Drugs List

Therapeutic Indications

Uses

Community acquired pneumonia when other treatment inappropriate
Treatment of skin and skin structure infections

Delafloxacin is indicated in the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community acquired pneumonia (CAP) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections.

Administration

Intravenous infusion.

Contraindications

Children under 18 years
Breastfeeding
End stage renal disease
History of tendon disorder secondary to quinolone use
Pregnancy

Precautions and Warnings

Family history of G6PD deficiency
Females of childbearing potential
Patients over 60 years
Predisposition to seizures
Severe immunosuppression
Solid organ transplant recipients
Aortic aneurysm
Aortic dissection
Central nervous system disorder
Cerebral arteriosclerosis
Diabetes mellitus
Epileptic disorder
G6PD deficiency
Heart valve disease
History of aneurysm
Moderate renal impairment
Myasthenia gravis
Neutropenia
Reduced seizure threshold

May exacerbate myasthenia gravis
Reduce dose in patients with creatinine clearance below 30ml/min
Advise ability to drive/operate machinery may be affected by side effects
Before initiating therapy enquire about previous hypersensitivity reactions
Consult national/regional policy on the use of anti-infectives
Monitor blood glucose closely in patients with diabetes mellitus
Monitor serum creatinine in patients with renal impairment
Advise patient to report mucosal/skin reactions (blistering or peeling)
Advise patient to report signs of neuropathy
Advise patient to seek medical attention if new onset of heart palpitations
Advise patient to seek medical attention in case of acute dyspnoea
Advise patient to seek medical attention in case of developing oedema
Advise pt. to seek medical attention if sudden abdominal,chest or back pain
Consider pseudomembranous colitis if patient presents with diarrhoea
Discontinue at the first sign of tendon inflammation
Discontinue if central nervous disturbances occur
Patients over 60 years are prone to tendon inflammation
Prolonged use may result in superinfection with non-susceptible organisms
Transplant patients are prone to tendon inflammation
Discontinue at once if pseudomembranous colitis occurs
Discontinue if hypersensitivity reactions occur
Female: Ensure adequate contraception during treatment

The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants and those treated concurrently with corticosteroids. Concomitant use of corticosteroids should be avoided. Treatment with delafloxacin should be discontinued and alternative treatment should be considered if signs and symptoms of tendinitis occur (e.g. painful swelling, inflammation).

Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with other quinolones. Delafloxacin should be used with caution in these patients.

Pregnancy and Lactation

Pregnancy

Delafloxacin is contraindicated during pregnancy.

Use of delafloxacin during pregnancy is contraindicated by the manufacturer. Animal studies have shown reproductive toxicity.

Lactation

Delafloxacin is contraindicated during breastfeeding.

Use of delafloxacin when breastfeeding is contraindicated by the manufacturer. Animal data show that delafloxacin is excreted in breast milk however presence in human breast milk is unknown.

Side Effects

Abdominal pain
Allergic dermatitis
Alopecia
Anaemia
Anaphylactic reaction
Anxiety
Aortic aneurysm
Aortic dissection
Arthralgia
Arthritis
Auditory hallucinations
Blurred vision
Bradycardia
Chills
CNS effects
Cold sweat
Constipation
Cough
Creatine phosphokinase increased
Crystalluria
Decreased appetite
Decreased serum albumin
Deep vein thrombosis (DVT)
Diarrhoea
Discolouration of stools
Dizziness
Dream abnormalities
Dry eyes
Dry mouth
Dry throat
Dysgeusia
Dyspepsia
Dyspnoea
Erosive gastritis
Exacerbation of myasthenia gravis
Fatigue
Flatulence
Flushing
Fungal infection
Gastroesophageal reflux disease
Glossodynia
Haematuria
Haemolytic anaemia
Headache
Heart valve regurgitation
Hyperglycaemia
Hyperhidrosis
Hyperkalaemia
Hypersensitivity reactions
Hypertension
Hyperuricaemia
Hypoaesthesia
Hypoglycaemia
Hypokalaemia
Hypotension
Impaired memory
Increase in alkaline phosphatase
Increase in serum transaminases
Infusion related reaction
Insomnia
Leucopenia
Local swelling
Muscle spasm
Musculoskeletal pain
Myalgia
Myositis
Nausea
Neutropenia
Night sweats
Oral hypoaesthesia
Oral paraesthesia
Palpitations
Paraesthesia
Paranoia
Peripheral neuropathy
Peripheral oedema
Phlebitis
Polyneuropathy
Presyncope
Pruritus
Pyrexia
Raised intracranial pressure
Rash
Renal impairment
Sinus tachycardia
Sinusitis
Stevens-Johnson syndrome
Stomatitis
Superinfections
Tendinitis
Tendon rupture
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Toxic psychosis
Urinary tract infections
Urticaria
Vertigo
Vomiting
Weakness

Presentation

Infusions of delafloxacin.

