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INTRODUCTION
DICLOLAB 25 INJECTION contains Diclofenac which belongs to group of medicines called Nonsteroidal anti-inflammatory drugs (NSAIDs). DICLOLAB 25 INJECTION is used to treat various painful conditions such as flare-ups of joint or back pain, gout attacks (a common and complex form of arthritis that is characterized by sudden, severe attacks of pain, swelling, redness and tenderness in one or more joints), pain caused by kidney stones or due to injuries, fractures or trauma. It is also used to prevent or treat pain following an operation.
Before receiving DICLOLAB 25 INJECTION inform your doctor if you have any allergies, heart, liver or kidney problems, clotting disorders, high blood pressure, diabetes, or any respiratory conditions, gastrointestinal problems such as stomach ulcer, ulcerative colitis or crohn's disease and bleeding in the stomach with symptoms such as black stools or blood in vomit.
DICLOLAB 25 INJECTION is not recommended for use in pregnant women especially if you are more than 6 months pregnant and it should be used with caution in breast-feeding women only if clearly advised by the doctor. DICLOLAB 25 INJECTION is not recommended for use in children and adolescents (below 18years of age). It should be used with caution in elderly patients.
The common side effects of receiving DICLOLAB 25 INJECTION are nausea and discomfort, pain, redness or lumps at the site of injection. Inform your doctor if any of the side effect gets worse.
USES OF DICLOLAB 25 INJECTION
Treats painful conditions such as:
- flare-ups of joint or back pain
- gout attacks
- pain caused by kidney stones or injuries, fractures, or trauma
- prevents or treat pain following an operation
HOW DICLOLAB 25 INJECTION WORKS
DICLOLAB 25 INJECTION works by inhibiting the activity of certain enzymes (called cyclooxygenase (COX) enzymes) which prevents the excess production of prostaglandins (which is responsible for causing pain and inflammation), thus helps in treating various painful conditions.
DIRECTIONS FOR USE
DICLOLAB 25 INJECTION will be given to you only by a doctor or a nurse into a muscle (usually into buttocks as an intramuscular injection) or under the skin (usually into buttocks or thigh as an subcutaneous injection) or into a vein (usually in upper arm as intravenous injection). Your doctor will decide the correct dose and duration of DICLOLAB 25 INJECTION for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF DICLOLAB 25 INJECTION
COMMON
- pain, redness or lumps at the injection site
- nausea
- discomfort in the injection site
UNCOMMON
- dizziness and headache
- diarrhoea, vomiting and constipation
- stomach pain, sickness and loss of appetite due to inflamed stomach lining
- problems in liver function
- skin rash, itching
RARE
Inform your doctor immediately if you experience any of the following side effects while receiving DICLOLAB 25 INJECTION:
- signs of bleeding in the stomach or intestine (bleeding while emptying your bowel, blood in vomit, black or tarry stools)
- persistent sore throat or high temperature
- sudden change in urine production and colour
- signs of severe allergic reactions (skin rash, swelling of face, throat or tongue, breathing difficulties, wheezing and runny nose)
- yellowing of the skin or white of the eyes
- chest pain due to serious allergic rection called kounis syndrome
- serious skin rashes with itching, hives, bruising, painful red areas, peeling or blistering of skin, giant wheals (burning itchy swollen skin), affecting mouth, lips, eyes, nose and genitals.
- bruising more easily than usual or having frequent sore throats or infections.
- severe stomach pain or persistent problem with indigestion, heartburn, wind and nausea or vomiting
- mild cramping or tenderness of the abdomen, followed by rectal bleeding or bloody diarrhea (usually within 24 hours of the onset of abdominal pain)
HOW TO MANAGE SIDE EFFECTS
Constipation
Try to eat more high-fiber foods such as fresh fruit, vegetables, cereals, and drink plenty of water. If this does not help, inform your doctor for receiving alternate treatment for constipation.
Diarrhea
Drink lot of fluids such as water to keep yourself hydrated. Avoid eating high fat or spicy foods. Inform your doctor if the symptom gets worse.
Headache
Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to be relaxed and stress free. Apply pain relieving balm on your forehead if necessary. Inform your doctor if the symptom does not improve.
Nausea And Vomiting
Stick to simple meals while receiving DICLOLAB 25 INJECTION. Avoid eating oily rich, fried or spicy foods. Do not lie down or sleep immediately after eating. Inform your doctor if the symptom does not improve.
