Active ingredients: Hydrocortisone (hydrocortisone acetate), Chloramphenicol
CORTISON CHEMYCETIN 2.5% + 2% ointment
CORTISON CHEMICETINA 0.5% + 1% ophthalmic ointment
Why is Cortison Chemicetina used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
CORTISON CHEMYCETIN 2.5% + 2% ointment
Weak corticosteroids, combinations with antibiotics
CORTISON CHEMICETINA 0.5% + 1% ophthalmic ointment
Corticosteroids and anti-infectives in combination
THERAPEUTIC INDICATIONS
CORTISON CHEMYCETIN 2.5% + 2% ointment
Topical treatment of acute inflammatory superficial skin lesions associated with bacterial infections from chloramphenicol susceptible strains.
CORTISON CHEMICETINA 0.5% + 1% ophthalmic ointment
Topical treatment of bacterial superficial ocular infections caused by strains sensitive to chloramphenicol, when an "anti-inflammatory action is required."
Contraindications When Cortison Chemicetina should not be used
Hypersensitivity to the active substances or to any of the excipients.
CORTISON CHEMYCETIN 2.5% + 2% ointment
Topical hydrocortisone is contraindicated in patients with acute skin infections untreated by herpes simplex, shingles, chicken pox or other viral infections; cutaneous tuberculosis; untreated fungal skin infections; acne rosacea; perioral dermatitis.
Topical chloramphenicol is contraindicated in patients with leg ulcers.
CORTISON CHEMICETINA 0.5% + 1% ophthalmic ointment
Topical hydrocortisone is contraindicated in patients with known or suspected ulcerative keratitis (for example due to herpes simplex or the use of contact lenses), even in the initial phase (positive fluorescein test); tuberculosis of the eye; fungal infections of the eye; acute purulent ophthalmias, conjunctivitis or blepharitis that may be masked or aggravated by corticosteroids; sty; ocular hypertension.
Precautions for use What you need to know before taking Cortison Chemicetin
If no improvement is observed after one week of treatment with Cortison Chemicetin, the treatment should be discontinued.
Chloramphenicol should not be used for mild infections or for prophylaxis of infections.
In severe skin or eye infections, Cortison Chemicetin can be administered in combination with systemic antibiotic therapy.
Corticosteroids can mask a hypersensitivity reaction to chloramphenicol.
Cortison Chemicetin should be used for short periods of treatment (maximum two weeks), since in the case of prolonged topical applications of corticosteroids and antibiotics, the development of resistant bacteria or mucocutaneous fungal infections may occur (see "Undesirable effects").
Use of contact lenses: particular attention is required in the use of Cortison Chemicetina in patients with contact lenses. Contact lenses must be removed before applying the ointment and cannot be used during the entire treatment period. .
Concomitant topical treatments: the simultaneous application of other topical preparations should be avoided; if necessary, the interval between different applications should be at least 30 minutes.
Interactions Which drugs or foods can modify the effect of Cortison Chemicetina
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Considering the topical and short-term use of Cortison Chemicetina, the occurrence of drug interactions is unlikely.
Concomitant use not recommended with the following drugs
Macrolides and clindamycin: avoid concomitant use as these drugs compete with chloramphenicol at binding sites, reducing the efficacy of chloramphenicol.
Drugs that induce bone marrow depression: Avoid concomitant use of drugs with known potential to suppress bone marrow function, such as clozapine (see "Special warnings").
Tacrolimus and cyclosporine: avoid concomitant use due to a potential increase in toxicity of tacrolimus and cyclosporine.
Concomitant use requiring caution
Anticoagulants: Chloramphenicol may potentiate the effect of anticoagulants, with an increased risk of bleeding. Close monitoring of prothrombin time is recommended if chloramphenicol is added or discontinued.
Phenytoin or Phenobarbital: Concomitant use may increase the risk of phenytoin or phenobarbital toxicity. In case of addition or suspension of chloramphenicol, careful monitoring of phenytoin or phenobarbital levels should be performed.
Sulfonylureas: The hypoglycaemic effect of sulfonylureas may be potentiated by chloramphenicol. In case of concomitant use, careful monitoring of blood glucose is recommended.
