Brand Name:- APR CEFFISAFE-100 TABLETS
PRODUCT CODE:- AB-07H1
COMPOSITION:- CEFIXIME 100MG
THERAPEUTIC:
DOSE FORM: TABLET
INFORMATION FOR THE USER
Cefixime 100mg Tablets
Read all of this information carefully before you start taking this medicine because it contains important information for you.
- Keep this information. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.
1.COMPOSITION:
Each tablet contains:
Cefixime – 100mg
For oral use only.
2. DESCRIPTION:
Cefixime is an anti-biotic that is very useful to treat a wide variety of infections. Cefixime belongs to the class of drugs known as cephalosporins and is classified as a 3rd generation cephalosporin.
3. PHARMACOLOGICAL ACTION:
Cefixime is an oral 3rd generation cephalosporin which has marked in vitro bactericidal activity against a wide variety of Gram-positive & Gram-negative organisms. Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella, Haemophilus influenzae (beta-lactamase positive & negative), Branhamella catarrhalis (beta-lactamase positive & negative) and Enterobacter species. It is highly stable in the presence of beta-lactamase enzymes.
4. CLINICAL PHARMACOKINETICS:
The absolute oral bioavailability of cefixime is in the range of 22-54%. Absorption is not significantly modified by the presence of food. It may be given without regard to meals. From in vitro studies, serum or urine concentrations of 1 mcg/mL or greater were considered to be adequate for most common pathogens against which it is active. Peak serum levels are between 1.5 & 3 mcg/mL. Little or no accumulation occurs following multiple dosing. The pharmacokinetics in healthy elderly (age > 64 years) & young volunteers (11-35) compared the administration of 400mg once daily for 5 days. Mean Cmax & AUC values were slightly greater in the elderly. Elderly patients may be given the same dose as the general population. It is predominantly eliminated as unchanged drug in urine. Glomerular filtration is considered the predominant mechanism. Metabolites have not been isolated from human serum/urine. Serum protein binding is well characterised for human. It is almost exclusively bound to albumin fraction, the mean free fraction being approx. 30%. Protein binding is only concentration dependent in human serum at very high concentrations which are not seen following clinical dosing.
5. INDICATIONS:
Cefixime is indicated for the treatment of the following acute infections when caused by susceptible micro-organisms:
- Upper Respiratory Tract Infections (URTI): e.g. otitis media & other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics, or where treatment failure may carry significant risk.
- Lower Respiratory Tract Infection: e.g. bronchitis.
- Urinary Tract Infections: e.g. cystitis, cystourethritis, uncomplicated pyelonephritis.
6. CONTRAINDICATIONS:
Cefixime tablets are contraindicated in the following cases:
- Hypersensitivity to cephalosporin antibiotics or to any of the excipients.
7. WARNINGS AND PRECAUTIONS:
Encephalopathy: Predisposes the patient to encephalopathy risk particularly in case of overdose/renal impairment.
Severe cutaneous adverse reactions: Severe cutaneous adverse reactions such as toxic epidermal necrolysis have been reported in some patients.
Should be given with caution to patients who have shown hypersensitivity to other drugs.
Hypersensitivity to penicillins: Should be given with caution to patients with a history of hypersensitivity to penicillin as there is some evidence of partial cross-allergenicity between penicillins & cephalosporins.
Haemolytic anaemia: Drug-induced haemolytic anaemia has been described for cephalosporins.
Acute renal failure: May cause acute renal failure including tubulointerstitial nephritis as an underlying pathological condition.
Renal impairment: Should be administered with caution in patients with markedly impaired renal function.
Paediatric use : Safety in premature/newborn infant has not been established.
8. ADVERSE EFFECTS:
Common side effects include:
- Gastrointestinal: Abdominal pain, diarrhea, dyspepsia, nausea, vomiting, flatulence
- Hepatobiliary: Jaundice
- Nervous system: Dizziness, headache, convulsions
- Respiratory: Dyspnoea
- Renal system: Renal failure
- Immune system: Allergic reactions
9. DRUG INTERACTIONS:
Anticoagulants: Increases in prothrombin times have been noted.
Should be administered with caution to patients receiving coumarin-type anticoagulants, e.g. warfarin potassium. Since it may enhance effects of the anticoagulants prolonged prothrombin time with/without bleeding may occur.
Other forms of interaction: False positive reaction for glucose in urine may occur with Benedict’s/ Fehling’s solutions/with copper sulphate test tablets but not with tests based on enzymatic glucose oxidase reactions.
False positive direct Coombs test has been reported.
10. DOSAGE:
Adults and Children over 10 Years or weighing more than 50 kg: 200-400 mg daily according to the severity of infection given either as a single dose/2 divided doses.
Elderly: May be given the same dose as recommended for adults.
Children under 10 Years: Not recommended for use in children under 10 years old.
The safety & efficacy has not been established in children less than 6 months.
11. ADMINISTRATION:
The tablets need to be swallowed with a glass of liquid. Do not crush or break the tablet as it will destroy the film coating.
12. STORAGE:
Do not store above 25°C. Store in the original package. Keep away from children. Do not expose to direct sunlight.
13. MANUFACTURED BY:
14. MARKETED BY:
Last revised on May 2019.