Firvanq – Uses, Side Effects, Dosage, Alcohol, Overdose, Pregnancy

Firvanq is is the brand name of a drug called vancomycin hydrochloride, an oral solution formulation that is approved for the treatment of Clostridium difficile associated diarrhea as well as Staphylococcus aureus enterocolitis.

It was first approved by the US Food and Drug Administration Home Page on January 26th, 2018. This medicine is manufactured by CutisPharma, Inc., a pharmaceutical company based in Wilmington, Mass, which has been the industry leader for 20 years in providing innovative solutions to pharmacists.

It is anticipated that this drug will launch on April 2, 2018, and it will replace First Vancomycin Unit-of-Use Compounding Kit.

Uses Of Vancomycin Hydrochloride

It is usually prescribed for the treatment of Clostridium difficile associated diarrhea, a serious condition which affects more than 500,000 people every year in the US. Clostridium difficile is a particularly dangerous organism which may colonize the large intestine if the normal healthy balance of the gut flora has been disturbed.

Early diagnosis and prompt aggressive medical treatment are very important in managing Clostridium difficile associated diarrhea. The mortality rate is 1 to 2.5%.

C. difficile infection is typically associated with recent antibiotic use and it most commonly occurs in hospitals, where a much higher percentage of patients carry the organism. Risk factors for C. difficile associated diarrhea include:

  • prolonged hospital stay;
  • extremes of age;
  • use of antibiotics;
  • low fiber diet;
  • living in a nursing home;
  • severe underlying disease.

Common symptoms of mild to moderate Clostridium difficile infection may include:

  • mild abdominal tenderness and cramping;
  • watery diarrhea 3 or more times per day for 48 hours or more.

This medication can also be prescribed for enterocolitis that is caused by Staphylococcus aureus, including methicillin-resistant strains. Staphylococcus aureus is a Gram-positive bacteria which appears in grape-like clusters.

Staph infections may cause serious problems due to the production of toxins by the bacteria or the direct infection. Impetigo (one of the most common skin infections in children), boils, cellulitis, food poisoning, and toxic shock syndrome (an infection that is characterized by rash, high fever, multiorgan failure, and hypotension) are all examples of conditions which can be caused by this bacterium.

Enterocolitis that is caused by Staphylococcus aureus has most commonly been described in people with a severe underlying disease, use of antipeptic ulcer medicines, previous gastrectomy, recent antibiotic use, and in people previously colonized with methicillin-resistant S. aureus (a gram-positive bacterium which is genetically different from other strains of S. aureus).

Dosage

This medication is available in 25 mg/mL and 50 mg/mL strengths in convenient 150 mL and 300 mL sizes. The usual recommended dose varies by indication as follows:

  • for the treatment of staphylococcal enterocolitis and Clostridium difficile associated diarrhea in pediatric patients, the usual recommended dose is 40 mg/kg in 3 or 4 divided doses for up to 10 days.
  • for the treatment of staphylococcal enterocolitis in adults, the usual recommended dose is a total daily dose of 500 mg to 2 g administered orally in 4 divided doses for up to 10 days;
  • for the treatment of Clostridium difficile associated diarrhea in adults, the usual recommended dose is 125 mg administered orally in 4 divided doses for 10 days. The total daily dose should not exceed 2 g.

Side Effects And Precautions Of Firvanq 

Common side effects may include:

  • hypokalemia (13 percent of patients);
  • abdominal pain (15 percent of patients);
  • nausea (17 percent of patients).

Rare side effects may include:

  • convulsions;
  • bladder pain;
  • fever;
  • swelling of the arms, face, lower legs, hands, or feet;
  • irregular heartbeat;
  • cloudy or bloody urine;
  • decreased urine;
  • loss of appetite;
  • difficult, painful, or burning urination;
  • dry mouth;
  • muscle cramps or pain;
  • frequent urge to urinate;
  • mood changes;
  • increased thirst;
  • shortness of breath;
  • lower back pain;
  • unusual weight loss or gain;
  • unusual weakness or tiredness;
  • rapid weight gain;
  • numbness or tingling in the feet, hands, or lips.

To be sure that this medicine is safe for you, tell your healthcare professional if have:

  • kidney disease;
  • an intestinal disorder, like – Crohn’s disease, inflammatory bowel disease, or ulcerative colitis;
  • if you are receiving any IV antibiotics;
  • hearing problems;
  • an allergic reaction to any type of medicine;
  • liver disease;
  • low blood pressure.

Pregnancy

The US Food and Drug Administration categorizes drugs based on safety for use during pregnancy. Therefore, there are 5 categories – A, B, C, D, and X used to classify the possible risks to an unborn baby when a drug is taken during pregnancy.

This medication is in category C, meaning that that are no clinical studies to determine whether this drug will harm an unborn baby. Hence, tell your healthcare provider if you are pregnant or plan to become pregnant while using this drug.

In addition, there are no well-done studies regarding the safe use by nursing women, therefore, contact your doctor if you are breast-feeding a baby before using this medicine.

Alcohol

Mixing this medication with alcohol can result in a dangerous combination. Also, healthcare professionals recommend avoiding alcohol while taking most medicines since alcohol can negatively interfere with a drug’s capacity to do its job as well as it can increase the risk of side effects.

Drug Interactions

Combining this medication with certain drugs may increase the risk of side effects and is typically not recommended. The following drugs are not recommended for use while taking this medication:

  • Tobi (tobramycin), a medication used to treat people with a certain inherited condition, like – cystic fibrosis;
  • Amikacin (amikacin sulfate), an antibiotic used for a variety of bacterial infections;
  • Colestid (colestipol), an oral cholesterol-lowering medication;
  • Questran (cholestyramine), a bile acid sequestrant;
  • Coumadin (warfarin sodium), a medication which is used as an anticoagulant;
  • Anectine (succinylcholine chloride), a prescription muscle relaxant;
  • Garamycin (gentamicin), a drug prescribed to treat numerous bacterial skin infections.

Overdose

If you take too much of this medication, call your local Poison Control Center (1-800-222-1222) or your doctor, or seek emergency medical attention right away.

Storage

It is recommended to store this medicine in the refrigerator, 36°F to 46°F (2°C to 8°C). Moreover, discard the reconstituted solution after two weeks or if it contains particulates or appears hazy.

References

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208910s000lbl.pdf

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