Ambroxol Cinfa 6 Mg/Ml Syrup 200 Ml

Ambroxol Cinfa 6 Mg/Ml Syrup 200 Ml

ACTION AND MECHANISM

- Mucolytic, expectorant. Ambroxol is the N-desmethyl-bromhexine, the active metabolite of bromhexine. Its administration leads to a decrease in the viscosity of bronchial secretions and an increase in their volume, while favoring their expulsion.

Its mechanism of action is unknown, but it could be related to the increase in the synthesis of sialomucins due to activation of sialyl-transferase, which would restore the normal glycoprotein composition of bronchial mucosa secretion, and would normalize the viscoelasticity of bronchial mucus.

It could also stimulate the mucous glands of the bronchial epithelium, increase lysozyme levels, which would cause the breakdown of mucopolysaccharides, and stimulate mucociliary activity.

PHARMACOKINETICS

- Absorption: it is rapidly and completely absorbed after oral administration, reaching a cmax of 88.8 ng/ml after 1-2.5 h (30 mg po, immediate release) or 6.5 h (prolonged release forms). After oral administration, it undergoes a first-pass effect, eliminating 30% of the dose. Its bioavailability is 79%.

Effect of food : they have no clinically significant effect on the pharmacokinetics of ambroxol.

- Distribution: rapid distribution in the body, with a t1/2 distribution of 1.3 h. It tends to accumulate especially in the lungs, reaching tissue concentrations up to 17 times the cp. Plasma protein binding is 90% and Vd 552 l. Ambroxol crosses the placenta and is excreted in milk.

- Metabolism: it is metabolized in the liver by hydrolysis and glucuronoconjugation through CYP3A4, giving rise to dibromoanthranilic acid (10%) and other metabolites in small amounts.

- Elimination: it is eliminated in urine (83%), recovering 26% as conjugates and 6% unchanged. The t1/2 is 10 h and the CLt is 660 ml/min.

Pharmacokinetics in special situations :

- Renal impairment: pharmacokinetic data are not available.

- Hepatic failure: cp increases 1.3-2 times.

No significant pharmacokinetic differences due to age or sex have been found.

INDICATIONS

- Reduction of [BRONCHIAL HYPERVISCOSITY] in [COMMON COLD] and [FLU].

POSOLOGY

"AMBROXOL 6 mg/ml SYRUP":

- Adults and adolescents over 12 years: 5 ml, 3 times a day for 2-3 days. Subsequently, 5 ml 2 times a day.

- Children from 6 to 12 years: 2.5 ml, 2-3 times a day.

- Children from 2 to 5 years: 1.25 ml, 3 times a day.

- Children < 2 years: not recommended.

- Elderly: no specific dosage recommendations have been made.

Duration of treatment : should not exceed 4-5 days without consulting a doctor.

DOSAGE IN RENAL FAILURE

It may be necessary to reduce the dose or increase the interval between dosing.

DOSAGE IN LIVER FAILURE

It may be necessary to reduce the dose or increase the interval between dosing.

CONTRAINDICATIONS

- Hypersensitivity to ambroxol, bromhexine or any other component of the medication.

- Children < 2 years. Risk of bronchial obstruction.

PRECAUTIONS

- Patients with severe [KIDNEY INSUFFICIENCY] (CLcr < 30 ml/min) or severe [LIVER INSUFFICIENCY] (Child-Pugh class C), due to the risk of accumulation.

- Gastric damage. The administration of mucolytics has been related to disruption of the gastric protective barrier and gastric damage. Evaluate its use in patients with a history of [GASTRITIS] or [PEPTICA ULCERA].

- Skin reactions. The administration of ambroxol has been related to the appearance of serious and life-threatening skin adverse reactions, such as [TOXIC EPIDERMAL NECROLYSIS] or [STEVENS-JOHNSON SYNDROME]. In the event of appearance or worsening of skin or mucous membrane lesions, ambroxol will be discontinued and a diagnosis of the patient will be made.

PRECAUTIONS RELATED TO EXCIPIENTS

- Because it contains benzoic acid as an excipient, it may increase the risk of [JAUNDICE] in newborns (up to 4 weeks of age).

