Cinfatusina 3.54 Mg/Ml Oral Suspension 1 Bottle 200 Ml

Cinfatusina (3.54 Mg/Ml Oral Suspension 1 Bottle 200 Ml)

ACTION AND MECHANISM

- Antitussive. Cloperastine is a cough suppressant structurally related to ethanolamine antihistamines. Its mechanism of action in cough is unknown, although a possible depression of the cough center, accompanied by a bronchodilator and local anesthetic effect on the bronchi, has been suggested.

It does not lead to dependence or significant nervous depression, compared to opioid antitussives. It has mild antihistamine activity.

PHARMACOKINETICS

- Absorption: good and rapid oral absorption, with tmax 1-1.5 h. The effects appear after 20-30 minutes and last for 3-4 hours.

Effect of food : do not affect the absorption of cloperastine.

- Distribution: no data available.

- Metabolism: extensive hepatic metabolism.

Enzyme inducing/inhibitory capacity : it does not seem to present important effects.

- Elimination: in urine, in the form of metabolites. The removal is complete in 24 hours.

Pharmacokinetics in special situations :

There are no specific pharmacokinetic data in children, the elderly or patients with renal or hepatic impairment:

INDICATIONS

- Symptomatic treatment of [DRY COUGH] and unproductive, such as irritative or nervous, in adults and children.

POSOLOGY

"CLOPERASTINE EFG"

Doses are expressed in mg of cloperastine fendizoate. 3.45 mg of cloperastine fendizoate is equivalent to 2 mg of cloperastine hydrochloride.

- Adults: 10 ml (approx. 35 mg), 3 times a day.

- Children and adolescents < 18 years:

* Adolescents > 12 years: 10 ml (approx. 35 mg), 3 times a day.

* Children 6-12 years: 5 ml (approx. 17.5 mg), 3 times a day.

* Children 2-6 years: 2.5 ml (approx. 8.75 mg), 3 times a day.

- Elderly: no specific dosage recommendations have been made.

Duration of treatment: prolong treatment as long as cough persists, and up to a maximum of 7 days, unless medically recommended.

Forgotten dose: administer the next dose at the usual time. Do not double the next dose.

DOSAGE IN KIDNEY FAILURE

No specific dosage recommendations have been made.

DOSAGE IN LIVER FAILURE

No specific dosage recommendations have been made.

RULES FOR CORRECT ADMINISTRATION

- Syrup, oral suspension: shake before use.

Administration with food : can be taken with or without food.

ADVICE TO THE PATIENT

- Avoid drinking alcohol during treatment.

- Tell your doctor and/or pharmacist if symptoms continue or worsen after 7 days of treatment, as well as if they are accompanied by fever, severe headache or skin rash.

- Inform your doctor and/or pharmacist if you have pathologies such as prostate hyperplasia, high blood pressure or other cardiovascular diseases or glaucoma.

- If you are going to undergo allergy diagnostic testing, stop cloperastine at least 3 days before the test.

- Tell your doctor and/or pharmacist if you experience symptoms such as:

* Dry mouth, constipation, drowsiness, insomnia or nightmares, as well as sudden loss of vision or eye pain.

CONTRAINDICATIONS

- Hypersensitivity to cloperastine, other antihistamines or any other component of the medication.

- Patients on treatment with MAOIs.

- Pregnancy and lactation.

Children < 2 years, pregnancy and breastfeeding.

PRECAUTIONS

- Anticholinergic effects. Cloperastine has anticholinergic effects, so it could aggravate pathologies such as [CONSTIPATION], [INTESTINAL OBSTRUCTION] (including [INTESTINAL ATONIA], [PEPTICA ULCER] stenosing), [ARTERIAL HYPERTENSION], [HEART FAILURE], [ISCHEMIC CARDIOPATHY], [ CARDIAC ARRHYTMIA], pathologies that give rise to [URINARY RETENTION] such as [PROSTATIC HYPERPLASIA], [MYASTHENIA GRAVE], [GLAUCOMA] or [HYPERTHYROIDISM], among others.

