Mucosolvan for acute and chronic disorders of the respiratory tract associated and exacerbations of chronic bronchitis

Mucosolvan® and Mucosolvan®LA (long acting)

Composition :

2 ml solution for oral or inhalation use contain 15 mg: 1 Tablet contains 30 mg: 1 LA capsule (long acting) contains 75 mg : 5 ml / liquid contain 15 mg : 1 ampoule of 2 ml contains 15 mg: trans 4- [(2-amino-3,5-dibromo-benzyl) amino] cyclohexanol hydrochloride
(= ambroxol hydrochloride) .

Properties :

Mucosolvan possesses mucokinetic and secretolytic properties. It promotes the removal of tenacious secretions in the respiratory tract and reduces mucus stasis. Expectoration of mucus is facilHated and breathing is eased considerably Mucus secretion is normalised during Mucosolvan treatment. Cough and sputum volume are often significanlly reduced. The film-like secretion on the surface of the respiratory mucosa can thus preform its normal protective function. Long-term use is possible because of the good tolerability of the preparation.

Indications :

Acute and chronic disorders of the respiratory tract associated with abnormal bronchial secretions, particularly in exacerbations of chronic bronchitis, asthmatic bronchitis and bronchial asthma. In pre- and post operative treatment. The ampoules are especially suitable for the prevention of pulmonary complications in intensive medicine.

Contraindications :

There are no known contraindications.

Pregnancy and lactation :

Preclinical studies have shown no hazard, but safety during human pregnancy has not yet been established. The usual precautions regardin the use of drugs at this time, eS[l8cially during the first trimester shoud be observed. Safety during lactation has not yet been established.

Special Precautions :

Mucosolvan solution contains the preservative benzalkonium chloride. It has been reported that this preservative may cause bronchoconstriction in some patients with hyperreactive airways.

Side Effects :

Mucosolvan is generally well tolerated. Mild gastro-Intestinal side effects have occasionally been reported. Allergic reactions have occurred rarely, some of the affected patients also showed allergic reactions to other substances.

Interactions :

The combination of Mucosolvan wHh other dnugs is possible. This refers particularly to preparations used as standard medication for bronchitic syndrome (cardiac glycosides, corticosteroids, bronchospasmolytics, diuretics and antibiotics).

Dosage and Administration :

The recommendations for children are based on a total daily dose of 1.2-1.6 mg Mucosolvan per kg body weight.

Unless otherwise prescribed :

Tablets 30 mg: Aduns: 1 tablet 3 times daily
In long – term therapy the dose may be reduced to twice daily. The tablets should be taken after meals with liquid.
LA capsules (long acting) 75 mg: Adults take 1 LA capsule daily, either in the morning or evening after a meal. The capsule should not be opened or chewed, but swallowed whole with ample liquid. The “carrier tablets” which are occasionally present in the stools have released the active substance during their passage through the digestive system and are therefore without significance. Mucosolvan LA capsules are not suitable for children.Liquid 15mg15ml (=1 measuring cup):Adults and children over 12years: 10 ml (2 measuring cups) 3 times daily for the first 2-3 days.
Later: 5 ml (1 measuring cup) 3 times daily Children 2-5 years: 2.5 ml (1/2 measuring cup) 3 times daliy
Children 5-12 years :5 ml (1 measuring cup) 2-3 times daily Children under 2 years: 2.5 ml (1/2 measuring cup) twice daily
The above regimen are sultable for the therapy of acute respiratory tract disorders and for the inHlal treatment of chronic conditions up to 14 days. In longer treatment the dose can be halved. Mucosolvan liquid should be taken at mealtimes. Solution 15 mgl2 ml for oral and inhalative use
Oral (1 ml = 25 drops): Adults: at the initiation of treatment. 4 ml 3 times daily.
In long – term treatment, the dose may 00 reduced to 2 mT 3 times daily.
Children over 5 years: 2 ml (= 50 drops) 2-3 times daily Children under 2 years: 1 ml ( = 25 drops) twice daily
Children 2-5 years 1 ml ( = 25 drops) 3 times daily
The drops should be taken with meals diluted with tea, fnuit juice, milk or water.
Inhalation: Adults and children over 5 years: 1-2 inhalations of 2-3 ml solution daily
Children under 5 years: 1-2 inhalations of 2 ml solution daily
Should only one inhalation per day be possible, a sustained action can be achieved by the supplementary administration of tablets or liquid. Mucosolvan inhalant solution can be used in all modern inhalation devices (excluding steam inhalers). It is miscible with physiological saline solution and may be diluted 1:1 in order to obtain optimal moisturisation of the respiratory air in a respirator. Since deep inhalation may provoke a cough impulse, the patient should breathe normally during the inhalation treatment. Warming the solution to body temperature before inhalation is recommended for sensitive patients. Patients with bronchial asthma should use a bronchospasmolytic before commencing inhalation.
Ampoules: Adults: In general good results have been obtained with the administration of 1 ampoule 2 or 3 times daily. In severe cases
the single dose may be increased to 2 ampoules. Administration should be Lv. or i.rn. although s.c. application is also well tolerated.
The following dosage is recommended for children:
Children over 5 years: 2-3 times daily 1 ampoule
Children 2-5 years: 3 times daily 112 ampoule
Administration should be Lv. although i.m. application is also well tolerated. If the intravenous administration is to rapid, headache,
pain in the legs and exhaustion may occur. The solution can also be administered as a drip iniusion together with glucose, laevulose, saline or Ringer’s solution. Mucosolvan (pH 5.0) should not be mixed with other solutions with a pH greater than 6.3, as precipitation of the free Mucosolvan base can result, due to the pH increase. The combination of parenteral and inhalative therapy with Mucosolvan has proved effective as intensive therapy. Therapy can then be continued wHh oral dosage forms.

Overdosage :

No symptoms of overdosage have been reported in man to date. If they occur, symptomatic treatment should be provided.

Availabilities :

Solution for oral or inhalative use 15 mgI2 ml – Tablets 30 mg – LA capsules long acting 75 mg liquid 15 mg /5 ml – ampoules 15 mg /2 ml

Produced by :

Chemical Industries Development
Under licence of: Boehringer Ingelheim. International GmbH
Ingelheim am Rhein, Germany

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