Azotek Tab 500 mg 6’s-Potential Overview

• Brand Name: Azotek
• Generic Name: Azithromycin
• Active Ingredient(s): Azithromycin

For the General Public:

• Uses:
  • This medicine is commonly used to treat a variety of bacterial infections such as:
    • Respiratory infections (e.g., pneumonia, bronchitis)
    • Skin and soft tissue infections
    • Sexually transmitted infections (e.g., chlamydia, gonorrhea)
    • Otitis media (middle ear infections)
    • Pharyngitis and tonsillitis
    • Sinusitis
    • Prophylaxis against endocarditis in high-risk patients
    • Mycobacterium avium complex (MAC) infections
  • Azithromycin works by inhibiting the growth of bacteria, preventing the bacteria from multiplying.
• Dosage:
  • Take one tablet once daily, with or without food. Always follow the instructions on the packaging or as prescribed by your doctor.
• Possible Side Effects:
  • Common side effects may include:
    • Diarrhea
    • Headache
    • Nausea
    • Abdominal pain
  • If you experience anything unusual, contact your healthcare provider.
• Common Side Effects:
  • Diarrhea
  • Headache
  • Nausea
  • Abdominal pain
• Serious (Less Common) Side Effects:
  • Severe allergic reactions (e.g., rash, itching, swelling)
  • Liver problems (e.g., yellowing of the skin or eyes)
  • Heart rhythm changes (e.g., palpitations)
  • Severe diarrhea
  • Hearing loss
• Important Information:
  • Dosage Instruction: Take one tablet once daily, with or without food. Do not skip doses and finish the full course of treatment even if you feel better. Stopping the medicine too early may cause the infection to return or worsen.
  • Usage Instruction: Take the tablet whole; do not chew, crush, or break it. It’s best to take it at the same time each day. Avoid taking antacids 2 hours before or after taking Azotek.
• General Information:
  • Do not take this medicine if you are allergic to azithromycin or have a history of severe liver disease.
  • If you are pregnant, breastfeeding, or planning to become pregnant, consult your doctor before use.
  • Keep out of reach of children.
  • If you miss a dose, take it as soon as you remember unless it’s almost time for the next dose. Do not double the dose.
• Drug Interactions:
  • Azotek may interact with certain medications, such as:
    • Antacids containing aluminum or magnesium
    • Warfarin (a blood thinner)
    • Digoxin (for heart conditions)
    • Other antibiotics
• Interactions with Food:
  • Azotek can be taken with or without food, but the presence of food might slightly delay the absorption. It does not significantly affect the efficacy.
• Regulatory Approval & Manufacturer:
  • Regulatory Approval: Azotek (Azithromycin) is approved by regulatory authorities such as the U.S. FDA, European Medicines Agency (EMA), and other national regulatory bodies for use in treating bacterial infections.
  • Manufacturer: Azotek is manufactured by Saffron Pharmaceuticals Pvt. Ltd.

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  Antidotes (If Over Dosage or Misused by Patients):

  • Overdose Management:
    • In the event of an overdose, supportive measures should be initiated. There is no specific antidote for azithromycin overdose.
    • Symptoms of overdose may include severe gastrointestinal distress (nausea, vomiting, diarrhea) and hearing issues.
    • If overdose occurs, contact poison control or seek emergency medical care immediately.

For Pharmacists

• Medicine Name: Azotek
• Brand: Azotek
• Active Ingredient(s): Azithromycin
• Indications:
  • Indicated for the management of bacterial infections such as respiratory tract infections, skin infections, and sexually transmitted infections.
• Pharmacodynamics:
  • Mechanism of Action: Azithromycin acts by inhibiting bacterial protein synthesis, thereby preventing bacterial growth and replication.
  • Pharmacological Effects: Reduces inflammation, helps in the resolution of infections by controlling bacterial growth.
  • Receptor Binding: Azithromycin binds to the 50S ribosomal subunit of bacteria, blocking protein synthesis.
• Pharmacokinetics:
  • Absorption: Azithromycin is rapidly absorbed after oral administration, with peak plasma concentration occurring within 2-3 hours.
  • Distribution: Widely distributed throughout the body, with high concentrations in tissues such as the lungs, liver, and tonsils.
  • Metabolism: Metabolized in the liver via the CYP450 enzyme system, particularly CYP3A4. It has a long half-life.
  • Elimination: Primarily excreted unchanged in the bile. Minor amounts are excreted in the urine.
  • Half-Life: Approximately 68 hours.
  • Bioavailability: Approximately 37% when taken orally.
  • Time to Peak Concentration: 2-3 hours.
  • Effect of Food: Food does not significantly affect the absorption, but it may delay the peak concentration.
• Dosage and Administration:
  • Adults: Typically, a dose of 500 mg once daily for 3-5 days, depending on the type of infection.
  • Pediatric: Dosing for children is based on weight and the infection being treated.
  • Special Populations: Dose adjustments may be necessary for elderly individuals or those with liver or kidney impairments.
• Contraindications:
  • Known hypersensitivity to azithromycin or any of its components.
  • Contraindicated in patients with a history of severe liver disease.
• Warnings and Precautions:
  • Use with caution in patients with gastrointestinal issues, cardiovascular disease, or renal impairment.
  • Monitor for potential adverse effects such as liver dysfunction, QT prolongation, and gastrointestinal distress.
• Drug-Drug Interactions for Pharmacist:
  • Azithromycin may interact with medications such as warfarin, digoxin, and certain antacids. It may increase the effects of anticoagulants like warfarin.
• Drug-Food Interactions for Pharmacist:
  • There are no significant interactions with food, but it is advisable to avoid antacids around the time of administration.
• Adverse Reactions:
  • Common: Diarrhea, nausea, abdominal pain.
  • Serious: Severe allergic reactions, liver damage, QT prolongation, hearing loss.
• Therapeutic Effects:
  • Helps treat bacterial infections, reduces inflammation, and relieves symptoms associated with bacterial infections.
• Storage:
  • Store at room temperature, between 15°C to 30°C, in a tightly closed container, away from moisture and light.
• Packaging:
  • Available in tablet form, typically in packs of 6 tablets.
• Clinical Considerations:
  • Pregnancy Category: Category B – No evidence of harm to an unborn baby in animal studies, but use should be limited to when necessary.
  • Lactation Category: It is excreted in breast milk, so consult a healthcare provider before use during breastfeeding.
  • Pediatric Category: Generally safe for children, but dosing adjustments are required based on weight.
  • Geriatric Category: No specific adjustments for elderly patients, but use with caution in those with comorbidities.
  • Adult Category: Safe for adult use, following standard dosing guidelines.
  • Child Category: Safe for children based on age-appropriate doses.
  • Other Considerations: Should be used cautiously in patients with underlying heart conditions, especially those at risk of QT prolongation.

Conclusion:

Azotek is an effective treatment for a variety of bacterial infections, including respiratory and skin infections. When used according to the prescribed instructions, it can provide relief from symptoms and improve the quality of life for patients. However, it is essential to follow proper dosage guidelines and be aware of potential side effects. Always consult with a healthcare professional if you have any concerns or experience unusual symptoms. Pharmacists should ensure that patients are educated about potential drug interactions and advise on proper usage, especially in vulnerable populations like pregnant women, elderly individuals, and those with underlying health conditions. Proper storage and disposal of the medication are also crucial for maintaining its effectiveness and safety.