Kefdil 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.

Cefadroxil Monohydrate (Cefadroxil Monohydrate) is used for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:

*Upper respiratory tract infections caused by Streptococcus pyogenes (Group A beta-hemolytic Streptococci) and Streptococcus pneumoniae.

* Urinary tract infections caused by E. coli, Proteus mirabilis, and Klebsiella species.

* Skin and soft tissue infections caused by Staphylococci (including penicillinase producing strains) and Streptococci.

Kefdil Ax is also used to associated treatment for these conditions: Airway secretion clearance therapyBacterial Infections, Infection and inflammatory reaction due to internal prosthetic device, implant, and graft, Skin and Subcutaneous Tissue Bacterial Infections, Streptococcal Pharyngitis, Streptococcal tonsillitis, Urinary Tract Infection

How Kefdil 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, cefadroxil 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 cefadroxil interferes with an autolysin inhibitor.

Dosage

Kefdil 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 bioavailability and consequent chemotherapeutic effects of Cefadroxil are unaffected by foods. It may, therefore, be taken with meals or on an empty stomach. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.IndicationAdult (dose)Children (Dose)

Upper respiratory tract Infections

1 gm per day in single (q.d.) or divided doses (b.i.d.) for 10 days 12 hourly

30 mg/kg/day in a single or in equally divided doses every 12 hours

Urinary Tract Infections

1 or 2 gm per day in single (q.d.) or divided doses (b.i.d.)

30 mg/kg/day in equally divided doses every 12 hours

For all other UTIs

2 gm per day in divided doses (b.i.d)

30 mg/kg/day in equally divided doses every 12 hours

Skin & soft tissue Infections

1 gm per day in single (q.d.) or divided doses (b.i.d.)

30 mg/kg/day in equally divided doses every 12 hours

Prophylaxis against bacterial endocarditis

2 gm 1 hour prior to the procedure

50 mg/kg 1 hour prior to the procedure

Direction for Reconstitution of suspension

For 100 ml suspension and 100 ml DS suspension: Add 65 ml (13 measuring spoonful) of boiled and cooled water to the dry mixture in the bottle. For ease of preparation add water to the bottle in two portions. Shake well after each addition until all the powder is in suspension.

For 60 ml suspension: Add 40 ml (8 measuring spoonful) of boiled and cooled water to the dry mixture in the bottle. For ease of preparation add water to the bottle in two portions. Shake well after each addition until all the powder is in suspension.

Paediatric Drops: Add 10 ml (2 measuring spoonful) to the bottle and shake vigorously.

Note: Shake both oral suspension and paediatric drops 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.

Generally cefadroxil is well tolerated. However, the most commonly reported side effects are gastrointestinal disturbances and hypersensitivity phenomena. Side effects including nausea, vomiting, diarrhoea, dyspepsia, abdominal discomfort, fever, dizziness, headache, arthralgia may also occur.

Toxicity

Nausea, vomiting, diarrhoea, allergic rashes may occur

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.

History of hypersensitivity to penicillins or any other β-lactam drugs. History of GI disease (particularly colitis), severe allergies or asthma. Renal impairment. Pregnancy and lactation.

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.

There is no known clinically important drug interactions with Cefadroxil.

Elimination Route

Rapid and almost complete.

Cefadroxil is well absorbed on oral administration; food does not interfere with its absorption.

Half Life

7-12 hours

1.5 hours

Elimination Route

Over 90% of the drug is excreted unchanged in the urine within 24 hours. Cefadroxil was detected in the placenta and breast milk.

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.

Cefadroxil (Cefadroxil Monohydrate) is widely used as a first-line oral antibiotic for the treatment of uncomplicated urinary tract infections in pregnant women.

Contraindication

Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

Cefadroxil is contraindicated in patients with a history of hypersensitivity to any of the ingredients.

Acute Overdose

If amounts >250 mg/kg is ingested, gastric lavage or simulation of vomiting is appropriate.

Storage Condition

Store between 20-25°C. Reconstituted powder for suspension: Store between 2-8°C.

Innovators Monograph

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