Augram 1 g 7 tablets

Augram 1 g 7 tablets

Composition:

Active Ingredients: Each tablet contains
Amoxicillin (as trihydrate) — 875 mg and Clavulanic Acid (as potassium salt) — 125 mg.
Excipients:
Colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose.

Product Description:

• Augram is a broad-spectrum combined antibacterial medication.
• It consists of amoxicillin (a semi-synthetic penicillin antibiotic) and clavulanic acid (a bacterial enzyme inhibitor).Its mechanism of action relies on the bactericidal effect of amoxicillin, which inhibits bacterial cell wall synthesis.
• Clavulanic acid binds beta-lactamases and prevents the enzymatic degradation of amoxicillin, broadening its spectrum of activity.
• The medication is active against Gram-positive and Gram-negative aerobic and anaerobic bacteria (including Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella species, Moraxella catarrhalis, Streptococcus species, Streptococcus pneumoniae, Enterococcus species, Bacillus anthracis, Listeria monocytogenes, Clostridium species, Peptococcus species, Peptostreptococcus species, Proteus species, Salmonella species, Shigella species, Bordetella pertussis, Yersinia species, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Campylobacter jejuni, Bacteroides fragilis).
• Clavulanic acid is not active against enzymes produced by Pseudomonas aeruginosa, Serratia species, or Acinetobacter species.

Indications for Use:

• Treatment of infectious and inflammatory diseases caused by susceptible microorganisms:
• Upper Respiratory Tract and ENT Infections: Acute and chronic sinusitis, tonsillitis, otitis media.
• Lower Respiratory Tract Infections: Acute and chronic bronchitis, pneumonia, pleural empyema, lung abscess.
• Genitourinary and Pelvic Infections: Acute and chronic pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, endometritis, bacterial vaginosis, septic abortion, chancroid, gonorrhea.
• Skin and Soft Tissue Infections: Erysipelas, impetigo, secondarily infected dermatoses, abscesses, phlegmons, wound infections.
• Bone and Joint Infections: Osteomyelitis.
• Surgical Infection Prophylaxis and Treatment: Postoperative wound infections.

Method of Administration and Dosage:

• Administered orally.
• To reduce gastrointestinal side effects and optimize absorption, it is recommended to take the tablet at the start of a meal.
• Swallow the tablet whole with a full glass of water.
• Adults and Children Over 12 Years (or Weight 40 kg and Above):
  Standard Dosage: 1 tablet (875 mg / 125 mg) 1–2 times daily (every 12–24 hours depending on severity).
• Duration of Therapy: The course of treatment should not exceed 10 days.
• Treatment should not exceed 14 days without medical re-evaluation.

Contraindications:

• Hypersensitivity to amoxicillin, clavulanic acid, penicillins, cephalosporins, or other beta-lactam antibiotics.
• Infectious mononucleosis (high risk of developing a rubelliform skin rash).
• Phenylketonuria.
• History of jaundice or hepatic dysfunction associated with amoxicillin/clavulanic acid therapy.
• Severe renal impairment (creatinine clearance less than 30 mL/min).

Precautions:

• Administration with Food: Take at the beginning of meals to minimize gastrointestinal discomfort.
• Monitoring: During prolonged therapy, monitor renal, hepatic, and hematopoietic function regularly.
• Cross-Allergy: Potential cross-reactivity may occur in patients with sensitivity to cephalosporins. Discontinue therapy if rash or itching occurs.
• Risk of Superinfection: Prolonged use may lead to overgrowth of non-susceptible organisms and fungal infections (candidiasis).
• Laboratory Testing: May produce false-positive results in urine glucose tests (enzymatic glucose oxidase methods should be used).

Adverse Reactions / Side Effects:

• Gastrointestinal System: Nausea, vomiting, diarrhea, loss of appetite, stomatitis, abdominal pain; rarely, elevated liver enzymes, hepatitis, cholestatic jaundice, tooth discoloration.
• Allergic Reactions: Pruritus, urticaria, skin rash; rarely, angioedema, erythema multiforme, anaphylactic shock, toxic epidermal necrolysis.
• Hematopoietic System: Leukopenia, thrombocytopenia, eosinophilia, anemia, increased prothrombin time.
• Nervous System: Dizziness, headache; rarely, hyperactivity, anxiety, seizures (with high doses).
• Other: Candidiasis (thrush), crystalluria.

Pregnancy and Lactation:

Use during pregnancy and breastfeeding is permissible only when the expected benefit to the mother outweighs the potential risk to the fetus or child, strictly under medical supervision.

Storage Conditions:

Store at a temperature not exceeding 25 °C in a dry place protected from direct sunlight.
Keep out of reach of children.

Packaging:

Cardboard box containing 1 blister pack of 7 film-coated tablets and a patient information leaflet.