Abapen Cap(Amoxicillin)100 Mg, 10’s-Potential Overview

Generic Information

• Brand Name: Abapen Cap
• Generic Name: Amoxicillin
• Strength: 100 mg per capsule, pack of 10
• Pharmaceutical Class:
  • Class: Penicillin Antibiotic
  • Type: Beta-lactam antibiotic

Indications for Use

Amoxicillin is used to treat various bacterial infections, including:

1. Respiratory Tract Infections (RTIs):
   • Acute bacterial otitis media
   • Streptococcal pharyngitis
   • Sinusitis
2. Urinary Tract Infections (UTIs):
   • Cystitis and pyelonephritis caused by susceptible organisms.
3. Gastrointestinal Infections:
   • Helicobacter pylori eradication in combination with other drugs for the treatment of peptic ulcers.
4. Skin and Soft Tissue Infections:
   • Impetigo, cellulitis, and wound infections.
5. Other Infections:
   • Lyme disease, endocarditis prophylaxis, and infections of the reproductive organs (e.g., gonorrhea).

Common Side Effects

• Nausea
• Vomiting
• Diarrhea
• Rash
• Headache
• Abdominal discomfort
• Changes in taste
• Vaginal yeast infections

Serious Side Effects (Less Common)

• Allergic Reactions:
  • Severe reactions including anaphylaxis, which can lead to difficulty breathing, swelling of the throat, or hives.
• Hematologic:
  • Thrombocytopenia, leukopenia, or eosinophilia.
• Liver Toxicity:
  • Hepatitis, jaundice, or elevated liver enzymes.
• Renal:
  • Interstitial nephritis, renal failure (rare).
• CNS:
  • Seizures, confusion, or hallucinations in severe cases.
• Clostridium difficile-Associated Diarrhea (CDAD):
  • Severe diarrhea and colitis due to disruption of normal intestinal flora.

Dosage and Usage Instructions

1. For Adults and Children Over 12 years:
   • Typical 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.
2. For Children (6 months to 12 years):
   • Dose: Based on weight, usually 20 to 40 mg/kg/day in divided doses.
3. For Children Under 6 months:
   • Dose: 30 mg/kg/day divided into two doses.
4. For Severe Infections or Specific Conditions:
   • Dose: Can be increased to 1 g every 8 hours as needed.

Usage Instructions:

• Amoxicillin can be taken with or without food.
• Take the full course of treatment as prescribed, even if symptoms improve before completing the therapy to prevent antibiotic resistance.
• If a dose is missed, take it as soon as remembered, but skip it if it’s almost time for the next dose. Do not double doses.

Drug Interactions

• With Food:
  • Amoxicillin can be taken with or without food, though taking it with food may reduce gastrointestinal discomfort.
• With Other Medications:
  • Oral Contraceptives: Amoxicillin may reduce the effectiveness of oral contraceptives, increasing the risk of pregnancy.
  • Allopurinol: Increased risk of rash when used concurrently.
  • Probenecid: Increases amoxicillin levels by inhibiting renal excretion.
  • Anticoagulants (e.g., warfarin): Amoxicillin may enhance the effects of anticoagulants, increasing the risk of bleeding.
  • Methotrexate: Increased levels of methotrexate due to decreased renal clearance when used with amoxicillin.
• Other Interactions:
  • Cholestyramine: Reduces absorption of amoxicillin when taken together.

Regulatory Approval and Manufacturer

• Regulatory Approval:
  • Amoxicillin is FDA-approved and has been approved for use in a variety of bacterial infections for both adults and children. It is listed in the World Health Organization’s Essential Medicines List.
• Manufacturer:
  • Various manufacturers globally produce amoxicillin, with many generic versions available. The brand “Abapen” may be marketed by specific 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 antibiotic in the penicillin class that works by inhibiting the synthesis of bacterial cell walls. It binds to and inactivates penicillin-binding proteins (PBPs) in the bacterial cell wall, leading to cell lysis and death, particularly in actively dividing bacteria.
   • Amoxicillin is effective against a wide variety of Gram-positive and Gram-negative bacteria.
2. Therapeutic Effects:
   • Amoxicillin is used to treat infections caused by susceptible organisms, including respiratory tract infections, urinary tract infections, and skin infections. It also serves as part of a combination therapy for H. pylori eradication in peptic ulcer disease.

Pharmacokinetics

1. Absorption:
   • Amoxicillin is well absorbed from the gastrointestinal tract after oral administration, with peak plasma concentrations occurring within 1 to 2 hours.
   • Bioavailability is approximately 95%, which means it is almost completely absorbed into the bloodstream.
2. Distribution:
   • Amoxicillin is widely distributed throughout the body and reaches therapeutic levels in most body fluids, including the lungs, urine, and middle ear.
   • It is approximately 20% to 30% protein-bound in plasma.
3. Metabolism:
   • Amoxicillin is minimally metabolized in the liver. Most of the drug is excreted unchanged in the urine.
   • Small amounts of amoxicillin are metabolized to penicilloic acid, but this metabolite is not active.
4. Excretion:
   • Amoxicillin is primarily excreted unchanged by the kidneys. About 60-70% of the drug is excreted in the urine within 6-8 hours after dosing.
5. Half-Life:
   • The half-life of amoxicillin is approximately 1 to 1.5 hours in healthy adults. In patients with impaired renal function, the half-life may be prolonged.

Drug Interactions

1. With Food:
   • No significant food interactions, but taking amoxicillin with food may help reduce gastrointestinal discomfort.
2. With Other Medications:
   • Oral Contraceptives: Amoxicillin may reduce the effectiveness of oral contraceptives. Additional contraception methods should be considered during treatment.
   • Methotrexate: The combination with methotrexate may increase the toxicity of methotrexate.
   • Anticoagulants: Monitor for increased risk of bleeding when amoxicillin is taken with anticoagulants like warfarin.
   • Probenecid: Probenecid can increase amoxicillin levels by decreasing renal clearance.
3. Other Interactions:
   • Cholestyramine: Reduces the absorption of amoxicillin when taken together.

Clinical Considerations

1. Pregnancy Category:
   • FDA Category B: Amoxicillin is considered safe during pregnancy, as animal studies have shown no evidence of harm, and human studies suggest it has a low risk to the fetus. However, it should only be used when clearly needed.
2. Lactation:
   • Amoxicillin is excreted in breast milk in small amounts. It is generally considered safe for use during breastfeeding, but the infant should be monitored for potential side effects such as diarrhea or thrush.
3. Pediatric Use:
   • Amoxicillin is commonly used in children to treat various bacterial infections, but the dosage must be adjusted based on the child’s weight and age.
   • For neonates and infants with renal impairment, dosage adjustment may be necessary.
4. Geriatric Use:
   • In elderly patients, especially those with renal impairment, dose adjustments may be required, and careful monitoring is necessary to avoid toxicity.
5. Other Considerations:
   • Amoxicillin should be used with caution in patients with a history of penicillin allergy, as cross-sensitivity to other beta-lactam antibiotics may occur.
   • Caution is also advised in patients with renal impairment, as dose adjustments may be required to avoid accumulation of the drug in the body.