Fixime Capsule

Fixime Capsule Uses, Dosage, Side Effects, Food Interaction and all others data.

Fixime Capsule is a semi-synthetic, broad spectrum cephalosporin antibiotic of third generation for oral administration. It is a bactericidal antibiotic, kills bacteria by interfering in the synthesis of the bacterial cell wall. Fixime Capsule is highly stable in the presence of beta-lactamase enzymes. Fixime Capsule has marked in -vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms including beta lactamase producers.

Clinical efficacy of Fixime Capsule has been demonstrated in infections caused by commonly occurring pathogens including Gram-positive organism Streptococcus pneumoniae, Streptococcus pyogenes, Gram-negative organism Escherichia coli, Proteus mirabilis, Klebsiella spp., Haemophilus influenzae (beta-lactamase positive and negative), Moraxella catarrhalis (beta-lactamase positive and negative), Salmonella typhi and Enterobacter species.

Fixime Capsule, an antibiotic, is a third-generation cephalosporin like ceftriaxone and cefotaxime. Fixime Capsule is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to cefixime. The antibacterial effect of cefixime results from inhibition of mucopeptide synthesis in the bacterial cell wall.

Trade Name Fixime Capsule
Availability Prescription only
Generic Cefixime
Cefixime Other Names Cefixim, Cefixima, Céfixime, Cefixime, Cefiximum
Related Drugs amoxicillin, prednisone, doxycycline, ciprofloxacin, cephalexin, metronidazole, azithromycin, clindamycin, ceftriaxone, levofloxacin
Weight 400mg
Type Capsule
Formula C16H15N5O7S2
Weight Average: 453.45
Monoisotopic: 453.041289239
Protein binding

65% (concentration independent)

Groups Approved, Investigational
Therapeutic Class Third generation Cephalosporins
Manufacturer Tagma Pharma (pvt) Ltd,
Available Country Pakistan
Last Updated: September 19, 2023 at 7:00 am
Fixime Capsule
Fixime Capsule

Uses

Fixime Capsule is used for the following infectious diseases -

Respiratory Tract Infections:

Pneumonia

Sinusitis

Pharyngitis and Tonsillitis

Acute Bronchitis and Acute Exacerbations of Chronic

Bronchitis (AECB)

Otitis Media

Typhoid Fever

Urinary Tract Infections

Uncomplicated gonorrhea (cervical/urethral)

Fixime Capsule is also used to associated treatment for these conditions: Acute Exacerbation of Chronic Bronchitis caused by Streptococcus Pneumoniae, Acute Exacerbations of Chronic Bronchitis caused by Haemophilus Influenzae, Bacterial Sinusitis, Community Acquired Pneumonia (CAP), Gonorrhea of anus, Lyme Disease, Salmonella Infections, Salmonella Typhi Infection, Shigella Infection, Streptococcal Pharyngitis, Streptococcal tonsillitis, Uncomplicated Urinary Tract Infections, Bacterial otitis media, Bacterial rhinosinusitis, Uncomplicated Gonorrhea

How Fixime Capsule works

Like all beta-lactam antibiotics, cefixime binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefixime interferes with an autolysin inhibitor.

Dosage

Fixime Capsule dosage

The usual treatment of Fixime Capsule is 7 days. This may be continued for up to 14 days according to the severity of infection.

Fixime Capsule Capsule

Adult and child over 12 years: 200 or 400 mg daily as a single dose or in two divided doses.

Fixime Capsule Suspension

Child over 6 months: 8 mg/kg daily as a single dose or in 2 divided doses

Direction for Reconstitution of Suspension

• To prepare 50 ml suspension, 25 ml boiled and cooled water is required.

• To prepare 40 ml suspension, 20 ml boiled and cooled water is required.

• To prepare 30 ml suspension, 15 ml boiled and cooled water is required.

• To prepare 50 ml DS suspension, 25 ml boiled and cooled water is required.

Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half of the total amount of water and shake well. Add remainder of water, and then shake again.

Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 14 days.

Side Effects

Fixime Capsule is generally well tolerated. The majority of adverse reactions observed in clinical trials are mild and self limiting in nature.

Gastro-intestinal disturbance: Diarrhea (if severe diarrhea occurs, Fixime Capsule should be discontinued), changes in the color of stool, nausea, abdominal pain, dyspepsia, vomiting, flatulence have been reported. CNS disturbances: Headache, dizziness.

Others: Hypersensitivity reactions which usually subsided upon discontinuation of therapy; infrequent and reversible hematological changes; elevation of serum amylase.

Toxicity

Symptoms of overdose include blood in the urine, diarrhea, nausea, upper abdominal pain, and vomiting.

Precaution

Fixime Capsule should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min)

Interaction

Increased prothrombin time (with or withot bleeding) with anticoagulants (e.g. warfarin). Increased plasma carbamazepine concentrations with concomitant use. Increased bioavailability with nifedipine. Increased serum concentration with probenecid.

Food Interaction

  • Take with or without food.

