Bupropion Granules Instructions
[Medication Name]
Generic Name: Ibuprofen Granules
English name: Ibuprofen Granules
Hanyu Pinyin: Buluofen Keli
[Composition] This product contains 0.2 grams of ibuprofen as the main ingredient. The excipients are lactose, mannitol, corn starch, sodium carboxymethyl starch, stevia, orange powder flavor, hydroxypropyl methylcellulose, and polysorbate 80.
[Properties] This product is white or yellow granules, aromatic; sweet taste. .
[Class of action] This product is an over-the-counter drug of antipyretic and analgesic class.
[Indications】 It is used to relieve mild to moderate pain such as headache, joint pain, migraine, toothache, muscle pain, neuralgia, menstrual pain. It is also used for fever caused by common cold or influenza.
[Gauge] Each contains 0.2g of Ibuprofen
[Dosage】 Take with warm water, 0.5 packets at a time for children 4 to 8 years old; 1 packet at a time for children over 8 years old and adults. If pain or fever persists, repeat the dose once at an interval of 4 to 6 hours, no more than 4 times in 24 hours.
[Adverse Reactions].
Of the 17485 total cases reported for the original product, 532 (3.04%) 690 adverse reactions occurred, mainly in the digestive system (stomach upset, loss of appetite, abdominal pain, nausea/vomiting, etc.: 2.99%), rash (0.20%), pruritus ( 0.14%), facial edema (0.15%), etc.
1. Important adverse reactions
(1) Shock, allergy-like symptoms
Symptoms of shock and allergy may occur (frequency unknown*), therefore, adequate observation should be made, discontinue the drug and take appropriate measures when symptoms such as chest tightness, chills, cold sweats, dyspnea, numbness of extremities, decreased blood pressure, angioedema, and urticaria occur.
(2) Aplastic anemia, hemolytic anemia, granulocytopenia, thrombocytopenia
Aplastic anemia, hemolytic anemia, granulocytopenia, and thrombocytopenia (all of unknown frequency*) may occur and should therefore be adequately observed, discontinued, and acted upon if abnormalities are detected.
(3) Peptic ulcer, gastrointestinal bleeding, ulcerative colitis
Peptic ulcer, gastrointestinal bleeding, ulcerative colitis (all of unknown frequency*) may occur, discontinue medication and take appropriate measures if abnormalities are detected.
(4) Toxic Epidermal Necrolysis (TEN), cutaneous mucocutaneous eye syndrome (Stevens-Johnson syndrome)
Toxic Epidermal Necrolysis (TEN), Cutaneous Mucocutaneous Eye Syndrome (Stevens-Johnson Syndrome) are possible (both of unknown frequency*) and should therefore be adequately observed and acted upon accordingly.
(5) Acute renal failure, interstitial nephritis, nephrotic syndrome
Acute renal failure, interstitial nephritis, and nephrotic syndrome (all of unknown frequency*) may occur and should therefore be adequately monitored, discontinued, and acted upon in the presence of oliguria, hematuria, elevated urine protein, BUN/blood creatinine, hyperkalemia, and hypoproteinemia. .
(6) Aseptic meningitis
Aseptic meningitis (frequency unknown*) is possible and should be adequately monitored, discontinued and acted upon if symptoms such as neck stiffness, fever, headache, vomiting/nausea or confusion occur.
[Particularly susceptible to aseptic meningitis in patients with SLE (systemic lupus erythematosus) or MCTD (mixed connective tissue disease)].
(7) Liver function disease, jaundice
There is a risk of liver function disorders (jaundice, elevated AST (GOT), elevated ALT (GPT), elevated γ-GTP, etc.), and fulminant hepatitis (all of unknown frequency*), so adequate observation should be made, discontinue the drug if abnormalities are detected, and take appropriate measures.
(8) Asthma attacks
There is a possibility that an asthma attack may be triggered (frequency unknown), so discontinue medication and take appropriate action if symptoms such as shortness of breath or dyspnea occur.
