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Augmentin Iv Inj

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1.2 GMProduct code 253492

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Product information

Manufacturer
Glaxo Smithkline Pharmaceuticals Ltd
Category
Allopathy
Composition
Not provided
Packaging
1.2 GM
Box / case pack
1 / —
Description

AUGMENTIN IV INJ by GLAXO SMITHKLINE PHARMACEUTICALS LIMITED

AUGMENTIN IV INJ is an antibiotic medication formulated for intravenous administration, produced by GlaxoSmithKline Pharmaceuticals Limited.

Name

  • Brand Name: AUGMENTIN IV INJ
  • Common Name: Amoxicillin sodium and Potassium clavulanate

Composition AUGMENTIN IV INJ contains two active ingredients: Amoxicillin (as amoxicillin sodium) and Clavulanic acid (as potassium clavulanate). It is available in various strengths, such as 600 mg (500 mg Amoxicillin and 100 mg Clavulanic acid) and 1.2 g (1 g Amoxicillin and 200 mg Clavulanic acid) per vial.

Uses AUGMENTIN IV INJ is indicated for the short-term treatment of a wide range of bacterial infections. These include:

  • Upper and Lower Respiratory Tract Infections: Such as recurrent tonsillitis, sinusitis, otitis media, acute exacerbation of chronic bronchitis, and pneumonia.
  • Genito-urinary Tract Infections: Including cystitis, urethritis, and pyelonephritis.
  • Skin and Soft Tissue Infections: E.g., boils, abscesses, cellulitis, and wound infections.
  • Bone and Joint Infections: Such as osteomyelitis.
  • Other Infections: Including intra-abdominal sepsis. It is also used for prophylaxis against infections associated with major surgical procedures. This medication is not effective against viral infections like the common cold or flu.

Dosage and Administration AUGMENTIN IV INJ is administered by a healthcare professional, typically via slow intravenous injection over 3-4 minutes or by intermittent infusion over 30-40 minutes. It is not suitable for intramuscular administration.

  • Adults and Children over 12 years: Usually 1.2 g every eight hours, which may be increased to six-hourly intervals for more serious infections.
  • Children 3 months-12 years: Typically 30 mg/kg every eight hours, or six-hourly for more severe infections. Dosage adjustments are necessary for patients with renal or hepatic impairment.

Side Effects Common side effects can include nausea, vomiting, diarrhea, stomach pain, bloating, headache, dizziness, skin rash, and pain or swelling at the injection site. Serious side effects, though rare, may include severe allergic reactions (anaphylaxis), severe skin reactions, liver dysfunction (hepatitis, cholestatic jaundice), and pseudomembranous colitis.

Precautions

  • Hypersensitivity: Contraindicated in patients with a history of hypersensitivity to penicillins, cephalosporins, or previous AUGMENTIN-associated jaundice/hepatic dysfunction.
  • Medical Conditions: Use with caution in patients with glandular fever, liver or kidney problems, or those not passing urine regularly.
  • Drug Interactions: Concomitant use with probenecid, allopurinol, oral anticoagulants (e.g., warfarin), methotrexate, and oral contraceptives may require dosage adjustment or monitoring.
  • Tests: Can affect the results of certain blood and urine tests.
  • Other: Monitor for potential superinfections or crystalluria.

Storage AUGMENTIN IV INJ vials should be stored in a dry place below 25°C. Reconstituted solutions should be used immediately upon preparation (within 20 minutes for direct injection). For infusions, stability varies with the diluent, but generally, infusions should be completed within four hours at room temperature (25°C) or up to eight hours if stored at 5°C in certain infusion fluids. Reconstituted solutions should not be frozen.

Frequently asked questions

Here are frequently asked questions about AUGMENTIN IV INJ by GlaxoSmithKline Pharmaceuticals Limited:

What is AUGMENTIN IV INJ used for?

AUGMENTIN IV INJ is an antibiotic used for the short-term treatment of various bacterial infections. These include upper and lower respiratory tract infections (like tonsillitis, sinusitis, otitis media, pneumonia, and bronchitis), genito-urinary tract infections (such as cystitis, urethritis, and pyelonephritis), skin and soft tissue infections (e.g., boils, abscesses, cellulitis, wound infections), and bone and joint infections (like osteomyelitis). It is also used for prophylaxis against infections associated with major surgical procedures, including gastrointestinal, pelvic, head and neck, cardiac, renal, joint replacement, and biliary tract surgeries.

How does AUGMENTIN IV INJ work?