Elimination Route

About 40%-50% absorbed orally whether administered with or without food, however, time to maximal absorption is increased approximately 0.8 hours when administered with food.

Half Life

3-4 hours (may range up to 9 hours). In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours.

Pregnancy & Breastfeeding use

Pregnancy: Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Lactation: It is not known whether Fixime Capsule is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.

Use in Elderly

No special precautions are necessary. No dosage adjustment is required for elderly

Contraindication

Patients with known hypersensitivity to cephalosporin antibiotics, children under 6 months.

Special Warning

Use in Children: Safety and effectiveness of cefixime in children aged less than 6 months have not been established. For children younger than 12 years or weighing less than 50 kg, the usual dose is 8 mg/kg/day.

Use in elderly: No special precautions are necessary. Old age is not an indication for dose adjustment.

Dosage in renal impairment:

  • Creatinine clearance: 20 ml/min or greater: normal dose
  • Creatinine clearance: <20 ml/min or chronic ambulatory peritoneal dialysis
  • Haemodialysis: daily dose should not exceed 200 mg.

Acute Overdose

Gastric lavage may be indicated; otherwise, no specific antidote exists. Fixime Capsule is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Fixime Capsule did not differ from the profile seen in patients treated at the recommended doses.

Interaction with other Medicine

Carbamazepine: Elevated carbamazepine levels have been reported in postmarketing experience when Fixime Capsule is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.

Warfarin and Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.

Storage Condition

Store in a cool and dry place below 30ºC

Innovators Monograph

You find simplified version here Fixime Capsule

Fixime Capsule contains Cefixime see full prescribing information from innovator Fixime Capsule Monograph, Fixime Capsule MSDS, Fixime Capsule FDA label

FAQ

What is Fixime Capsule used to treat?

Fixime Capsule is used to treat bacterial infections in many different parts of the body.

How does Fixime Capsule work?

Fixime Capsule works by killing bacteria.

What are the common side effects of Fixime Capsule?

Common side effects of Fixime Capsule are include:

  • diarrhea.
  • stomach pain.
  • gas.
  • heartburn.
  • nausea.
  • vomiting.

Is Fixime Capsule safe during pregnancy?

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Use is recommended only if clearly needed and the benefit outweighs the risk.

Is Fixime Capsule safe during breastfeeding?

Fixime Capsule is acceptable in nursing mothers.

Can I drink alcohol with Fixime Capsule?

It Is generally OK to drink alcohol in moderation while taking Fixime Capsule.

Can I drive after taking Fixime Capsule?

If you experience any of these, do not drive any vehicle or use machinery.

How long does it take Fixime Capsule to work?

Fixime Capsule takes approximately 7 to 14 days to be effective and cure gonorrhoea. For other conditions, it may vary from individual to individual and their tolerance for the medicine. It's typically taken once or twice a day.

When should be taken of Fixime Capsule?

It is usually taken with or without food every 12 or 24 hours.

How long does Fixime Capsule stay in my system?

The half-life is about 3 to 4 hours and is not dose dependent.Fixime Capsule is excreted by renal and biliary mechanisms. About 50% of the absorbed dose is excreted unchanged in the urine within 24 hours.

How long does it take for Fixime Capsule to get out of your system?

Each antibiotic may stay in the body for different lengths of time, but common antibiotics such Fixime Capsule stay in your system for about 24 hours after taking the last dose. It might take longer for people with impaired kidney function to eliminate the drug from the body.

Can I take Fixime Capsule for a long time?

Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. 

What happens if you stop taking Fixime Capsule?

If you stop taking Fixime Capsule too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Is Fixime Capsule safe for kidneys?

When acute renal failure occurs, Fixime Capsule should be discontinued and appropriate therapy and measures should be taken.

Who should not take Fixime Capsule?

You should not take Fixime Capsule if you are allergic to Fixime Capsule, or to similar antibiotics.Tell your doctor if you are allergic to Fixime Capsule.

How should I take Fixime Capsule?

You may take Fixime Capsule with or without food.The Fixime Capsule chewable tablet must be chewed before you swallow it.Follow all directions on your prescription label. Do not take Fixime Capsule in larger or smaller amounts or for longer than recommended.

What happens if I miss a dose of Fixime Capsule?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Can I take overdose on Fixime Capsule?

If Fixime Capsule  is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

How quickly does Fixime Capsule work?

Fixime Capsule takes approximately 7 to 14 days to be effective and cure gonorrhoea.

How much Fixime Capsule should I take to cure gonorrhea?

In the treatment of uncomplicated gonorrhea, a single dose of Fixime Capsule given orally appears to be as effective .

Is Fixime Capsule good for kidney?

About 20% of  the Fixime Capsule is excreted by the kidneys as active drug.

Can Fixime Capsule damage liver?

Moderate Potential Hazard, Moderate plausibility. Cases of hepatitis have been reported with the use of certain cephalosporins.

*** Taking medicines without doctor's advice can cause long-term problems.
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