ACTONORM GEL Price

Overview

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This medicine contains an important and useful components, as it consists of
Aluminium hydroxide, Magnesium hydroxide, Dimethiconeis available in the market in concentration

Name

Ceftriaxone

Precaution

- **Special Populations**: Ceftriaxone is classified as a pregnancy category B drug, which means that animal studies have shown no harm to the fetus, but there are insufficient studies in pregnant women. It should only be used during pregnancy if the potential benefits outweigh the risks. Ceftriaxone is excreted in breast milk, but it is generally considered safe for use during breastfeeding at therapeutic doses. However, it should be used with caution in neonates, particularly those with hyperbilirubinemia or those who are premature, due to the risk of bilirubin displacement and kernicterus. - **Renal and Hepatic Impairment**: In patients with renal or hepatic impairment, particularly those with severe liver dysfunction or concurrent renal failure, dosing adjustments may be required. Ceftriaxone is primarily excreted through the liver, so those with liver impairment may require dose reduction or extended dosing intervals. Regular monitoring of liver and renal function is recommended. - **Monitoring Parameters**: For safety, patients on Ceftriaxone should undergo monitoring of renal function, liver enzymes (especially ALT and AST), and complete blood counts (CBC). Blood clotting parameters, particularly prothrombin time (PT), should also be monitored in patients on prolonged therapy. - **Misuse or Dependency**: Ceftriaxone is not habit-forming and has no risk of misuse or dependency. However, its overuse or inappropriate use can contribute to antimicrobial resistance. Therefore, it should only be used for the specific infections for which it is prescribed.

Indication

- **Primary Indications**: Ceftriaxone is a broad-spectrum third-generation cephalosporin used to treat a variety of bacterial infections. These include: - **Severe infections**: Such as pneumonia (community-acquired and hospital-acquired), meningitis, and sepsis. - **Urinary tract infections (UTIs)**: Including complicated UTIs caused by resistant organisms. - **Intra-abdominal infections**: Such as peritonitis and abscesses. - **Skin and soft tissue infections**: Including cellulitis and wound infections. - **Bone and joint infections**: Such as osteomyelitis and septic arthritis. - **Evidence-Based Context**: Ceftriaxone is highly effective against Gram-negative and Gram-positive bacteria, including *Streptococcus pneumoniae*, *Haemophilus influenzae*, and *Neisseria gonorrhoeae*. It is particularly valued for its broad coverage and its ability to penetrate the central nervous system, making it effective in treating bacterial meningitis. - **Off-label Uses**: Off-label uses include treatment for severe Lyme disease, bacterial endocarditis (in combination with other antibiotics), and prophylaxis for certain surgical procedures.

Contra indication

- **Exclusion Criteria**: Ceftriaxone is contraindicated in patients with a history of hypersensitivity reactions (e.g., anaphylaxis, Stevens-Johnson syndrome) to cephalosporins or any component of the formulation. It is also contraindicated in neonates who require calcium-containing solutions or in premature infants with hyperbilirubinemia, as there is a risk of precipitating calcium ceftriaxone salts, which can lead to life-threatening complications. - **Rationale**: The primary reason for these contraindications is the risk of severe hypersensitivity reactions, which can be fatal, and the potential for serious neonatal complications due to the calcium-ceftriaxone precipitate formation in the bloodstream. - **Age and Demographic Considerations**: Special caution is advised in elderly patients, as they may be more susceptible to the side effects, especially renal dysfunction. In neonates and infants, dose adjustments and careful monitoring are critical due to potential risks.

Side Effect

- **Common Side Effects**: - **Gastrointestinal**: Nausea, vomiting, diarrhea, and abdominal pain are the most commonly reported side effects. Diarrhea is particularly common, and in some cases, can be severe (e.g., *Clostridium difficile* infection). - **Injection Site Reactions**: Pain, swelling, or irritation at the injection site can occur, especially with intravenous administration. - **Serious Side Effects**: - **Hypersensitivity Reactions**: Severe allergic reactions such as anaphylaxis, angioedema, and Stevens-Johnson syndrome, though rare, can occur. Immediate cessation of the drug is necessary if any of these reactions are suspected. - **Biliary Sludging and Cholelithiasis**: Ceftriaxone can cause the formation of "biliary sludging" (a type of sediment) or gallstones, especially in long-term therapy, particularly in children. This may cause abdominal pain and jaundice. - **Neurotoxicity**: In cases of renal impairment or overdose, Ceftriaxone may cause central nervous system toxicity, manifesting as seizures or encephalopathy. - **Hematologic Issues**: Thrombocytopenia (low platelet count) or neutropenia (low white blood cell count) may occur with prolonged use. - **Mitigation and Monitoring**: To minimize the risk of gastrointestinal upset, Ceftriaxone can be administered with food. Patients should be monitored for signs of severe allergic reactions, including difficulty breathing or swelling. Any abnormal lab results, especially liver or kidney function tests, should be investigated, and dose adjustments may be required.

