Rupafin for allergy – composition, action, indications, contraindications, method of administration and dosage

Proven content

Rupafin, an antihistamine drug, is used in allergology, dermatology and venereology. The active substance is rupatadine, which relieves the symptoms of allergic rhinitis and the symptoms of urticaria. This preparation is available only on prescription and can be used by adults and children over 2 years of age. What is the composition and action of Rupafin? What are the indications and contraindications for its use? What are the side effects of taking this medication? How to take Rupafin and with what drugs should not combine this preparation?

Allergy is an excessive and abnormal reaction of the immune system to the surrounding allergens. Symptoms of allergies can cause us many inconveniences in everyday life and it is worth asking a doctor to prescribe an effective drug that will help alleviate or eliminate the symptoms of allergy. One of such preparations is the drug Rupafin.

Rupafin – general characteristics of the drug

Rupafin is an antihistamine with the international name Rupatadinum. It is a prescription-only drug with antiallergic properties.

It is mainly used to relieve the symptoms of allergic rhinitis, which include sneezing, nasal discharge, and itchy eyes and nose.

In addition, it is also often used to relieve symptoms associated with urticaria, such as itching and local redness and swelling of the skin.

The drug contains the active substance rupatadine in the form of fumarate, thanks to which Rupafin is a histamine antagonist with a long, selective action on peripheral H1 receptors.

Rupafin is available in two forms. Rupafin as round pale salmon tablets is supplied in blister packs of 10 mg unit doses containing 3, 7, 10 or 15 tablets. The outer package contains 3, 7, 10, 15, 20, 30, 50 or 100 tablets. The price of this preparation ranges from PLN 15 for a package of 15 tablets to PLN 26 for a package of 30 tablets.

On the other hand, Rupafin syrup in the form of a clear, yellow oral solution is available in a PET bottle with a LDPE adapter and a 120 ml HDPE closure, in which 1 ml of the syrup contains a dose of 1 mg of rupatadine. The package includes an oral dosing syringe made of PP / PE with a capacity of 5 ml, graduated with an accuracy of 0,25 ml. Rupafin syrup price is about PLN 40 per package and is not refundable.

Always keep the packaging with the drug out of the sight and reach of children, in the original packaging.

The manufacturer of Rupafin is the Spanish company Uriach & Cia SA, which is the second oldest laboratory in Europe. It was established in 1838 and to this day is an independent family company operating as a corporation with branches in over 70 countries around the world.

The distributor in Poland is Takeda Pharma Sp. z o. o. which is a global biopharmaceutical company. The company was founded in 1781, when Chobei Takeda I began selling traditional Japanese and Chinese medicines in one part of Osaka – Doshomachi. It currently has branches in 80 countries and holds a leading position in Japan and the USA, which are respectively the third and first largest pharmaceutical markets in the world. Highlights of the company’s operations are its own prescription drugs for gastrointestinal disease, oncology, pain relief and tissue regeneration, and a wide range of over-the-counter (OTC) products.

What is desensitization and when is it worth doing? Check: Desensitization is an effective method of treating allergies

Rupafin – composition and action of the drug

The active ingredient of Rupafin is Rupatadyna being a multifunctional organic chemical compound, an n-alkyl derivative of pyridine, a second generation antihistamine having anti-platelet activating factor (PAF) activity.

Rupatadine is a histamine antagonist that selectively blocks peripheral type 1 (H1) histamine receptors. As a result, it relieves the histamine-dependent symptoms of an allergic reaction such as sneezing, swelling and itching of the mucous membranes, runny nose and skin reaction.

Additionally, the metabolites of rupatadine, desloratadine and its hydroxylated metabolite, maintain the antihistamine effect and may help the overall effectiveness of the preparation.

Rupatadine at high concentrations inhibits mast cell degranulation as well as inhibits the release of cytokines by human mast cells and monocytes.

After oral ingestion, Rupafin is rapidly absorbed from the gastrointestinal tract. Rupatadine is 98,5-99% bound to plasma proteins and is practically completely metabolised mainly by the cytochrome P3 4A450 isoenzyme, and then eliminated from the body in faeces and urine as metabolites. The maximum concentration is obtained approx. 45 minutes after taking the preparation.

One Rupafin tablet contains 10 mg of rupatadine as rupatadine fumarate. The other substances included in the drug are: pregelatinized maize starch, microcrystalline cellulose, red iron oxide (E 172), yellow iron oxide (E 172), lactose monohydrate and magnesium stearate.

