Ciprofloxacin Injection USP 200 mg/10Oml

PHARMACEUTICAL/THERAPEUTIC CATEGORY AND MODE OF ACTION

CLAMOXIN is a combined preparation comprising a broad-spectrum antibiotic (amoxicillin) and a B-lactamase inhibitor (clavulanic acid). It acts against certain bacteria.

PHARMACOLOGY

Mode of action: The efficacy of Amoxicillin + Clavulanic acid is the result of bactericidal activity of Amoxicillin combined with the inhibitory activity of clavulanic acid on ß-lactamases produced by different bacterial strains. Like other ß-lactams, clavulanic acid penetrates through the bacterial cell wall, but it generally possesses poor intrinsic antimicrobial activity and is generally a more potent inhibitor of cell free B- lactamases. The binding of ß-lactamases with clavulanic acid is a complex physiochemical process, which rapidly leads to lysis of the cell.

PHARMACOKINETICS

Amoxicillin and Clavulanate potassium are well absorbed from gastrointestinal tract after oral administration of Amoxicillin- Clavulanate potassium. The safety and efficacy of Amoxicillin, Clavulanate Potassium have been established in clinical trials where Amoxicillin, Clavulanate Pottasium was taken without regard to meals. Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues. Approximately 50 % to 70% of the amoxicillin and approximately 25% to 40 % of the clavulanic acid are excreted unchanged in urine during the first 6 hours after oral administration.

INDICATIONS

CLAMOXIN is indicated for the treatment of bacterial infections caused by organisms sensitive to amoxicillin and clavulanic acid such as:

• Infection of the upper and lower respiratory tract.
• Otitis media (inflammation of the middle ear).
• Acute sinusitis.
• Acute exacerbation of chronic bronchitis. 
• Pneumonia.
• Infections of the kidneys and lower urinary tract.
• Infections of the skin and soft tissues.

CONTRAINDICATIONS

Known hypersensitivity to certain B-lactam antibiotics (e.g. penicillin, cephalosporins), as there is a risk in such cases of allergy-induced shock.

DOSAGE AND ADMINISTRATION

Adults and Children greater than 40 KG:

Usual dose: One Clamoxin 1g tablet two times a day. One Clamoxin 625/375 tablet three times a day.

For otitis media, sinusitis, lower respiratory tract infections and urinary tract infections: One Clamoxin 1g tablet three times a day.

CHILDREN lesser than 40 kg:

Children may be treated with formulation found appropriate for the age of the child and severity of the disease.

Usual Dose: Clamoxin 1 g Tablets: 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day given as two divided doses. Clamoxin 625 Tablets: 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in three divided doses.

For Otitis media, sinusitis and lower respiratory tract infections: Clamoxin 1 g Tablets: Up to 70 mg/10 mg/kg/day given as two divided doses may be considered.

The duration of therapy should be determined by the response of the patient. Some infections (e.g. osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days without review.

As the tablets cannot be divided, children weighing less than 25 kg must not be treated with Clamoxin tablets.

Method of administration

Clamoxin Tablets are for oral use.

Administer at the start of a meal to minimize potential gastrointestinal intolerance and optimise absorption of amoxicillin/clavulanic acid.

PRECAUTIONS FOR USE AND SPECIAL WARNINGS

Pregnancy and lactation: By way of a precaution CLAMOXIN should be used during pregnancy only if, in the physician judgement, the potential benefits outweigh the possible risks. Amoxicillin is eliminated into breast milk. Breast-fed babies may therefore have diarrhea and colonization of the mucous membranes by yeasts, possibly resulting in a need to discontinue breast-feeding. The possibility of sensitization must also be taken into account.

Interactions: The following substances or drugs (including drugs taken until shortly before the start of therapy) can interact with CLAMOXIN.

Other specific antibiotics such as tetracyclines, macrolides, sulphonamides or chloramphenicol, probenecid, allopurinol, diuretics, hormonal contraceptives, digoxin, disulfiram, specific anticoagulants.

UNDESIRABLE EFFECTS: 

Hypersensitivity reactions. Skin reactions in the form of exanthemas rash and itching have been reported with some frequency. The typical measles-like rash occurs 5 to 11 days after the start of treatment. An immediate skin reaction in the form of a nettle rash usually indicates a real penicillin allergy in which case treatment must be discontinued. Inflammation of the mucous membranes, particularly in the mouth, can occur occasionally. Black tongue has been observed in very rare instances. Dryness of the mouth and changes in the taste can occur.

Severe allergic reactions, e.g. threatening shock, drug fever, increase in certain blood cells (eosinophilia), painful swelling of the skin and mucous membranes swelling of the inner larynx with constriction of the respiratory passages and difficulty in breathing, serum sickness, hemolytic anemia, allergic vasculitis or nephritis and skin reactions with life threatening general reactions such as Stevens-Johnson; Lyeil syndrome and exfoliative dermatitis (blistering of the skin) have been observed. Immediate medical assistance is required if these symptoms occur. In patients who have or had a cutaneous fungal infection, hypersensitivity reactions cannot be ruled out even if the patients are receiving penicillin for the first time.

OVERDOSE

The symptoms of overdose are essentially the same as the side effects. With very high doses nausea, vomiting, abdominal pain and diarrhea can occur. No specific measures are normally required except for discontinuation of the drug.

STORAGE

Store in a dry place below 25°C. Protect from light and moisture.

Keep out of the reach and sight of children.

If you have any questions about this product or would like to report an adverse reaction, contact us by phone / email: 0018888306075 / drug.safety@blissgvs.com.