Levotuss Syrup 200ml 30mg / 5ml

WARNINGS
The observation that the pharmacokinetic profiles of levodropropizin are not markedly altered in the elderly suggests that dose adjustments or modification of the intervals between administrations may not be required in the third age. However, in light of the evidence that sensitivity to various drugs is altered in the elderly, special caution should be used when levodropropizin is administered to elderly patients. Caution is advised in patients with severe renal insufficiency (creatinine clearance below 35 ml / min). It is advisable to use caution even in case of simultaneous intake of sedative drugs in particularly sensitive individuals. This medicine contains 4 g of sucrose per dose (10 ml). To be taken into consideration for administration to subjects with diabetes mellitus. The medicine contains methyl para-hydroxybenzoate and propyl para-hydroxybenzoate, known for the possibility of causing urticaria. In general, para-hydroxybenzoates can cause delayed reactions, such as contact dermatitis and rarely immediate reactions with manifestation of urticaria and bronchospasm. Antitussive drugs are symptomatic and should only be used pending diagnosis of the underlying cause and / or therapy effect of the underlying disease. In the absence of information on the effect of food intake on drug absorption, it is advisable to take the drug between meals. The medicine does not contain gluten; therefore it can be administered to patients with celiac disease.
PHARMACOTHERAPEUTIC CATEGORY
Antitussives, excluding associations with expectorants.
STORAGE
No particular precautions for storage.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients; the administration of the drug should be avoided in patients with bronchorrhea and with reduced mucociliary function (Kartagener's syndrome, ciliary dyskinesia); pregnancy and breastfeeding; do not administer to children younger 'less than 2 years.
NAME
LEVOTUSS 30 MG / 5 ML SYRUP
EXCIPIENTS
Sucrose, methyl-para-hydroxybenzoate, propyl-para-hydroxybenzoate, citric acid monohydrate, sodium hydroxide, cherry flavor, purified water.
SIDE EFFECTS
Palpitations, tachycardia, nausea, vomiting, diarrhea, erythema may occur during treatment with levodropropizin. Reactions reported as serious are urticaria and anaphylactic reaction. Most of the reactions that occur following levodropropizin are non-serious and symptoms have resolved with discontinuation of therapy and, in some cases, with specific pharmacological treatment. The adverse reactions reported (incidence unknown) are as follows. Eye disorders: mydriasis, bilateral blindness. Immune system disorders: allergic and anaphylactoid reactions, eyelid edema, angioneurotic edema, urticaria. Psychiatric disorders: nervousness, drowsiness, personality alteration or personality disorder. Nervous system disorders: syncope, dizziness, vertigo, tremors, paraesthesia, tonic-clonic convulsion and petit mal attack, hypoglycemic coma. Cardiac disorders: palpitations, tachycardia, atrial bigeminy. Vascular disorders: hypotension. Respiratory, thoracic and mediastinal disorders: dyspnoea, cough, edema of the respiratory tract. Gastrointestinal disorders: gastric pain, abdominal pain, nausea, vomiting, diarrhea. Hepatobiliary disorders: cholestatic hepatitis. Skin and subcutaneous tissue disorders: urticaria, erythema, rash, pruritus, angioedema, skin reactions, glossitis and aphthous stomatitis. Epidermolysis. Musculoskeletal and connective tissue disorders: weakness of the lower limbs. General disorders and administration site conditions: general malaise, generalized edema, asthenia. Pediatric population: A case of somnolence, hypotonia and vomiting has been reported in a neonate following the nursing mother's intake of levodropropizin. Symptoms appeared after the feed and resolved spontaneously by suspending breastfeeding for a few feedings.
PREGNANCY AND BREASTFEEDING
Studies of teratogenesis, reproduction and fertility as well as peri and postnatal studies did not reveal specific toxic effects. However, since in the toxicological studies in animals at the dose of 24 mg / kg a slight delay in body weight gain and growth was observed and since levodropropizine is able to overcome the placental barrier in the rat, the use of the drug is contraindicated in women who intend to become or are already pregnant since its safety of use is not documented. Studies in rats indicate that the drug is found in breast milk for up to 8 hours after administration. Therefore the use of the drug during breastfeeding is contraindicated.
INDICATIONS
Symptomatic cough therapy.
INTERACTIONS
Animal pharmacology studies have shown that levodropropizine does not potentiate the pharmacological effect of active substances on the central nervous system (eg benzodiazepines, alcohol, phenytoin, imipramine). In animals, the product does not modify the activity of oral anticoagulants, such as warfarin, nor does it interfere with the hypoglycemic action of insulin. In human pharmacology studies the association with benzodiazepine does not modify the EEG picture. However, it is necessary to use caution in case of simultaneous intake of sedative drugs in particularly sensitive individuals. Clinical studies show no interaction with drugs used in the treatment of bronchopulmonary diseases such as b2-agonists, methylxanthines and derivatives, corticosteroids, antibiotics, mucoregulators and antihistamines.
DOSAGE
The package contains a measuring cup with notches corresponding to 3, 5 and 10 ml. To open the package it is necessary to press the cap firmly and turn it counterclockwise at the same time. Adults: 10 ml of syrup up to 3 times a day at intervals of at least 6 hours. Children: 10-20 kg 3 ml 3 times a day; 20-30 kg 5 ml 3 times a day. Treatment should be continued until the cough subsides. However, if after 2 weeks of therapy the cough is still present, it is advisable to stop the treatment and ask your doctor for advice. In fact, cough is a symptom and the causal pathology should be studied and treated. Pediatric population: do not administer to children younger 'less than 2 years.
ACTIVE PRINCIPLES
Levodropropizina.