However, 1 ml of Rupafin syrup contains 1 mg of rupatadine in the form of rupatadine fumarate and other ingredients such as: propylene glycol, anhydrous citric acid, disodium phosphate anhydrous, sodium saccharin, sucrose, methyl parahydroxybenzoate (E 218), quinoline yellow (E 104), aromatic banana and purified water.

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Rupafin – indications for the use of the drug

Rupafin is an antihistamine that is mainly used to relieve allergic symptoms. It is intended for use by patients in the symptomatic treatment of allergic rhinitis also in chronic ailments.

Rupafine in tablets is indicated in adults and adolescents from 12 years of age to relieve symptoms of allergic rhinitis such as sneezing, runny nose, itchy eyes and nose.

In addition, it is indicated for the relief of symptoms associated with urticaria, i.e. allergic skin rash, itching, and local redness and swelling of the skin.

Rupafin in the form of a syrup is indicated mainly for children from 2 to 11 years of age. It is also given to relieve the symptoms of allergic mucositis and the symptoms associated with urticaria.

How to recognize an allergy and not to confuse it with hypersensitivity or intolerance. Read on: A pesky world. Allergy, hypersensitivity or intolerance?

Rupafin – contraindications to use

The use of Rupafin is often impossible despite the indications for starting therapy. There are contraindications that prevent the implementation of this preparation for treatment.

According to the manufacturer, this drug should not be used in people who are hypersensitive to rupatadine or any of its ingredients.

The contraindications to the use of Rupafin also include certain diseases and circumstances that may require you to completely abandon the drug or change the dosage of the preparation.

The use of Rupafin requires specific control tests.

Taking special precautions when using Rupafin is recommended in people:

1. with uncontrolled hypokalaemia (when the patient has low potassium levels in the blood);
2. with diseases predisposing to the occurrence of arrhythmias (such as clinically significant bradycardia or acute myocardial ischemia);
3. with known prolongation of the QT interval on the ECG;
4. in the elderly (after the age of 65);
5. with impaired liver or kidney function, due to lack of clinical experience;
6. with galactose intolerance, lactase deficiency or malabsorption of glucose-galactose, because the drug contains lactose;
7. in pregnant women and women during breastfeeding;
8. in children under 2 years of age, as the safety and effectiveness of the preparation have not been established;
9. with hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

What are the consequences of an untreated allergy? Check: Effects of untreated allergies

Rupafin – method of taking and dosage of the drug

Rupafin, a prescription-only medicine, should be used as prescribed by your doctor or pharmacist. In case of any doubts, consult a doctor or pharmacist, as the effect of the drug taken in the wrong doses may be harmful to health and life.

Rupafin for adults and adolescents over 12 years of age it is recommended to use the preparation in the form of tablets. The daily dose should be 10 mg (1 tablet) and can be taken with or without food. The doctor decides on the duration of treatment with the preparation.

Rupatadine should be used with particular caution in the elderly.

Rupafin tablets are not recommended for use in children under 12 years of age. The oral solution is recommended for this age group. The dose of the drug in children depends on the patient’s body weight and is:

1. with a body weight of more than or equal to 25 kg – 5 mg of the drug (5 ml of solution) once a day;
2. with a body weight of 10-25 kg – 2,5 mg of the drug (2,5 ml of solution) once a day.

The pack of Rupafin syrup contains a measuring syringe, enabling the correct measuring of the recommended dose. The oral solution should be administered directly into the mouth from the dosing syringe. As with Rupafin tablets, the attending physician decides on the duration of the therapy. The preparation can be used regardless of meals.

Rupafin should always be used exactly as prescribed by your doctor. If you accidentally take too much medicine, contact your doctor or pharmacist immediately. However, if one dose is missed, the missed tablet should not be taken or a double dose should not be taken.

If you have any doubts about the method of taking and dosage of Rupafin, consult your doctor and pharmacist.

What is hives? How to recognize and treat it? Read on: Know the allergy on your own skin – urticaria

Rupafin – possible side effects

Rupafin, like all medicines, can cause side effects that do not have to occur in every person using this medicine. After authorization of the medicinal product, it is important to report any suspected adverse reactions so that the benefit / risk balance of the medicinal product can be monitored.

The general classification of the frequency of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare ( ≥100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

For Rupafin, most of the side effects seen in clinical trials were mild to moderate and generally did not require treatment discontinuation. Much more side effects were observed when patients took the preparation in the form of tablets during therapy.

