MAXIMA Capsules 400mg(CEFIXIME) Oral Uses , Side effects, Dose , Contraindication In Urdu

MAXIMA Capsules 400mg(CEFIXIME 400) Oral Uses , Side effects, Dose , Contraindication In Urdu

MAXIMA Capsules 400mg (CEFIXIME 400) Oral Uses , Side effects, Dose , Contraindication In Urdu

COMPOSITION

Maxima (400 mg Capsules)
Each Capsule contains:
Cefixime trihydrate USP
equivalent to Cefixime 400 mg.

• Maxima (200 mg Tablets) Each tablet contains:
  Cefixime Maxima Capsules (as Trihydrate) 200 mg.
  Maxima Suspension (100 mg/5 ml) Each 5 ml (approx. 1 teaspoonful) of
• reconstituted suspension contains: Cefixime trihydrate USP
  equivalent to Cefixime 100 mg.
  Maxima DS Suspension (200 mg/5 ml)
  Each 5 ml (approx. 1 teaspoonful) of reconstituted suspension contains:
• Cefixime trihydrate USP
  equivalent to Cefixime 200 mg.

Maxima Capsules 400mg INDICATIONS

• Maxima Capsules 400mg is an orally active cephalosporin antibiotic, which has marked in vitro bactericidal activity against a wide variety of Gram positive & Gram negative organism.
• It is indicated for the treatment of the following acute infections when caused by susceptible microorganisms.
• Maxiam Capsules 400mg Upper respiratory tract infections (URTI): e.g. otitis media, sinusitis, pharyngitis & tonsillitis.
• Lower respiratory tract infections (LRTI): e.g. bronchitis.
• Maxima Capsules 400mg Urinary tract infections (UT!): e.g. cystitis, cystourethritis, uncomplicated, pyelonephritis.
• Uncomplicated gonorrhoea: (cervical/urethral,rectal and pharyngeal). in vitro activity:

Cefixime 400mg Effect On Micro organism infection

•  Maxima Capsules 400mg Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus Pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, (beta-lactamase positive & negative) & Enterobacter species.Maxima Capsules 400mg is highly stable in the presence of beta lactamase enzymes.
  Maxima have been shown to be active in vitro against most strains of the following organisms; however, clinical efficacy has not been established.

• Streptococcus agalactiae, Haemophilus parainfluenzae (beta-lactamase positive & negative strains), proteus vulgaris, Pasteurella multocida (P, septica), Providencia species, Salmonella species, Shigella species, Citrobacter diversus & Serratia marcescens.
• Most strains of Enterococci (Streptococcus faecalis, group D streptococci) 2 Staphylococcus (including coagulase positive & negative strains &
  resistant strains) are resistant to Maxima. In addition most strains of Pseudomonas Bacteroides fragilis. Listeria monocvtooenes & Clostridia are resistant to Maxima

Maxima Capsules 400mg CONTRAINDICATIONS :

• Patients with known hypersensitivity to cephalosporin antibiotics.

Maxima Capsules SIDE-EFFECTS

• Maxima Capsules 400mg is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self limiting in nature.
  

  Gastrointestinal Disturbances:

• The most frequent side effects seen with Maxima Capsules 400mg are diarrhoea and stool changes. Some cases of moderate to severe diarrhoea have been reported; this has occasionally warranted cessation of therapy. Maxima should be discontinued if marked diarrhoea occurs. Other Maxima Capsules 400 gastrointestinal side effects seen less frequently are
• nausea,
• abdominal pain,
• dyspepsia,
• vomiting and flatulence
•  Pseudo- membranous colitis has been reported (see above).
• Central Nervous System: Headache and dizziness.
  

  Hypersensitivity Reactions:

• Allergies in the form of rash,
• pruritis,
• urticaria,
• drug fever and arthralgia have been observed.
• These reactions usually subsided upon discontinuation of therapy.
  Hematological and clinical chemistry:
• Thrombocytopenia,
• leukopenia and eosinophilia have been reported.
• These reactions were infrequent and reversible.
• Mild transient changes in liver and renal function tests have been observed.
• Miscellaneous: Other possible reactions include genital pruritis and vaginitis.