Drugs List

Therapeutic Indications

Uses

Community acquired pneumonia when other treatment inappropriate
Treatment of skin and skin structure infections

Delafloxacin is indicated in the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community acquired pneumonia (CAP) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections.

Dosage

Adults

Patients with Renal Impairment

Administration

Intravenous infusion.

Contraindications

Children under 18 years
Breastfeeding
End stage renal disease
History of tendon disorder secondary to quinolone use
Pregnancy

Precautions and Warnings

Family history of G6PD deficiency
Females of childbearing potential
Patients over 60 years
Predisposition to seizures
Severe immunosuppression
Solid organ transplant recipients
Aortic aneurysm
Aortic dissection
Central nervous system disorder
Cerebral arteriosclerosis
Diabetes mellitus
Epileptic disorder
G6PD deficiency
Heart valve disease
History of aneurysm
Moderate renal impairment
Myasthenia gravis
Neutropenia
Reduced seizure threshold

May exacerbate myasthenia gravis
Reduce dose in patients with creatinine clearance below 30ml/min
Advise ability to drive/operate machinery may be affected by side effects
Before initiating therapy enquire about previous hypersensitivity reactions
Consult national/regional policy on the use of anti-infectives
Monitor blood glucose closely in patients with diabetes mellitus
Monitor serum creatinine in patients with renal impairment
Advise patient to report mucosal/skin reactions (blistering or peeling)
Advise patient to report signs of neuropathy
Advise patient to seek medical attention if new onset of heart palpitations
Advise patient to seek medical attention in case of acute dyspnoea
Advise patient to seek medical attention in case of developing oedema
Advise pt. to seek medical attention if sudden abdominal,chest or back pain
Consider pseudomembranous colitis if patient presents with diarrhoea
Discontinue at the first sign of tendon inflammation
Discontinue if central nervous disturbances occur
Patients over 60 years are prone to tendon inflammation
Prolonged use may result in superinfection with non-susceptible organisms
Transplant patients are prone to tendon inflammation
Discontinue at once if pseudomembranous colitis occurs
Discontinue if hypersensitivity reactions occur
Female: Ensure adequate contraception during treatment

The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants and those treated concurrently with corticosteroids. Concomitant use of corticosteroids should be avoided. Treatment with delafloxacin should be discontinued and alternative treatment should be considered if signs and symptoms of tendinitis occur (e.g. painful swelling, inflammation).

Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with other quinolones. Delafloxacin should be used with caution in these patients.

Pregnancy and Lactation

Pregnancy

Delafloxacin is contraindicated during pregnancy.

Use of delafloxacin during pregnancy is contraindicated by the manufacturer. Animal studies have shown reproductive toxicity.

Lactation

Delafloxacin is contraindicated during breastfeeding.

Use of delafloxacin when breastfeeding is contraindicated by the manufacturer. Animal data show that delafloxacin is excreted in breast milk however presence in human breast milk is unknown.

Side Effects

Abdominal pain
Allergic dermatitis
Alopecia
Anaemia
Anaphylactic reaction
Anxiety
Aortic aneurysm
Aortic dissection
Arthralgia
Arthritis
Auditory hallucinations
Blurred vision
Bradycardia
Chills
CNS effects
Cold sweat
Constipation
Cough
Creatine phosphokinase increased
Crystalluria
Decreased appetite
Decreased serum albumin
Deep vein thrombosis (DVT)
Diarrhoea
Discolouration of stools
Dizziness
Dream abnormalities
Dry eyes
Dry mouth
Dry throat
Dysgeusia
Dyspepsia
Dyspnoea
Erosive gastritis
Exacerbation of myasthenia gravis
Fatigue
Flatulence
Flushing
Fungal infection
Gastroesophageal reflux disease
Glossodynia
Haematuria
Haemolytic anaemia
Headache
Heart valve regurgitation
Hyperglycaemia
Hyperhidrosis
Hyperkalaemia
Hypersensitivity reactions
Hypertension
Hyperuricaemia
Hypoaesthesia
Hypoglycaemia
Hypokalaemia
Hypotension
Impaired memory
Increase in alkaline phosphatase
Increase in serum transaminases
Infusion related reaction
Insomnia
Leucopenia
Local swelling
Muscle spasm
Musculoskeletal pain
Myalgia
Myositis
Nausea
Neutropenia
Night sweats
Oral hypoaesthesia
Oral paraesthesia
Palpitations
Paraesthesia
Paranoia
Peripheral neuropathy
Peripheral oedema
Phlebitis
Polyneuropathy
Presyncope
Pruritus
Pyrexia
Raised intracranial pressure
Rash
Renal impairment
Sinus tachycardia
Sinusitis
Stevens-Johnson syndrome
Stomatitis
Superinfections
Tendinitis
Tendon rupture
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Toxic psychosis
Urinary tract infections
Urticaria
Vertigo
Vomiting
Weakness

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: July 2021

Reference Sources

Summary of Product Characteristics: Quofenix 300mg powder for concentrate for solution for infusion. A. Menarini Farmaceutica Internazionale SRL. Revised March 2021.