Warnings It is important to know that:
Children may have a higher risk of developing topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome than adult patients, due to the higher ratio of skin surface area to body weight (see "Effects This risk increases with prolonged use of potent high-dose topical corticosteroids: considering that hydrocortisone is a low potency corticosteroid and considering the recommended dose of Cortison Chemicetin for short-term use, the onset of such side effects is unlikely.
In infants, the use of excessive doses of chloramphenicol can develop a fatal gray syndrome (abdominal distension, vomiting, cyanosis and circulatory collapse), due to the inability to metabolise and eliminate the drug (see "Undesirable effects"). The onset of this syndrome is dose-dependent and is generally associated with a neonate serum chloramphenicol concentration greater than 5 mg / L. However, Cortison Chemicetin should be administered with caution in neonates.
Elderly patients may be at a higher risk of skin atrophy from topical corticosteroids (see "Undesirable Effects") due to increased skin fragility due to aging.
Topical corticosteroid therapy has been associated with ocular adverse events, including posterior sub capsular cataract, and increased ocular pressure, particularly with prolonged use (see "Undesirable Effects"): therefore, patients with cataracts and glaucoma should be treated with caution.
Potentially life-threatening adverse events such as aplastic anemia and bone marrow depression have been reported following the use of chloramphenicol, including for topical application (see "Undesirable Effects"). A dose-dependent and reversible bone marrow depression may occur when serum chloramphenicol levels exceed 25 mg / L for prolonged periods. Aplastic anemia can be idiosyncratic and irreversible, and can occur weeks or months after drug withdrawal. Available epidemiological data indicate that the risk of aplastic anemia after topical treatment with chloramphenicol is extremely low. However, patients with a history of myeloproliferative disorders or white blood cell count abnormalities or who use concomitant medications that may increase the risk of bone marrow depression (see "Interactions with other medicinal products and other forms of interaction") should be treated with caution. In these patients, careful monitoring of the white blood cell count is recommended and treatment should be stopped immediately if the white blood cell count falls below 3000 / mm3 (3.0 x 109) or if the absolute neutrophil count falls below 1500 / mm3 (1.5 x 109). . Considering the route of administration and the recommended dose for short treatment periods, the occurrence of these undesirable effects with Cortison Chemicetin is unlikely.
Pregnancy and breastfeeding
Pregnancy:
Ask your doctor or pharmacist for advice before taking any medicine. Data on a large number of exposed pregnancies indicate no undesirable effects of hydrocortisone or chloramphenicol on pregnancy or fetal health. To date, no other relevant epidemiological data are available. Caution should be exercised in prescribing Cortison Chemicetin to pregnant women. state of pregnancy. Systemic administration of chloramphenicol at the end of pregnancy can lead to the onset of gray syndrome in the newborn (see "Special warnings"): therefore, the use of Cortison Chemicetin should be avoided during the last week before delivery. .
Feeding time:
Systemically administered hydrocortisone or chloramphenicol is excreted in breast milk. It is not known whether topically administered hydrocortisone or chloramphenicol can be excreted in breast milk.
Theoretically, the infant's intake of corticosteroids can cause growth retardation or interfere with the production of endogenous corticosteroids.
Chloramphenicol given directly to the neonate has been associated with jaundice and gray syndrome. In addition, there may be a potential risk of dose-dependent bone marrow depression in the infant (see "Special warnings"). Therefore, Cortison Chemicetin should not be used while breastfeeding.
Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been performed, but based on the pharmacodynamic properties and topical use of the drug, it is unlikely that Cortison Chemicetin will affect these abilities. Vision may be temporarily blurred after applying ophthalmic ointment.
Important information about some of the ingredients of Cortison Chemicetina
Cortison Chemicetina contains lanolin which may cause local skin reactions (eg contact dermatitis) (see "Undesirable effects"); in case of sensitization, treatment should be stopped.
Dosage and method of use How to use Cortison Chemicetina: Dosage
CORTISON CHEMYCETIN 2.5% + 2% ointment
Before application, wash your hands and the affected skin area. Apply a thin layer of ointment and rub it gently. After application the treated area should not be washed or rubbed. Wash hands again after use. In case of severe skin conditions, an occlusive dressing may be necessary.
Adults:
Cortison Chemicetina ointment should be applied 2-3 times a day. The single dose should be prescribed based on the severity of symptoms and the surface of the lesion. Cortison Chemicetin ointment treatment should continue for at least one week.