Pregnancy Category ID

2

Mode of Action

- **Mechanism**: Ceftriaxone is a third-generation cephalosporin that inhibits bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs), essential enzymes in the formation of the bacterial cell wall. This binding disrupts peptidoglycan cross-linking, weakening the cell wall and leading to bacterial lysis. - **Pharmacodynamics and Pharmacokinetics**: Ceftriaxone is bactericidal, with broad-spectrum activity against both Gram-positive and Gram-negative organisms. It has a long half-life (about 6-9 hours), which allows for once-daily dosing. Ceftriaxone is highly protein-bound in the bloodstream (about 85-95%) and is primarily excreted in the urine and bile. It also penetrates well into the cerebrospinal fluid, making it effective for treating meningitis. - **Distinctive Action**: The long half-life and excellent penetration into tissues, including the central nervous system, set Ceftriaxone apart from many other antibiotics. Its broad-spectrum activity and effectiveness in serious infections make it a mainstay in hospital settings.

Interaction

- **Drug-Drug Interactions**: - **Calcium-containing solutions**: Ceftriaxone should not be administered simultaneously with calcium-containing intravenous solutions in neonates due to the risk of calcium ceftriaxone precipitates. In adults and older children, concurrent use of calcium salts can cause precipitation, especially when administered through the same IV line. - **Warfarin**: Ceftriaxone can increase the anticoagulant effects of warfarin by interfering with vitamin K metabolism, potentially leading to bleeding. Monitoring of prothrombin time (PT) and INR is recommended for patients on both drugs. - **Aminoglycosides**: Co-administration of Ceftriaxone with aminoglycosides can increase the risk of nephrotoxicity, though this interaction is generally less common with appropriate dosing regimens. - **Probenecid**: This drug inhibits the renal excretion of Ceftriaxone, which may increase its plasma concentration and prolong its effects. Careful monitoring is necessary when both drugs are co-administered. - **Food and Alcohol Interactions**: Ceftriaxone has no significant interactions with food or alcohol. It can be taken with or without food. However, alcohol should be avoided with certain antibiotics as it can sometimes exacerbate side effects such as gastrointestinal upset. - **Clinical Recommendations**: Close monitoring is advised when Ceftriaxone is used with warfarin, calcium solutions (in neonates), and probenecid. Dosage adjustments or avoidance may be necessary in these cases.

Pregnancy Category Note

Information not available

Adult Dose

- **Standard Dosage**: The typical adult dose of Ceftriaxone for most infections is 1-2 grams once daily, administered either as an intravenous (IV) infusion or an intramuscular (IM) injection. - For severe infections, the dose may be increased to 2 grams once daily. - For meningitis or infections caused by highly resistant organisms, up to 4 grams per day may be used. - **Administration**: Ceftriaxone can be given intravenously or intramuscularly. For IV administration, it is diluted in a compatible solution and given slowly over 30 minutes. It is not recommended for bolus injection due to the risk of thrombophlebitis. - **Maximum Dosage**: The maximum daily dose in adults is generally 4 grams, although higher doses may be used in specific, severe cases like bacterial meningitis.

Child Dose

- **Pediatric Dosing**: For children aged 15 days and older, the typical dose is 50-75 mg/kg once daily, up to a maximum of 2 grams per day for most infections. For more severe infections like meningitis, doses up to 100 mg/kg per day may be used. - **Safety and Efficacy**: Ceftriaxone is effective in treating a variety of serious infections in children, including meningitis, pneumonia, and sepsis. However, caution should be exercised in neonates, particularly with the risk of hyperbilirubinemia and kernicterus. - **Pediatric Monitoring**: Pediatric patients, especially neonates and those with renal or hepatic impairments, require careful monitoring of renal function, bilirubin levels, and signs of adverse reactions, such as jaundice or respiratory distress.

Renal Dose

- **Renal Impairment**: In patients with renal impairment, especially those with a creatinine clearance (CrCl) <10 mL/min, the dose of Ceftriaxone should be reduced or given at extended intervals (e.g., every 48 hours instead of every 24 hours). - **Monitoring Recommendations**: Renal function should be closely monitored during treatment, particularly in those with severe renal dysfunction, as accumulation can lead to toxicity, especially with long-term therapy.

Administration

Information not available