Ultraxin Capsules

Uses

Ultraxin Capsules is used for the treatment of infections caused by Grampositive organisms including infections caused by β-lactamase producing Staphylococci such as :

• Skin and soft tissue infections : Boils, Abscesses, Carbuncles, Furunculosis, Cellulitis, Infected wounds, Infected burns, Otitis media and externa, Protection of skin graft and Skin infections like ulcer, eczema, acne, etc.
• Respiratory tract infections : Pneumonia, Lung abscess, Empyema, Sinusitis, Pharyngitis and Tonsillitis.
• Other infections caused by sensitive organisms : Osteomyelitis, Enteritis, Endocarditis, Urinary tract infection, Meningitis and Septicaemia.

Ultraxin Capsules is also used to associated treatment for these conditions: Infection caused by staphylococci, Infections caused by penicillinase-producing staphylococci, Pneumococcal Infection, Streptococcal Infections

How Ultraxin Capsules works

By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, cloxacillin 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 cloxacillin interferes with an autolysin inhibitor.

Dosage

Ultraxin Capsules dosage

Upper Respiratory Tract Infection (Adult):

• Usual Dose: 250 mg orally every 6 hours for 7 to 14 days, depending on the nature and severity of the infection.
• Maximum dose: 4 g/day.

Upper Respiratory Tract Infection (Pediatric):

• Usual Dose: The safety and efficacy of cloxacillin in children < 1 year have not been established.
• ≥ 1 year to 18 years: 50 to 100 mg/kg/day orally divided every 6 hours.
• Maximum dose: 4 g/day.

Pneumonia(Adult):

• Usual Dose: 500 mg orally every 6 hours for up to 21 days, depending on the nature and severity of the infection.
• Maximum dose: 4 g/day.

Pneumonia(Pediatric):

• Usual Dose: The safety and efficacy of cloxacillin in children < 1 year have not been established.
• ≥ 1 year to 18 years: 50 to 100 mg/kg/day orally divided every 6 hours.
• Maximum dose: 4 g/day.

Skin and Structure Infection(Adult):

• Usual Dose: 500 mg orally every 6 hours for 7 days, or until 3 days after acute inflammation resolves, depending on the nature and severity of the infection.
• Maximum dose: 4 g/day.

Skin and Structure Infection (Pediatric):

• Usual Dose: The safety and efficacy of cloxacillin in children < 1 year have not been established.
• ≥ 1 year to 18 years: 50 to 100 mg/kg/day orally divided every 6 hours.
• Maximum dose: 4 g/day.

Cystitis:

• Usual Adult Dose: 250 mg orally every 6 hours for 3 to 7 days, depending on the nature and severity of the infection. Ultraxin Capsules is rarely indicated for the treatment of cystitis.
• Maximum dose: 4 g/day.

Side Effects

Common side effects are skin rash, transient diarrhoea, nausea, heartburn, pruritus and disturbance of blood electrolyte. Rarely anaphylactic shock.

Toxicity

Oral LD₅₀ in rat and mouse is 5000 mg/kg. Intravenous LD₅₀ in rat is 1660 mg/kg. Symptoms of overdose include wheezing, tightness in the chest, fever, itching, bad cough, blue skin color, fits, and swelling of face, lips, tongue, or throat.

Precaution

Ultraxin Capsules should be given with caution to patients with known history of allergy.

Interaction

May diminish the effect of BCG and typhoid vaccine. May increase risk of methotrexate toxicity. May diminish the therapeutic effect of Na picosulfate. May decrease serum concentrations of mycophenolate. May prolong bleeding time with anticoagulants. Increased serum concentrations with probenecid. Tetracycline may antagonise the bactericidal effect of cloxacillin.

Food Interaction

• Take on an empty stomach. Orally administered cloxacillin should be taken 1-2 hours prior to meals as the presence of food in the stomach and intestine reduces drug absorption.

[Moderate] ADJUST DOSING INTERVAL: Certain penicillins may exhibit reduced gastrointestinal absorption in the presence of food.

The therapeutic effect of the antimicrobial may be reduced.

MANAGEMENT: The interacting penicillin should be administered one hour before or two hours after meals.

Penicillin V and amoxicillin are not affected by food and may be given without regard to meals.

Ultraxin Capsules Hypertension interaction

[Moderate] Each 250 mg capsule of cloxacillin sodium contains approximately 14 mg (0.6 mEq) of sodium, and each teaspoonful of the 125 mg<5 mL oral solution contains approximately 11 mg (0.48 mEq) of sodium.

The sodium content should be considered in patients with conditions that may require sodium restriction, such as congestive heart failure, hypertension, and fluid retention.

Ultraxin Capsules Drug Interaction

Unknown: aspirin, aspirin, epinephrine, epinephrine, amoxicillin / clavulanate, amoxicillin / clavulanate, ciprofloxacin, ciprofloxacin, acetaminophen, acetaminophen, multivitamin, multivitamin, thiamine, thiamine, cyanocobalamin, cyanocobalamin, pyridoxine, pyridoxine, cholecalciferol, cholecalciferol

Ultraxin Capsules Disease Interaction

Major: colitis, marrow toxicityModerate: sodium

Elimination Route

Well absorbed from the gastrointestinal tract.

Pregnancy & Breastfeeding use

Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal 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).

Contraindication

Ultraxin Capsules should not be given to patients known to be hypersensitive to penicillin.

Storage Condition

Dry powder: Store below 25° C. Reconstituted solution: Store between 2-8° C (stable for 4 days); 23° C (stable for 24 hr).

Innovators Monograph

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