Children:
Cortison Chemicetina ointment should be applied 2-3 times a day. Cortison Chemicetin should be used with caution in neonates (see "Special warnings"). In children over 10 years of age, the single dose must be adapted according to the surface to be treated. Treatment with Cortison Chemicetin ointment should continue for at least one week.
CORTISON CHEMICETINA 0.5% + 1% ophthalmic ointment
Wash your hands before application. Tilt your head back and pull the lower eyelid down. Place the tube directly over the eye and squeeze a small amount of Cortison Chemicetina ophthalmic ointment into the lower conjunctival sac. The eye should be gently rotated for 1 - 2 minutes to distribute the ointment. Do not rub the eye. Excess ointment can be removed and hands should be washed again after use.
Adults:
Cortison Chemicetina ophthalmic ointment should be applied 1-3 times a day or more as needed for the first 48 hours. After the first 48 hours, the interval between applications may be increased. Treatment should continue for at least 48 hours after the appearance of the eye has normalized.
Children:
In children, the recommendations for adults apply. In neonates Cortison Chemicetina should be used with caution (see "Special warnings"). Dermatological and ophthalmological indications
Senior citizens:
No dose adjustment is required in elderly patients: however it should be used with caution due to skin fragility linked to aging (see "Special warnings").
Renal / hepatic insufficiency:
In view of the topical use and the short duration of treatment, no dose adjustment is required, although no data are available in these patient populations.
Overdose What to do if you have taken an overdose of Cortison Chemicetin
Symptoms
Since marketing, no cases of overdose with Cortison Chemicetin have been reported. Considering the recommended dosage of Cortison Chemicetin and the route of administration, overdose is unlikely. Accidental ingestion of the ointment is unlikely to cause toxic effects, due to the low corticosteroid and antibiotic content.
Treatment
If burning, swelling, tearing or photophobia occur after accidental eye contact, the exposed eye should be irrigated with copious amounts of room temperature water for at least 15 minutes. If symptoms persist after 15 minutes of irrigation, it should be considered. the possibility of an eye exam. In case of accidental ingestion / intake of an overdose of Cortison Chemicetin, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Cortison Chemicetin, ask your doctor or pharmacist.
Side Effects What are the side effects of Cortison Chemicetina
Like all medicines, Cortison Chemicetin can cause side effects, although not everybody gets them.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.
The following side effects have been reported with Cortison Chemicetin during marketing:
Skin and subcutaneous tissue disorders:
contact dermatitis, eczema, erythema, rash, urticaria
General disorders and administration site conditions:
generalized edema
Prolonged use of Cortison Chemicetina can induce sensitization due to the presence of lanolin.
The following undesirable effects have been observed in patients treated with hydrocortisone or topical corticosteroids.
Skin atrophy is the most common adverse event of topical corticosteroids.
Other effects include:
Infections and infestations: fungal infections
Neoplasms benign, malignant and unspecified (including cysts and polyps): Kaposi's sarcoma
Metabolism and nutrition disorders: hyperglycemia, hypocalcemia
Nervous system disorders: increased intracranial pressure
Eye disorders: glaucoma, ulcerative keratitis, cataracts, ocular hypertension, corneal thinning
Skin and subcutaneous tissue disorders: hirsutism, acne or worsening of acne, telangiectasia, worsening of rosacea, perioral dermatitis, skin hypo or hyperpigmentation, purpura, atrophic striae
General disorders and administration site conditions: difficulty in healing wounds, edema
In pediatric patients (see "Special warnings"):
Endocrine disorders: Cushing's syndrome
Musculoskeletal and connective tissue disorders: growth retardation
The following undesirable effects have been reported in patients treated with topical chloramphenicol:
Blood and lymphatic system disorders: aplastic anemia, neutropenia, thrombocytopenia Immune system disorders: anaphylactic shock, hypersensitivity
Nervous system disorders: burning sensation
Eye disorders: optic atrophy, eye irritation, hyperemia, eyelid edema Skin and subcutaneous tissue disorders: angioedema, pruritus, vesicular rash, maculo-papular rash
General Disorders and Administration Site Conditions: Fever
In infants:
Cardiac disorders: Neonatal gray syndrome (see "Special warnings").
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
EXPIRY: see expiry date printed on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
CORTISON CHEMICETINA 0.5% + 1% ophthalmic ointment: validity after first opening: 28 days.
WARNING: do not use the medicine after the expiry date indicated on the package.
