Ampicillin & Cloxacillin

Bluepillexpress is a trusted name in the pharmaceutical industry, committed to delivering quality-assured medicines with a focus on patient care and therapeutic effectiveness. Among our wide range of antibiotic formulations, our Ampicillin & Cloxacillin Capsules are one of the most sought-after combinations, designed to combat a broad spectrum of bacterial infections. Manufactured under stringent quality standards, this formulation exemplifies our mission to provide effective, reliable, and affordable healthcare solutions.

The Ampicillin and Cloxacillin combination is a synergistic antibiotic therapy widely used in clinical practice. As a third-party manufacturing partner, Bluepillexpress offers high-volume, custom-branded manufacturing solutions for hospitals, clinics, and pharmaceutical distributors looking to source high-quality beta-lactam antibiotics.

Product Overview

• Product Name: Ampicillin & Cloxacillin Capsules
• Manufacturer: Bluepillexpress
• Dosage Form: Hard gelatin capsule
• Available Strengths: Ampicillin 250 mg + Cloxacillin 250 mg / Ampicillin 500 mg + Cloxacillin 500 mg
• Packaging: Available in alu-alu and blister packs; customizable according to client requirement
• Therapeutic Category: Broad-spectrum Penicillin Antibiotic
• Prescription Status: Schedule H drug; to be sold by retail on the prescription of a registered medical practitioner only

Composition

Each capsule contains:

• Ampicillin: A broad-spectrum, semi-synthetic penicillin derived from the basic penicillin nucleus. It is active against both Gram-positive and certain Gram-negative organisms.
• Cloxacillin: A semi-synthetic penicillin that is resistant to penicillinase enzymes produced by penicillin-resistant staphylococci. It primarily acts against Gram-positive bacteria, particularly penicillinase-producing Staphylococcus aureus.

This combination broadens the antibacterial spectrum of the formulation, making it a potent dual-action therapy against infections caused by mixed bacterial flora.

Mechanism of Action

Ampicillin inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). This action disrupts the cross-linking of the peptidoglycan layer, a key structural component of the bacterial cell wall, ultimately leading to cell lysis and death in susceptible bacteria.

Cloxacillin also acts on the bacterial cell wall but is particularly notable for its resistance to beta-lactamase (penicillinase), an enzyme produced by resistant strains of Staphylococcus. Its stability in the presence of this enzyme allows it to effectively treat penicillin-resistant staphylococcal infections.

Together, Ampicillin and Cloxacillin provide a comprehensive approach to infection management, combining the broad Gram-positive and Gram-negative activity of Ampicillin with the penicillinase-resistant activity of Cloxacillin.

Indications

Ampicillin & Cloxacillin capsules are indicated in the treatment of infections caused by susceptible organisms. These include:

• Upper and lower respiratory tract infections (e.g., bronchitis, pneumonia, sinusitis, pharyngitis, tonsillitis)
• Skin and soft tissue infections (e.g., cellulitis, abscesses, impetigo)
• Bone and joint infections (e.g., osteomyelitis)
• Genitourinary tract infections
• Ear, nose, and throat infections
• Septicemia and bacteremia caused by sensitive strains
• Post-surgical infections and wound infections

Dosage and Administration

The dosage of Ampicillin & Cloxacillin should be determined by a healthcare professional based on the severity of the infection, patient weight, and renal function. Typical adult dosing ranges from 500 mg to 1 g every 6 hours. Pediatric dosing is based on body weight, with close monitoring.

Capsules should be taken on an empty stomach, preferably one hour before or two hours after meals, to maximize absorption. It is important for patients to complete the full course of therapy as prescribed, even if symptoms improve earlier, to prevent bacterial resistance.

Contraindications

This product is contraindicated in individuals with:

• Known hypersensitivity to penicillins or any of the formulation components
• History of anaphylactic reactions to beta-lactam antibiotics
• Infectious mononucleosis (risk of rash may increase with ampicillin use)
• Previous history of severe gastrointestinal disturbances or antibiotic-associated colitis

Warnings and Precautions

• Allergic Reactions: Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Immediate medical attention is necessary if any signs of hypersensitivity occur.
• Renal Impairment: Dosage adjustments may be required in patients with impaired kidney function.
• Superinfections: Prolonged use may result in overgrowth of non-susceptible organisms including fungi and yeast. Appropriate measures should be taken if superinfections occur.
• Hepatic Monitoring: Liver function tests should be monitored in patients receiving prolonged treatment.
• Diarrhea & Clostridium difficile-associated Diarrhea (CDAD): Antibiotic-associated colitis is a possibility with nearly all antibacterial agents and should be considered in any patient presenting with diarrhea following antibiotic use.

