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BIOXOL SR CAPSULES

Quick Overview

The pedigree of SAVA Medica Ltd stands tall as our Nasal spray and Dry powder inhaler technology and expertise.


Our aim is to reach out to the globe within shortest possible time frame


To promote this objective, not only we distribute and market our respiratory range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as Bioxol SR capsule which contains  Ambroxol Hydrochloride BP ……. 75 mg


This Bioxol SR contains same active ingredient  as Ambrolex from GlaxoSmithKline


 


 

Bioxol SR Caps

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Details

Each capsule contains:

 Ambroxol Hydrochloride BP ……. 75 mg

(As Sustained Release Pellets)

Empty gelatin capsule contains approved colours.

CHEMICAL NAME: trans-4-[(2-Amino-3,5-dibromobenzyl)amino]

cyclohexanol hydrochloride.

CATEGORY: Mucolytic agent

CLINICAL PHARMACOLOGY

Mechanism of action:

Ambroxol is an active N-desmethyl metabolite of the mucolytic, bromhexine. Ambroxol is shown to exert several activities, as follows: Its mucolytic activity by which it facilitates breakdown of acid mucopolysaccharide fibres in the mucous making it thinner and less viscous and, therefore, easy for expectoration; it stimulates the ciliary activity thereby improving mucokinesis (transport of mucous); it stimulates production of pulmonary surfactant, a substance found to play a major role in the lung host defense mechanism, thereby further protecting against lung inflammation and infection; also exhibits anti-inflammatory and antioxidant activity. When administered orally, onset of action occurs after about 30 minutes.

Pharmacokinetic Actions

Absorption:

Ambroxol hydrochloride is rapidly absorbed (70-80%) after oral administration. The time to reach peak plasma concentration is approximately 2 hours.

Distribution:

 The distribution half-life of ambroxol hydrochloride is around 1.3 hours.

Metabolism:

Metabolite is dibromoanthranilic acid (activity unspecified).

Excretion:

Primarily via the kidneys. Renal clearance (rate) is approximately 53 ml/minute; approximately 5-6% of a dose is excreted unchanged in the urine. The elimination half-life of ambroxol hydrochloride is biphasic, with an alpha half-life of 1.3 hours and a beta half-life of 8.8 hours.

INDICATIONS:

Acute and chronic diseases of respiratory tract, with symptoms of thick mucus retention. Bronchitis, bronchial asthma, bronchiecstasia and silicosis.

CONTRAINDICATIONS

Contraindicated in patients with a history of hypersensitivity to any of the component of the product or its parent compounds. It is also contraindicated in patients with completely impaired renal function and with gastric ulceration.

DRUG INTERACTIONS:

Drug interactions for ambroxol hydrochloride are not known.

ADVERSE EFFECTS

At the recommended doses, ambroxol is well tolerated. Nausea, headache and gastrointestinal disorders have been observed rarely. Other toxic effects include skin irritation, eye irritation and respiratory tract irritation. Ingestion of large doses may cause gastrointestinal tract irritation with decreased motility or constipation, ulceration or bleeding from the stomach or duodenum, and peritonitis. It may affect behaviour/CNS (tremor, convulsions, ataxia and somnolence), respiration (dyspnoea, respiratory stimulation), the liver, blood (changes in white blood cell count) and the urinary system. Occasional gastrointestinal side effects may occur but these are normally mild.

PRECAUTIONS

Pregnancy

Ambroxol hydrochloride has not been shown to have any teratogenic or toxic effects on the foetus. It is advisable to avoid use during the first trimester of pregnancy.

DOSAGE

Adults and children over 12 years: 1 capsule, once daily.

OVERDOSAGE

No information is available on overdosage with ambroxol hydrochloride.

Packing: Blister of 10 capsules.

Storage: Store in a dry place below 30OC. Protect from light.

Keep out of reach of children.

 

 

 

 
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