dermatitis.

It is recommended in these cases to immediately consult the doctor with whom to evaluate the possibility of suspending the therapy in progress.

Note

BETABIOPTAL ® is a drug subject to mandatory medical prescription.