Co-Amoxiclav (RETACLAV-R) 625gm Tablet 20s Lot No 25520071 EXP 1/1/2027

About Co-Amoxiclav (RANICLAV) 625mg Tablet

Co-Amoxiclav (RANICLAV) 625mg Tablet is a combination antibiotic containing amoxicillin (a penicillin-type antibiotic) and clavulanic acid (a beta-lactamase inhibitor). The combination of these two active ingredients enhances the effectiveness of amoxicillin by inhibiting beta-lactamase enzymes produced by certain bacteria that would otherwise degrade amoxicillin. This results in a broader spectrum of activity against both gram-positive and gram-negative bacteria.

Each Co-Amoxiclav (RANICLAV) 625mg Tablet contains:

• Amoxicillin (as trihydrate) 500mg
• Clavulanic acid (as potassium clavulanate) 125mg

It is available in packs of 20 tablets.

Indications:

Co-Amoxiclav (RANICLAV) 625mg Tablet is used to treat infections caused by susceptible bacteria. It is commonly prescribed for the treatment of the following conditions:

• Respiratory Tract Infections:
  • Sinusitis.
  • Otitis media (middle ear infection).
  • Pharyngitis and tonsillitis.
  • Acute exacerbations of chronic bronchitis.
  • Community-acquired pneumonia.
• Urinary Tract Infections (UTIs):
  • Cystitis (bladder infection).
  • Pyelonephritis (kidney infection).
  • Urethritis.
• Skin and Soft Tissue Infections:
  • Cellulitis.
  • Abscesses.
  • Wound infections.
• Bone and Joint Infections:
  • Osteomyelitis.
  • Septic arthritis.
• Dental Infections:
  • Dental abscesses.
  • Periodontal infections.
• Intra-abdominal Infections:
  • Peritonitis.
  • Cholecystitis (gallbladder infection).
  • Diverticulitis.
• Post-surgical Infections:
  • Prophylactic treatment in certain surgical procedures where bacterial infection risk is high.

Dosage:

The typical dosage of Co-Amoxiclav (RANICLAV) 625mg Tablet is based on the patient’s condition, age, and renal function.

For Adults and Children Over 12 Years Old:

• Standard dose: 1 tablet (625mg) every 8 hours (three times a day).
• In more severe infections, a healthcare provider may increase the dose or adjust the frequency.

For Children (Age 6 to 12 years):

• Dosage is usually determined by body weight and the severity of the infection. The pediatric dose typically ranges from 20-40mg/kg per day, divided into 3 doses.

For Children (Age 2 to 6 years):

• The dosage is typically around 125mg-250mg every 8 hours, but this can vary based on the child’s condition.

Renal Impairment:

• For patients with impaired renal function, the dosing frequency may need to be reduced, and a lower dose may be required. Dosing adjustments should be made by a healthcare provider based on creatinine clearance.

Administration:

• Co-Amoxiclav (RANICLAV) 625mg Tablet should be taken with food to help reduce potential stomach upset.
• The tablet should be swallowed whole, and chewing the tablet is not recommended.

 

Side Effects:

Like all medications, Co-Amoxiclav (RANICLAV) 625mg Tablet can cause side effects, although not everyone will experience them. Some common and serious side effects include:

 

Common Side Effects:

• Gastrointestinal disturbances: nausea, vomiting, diarrhea, abdominal pain.
• Skin rash or itching.
• Headache.
• Dizziness or fatigue.

 

Serious Side Effects (requiring immediate medical attention):

• Severe allergic reactions: Anaphylaxis, swelling of the face, lips, tongue, or throat, difficulty breathing, severe rash or hives.
• Liver problems: Jaundice (yellowing of the skin or eyes), dark urine, unusual tiredness, or persistent abdominal pain.
• Severe gastrointestinal symptoms: Persistent diarrhea, especially if accompanied by blood or mucus, which could indicate Clostridium difficile-associated diarrhea.
• Blood disorders: Unexplained bruising, bleeding, or pale skin, which could indicate a problem with blood cell production.
• Severe skin reactions: Such as peeling, blistering, or flaking skin.
• Kidney problems: Difficulty urinating or changes in the amount of urine.

Other Possible Side Effects:

• Vaginal yeast infections.
• Mouth sores.
• Fatigue or feeling unwell.
• Thrush (oral candidiasis).

Contraindications:

Co-Amoxiclav (RANICLAV) 625mg Tablet should not be used in the following situations:

• Hypersensitivity to amoxicillin, clavulanic acid, or any other components of the formulation:
  • Individuals who are allergic to penicillins or cephalosporins may experience cross-reactivity and should avoid this medication.
• History of Severe Liver Disease or Jaundice:
  • Co-Amoxiclav should be avoided in patients with a history of cholestatic jaundice or liver dysfunction associated with the use of amoxicillin-clavulanate combination.
• Previous Allergic Reactions to Beta-lactam Antibiotics:
  • If the patient has had a serious allergic reaction (e.g., anaphylaxis) to amoxicillin, penicillins, cephalosporins, or any other beta-lactam antibiotics, this drug is contraindicated.
• Mononucleosis (Infectious Mononucleosis):
  • Co-Amoxiclav should not be used in patients with mononucleosis, as they are more likely to develop a rash.
• Severe Renal Impairment:
  • Patients with severe renal impairment (e.g., creatinine clearance <30 mL/min) may require dose adjustments or a different antibiotic regimen.
• Pregnancy and Breastfeeding:
  • Pregnancy Category B: Co-Amoxiclav is generally considered safe to use during pregnancy, but it should be used only when clearly needed and prescribed by a healthcare provider.
  • Breastfeeding: Amoxicillin passes into breast milk in small amounts. Although it is generally considered safe for breastfeeding mothers, it is important to consult a healthcare provider for proper advice.

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