- This medicine contains sorbitol. Patients with hereditary [FRUCTOSE INTOLERANCE] should not take this medication.

ADVICE TO THE PATIENT

- Drink plenty of water during treatment.

- Do not use antitussives while using ambroxol.

- Consult with the doctor and/or pharmacist if the symptoms worsen or do not improve in 5 days, or if fever, headache or sore throat appears.

- Inform your doctor and/or pharmacist if skin rashes appear during treatment, sometimes associated with the appearance of blisters or lesions on the mucous membranes.

SPECIAL WARNINGS

- The use of mucolytics and expectorants in children under 2 years of age is contraindicated due to the risk of bronchial obstruction.

- In case of appearance of cutaneous eruptions on the skin or mucous membranes, ambroxol will be discontinued and the possibility of conditions such as toxic epidermal necrolysis or Stevens-Johnson syndrome will be evaluated.

PREGNANCY

Animal safety : Ambroxol did not cause teratogenic or embryotoxic effects at doses of 3,000 mg/kg/24 h (rat) or 200 mg/kg/24 h (rabbit). Cases of decreased fetal body weight and the number of live pups were reported at maternotoxic doses.

Safety in humans : Clinical use has not revealed any adverse effects on pregnancy or postnatal development when administered from the 28th week of gestation. There are no adequate and well-controlled studies in humans. Its administration is only accepted if there are no safer therapeutic alternatives, and the benefits outweigh the possible risks.

Effects on fertility : Ambroxol did not give rise to secondary effects on fertility in male or female animals at doses of 500 mg/kg/24 h. No specific studies have been conducted in humans.

LACTATION

Safety in animals: no data available.

Safety in humans: Ambroxol is excreted in milk. The consequences that it could have for the infant are unknown. Its administration during lactation is not recommended.

CHILDREN

The use of mucolytics in children under 2 years of age has been associated with the appearance of bronchial obstruction, as a consequence of increased production and fluidization of bronchial secretion and insufficient bronchial drainage. Therefore, the use of mucolytics in these children is contraindicated.

In older children, the pharmaceutical form and dose should be adapted to the age of the child ( see Dosage ).

ADVANCED AGE

No specific problems have been described in the elderly that require a dose readjustment.

EFFECTS ON DRIVING

It does not seem likely that ambroxol could adversely affect the ability to drive.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency interval, being considered very common (>10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%), very rare (<0.01%) or unknown frequency (cannot be estimated from the available data).

- Digestive: frequent [NAUSEA], [DYSGEUSIA], [HYPOESTHESIS] oral; uncommon [VOMITING], [DIARRHEA], [DYSPEPSIA], [ABDOMINAL PAIN], [DRY MOUTH]; rare dry throat.

- Dermatological: rare [EXANTEMATIC ERUPTIONS], [URTICARIA]; unknown frequency [ERYTHEMA MULTIFORME], [STEVENS-JOHNSON SYNDROME], [TOXIC EPIDERMAL NECROLYSIS], acute generalized exanthematous pustulosis.

- Allergic: rare [HYPERSENSITIVITY REACTIONS]; unknown frequency [ANAPHYLAXIA], [ANGIOEDEMA], [PRURITUS].

OVERDOSE

Symptoms : Serious reactions due to ambroxol poisoning have not been reported. As a general rule, the administration of doses of 15 mg/kg/24 h (iv) or 25 mg/kg/24 h (po) was well tolerated. Overdose symptoms included nervousness and diarrhea. In case of significant overdose, drooling, nausea and vomiting and hypotension have been reported.

Measures to take :

- Antidote: there is no specific antidote.

- General elimination measures: the establishment of measures such as induced emesis or gastric lavage is not indicated, except in the case of very serious poisoning. Forced diuresis or dialysis do not appear to be effective measures for the treatment of overdose due to their high plasma protein binding.

- Patient care: keep the respiratory tract free of secretions, lying the patient down and performing a bronchial aspiration.

- Treatment: symptomatic treatment.

Leaflet Ambroxol Cinfa 6 Mg/Ml Syrup 200 Ml