Consumer medicine information

1. Why am I using Parecoxib Sandoz?

Parecoxib Sandoz contains the active ingredient parecoxib. Parecoxib Sandoz is used for the prevention and treatment of pain. It can be used to relieve pain and reduce inflammation (swelling and soreness) which may occur after surgery.
For more information, see Section 1. Why am I using Parecoxib Sandoz? in the full CMI.

2. What should I know before I use Parecoxib Sandoz?

Do not use Parecoxib Sandoz if you have ever had an allergic reaction to parecoxib or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. You must not be given Parecoxib Sandoz if you have had an attack of asthma, hives, itching, skin rash or a runny nose after taking aspirin or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, medicines used to treat pain and inflammation), including other Coxib medicines.
For more information, see Section 2. What should I know before I use Parecoxib Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Parecoxib Sandoz and affect how it works.
Your doctor and nurse need to know if you are taking any medicines used to treat high blood pressure or other heart problems. These include ACE inhibitors, angiotensin receptor antagonists, beta blockers and diuretics (also called fluid or water tablets).
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Parecoxib Sandoz?

• Your doctor will decide how much Parecoxib Sandoz you need. The usual recommended dose is a single 40 mg injection.

• Your doctor may adjust the dosage you are given depending on your condition.

5. What should I know while using Parecoxib Sandoz?

6. Are there any side effects?

Common side effects: changes in blood pressure, dizziness or light-headedness due to low blood pressure, back pain, ear ache, feeling numb, stomach upset.
Serious side effects: skin rash, blistering and bleeding in the lips, eyes, mouth, nose and genitals, a slow heartbeat, a severe or persistent headache, fever, stick neck, sensitivity to light and vomiting.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Parecoxib (as sodium).

2 Qualitative and Quantitative Composition

Each vial of Parecoxib Sandoz injection contains 42.36 mg parecoxib sodium corresponding to 40 mg parecoxib.
Excipient with known effect. When reconstituted in sodium chloride (0.9% w/v), Parecoxib Sandoz injection contains approximately 0.44 mEq of sodium per 40 mg vial.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for injection.
Parecoxib Sandoz injection is a white to off-white lyophilised cake or powder in a single-use vial.
When reconstituted with 0.9% NaCl, solution is clear and colourless.

4 Clinical Particulars

4.9 Overdose

Clinical experience of overdose is limited and a minimum human toxic dose has not been established. No symptoms of overdose have been observed with single IV doses of up to 200 mg of parecoxib sodium or oral doses up to 400 mg of valdecoxib in healthy subjects. Parecoxib sodium doses of 50 mg BD IV for 7 days did not result in any signs of toxicity.
Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, epigastric pain, and other gastrointestinal effects, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Treatment of overdosage. There are no specific antidotes. Patients should be managed by symptomatic and supportive care following an overdose. Monitor patients for signs and symptoms of gastrointestinal ulceration and/or haemorrhage. Monitor serum electrolytes, renal function and urinalysis after significant overdose.
Valdecoxib is not removed by haemodialysis. Forced diuresis or alkalinisation of urine may not be useful due to high protein binding of valdecoxib.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Parecoxib sodium was not mutagenic in bacterial cells and the hypoxanthine-guanine phosphoribosyl transferase (HGPRT) mutation assay in Chinese hamster ovary (CHO) cells. Parecoxib increased the incidence of chromosomal aberrations in an in vitro CHO cell assay, however, it was negative in an in vivo micronucleus and chromosomal aberration test in rat bone marrow. Valdecoxib was negative in assays for gene mutations and clastogenicity.
Carcinogenicity. Long-term animal studies to evaluate the carcinogenic potential of parecoxib sodium have not been conducted.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPARECO.gif Chemical name: N-[[4-(5-methyl-3-phenyl-4 isoxazolyl) phenyl]sulfonyl]propanamide, sodium salt.
Molecular formula: C₁₉H₁₇N₂O₄SNa.
Molecular weight: 392.41.
Parecoxib sodium is a white to off-white solid that is very soluble in water. The formulated drug product is soluble in normal (0.9%) saline at > 50 mg/mL.
CAS number. 198470-85-8.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PCXSANST.gif