CURAM 457/MG/5/ML 70/ML SUSP

Indications

Approved Uses

Treatment of susceptible bacterial infections such as: acute otitis media, acute bacterial sinusitis, lower respiratory tract infections (e.g., community-acquired pneumonia, acute exacerbation of chronic bronchitis), urinary tract infections, skin and soft tissue infections (including dental infections); may also be used for bone and joint infections when pathogens are susceptible.

Off-Label Uses

Bite-wound prophylaxis/treatment (animal or human) and selected polymicrobial skin/soft-tissue infections when susceptible; other uses (e.g., chronic rhinosinusitis) may be considered case-by-case based on culture/local guidance.

Dosage & Administration

Dosing by Condition

Pediatrics (using amoxicillin component): AOM/acute bacterial sinusitis: 45 mg/kg/day divided q12h (standard) or 80-90 mg/kg/day divided q12h (high-dose) for ~5-10 days; other susceptible infections commonly 25-45 mg/kg/day divided q12h (severity/site dependent). Adults: commonly 500/125 mg q8h or 875/125 mg q12h for ~5-14 days depending on indication/severity/local guidance.

Initial Dose

Children: 45mg/kg/day of amoxicillin component in 2 divided doses (using 400/57mg per 5ml suspension). Adults: 875mg/125mg every 12 hours or 500mg/125mg every 8 hours.

Maintenance Dose

For children >3 months and <40 kg with more severe infections (e.g., otitis media, sinusitis): 45 mg/kg/day (based on amoxicillin component) divided every 12 hours.

Maximum Dose

Children: up to 90 mg/kg/day (amoxicillin component) in divided doses for selected severe infections; usual pediatric maximum amoxicillin is 4 g/day. Adults: typical maximum amoxicillin 4 g/day (regimen-dependent).

Children's Dosage

Neonates and infants <3 months: 30mg/kg/day amoxicillin component in 2 divided doses. Children 3 months to 12 years (<40kg): 25-45mg/kg/day amoxicillin component in 2 divided doses (standard); up to 90mg/kg/day for high-dose regimen. Children ≥40kg: use adult dosing.

Dose Adjustment Notes

Renal impairment: dose/interval adjustment is required (especially when CrCl <30 mL/min; avoid 875/125 mg-type regimens in severe renal impairment); hepatic impairment: use with caution and monitor liver function; high-dose pediatric regimens (amoxicillin 80-90 mg/kg/day) may be used for selected indications (e.g., AOM/sinusitis with risk of resistant S. pneumoniae).

How to Take

Reconstitute with water as directed; shake well before each dose; measure with an oral syringe/medicine spoon; administer at the start of a meal (or with food) to improve GI tolerability; complete the full prescribed course.

How to Prepare

Tap bottle to loosen powder; add water in two steps (first to about half/just below the mark, shake well; then add water up to the mark/final volume 70 mL and shake vigorously); allow foam to settle and recheck the level, then shake again before dosing.

Side Effects

Common Side Effects

Diarrhea, nausea, vomiting, abdominal pain/indigestion, skin rash/urticaria, and candidiasis (e.g., oral thrush or vaginal yeast infection).

Side Effect Frequency

Very common (≥10%): diarrhea. Common (1-10%): nausea, vomiting, mucocutaneous candidiasis; rash/urticaria may occur (frequency varies by population). Uncommon (0.1-1%): indigestion, abdominal pain, headache, dizziness, elevated liver enzymes. Rare/very rare: cholestatic hepatitis/jaundice, severe cutaneous adverse reactions (SJS/TEN), anaphylaxis, C. difficile-associated diarrhea, blood dyscrasias, seizures (usually with renal impairment/high doses), interstitial nephritis/crystalluria.

Safety & Warnings

Contraindications

Hypersensitivity to amoxicillin/clavulanate or other beta-lactams (e.g., penicillins; consider cephalosporin cross-reactivity) and previous cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate.

Warnings & Precautions

Screen for beta-lactam allergy and stop immediately if reaction occurs; monitor for C. difficile diarrhea; use caution/monitoring in hepatic disease and avoid if prior Augmentin-related liver injury; adjust dosing in renal impairment; consider rash risk in infectious mononucleosis; prolonged therapy may cause superinfection.

Age Restriction

Not recommended for infants <3 months for this 400/57 mg per 5 mL (7:1) suspension; use an age-appropriate formulation/dosing guidance for neonates/young infants if needed.

Drug Interactions

Drug Interactions

Key interactions: warfarin/other oral anticoagulants (↑INR/bleeding risk-monitor), methotrexate (↑toxicity), allopurinol (↑rash risk), probenecid (↑amoxicillin levels); possible reduced efficacy of oral contraceptives (counsel backup if vomiting/diarrhea or per local guidance); may reduce efficacy of live oral typhoid vaccine.

