Bambang Pharmaceutical Depot Inc.
Co Amoxiclav (Orapen) 625mg Antibacterial Tablet 20's
Co Amoxiclav (Orapen) 625mg Antibacterial Tablet 20's
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Product Description:
Co-Amoxiclav (Orapen) 625mg 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 (Orapen) 625mg tablet contains:
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Amoxicillin (as trihydrate) 500mg
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Clavulanic acid (as potassium clavulanate) 125mg
It is available in packs of 20 tablets.
Indications:
Co-Amoxiclav (Orapen) 625mg is used to treat infections caused by susceptible bacteria. It is commonly prescribed for the treatment of the following conditions:
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Respiratory Tract Infections:
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Sinusitis.
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Otitis media (middle ear infection).
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Pharyngitis and tonsillitis.
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Acute exacerbations of chronic bronchitis.
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Community-acquired pneumonia.
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Urinary Tract Infections (UTIs):
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Cystitis (bladder infection).
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Pyelonephritis (kidney infection).
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Urethritis.
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Skin and Soft Tissue Infections:
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Cellulitis.
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Abscesses.
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Wound infections.
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Bone and Joint Infections:
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Osteomyelitis.
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Septic arthritis.
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Dental Infections:
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Dental abscesses.
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Periodontal infections.
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Intra-abdominal Infections:
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Peritonitis.
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Cholecystitis (gallbladder infection).
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Diverticulitis.
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Post-surgical Infections:
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Prophylactic treatment in certain surgical procedures where bacterial infection risk is high.
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Dosage:
The typical dosage of Co-Amoxiclav (Orapen) 625mg is based on the patient's condition, age, and renal function.
For Adults and Children Over 12 Years Old:
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Standard dose: 1 tablet (625mg) every 8 hours (three times a day).
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In more severe infections, a healthcare provider may increase the dose or adjust the frequency.
For Children (Age 6 to 12 years):
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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):
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The dosage is typically around 125mg-250mg every 8 hours, but this can vary based on the child’s condition.
Renal Impairment:
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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:
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Co-Amoxiclav (Orapen) 625mg tablets should be taken with food to help reduce potential stomach upset.
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The tablet should be swallowed whole, and chewing the tablet is not recommended.
Side Effects:
Like all medications, Co-Amoxiclav (Orapen) 625mg can cause side effects, although not everyone will experience them. Some common and serious side effects include:
Common Side Effects:
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Gastrointestinal disturbances: nausea, vomiting, diarrhea, abdominal pain.
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Skin rash or itching.
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Headache.
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Dizziness or fatigue.
Serious Side Effects (requiring immediate medical attention):
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Severe allergic reactions: Anaphylaxis, swelling of the face, lips, tongue, or throat, difficulty breathing, severe rash or hives.
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Liver problems: Jaundice (yellowing of the skin or eyes), dark urine, unusual tiredness, or persistent abdominal pain.
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Severe gastrointestinal symptoms: Persistent diarrhea, especially if accompanied by blood or mucus, which could indicate Clostridium difficile-associated diarrhea.
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Blood disorders: Unexplained bruising, bleeding, or pale skin, which could indicate a problem with blood cell production.
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Severe skin reactions: Such as peeling, blistering, or flaking skin.
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Kidney problems: Difficulty urinating or changes in the amount of urine.
Other Possible Side Effects:
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Vaginal yeast infections.
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Mouth sores.
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Fatigue or feeling unwell.
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Thrush (oral candidiasis).
Contraindications:
Co-Amoxiclav (Orapen) 625mg should not be used in the following situations:
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Hypersensitivity to amoxicillin, clavulanic acid, or any other components of the formulation:
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Individuals who are allergic to penicillins or cephalosporins may experience cross-reactivity and should avoid this medication.
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History of Severe Liver Disease or Jaundice:
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Co-Amoxiclav should be avoided in patients with a history of cholestatic jaundice or liver dysfunction associated with the use of amoxicillin-clavulanate combination.
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Previous Allergic Reactions to Beta-lactam Antibiotics:
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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.
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Mononucleosis (Infectious Mononucleosis):
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Co-Amoxiclav should not be used in patients with mononucleosis, as they are more likely to develop a rash.
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Severe Renal Impairment:
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Patients with severe renal impairment (e.g., creatinine clearance <30 mL/min) may require dose adjustments or a different antibiotic regimen.
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Pregnancy and Breastfeeding:
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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.
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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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Precautions:
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Allergic Reactions: Caution should be taken in patients with a history of allergies or asthma, as they may be at higher risk for hypersensitivity reactions.
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Renal Function: In patients with impaired renal function, the dose of Co-Amoxiclav may need to be adjusted. Close monitoring is required.
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Long-term Use: Prolonged use of Co-Amoxiclav can lead to superinfection (e.g., fungal infections or resistance).
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Drug Interactions: Co-Amoxiclav may interact with certain medications, including:
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Probenecid: May increase amoxicillin levels.
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Oral contraceptives: May reduce the effectiveness of oral contraceptives; additional contraceptive methods may be recommended.
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Methotrexate: May increase the risk of methotrexate toxicity.
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Conclusion:
Co-Amoxiclav (Orapen) 625mg is a broad-spectrum antibiotic used to treat a variety of bacterial infections, including respiratory, urinary tract, skin, and dental infections. It works by combining amoxicillin, a penicillin-type antibiotic, with clavulanic acid, which helps protect the antibiotic from being broken down by bacteria. Although it is generally well-tolerated, side effects such as gastrointestinal disturbances and allergic reactions may occur. It is contraindicated in individuals with certain allergies or liver conditions. As with all antibiotics, it is important to complete the prescribed course to prevent resistance and ensure effective treatment.
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