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CLAMOVID BID 1000 TABLET

CLAMOVID BID GRANULES

CLAMOVID BID FORTE GRANULES


Description
Tablet : White, oblong film-coated tablet.
Granules: Creamy. white coloured homogenous powder.


Composition
Clamovid BID 1000 Tablet
Amoxycillin (as trihydrate) ........................... 875 mg/tab

Clavulanic Acid (as potassium clavulanate) ...125 mg/tab


Clamovid BID Granules
Amoxycillin (as trihydrate) .......................... 200 mg/5 ml
Clavulanic Acid (as potassium clavulanate) .. 28 mg/5 ml

Clamovid BID Forte Granules
Amoxycillin (as trihydrate) ............................ 400 mg/5 ml
Clavulanic Acid (as potassium clavulanate) .... 57 mg/5 ml


Actions and Pharmacology
Amoxycillin is a broad-spectrum bactericidal antibiotic which exerts its killing action on growing and dividing bacteria by inhibiting bacterial cell wall synthesis. Clavulanic acid by itself has little antibacterial activity. However, in combination with amoxycillin, it extends the spectrum of amoxycillin to cover a wider range of organisms, including many resistant to other beta-lactam antibiotics.


Oral absorption of Clamovid is optimised at the start of a meal. The presence of food does not appear to diminish the total amount absorbed. Amoxycillin is widely distributed in body tissues and fluids. It crosses the placenta and small amounts are excreted in breast milk. Amoxycillin is metabolised to a limited extent to penicilloic acid whilst clavulanic acid may be metabolised more extensively than amoxycillin. Excretion is mainly via renal and biliary systems.


Indications
For treatment of acute otitis media, sinusitis, pneumonia, skin and soft tissue infections, urinary tract infections caused by betalactamase-producing bacteria.


Contraindications
- Contraindicated in patients known to be hypersensitive to penicillin. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporins.

- Contraindicated in patients with a previous history of penicillinassociated jaundice/hepatic dysfunction.
- Contraindicated in patients with infectious mononucleosis.


Precautions / Warnings
- Patients sensitive to one penicillin may be allergic to other penicillins or related antibiotics such as cephalosporins, cephamycins or beta-lactamase inhibitors. - Caution in patients with history of allergy such as asthma, eczema, hay fever or hives.
- Caution in patients with a history of bleeding disorders.
- Caution in patients with a history of gastrointestinal disease especially ulcerative colitis, regional enteritis or antibiotic associated colitis.
- Caution in patients with impaired renal function. Adjustment of dosage may be necessary.
- Use with caution in patients with hepatic dysfunction as changes in liver function tests have been observed.
- Erythematous rashes have been associated with glandular fever in patients receiving amoxycillin.
- Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.

Use in Pregnancy and Lactation
- Use should be avoided in pregnancy, especially in the first trimester, unless considered essential by the physician.

- Clamovid may be administered during the period of lactation. With the exception of the risk of sensitisation, associated with the excretion of trace quantities in breast milk, there are no known detrimental effects for the breast-fed infant.

Side/Adverse Effects
Side effects are uncommon and mainly of a mild and transitory nature.
- Gastrointestinal effects : Diarrhoea, indigestion, nausea, vomiting and mucocutaneous candidiasis have been reported. Taking Clamovid at the start of meals may reduce them.
- Genito-urinary effects :Vaginal itching, soreness and discharge.
- CNS effects Convulsions may occur with impaired renal function or in those receiving high doses.
- Hepatic effects Moderate and symptomatic rises in AST and /or ALT and alkaline phosphatase. The risk increases with the duration of treatment longer than 14 days.
- Hypersensitivity reactions : Urticarial and erythematous skin rashes, angioedema and anaphylaxis have been reported. Treatment should be discontinued if these symptoms occurs.

- Haematological effects : As with other beta-lactams, transient leucopenia, thrombocytopenia and haemolytic anaemia have been reported rarely.

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