Intaclox D

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.

Dicloxacillin is used for Boils, Carbuncles, Cellulitis, Endocarditis, Folliculitis, Impetigo, Mastitis, Osteomyelitis, Otitis externa, Pneumonia, Septic Arthritis, Staphylococcal skin infections, Streptococcus Septicaemia, Surgical Prophylaxis, Throat infections

Intaclox D 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 InfectionsAnimal bite, Impetigo, Infection caused by staphylococci

How Intaclox D 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.

Dicloxacillin exerts a bactericidal action against penicillin-susceptible microorganisms during the state of active multiplication. All penicillins inhibit the biosynthesis of the bacterial cell wall. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, dicloxacillin 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 dicloxacillin interferes with an autolysin inhibitor.

Dosage

Intaclox D 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.

Adult: 125-250 mg 6 hourly. Doses may be doubled in severe infections.

Child: <40 kg: 12.5-25 mg/kg 6 hourly.

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

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).

Hypersensitivity reactions (e.g. urticaria, fever, joint pains, rashes, angioedema, serum sickness-like reactions), nausea, vomiting, diarrhoea, stomatitis, black/hairy tongue, neurotoxic reactions, renal tubular damage, interstitial nephritis, eosinophilia, haemolytic anaemia, agranulocytosis, neutropenia, leucopenia, granulocytopenia, bone marrow depression, hepatotoxicity, cholestatic hepatitis.

Toxicity

Oral LD₅₀ in rat is 3579 mg/kg. Symptoms of overexposure include irritation, rash, labored breathing, hives, itching, wheezing, nausea, chills, and fever.

Precaution

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

Patient with history of allergy esp β-lactam allergy, asthma. Pregnancy and lactation.

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.

Probenecid prolongs serum levels of dicloxacillin. Bacteriostatic drugs (e.g. chloramphenicol, tetracyclines) may antagonise the bactericidal effect of dicloxacillin. May reduce anticoagulant response to dicumarol and warfarin. May increase risk of methotrexate toxicity. May diminish the effect of live vaccines (e.g. typhoid vaccine).

Elimination Route

Absorption of the isoxazolyl penicillins after oral administration is rapid but incomplete: peak blood levels are achieved in 1-1.5 hours. Oral absorption of cloxacillin, dicloxacillin, oxacillin and nafcillin is delayed when the drugs are administered after meals.

Half Life

The elimination half-life for dicloxacillin is about 0.7 hour.

Elimination Route

Ampicillin is excreted largely unchanged in the urine.

Dicloxacillin sodium is rapidly excreted as unchanged drug in the urine by glomerular filtration and active tubular secretion.

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. 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).

Contraindication

Hypersensitivity to ampicillin and other penicillins.

Hypersensitivity to dicloxacillin and other penicillins.

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 between 20-25° C.

Innovators Monograph

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