2. Other adverse reactions
Frequency
Categories0.1~5%≤ 0.1%Frequency unknown*Blood Decreased platelet function (prolonged bleeding time)Digestive systemLoss of appetite, nausea/vomiting, upset stomach, abdominal pain, indigestion, diarrheaThirst, stomatitis, bloating Liver AST(GOT) elevation, ALT(GPT) elevation, Al-P elevation, etc.Jaundice** Allergies**Rash, itchingHives, eczemaPurpuraSensory organs Blurred vision and other visual abnormalities**Deafness, tinnitus, abnormal tastePsychoneurologyHeadache, drowsiness, vertigo, and insomnia DepressionCardiovascular Systems Increased blood pressure, palpitationsLower blood pressureOtherOedemaTired, feverishRhinorrhea*: Frequency of adverse reactions spontaneously reported from the originator product or occurring abroad is unknown.
**: Discontinuation of the drug in the event of an adverse reaction.
A few patients may experience nervousness; rare bronchospasm.
[Contraindications].
1. Patients with peptic ulcer (refer to [Precautions]) [potential for exacerbation of peptic ulcer due to decreased gastric mucosal defense caused by prostaglandin synthesis inhibition].
2. Patients with severe hematologic abnormalities [may have adverse reactions such as blood disorders and therefore may further worsen hematologic abnormalities].
3. Patients with severe liver dysfunction [may experience adverse reactions such as liver disease and therefore may further worsen liver disease].
4. Patients with severe renal impairment [risk of further worsening of renal disease due to decreased renal blood flow, etc. due to prostaglandin synthesis inhibition].
5. Patients with severe cardiac insufficiency [at risk of further worsening cardiac insufficiency due to water and sodium retention from prostaglandin synthesis inhibition].
6. Patients with severe hypertension [at risk of further elevation of blood pressure due to water and sodium retention from prostaglandin synthesis inhibition].
7. Patients with a prior history of hypersensitivity to the components of this product.
8. Patients with hypersensitivity to other NSAIDs.
9. Patients with aspirin asthma (triggering asthma attacks caused by non-steroidal anti-inflammatory analgesics, etc.) or their past medical history [which may trigger asthma attacks], and patients with asthma who are allergic to aspirin.
10. Patients using zidovudine [refer to [drug interactions]].
11. Contraindicated in pregnant and lactating women.
[Precautions].
1. Use with caution (caution in the following patients)
(1) Peptic ulcers due to long-term use of NSAIDs in patients who require long-term use of this product and are receiving misoprostol [Misoprostol is indicated for NSAID-induced peptic ulcers but there are also treatment-resistant peptic ulcers to misoprostol, so the process should be fully observed and used with caution when using this product long-term].
(2) Patients with a prior history of peptic ulcers [with the potential for peptic ulcer recurrence].
(3) Patients with a prior history of hematologic abnormalities or their past history [risk of worsening or recurrence of hematologic abnormalities].
(4) Patients with bleeding tendencies [may cause a decrease in platelet function and therefore have the potential to exacerbate bleeding tendencies].
(5) Patients with liver disease or their prior history [may worsen or recurrence of liver disease].
(6) Patients with renal disease or their prior history or reduced renal blood flow [at risk for worsening or recurrence of renal disease].
(7) Patients with abnormal cardiac function [with the potential to exacerbate abnormal cardiac function].
(8) Patients with hypertension [with the potential to increase blood pressure].
(9) Patients with a prior history of allergy.
(10) Patients with bronchial asthma [patients with bronchial asthma also include patients with aspirin asthma, which may cause asthma attacks in these patients].
(11) Patients with systemic lupus erythematosus (SLE) [there is a risk of worsening SLE symptoms (kidney disease, etc.). Also, there is a risk of aseptic meningitis].
(12) Patients with mixed connective tissue disease [at risk of aseptic meningitis].
(13) Patients with ulcerative colitis [worsening of symptoms with other NSAIDs has been reported].
