Moxikind-CV

About Moxikind-CV

Moxikind-CV is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxycillin and the β-lactamase inhibitor clavulanate potassium (the potassium salt of Clavulanic acid). Moxikind-CV is mainly indicated for different infections such as dental, respiratory tract, skin and soft tissue, deep neck space, surgical site and other infections like acute otitis media and sinusitis.


Manufactured through EPA technology


(Enzymatically Processed Amoxycillin)*


Ensuring Less Gastrointestinal Side effects (abdominal pain and diarrhoea)1

reporting

Faster Dissolution2

Higher Bioavailability3


Categorized Amoxycillin and Clavulanic acid in Model list of medicines which has Low-Resistance Potential 4

Effectiveness of Moxikind-CV 625

reporting

Upper and lower respiratory tract infections

Genito-urinary tract infections

Skin and soft tissue infections

Bone and joint infections

Dental infections

The Indian Council of Medical Research (ICMR) in their Treatment guidelines 2019 recommends the use of Amoxycillin-Clavulanic acid in the following conditions 5 :


For Dental infections

Site of infection Organisms Dosage
Ludwig’s angina Group A Streptococci, oral anaerobes 625 mg 8 hourly
Odontogenic Polymicrobial-strict anaerobes (anaerobic cocci and facultative anerobe) and Viridians group (other streptococci, Peptostreptococcus and other oral anaerobes ) 625 mg 8 hourly

For Ear,Nose and Throat infections

Condition Organisms Dosage
Acute otitis media Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis 1.2 g 8 hourly, for severe infections: 1.2 g 6 hourly
Acute sinusitis Viral, S. pneumoniae, H. influenzae, M. catarrhalis 1.2 g 8 hourly,for severe infections: 1.2 g 6 hourly
Bacterial sinusitis Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes 1.2 g 8 hourly, for severe infections: 1.2 g 6 hourly

For General Infections

Infection Organisms Dosage
Empiric therapy of suspected Gram positive infections Streptococcus pneumoniae, Streptococcus pyogenes,S. aureus 1.2 g 8 hourly, for severe infections: 1.2 g 6 hourly

Respiratory tract infections

Clinical condition Common pathogens Dosage
Community acquired pneumonia (CAP) Outpatients without co-morbidities
S. pneumonia, Haemophilus influenzae, S. aureus, S. pyogene
1 gm BD/ 625 mg TBD
CAP Outpatients with co-morbidities* or use of antimicrobial in 3 months *Chronic heart, liver, renal or lung disease, diabetes mellitus, malignancies, alcoholism or use of immunosuppressive drugs S. pneumonia, Haemophilus influenzae, S. aureus, S. pyogene 1 gm BD/ 625 mg TBD
Pediatric CAP Age less than 5 years Outpatient and Inpatients. S. pneumonia, Haemophilus influenzae, S. aureus, S. pyogene 15-20 mg/kg dose of Amoxycillin twice daily Per os
Pediatric CAP Age more than 5 years Inpatients S. pneumonia Haemophilus influenzae, S. aureus, S. pyogene 15-20 mg/kg dose of Amoxycillin twice daily Per os

For skin and soft-tissue infections (SSTIs)

Condition Organism Duration Dosage
Cellulitis S.pyogenes, S.aureus 5-7 days (longer if clinically indicated) Oral: 1g BD/ 1.2gm TDS
Erysipelas Propionibacterium acnes/MSSA 5-7 days Oral: 1g BD/ 1.2gm TDS
Skin Abscess S. pyogenes, Oral anaerobes 5-7 days Oral: 1g BD/ 1.2gm TDS

For deep neck space infections

Site of infection Organisms Dosage
Peri-tonsillar abscess (Quinsy) S.pyogenes, Oral anaerobes 1.2 g 8 hourly (for Peri-tonsillar abscess)
Head & neck space infections Polymicrobial, S. pyogenes, S. aureus, viridans streptococci, oral anaerobes 1.2 g 8 hourly, for severe infections: 1.2 g 6 hourly
Suppurative parotitis Streptococci, Staphylococcus aureus, oral anaerobes 625 mg 8 hourly

Surgical Site Infections (SSI)

Operations Likely Pathogens Dosage
Head and neck (major procedures with an incision through oropharyngeal mucosa) Staphylococcus aureus; streptococci; oropharyngeal anaerobes (e.g., peptostreptococci) 1.2 g every 8 hourly

Moxikind-CV 625 has high Susceptibility to resistant Pathogens5

  • Neisseria gonorrhoeae
  • Haemophilus influenzae
  • Staphylococcus aureus
  • Enterobacter
  • Enterococcus faecalis
  • Staphylococcus epidermidis
  • Staphylococcus saprophyticus
  • Eikenella corrodens
  • Proteus mirabilis
  • Escherichia coli
  • Klebsiella
  • Moraxella catarrhalis
  • Clostridium difficile
  • Fusobacterium
  • Bacteroides fragilis
  • Streptococcus pneumoniae

Frequently Asked Questions6,7,8

  • Moxikind-CV is an oral antibacterial combination consisting of the semisynthetic antibiotic Amoxycillin and the β-lactamase inhibitor, Clavulanic potassium (the potassium salt of Clavulanic acid). Amoxycillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid.

    Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins

    • Absorption: Rapidly and well absorbed from GI tract. Bioavailability: Approx. 70%. Time to peak plasma concentration: 1-2.5 hr
    • Distribution:
      • It crosses the placental barrier (category B); enters breast milk (small amounts); readily distributes into most body tissues and fluid
      • Amoxycillin Readily distributes except into cerebrospinal fluid. Volume of distribution: Approx. 0.3-0.4 L/kg (Amoxycillin); approx. 0.2 L/kg (Clavulanic acid). Plasma protein binding: Approx. 18% (Amoxycillin); approx. 25% (Clavulanic acid)
    • Excretion:
      • Via urine (Amoxycillin: Approx. 50-70% ; Clavulanic acid: Approx. 25-40%) as unchanged drug during the 1st 6 hr. after administration
      • Mean elimination half-life: Approx. 1 hr
  • Amoxycillin is susceptible to degradation by β-lactamases. Clavulanic acid component of Moxikind-CV protects Amoxycillin degradation by β-lactamase enzymes. Thereby, effectively extends the antibiotic spectrum of Amoxycillin to include many bacteria normally resistant to β-lactams.

  • Moxikind-CV is indicated for short-term treatment of bacterial infections:

    • Upper Respiratory Tract Infections (Including ENT) E.G. Tonsillitis, Sinusitis, Otitis Media
    • Lower Respiratory Tract Infections - Acute Exacerbation Of Chronic Bronchitis, Lobar And Bronchopneumonia
    • Genito-urinary Tract Infections - Cystitis, Urethritis, Pyelonephritis
    • Skin And Soft Tissue Infections - Boils, Abscesses, Cellulitis, Wound Infections
    • Bone And Joint Infections - Osteomyelitis
    • Dental Infections - Dentoalveolar Abscess
    • Other Infections - Septic Abortion, Puerperal Sepsis, Intra-abdominal Sepsis
  • Moxikind-CV is available as the following formula

    • Adults
      • Moxikind-CV – (Tablets)- Amoxycillin 875 mg + Clavulanic acid 125 mg
      • Moxikind-CV – (Tablets)- Amoxycillin 500 mg + Clavulanic acid 125 mg
      • Moxikind-CV – (Tablets)- Amoxycillin 250 mg + Clavulanic acid 125 mg
    • Paediatric :
      • Moxikind-CV – (Dry Syrup)- Amoxycillin 200 mg + Clavulanic acid 28.5mg /5ml
      • Moxikind-CV – (Forte Dry Syrup)- Amoxycillin 400 mg + Clavulanic acid 57 mg/ 5 ml
      • Moxikind-CV – (Drops)- Amoxycillin 80 mg + Clavulanic acid 11.4 mg/ ml
      • Moxikind-CV – (Kids Tablet)- Amoxycillin 200 mg + Clavulanic acid 28.5 mg
    • Adult-
      • The usual adult dose is one 625-mg tablet of Moxikind-CV every 12 hours. For more severe infections and infections of the Respiratory tract, the dose should be one 875-mg tablet every 12 hours or one 625-mg tablet every 8 hours
    • Pediatric
      • Neonates and Infants Aged <12 weeks (<3 months): 30 mg/kg/day divided every 12 hours
      • Patients Aged 12 weeks (3 months) and Older: 200mg/5ml or 400mg/5ml orally in every 12 hours. 125mg/5ml or 250 mg/5ml orally in every 8 hours.
  • Very common- Diarrhoea, abdominal pain


    Common - Mucocutaneous candidiasis, Nausea, vomiting


    Uncommon - Dizziness, headache, Indigestion, A moderate rise in AST and/or ALT has been noted in patients treated with beta-lactam class antibiotics, but the significance of these findings is unknown


    Very Rare - Hepatitis and cholestatic jaundice, Antibiotic-associated colitis, Reversible agranulocytosis and haemolytic anaemia, Prolongation of bleeding time and prothrombin time, Angioneurotic oedema, anaphylaxis, serum sickness-like syndrome, hypersensitivity vasculitis

  • Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients. In the case of overdosage, discontinue Moxikind-CV, treat symptomatically, and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed.

  • Moxikind-CV is contraindicted with

    • Hypersensitivity to Penicillins
    • Those who have a history of severe immediate hypersensitivity reaction to another β-lactam agent (e.g. cephalosporins, carbapenem or monobactam)

    Discontinue Moxikind-CV if you experienced Moxikind-CV associated cholestatic Jaundice/Hepatic Dysfunction

  • The following conditions should be monitored periodically:

    • Renal and hepatic impairment
    • Pregnancy and lactation
    • Monitoring Parameters: Periodically monitor renal, hepatic and hematologic function
    • Monitor for signs of Anaphylaxis during 1st dose
  • The use of Moxikind-CV is restricted to individuals with hepatic impairment, pregnant and lactating.

  • If you miss a dose of Moxikind-CV, take it as soon as possible. However two 375-mg tablets should not be substituted for one 625-mg tablet since both the 375-mg and 625-mg tablets contain the same amount of Clavulanic acid.

  • Tablet starts working and showing improvement within an hour to 2.5 hrs. It may take a little longer to notice full benefits.

  • Store Moxikind-CV tablets at or below 25°C (77°F).

References

* Data on File #Bioequivalence Study. 1.The Indian Practitioner, "November 2015:Volume 68". 2. Christopher Vimalson, et al: Techniques to enhance the solubility of the hydrophobic drug, Asian Journal of Pharmaceutics, April-June 2016. 3. Young Jae rye et al , comparison of blood concentration for oral administration of micronized and non micronized Amoxycillin in Sprague - Dawley rats,J Blomed Res 4.WHO Executive Summary The selection and Use of Essential Medicines 2017 5.Treatment Guidelines for Antimicrobial use in Common Syndromes. 2019 6. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically – Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25. NCCLS, Villanova, PA, Dec. 1993 7. National Committee for Clinical Laboratory Standards. Performance Standard for Antimicrobial Disk Susceptibility Tests – Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24. NCCLS, Villanova, PA, Dec. 1993. 8. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol 1988;30:66-67.