Butibac90 mg/5 ml

Established (FDA-Approved) Indications

Butibac is indicated for the treatment of mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

• Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or penicillin-susceptible Streptococcus pneumoniae.
• Acute bacterial otitis media due to Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes.
• Pharyngitis and tonsillitis due to Streptococcus pyogenes.

Important Limitation of Use

Butibac is not reliably effective against penicillin-resistant strains of Streptococcus pneumoniae. Whenever possible, culture and susceptibility testing should guide the decision to use Butibac, and it should be reserved for infections proven or strongly suspected to involve susceptible organisms, consistent with antibiotic stewardship principles.

General Use Note

Butibac is a third-generation oral cephalosporin antibiotic used only for bacterial infections. Butibac is not effective against viral infections such as the common cold or influenza (flu).

Each dose of Ceftibuten Dihydrate provides ceftibuten (as ceftibuten dihydrate) as the active ingredient. Ceftibuten Dihydrate is marketed in Bangladesh as capsules of 200 mg and 400 mg, and as an oral powder for suspension that provides 90 mg/5 mL after reconstitution.

Butibac is an oral antibiotic belonging to the third-generation cephalosporin class. It works by preventing certain bacteria from building their protective cell walls, which kills the bacteria responsible for an infection. Healthcare professionals prescribe Butibac for specific respiratory, ear, and throat infections — such as flare-ups of chronic bronchitis, acute middle-ear infections, and pharyngitis/tonsillitis — when these are caused by bacteria known to respond to Butibac. Butibac does not treat viral illnesses such as the common cold or flu. Butibac should only be used exactly as directed by a qualified healthcare professional.

Antibiotic (Third-Generation Oral Cephalosporin)

Ceftibuten Dihydrate is a semi-synthetic, third-generation cephalosporin taken by mouth. After oral administration, Ceftibuten Dihydrate is well absorbed from the gastrointestinal tract, although food (particularly a high-fat meal) can reduce and delay its absorption, which is why it is generally taken apart from meals. Ceftibuten Dihydrate is eliminated largely unchanged by the kidneys, so its clearance from the body depends on kidney function and doses must be adjusted in patients with reduced renal function. Ceftibuten Dihydrate is also stable against breakdown by many bacterial beta-lactamase enzymes, which contributes to its activity against beta-lactamase-producing strains of Haemophilus influenzae and Moraxella catarrhalis.

• Take Butibac exactly as prescribed by your healthcare professional, at the same time each day.
• Take Butibac on an empty stomach where possible — at least 2 hours before or 1 hour after a meal — for optimal absorption.
• Swallow capsules of Butibac whole with a glass of water; do not crush or chew unless your healthcare professional advises otherwise.
• If using the oral suspension of Butibac, shake the bottle well before every dose so the medicine is evenly mixed.
• Measure each dose of the oral suspension of Butibac using the measuring spoon or cup provided — do not use an ordinary household spoon.
• Take the complete course of Butibac exactly as prescribed; do not stop, extend, skip, or share doses of Butibac without medical advice, even if you feel better.
• If a dose of Butibac is missed, take it as soon as you remember unless it is almost time for the next dose; do not double the dose.
• Patients with diabetes should be aware that the oral suspension of Butibac contains sucrose (sugar).

• Antacids: Single doses of aluminum- or magnesium-containing antacids have not been shown to significantly change absorption of Butibac, though spacing the doses apart is still reasonable practice.
• H2-receptor blockers (e.g., ranitidine): May modestly increase blood levels of Butibac (peak concentration and overall exposure); the clinical significance is unclear, so use together only under medical supervision.
• Theophylline: No significant pharmacokinetic interaction has been demonstrated between Butibac and intravenous theophylline; interaction with oral theophylline has not been specifically studied.
• Oral anticoagulants (e.g., warfarin): Cephalosporin-class antibiotics, including Butibac, have in some cases been associated with enhanced anticoagulant effect; closer monitoring of clotting parameters (INR) may be advisable when Butibac is used together with warfarin or similar medicines.
• Laboratory test interference: Cephalosporin-class antibiotics such as Butibac can cause a false-positive direct Coombs' test and false-positive results on certain (non-enzymatic) urine glucose tests; inform your laboratory that you are taking Butibac.

Common Side Effects

• Nausea
• Diarrhea (more frequent in young children)
• Headache
• Indigestion (dyspepsia)
• Abdominal pain
• Dizziness
• Vomiting
• Loose stools

Serious Side Effects — Seek Medical Attention

• Signs of a severe allergic reaction (anaphylaxis) to Butibac: swelling of the face, lips, tongue, or throat, difficulty breathing, or severe rash/hives — seek emergency care immediately.
• Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis (widespread blistering or peeling skin).
• Severe, persistent, or bloody diarrhea, which may indicate Clostridium difficile-associated diarrhea/colitis (see Precautions and Warnings for full details) — do not self-treat with anti-diarrheal medicine; contact a doctor promptly.
• Signs of a blood disorder, such as unusual bruising or bleeding, persistent fever, or severe sore throat.
• Yellowing of the skin or eyes (jaundice) or other signs of liver problems.
• Seizures or unusual behavioral/neurological changes, reported mainly in patients with reduced kidney function receiving high doses.

