Description
Ampicillin & Dicloxacillin Capsules
Healthy Inc is a specialized global supplier and exporter of advanced, synergistic beta-lactam antimicrobials. We provide high-purity Ampicillin (250 mg) & Dicloxacillin (250 mg) Capsules, manufactured in WHO–GMP certified, completely dedicated penicillin oral solid dosage facilities. This “Broad-Spectrum & Beta-Lactamase Resistant” combination is a massive-volume, high-priority export to surgical centers, primary care clinics, and government health ministries in LATAM, Southeast Asia, and Africa, serving as the gold-standard empirical intervention for mixed respiratory, dermatological, and post-operative infections.
Product Overview
This formulation contains two highly complementary penicillins: Ampicillin (an extended-spectrum aminopenicillin) and Dicloxacillin (a narrow-spectrum, highly beta-lactamase-resistant isoxazolyl penicillin).
The “Dual-Action Synergistic” Specialist:
- Mechanism 1 (Ampicillin – Broad Coverage): Ampicillin easily penetrates the outer membrane of Gram-negative bacteria via porin channels, binding to Penicillin-Binding Proteins (PBPs) to halt cell wall synthesis. It provides excellent coverage against Streptococcus, Enterococcus, Haemophilus influenzae, and E. coli. However, it is highly susceptible to destruction by beta-lactamase enzymes.
- Mechanism 2 (Dicloxacillin – The Staph Shield): Dicloxacillin features a bulky side chain that sterically hinders beta-lactamase enzymes from breaking its beta-lactam ring. It aggressively targets and destroys penicillinase-producing Staphylococcus aureus (MSSA), which would otherwise survive and neutralize the Ampicillin. Dicloxacillin is noted for having particularly excellent oral absorption among the anti-staphylococcal penicillins.
- The Empirical Advantage: In severe skin infections, wound infections, or respiratory exacerbations, it is often unclear if the pathogen is a Strep, a Gram-negative rod, or a Staph. This 500 mg FDC provides immediate, comprehensive empirical coverage against all three major threats simultaneously, halting tissue destruction while awaiting laboratory cultures.
Product Composition & Strength
We supply this product as a Hard Gelatin Capsule, packed in specialized moisture-resistant Alu-Alu or heavy-gauge Alu-PVC blister strips to preserve the highly hygroscopic Dicloxacillin salt.
| Active Ingredient | Strength (Base Equivalent) | Release Profile Function |
|---|---|---|
| Ampicillin Trihydrate USP/BP | 250 mg | Broad-spectrum component for Gram-positive/negative systemic clearance. |
| Dicloxacillin Sodium USP/BP | 250 mg | Beta-lactamase resistant component targeting Staphylococcal clearance. |
| Excipients | Magnesium Stearate / Microcrystalline Cellulose | Lubricant / Diluent (Ensures rapid gastric dispersion and powder flow) |
*Pack Sizes: 10×10 Alu-Alu Blisters or 10×10 heavy-gauge Alu-PVC Blisters (Crucial for tropical export climates).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Hospital Distributors.
| HS Code | 3004.10.90 (Medicaments containing penicillins or derivatives thereof) |
| CAS Numbers | 7177-48-2 (Ampicillin Trihydrate) / 13412-64-1 (Dicloxacillin Sodium) |
| Dosage Form | Hard Gelatin Capsule |
| Packaging | Alu-Alu Blisters or High-Barrier Alu-PVC (CRITICAL). Dicloxacillin sodium degrades rapidly if exposed to moisture. |
| Storage | Store below 25°C in a dry place. Protect strictly from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- 100% Dedicated Penicillin Isolation: Regulatory guidelines strictly mandate that penicillins be manufactured in completely isolated facilities to prevent fatal cross-contamination with other drug classes. Our combination capsules are processed in a segregated block with dedicated HVAC and air-filtration systems.
- Hygroscopic Environmental Control: Because Dicloxacillin Sodium degrades in the presence of humidity, our encapsulation lines are rigorously controlled at Relative Humidity (RH) levels below 30%, guaranteeing absolute API stability and full therapeutic potency through the expiry date.
Therapeutic Indications (Human Use)
Indicated for the empirical treatment of severe, mixed bacterial infections:
- Skin and Soft Tissue Infections (SSTIs): Cellulitis, severe boils, abscesses, carbuncles, and infected surgical wounds where both Staph and Strep are suspected.
- Respiratory Tract Infections (RTIs): Bronchopneumonia, acute exacerbations of chronic bronchitis, and severe otitis media.
- Post-Operative Prophylaxis: Administered to prevent mixed infections following orthopedic or general surgery.
- Bone and Joint Infections: Osteomyelitis caused by susceptible organisms.
Dosage & Administration
Recommended Dosage (Strictly as per Physician):
- Administration (TIMING): Capsules MUST be taken on an empty stomach (at least 30 minutes before or 2 hours after meals). Food heavily impairs the absorption of both Ampicillin and Dicloxacillin, severely reducing peak blood concentrations.
- Standard Adult Dose: One capsule (250mg/250mg) every 6 hours (four times daily).
- Severe Infections: Dosing frequency or capsule volume may be increased under strict medical supervision depending on the severity of the infection.
Safety Warnings (CRITICAL):
- BLACK BOX WARNING (Anaphylaxis): Serious and fatal hypersensitivity reactions occur in patients allergic to penicillins. Strictly contraindicated in patients with a history of penicillin or cephalosporin allergy.
- Gastrointestinal Disruption: Dicloxacillin is known to cause gastrointestinal upset, including nausea, vomiting, and diarrhea. If severe, persistent diarrhea occurs, Clostridioides difficile-associated colitis (CDAC) must be ruled out.
- The “Mononucleosis Rash”: Administering Ampicillin to patients with infectious mononucleosis (Epstein-Barr virus) causes a severe, generalized maculopapular rash. It should not be used if viral mononucleosis is suspected.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Dedicated Penicillin Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in LATAM or a B2B Pharma Marketplace partner for Africa, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.








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