AUGMENTIN IV INJ contains two active ingredients: amoxicillin and clavulanic acid. Amoxicillin is a penicillin-class antibiotic that works by inhibiting the synthesis of bacterial cell walls, leading to the disruption and death of the bacteria. However, some bacteria produce enzymes called beta-lactamases, which can inactivate amoxicillin. Clavulanic acid is a beta-lactamase inhibitor that blocks these enzymes, thereby protecting amoxicillin from degradation and extending its spectrum of activity against a wider range of bacteria, including those resistant to amoxicillin alone.

What is the usual dosage of AUGMENTIN IV INJ?

AUGMENTIN IV INJ is administered by a healthcare professional through intravenous (IV) injection or intermittent infusion in a hospital or clinical setting. For adults and children over 12 years, the usual dose for treating infections is 1.2 g (1 g amoxicillin and 200 mg clavulanic acid) every eight hours, which can be increased to six-hourly intervals for more serious infections. For surgical prophylaxis, a 1.2 g dose is typically given at the induction of anesthesia. In high-risk operations, three to four doses of 1.2 g may be given in a 24-hour period, usually at 0, 8, 16 (and 24) hours. Dosage adjustments are necessary for patients with renal impairment. AUGMENTIN IV is not suitable for intramuscular administration.

What are the possible side effects of AUGMENTIN IV INJ?

Common side effects of AUGMENTIN IV INJ can include diarrhea, nausea, vomiting, skin rash, pain, and swelling at the injection site, headache, weakness, and dizziness. Serious, though rare, side effects can include severe allergic reactions (anaphylaxis), liver problems (jaundice, hepatitis), severe skin reactions (like Stevens-Johnson syndrome), inflammation of the large intestine (colitis), and drug-induced enterocolitis syndrome (DIES), particularly in children. If you experience any severe or persistent side effects, medical attention should be sought immediately.

Is it safe during pregnancy or breastfeeding?

While animal studies have shown no teratogenic effects, whether AUGMENTIN IV INJ is safe to take during pregnancy is not fully understood. Doctors may prescribe it during pregnancy if there is a clear medical need and no safer alternative. Small amounts of amoxicillin and clavulanic acid are excreted into breast milk, but AUGMENTIN IV INJ is generally considered safe during breastfeeding. However, it may cause mild side effects in breastfed infants, such as diarrhea, rash, or restlessness. It's crucial to consult your doctor if you are pregnant or breastfeeding to weigh the benefits against potential risks.

Can it be taken with other medications?

AUGMENTIN IV INJ can interact with several other medications. For example, concomitant use with allopurinol (for gout) may increase the likelihood of allergic skin reactions. Probenecid (also for gout) can increase and prolong blood levels of amoxicillin. Taking AUGMENTIN with oral anticoagulants like warfarin may increase the blood-thinning effects and the risk of bleeding, requiring close monitoring of blood tests. Some antibiotics, including Augmentin, might decrease the effectiveness of combined oral contraceptives. It can also affect how methotrexate (used for cancer or rheumatic diseases) works, potentially raising its levels and increasing side effects. Always inform your doctor or pharmacist about all prescription, over-the-counter, and herbal medications you are taking to avoid potential interactions.

What precautions should be taken?

Before receiving AUGMENTIN IV INJ, inform your healthcare provider if you have a history of allergies to penicillins, cephalosporins, or other allergens, as severe allergic reactions can occur. Use with caution if you have glandular fever (infectious mononucleosis), liver or kidney problems, or are not passing water regularly. Prolonged use can occasionally lead to the overgrowth of non-susceptible organisms. Regular monitoring of organ system functions, including renal, hepatic, and hematopoietic function, is advisable during prolonged therapy.

What happens if a dose is missed?

If a dose of AUGMENTIN IV INJ is missed, it should be administered as soon as remembered, unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped, and the next dose should be taken at the regular time. Never take a double dose to make up for a missed one, as this can increase the risk of side effects. It's important to complete the full prescribed course of antibiotics, even if symptoms improve, to ensure the infection is fully cleared and to prevent antibiotic resistance.

How should it be stored?

AUGMENTIN IV INJ is supplied as a sterile powder for injection. Vials should be stored in a dry place below 25°C, out of the sight and reach of children. Once reconstituted with Water for Injections, solutions for intravenous injection should be used immediately, ideally within 20 minutes, and given over 3-4 minutes. For intravenous infusions, the reconstituted solution should be diluted further and infused over 30-40 minutes, to be completed within four hours if kept at room temperature (25°C). If stored at 5°C, reconstituted solutions in pre-refrigerated infusion bags can be kept for up to 8 hours. Reconstituted solutions should not be frozen, and are less stable in infusions containing glucose, dextran, or bicarbonate. Any unused solution should be discarded.