Dextein

Dextein

acetylcysteine

Manufacturer:

Temmler Pharma GmbH

Distributor:

Oxford Distributions

Marketer:

Glorious Dexa
Full Prescribing Info
Contents
Acetylcysteine.
Description
Each effervescent tablet contains Acetylcysteine 600 mg.
Indications/Uses
Used for its mucolytic activity in respiratory disorders associated with acute cough.
Pneumology: Acute and chronic forms of diseases of the airways, especially acute and chronic bronchitis, bronchoectasis, asthmoid bronchitis, asthma bronchiale, bronchiolitis, mucoviscidosis.
Ear, nose and throat diseases: Laryngitis, acute and chronic sinusitis, otitis media with effusion.
Dosage/Direction for Use
Manner and duration of administration: The effervescent tablets should be taken dissolved in glass of water after the meals. The liquid should not be mixed with a silver spoon, as silver may be released in small quantities.
Note: The mucolytic effect of Dextein 600 mg effervescent tablet is supported by hydration. The duration of the treatment is depending on the severity of the disease and should be decided by the treating physician.
In chronic bronchitis and in mucoviscidosis the treatment last for a longer period of time in order to achieve an infect prophylaxis.
If not otherwise prescribed, the following dosages are recommended: (See table.)

Click on icon to see table/diagram/image
Overdosage
With oral administration forms of acetylcysteine no cases of toxic overdose were observed so far. Volunteers were treated for 3 months with a daily dose of 11.6 g, without that severe side effects were observed. Oral doses of up to 500 mg acetylcysteine/kg body weight were tolerated without toxic symptoms.
Symptoms of Intoxication: Overdosage may lead to gastrointestinal symptoms like nausea, vomiting and diarrhea. In infants there is the danger of hypersecretion.
Therapy of Intoxication: Symptomatic treatment if necessary.
From the I.V. acetylcysteine treatment in case of paracetamol intoxication in humans there is experience with daily maximum doses up to 30 g of acetylcysteine. The I.V. application of highly concentrated acetylcysteine especially in case of fast application has lead to partly irreversible "anaphylactoid" reactions.
Contraindications
Dextein 600 mg effervescent tablet should not be administered to children below 14 years of age because of its high content of the active ingredient.
Dextein 600 mg effervescent tablet must not be applied in infants up to the 10th day of age, as Acetylcysteine may only be applied in newborns in case of life-threatening indication (10 mg/kg body weight) and under strictest medical control.
Furthermore, Dextein 600 mg effervescent tablet should not be administered in cases of hypersensitivity to acetylcysteine or to any other ingredient.
Special Precautions
Dextein 600 mg effervescent tablet contains 20 mg of Aspartame as a source of phenylalanine (corresponding to 11.2 mg phenylalanine per effervescent tablet) and may be harmful for patients with phenylketonuria.
Use In Pregnancy & Lactation
As there is no sufficient experience with regard to the application of acetylcysteine during pregnancy and lactation the preparations should not be applied during these periods. Studies in animals (rabbits, rats) gave no indication of a teratogenic potential of the substance.
Side Effects
In very rare cases heart-burn, nausea, vomiting or diarrhea may occur. Rarely, the appearance of stomatitis, headache and tinnitus was reported.
According to single reports, allergic reactions were observed after the acetylcysteine application e.g. unloads, pruritus, exanthema, rash, swelling of the oro-pharyngeal mucous membranes, bronchospasms, tachycardia and a decrease of the blood pressure. The individually reported cases of bronchospasms were mostly found in patients having a hyper-reacting bronchial system in connection with asthma bronchiale, so-called "hyper-responders" (increased bronchial sensitivity to different stimuli).
Drug Interactions
Because of the impaired cough reflex the combined use of acetylcysteine together with antitussives may lead to a dangerous congestion of the mucous secretion, which means that the indication for such a combined treatment must be worked out very carefully. Tetracycline hydrochloride should be administered separately and at least 2 hours apart (not valid for Doxycycline).
Until now, reports on the inactivating effect of acetylcysteine or other mucolytic agents for antibiotics were only found in connection with in-vitro tests where the respective substances were mixed directly. Nevertheless, for security reasons the oral administration of antibiotics should take place separately and after a delay of at least 2 hours. In vitro-interactions are described previously all for semisynthetic penicillin, tetracycline, cephalosporins as well as aminoglycosides. For antibiotics as amoxycline, doxycycline, erythromycin, or thiamphenicol, as well as cefuroxime, no interactions were reported here.
There have been reports on an increase of the vasodilating and platelet aggregation inhibiting effect of trinitroglycerin (nitroglycerin) under concomitant application with acetylcysteine. A judgment with regard to the clinical relevance is, however, not yet possible for the time being.
Storage
Store in the original package and at temperatures not exceeding 30°C.
Keep the tablet container tightly closed in order to protect from moisture.
ATC Classification
R05CB01 - acetylcysteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Presentation/Packing
Effervescent tab 600 mg x 10's.
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