The most common (not more than 1 in 10 patients) side effects are: drowsiness, headache and dizziness, dry mouth, feeling weak, tiredness, asthenia.

Uncommon, i.e. not more than 1 in 100 patients, the following side effects may occur: increase in appetite, irritability, difficulty concentrating, nosebleed, dry nose, sore throat, cough, dry throat, rhinitis , nausea, abdominal pain, diarrhea, vomiting, constipation, indigestion, rash, pain in the back, joints, muscles, thirst, general malaise, fever, liver function test abnormal, and weight gain.

However, not more than 1 in 1000 patients, i.e. rarely the following may occur: palpitations, increased heart rate, allergic reactions (itching, hives, swelling of the face, lips, tongue or throat).

In the case of Rupafin syrup, side effects such as headache and somnolence have been reported frequently (may affect up to 1 in 10 patients).

Uncommon (may affect up to 1 in 100 patients) influenza, nasopharyngitis, upper respiratory tract infection, eosinophilia, neutropenia, dizziness, nausea, eczema, night sweats and tiredness have been observed.

The expected benefits of using Rupafin, as a rule, are greater than the harm resulting from the occurrence of side effects. However, if you experience severe side effects after using Rupafin tablets or syrup, consult your doctor or pharmacist.

How to distinguish a runny nose from allergies? Check: Common runny nose or allergy? How to tell them apart?

Rupafin – pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor before taking any medication to explain all the potential risks and benefits of any medication.

It is recommended that if a woman is pregnant, suspects she may be pregnant or is planning to have a baby, she should inform the prescribing physician about this.

It is generally recommended to avoid the use of rupatadine during pregnancy, although there is limited information available on the safety of the drug in pregnant women. Rupatadine has not been reported to have any negative effects on the course of pregnancy, the mother, the development of the fetus or childbirth, however, taking Rupafin during pregnancy is not recommended due to the low level of observation.

Also, the conducted studies did not prove whether rupatadine is excreted in human milk. However, studies have shown excretion into animal milk, therefore you should inform your doctor if you are breastfeeding. Your doctor will consider the benefits for the mother and the risks to the baby and will decide whether to start treatment and wean your baby, or to stop treatment and continue breastfeeding.

What is worth knowing about proper supplementation during pregnancy? Check: Conscious choices. Diet and supplementation in pregnancy

Rupafin – interactions with other substances

The initiation of treatment with Rupafin requires a detailed interview with regard to all recently taken medications, including over-the-counter medications.

Taking certain medications at the same time as taking Rupafin can cause serious side effects. In the case of Rupafin, the following drugs should be avoided:

1. containing ketoconazole (a medicine for fungal infections) or erythromycin (a medicine for bacterial infections) as they significantly increase the systemic exposure to rupatadine (no effect on the QT interval on the ECG or the severity of side effects);
2. central nervous system depressants, statins (medicines used to treat high cholesterol) or midazolam (short-acting sedative and hypnotic drugs).

Rupafine is also not recommended for use in people who are taking strong CYP3A4 inhibitors as they may increase the blood levels of rupatadine. Therefore, the concomitant use of Rupafin with substances such as ketoconazole, itraconazole, posaconazole, voriconazole or clarithromycin should be avoided.

Caution should also be exercised when combining Rupafin with moderate-acting inhibitors of CYP3A4, including erythromycin, fluconazole or diltiazem.

In addition, it is not recommended to combine the therapy with substances sensitive to CYP3A4, such as simvastatin and lovastatin, as well as with substances with a narrow therapeutic index, which are substrates for the CYP3A4 isoenzyme – cyclosporin, everolimus, tacrolimus, sirolimus, cisapride, which is due to the fact that rupate can increase the concentration of these substances in your blood.

Due to the relatively limited amount of data on the effects of Rupafin on other drugs, caution should be exercised when combining it with other drugs not listed above.

It is very important not to consume grapefruit juice while taking Rupafin, as it affects compounds that inhibit CYP3A4 and the intestinal drug transport system. In addition, grapefruit and grapefruit juice increase the concentration of the drug in the body, which increases the risk of side effects.

To avoid interactions, do not drink grapefruit juice or eat grapefruit at least 4 hours before and 4 hours after taking the medicine.

Also, during treatment with Rupafin, alcohol should not be consumed as this may increase the risk of psychosomatic disorders worsening.

If you have any doubts about combining Rupafin with other preparations and substances, consult your doctor who will individually assess the risk of using the drug in the patient.

Which drugs should never be combined with each other? Check: Dangerous interactions