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PRODUCT
Rupafin Tab,
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product information
Rupafin Tab.
| Classification | Ethical the Counter(ETC) |
|---|---|
| Major Ingredients | Rupatadine purmate |
| Efficacy/Effectiveness | Allergic rhinitis, Urtinia (microthrepsia, pulmation, etc.) |
| Appearance | A round yellow, pink, and raised crown |
product information
Information
1. Not for the next patient.
1) A patient who is allergic to this medication or its ingredients.
2) This drug contains lactose and therefore has galactose-intolerance glucose, or alkaloidase deficiency of lapp lactose.
2. We'll give it to the next patient.
1) Elderly
3. Adverse reaction
Clinical trial
Overseas, the drug administered to more than 2025 adults and 12 year olds in clinical trials, of which 120 have been administered for more than a year.
The most common adverse reactioss were drowsiness (9.5 %), headaches (6.9 %) and fatigue (3.2 %). Most of the adverse reactios were mild to medium-level symptoms and did not require any interruption in treatment.
The frequency of adverse reactioss was ' common ' (12.4 110, < 110), ' uncommon ' (12.4 1100, < 1100), and (≥ 11000) (≥ 1000).
A domestic clinical trial
In Korea, the drug was tested on 108 adults with allergic rhinitis symptoms and on children 12 years old or older. The most common adverse events were ' drowsiness ' (9.3 %), ' headaches (6.5 %), ' rhinopharynx (4.6 %), ' menstrual cramps ' (4.6 %) and ' diarrhea ' (2.8 %). No significant adverse events occurred in domestic clinical trials, mostly minor. Frequency of occurrence of adverse events was " commonly " (= 1100, < 110]), " unusually " (= 1100, < 1100), " rarely " (x.x.10m),
1) A patient who is allergic to this medication or its ingredients.
2) This drug contains lactose and therefore has galactose-intolerance glucose, or alkaloidase deficiency of lapp lactose.
2. We'll give it to the next patient.
1) Elderly
3. Adverse reaction
Clinical trial
Overseas, the drug administered to more than 2025 adults and 12 year olds in clinical trials, of which 120 have been administered for more than a year.
The most common adverse reactioss were drowsiness (9.5 %), headaches (6.9 %) and fatigue (3.2 %). Most of the adverse reactios were mild to medium-level symptoms and did not require any interruption in treatment.
The frequency of adverse reactioss was ' common ' (12.4 110, < 110), ' uncommon ' (12.4 1100, < 1100), and (≥ 11000) (≥ 1000).
A domestic clinical trial
In Korea, the drug was tested on 108 adults with allergic rhinitis symptoms and on children 12 years old or older. The most common adverse events were ' drowsiness ' (9.3 %), ' headaches (6.5 %), ' rhinopharynx (4.6 %), ' menstrual cramps ' (4.6 %) and ' diarrhea ' (2.8 %). No significant adverse events occurred in domestic clinical trials, mostly minor. Frequency of occurrence of adverse events was " commonly " (= 1100, < 110]), " unusually " (= 1100, < 1100), " rarely " (x.x.10m),
Details
4. General Attention
There was no effect on the operational and mechanical operation of the patients who were given this drug. However, this drug may cause drowsiness, so it is important to pay attention to the operation of the machine, etc., that can cause danger.
5. Interaction
1) Erisro misin and ketoconazole : When administered with 20mgL of rupatadine, ketoconazole, and erisin, the concentration of the blood increased tenfold. While this increase does not increase the QT aperture and adverse reactios, the drug should be carefully administered with attention to other CYP 3 A4 inhibitors.
2) Grapefruit : In combination with grapefruit juice, the blood concentration increased 3.5 times. Do not administer grapefruit juice together.
3) Alcohol : 10 mg of rupatadine with alcohol had a marginal effect on the psychomotor ability, but there was no noticeable difference between alcohol intake alone. The effect of alcohol on the spermatadine's ability to regulate movement increased when 20 milligrams of rupatadine.
4) Central nervous system inhibitor : As with any antihistamine, no interaction with central nervous system inhibitor can be ruled out.
5) Statins family of drugs : The clinical trial produced a number of non - performance-free CPK increases. The risks of interacting with statin-based medications are not clear, so use caution when administered in combination.
6. Medication
1) The drug has insufficient clinical data for pregnant women and has not demonstrated any direct or indirect adverse effects on pregnancy, fetus generation, or post-natal occurrence as a result of animal testing.
2) As animal tests report that the breast milk is transferred to the breast, it is desirable not to administer the medication to the nursing wife, but when this medicine is administered it is unavoidable, breast-feeding is necessary.
7. Administration of children
Safety and efficacy of this drug was not established in children under 12 years of age.
8. Administration for the Elderly
The institution carefully administered to elderly patients.
9. A patient with renal failure and liver failure
Safety and efficacy of this drug has not been established in patients with neuropathy and liver diseases.
10. Eliminate excess administration
No cases of over-injection were reported. No significant effects were observed in clinical trials, which administered 100 mg of rupatadine daily for six days, and the most frequent adverse events were drowsiness. Hypertension therapy and support therapy are recommended when taking excessive doses.
11. Storage and supply precautions
1) Keep the product out of the reach of children.
2) Store in the enclosure (casing) for protection against light.
There was no effect on the operational and mechanical operation of the patients who were given this drug. However, this drug may cause drowsiness, so it is important to pay attention to the operation of the machine, etc., that can cause danger.
5. Interaction
1) Erisro misin and ketoconazole : When administered with 20mgL of rupatadine, ketoconazole, and erisin, the concentration of the blood increased tenfold. While this increase does not increase the QT aperture and adverse reactios, the drug should be carefully administered with attention to other CYP 3 A4 inhibitors.
2) Grapefruit : In combination with grapefruit juice, the blood concentration increased 3.5 times. Do not administer grapefruit juice together.
3) Alcohol : 10 mg of rupatadine with alcohol had a marginal effect on the psychomotor ability, but there was no noticeable difference between alcohol intake alone. The effect of alcohol on the spermatadine's ability to regulate movement increased when 20 milligrams of rupatadine.
4) Central nervous system inhibitor : As with any antihistamine, no interaction with central nervous system inhibitor can be ruled out.
5) Statins family of drugs : The clinical trial produced a number of non - performance-free CPK increases. The risks of interacting with statin-based medications are not clear, so use caution when administered in combination.
6. Medication
1) The drug has insufficient clinical data for pregnant women and has not demonstrated any direct or indirect adverse effects on pregnancy, fetus generation, or post-natal occurrence as a result of animal testing.
2) As animal tests report that the breast milk is transferred to the breast, it is desirable not to administer the medication to the nursing wife, but when this medicine is administered it is unavoidable, breast-feeding is necessary.
7. Administration of children
Safety and efficacy of this drug was not established in children under 12 years of age.
8. Administration for the Elderly
The institution carefully administered to elderly patients.
9. A patient with renal failure and liver failure
Safety and efficacy of this drug has not been established in patients with neuropathy and liver diseases.
10. Eliminate excess administration
No cases of over-injection were reported. No significant effects were observed in clinical trials, which administered 100 mg of rupatadine daily for six days, and the most frequent adverse events were drowsiness. Hypertension therapy and support therapy are recommended when taking excessive doses.
11. Storage and supply precautions
1) Keep the product out of the reach of children.
2) Store in the enclosure (casing) for protection against light.