(14) Patients with Crohn’s disease [worsening of symptoms with other NSAIDs has been reported].
2. Important Basic Precautions
(1) Please note that treatment with anti-inflammatory analgesics is not allopathic; it is an allopathic medicine and should not be used long-term or in large amounts for more than 5 days for pain relief and 3 days for fever relief; if symptoms do not resolve, consult your physician or pharmacist.
(2) When using this product to relieve pain in chronic diseases, the following should be noted.
(1) Regular laboratory tests (urinalysis, hematology and liver function tests, etc.) are required when using this product for a long period of time. Take immediate measures such as dose reduction and discontinuation if abnormalities are detected.
2) Treatment other than pharmacotherapy should be considered.
(3) The following should be observed when using this product for pain relief in acute illness.
(1) Analyze the degree of acute inflammation, pain, and fever before administering the medication.
2) Avoiding, in principle, long-term use of the same medication.
3) If an allopathic approach is available, it should be used.
(4) Observe the patient’s status adequately and watch for adverse effects. There is a risk of hypothermia, deficiency, and cold hands and feet, especially in children and elderly patients with hyperthermia or wasting disease, and the patient’s status needs to be adequately observed after administration.
(5) There is a risk of occult infection, so it should be used in combination with appropriate antibacterial drugs for the treatment of infectious inflammation, with adequate observation and caution.
(6) Combination with other anti-inflammatory and analgesic drugs should be avoided.
(7) Alcohol or beverages containing alcohol should not be consumed while taking this product.
(8) In case of overdose or serious adverse reactions, seek immediate medical attention.
(9) Contraindicated in persons with hypersensitivity to this product.
(10) It is contraindicated when the product’s properties are changed.
(11) Keep this product out of the reach of children.
(12) Must be used by children under adult supervision.
(13) Consult your physician or pharmacist before using this product if you are using other drugs.
(14) If gastrointestinal bleeding or ulcers, chest pain, shortness of breath, weakness, or slurred speech occur, discontinue the drug and consult your physician.
3.
There have been reports of transient infertility in women who use NSAIDs for long periods of time.
[Drug interactions].
This product is primarily metabolized by the hepatic metabolizing enzyme CYP2C9.
1. Contraindications to co-administration (prohibited)
Drug names and moreClinical symptoms and managementMechanisms and risk factorsZi Dovudine (Rituxan)It has been reported to enhance the bleeding tendency in patients with hemophilia. The mechanism is unknown. 2. Collocation considerations (note collocation)
Drug names, etc. Clinical symptoms and managementMechanisms and risk factorsCoumarin-based anticoagulants such as warfarinThere are may potentiate the effect of coumarin-based anticoagulants (warfarin), so care should be taken to adjust the dosage. Competitive binding of this product to plasma proteins of warfarin and increased free warfarin. Aspirin preparations (when used as an antiplatelet agent)Aspirin has been reported to impair platelet aggregation inhibition. This product is thought to inhibit the binding of platelet cyclooxygenase-1 (COX-1) to aspirin. Anticoagulants such as warfarin
Antiplatelet agents such as clopidogrel
Selective 5-hydroxytryptamine reuptake inhibitors (SSRIs) fluvoxamine, paroxetine, etc.There is a risk of increased gastrointestinal bleeding. There is potential for enhanced interactions. Lithium formulations such as lithium carbonateThere have been reports of elevated blood lithium concentrations and lithium toxicity, so the combination should be adequately monitored, such as monitoring blood lithium concentrations, and used with caution. The drug should be administered with caution, such as monitoring blood lithium concentrations. Due to the inhibitory effect of this product on prostaglandin synthesis, resulting in decreased renal sodium excretion, decreased lithium clearance, and increased lithium concentrations in the blood. Thiazide diuretics such as hydrochlorothiazide
