Ambrobene stoptussin drops vn.pr. 25ml vial, cap.

Description

Composition
Active substance:
0.100 g of guaifenesin, butamirata citrate 0.004 g;
Excipients:
Ethanol 96% 0.300 g, floral flavor (aroma alpine colors) 0.002 g 0.007 g purified water, polysorbate 80 0,001 g, licorice extract liquid 0,003 g, and 1,000 ml of propylene glycol.
Description:
Transparent viscous liquid from yellow to yellowish-brown.
Product form:
Drops for oral administration of 4 mg + 100 mg / ml.
25 ml amber glass vials with a polyethylene dropper cap with tamper evident.
Each vial is placed in a cardboard box, together with instructions for use.
Contraindications
Hypersensitivity to the components of the preparation components, children up to 6 months, the first trimester of pregnancy, myasthenia gravis.
Carefully
The drug should be used with caution in patients with a tendency to the development of drug dependence, liver disease, alcoholism, epilepsy, brain diseases, as well as children and pregnant and lactating women.
Dosage
4 mg + 100 mg / ml
Indications
Dry, irritating, difficult-to-relief of cough of different etiology; cough relief in the pre- and postoperative period.
Interaction with other drugs
Guaifenesin increases the analgesic effect of acetaminophen and acetylsalicylic acid; It enhances the sedative effect of alcohol, sedatives, hypnotics and general anesthetics on the central nervous system; It enhances the effect of muscle relaxants.
In determining the concentration vanillylmandelic and 5-hydroxyindoleacetic acid using nitrosonaftola in falsely elevated results can be obtained as a reactant. Therefore, the use of preparations containing guaifenesin must stop 48 hours before the urine collection for this analysis.
Overdose
Symptoms: If overdose is dominated by signs of toxic effects of guaifenesin: sleepiness, muscle weakness, nausea and vomiting. Perhaps the development of urolithiasis.
Treatment: In case of overdose, seek medical attention. Guaifenesin has no specific antidote. Assign gastric lavage, activated charcoal, symptomatic therapy aimed at supporting the cardiovascular, respiratory and renal function, electrolyte balance.
pharmachologic effect
Pharmacological group:
antitussive expectorant Myramistin +
Pharmacodynamics:
Combined product has antitussive and expectorant action.
Butamirata has a peripheral mestnoaneste- ziruyuschee effect on sensory nerve endings of the bronchial mucosa, providing antitussive effect.
Guaifenesin increases the secretion of bronchial glands and reduces the viscosity of the mucus. Increased secretion caused both by direct action on bronchial gland – stimulation of secretion from bronchial gland and removing acid from glycoproteins acinar cells and by reflex, occurs when parasympathetic afferent fibers irritation of the gastric mucosa and depression of the respiratory center. Increasing vagal tone (n. Vagus) stimulates bronchial secretions. The mucus produced by bronchial glands, enhances mucociliary activity, resulting in easier evacuation of bronchial mucus and her cough.
Pharmacokinetics:
If ingestion butamirata citrate is rapidly and completely absorbed. Communication with the plasma protein is 94%. It is metabolized to form two metabolites also possess antitussive effect. Metabolites are mainly (90%) of the kidneys and only a small part – through the intestine.
The half-life (T 1/2) – 6 hours.
Guaifenesin ingestion is rapidly absorbed from the gastrointestinal tract. Relationship to plasma proteins is insignificant. Guaifenesin is rapidly metabolized to form inactive metabolites that are excreted by the kidneys. T 1/2 – 1 hour.
Pregnancy and breast-feeding
Controlled clinical studies on the effect of the drug in pregnant women or animal studies have not been conducted.
At reception of guaifenesin in the first trimester of pregnancy were described in more frequent instances of the possible formation of an inguinal hernia in the neonatal period. The drug should not be taken during the first 3 months of pregnancy. Use of the drug in the second and third trimesters of pregnancy is possible in cases where the expected benefit to the mother exceeding
creases the potential risk to the fetus.
It is not known whether guaifenesin butamirata and penetrate into breast milk. Due to the lack of information on the use of these drugs during the breastfeeding period can not be unambiguously eliminate the risk of side effects in infants. Use of the drug during breastfeeding is possible in cases where the expected benefit to the mother outweighs the potential risk to the infant.
Conditions of supply of pharmacies
Without a prescription.
side effects
In compliance with the recommended dosing regimen, patients usually tolerate the drug well. The most commonly reported digestive disorders (nausea, lack of appetite, pain in the stomach, vomiting, diarrhea), headache, dizziness and drowsiness, which occur in approximately 1% of patients. These side effects usually diminish after dose reduction. There were also skin allergic reactions.
The frequency of adverse reactions listed below, was determined according to the following criteria: very often (> 1/10); often (> 1/100 –
special instructions
During treatment is not recommended to drink alcohol.
If symptoms persist or enhancement should consult a doctor.
The drug contains 35.6 vol. % Ethanol, the maximum single dose (40 drops) contains up to 0.322 g ethanol. This should be considered when administering the drug to patients suffering from liver disease,
epilepsy, pregnant and lactating women and children.
The drug should not be administered with productive cough patients suffering from prolonged or chronic cough (including those caused by smoking), bronchial asthma, chronic bronchitis or emphysema.
If you missed taking the drug, do not increase the next dose to make up for the missed.
If you have questions regarding taking the medication, talk to your doctor.
Effect on the ability to drive mechanisms and
The drug may have an adverse impact on activities that require high concentration and psychomotor speed reactions (eg, driving, working with machinery and high-altitude work).
Storage conditions
In the dark place at a temperature of from 10 to 25 degrees.
Keep out of the reach of children.
Dosing and Administration
The drug is taken after a meal, the corresponding number of droplets is dissolved in 100 ml of liquid (water, tea, fruit juice and so on. P.). If the drug is attached to the syringe for dispensing, you can use it for accurate preparation.
Dosed according to patient body weight:
• up to 7 kg 8 drops 3-4 times a day,
• 7-12 kg to 9 drops 3-4 times a day,
• 12-20 kg of 14 drops three times a day,
• 20-30 kg to 14 drops 3-4 times a day,
• 30-40 kg to 16 drops 3-4 times a day,
• 40-50 kg of 25 drops three times a day,
• 50-70 kg 30 drops 3 times a day,
• more than 70 kg of 40 drops three times a day.
In case of deterioration or absence of improvement for 3 days should consult a physician.
Use the drug without a doctor’s prescription can be no more than 7 days.
on the use of a syringe for dosing instructions
For easy and accurate dosing of the drug you can use a syringe for dispensing (if attached).
The scale on the syringe indicates the number of droplets in metered dose.
1. Remove the bottle cap (anticlockwise).
2. Place the syringe into the adapter on the neck of the bottle in a vertical position.
3. Bottle syringe turn placed upside down into it. Firmly hold the syringe and pulling the piston, dial the required amount of the drug.
4. If you want to measure the dose 40 drops – type 10 + 30 drops.
5. Turn the bottle back to a vertical position.
6. Carefully remove the syringe with medication from the vial adapter.
7. Dissolve the dialed dose in water, tea or fruit juice.
8. Replace the cap on the vial (clockwise).
9. After use, the syringe rinse with warm water.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist