Parecoxib parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of parecoxib.
Drugs List
Therapeutic Indications
Uses
Treatment of post-operative pain
Dosage
The decision to prescribe parecoxib should be based on an assessment of the individual patient's overall risk.
Patients should be reviewed after each dose increase, as higher dose parecoxib use can increase adverse reactions. Other therapeutic options should be considered if increased efficacy is absent.
There is limited experience with parecoxib treatment beyond 3 days.
Adults
40mg followed every 6 to 12 hours by 20mg or 40mg as required for up to 3 days (maximum daily dose 80mg).
Elderly
Patients 65 years and over weighing less than 50kg, treatment should be initiated at 20mg (maximum daily dose 40mg).
Patients with Renal Impairment
Creatinine clearance 10 to 30ml/minute: Initiate dose at 20mg and monitor renal function closely.
Patients with Hepatic Impairment
Moderate hepatic impairment (Child-Pugh score 7 to 9): Initiate dose at 20mg (maximum daily dose 40mg).
Additional Dosage Information
Patients with predisposition to fluid retention: Initiate dose at 20mg and monitor renal function closely.
Administration
The dose may be administered intravenously or intramuscularly after reconstitution.
The intramuscular injection should be given slowly and deeply into the muscle.
The intravenous bolus injection may be given rapidly and directly into a vein or into an existing intravenous line. If other drugs are delivered through the same IV line, the line must be flushed before and after parecoxib injection with a compatible fluid.
Contraindications
Children under 18 years
Coronary artery bypass graft
Asthma, urticaria or acute rhinitis associated with NSAIDS
Breastfeeding
Cerebrovascular disorder
Congestive cardiac failure
Gastrointestinal haemorrhage
History of severe cutaneous adverse reactions
Inflammatory bowel disease
Ischaemic heart disease
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Peptic ulcer
Peripheral vascular disease
Severe hepatic impairment
Third trimester of pregnancy
Precautions and Warnings
Elderly patients weighing less than 50kg
Females attempting to conceive
Oedema
Predisposition to fluid retention
Risk factors for cardiovascular disorder
Cardiac disorder
Coagulopathy
Connective tissue disorder
Dehydration
First trimester of pregnancy
History of cardiac failure
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of gastrointestinal ulceration
Hypertension
Moderate hepatic impairment
Renal impairment
Second trimester of pregnancy
May mask fever
May mask signs of inflammation
Advise ability to drive/operate machinery may be affected by side effects
Correct severe dehydration before commencing therapy
Monitor blood pressure
Monitor incision site for signs of infection in surgical patients
Discontinue if any deterioration in cardiac status occurs
Risk of gastro-intestinal bleeding increased in the elderly
Discontinue if hepatic function deteriorates
Discontinue if hypersensitivity reactions occur
Discontinue if patient is attempting to conceive
Discontinue if renal function deteriorates
Discontinue treatment if rash occurs
Continue concurrent antiplatelet therapies eg aspirin
Reduce dose in elderly patients weighing less than 50kg
Use the lowest dose resulting in effective analgesia
Maximum treatment 3 days
Advise patients to report skin rash
Pregnancy and Lactation
Pregnancy
Parecoxib is contraindicated during the 3rd trimester of pregnancy. Use with caution during the 1st and 2nd trimester.
Use of parecoxib during the 3rd trimester of pregnancy is contraindicated by the manufacturer. The manufacturer does not recommend using parecoxib during the 1st and 2nd trimester of pregnancy. At the time of writing there is limited published information regarding the use of parecoxib during pregnancy and labour. However, the effects of NSAIDs in pregnancy pose a potential risk that cannot be ruled out. The risks include serious birth defects when parecoxib is administered during the 3rd trimester of pregnancy. This is due to the nature of NSAIDs as a prostaglandin synthesis inhibitor where premature closure of the ductus arteriosus or uterine inertia may be caused. Animal studies have shown an increased in pre- and post-implantation loss and embryo-foetal lethality. Available data indicates that the risk of miscarriage increases in early pregnancy after the use of prostaglandin synthesis inhibitors. Therefore, avoid using parecoxib during the 1st and 2nd trimester unless deemed necessary. If NSAIDs are used, monitoring of amniotic fluid volume is recommended.
Lactation
Parecoxib is contraindicated during breastfeeding.
Use of parecoxib when breastfeeding is contraindicated by the manufacturer. Parecoxib and its active metabolite valdecoxib is present in human breast milk in a relatively small amount at approximately 1% of the weight-adjusted maternal dose. Effects on exposed infants are unknown.
Side Effects
Abnormal sternal serous wound drainage
Acute renal failure
Aggravation of existing hypertension
Agitation
Alveolar osteitis
Anaphylaxis
Angioedema
Anorexia
Arthralgia
Asthenia
Back pain
Bradycardia
Bronchospasm
Cardiovascular effects
Cerebrovascular disorders
Circulatory collapse
Congestive cardiac failure
Creatine phosphokinase increased
Deep vein thrombosis (DVT)
Dizziness
Dry mouth
Dyspnoea
Ear pain
Ecchymosis
Erythema multiforme
Exfoliative dermatitis
Flatulence
Fluid retention
Gastro-intestinal disturbances
Hepatitis
Hyperglycaemia
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Hypokalaemia
Hypotension
Increase in blood urea nitrogen
Increase in lactate dehydrogenase
Increase in serum ALT/AST
Injection site reactions
Insomnia
Local pain (injection site)
Mouth swelling
Myocardial infarction
Oliguria
Orthostatic hypotension
Pancreatitis
Peripheral oedema
Pharyngitis
Postoperative anaemia
Pruritus
Pulmonary embolism
Rash
Renal failure
Renal impairment
Respiratory insufficiency
Serum creatinine increased
Skin reactions
Stevens-Johnson syndrome
Stroke
Tachycardia
Thrombocytopenia
Thromboembolic complications
Toxic epidermal necrolysis
Transient ischaemic attack
Urticaria
Vertigo
Wound healing retarded
Wound infection
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: October 2021
Reference Sources
Summary of Product Characteristics: Dynastat 40mg Powder and Solvent for Solution for Injection. Pfizer. Revised October 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 25 October 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.