SPECIAL STORAGE PRECAUTIONS: Store at a temperature not exceeding 25 ° C.
Keep this medicine out of the reach and sight of children
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
COMPOSITION
CORTISON CHEMYCETIN 2.5% + 2% ointment
100 g contain:
Active ingredients: hydrocortisone acetate 2.5 g; chloramphenicol 2 g.
Excipients: liquid paraffin; anhydrous lanolin; white petroleum jelly.
CORTISON CHEMICETINA 0.5% + 1% ophthalmic ointment
100 g contain:
Active ingredients: chloramphenicol 1 g; hydrocortisone acetate 0.5 g
Excipients: liquid paraffin; anhydrous lanolin; white petroleum jelly
PHARMACEUTICAL FORM AND CONTENT
Ointment - Aluminum tube and polythene cap - 20 g tube Ophthalmic ointment - Aluminum tube and polythene cap - 3 g tube
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
CORTISON CHEMYCETIN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
CORTISON CHEMYCETIN 2.5% + 2% ointment
100 g contain:
Active principles:
Hydrocortisone acetate 2.5 g; Chloramphenicol 2 g.
CORTISON CHEMICETINA 0.5% + 1% ophthalmic ointment
100 g contain:
Active principles:
Chloramphenicol 1 g; Hydrocortisone acetate 0.5 g.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Ointment.
Ophthalmic ointment.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
CORTISON CHEMYCETIN 2.5% + 2% ointment
Topical treatment of acute inflammatory superficial skin lesions associated with bacterial infections from chloramphenicol susceptible strains.
CORTISON CHEMICETINA 0.5% + 1% ophthalmic ointment
Topical treatment of bacterial superficial ocular infections caused by strains sensitive to chloramphenicol, when an "anti-inflammatory action is required."
04.2 Posology and method of administration
CORTISON CHEMYCETIN 2.5% + 2% ointment
Before application, wash your hands and the affected skin area. Apply a thin layer of ointment and rub it gently. After application the treated area should not be washed or rubbed. Wash hands again after use.
In case of severe skin conditions, an occlusive dressing may be necessary.
Adults
Cortison Chemicetina ointment should be applied 2-3 times a day. The single dose should be prescribed based on the severity of symptoms and the surface of the lesion.
Treatment with Cortison Chemicetin ointment should continue for at least one week.
Children
Cortison Chemicetina ointment should be applied 2-3 times a day. Cortison Chemicetin should be used with caution in neonates (see section 4.4).
In children over 10 years of age, the single dose must be adapted according to the surface to be treated.
Treatment with Cortison Chemicetin ointment should continue for at least one week.
CORTISON CHEMICETINA 0.5% + 1% ophthalmic ointment
Wash your hands before application. Tilt your head back and pull the lower eyelid down. Place the tube directly over the eye and squeeze a small amount of Cortison Chemicetina ophthalmic ointment into the lower conjunctival sac. The eye should be gently rotated for 1 - 2 minutes to distribute the ointment. Do not rub the eye. Excess ointment can be removed and hands should be washed again after use.
Adults
Cortison Chemicetina ophthalmic ointment should be applied 2-3 times a day or more as needed for the first 48 hours. After the first 48 hours, the interval between applications may be increased. Treatment should continue for at least 48 hours after the appearance of the eye has normalized.
Children
In children, the recommendations for adults apply. Cortison Chemicetin should be used with caution in neonates (see section 4.4).
Dermatological or ophthalmological indications
Senior citizens
No dose adjustment is required in elderly patients: however it should be used with caution due to skin fragility linked to aging (see section 4.4).
Renal / hepatic insufficiency
In view of the topical use and the short duration of treatment, no dose adjustment is required, although no data are available in these patient populations.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
CORTISON CHEMYCETIN 2.5% + 2% ointment
Topical hydrocortisone is contraindicated in patients with untreated acute skin infections herpes simplex, herpes zoster, chicken pox or other viral infections; cutaneous tuberculosis, untreated fungal skin infections; rosacea acne; perioral dermatitis.
Topical chloramphenicol is contraindicated in patients with leg ulcers.
CORTISON CHEMICETINA 0.5% + 1% ophthalmic ointment
Topical hydrocortisone is contraindicated in patients with known or suspected ulcerative keratitis (e.g. due to herpes simplex o to the use of contact lenses), even in the initial phase (positive fluorescein test); tuberculosis of the eye, fungal infections of the eye; ophthalmias, conjunctivitis or acute purulent blepharitis that can be masked or aggravated by corticosteroids; stye; ocular hypertension.
