Dinox - instructions for use, dose, side effects, contraindications

Excipients: Cellulose 261.13 mg mannitol 83.34 mg corn starch 67.67 mg Croscarmellose sodium 48.00 mg Colloidal silica 12.33 mg Magnesium stearate 7.53 mg; shell composition: Opadry Pink (67.995% hypromellose, titanium dioxide (E171) 25.055%, macrogol-400 6.800%, Iron oxide black dye (E172) 0.036% red colorant amazing (E129) 0.114%) 18.00 mg.

Description:

Oval, biconvex tablets, covered with a film shell of pink color, embossed with "FXF"on one side, and on the other -" 120 ", on the cross-section - the core is white or almost white.

Pharmacotherapeutic group:antiallergic agent - H1-histamine receptor blocker

ATX: & nbsp

R.06.A.X.26 Fexofenadine

Pharmacodynamics:

Fexofenadine is a pharmacologically active metabolite of terfenadine. Selectively blocks H₁-gastamine receptors and stabilizes the membranes of mast cells, reduces the release of histamine and other biologically active substances from them.

Does not possess anticholinergic or anti-adrenergic activity. Even in high doses fexofenadine does not block potassium channels in myocardiocytes, thus, does not have a cardiotoxic effect (prolongation of the QT interval, arrhythmia).

Does not have a sedative effect.

The antihistamine effect is manifested within the first hour after ingestion, reaches a maximum after 6 hours and lasts for 24 hours. After 28 days of fexofenadine, there was no development of tolerance to the drug. In the dose range of 10-130 mg, a dose-dependent effect is noted.

Pharmacokinetics:

Suction and distribution

After oral administration, it is rapidly absorbed from the gastrointestinal tract,the time to reach the maximum concentration (T_max) is 1-3 hours. The average value of the maximum concentration (C_max) after ingestion of a single dose of 120 mg-289 ng / ml. The connection with plasma proteins is 60-70%.

Metabolism

It is exposed (5% of the dose) to partial extrahepatic metabolism.

Excretion

Output is unchanged with bile through the intestine (80%), kidney (11.5%).

Biphasic withdrawal. The half-life (T_1/2) after repeated administration is 11-15 hours.

Pharmacokinetics with a single and repeated use of fexofenadine (up to 120 mg twice a day inwards) is linear.

Pharmacokinetics in specific patient groups

In patients with moderate renal insufficiency (creatinine clearance 41-80 ml / min) and severe degree (11-40 ml / min) T_1/2increases by 59 and 72%, respectively; in patients on hemodialysis, T_1/2increases by 31%.

Indications:

Seasonal allergic rhinitis (to reduce symptoms).

Contraindications:

- Hypersensitivity to fexofenadine and other components of the drug;

- pregnancy;

- the period of breastfeeding;

- children under 12 years.

Carefully:

Chronic renal failure, chronic hepatic insufficiency, elderly age, cardiovascular diseases, including in the anamnesis.

Pregnancy and lactation:

There is insufficient data on the use of fexofenadine in pregnant women. Limited studies in animals showed no evidence of adverse effects on pregnancy, intrauterine development, childbirth and postnatal development. Fexofenadine should not be used during pregnancy.

Data on the content of fexofenadine in breast milk when it is taken by breast-feeding women are not available. However, when taking terfenadine (fexofenadine metabolite terfenadine), its presence was found in breast milk. Therefore, the use of fexofenadine during the period of breastfeeding is not recommended.

Dosing and Administration:

Inside, adults and children over 12 years.

The recommended dose is 120 mg 1 time per day before meals.

Special categories of patients

In elderly patients, patients with impaired renal and hepatic function, dose adjustment is not required.

Side effects:

The incidence of adverse drug reactions and / or adverse events is described in accordance with the following gradation: very frequent (> 1/10), frequent (1/10 - 1/100), infrequent (1/100 - 1/1000), rare 1/1000 - 1/10000), very rare (<1/10000) or the frequency is unknown (post-registration data).

In placebo-controlled clinical trials, the incidence of side effects such as headache, drowsiness, dizziness and nausea was similar to that of placebo.

Disturbances from the nervous system: often - headache, drowsiness, dizziness; frequency is unknown - insomnia, nervousness, sleep disturbance, nightmares. Disorders from the gastrointestinal tract: often - nausea; frequency is unknown - diarrhea.

Disturbances from the skin and subcutaneous tissues: rarely - exanthema; frequency unknown - rash, hives, itching.

Disorders from the cardiovascular system: the frequency is unknown - tachycardia, palpitation.

Immune system disorders: frequency is unknown - reactions hypersensitivity (angioedema, difficulty breathing, shortness of breath, skin flushing, systemic anaphylactic reactions).

Other: often - fatigue; infrequently, weakness.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Symptoms: dizziness, drowsiness, dry mouth.

Treatment: Conducting standard measures to remove unabsorbed medication from the gastrointestinal tract (gastric lavage, activated charcoal intake). Symptomatic and supportive therapy. Hemodialysis is ineffective.

Interaction:

When combined with erythromycin or ketoconazole, the concentration of fexofenadine in plasma increases 2-3 times, which is probably due to an increase in absorption in the gastrointestinal tract and a reduction in either excretion of bile or gastrointestinal secretion (not accompanied by increased side effects , including the lengthening of the interval QT).

Reception of aluminum-or magnesium-containing antacids 15 minutes before fexofenadine intake leads to a decrease in bioavailability of the latter (the time interval between their intake should be at least 2 hours).

Fexofenadine does not interact with omeprazole and drugs metabolized in the liver.

Special instructions:

It is recommended that the time interval between taking fexofenadine and antacids containing aluminum and magnesium is at least 2 hours.

In patients with chronic renal and hepatic insufficiency,as well as in elderly patients is used with caution (lack of clinical experience in this category of patients).

Patients with cardiovascular diseases, including in the anamnesis, is used with caution (antihistamines can cause palpitations and tachycardia, see the "Side effect" section).

Effect on the ability to drive transp. cf. and fur:

When taking the drug, it is possible to perform work that requires a high concentration of attention and speed of psychomotor reactions (with the exception of patients who have an unconventional reaction). It is recommended to check up individual reaction to fexofenadine intake before taking these activities.

Form release / dosage:

Tablets, film-coated, 120 mg.

Packaging:

For 10 tablets in PVDC / PE / PVC / / aluminum blister.

For 1 blister in a pack of cardboard with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003926

Date of registration:25.10.2016

Expiration Date:25.10.2021

The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India

Manufacturer: & nbsp

DR. REDDY`S LABORATORIES, LTD. India

Representation: & nbspDR REDDY'S LABORATORIS LTD. DR REDDY'S LABORATORIS LTD. India

Information update date: & nbsp11.11.2016

Illustrated instructions

Instructions

Dinox® (Dinox®)