Tab diuretics such as tachyphylaxisThe report notes that weakening the effects of these diuretics. Water and sodium retention in vivo due to the inhibitory effect of this product on prostaglandin synthesis. ACE inhibitors such as enalapril
β-blockers such as propranololHas the potential to weaken the antihypertensive effect. Vasodilation and water and sodium excretion are inhibited due to the inhibitory effect of this product on prostaglandin synthesis. Tacrolimus hydrateAcute renal failure has been reported. Nephritic damage from tamoxifen hydrate is exacerbated by the prostaglandin synthesis inhibition of this product. New quinolone antibacterial agents such as enoxacin hydrateThere have been reports of spasticity caused by the combination of other NSAIDs for analgesia. The combination enhanced the GABA inhibitory effect of the neoquinolone antimicrobial agent. MethotrexateThere is a possibility that the effects of methotrexate may be enhanced, so care should be taken to adjust the dosage, etc. Inhibition of prostaglandin synthesis by this product results in decreased renal blood flow, inhibition of renal excretion of methotrexate, and increased blood concentrations of methotrexate. DeglutethimideIt is possible to reduce the blood concentration of this product. Decholamine is an anion-exchange resin that binds to this product in the GI tract and delays/inhibits its absorption. Sulfonylurea hypoglycemic agents such as chlorosulfaprepiride and glibenclamideThere is a potential for enhanced hypoglycemic effects (hypoglycemia), so care should be taken to adjust the dosage. The product binds competitively to the plasma proteins of these drugs and the free form is increased. Drugs that inhibit CYP2C9 such as voriconazole, fluconazoleIt is possible to elevate blood concentrations of this product. These drugs inhibit the enzyme (CYP2C9) that metabolizes this product. 1) This product can increase gastrointestinal side effects when used with other antipyretic, analgesic, and anti-inflammatory drugs and may cause ulcers.
2) When this product is used with furosemide (furanilic acid), the sodium-removal and antihypertensive effects of the latter are reduced; when used with antihypertensives, the antihypertensive effects of the latter are also reduced.
3) Concomitant use of this product with digoxin can increase the blood concentration of these drugs and should not be used together.
4) Drug interactions may occur if used concomitantly with other drugs; consult your physician or pharmacist for details.
[Pharmacological effects
This product inhibits the synthesis of prostaglandins and has analgesic, antipyretic and anti-inflammatory effects. This product is rapidly absorbed orally.
1. Anti-inflammatory effects
The ID50 (administered orally) of this product against acute inflammation in ultraviolet erythema (guinea pigs) and keratocystis edema (rats) were 4.4 mg/kg and 22 mg/kg, respectively, compared with aspirin (ID 50 115 mg/Kg, 200 mg/Kg, respectively) showed stronger anti-inflammatory effects compared with aspirin. The chronic inflammation of adjuvant arthritis was inhibited at doses of 10-30 mg/kg/day, which was 5-10 times more effective than aspirin.
2. Analgesic effects
Rats showed analgesic effects on inflammatory pain of the foot pad (Randall-Selitto method) when given 2~30 mg/kg of this product orally, 30 times more effective than aspirin. The ID50 (administered orally) for acetylcholine-induced elevation (in mice) was 1.9 mg/kg and was 28 times more effective than aspirin.
3. Antipyretic effect
The oral administration of 5-10 mg/kg of this product to rats significantly inhibited the fever induced by the injection of yeast suspension, and the effect was 20 times that of aspirin.
[Storage] Store at room temperature.
[Package] Polyester/aluminum/polyethylene pharmaceutical packaging with laminated film bags, each containing 0.2 g of ibuprofen, 9 packs per box; 12 packs per box; 20 packs per box.
[Effective period] 18 months
[Executive Standard
[Approval number] 国药准字H10970046
[Instruction revision date
[Manufacturer
Company Name: Zhejiang Kang’enbei Pharmaceutical Co.
Production Address: No. 1, Kang’enbei Avenue, Lanxi City, Zhejiang Province
Postal code: 321109
Phone number: 0579-88901537
Fax number: 0579-88276589
Website: http://www.conbagroup.com
Contact the manufacturer if you have any questions