Maxima (CEFIXIME)

Maxima (CEFIXIME)

CAPSULE| TABLET |SUSPENSION

میکزیما

( سینکوائم )

COMPOSITION:

Maxima (400 mg Capsules)

Each Capsule contains:

Cefixime trihydrate USP

equivalent to Cefixime Innovator’s Specifications

400 mg

Maxima (200 mg Tablets)

Each tablet contains

Cefixime (as Trihydrate) USP USP Specifications

200 mg

Maxima Suspension (100 mg/5 ml) Each 5 ml contains

Cefixime trihydrate USP

equivalent to Cefixime

100 mg

USP Specifications

Maxima DS Suspension (200 mg/5 ml)

Each 5 ml containe

Cefixime trihydrate USP

equivalent to Cefixime

USP Specifications

200 mg

INDICATIONS:

Maxima: 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 shown for the treatment of the accompanying intense diseases when brought about by defenseless microorganisms.

Upper respiratory tract infections (URTI): e.g. ofitis media, sinusitis, pharyngitis & tonsilitis Lower respiratory tract infections (LRTI); e.g. bronchilis

Urinary tract infections (UTI): eg. cystitis, cystourethritis, uncomplicated, pyelonephritis

Uncomplicated gonorrhoes: (cervical/urethral, rectal and pharyngeal)

lo vitro activity: Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus Pyogenes, Eschenchia coli, Proteus mirabilis, Klebsiella species, (beta-lactamase positive & negative) & Enterobacter species. Maxima is highly stable in the presence of beta lactamase enzymes

Maxima have been shown to be active in 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 vulgans, Pasteurella multocida (P. septica), Providencia species, Salmonella species, Shigella species, Clérobacter diversus & Sematia martescens. Most strains of Enterococti (Streptococcus faecalis group D streptococci) 3

Staphylococcus (including coagulase positive & negative strains & methicillin

CONTRAINDICATIONS:

Patients with known hypersensitivity to cephalosporin antibiotics.

SIDE-EFFECTS:

Maxima is generally well tolerated. Most of antagonistic responses saw in clinical preliminaries were gentle and self restricting in nature.

Gastrointestinal Disturbances: The most frequent side effects seen with Maxima are diarrhoea and stool changes. An instances of moderate to extreme the runs have been accounted for; this has periodically justified end of treatment. Maxima should be discontinued if marked diarrhoea occurs. Other Maxima 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.

Extreme touchiness Responses: Sensitivities as rash, pruritis, urticaria, drug fever and arthralgia have been noticed. These responses generally died down upon cessation of treatment.

Hematological and Clinical Science: Thrombocytopenia, leukopenia and eosinophilia have been accounted for. These responses were rare and reversible. Gentle transient changes in liver and renal capability tests have been noticed.

Miscellaneous: Other possible reactions include genital pruritis and vaginitis.

WARNING & PRECAUTIONS:

Maxima should be administered with caution in patients with markedly impaired renal function (see dosage in renal impairment).

Treatment with expansive range anti-infection agents modifies the typical greenery of the colon and may allow abundance of clostridia. Studies Demonstrate that a poison created by Clostridium difficile is an essential driver of anti-toxin related loose bowels.

Side effects of pseudomembranous colitis might happen during or after anti-infection treatment. The executives of pseudomembranous colitis ought to incorporate sigmoidoscopy, suitable bacteriologic investigations, liquids, electrolytes and protein supplementation. In the event that the colitis doesn’t further develop after the medication has been

Use in pregnancy and breast feeding:

Also 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 micro flora of the intestine. There were no satisfactory and all around controlled examinations in pregnant ladies.

INTERACTIONS:

Also  false positive reaction for glucose in the urine may occur with Benedicts or Fehlings solutions or with copper sulphate test tables, but not with tests based on enzymatic glucose oxidase reactions.

DOSAGE & ADMINISTRATION:

Absorption The usual course of treatment is 5-14 days.

Maxima Suspension (100 mg/5 ml)

Children 1-4 Years:

100 mg daily (5 ml once daily)

Children 5-9 Years:

200 mg daily (10 ml once daily)

Children 10-12 Years:

Maxima Suspension DS (200 mg/5 ml)

Children 1-4 Years:

Children 10-12 Years:

300 mg daily (7.5 ml once daily)

The Elderly:

Dosage in Renal Impairment:

OVERDOSE:

There is no experience with overdoses of Maxima. Adverse reactions seen at dose levels up 2g Cefixime in normal subjects did not differ from the profile seen in patients treated at the recommended doses.

Method of reconstitution: well to form uniform suspension. For accurate measurement of dosage a spoon is

provided.

DOSAGE:

As directed by the physician.

STORAGE AND INSTRUCTIONS:

Store between 15°C to 30°C.

Protect from sunlight, heat and moisture.

Keep out of the reach of children.

Close the bottle properly after use.

The termination date alludes to the item accurately put away at the expected condition.

PRESENTATION:

روا بنانے کا طریقہ:

سپنشن تیار کرنے کے لئے ابلا ہوا ٹھنڈا پانی لیبل پر دیے گئے نشان تک بھر لیں اور اچھی طرح ہلائیں کہ یکجان ابلا پانی پر سپنشن تیار ہو جائے ۔ خوراک کی صحیح پیمائش کے لئے چیچہ دیا گیا ہے۔

خوراک: ڈاکٹر کی ہدایت کے مطابق استعمال کریں۔

ہدایات:

۱۵ سے ۳۰ ڈگری سینٹی گریڈ کے درمیان رکھیں۔

دھوپ ، گرمی اور نمی سے محفوظ رکھیں۔

بچوں کی پہنچ سے دور رکھیں ۔

استعمال سے قبل بوتل کو اچھی طرح ہلائیں۔

استعمال کے بعد بوتل کو اچھی طرح بند رکھیں ۔

Manufactured by:

Macter International Limited

تیار شدہ پنشن کو ۸ سے ۱۵ ڈگری سینٹی گریڈ پر رکھیں تا کہ

دوا کی تاثیر بر قرار رہے اور کے دن کے اندر استعمال کر لیں۔

صرف رجسٹر ڈ ڈاکٹر کے نسخے پر استعمال کی جائے۔ کی