Panatus film-coated tablets 20 mg No. 10
pharmachologic effect
Antitussive agent of central action. Butamirate is not an opium alkaloid. Suppresses cough by directly affecting the cough center. It has an expectorant, moderate bronchodilator and anti-inflammatory effect. Improves spirometry (reduces airway resistance) and blood oxygenation.
Pharmacokinetics
Quickly and completely absorbed when taken orally. With repeated use, its concentration in the blood plasma remains linear and no accumulation is observed. In the blood it undergoes hydrolysis to form 2-phenylbutyric acid and diethylaminoethoxyethanol. These metabolites also have antitussive activity. The binding of butamirate and its metabolites to plasma proteins is about 95%, this is due to their long T1/2 and long-term antitussive effect. Metabolites are excreted primarily by the kidneys, with acidic metabolites largely associated with glucuronic acid. T1/2 - 6 hours.
Indications
Dry cough of any etiology (for colds, flu, whooping cough and other conditions).
Cough in the preoperative and postoperative period, during surgical interventions, bronchoscopy.
Dosage regimen
For oral administration.
The dose is set individually, depending on the dosage form used and the age of the patient.
Side effect
From the side of the central nervous system: rarely (≥1/10,000 to <1/1000) - drowsiness, dizziness.
From the digestive system: rarely (≥1/10,000 to <1/1000) - nausea, vomiting, diarrhea.
From the skin: rarely (≥1/10,000 to <1/1000) - exanthema.
Other: allergic reactions may develop.
Contraindications for use
I trimester of pregnancy, lactation period (breastfeeding); children up to 2 months; children up to 3 years of age (for syrup), children up to 6 years of age (for tablets); children under 18 years of age (for modified-release tablets); hypersensitivity to butamirate.
Carefully
II and III trimesters of pregnancy.
Use during pregnancy and breastfeeding
Use is contraindicated in the first trimester of pregnancy and during lactation (breastfeeding). In the second and third trimesters of pregnancy, it is used with caution and only in cases where the expected benefit of therapy for the mother outweighs the potential risk for the fetus.
Use in children
Contraindication: children under 2 months (for drops), up to 3 years (for syrup), up to 12 years (for depot tablets).
special instructions
In children it should be used only in dosage forms that are specifically intended for this category of patients in accordance with age.
Impact on the ability to drive vehicles and machinery
Butamirate can cause drowsiness, so during treatment patients should be careful when driving vehicles and other activities that require increased concentration and speed of psychomotor reactions.
Drug interactions
Due to the fact that butamirate suppresses the cough reflex, the simultaneous use of expectorants should be avoided to avoid the accumulation of sputum in the respiratory tract.
During treatment with butamirate, the use of drugs that have a depressant effect on the central nervous system (including sleeping pills, antipsychotics, tranquilizers) is not recommended.
Panatus forte tablet p o film 50 mg x10
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION, INSTRUCTIONS for the use of the medicinal product for medical use Panatus forte Panatus, forte, Registration number: Trade name: Panatus forte International nonproprietary or generic name: butamirate Dosage form: film-coated tablets, Composition per tablet: Active ingredient : Butamirate citrate 50.00 mg Excipients: lactose, monohydrate, 285.00 mg, povidone, K-25, 5.00 mg, hypromellose, K15M, Premium, 20.00 mg, talc , 5.00 , mg, , magnesium , stearate , 4.00 , mg , colloidal silicon dioxide 1.00 mg Shell , film: , hypromellose , 6 , mPas , 7.50 , mg , , titanium dioxide , (E171 ) , 1.10, mg, iron dye red oxide (E172) 0.70 mg, talc 0.70 mg, propylene glycol 0.50 mg, Description Round, biconvex, tablets, beveled, film-coated , red-brown in color. Appearance on the fracture: white, rough, mass, with a filmy shell, red-brown in color. , Pharmacotherapeutic group: centrally acting antitussive ATC code: R05DB13 , Pharmacological properties Pharmacodynamics Butamirate, the active substance of the drug Panatus forte, is a centrally acting antitussive, not related to opium alkaloids either chemically or pharmacologically. Suppresses cough, having a direct effect on the cough center. It has a bronchodilator effect. Promotes easier breathing, improving spirometry (reduces airway resistance), and blood oxygenation. Pharmacokinetics Butamirate is rapidly and completely absorbed when taken orally. With repeated use of butamirate, its concentration in plasma and blood remains linear and no accumulation is observed. Hydrolysis of