ACTION AND MECHANISM - [ANTITUSSIVE]. Levodropropizine has shown antitussive activity, although its mechanism of action is unclear. It appears to be due to interference with the release of sensory neuropeptides in the respiratory tract (inhibiting capsaicin-induced cough). It seems to act at the peripheral tracheobronchial level, exerting antiallergic and antispasmodic effects. A local anesthetic effect has been observed in experimental animals. The combination of these activities could reduce vagal afferent stimulation. It exhibits some activity on H1 and alpha-adrenergic receptors. It does not bind to muscarinic or opioid receptors. It appears to be more effective than cloperastine in cases of cough induced by peripheral stimuli, while in coughs of central origin it has shown effects up to ten times weaker than those of codeine. Its action usually begins within one hour and can last up to six hours after administration of a 60 mg dose. SENIORS Levodropropizine may cause drowsiness and substantially impair the ability to drive and/or operate machinery in certain predisposed patients. Patients should avoid operating dangerous machinery, including automobiles, until they are reasonably certain that the medication does not adversely affect them. PATIENT ADVICE - This medication should be administered at least half an hour before meals. - It can cause drowsiness, so caution is advised when driving. If, after a 4-day treatment period, the cough persists or is accompanied by severe headache, fever, or rash, it is advisable to consult a doctor. It is not recommended to administer the medication for more than 7 days. CONTRAINDICATIONS - Hypersensitivity to levodropropizine or any component of the drug. - Patients with bronchorrhea or impaired mucociliary function: [KARTAGENER SYNDROME], bronchial ciliary dyskinesia. - Pregnancy and breastfeeding. - Children under 2 years old EFFECTS ON DRIVING Levodropropizine may cause drowsiness and substantially impair the ability to drive and/or operate machinery in certain predisposed patients. Patients should avoid operating dangerous machinery, including automobiles, until they are reasonably certain that the medication does not adversely affect them. PREGNANCY Studies in rodents have shown that administration of levodropropizine at a dose of 24 mg/kg resulted in decreased body weight in offspring. Levodropropizine crosses the placenta in rats, although it is unknown whether it also crosses the human placenta. There are no adequate and well-controlled studies in humans. Therefore, it is recommended to avoid administering this drug to pregnant women and to women of childbearing potential who are not using contraception. PHARMACOKINETICS Oral route: - Absorption: After oral administration, it exhibits very rapid absorption, with bioavailability values ​​of up to 75%. - Distribution: It binds very little to plasma proteins (11-14%). Vd: 3.4 L/kg. - Metabolism: It is partially metabolized in the liver, giving rise to p-hydroxy-levodropropizine and conjugates of this metabolite and the unchanged drug. - Elimination: Levodropropizine is primarily eliminated via urinary excretion, with 35% of the administered dose being recovered after 48 hours. It may appear in urine unchanged or as metabolites. The elimination half-life is 2 hours. Pharmacokinetics in special situations: - Children, the elderly and patients with mild or moderate renal impairment (CLcr between 30-90 ml/minute): No significant pharmacokinetic differences were found. INDICATIONS - [DRY COUGH]. Treatment of unproductive cough, such as irritative or nervous cough in adults, adolescents and children from 2 years of age. INTERACTIONS - Expectorants and mucolytics. Inhibition of the cough reflex could lead to pulmonary obstruction in cases of increased volume or fluidity of bronchial secretions. - CNS depressants: possible increase in sedative effects. LACTATION It is unknown whether levodropropizine is excreted in breast milk, but it has been detected in rats. The potential effects on the infant are also unknown. Therefore, it is