Alcillin Bx

Uses

Ampicillin is used for the treatment of infections caused by susceptible strains of the designated organism listed below:

• Infections of the Genitourinary Tract Including Gonorrhea: E. coli, P. mirabilis, enterococci, Shigella, S. typhosa and other Salmonella, and nonpenicillinase-producing N. gononhoeae.
• Infections of the Respiratory Tract: Nonpenicillinase-producing H. influenzae and staphylococci, and streptococci including streptococcus pneumoniae.
• Infections of the Gastrointestinal Tract: Shigella, S. typhosa and other Salmonella, E. coli, P. mirabilis, and enterococci.
• Meningitis: O. Meningitides.

Bacteriology studies to determine the causative organisms and their sensetivity to ampicillin should be performed. Therapy may be instituted prior to the results of susceptibility testing.

Bromhexineis used for the treatment of respiratory disorders associated with productive cough. These include; tracheobronchitis, bronchitis with emphysema, bronchiectasis, bronchitis with bronchospasm, chronic inflammatory pulmonary conditions and pneumoconiosis.

Alcillin Bx is also used to associated treatment for these conditions: Bacterial Infections, Bloodstream Infections, Endocarditis, Gastrointestinal Infections, Genitourinary tract infection, Infection, Infection caused by eikenella corrodens, Listeria infection, Meningitis, Bacterial, Pertussis, Respiratory Tract Infections (RTI), Salmonella, Salmonella Typhi Infection, Shigella, Skin Infections, Bacterial, Subcutaneous bacterial infection, Urinary Tract Infection, Perinatal group B streptococcus, Susceptible Bacterial InfectionsBronchiectasis, Common Cold, Cough, Cough caused by Common Cold, Nasal Congestion, Whooping Cough, Airway secretion clearance therapy

How Alcillin Bx works

By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, Ampicillin inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that Ampicillin interferes with an autolysin inhibitor.

Inflammation of the airways, increased mucus secretion, and altered mucociliary clearance are the hallmarks of various diseases of the respiratory tract. Mucus clearance is necessary for lung health; bromhexine aids in mucus clearance by reducing the viscosity of mucus and activating the ciliary epithelium, allowing secretions to be expelled from the respiratory tract.

Recent have studies have demonstrated that bromhexine inhibits the transmembrane serine protease 2 receptor (TMPRSS2) in humans. Activation of TMPRSS2 plays an important role in viral respiratory diseases such as influenza A and Middle East Respiratory Syndrome (MERS). Inhibition of receptor activation and viral entry by bromhexine may be effective in preventing or treating various respiratory illnesses, including COVID-19. In vitro studies have suggested the action of ambroxol (a metabolite of bromhexine) on the angiogensin-converting enzyme receptor 2 (ACE2), prevents entry of the viral envelope-anchored spike glycoprotein of SARS-Cov-2 into alveolar cells or increases the secretion of surfactant, preventing viral entry.

Dosage

Alcillin Bx dosage

Intra-articular:Supplement in systemic therapy for treatment of susceptible infections-

• Adult:500 mg daily.
• Child:<10 yrHalf of adult routine dosage.

Intraperitoneal:

Supplement in systemic therapy for treatment of susceptible infections-

• Adult:500 mg daily.
• Child:<10 yrHalf of adult routine dosage.

Intrapleural:

Supplement in systemic therapy for treatment of susceptible infections-

• Adult:500 mg daily.
• Child:<10 yrHalf of adult routine dosage

Intravenous:

Meningitis-

• Adult:2 gm 6 hrly.
• Child:150 mg/kg daily in divided doses.

Intrapartum prophylaxis against group B Streptoccocal infection in neonates-

• Adult:Initially, 2 gm via IV inj followed by 1 gm 4 hrly until delivery.

Oral:

Biliary tract infections, Bronchitis, Endocarditis, Gastroenteritis, Listeriosis, Otitis media, Perinatal streptococcal infections, Peritonitis-

• Adult:0.25-1 gm 6 hrly.
• Child:<10 yrHalf of adult routine dosage.

Typhoid and paratyphoid fever-

• Adult:1-2 gm 6 hrly for 2 wk in acute infections, and 4-12 wk in carriers.

Uncomplicated gonorrhoea-

• Adult:2 gm with 1 gm of probenecid as single dose, recommended to be repeated in female patients.

Urinary tract infections-

• Adult:500 mg 8 hrly.

Parenteral:

Susceptible infections-

• Adult:500 mg 6 hrly, via IM or slow IV inj over 3-5 min or by infusion.
• Child:<10 yrHalf of adult routine dosage.

Septicaemia-

• Adult:150-200 mg/kg daily. Initiate with IV admin for at least 3 days, then continue with IM inj 3-4 hrly. Continue treatment for at least 48-72 hr after the patient has become asymptomatic or when there is evidence of bacterial eradication. Recommended treatment duration for infections caused by group-A β-haemolytic streptococci: At least 10-days, to prevent occurrence of acute rheumatic fever or acute glomerulonephritis.
• Child:Same as adult dose.