Side Effects

Ampicillin & Cloxacillin is generally well-tolerated. However, like all medications, it may cause side effects in some patients. The most commonly reported adverse reactions include:

• Gastrointestinal disturbances such as nausea, vomiting, abdominal pain, and diarrhea
• Skin rash, urticaria, or other mild allergic reactions
• Elevated liver enzymes and transient liver function abnormalities
• Rare cases of Stevens-Johnson syndrome, erythema multiforme, or anaphylaxis
• Blood dyscrasias such as neutropenia, thrombocytopenia, or hemolytic anemia (rare)

Patients should be advised to report any persistent or severe side effects to their healthcare provider.

Drug Interactions

• Allopurinol: Concurrent use may increase the likelihood of skin rash.
• Oral contraceptives: Antibiotics like Ampicillin may reduce the efficacy of hormonal contraceptives. Additional birth control methods should be advised.
• Probenecid: May prolong the serum half-life of penicillins by decreasing renal excretion.
• Anticoagulants: Careful monitoring of INR or prothrombin time is advised when used with warfarin or other anticoagulants.

Quality Assurance at Bluepillexpress

At Bluepillexpress, we prioritize quality at every step of the manufacturing process. Our Ampicillin & Cloxacillin Capsules are manufactured in WHO-GMP certified facilities that follow strict protocols related to:

• Raw material sourcing and validation
• In-process controls and batch consistency
• Final product testing, including dissolution, uniformity, sterility, and microbial limits
• Stability testing under ICH guidelines to ensure shelf-life integrity
• Regulatory documentation support including COAs, MSDS, and stability reports

We are equipped to handle large-scale production batches for domestic as well as export markets, and we offer complete customization options including private labeling, custom pack sizes, and multilingual packaging support.

Third-Party Manufacturing Services

Bluepillexpress provides end-to-end third-party manufacturing services for Ampicillin & Cloxacillin Capsules, including:

• Product development support and technical dossier preparation
• Brand and packaging design consultation
• Customizable batch sizes based on client requirements
• Regulatory documentation and product registration assistance
• Timely delivery with robust logistics management

Our clients range from hospital pharmacies and local distributors to international partners in regulated and semi-regulated markets.

Why Choose Bluepillexpress?

• Experience: With years of experience in antibiotic formulation, we understand the nuances of quality, compliance, and efficacy.
• Compliance: Our facilities meet national and international regulatory standards including WHO-GMP, ISO, and applicable pharmacopoeias (IP, BP, USP).
• Customization: We offer full flexibility in packaging, labeling, and branding to match your market needs.
• Support: Our dedicated technical and customer service team ensures that you receive consistent communication and support throughout the process.
• Scalability: Whether you require small batches or bulk manufacturing, we are equipped to deliver without compromising quality or timelines.

Shelf Life and Storage

• Shelf Life: 24 to 36 months from the date of manufacture (depending on packaging and market)
• Storage Conditions: Store in a cool, dry place below 25°C. Protect from direct sunlight and moisture.

Regulatory and Documentation Support

As a third-party manufacturer, Bluepillexpress provides full regulatory and technical documentation support, including:

• Certificate of Analysis (COA)
• Batch Manufacturing Records (BMR)
• Product Specifications
• Master Formula Records (MFR)
• Stability data (on request)
• Technical Data Sheets (TDS)

This ensures your product meets both domestic compliance and export documentation standards.

Conclusion

Ampicillin & Cloxacillin Capsules from Bluepillexpress represent a trusted and therapeutically effective solution for the treatment of a wide range of bacterial infections. Combining the strengths of two potent penicillins, this formulation is ideal for healthcare providers seeking reliable infection control.

With a strong emphasis on quality, regulatory compliance, and customer support, Bluepillexpress stands as a dependable third-party manufacturer for all your antibiotic formulation needs. Whether you are a healthcare distributor, hospital procurement officer, or a marketing company seeking a trusted manufacturing partner, Bluepillexpress is your go-to source for Ampicillin & Cloxacillin