Saturday, September 14, 2013

Ambroxol

Ambroxol
Ambroxol
QUALItATIVE AND QUANTITATIVE COMPOSITION 
Ambranol SR Capsale 75 mg
Each- capsule contains 75mg of ambrosol (present as Ambroxol hydroehluride(
Eacipienta: Sucrose, Maize starch, Eadrugit BLIOG, Diethylphthalate, talc.
Ambroanl 30mg tablets
Each tablet contains 30mg of ambroool (present as Ambrouol hydrochloride)
Eacipients: Lactose, maize starch, Microcrystalline cellulose, Povidone, Erythrosine red, Magnesium
rtearate, Tale parified.
Ambruool, 7.5mg arnl drops
Each 1 ml contains 7.5mg of amhrosol (present as Ambronol hydrochloride)
Exeipients: Glycerin, Propylene glycol, Sorbitol 70%, Strawberry l.iqaid, Carmosine red, Sodium citrate
tribasic, Purified water. 
Ambrosol, 1 Smg/5m1 syrup
Each SmI contains 15mg of ambroxol (presentasAmbroaol hydrochloride)
Eacipients: Glycerin, sodium benzoate, Sorbitol 70%, Sucrose, citric acid monohydrate, Cherry flavor,
Purified water. 
Properties 
Ambroxol possesses mucokinetic and secrolytic properties it promotes the rbmaval of tenacious
secretions in the respiratory tract avd reduces macus statis.Eapectoration of macus is facilitated and
breathing is eased considerably mucus secretion is vormalized during Ambrosol treatment Coa9h & sputum volume ore often significantly redaced. The film like secretion oo the surface of the respiratory mocosa ran thus perform its normal protective-function. Lang term-as&is possible because of the good tolerability of the preparation.
Indication 
Acate & chronic disorders of the respiratory tract associated -with abnormal bronchial secretions, particularly in eoacerbotion of chronit brnnchitis, Asthmatic bronchitis and bronchial asthma. In pre and post operative treatment.
Contraindications: there are no kntwn contraindications.
Pregnancy & Lactation: 
Preclinical studies have showy no hazard, But safety daring human pregnancy has not yet been established, the usoal precautions regarding the use of drugs at this time, especially during the first trimester should be observed. Safety daring lactation has not been established,
Side effects: 
Ambroool 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 Ambrosol with other drugs is possible. This refers particularly to preparation ased as standard medication for bronchitic syndrome (cardiac glycosides, Cortleosteroids, Bronchospasmolyties, Diuretics and Antibiotics)
Dosage & Administratian 
The recommendations for children are based on a)i’atlydose af U2—t.B Ambrouol 1Kg body weight 
unless otherwise prescribed.
1) Tablets 30mg.
- Adult: 1 tablee 3 times daily
In lung term therapy the dose may be reduced to twice daily. The tablets should be taken after meals wieh
liquid
CP025103 2) Ambronol SR Capsule 75 mg
___________ — Adults: 1 capsule daily, either in the morning or evening after a meal. The capsule should not be npened
or chewed, but swallowed whole with ample liquid. The carrier tablets which ore occasionally preseot in
the stools have released the active substance durivg their passage through the ditestive system and are
therefore without significance. Ambrovol
Capsules are not suitable for children.
3) Ambroxol Liquid 15 mg1S ml 1 measaring cap
- Adults & children over t2 years: 10 ml (2 measuring caps) 3 times daily for the rst 2—3 days.
Later: SmI (1 measuring cup) 3 times daily
- Children 2-S years: 2,5 ml (1/2 measuring cap) 3 times daily
— Children 5—12 years: hmI (1 measarint cup) 2—3 times daily
- Children under 2 years: 2.5 ml (112 measuring cup) twice daily
The above regimen is suitable for the therapy of acute respiratory tract disorders and for the initial
treatment of chronic conditions up to 14 days.
In longer treatment the dose con be halved. Ambroool liquid should he taken at mealtimes.
4) Ambronal, 7.5mg neal drops
- Adults: At the initiation of treatment 4 ml 3 times daily.
In long term treatment, the dose maybe reduced to 2 ml 3 times daily
- Children over t years : 2 ml (=50 drops( 2-3 times doily.
— Children under 2 years:1 ml (=2t drops) twice doily.
— Children 2-5 years 1 ml (= 25 drops) 3 times daily.
The drops should he token with meals dilated with tea, fruit juice, milk or water.
Overdosage: 
No symptoms or overdosage have beev reported in man to date. If they occur, symptomatic treatment
should be provided.
Stored at temperature not enceedint 30t in a dry place.
Pack:
Amhrnool SR Capsale 75 mg:
Carton boo contain AIIPVC /l’s/DC strip of 15 capsules with insert leaflet
Ambrovol 30mg tablets
Carton boo contain 2 Al/PVC strips each of 10 tablets with insert leaflet.
Amhroool, 7.5mg oral drops
Carton boo contain bottle of 15 ml.
Ambroaol, 15mg/S ml syrap
Carton boo contain umber glass bottle of 120 ml syrup with ROPP cap & inner leaflet.
Wseo)n:
Keep medicament out of reach of children.
Manufacturer: GSK tgypt — ElSalam city — Cairo - Egypt 
DCIaxoSmthKline