Imox 500 Amoxicillin Capsules

IMOX-500 Amoxicillin 500mg capsules

Composition, Clinical pharmacology, Absorption and excretion, Indications and usage, Contraindications, Interactions, Warning, Precautions, Fertility, pregnancy and lactation effects, Adverse effects, Overdose, Dosage and administration, Storage, Presentation, Shelf life, Manufacturer and NAFDAC Reg. No. of Imox 500 Capsule Medicine for Infections.

 

COMPOSITION

Each hard gelatin capsule contains:

Amoxicillin Trihydrate equivalent to Amoxicillin 500mg.

Excipients Quantity sufficient

Capsule shells contain approved colours.

 

CLINICAL PHARMACOLOGY

IMOX, a brand of Amoxicillin, is a semisynthetic Penicillin, and an analogue of Ampicillin with a broad spectrum, bactericidal activity against susceptible Gram positive bacteria like Staphylococcus aureus, Streptococcus species, Diplococcus pneumoniae, Corynebactertum species, Clostridium species, Bacillus anthracis, and susceptible Gram negative organisms like Neisseria species, Haemophilus influenzae, Bordetella pertussis, Escherichia coli, Salmonella typhi, Shigella species, Proteus mirabilis, Brucella species. It is usually the drug of choice within the class because it is better absorbed following oral administration, than other beta-lactam antibiotics but it is also destroyed by beta-lactamases. It acts by the inhibition of peptidoglycan, a mucopeptide in bacteria cell walls.

 

ABSORPTION AND EXCRETION

IMOX is stable in gastric acid and 50% to 90% is absorbed in oral administration. Its absorption is more complete than of Ampicillin and its well absorbed in the presence or absence of food and distributed in most body and tissue fluids. Penetration into the cerebrospinal fluid and brain occur only with meningeal inflammation. It is partially metabolized to inactive metabolites and excreted in urine. In patients with normal renal functions, higher and more prolonged level may be achieved by concurrent administration of Probenecid.

 

INDICATIONS AND USAGE

Amoxicillin is indicated for the treatment of the following bacterial infection caused by susceptible organisms: Infections of the upper respiratory tract, including infection of the ears, nose and throat: Acute sinusitis and bacterial pharyngitis. Infection of the lower respiratory tract: Acute exacerbation of chronic bronchitis, community-acquired pneumonia, otitis media, dental abscess and other oral infections. Infections of the lower urinary tract: Cystitis, Prophylaxis of endocarditis in patients at risk i.e. surgery in the oral cavity or upper airways, osteomyelitis, Lyme disease, post-splenectomy prophylasis, gynaecological infections, gonorrhea, Helicobacter pylori indication in peptic ulcer disease, anthrax, bacteriuria in pregnancy, typhoid and paratyphoid.

 

CONTRAINDICATIONS

IMOX capsule is contraindicated in individuals with history of hypersensitivity reaction to Penicillin derivatives or any of the Cephalosporins or any of the beta lactams and patients with infectious mononucleosis.

 

INTERACTIONS

Increase levels of Amoxicillin with Disulfiram and Probenecid. Decreased levels with Tetracyclines and Chloramphenicol. Increased risk of rash when administered concurrently with Allopurinol, reduced contraceptive effect of oestrogens, reduced excretion of methotrexate.

 

WARNING

Before initiating the therapy with IMOX capsule, careful inquiry should be made concerning previous hypersensitivity reactions to beta lactams.

 

PRECAUTIONS

History of allergy and anaphylactic reactions. Periodic assessment of renal, hepatic and haematopoietic functions should be made during prolonged therapy. In case of superinfections with mycotic or bacterial pathogens (usually Enterobacter, Pseudomonas or Candida) the drug should be discontinued. Erythematous rashes common in glandular fever, cytomegalovirus infection, chronic lymphatic leukemia and possible HIV infection. Maintain adequate hydration with high doses (risk of crystalluria)

 

FERTILITY, PREGNANCY AND LACTATION

Pregnancy: IMOX capsules may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.

Breastfeeding: IMOX capsules are excreted into breast milk in small quantities with the possible risk of sensitization. So, it should only be used during breastfeeding after benefit/risk assessment by the physician in charge.

Fertility: There are no data on the effect of Amoxicillin on fertility in human. Reproductive studies in animals have shown no effect on fertility.

 

ADVERSE EFFECTS

IMOX is generally well tolerated. Hypersensitivity reactions presenting as skin rash, Pruritus, Urticaria, Angioedema, Anaphylaxis, Erythema multiforme, Stevens-Johnson syndrome and exfoliative dermatitis. If a rash occurs, treatment should be discontinued. Other are blood dyscrasias, diarrhoea, nausea, vomiting, neuromuscular hypersensitivity, Pseudomembraneous colitis.

 

OVERDOSE

In case of overdose, gastrointestinal symptoms and disturbance of the fluid and electrolyte balance may be evident. They may be treated symptomatically and supportive with attention to the water/electrolyte balance. In the absence of an adequate fluid intake and urinary output, crystalluria is a possibility and the antibiotic may be removed from the circulation by haemodialysis.

 

DOSAGE AND ADMINISTRATION

Amoxicillin can be taken with or without food. The dose of Amoxicillin selected to treat an individual infection should take into account the expected pathogens and their likely susceptibility, the severity and sight of infection, the age, weight and renal function of the patient. In the elderly no dosage adjustment is required necessary. In patients with renal impairment, the dove should be adjusted according to the degree of impairment.

Standard adult dosage (≥40kg). One capsule (500mg) every 8 hours
‘OR’ As directed by the physician.

 

STORAGE

Store below 30°C, away from direct sunlight. Keep all medicines out of the reach of children.

 

PRESENTATION

1. 10 capsules in one regular blister and 10 regular blisters in one clinical box.

2. 10 capsules in one tropical blister and 2 such tropical blisters in one clinical box.

 

SHELF LIFE

Two years from the date of manufacturing.

 

NAFDAC REG. NO.: 04-2284

 

MANUFACTURED BY

Chris-Ejik Pharmaceuticals & Health Care Products Ltd.,

3, Oje-Imianvan Street, Off Oregon Road, lkeja,

Lagos, Nigeria.

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