Bactidol Heavy Phlegm Relief

Guaifenesin + Bromhexine HCl (Bactidol Heavy Phlegm Relief) 100 mg/4 mg per 5 mL Syrup is a clear and colorless liquid with a characteristic berry flavour and odour.
Each 5 mL contains: Guaifenesin, USP 100 mg, Bromhexine HCl, Ph. Eur 4 mg.

Expectorant/Mucolytic.

For symptomatic relief of productive cough.
Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Adults and children above 12 years: For adults and children 12 years of age and older, the recommended dose is 10-15 mL or 2-3 teaspoons at least every 6 hours, as needed. Not to exceed 60 mL in 24 hours.
Children aged from 6 to 12 years: For children 6 to 12 years, the recommended dose is 5-10 mL or 1-2 teaspoons at least every 6 hour, as needed. Not to exceed 30 mL in 24 hours.
Children aged from 4 to 6 years: For children 4 to 6 years, the recommended dose is 2.5 to 5 mL or ½ to 1 teaspoon at least every 6 hours, as needed. Not to exceed 15 mL in 24 hours.
Not recommended for use in children under 4 years of age.
What should the patient do if they miss a dose: Continue medication based on dosage and/or consult the doctor.

Signs and Symptoms of Overdose: There are no reports found in the literature describing the overdose potential of the combination bromhexine hydrochloride/guaifenesin.
No adverse events were identified from the post marketing analysis of bromhexine HCl/guaifenesin which warrants inclusion in this section of the monograph.
The information presented as follows describes overdose with the single active ingredients.
Bromhexine: Symptoms of overdose may include nausea and vomiting at high doses.
Guaifenesin: When taken in excess, guaifenesin may cause renal calculi.
In the event of overdose, get medical help or contact a Poison Control Center right away.
What to do when the patient has taken more than the recommended dosage: Consult the doctor if the patient has taken more than the recommended dosage.

Hypersensitivity or anaphylactic reaction to bromhexine, ambroxol, guaifenesin or to any of the ingredients.

There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) associated with the administration of bromhexine hydrochloride. Stop use and seek medical attention at the first appearance of skin rash (sometimes associated with blisters or mucosal lesions) or any other sign of hypersensitivity.
Should not be used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician.
If symptoms persist or get worse, or if new symptoms occur, patients should stop use and consult a physician.
When should the patient consult their doctor: If symptoms persist or worsen, or if new symptoms occur, stop use and consult the doctor.
Effects on Ability to Drive or Use Machines: It is not known if the combination of bromhexine and guaifenesin has an effect on the ability to drive and use machines.

Bromhexine, Guaifenesin Combination: There are no adequate and well-controlled clinical studies in pregnant or breastfeeding women for the combination of bromhexine and guaifenesin.
Bromhexine: Pregnancy: Bromhexine passes the placental barrier. Animal studies have not shown any direct or indirect negative effect on pregnancy, development of the fetus, the delivery or postnatal development.
Up to now, clinical experience has not given any evidence for adverse effects on the fetus during pregnancy. However, normal caution should be used when use of drugs during pregnancy.
Especially during the first trimester, bromhexine should be avoided.
Lactation: Bromhexine is excreted into breast milk. Bromhexine is not recommended during lactation, inspite of the fact that no adverse effects in breastfed children can be expected.
Guaifenesin: There are no adequate and well-controlled studies in pregnant or breastfeeding women for guaifenesin.
This product should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the developing fetus or nursing infant. Ask a physician before use if the patient is pregnant or breastfeeding.

Clinical Trial Data: Placebo-controlled studies with sufficient adverse event data were not available for the combination of bromhexine and guaifenesin.
Post Marketing Data: Adverse drug reactions (ADRs) identified during post-marketing experience with bromhexine and guaifenesin or the combination of bromhexine and guaifenesin are presented in Table 1 and Table 2. The frequencies are provided according to the following convention: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000; Not known (cannot be estimated from the available data). (See Tables 1 and 2.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Erythromycin, Amoxicillin, Cefixime and Ofloxacin Bromhexine (as well as ambroxol, a metabolite of bromhexine) has been shown to enhance the penetration of erythromycin, amoxicillin, cefixime and ofloxacin into bronchial secretions when administered concomitantly and has therefore been used as adjuvant treatment for respiratory infections.
Bromhexine acts by disrupting mucopolysaccharides of bronchial secretions, and as a result increases the bronchial penetration of anti-microbial drugs as evaluated on the basis of percentage penetration ratio.

Store at temperatures not exceeding 30°C.

Cough & Cold Preparations

R05CB10 - combinations ; Belongs to the class of mucolytics. Used in the treatment of wet cough.

Non-Rx