Interaction Severity

MAJOR: Warfarin/other vitamin K antagonists (↑INR/bleeding-monitor INR), Methotrexate (↓clearance-↑toxicity). MODERATE: Probenecid (↑amoxicillin levels), Allopurinol (↑rash risk), Mycophenolate (↓MPA exposure-monitor), Oral contraceptives (counsel; backup if vomiting/diarrhea). MINOR: Live oral typhoid vaccine (reduced vaccine efficacy).

Food Interaction

Take at the start of a meal (with food).

Special Populations

Children

Neonates and infants <3 months: 30mg/kg/day amoxicillin component in 2 divided doses. Children 3 months to 12 years (<40kg): 25-45mg/kg/day amoxicillin component in 2 divided doses (standard); up to 90mg/kg/day for high-dose regimen. Children ≥40kg: use adult dosing.

Kidney Impairment

CrCl >30 mL/min: no adjustment typically needed; CrCl 10-30 mL/min: extend interval (e.g., q12h); CrCl <10 mL/min: q24h; hemodialysis: dose after dialysis. Note: the 400/57 mg per 5 mL (7:1) suspension is generally not recommended when CrCl <30 mL/min-use an alternative formulation/ratio.

Storage & Patient Advice

Storage Conditions

Before reconstitution: store below 30°C (per SFDA). After reconstitution: refrigerate at 2-8°C, do not freeze, and discard after 7 days.

Preparation Instructions

Tap bottle to loosen powder; add water in two steps (first to about half/just below the mark, shake well; then add water up to the mark/final volume 70 mL and shake vigorously); allow foam to settle and recheck the level, then shake again before dosing.

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and continue the regular schedule; do not double doses.

Stopping the Medicine

Complete the full prescribed course; do not stop early even if symptoms improve.

Overdose

Likely GI upset (nausea/vomiting/diarrhea/abdominal pain); possible crystalluria/renal effects and, rarely, seizures especially with very high doses or renal impairment-seek urgent medical care; management is supportive, maintain hydration, consider activated charcoal if early, and hemodialysis can remove amoxicillin.

Patient Counseling

Shake well before each dose; give at the start of a meal/with food to improve tolerance and clavulanate absorption; measure doses with an oral syringe; complete the full prescribed course; if rash, hives, facial swelling, wheeze or breathing difficulty occur stop and seek urgent care (penicillin allergy); seek medical advice for severe/persistent diarrhea (possible C. difficile) and avoid antidiarrheals unless advised; tell the prescriber about prior liver problems/jaundice with co‑amoxiclav; after reconstitution store refrigerated (2-8°C), do not freeze, and discard after 7 days; keep out of reach of children.

Monitoring Requirements

No routine labs are required for short courses in otherwise healthy patients; for prolonged therapy or high-risk patients, monitor renal function, hepatic function, and CBC; monitor INR closely if used with warfarin.

Pharmacology

Mechanism of Action

Amoxicillin inhibits bacterial cell-wall synthesis by binding PBPs; clavulanic acid inhibits many beta-lactamases, protecting amoxicillin and extending spectrum.

Onset of Action

Peak concentrations occur about 1-2 hours after an oral dose; clinical improvement is typically seen within 48-72 hours if the pathogen is susceptible.

Duration of Effect

Typical dosing intervals are every 8-12 hours (q8h or q12h) depending on formulation and indication; clinical effect requires completing the prescribed course.

Half-Life

Amoxicillin: ~1.0-1.5 hours; Clavulanic acid: ~0.8-1.2 hours (normal renal function).

Bioavailability

Amoxicillin: ~75-90% (fasting); Clavulanic acid: ~60% (range ~50-70%).

Metabolism

Amoxicillin: minimal metabolism (most eliminated unchanged); Clavulanic acid: partially/extensively metabolized (hepatic/non‑renal metabolism) to inactive metabolites.

Excretion

Amoxicillin: primarily renal, ~60-70% excreted unchanged in urine; Clavulanic acid: eliminated by both renal and non‑renal routes, with ~30-50% excreted unchanged in urine and the remainder as metabolites.

Protein Binding

Amoxicillin: ~17-20%; Clavulanic acid: ~22-30% (often cited ~25%).

Product Information

Available Dosage Forms

For this SFDA-registered product: Powder for oral suspension (oral use) in a bottle (70 mL after reconstitution).

Composition per Dose

Each 5ml of reconstituted suspension contains: 400mg amoxicillin as trihydrate and 57mg clavulanic acid as potassium clavulanate.

Generic Availability

Yes

OTC Alternatives

No OTC alternative - prescription required for all amoxicillin/clavulanate products

Spectrum

Broad-spectrum

Antibiotic Class

Penicillin

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