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Amoxicillin Stada 1000 mg - 12 F.C. Tablet
This page may not cover all the information mentioned in the attached pamphlet of the manufacturing company
Medical Description
Antibiotic; belongs to the penicillin group used in the treatment of acute otitis media, pneumonia, acute bacterial rhinosinusitis, streptococcal pharyngitis, urinary tract infection, Helicobacter pylori eradication and odontogenic infection.
Indication & Usage
-Adult dosing: Usual dosage range: Immediate release: Oral: 500 mg to 1 g every 8 to 12 hours. Or extended release: Oral: 775 mg once daily.
-Acute otitis media: Oral: 500 mg every 8 hours or 875 mg every 12 hours. Duration is 5 to 7 days for mild to moderate infection and 10 days for severe infection.
-Community acquired pneumonia: Empiric therapy, outpatient (patients without comorbidities or risk factors for antibiotic-resistant pathogens): Oral: 1 g 3 times daily, while in case of using it as oral step-down therapy following initial parenteral therapy, inpatient: Oral: 1 g 3 times daily; duration is for a minimum of 5 days; patients should be clinically stable with normal vital signs before therapy is discontinued.
-Acute bacterial rhinosinusitis: Oral: 500 mg every 8 hours or 875 mg every 12 hours for 5 to 7 days.
-Streptococcal pharyngitis (group A): Oral: 500 mg twice daily or 1 g once daily for 10 days. Or extended release: 775 mg once daily for 10 days.
-Urinary tract infection: Asymptomatic bacteriuria (≥105 CFU per mL) in pregnancy (eg, group B Streptococcus): Oral: 500 mg every 8 hours or 875 mg every 12 hours for 4 to 7 days. While in case of acute uncomplicated or acute simple cystitis (infection limited to the bladder without signs/symptoms of upper tract, prostate, or systemic infection) due to Enterococcus spp.: Oral: 500 mg every 8 hours or 875 mg every 12 hours for 5 days.
-For the rest of adult dosing see dosage and administration.
Active Ingredients
Amoxicillin
Recommended Doctors
Dosage & Administration
-Administer around-the-clock to promote less variation in peak and trough serum levels.
-Immediate release: May be administered on an empty or full stomach
-Extended release: Administer within 1 hour of finishing a meal; do not chew or crush tablet.
-Suspension: Shake well before use.
-Adult dosing (continue):Helicobacter pylori eradication: Oral:
1-Clarithromycin triple regimen: Amoxicillin 1 g twice daily in combination with clarithromycin 500 mg twice daily, plus a standard-dose or double-dose proton pump inhibitor; continue regimen for 14 days.
2-Concomitant regimen: Amoxicillin 1 g twice daily in combination with clarithromycin 500 mg twice daily, either metronidazole or tinidazole 500 mg twice daily, plus a standard-dose proton pump inhibitor twice daily; continue regimen for 10 to 14 days.
3-Sequential regimen: Amoxicillin 1 g twice daily plus a standard-dose proton pump inhibitor twice daily for 5 to 7 days; followed by clarithromycin 500 mg twice daily, either metronidazole or tinidazole 500 mg twice daily, plus a standard-dose proton pump inhibitor twice daily for 5 to 7 days.
4-hybrid regimen: Amoxicillin 1 g twice daily, plus a standard-dose proton pump inhibitor twice daily for 7 days; followed by amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, either metronidazole or tinidazole 500 mg twice daily, plus a standard-dose proton pump inhibitor twice daily for 7 days.
5-Levofloxacin triple regimen: Amoxicillin 750 mg 3 times daily in combination with a double-dose proton pump inhibitor twice daily plus levofloxacin 500 mg once daily; continue regimen for 14 days.
-Odontogenic infection: Oral: 500 mg every 8 hours in combination with metronidazole for 7 to 14 days.
Side Effects
-Antibiotic-associated diarrhea (AAD), nausea, and vomiting, Clostridioides difficile infection (CDI), drug-induced liver injury, urticaria, angioedema and anaphylaxis.
-Diarrhea, nausea, vulvovaginal infection, headache, abdominal pain, vomiting, hypersensitivity angiitis, acute generalized exanthematous pustulosis, erythema multiforme, erythematous maculopapular rash, exfoliative dermatitis, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, crystalluria, agranulocytosis, anemia, eosinophilia, hemolytic anemia, immune thrombocytopenia, leukopenia, neutropenia, thrombocytopenia, cholestatic hepatitis, cholestatic jaundice, hepatitis, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, agitation, anxiety, behavioral changes, confusion, dizziness, hyperactive behavior, insomnia and seizure.
Safety Advice
-Should not be given to patients suffering from hypersensitivity to amoxicillin.
-Use is contraindicated in patients with a history of amoxicillin-associated hepatic dysfunction.
-A high percentage of patients with infectious mononucleosis develop an erythematous rash during amoxicillin therapy; avoid use in these patients.
-Prolonged use may result in fungal or bacterial superinfection.
-Use with caution in patients with renal impairment.
-Older adults are at increased risk for neurotoxicity (eg, seizures) related to penicillins due to decreased renal clearance.
-In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.
Storage
Store at room temperature.
Drug Interactions
-Allopurinol: May enhance the potential for allergic or hypersensitivity reactions to Amoxicillin.
-Aminoglycosides: Penicillins may decrease the serum concentration of Aminoglycosides.
-Acemetacin: May increase the serum concentration of Penicillins.
-BCG Vaccine: Antibiotics may diminish the therapeutic effect of BCG Vaccine.
-Methotrexate: Penicillins may increase the serum concentration of Methotrexate.
-Mycophenolate: Penicillins may decrease serum concentrations of the active metabolite(s) of Mycophenolate.
-Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate.
-Tetracyclines: May diminish the therapeutic effect of Penicillins.
-Vitamin K Antagonists (eg, warfarin): Penicillins may enhance the anticoagulant effect of Vitamin K Antagonists.
Pregnancy & Lactation
-Amoxicillin crosses the placenta. As a class, penicillin antibiotics are widely used in pregnant patients. Based on available data, penicillin antibiotics are generally considered compatible for use during pregnancy. Amoxicillin is considered compatible for the treatment airway diseases in pregnant patients.
-Amoxicillin is present in breast milk, amoxicillin is considered compatible with breastfeeding when used in usual recommended doses. Amoxicillin may be used to treat mastitis in breastfeeding patients.
-Ask your physician before taking any medication during pregnancy or lactation.
Manufacture
MISR
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