04.4 Special warnings and appropriate precautions for use
If no improvement is observed after one week of Cortison treatment
Chemicetin, treatment must be stopped.
Chloramphenicol should not be used for mild infections or for prophylaxis of infections.
In severe skin or eye infections, Cortison Chemicetin can be administered in combination with systemic antibiotic therapy.
Corticosteroids can mask a hypersensitivity reaction to chloramphenicol.
Use of contact lenses: particular attention is required in the use of Cortison Chemicetina in patients with contact lenses. Contact lenses must be removed first
application of the ointment and cannot be used during the entire treatment period.
Concomitant topical treatments: the simultaneous application of other topical preparations should be avoided; if necessary, the interval between different applications should be at least 30 minutes.
Children may have a higher risk of developing topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome than adult patients due to the higher skin surface area to body weight ratio (see section 4.8). This risk increases following prolonged use of high-dose potent topical corticosteroids: considering that hydrocortisone is a low potency corticosteroid and considering the recommended dose of Cortison Chemicetin for short-term use, the onset of such undesirable effects it is unlikely.
In neonates, the use of excessive doses of chloramphenicol can develop a fatal gray syndrome (abdominal distension, vomiting, cyanosis and circulatory collapse), due to the inability to metabolise and eliminate the drug (see section 4.8). The onset of this syndrome is dose-dependent and is generally associated with a neonate serum chloramphenicol concentration greater than 5 mg / L (see section 5.2). However, Cortison Chemicetin should be administered with caution in neonates.
Elderly patients may be at higher risk of topical corticosteroid skin atrophy (see section 4.8) due to increased skin fragility due to aging.
Cortison Chemicetin should be used for short treatment periods (maximum two weeks), as development of resistant bacteria or mucocutaneous fungal infections may occur in case of prolonged topical applications of corticosteroids and antibiotics (see section 4.8).
Topical corticosteroid therapy has been associated with ocular adverse events, including posterior sub capsular cataract, and increased ocular pressure, particularly with prolonged use (see section 4.8): therefore, patients with cataracts and glaucoma should be treated. with caution.
Potentially life-threatening adverse events such as aplastic anemia and bone marrow depression have been reported following the use of chloramphenicol, including for topical application (see section 4.8). A dose-dependent and reversible bone marrow depression can occur when serum levels chloramphenicol exceeds 25 mg / L for prolonged periods. Aplastic anemia can be idiosyncratic and irreversible, and can occur weeks or months after drug withdrawal. Available epidemiological data indicate that the risk of aplastic anemia after topical treatment with chloramphenicol is extremely low. However, patients with a history of myeloproliferative disease or white blood cell count abnormalities or who use concomitant medications that may increase the risk of bone marrow depression (see section 4.5), should be treated with caution. In these patients, careful monitoring of the white blood cell count is recommended and treatment should be stopped immediately if the white blood cell count falls below 3000 / mm3 (3.0 x 109) or if the absolute neutrophil count falls below 1500 / mm3 (1.5 x 109). .
Considering the route of administration and the recommended dose for short treatment periods, the occurrence of these undesirable effects with Cortison Chemicetin is unlikely.
Cortison Chemicetina contains lanolin which can induce sensitization phenomena (see section 4.8); in case of sensitization, treatment should be stopped.
04.5 Interactions with other medicinal products and other forms of interaction
Considering the topical and short-term use of Cortison Chemicetina, the occurrence of drug interactions is unlikely.
Concomitant use not recommended with the following drugs
Macrolides and clindamycin : Avoid concomitant use as these drugs compete with chloramphenicol at binding sites, reducing the efficacy of chloramphenicol.
Drugs that induce bone marrow depression: Avoid concomitant use of drugs with known potential to suppress bone marrow function, such as clozapine (see section 4.4).
Tacrolimus and cyclosporine : avoid concomitant use due to a potential increase in toxicity of tacrolimus and cyclosporine.
Concomitant use requiring caution
Anticoagulants : chloramphenicol may potentiate the effect of anticoagulants, with an increased risk of bleeding. Careful monitoring of prothrombin time is recommended in case of addition or withdrawal of chloramphenicol.