In addition, there may be a reduction in salivation, with the risk of dental [DENTAL CARIES].

- Persistent cough. Extreme caution is recommended in patients with chronic cough, such as that which accompanies [SMOKING], [PULMONARY EMPHYSEMA] or [ASTHMA], or in case of [PRODUCTIVE COUGH], because by inhibiting the cough reflex, it could alter expectoration and increase airway resistance. Furthermore, due to the anticholinergic effects, the volume of bronchial secretion could be decreased, increasing its viscosity and worsening these conditions.

You should see a doctor if the cough persists for more than a week, or if it is accompanied by a high fever, skin rash or persistent headache.

- Skin tests for hypersensitivity to allergenic extracts. Due to their antihistamine effects, they could give false negatives in diagnostic tests using these extracts. It is recommended to stop administration at least 72 hours before performing the test.

INTERACTIONS

- Alcohol and sedatives (other H1 antihistamines, benzodiazepines, antipsychotics, opiates). Risk of enhanced sedation.

- Anticholinergic drugs. The anticholinergic effects could be enhanced when combined with other drugs such as certain antihistamines, antiparkinsonian drugs, antipsychotics or antidepressants.

- Expectorants and mucolytics. Inhibition of the cough reflex could lead to pulmonary obstruction in the event of an increase in the volume or fluidity of bronchial secretions.

PREGNANCY

Safety in animals: Cloperastine was not teratogenic in animals.

Safety in humans: There are no adequate and well-controlled studies in humans. Its use is contraindicated during pregnancy.

Effects on fertility: no specific studies have been performed in humans.

LACTATION

Safety in animals: no data available.

Safety in humans: it is unknown if it is excreted with milk, and the consequences it could have for the infant. Is recomended to suspend the lactancy or evy the administration.

CHILDREN

Cloperastine can be used in children from 2 years of age, adjusting the dose depending on the child's age. However, it should be kept in mind that children may be more sensitive to anticholinergic effects.

Its use is contraindicated in < 2 years.

ADVANCED AGE

No specific problems have been described in the elderly that require dosage readjustment. However, the elderly may be more sensitive to the anticholinergic effects of cloperastine, and may also present pathologies in which the drug could cause aggravation, such as glaucoma or prostatic hyperplasia.

EFFECTS ON DRIVING

Cloperastine does not appear to have significant effects on the ability to drive, although in rare cases it may cause drowsiness or dizziness.

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 of unknown frequency (cannot be estimated from the available data).

- Digestive: infrequent [DRY MOUTH].

- Neurological/psychological: infrequent [SOMNOLENCE], [DYSTONIA], [TREMBOR], [DIZZY].

- Respiratory: unknown frequency [EPISTAXIS].

- Dermatological: very rare [URTICARIA].

- Allergic: very rare [ANAPHYLAXIA].

ADVERSE REACTIONS RELATING TO EXCIPIENTS

- Because it contains propyl parahydroxybenzoate, it may cause [ALLERGY TO PARABENS], possibly delayed.

- Because it contains methyl parahydroxybenzoate, it may cause [ALLERGY TO PARABENS], possibly delayed.

OVERDOSE

Symptoms : Cloperastine poisoning may lead to initial excitability, followed by CNS depression. Likewise, an enhancement of anticholinergic symptoms could appear, although it is not a powerful anticholinergic.

Measures to take :

- Antidote: severe anticholinergic symptoms, if they appear, could be treated with physostigmine. However, serious poisoning does not seem likely.

- General elimination measures: perform gastric lavage and administer activated charcoal if the poisoning is recent, the patient is conscious and the airway can be protected.

- Monitoring: monitor electrolyte levels and blood pH.

- Treatment: symptomatic.

Leaflet Cinfatusina 3.54 Mg/Ml Oral Suspension 1 Bottle 200 Ml