Abapen Cap(Amoxicillin) 300Mg, 10’s-Potentail Overview

Generic Information

• Brand Name: Abapen Cap
• Generic Name: Amoxicillin
• Strength: 300 mg per capsule, pack of 10
• Pharmaceutical Class:
  • Class: Penicillin Antibiotic
  • Type: Beta-lactam antibiotic

Indications for Use

Amoxicillin is used for the treatment of a variety of bacterial infections, including:

1. Respiratory Tract Infections (RTIs):
   • Acute bacterial otitis media
   • Streptococcal pharyngitis
   • Sinusitis
   • Chronic obstructive pulmonary disease (COPD) exacerbations
2. Urinary Tract Infections (UTIs):
   • Cystitis, pyelonephritis
3. Gastrointestinal Infections:
   • Helicobacter pylori eradication (in combination therapy for peptic ulcers).
4. Skin and Soft Tissue Infections:
   • Cellulitis, wound infections, impetigo.
5. Other Infections:
   • Lyme disease, endocarditis prophylaxis, gonorrhea, and infections of reproductive organs.

Common Side Effects

• Nausea
• Vomiting
• Diarrhea
• Rash
• Abdominal discomfort
• Headache
• Vaginal yeast infections (Candida)
• Oral thrush

Serious Side Effects (Less Common)

• Allergic Reactions:
  • Severe allergic reactions (e.g., anaphylaxis, swelling of the throat, or difficulty breathing).
• Hematologic:
  • Thrombocytopenia, leukopenia, or eosinophilia.
• Liver Toxicity:
  • Hepatitis, jaundice, elevated liver enzymes.
• Renal:
  • Interstitial nephritis, renal failure (rare).
• CNS:
  • Seizures, confusion, or hallucinations in severe cases.
• Clostridium difficile-Associated Diarrhea (CDAD):
  • Severe diarrhea, colitis, abdominal pain.

Dosage and Usage Instructions

1. For Adults and Children Over 12 years:
   • Usual Dose: 250 mg to 500 mg every 8 hours or 500 mg to 875 mg every 12 hours, depending on the severity and type of infection.
   • For severe infections, the dose can be increased to 1 g every 8 hours.
2. For Children (6 months to 12 years):
   • Dose: Based on weight, usually 20 to 40 mg/kg/day in divided doses (administered in 2-3 doses per day).
3. For Children Under 6 months:
   • Dose: Typically 30 mg/kg/day, divided into two doses.
4. For Special Conditions (e.g., severe infections, H. pylori eradication):
   • Higher doses may be required, depending on the infection. Consult a healthcare provider for specific dosing.

Usage Instructions:

• Amoxicillin can be taken with or without food.
• It is essential to take the full prescribed course to prevent the development of antibiotic-resistant bacteria.
• If a dose is missed, take it as soon as possible, but if it is almost time for the next dose, skip the missed dose. Do not take two doses at once.

Drug Interactions

• With Food:
  • Food does not significantly affect the absorption of amoxicillin, but taking it with food may help prevent gastrointestinal discomfort.
• With Other Medications:
  • Oral Contraceptives: Amoxicillin may reduce the effectiveness of oral contraceptives, so additional contraceptive methods should be considered during therapy.
  • Allopurinol: There is an increased risk of developing a rash when amoxicillin is taken with allopurinol.
  • Probenecid: Increases amoxicillin levels by inhibiting renal excretion.
  • Methotrexate: Amoxicillin can increase methotrexate levels, leading to potential toxicity.
  • Anticoagulants (e.g., warfarin): Co-administration may increase the risk of bleeding due to potentiation of anticoagulant effects.
• Other Interactions:
  • Cholestyramine: Reduces the absorption of amoxicillin when taken simultaneously.

Regulatory Approval and Manufacturer

• Regulatory Approval:
  • Amoxicillin has received FDA approval for use in treating a variety of bacterial infections. It is included in the World Health Organization’s List of Essential Medicines.
• Manufacturer:
  • Abapen is produced by various manufacturers, with many generic versions of amoxicillin available globally. The brand may be marketed by different pharmaceutical companies in different regions.

Pharmacist-Related Data

Drug Name and Chemical Details

• Generic Name: Amoxicillin
• Chemical Formula: C16H19N3O5S
• Molecular Weight: 365.4 g/mol
• CAS Number: 26787-78-0

Pharmacodynamics

1. Mechanism of Action:
   • Amoxicillin is a broad-spectrum penicillin antibiotic that inhibits bacterial cell wall synthesis. It binds to and inactivates penicillin-binding proteins (PBPs) located on the bacterial cell wall, leading to cell lysis and bacterial death, especially in rapidly dividing bacteria.
2. Therapeutic Effects:
   • Amoxicillin is effective in treating a wide variety of infections caused by susceptible organisms, including respiratory, urinary, and gastrointestinal infections, as well as skin and soft tissue infections.

Pharmacokinetics

1. Absorption:
   • Amoxicillin is rapidly absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations occur within 1-2 hours.
   • Bioavailability: Approximately 95%, meaning it is almost completely absorbed into the bloodstream.
2. Distribution:
   • Amoxicillin is widely distributed throughout the body and reaches therapeutic levels in tissues such as the lungs, middle ear, urine, and liver.
   • It is approximately 20-30% protein-bound in plasma.
3. Metabolism:
   • Amoxicillin is only minimally metabolized by the liver, with the majority of the drug remaining unchanged in the body. It is converted to penicilloic acid, an inactive metabolite.
4. Excretion:
   • Amoxicillin is primarily excreted unchanged in the urine via renal elimination. About 60-70% of the drug is excreted within 6-8 hours after dosing.
5. Half-Life:
   • The half-life of amoxicillin is about 1 to 1.5 hours in healthy adults. In patients with renal impairment, the half-life may be prolonged.

Drug Interactions

1. With Food:
   • Food does not significantly affect the absorption of amoxicillin. It can be taken with or without food.
2. With Other Medications:
   • Oral Contraceptives: Amoxicillin may reduce the effectiveness of oral contraceptives. Alternate methods of contraception are advised.
   • Methotrexate: The combination of amoxicillin and methotrexate can increase methotrexate levels, leading to toxicity.
   • Probenecid: Probenecid can increase the plasma concentration of amoxicillin by inhibiting its renal excretion.
   • Anticoagulants (e.g., warfarin): Concurrent use may increase the risk of bleeding. Close monitoring of INR (International Normalized Ratio) is recommended.
3. Other Interactions:
   • Cholestyramine: Reduces the absorption of amoxicillin, so it is advised not to take them together.

Clinical Considerations

1. Pregnancy Category:
   • FDA Category B: Amoxicillin is generally considered safe during pregnancy. Studies in animals have shown no harm, and limited human studies also suggest low risk. It should only be used when the benefit outweighs the risk.
2. Lactation:
   • Amoxicillin is excreted in breast milk in small amounts. It is considered safe for use during breastfeeding, but infants should be monitored for potential side effects like diarrhea or thrush.
3. Pediatric Use:
   • Amoxicillin is commonly used in pediatric patients to treat various bacterial infections. The dosage is usually based on the child’s weight.
   • For neonates and infants with renal impairment, dose adjustments may be necessary.
4. Geriatric Use:
   • In elderly patients, especially those with renal impairment, dose adjustments may be necessary to avoid toxicity. Regular monitoring is advised.
5. Other Considerations:
   • Amoxicillin should be used cautiously in patients with a history of allergy to penicillin or other beta-lactam antibiotics due to the risk of cross-sensitivity.
   • Caution is advised in patients with renal impairment, as dose modifications may be required.