Stomach Pain
Try to rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. If the symptom does not improve, inform your doctor.
WARNING & PRECAUTIONS
PREGNANCY
Monitoring requiredDICLOLAB 25 INJECTION is not recommended for use during pregnancy especially if you are more than 6 months pregnant as it may affect the baby’s circulation or damage the baby’s kidney and may delay or prolong your labour. Your doctor may take decision whether to continue the use of DICLOLAB 25 INJECTION if you are pregnant or planning to get pregnant. Consult your doctor before receiving DICLOLAB 25 INJECTION as it may make you more difficult to get pregnant during treatment with this medicine.
BREASTFEEDING
Monitoring requiredDICLOLAB 25 INJECTION should be used in breastfeeding women only if clearly advised by the doctor. Therefore, consult your doctor before receiving DICLOLAB 25 INJECTION.
DRIVING AND USING MACHINES
Use with CautionDo not drive or operate any machines if you feel dizzy, tired, sleepy or have blurred vision after receiving DICLOLAB 25 INJECTION.
KIDNEY
Consult your doctorDICLOLAB 25 INJECTION is not recommended for patients having or have had severe kidney failure and moderate or severe impairment in kidney function. It should be used with caution in patients having or have ever had kidney problems. Consult your doctor for advice before receiving DICLOLAB 25 INJECTION.
LIVER
Consult your doctorDICLOLAB 25 INJECTION is not recommended for use in patients having or have had liver failure. It should be used with caution in patients with liver problems. Consult your doctor for advice before receiving DICLOLAB 25 INJECTION.
ALLERGY
ContraindicatedDICLOLAB 25 INJECTION is not recommended for use if you are allergic to diclofenac, aspirin, ibuprofen or any other non-steroidal anti-inflammatory drugs (NSAIDs) (such as indomethacin).
LUNGS
Consult your doctorDICLOLAB 25 INJECTION is not recommended for use in patients with history of asthma. It should be used with caution in patients with chronic obstructive pulmonary disease (COPD or hay fever. Consult your doctor for advice before receiving DICLOLAB 25 INJECTION
HEART DISEASE
Consult your doctorDICLOLAB 25 INJECTION is not recommended for use in patients with severe heart failure, heart disease or cerebrovascular disease such as heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or had an operation to clear or bypass blockages and cerebrovascular bleeding. It should be used with caution in patients having angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides. Consult your doctor for advice before receiving DICLOLAB 25 INJECTION.
OTHERS
DICLOLAB 25 INJECTION is not recommended for use if you:
- have a history of bleeding in your stomach or bowels after you have taken NSAIDs
- had two or more episodes of stomach or duodenal ulcers or bleeding in the digestive tract
- have a blood clotting disorder
- have an history of bleeding diathesis (specifically cerebrovascular bleeding)
- had operation with high risk of haemorrhage
- are dehydrated
- have suffered from heavy blood loss
Before receiving DICLOLAB 25 INJECTION, inform your doctor if you:
- have smoking habit
- have diabetes
- have systemic lupus erythematosus or any similar problem
- have porphyria or nasal polyps
- are recovering from surgery
- are going to undergo gut surgery
- have any bowel disorders including ulcerative colitis or Crohn’s disease
Use in Paediatrics:
DICLOLAB 25 INJECTION is not recommended for use in children and adolescents (below 18 years of age). Consult child’s doctor for advice.
Use in Geriatrics:
DICLOLAB 25 INJECTION should be used with caution in elderly patients. Your doctor may initiate the treatment with the lowest effective dose. Consult your doctor for advice before receiving DICLOLAB 25 INJECTION.