 WARNING & PRECAUTIONS:

Maxima Capsules 400 should be given with caution to patients who have shown hypersensitivity to other drugs. Cephalosporins Maxima 400mg  would be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Patients have had severe reactions (including-anaphylaxis) to both classes of drugs. If an allergic effect occurs with Maxima the drug should be discontinued and the patient treated with appropriate agents, if necessary.

Maxima  Capsules 400mg should be administered with caution in patients with markedly impaired renal function (see Dosage in renal impairment). Treatment with broad-spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associated diarrhea.

warning:

Pseudomembranous colitis is associated with the use of broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins, lincosamides, and cephalosporins), it is, therefore, important to consider its diagnosis on patients who develop diarrhea in association with the use of antibiotics. Symptoms of pseudomembranous colitis may occur during or after antibiotic treatment. Management of pseudomembranous colitis should include sigmoidoscopy, appropriate bacteriologic studies, fluids, electrolytes, and protein supplementation. If the colitis does not improve after the drug has been discontinued, or if the symptoms are severe, oral vancomycin is the drug of choice for antibiotic-associated pseudomembranous colitis produced by C. difficile. Other causes of colitis must be excluded.

 Use in pregnancy and breastfeeding:

Maxima Capsules 400mg Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have no related evidence of impaired fertility or harm to the fetus due to Cefixime Trihydrate. In the rabbit, at doses up to 4 times the human dose, there was no evidence of a teratogenic effect; there was a high incidence of abortion and maternal death which is an expected consequence of the known sensitivity of rabbits to antibiotic-induced changes in the population of the microflora of the intestine. There were no adequate and well-controlled studies in pregnant women. Maxima Capsules 400mg  should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.

 INTERACTIONS

No significant drug interactions have been reported to date. A false-positive reaction for glucose in the urine may occur with Benedicts or Fehling’s solutions or with copper sulfate test tables, but not with tests based on enzymatic glucose oxidase reactions. A false-positive direct Coombs test has been reported during treatment with cephalosporin antibiotics, therefore it should be recognized that a positive Coombs test may be due to the drug.

Cefixime 400mg DOSAGE & ADMINISTRATION

Absorption of Maxima Capsules 400 is not significantly modified by the presence of food. The usual course of treatment is 5-14 days.
Adults and Children over 12 years:
Maxima 400 recommended adult dosage is 200 mg to 400 mg daily administered as a single dose.
Children (Use Pediatric Oral Suspension):
The recommended dosage for children is 8 mg/kg/day administered as a single dose. As a general guide for prescribing in children, the following daily doses are suggested.

 Suspension (100 mg/5 ml)

 Children 1-4 Years: 100 mg daily (5 ml once daily)
 5-9 Years: 200 mg daily (10 ml once daily)
 10-12 Years: 300 mg daily (15 ml once daily) Maxima Suspension DS (200 mg/5 ml)
Children 1-4 Years: 100 mg daily (2.5 ml once daily)
5-9 Years: 200 mg daily (5 ml once daily)
10-12 Years: 300 mg daily (7.5 ml once daily)
In 6 months to 1 year, the dosage should be calculated on an mg/kg basis. Children, more than 30 kg or older than 12 years should be treated with the recommended adult dose. The efficacy and safety of cefixime in children less than 6 months has not been established.

The Elderly:

Elderly patients may be given the same dose as recommended for adults. Renal function should be assessed dosage should be adjusted in severe renal impairment. Dosage in Renal Impairment:
Maxima Capsules 400mg may be administered in the presence of impaired renal function, Normal dose & schedule may be given to patients with a creatinine clearance of 40 ml/min or greater. Patients whose clearance is between 20 and 40 ml/min or patients who are on renal hemodialysis may be given 75% of the standard dosage. Patients with a creatinine clearance of less than 20 ml/min should be given 50% of the standard dosage.

Cefixime 400mg OVERDOSE

There is no experience with overdoses of Maxima Capsules 400. Adverse reactions seen at dose levels up 2 g Cefixime Capsules 400 in normal subjects did not differ from the profile seen in patients treated at the recommended doses. Gastric lavage may be initiated in overdosage. No specific antidote exists. Maxima Capsules 400mg is not removed from the circulation in significant quantities by dialysis