Phenytoin or Phenobarbital : Concomitant use may increase the risk of phenytoin or phenobarbital toxicity. In case of addition or suspension of chloramphenicol, careful monitoring of phenytoin or phenobarbital levels should be performed.
Sulfonylureas : The hypoglycaemic effect of sulfonylureas may be potentiated by chloramphenicol. In case of concomitant use, careful monitoring of blood glucose is recommended.
04.6 Pregnancy and lactation
Pregnancy:
Data on a large number of exposed pregnancies indicate no undesirable effects of hydrocortisone or chloramphenicol on pregnancy or fetal health. To date, no other relevant epidemiological data are available.
Caution should be exercised in prescribing Cortison Chemicetin to pregnant women.
Systemic administration of chloramphenicol at the end of pregnancy can lead to the onset of gray syndrome in the newborn (see section 4.4): therefore, the use of Cortison Chemicetin should be avoided during the last week before delivery.
Feeding time:
Systemically administered hydrocortisone or chloramphenicol is secreted into breast milk.
It is not known whether topically administered hydrocortisone or chloramphenicol can be secreted into breast milk.
Theoretically, the infant's intake of corticosteroids can cause growth retardation or interfere with the production of endogenous corticosteroids.
Chloramphenicol given directly to the neonate has been associated with jaundice and gray syndrome. In addition, there may be a potential risk of dose-dependent bone marrow depression in the infant (see section 4.4).
Therefore, Cortison Chemicetin should not be used while breastfeeding.
04.7 Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been performed, but based on the pharmacodynamic properties and topical use of the drug, it is unlikely that Cortison Chemicetin will affect these abilities. Vision may be temporarily blurred after applying ophthalmic ointment.
04.8 Undesirable effects
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.
The following side effects have been reported with Cortison Chemicetin during marketing:
Skin and subcutaneous tissue disorders: contact dermatitis, eczema, erythema, rash, urticaria
General disorders and administration site conditions: generalized edema
Prolonged use of Cortison Chemicetina can induce sensitization due to the presence of lanolin.
The following undesirable effects have been observed in patients treated with hydrocortisone or topical corticosteroids.
Skin atrophy is the most common adverse event of topical corticosteroids.
Other effects include:
Infections and infestations: fungal infections
Neoplasms benign, malignant and unspecified (including cysts and polyps): Kaposi's sarcoma
Metabolism and nutrition disorders: hyperglycemia, hypocalcemia
Nervous system disorders: increased intracranial pressure
Eye disorders: glaucoma, ulcerative keratitis, cataracts, ocular hypertension, corneal thinning
Skin and subcutaneous tissue disorders: hirsutism, acne or worsening of acne, telangiectasia, worsening of rosacea, perioral dermatitis, skin hypo or hyperpigmentation, purpura, atrophic striae
General disorders and administration site conditions: difficulty in healing wounds, edema.
In pediatric patients (see section 4.4):
Endocrine pathologies: Cushing's syndrome
Musculoskeletal and connective tissue disorders: growth retardation
The following undesirable effects have been reported in patients treated with topical chloramphenicol:
Disorders of the blood and lymphatic system: aplastic anemia, neutropenia, thrombocytopenia
Disorders of the immune system: anaphylactic shock, hypersensitivity
Nervous system disorders: burning sensation
Eye disorders: optic atrophy, eye irritation, hyperemia, eyelid edema
Skin and subcutaneous tissue disorders: angioedema, pruritus, vesicular rash, maculo-papular rash
General disorders and administration site conditions: fever
In infants:
Cardiac disorders: Neonatal gray syndrome (see section 4.4).
04.9 Overdose
Symptoms
Since marketing, no cases of overdose with Cortison Chemicetin have been reported. Considering the recommended dosage of Cortison Chemicetin and the route of administration, overdose is unlikely.
Accidental ingestion of the ointment is unlikely to cause toxic effects due to the low corticosteroid and antibiotic content.
Treatment
If burning, swelling, tearing or photophobia occur after accidental eye contact, the exposed eye should be irrigated with copious amounts of room temperature water for at least 15 minutes. If symptoms persist after 15 minutes of irrigation, it should be considered. the possibility of an eye exam.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
CORTISON CHEMYCETIN 2.5% + 2% ointment
Therapeutic drug category: weak corticosteroids, combinations with antibiotics.
ATC code: D07CA01.
