Tebipenem P Granules (Tebipenem) is an oral carbapenem antibiotic formulated as fine granules specifically for pediatric use. Its active ingredient is tebipenem pivoxil, which exerts bactericidal effects by inhibiting bacterial cell wall synthesis.
What are the Indications for Tebipenem P Granules (Tebipenem)?
Pneumonia
It is indicated for the treatment of pulmonary infections caused by tebipenem-susceptible Streptococcus pneumoniae (including penicillin-resistant and erythromycin-resistant strains), Haemophilus influenzae (including ampicillin-resistant strains), and Moraxella catarrhalis.
Clinical trials have shown that its efficacy rate in pediatric pneumonia reaches 98.3%, with particularly significant antibacterial activity against drug-resistant Streptococcus pneumoniae.
Otitis Media
It has strong inhibitory effects on common pathogens of otitis media, such as Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes.
Relevant research reports indicate that the clinical efficacy rate for children with otitis media is 98.0%, and the bacterial eradication rate is close to 100%.
Paranasal Sinusitis
It is suitable for mild to moderate sinus infections, especially for cases where conventional antibiotic therapy has poor efficacy.
It should be particularly noted that this drug is a carbapenem antibiotic with a special clinical positioning. It should only be used when other antibacterial drugs are ineffective, and its use must strictly comply with the results of etiological testing.
Specifications and Properties of Tebipenem P Granules (Tebipenem)
Specification Composition
Each 1 gram of granules contains 100 mg of tebipenem pivoxil (calculated by potency).
Excipients include 16 components such as microcrystalline cellulose, hydroxypropyl cellulose, hypromellose, talc, and ethylcellulose, with additional aspartame (containing phenylalanine) and vanillin as flavoring agents.
The packaging is available in 50g/bottle, 100g/bottle, and divided packaging of 0.5g×120 sachets.
Physicochemical Properties
Dosage form: Orange to light red fine granules.
Odor: Has an aromatic fragrance.
Solubility: The active ingredient is readily soluble in methanol and acetonitrile, and extremely insoluble in water.
This formulation balances pediatric medication compliance and drug stability, and its sweet and fragrant taste can reduce young children’s resistance to taking the medicine.
Storage Methods for Tebipenem P Granules (Tebipenem)
Storage Conditions
This product should be stored in a sealed container at room temperature, away from moisture and high-temperature environments.
The bottle cap should be tightly fastened immediately after opening, and the divided sachets should only be opened at the time of administration.
Validity Period and Supervision
The validity period is 3 years from the date of manufacture.
It is a prescription drug and must be used with a doctor’s prescription.
Attention should be paid to moisture protection; divided sachets that are not taken in a timely manner should be discarded.