INTERACTIONS
A. Drug-Drug Interactions:
Before receiving DICLOLAB 25 INJECTION, inform your doctor if you are taking any of the following medicines:
- other medicines used to provide pain relief (Ex. aspirin, ibuprofen)
- medicines used to treat high blood pressure (Ex. captopril, atenolol, metoprolol)
- digoxin (used to treat heart problems)
- methotrexate, pemetrexed (used in cancer treatment)
- spironolactone, furosemide (used to remove excess water form body)
- lithium (used to treat mental health problems)
- warfarin or heparin (used to prevent or treat blood clots)
- mifepristone (used to terminate pregnancy)
- medicine used to suppress inflammation (Ex. prednisolone)
- medicines used to suppress immunity (Ex. ciclosporin and tacrolimus)
- citalopram (used to treat depression)
- medicines used to treat bacterial infections (Ex. ciprofloxacin, ofloxacin)
- phenytoin (used to treat seizures)
- voriconazole (used to treat fungal infections)
- medicines used to lower cholesterol (Ex. colestipol, cholestyramine)
- sulfinpyrazone (used in gout treatment)
- zidovudine (used in HIV treatment)
- anti-diabetics such as metformin (used to treat diabetics)
- deferasirox (used to treat iron overload due to blood transfusions)
Overdosage:
DICLOLAB 25 INJECTION will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms such as nausea, vomiting, stomach pain, stomach or bowel bleeding, dizziness, tinnitus (ringing noise in ears) and occasionally convulsions (fits). In severe cases it may cause kidney or liver damage (signs include difficulty in passing urine or passing more water than usual, tiredness, muscle cramps, swelling in your hands, feet or face, nausea or vomiting and yellowing of the skin).
SYNOPSIS
| Drug | : | Diclofenac |
| Pharmacological Category | : | Cyclooxygenase Inhibitors |
| Therapeutic Indication | : | Pain relief |
| Dosage Forms | : | Tablet, Capsule, Dispersible tablet, Injection, Eye drops, Gel, Spray, Solution, Liniment, Suppository, Ointment, Transdermal patch, Spray |
MORE INFORMATION
- Store DICLOLAB 25 INJECTION at room temperature
FAQs ABOUT DICLOLAB 25 INJECTION
Q: What is DICLOLAB 25 INJECTION used for?
A: DICLOLAB 25 INJECTION is used to treat various painful conditions such as flare-ups of joint or back pain, gout attacks, pain caused by kidney stones or due to injuries, fractures or trauma. DICLOLAB 25 INJECTION is also used to prevent or treat pain following an operation.
Q: What common side effects are seen with DICLOLAB 25 INJECTION?
A: The common side effects of receiving DICLOLAB 25 INJECTION are nausea and discomfort, pain, redness or lumps at the site of injection. Inform your doctor if any of the side effect gets worse during or after treatment with DICLOLAB 25 INJECTION.
Q: Can DICLOLAB 25 INJECTION be used in breast-feeding women?
A: DICLOLAB 25 INJECTION should be used in breastfeeding women only if clearly advised by your doctor. Consult your doctor before receiving DICLOLAB 25 INJECTION if you are breast-feeding your child or wish to breast-feed if your baby is born prematurely.
Q: Can DICLOLAB 25 INJECTION be used in elderly patients?
A: DICLOLAB 25 INJECTION should be used with caution in elderly patients. Your doctor may initiate the treatment with the lowest effective dose. Consult your doctor for advice before receiving DICLOLAB 25 INJECTION.
Q: Is DICLOLAB 25 INJECTION safe to use in patients with liver problems?
A: DICLOLAB 25 INJECTION is not recommended for use in patients with liver failure. It should be used with caution in patients with liver problems and your doctor may monitor your liver function test during treatment with this medicine. Consult your doctor for advice before receiving DICLOLAB 25 INJECTION.
REFERENCES
1. KD. Tripathi. Nonsteroidal Anti-inflammatory Drugs and Antipyretic-Analgesics. Seventh edition. 2013. Page – 192 & 210
2. Gan, Tong J. Diclofenac: an update on its mechanism of action and safety profile. Current medical research and opinion. May 2010. [Accessed on 16th August 2022] https://www.tandfonline.com/doi/abs/10.1185/03007995.2010.486301
3. Altman, Roy, Bill Bosch, Kay Brune, Paola Patrignani, and Clarence Young. Advances in NSAID development: evolution of diclofenac products using pharmaceutical technology. Springer link. May 2015. [Accessed on 16th August 2022] https://link.springer.com/article/10.1007/s40265-015-0392-z
4. IBSA Farmaceutici Italia Srl. Electronic Medicines Compendium (EMC). [Revised in September 2020]. [Accessed on 16th August 2022] https://www.medicines.org.uk/emc/files/pil.9399.pdf
5. Hospira, Inc. U.S. Food & Drug Administration. [Revised in December 2014] [Accessed on 16th August 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022396lbl.pdf
USEFUL DIAGNOSTIC TESTS
- Liver function test
- Complete blood count
AUTHOR DETAILS
Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 03 Feb 2023 | 11:14 AM(IST)
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