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Description
The instruction for use
of medicine for experts
(summary insert)
of AMBROSAN (AMBROSAN)
the Registration number: RK-LS-5 No. 003302 of December 1, 2005.
A trade name
Ambrosan
Mezhdunarodnoye
contains the unlicensed name Ambroxol Dosage Form of the Tablet Structure One Tablet:
Active ingredient: 30 mg of Ambroxol of a hydrochloride,
Excipients: lactose monohydrate, the granulated microcrystalline cellulose, kopovidon, magnesium stearate.
The description
of White or almost white color, round, flat, with risky on the one hand.
Pharmacotherapeutic group
Mucolytic means.
The code of automatic telephone exchange R05CB06
the Pharmacological
Pharmacodynamics Ambroxol properties is a metabolite of Bromhexine and gives more significant
expectorant effect. Ambroxol stimulates serous cells of glands
of a mucous membrane of bronchial tubes, increasing the content of mucous secretion,
changes the broken ratio of serous and mucous components
of a phlegm and also activates the hydrolyzing enzymes. Normalizes
patholologically the changed formation of a bronchial secret that facilitates
its discharge, accelerates mukotsiliarny clearance, reduces viscosity
of a phlegm. Thereof ventilation of the lungs improves and
cough decreases.
The pharmacokinetics
At oral administration Ambroxol is quickly and completely absorbed in
digestive tract and, thanks to a high tropnost, perfectly
gets into a mucous membrane of bronchial tubes and pulmonary fabric. The maximum
concentration is reached in 1-1.5 hours after reception. The bioavailability
is 70-80%. Elimination half-life of Ambroxol long also
makes 8-10 hours. Excretion of Ambroxol
generally comes from a human body through kidneys. Unlike Bromhexine, Ambroxol
does not need additional biotransformation in a liver that allows
to appoint it to patients with associated diseases of a liver.
Indications:
– the Acute bronchitis, tracheitis, laryngitis, pharyngitis
– Chronic bronchitis in an aggravation stage
– Bronchial asthma
– Bronchial pneumonia
– the Mucoviscidosis
– the Bronchoectatic disease
– Prevention of developments of stagnation in a bronchopulmonary system after big
operational interventions, injuries, etc.
Contraindications
– the I trimester of pregnancy
– the Peptic ulcer of a stomach and a 12-perstny gut in an aggravation stage
– Hypersensitivity to drug.
The route of administration and doses
to Adults and children are more senior than 12 years appoint 30 mg (1 tab.) 2-3 times a day
inside (in especially hard cases the daily dose can be increased up to 180
mg). To children at the age of 5-12 years – on 15 mg (1/2 tab.) 2-3 times a day, at the age of
2-5 years – on 7.5 mg (1/4 tab.) 3 times a day, aged up to 2 years – on 7.5 mg (1/4
tab.) 2 times a day. Drug is used in time or after a meal, washing down
with a small amount of liquid.
Interaction with other medicines
At the combined use Ambroxol can enhance efficiency
of antibacterial agents (ampicillin, amoksitsiklin, etc.) and theophylline,
increasing their concentration in blood that can reduce treatment terms.
Side effect
Allergic reactions in the form of skin rash, a small tortoiseshell, a Quincke’s disease are observed less, than at 1% of patients.
Overdose
Range between therapeutic and toxic doses of drug
very wide therefore the possibility of its overdose is practically absent.
A form of release
of the Tablet on 30 mg, in packing of 20 tablets.
To Store storage conditions at the room temperature in the dry, dark place inaccessible for children.
Expiration date
3 years.
Drug should not be used after expiry date.
Prescription status
It is released without prescription of the doctor.
PRO.MED.CS Praha a.s producer.
Telcska 1, 140 00 Praha 4
Additional information
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