butamirate, initially, to 2-phenylbutyric acid and diethylaminoethoxyethanol, begins in the blood. These metabolites also have antitussive activity. Butamirate and its metabolites have an almost maximum (about 95%) degree of binding to plasma and blood proteins, which determines their long half-life (T 1/ 2), and long-term antitussive action. Metabolites are excreted primarily by the kidneys, with acidic metabolites largely associated with glucuronic acid. T 1/2 is 6 hours. , Indications for use Dry , cough , of any , etiology , including , with , whooping cough , for , suppression , of cough , in the preoperative and postoperative period , during surgical interventions and bronchoscopy . , Contraindications Increased , sensitivity , to , components , of the drug , pregnancy , (I , trimester), period , breast , feeding , , children , age , up to , 12 , years , , lactase deficiency , lactose intolerance , glucose-galactose syndrome malabsorption. , With caution Pregnancy (II-III trimesters). , Use during pregnancy and breastfeeding There is no data on the safety of using the drug Panatus forte during pregnancy and its passage through the placental barrier. The drug is not recommended for use in the first trimester of pregnancy. During the II and III trimesters of pregnancy, it is possible to use the drug only after consulting a doctor. Considering the lack of data on the release of butamirate into maternal milk, the use of the drug Panatus Forte during breastfeeding is not recommended. , Method of administration and dosage: Orally, before meals. Children over 12 years old: 1 tablet 1-2 times a day, adults: 1 tablet 2-3 times a day. If the cough persists for more than 5-7 days, you should consult a doctor. , Side effect Classification , frequency , development , side , effects , World , Health Organization (WHO): very often , , , , , , ≥ 1/10 often , , , , , , , , , , , , , , , , from ≥ 1/100 to <, 1/10 uncommon , , , , , , , , , , , , from ≥ 1/1000 to <, 1/100 rare , , , , , , , , , , , , , , , ≥ 1/10000 to <, 1/1000 very rare , , , , , , ≥ 1/100000, including isolated reports. From the central nervous system (CNS): rarely: drowsiness, dizziness. From the digestive system: rarely: nausea, vomiting, diarrhea. From the skin: rarely: exanthema. Other: allergic reactions may develop. , Overdose Symptoms: , drowsiness, , dizziness, , nausea, , vomiting, , abdominal pain, , diarrhea, irritability, , impaired coordination , movements, , decreased , blood pressure. , Treatment: , rinse , the stomach , , prescribe , activated , charcoal , , laxatives , medications , and also , carry out , measures , to , maintain , the , function of the , cardiovascular , and respiratory systems . There is no antidote. Treatment is symptomatic. , Interaction with other drugs No drug interactions have been described for butamirate. Due to the fact that butamirate suppresses the cough reflex, the simultaneous use of expectorants should be avoided to avoid the accumulation of sputum in the respiratory tract. During the period of use of the drug Panatus Forte, the use of ethanol, as well as drugs, CNS depressants (hypnotics, neuroleptics, tranquilizers, etc.) is not recommended. , Special instructions One , film-coated tablet contains , 285 , mg , of lactose. At each dose of the drug, in accordance with the instructions for use, the patient takes up to 285 mg of lactose. The drug Panatus forte is not used in patients with lactase deficiency, lactose deficiency, glucose-galactose malabsorption syndrome. If, after 5-7 days of using the drug, Panatus, Forte, the cough does not stop, you should consult a doctor. , The influence , on , the , ability , of , performing , potentially , dangerous , activities , requiring , special , attention , and , quick , reactions , (for example, driving a vehicle, working with moving mechanisms) The drug , Panatus , forte , can cause , drowsiness, therefore, it is necessary to be careful when , driving , vehicles , and , working , with , complex technical , devices , requiring , increased , concentration , attention , and speed of psychomotor reactions . , Release form: Film-coated tablets, 50 mg. 10 tablets are placed in a blister made of PVC/Al foil. 1 blister is placed in a cardboard pack along with instructions for use. , Storage conditions At a temperature not exceeding 25 ºС, in the original packaging. Keep out of the reach of children. .. Shelf life 5 years. Do not use the drug after the expiration date. , Dispensing conditions Dispensed without a prescription. , , Šmarješka cesta 6, 8501 Novo mesto, Slovenia, Representative office of JSC "KRKA, d.d., Novo mesto" in the Russian Federation / Organization accepting consumer complaints: 125212, Moscow, Golovinskoe highway, building 5, building 1 Tel. , Fax ,
