Axcel Bromhexine

Axcel Bromhexine

bromhexine

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma
Full Prescribing Info
Contents
Bromhexine hydrochloride.
Description
Syr: Each 5ml contains Bromhexine HCl 4 mg, Sodium Benzoate 0.1% w/v as preservative.
Action
Pharmacology: Mechanism of Action: Bromhexine HCl is a mucolytic expectorant whose action is to stimulate the mucous glands to produce a secretion which is less viscid and has a reduced content of acid glycoprotein fibres.
Pharmacokinetics: Bromhexine HCl is rapidly absorbed from the gastrointestinal tract and about 85% to 90% of a dose is excreted in the urine mainly as metabolites. Ambroxol is a metabolite of bromhexine. Bromhexine is highly bound to plasma proteins.
Indications/Uses
Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport.
Dosage/Direction for Use
For oral administration only.
To be taken 3 times a day.
Children under 2 years: 1.25ml (1mg).
Children 2-6 years: 2.5ml (2mg).
Children 7-12 years: 5ml (4mg).
Adult & Children more than 12 years: 10ml (8mg).
Overdosage
Cases of overdosage, if occur, should be managed symptomatically.
Contraindications
None known.
Special Precautions
It should be given with caution in patients with history of gastric ulceration. Very rare cases of chronically associated severe skin impairments such as Stevens Johnson Syndrome, Toxic Epidermal Necrolysis (TEN), Erythema Multiforme (EM) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported. In most cases, these could be explained by the severity of the underlying disease or concomitant administration of another drug. In the early stages of such severe skin reactions, initially only nonspecific flu-like symptoms appear, e.g. fever, arthralgia, runny nose, cough, and sore throat. If skin or mucous membrane damage occurs, seek medical advice immediately and discontinue treatment as a precaution.
Use in Pregnancy and Lactation: No evidence of ill-effects during pregnancy, but the use of drugs 1st trimester of pregnancy should be observed. Bromhexine HCl is expected to enter breast milk and thus should be avoided during lactation.
Use In Pregnancy & Lactation
No evidence of ill-effects during pregnancy, but the use of drugs 1st trimester of pregnancy should be observed. Bromhexine HCl is expected to enter breast milk and thus should be avoided during lactation.
Side Effects
Occasional gastrointestinal discomfort may occur, but these are almost invariably mild. There may be a transitory rise in serum transaminase levels in some patients. With continuation of the drug, transaminases return to pretreatment levels, even in those patients with pre-existing impairment of hepatic function.
Immune System Disorders: Frequency not known: Anaphylactic reactions including anaphylactic shock.
Skin and Subcutaneous Skin Disorders: Frequency not known: Severe skin reactions (including Stevens Johnson Syndrome, Toxic epidermal necrolysis (TEN), Erythema Multiforme (EM) and Acute Generalized Exanthematous Pustulosis (AGEP).
Drug Interactions
Bromhexine has been shown to enhance the response of erythromycin, cephalexin and amoxycillin.
Storage
Keep container well closed. Store below 30°C. Protect from light.
MIMS Class
Cough & Cold Preparations
ATC Classification
R05CB02 - bromhexine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Presentation/Packing
Form
Axcel Bromhexine Childn syr 4 mg/5 mL
Packing/Price
(fruity flavour) 100 mL x 1's; (fruity flavour) 60 mL x 1's
Form
Axcel Bromhexine tab 8 mg
Packing/Price
10 × 10 × 10's
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