Bactilem Ax

Uses

• • Acute and chronic diseases of respiratory tracts associated with viscid mucus including acute and chronic bronchitis
• • Productive cough
• • Inflammatory diseases of Rhinopharyngeal tract (e.g. Laryngitis, Pharyngitis, Sinusitis and Rhinitis) associated with viscid mucus
• • Asthmatic bronchitis, Bronchial asthma with difficult departure of mucus
• • Bronchiectasis
• • Chronic pneumonia.

Cefixime is used for the following infectious diseases -

Respiratory Tract Infections:

Pneumonia

Sinusitis

Pharyngitis and Tonsillitis

Acute Bronchitis and Acute Exacerbations of Chronic

Bronchitis (AECB)

Otitis Media

Typhoid Fever

Urinary Tract Infections

Uncomplicated gonorrhea (cervical/urethral)

Lactic acid is an emollient and keratolytic used agent in various cosmetic products and used as an additive in various pharmaceutical products for its antibacterial properties.

For use as an alkalinizing agent.

Bactilem Ax is also used to associated treatment for these conditions: Airway secretion clearance therapyAcute Exacerbation of Chronic Bronchitis caused by Streptococcus Pneumoniae, Acute Exacerbations of Chronic Bronchitis caused by Haemophilus Influenzae, Bacterial Sinusitis, Community Acquired Pneumonia (CAP), Gonorrhea of anus, Lyme Disease, Salmonella Infections, Salmonella Typhi Infection, Shigella Infection, Streptococcal Pharyngitis, Streptococcal tonsillitis, Uncomplicated Urinary Tract Infections, Bacterial otitis media, Bacterial rhinosinusitis, Uncomplicated GonorrheaCorns, Dehydration, Fluid Loss, Hyperkeratosis, Lichenification, Shock, Hypovolemic, Vasoplegic Shock, Warts, Mild Metabolic acidosis, Mild, moderate Metabolic Acidosis, Moderate Metabolic acidosis, Chemical contraception, Electrolyte replacement, Fluid replacement therapy, Parenteral Nutrition, Peritoneal dialysis therapy, Urine alkalinization therapy

How Bactilem Ax works

Ambroxol is a mucolytic agent. Excessive Nitric oxide (NO) is associated with inflammatory and some other disturbances of airways function. NO enhances the activation of soluble guanylate cyclase and cGMP accumulation. Ambroxol has been shown to inhibit the NO-dependent activation of soluble guanylate cyclase. It is also possible that the inhibition of NO-dependent activation of soluble guanylate cyclase can suppress the excessive mucus secretion, therefore it lowers the phlegm viscosity and improves the mucociliary transport of bronchial secretions.

Like all beta-lactam antibiotics, cefixime binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of 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 cefixime interferes with an autolysin inhibitor.

Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

Dosage

Bactilem Ax dosage

Average daily dose (preferably after meal):Pediatric Drops:

• 0-6 months: 0.5 ml 2 times a day
• 6-12 months: 1 ml 2 times a day
• 1-2 years: 1.25 ml 2 times a day

Syrup:

• 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
• 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
• 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.

Sustained release capsule:

• Adult and children over 12 years old: 1 capsule once daily

Specific application features: Ambroxol may be prescribed to patients suffering from diabetes mellitus.

The usual treatment of Cefixime is 7 days. This may be continued for up to 14 days according to the severity of infection.

Cefixime Capsule

Adult and child over 12 years: 200 or 400 mg daily as a single dose or in two divided doses.

Cefixime Suspension

Child over 6 months: 8 mg/kg daily as a single dose or in 2 divided doses

Direction for Reconstitution of Suspension

• To prepare 50 ml suspension, 25 ml boiled and cooled water is required.

• To prepare 40 ml suspension, 20 ml boiled and cooled water is required.

• To prepare 30 ml suspension, 15 ml boiled and cooled water is required.

• To prepare 50 ml DS suspension, 25 ml boiled and cooled water is required.

Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half of the total amount of water and shake well. Add remainder of water, and then shake again.

Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 14 days.

Side Effects

Gastrointestinal side-effects like epigastric pain, gastric fullness may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema may occur.

Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials are mild and self limiting in nature.

Gastro-intestinal disturbance: Diarrhea (if severe diarrhea occurs, Cefixime should be discontinued), changes in the color of stool, nausea, abdominal pain, dyspepsia, vomiting, flatulence have been reported. CNS disturbances: Headache, dizziness.

Others: Hypersensitivity reactions which usually subsided upon discontinuation of therapy; infrequent and reversible hematological changes; elevation of serum amylase.

Toxicity

Symptoms of overdose include blood in the urine, diarrhea, nausea, upper abdominal pain, and vomiting.

Precaution

Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.

Cefixime should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min)

Interaction

Ambroxol has no interaction with cardioactive glycosides, corticosteroids, bronchodilators, diuretics and antibiotics (normally used in the treatment of bronchopulmonary affections). But Ambroxol should not be taken simultaneously with antitussives (e.g. Codeine) because mucus, which has been liquefied by Ambroxol, might not be expectorated.

Increased prothrombin time (with or withot bleeding) with anticoagulants (e.g. warfarin). Increased plasma carbamazepine concentrations with concomitant use. Increased bioavailability with nifedipine. Increased serum concentration with probenecid.

Elimination Route

Rapid and almost complete.

About 40%-50% absorbed orally whether administered with or without food, however, time to maximal absorption is increased approximately 0.8 hours when administered with food.

Half Life

7-12 hours

3-4 hours (may range up to 9 hours). In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours.

Pregnancy & Breastfeeding use

Pregnancy: Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use during pregnancy, especially in the 1st trimester.

Lactation: Safety during lactation has not been established.

Pregnancy: Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Lactation: It is not known whether Cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.

Use in Elderly

No special precautions are necessary. No dosage adjustment is required for elderly

Contraindication

Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

Patients with known hypersensitivity to cephalosporin antibiotics, children under 6 months.

Special Warning

Use in Children: Safety and effectiveness of cefixime in children aged less than 6 months have not been established. For children younger than 12 years or weighing less than 50 kg, the usual dose is 8 mg/kg/day.

Use in elderly: No special precautions are necessary. Old age is not an indication for dose adjustment.

Dosage in renal impairment:

• Creatinine clearance: 20 ml/min or greater: normal dose
• Creatinine clearance: <20 ml/min or chronic ambulatory peritoneal dialysis
• Haemodialysis: daily dose should not exceed 200 mg.

Acute Overdose

Gastric lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Storage Condition

Store in a cool and dry place below 30ºC

Innovators Monograph

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