CORTISON CHEMICETINA 0.5% + 1% ophthalmic ointment
Therapeutic drug category: corticosteroids and anti-infectives in combination.
ATC code: S01CA03.
Cortison Chemicetina is a fixed combination of hydrocortisone and chloramphenicol.
Hydrocortisone is a low-potency topical corticosteroid with anti-inflammatory activity.
Chloramphenicol is a broad spectrum antibiotic against Gram positive and Gram negative bacteria and with little evidence of acquired resistance. Chloramphenicol inhibits bacterial protein synthesis by reversibly binding to the 50S subunit of the bacterial ribosome. Chloramphenicol is primarily bacteriostatic. Therefore, after the drug is stopped, protein synthesis starts again. The bacteria that have most frequently been isolated from skin and eye infections and which are sensitive to chloramphenicol are: enterobacteria included Escherichia coli (MIC90 3-12 mcg / ml); Haemophilus influenzae; Klebsiella species; Moraxella species; Neisseria species; Staphilococcus aureus (MIC90 3-12 mcg / ml); streptococci including it Streptococcus pneumoniae (MIC90 1-8 mcg / ml) (Pneumococcus). Chloramphenicol may also be effective against chlamydia.
Topical chloramphenicol is considered the antibiotic of choice for the treatment of superficial ocular infections.
05.2 Pharmacokinetic properties
Topically administered hydrocortisone and chloramphenicol have limited systemic absorption. Factors that may increase systemic absorption are site of application, surface treated, severity of skin inflammation, duration of treatment and use of occlusive bandages.
Hydrocortisone
Absorption
The absorption of topical hydrocortisone depends on the thickness of the stratum corneum and the lipid composition of the skin: for this reason the greatest penetration of the skin is observed at the level of the eyelids and the least at the plantar level.
Distribution
Plasma protein binding is 90%, mainly to corticosteroid-binding globulin. Only hydrocortisone not bound to plasma proteins is biologically active.
Metabolism
Hydrocortisone is metabolised in tissues and the liver to biologically inactive compounds, including glucuronides and sulfates.
Elimination
The elimination half-life ranges from 1 to 2 hours. Inactive metabolites are excreted in the urine: less than 1% of hydrocortisone is excreted unchanged in the urine.
Chloramphenicol
Absorption
The ocular bioavailability of topical chloramphenicol is 16% and the total bioavailability is 34%. The intraocular penetration of chloramphenicol is high due to its high fat solubility.
Distribution
Chloramphenicol is partially unbound to plasma proteins and has a volume of distribution ranging from 0.5 to 1 l / kg.
Metabolism
Chloramphenicol is extensively metabolised in the liver by glucuronidation to inactive metabolites.
Elimination
The elimination half-life is approximately 3 hours. Approximately 90% of the administered oral dose is excreted in the urine (primarily as an inactive glucuronide) and to a lesser extent in the faeces and bile.
In neonates glucuronidation and renal elimination are markedly reduced (see section 4.4).
05.3 Preclinical safety data
Hydrocortisone
Long-term animal studies have not been performed to evaluate the carcinogenic potential or effects on fertility of topical corticosteroids.
Studies with hydrocortisone did not show mutagenic potential.
Chloramphenicol
Chloramphenicol is suspected of being a human carcinogen and has been found to be positive in genotoxicity studies.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
CORTISON CHEMYCETIN 2.5% + 2% ointment
Liquid paraffin; anhydrous lanolin; white petroleum jelly.
CORTISON CHEMICETINA 0.5% + 1% ophthalmic ointment
Liquid paraffin; anhydrous lanolin; white petroleum jelly.
06.2 Incompatibility
Not applicable.
06.3 Period of validity
2 years.
CORTISON CHEMICETINA 0.5% + 1% ophthalmic ointment: validity after first opening: 28 days.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
Ointment - Aluminum tube and polythene cap - 20 g tube
Ophthalmic ointment - Aluminum tube and polythene cap - Tube 3 g.
06.6 Instructions for use and handling
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations
07.0 MARKETING AUTHORIZATION HOLDER
Teofarma S.r.l. Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
08.0 MARKETING AUTHORIZATION NUMBER
Ointment A.I.C. n. 010495051
A.I.C. ophthalmic ointment n. 010495048
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
17-01-1956/31-05-2010
10.0 DATE OF REVISION OF THE TEXT
January 2014
