Levotics CR

Levodropropizine.

Each controlled-release tablet contains: Levodropropizine, EP 90 mg.

Cough Suppressant.
Pharmacology: Pharmacodynamics: Levodropropizine has antitussive effects in particular on the peripheral type at the tracheobronchial level, accompanied by anti-allergy and anti-biochemical effects. In animals, the product also exhibited local anesthetic activity.
Mechanism of action: Levodropropizine acts antitussively via inhibition at the C-fiber level.
In vitro, it has been shown to be capable of inhibiting the release of neuropeptides from C-fibers. In cats in anesthesia, levodropropizine significantly reduces activation of C-fibers and prevents associated reflexes.
Levodropropizine acts on the bronchopulmonary system by inhibiting bronchospasm induced by histamine, serotonin or bradykinin.
In animals, levodropropizine does not induce attenuation of respiratory function, does not have significant cardiovascular effects, nor does it cause constipation.
In humans, levodropropizine does not inhibit respiratory function or mucociliary clearance.
The antitussive effect of levodropropizineis comparable to the effect of centrally acting medicinal products, but levodropropizine exhibits better tolerability, particularly with respect to central sedative effects.
Pharmacokinetics: In humans, levodropropizine is rapidly absorbed and rapidly distributed throughout the body after oral administration.
Biological half-life is approximately 1-2 hours. Excretion takes place via the primary urine. The preparation is eliminated in unchanged form and at the same time in the form of metabolites such as conjugated levodropropizine and free or conjugated p-hydroxyleodropropizine. Excretion of the product and its metabolites in urine accounts for approximately 35% of the administered dose within 48 hours.
Pharmacokinetic studies were conducted in rats, dogs and humans. It has been shown that absorption, distribution, metabolism and excretion are very similar in all three species, with a bioavailability exceeding 75% when administered per os.
Binding to blood plasma proteins in humans is insignificant (11-14%) and is comparable to the values observed in dogs and rats.
Tests in which the drug has been repeatedly administered indicate that treatment for eight days (3 times a day) does not affect the absorption and excretion characteristics of the product. The cumulative effect and metabolic autoinduction can therefore be ruled out.
Recovery of radioactivity after oral administration was 93%.
No significant changes in the pharmacokinetic properties of the product in children, elderly patients with moderate or severe renal insufficiency were observed.
The pharmacokinetics and bioavailability of the drop formulation are the same as the syrup dosage form.

Cough in the following diseases: acute and chronic bronchitis.

Adults: The recommended dose is 90 mg twice a day orally.
Levodropropizine (LEVOTICS CR) is a controlled-release tablet, so it should not be split or broken, and should be swallowed as a whole.

No significant undesirable effects have been observed following single dose administration of up to 240 mg or up to 120 mg (3 times daily) for eight days.
There is a single case of overdose in a three-year-old child treated with a daily dose of levodropropizine 360 mg. The patient had abdominal and vomitus pains that were not severe and resolved without consequence. In the case of overdosage, the usual therapeutic measures (gastric lavage, charcoal, parenteral fluid administration, etc.) should be performed.

Patients with known hypersensitivity to the drug or to any of the excipients.
Patients with phlegm or mucociliary dysfunction.
Patient with excessive discharge of mucus, limited mucociliary function (Kartagener's syndrome, ciliary dyskinesia) or bronchorrhea.
Pregnant women, women of childbearing potential and nursing mothers.
Patients with severe hepatic disorder.

Caution should be exercised when administering the product to the following: Patients with severe heart failure.
Patients with severe renal impairment (creatinine clearance <35 mL/min).
Elderly patients who have a generally altered sensitivity to different types of drugs.
Effects on Ability to Drive and Use Machine: This product may occasionally cause drowsiness. Therefore, caution should be recommended when driving a car or operating machinery.
Use in Children: 1) Levodropropizine (LEVOTICS CR) is a controlled-release tablet, so a different formulation, which can be split, should be used.
2) Efficacy studies after administration to children less than 2 years of age have not been performed to a sufficient extent and therefore the product should be administered with caution to this patient group.

The drug should be not used in pregnant women or suspected women of pregnancy.

(1) Adverse reactions of Levodropropizine (LEVOTICS CR) controlled-release tablet: Multi-center, double-dummy, double-blind, randomized, active-controlled, and parallel group phase 3 clinical study was conducted for patients with acute or chronic bronchitis.
Acute bronchitis: Among a total of 136 patients, 10 side effects were reported in 8 patients (11.59%) in the test group (controlled-release tablet), 5 side effects were reported in 5 patients (7.46%) in the control group (normal tablet), 7 adverse drug reactions were reported in 6 patients (8.70%) in the test group, and 4 adverse reactions were reported in 4 patients (5.97%) in the control group. Severe side effects were reported in neither the test group nor the control group.
Chronic bronchitis: Among a total of 136 patients, 8 side effects were reported in 8 patients (11.94%) in the test group (controlled-release tablet), 8 side effects were reported in 8 patients (11.59%) in the control group (normal tablet), 5 adverse drug reactions were reported in 5 patients (7.46%) in the test group, and 2 adverse reactions were reported in 2 patients (2.90%) in the control group. Severe side effects were reported in neither the test group nor the control group.
(2) Adverse reactions of Levodropropizine normal tablet: Gastrointestinal: nausea, heartburn, diarrhea, vomiting.
Central nervous system: fatigue, weakness, dizziness, drowsiness, headache.
Circulatory system: heart palpitations.
Skin: rarely allergic reactions.

Potentially Fatal: Additive sedation with sedatives and alcohol.

Store at temperatures not exceeding 30°C.
Special Precautions for Storage: Do not preserve in other containers in order to avoid accident or quality control problem.

Cough & Cold Preparations

R05DB27 - levodropropizine ; Belongs to the class of other cough suppressants.

Rx