Pregnancy

Animal reproduction studies with Butibac have not shown evidence of harm to the fetus, but adequate and well-controlled studies in pregnant women are lacking. Butibac should be used during pregnancy only if a qualified healthcare professional determines that the potential benefit justifies the potential risk.

Breastfeeding

It is not known whether Butibac passes into human breast milk. Caution is advised, and a healthcare professional should be consulted before using Butibac while breastfeeding.

• Clostridium difficile-associated diarrhea (CDAD): As with nearly all antibacterial agents, including Butibac, treatment can allow overgrowth of Clostridium difficile, whose toxin causes diarrhea and colitis ranging from mild to life-threatening (pseudomembranous colitis). CDAD should be considered in any patient who develops diarrhea during or after treatment with Butibac. Mild cases often improve with discontinuation alone, but moderate-to-severe cases may need fluid/electrolyte support and specific treatment directed against C. difficile; do not use anti-peristaltic (anti-diarrheal) agents without medical advice.
• Hypersensitivity and cross-reactivity with penicillins: Before starting Butibac, tell your healthcare professional about any previous allergic reactions to cephalosporins, penicillins, or other drugs. Cross-reactivity between cephalosporins and penicillins can occur in a meaningful proportion of penicillin-allergic patients, so Butibac should be used with caution in this group. Serious acute hypersensitivity reactions to Butibac may require emergency treatment, including epinephrine.
• Renal impairment: Because Butibac is cleared mainly by the kidneys, dose reduction is required in patients with a creatinine clearance below 50 mL/min and in patients on hemodialysis; kidney function should be assessed before and, when relevant, during treatment.
• Prolonged use and superinfection: Extended or repeated use of Butibac may result in overgrowth of non-susceptible organisms, including fungi; monitor for signs of secondary infection.
• Not effective for viral infections: Butibac treats bacterial infections only. Using Butibac for viral infections such as colds or flu will not help and contributes to antibiotic resistance.
• Diabetic patients: The oral suspension formulation of Butibac contains sucrose; diabetic patients should take this into account.
• Gastrointestinal disease history: Butibac should be used with caution in patients with a history of gastrointestinal disease, particularly colitis.

Specific human overdose data for Butibac are limited. As with other cephalosporin antibiotics, an overdose could theoretically cause cerebral irritation and, rarely, seizures (convulsions), particularly in patients with reduced kidney function. A significant portion of Butibac can be removed from the blood by hemodialysis. If an overdose of Butibac is suspected, do not induce vomiting unless specifically directed to do so by a healthcare professional or poison control center, and seek emergency medical care or contact a poison control center immediately.

Store Butibac according to the instructions on the product label, generally at room temperature, protected from direct heat, light, and moisture, and out of reach of children. If the oral suspension of Butibac has been reconstituted, follow the pharmacist's or product label's instructions regarding refrigeration and the discard date, as reconstituted suspensions of Butibac are generally stable for only a limited number of days.

Children

Butibac is approved for use in children 6 months of age and older, dosed by body weight (9 mg/kg once daily, up to a maximum of 400 mg/day), typically given as the oral suspension. Safety and effectiveness of Butibac have not been established in infants younger than 6 months.

Elderly

Older adults can generally receive the standard adult dose of Butibac, but kidney function should be assessed, as dose adjustment may be needed given the higher likelihood of age-related decline in renal function.

Renal Impairment

Dose reduction of Butibac is required for patients with creatinine clearance below 50 mL/min and for those on hemodialysis, as detailed in the Dosage section.

Hepatic Impairment

Specific dose-adjustment data for Butibac in patients with hepatic impairment have not been established; Butibac should be used with caution and under medical supervision in this population.

Other Populations

Patients with a history of gastrointestinal disease, particularly colitis, should use Butibac with caution and under close medical supervision.

The duration of treatment with Butibac is determined by a healthcare professional and depends on the specific infection being treated. In typical clinical use, Butibac is given for 10 days for acute bacterial exacerbation of chronic bronchitis, acute bacterial otitis media, and pharyngitis/tonsillitis. Even if symptoms improve earlier, the full prescribed course of Butibac should be completed only as directed by the prescriber; do not stop, extend, skip, or share doses of Butibac without medical advice.

The oral powder-for-suspension formulation of Butibac is prepared (reconstituted) by the pharmacist with the correct amount of water before it is dispensed. The pharmacist shakes the bottle to ensure the powder is evenly suspended and labels it with the discard date; patients or caregivers should not attempt to reconstitute Butibac themselves.

Cephalosporin antibiotic; Third-generation oral cephalosporin; Beta-lactam antibiotic

Ceftibuten Dihydrate acts by binding to essential penicillin-binding proteins involved in bacterial cell-wall synthesis. This binding inhibits the final step of bacterial cell-wall construction, producing a defective cell wall and resulting in bactericidal (bacteria-killing) activity against susceptible organisms.

Butibac is approved for use in children 6 months of age and older for acute bacterial otitis media, pharyngitis/tonsillitis, and (in appropriate age groups) acute bacterial exacerbation of chronic bronchitis, when caused by susceptible organisms. The pediatric dose of Butibac is calculated by body weight — 9 mg/kg once daily, up to a maximum of 400 mg/day — usually given for 10 days using the oral suspension formulation. Safety and effectiveness of Butibac have not been established in infants younger than 6 months. Parents and caregivers should shake the suspension well, measure each dose of Butibac carefully using the provided measuring device, and complete the full prescribed course exactly as directed.