BromhexineTablet:

Adults and children over 10 years: 8-16 mg 3 times daily. Children 5-10 years: 4 mg 3 times daily.

BromhexineSyrup:

Adults: The recommended daily dose is 2 to 4 teaspoonful 3 times. Initially 4 teaspoonful 3 times daily and then as required.

Children: Suggested dosage for children under 2 years is 1/4 teaspoonful 3 times daily, for 2-5 years 1/2 teaspoonful 3 times daily and for children aged 5-10 years 1 teaspoonful 3 times daily.

Should be taken on an empty stomach. Take 1 hr before or 2 hr after meals.

Intramuscular: Add 1.5 mL water for inj to 500 mg vial contents.

Intravenous: Dissolve 500 mg in 10 mL water for inj. May be added to infusion fluids or injected, suitably diluted into the drip tube.

Intra-articular: Dissolve 500 mg in up to 5 mL of water for inj or sterile procaine HCl 0.5% soln.

Intraperitoneal: Dissolve 500 mg in up to 10 mL water for inj.

Intrapleural: Dissolve 500 mg in 5-10 mL water for inj.

Side Effects

Nausea, vomiting, diarrhoea, erythematous maculo-papular rashes, sore mouth, black/hairy tongue, rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, fever, joint pains, serum sickness-like symptoms, haemolytic anaemia, thrombocytopenia, leucopenia, neutropenia, coagulation disorders, prolonged bleeding time and prothrombin time, CNS toxicity (e.g. convulsions); paraesthesia, nephropathy, interstitial nephritis, hepatitis, cholestatic jaundice, moderate and transient increase in transaminases, Anaphylaxis, Clostridium difficile-associated diarrhoea (CDAD).

Gastrointestinal side-effects may occur occasionally with Bromhexine and a transient rise in serum aminotransferase values has been reported. Other reported adverse effects include headache, dizziness, sweating and skin rash.

Toxicity

The oral LD50 of bromhexine in rats is 6 g/kg. The observed symptoms of accidental overdose with bromhexine are consistent with the known adverse effects of bromhexine, including headache, nausea, and vomiting, among other symptoms. Provide symptomatic treatment and contact poison control services if an overdose is confirmed or suspected.

Precaution

Patient with history of β-lactam allergy. During renal impairment, Pregnancy and lactation.

Since mucolytics may disrupt the gastric mucosa so Bromhexine should be used with care in patients with a history of peptic ulceration.

Interaction

May reduce the efficacy of oral contraceptives. May alter INR while on warfarin and phenindione. May reduce the efficacy of oral typhoid vaccines. May reduce the excretion of methotrexate. Reduced excretion with probenecid and sulfinpyrazone, resulting to increased risk of toxicity. Allopurinol increases ampicillin-induced skin reactions. Reduced absorption with chloroquine. Bacteriostatic antibacterials (e.g. erythromycin, chloramphenicol, tetracycline) may interfere with the bactericidal action of ampicillin.

Volume of Distribution

After intravenous administration in a pharmacokinetic study, bromhexine was found to be widely distributed. Bromhexine is known to cross the blood-brain barrier; small concentrations may cross the placenta. The average volume of distribution of bromhexine was 1209 ± 206 L (19 L/kg). Lung tissue concentrations of bromhexine two hours after a dose were 1.5 to 3.2 times higher in bronchial tissues than plasma concentrations. Pulmonary parynchema concentrations were 3.4 to 5.9 times higher when compared to plasma concentrations.

Elimination Route

After oral administration, bromhexine demonstrates linear pharmacokinetics when given in doses of 8-32 mg. Bromhexine is readily absorbed in the gastrointestinal tract at a rapid rate. This drug undergoes extensive first-pass effect in the range of 75-80%. The bioavailability is therefore reduced to approximately 22-27%.

Half Life

Following single oral doses ranging from 8 and 32 mg, the terminal half-life of bromhexine has been measured between 6.6 and 31.4 hours.

Clearance

The clearance of bromhexine ranges from 843-1073 mL/min, within the range of the hepatic circulation.

Elimination Route

Ampicillin is excreted largely unchanged in the urine.

After a dose of bromhexine was administered during a pharmacokinetic study, approximately 97% of the radiolabeled dose was detected in the urine; under 1% was detected as the parent drug.

Pregnancy & Breastfeeding use

Pregnancy Category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Pregnancy Category B. Bromhexine has been taken by a large number of pregnant women and women of child bearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

It is not known whether bromhexine is excreted in breast milk or whether it has a harmful effect on the breastfeeding infant. Therefore it is not recommended for breast feeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant.

Contraindication

Hypersensitivity to ampicillin and other penicillins.

Contraindicated to those who are hypersensitive to Bromhexine Hydrochloride.

Special Warning

Renal Impairment: CrCl<10: Dose reduction or increase in dose interval.

Acute Overdose

Symptoms: Nausea, vomiting and diarrhoea. Management: Symptomatic and supportive treatment. May be removed from the circulation by haemodialysis.

Storage Condition

Store between 20-25° C. Reconstituted oral susp: Store between 2-8° C (discard after 14 days).

Store below 25° C. Protect from light. Keep the container tightly closed.

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