recommended to avoid administering this medication during breastfeeding. CHILDREN There are no significant pharmacokinetic changes in children. It is not indicated for children under 2 years of age because its safety and efficacy have not been established. In children aged 2 to 6 years, it should only be administered under medical supervision. GUIDELINES FOR PROPER ADMINISTRATION The daily dose will be administered in 3 doses, on an empty stomach, separated by at least a period of 6 hours. The syrup should be administered directly using the dosing cap. This cap should be washed after each dose. The drops should be administered dissolved in half a glass of water. 20 drops are equivalent to 1 ml. POSOLOGY - Adults, oral: 10 ml/6-8 h (syrup) or 20 drops (1 ml)/8 h (drops). Do not administer more than 3 times a day. - Children >= 2 years, oral: 1 mg/kg/dose (every 6-8 hours. No more than 3 doses per day). * Syrup: 10-15 kg: 2.5 ml, 3 times a day. 16-20 kg: 3 ml, 3 times a day. 21-30 kg: 5 ml, 3 times a day. 31-45 kg: 7.5 ml, 3 times a day. Over 45 kg: 10 ml, 3 times a day. Maximum dose: 10 ml, 3 times a day. * Drops (20 drops = 1 ml) (dosage according to weight): 11-13 kg: 4 drops, 3 times a day. 14-16 kg: 5 drops, 3 times a day. 7-19 kg: 6 drops, 3 times a day. 20-22 kg: 7 drops, 3 times a day. 23-25 ​​kg: 8 drops, 3 times a day. 26-28 kg: 9 drops, 3 times a day. 29-31 kg: 10 drops, 3 times a day. 32-34 kg: 11 drops, 3 times a day. 35-37 kg: 12 drops, 3 times a day. 38-40 kg: 13 drops, 3 times a day. 41-43 kg: 14 drops, 3 times a day. 44-46 kg: 15 drops, 3 times a day. > 46 kg: 20 drops, 3 times a day. Maximum dose: 20 drops, 3 times a day. 1 drop contains 3 mg of levodropropizine. - Children < 2 years: Safety and efficacy have not been evaluated. Treatment duration: until the cough disappears, or as prescribed by the doctor. It is not advisable to administer the medication for more than 7 days. PRECAUTIONS - [RENAL INSUFFICIENCY]. Caution. It is mostly excreted in the urine. - [LIVER INSUFFICIENCY]: Caution. It is mainly metabolized in the liver. - Persistent cough. Extra caution is advised in patients with chronic cough, such as that associated with smoking, emphysema, asthma, or productive cough, because by inhibiting the cough reflex, it could impair expectoration and increase airway resistance. A doctor should be consulted if the cough persists for more than two weeks in adults or one week in children, or if it is accompanied by high fever, skin rashes, or persistent headache. PRECAUTIONS RELATING TO EXCIPIENTS - Because it contains methyl parahydroxybenzoate, it may cause allergic reactions (possibly delayed). ADVERSE REACTIONS Levodropropizine is generally well tolerated by patients. In clinical trials, only 4% of patients experienced adverse effects of any kind, which were mild and resolved upon discontinuation of treatment. The most frequent adverse effects included: - Digestive. (1-10%): [NAUSEA], [VOMITING], [DIARRHEA], [DYSPEPSIA] and [GASTRIC HYPERACIDITY], [ABDOMINAL PAIN]. - Neurological/psychological. (1-10%): [ASTHENIA], [DROWSY], [HEADACHE] or [VERTIGO]. - Cardiovascular. (1-10%): [PALPITATIONS]. Isolated cases of [PRECORDIAL PAIN]. - Respiratory: (<1%): [DYSPNEA]. - Allergic/dermatological. (<1%): [HYPERSENSITIVITY REACTIONS]. - Ocular: Isolated cases of visual disturbances. OVERDOSE Symptoms: No cases of levodropropizine overdose have been reported. Following administration of single 240 mg doses or multiple 120 mg doses for 8 days, no significant adverse effects have been reported. In the event of a significant overdose, mild and transient tachycardia may occur. Treatment: There is no specific antidote. In the event of an overdose, standard drug elimination measures should be implemented, including gastric lavage, activated charcoal, and parenteral fluid administration. Symptomatic treatment should be initiated. COMPOSITION LEVODROPROPIZINE: 6 MILLIGRAMS SUCROSE (EXCIPIENT): 350 MILLIGRAMS METHYL PARAHYDROXYBENZOATE (E-218) (EXC): 1.2 MILLIGRAMS PROPYL PARAHYDROXYBENZOATE (E-216) (EXC: 0.3 MILLIGRAMS