Adenorm

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Terms and conditions of storage

Adenorm is an antagonist of α ₁ -adrenergic receptors, an agent for the treatment of benign prostatic hyperplasia (BPH).

Release form and composition

Dosage form - capsules with modified release: size No. 2, gelatinous solid, with an orange body and a light green cap; contents - almost white or white spherical pellets (10 pcs. in blisters, 3 blisters in a pack).

Active ingredient: tamsulosin hydrochloride (in the form of tamsulosin hydrochloride 0.15% SR, pellets), in 1 capsule - 0.4 mg.

Auxiliary components: hydroxypropyl methylcellulose, hypromellose phthalate, ethyl cellulose, cetyl alcohol, povidone, talc, diethyl phthalate, spherical sugar.

The composition of the capsule: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), indigotine dye (E 132).

Indications for use

Adenorm is a drug for the treatment of functional disorders of the lower urinary tract caused by benign prostatic hyperplasia.

Contraindications

severe liver failure;
a history of orthostatic hypotension;
age up to 18 years;
concomitant use of strong CYP3A4 inhibitors in patients with low CYP2D6 metabolism;
hypersensitivity to any component of Adenorm.

The drug is not intended for the treatment of women.

Carefully:

severe renal failure (creatinine clearance <10 ml / min);
concomitant use of strong and moderate CYP3A4 inhibitors;
a history of allergic reactions to sulfonamides.

Method of administration and dosage

Adenorm is prescribed 1 capsule per day.

The drug should be taken orally after breakfast: swallow the capsule whole with water or milk (150 ml).

Side effects

on the part of the reproductive system: ejaculation disorders, including insufficient ejaculation and retrograde ejaculation;
from the cardiovascular system: orthostatic hypotension, palpitations;
from the gastrointestinal tract: nausea, constipation or diarrhea, vomiting;
from the nervous system: headache, dizziness, fainting;
on the part of the organs of vision: impairment and blurred vision;
from the skin and mucous membranes: skin rashes, urticaria, itching, exfoliative dermatitis, Stevens-Johnson syndrome, angioedema, erythema multiforme;
respiratory mediastinal disorders: epistaxis, rhinitis;
others: asthenia.

Dyspnea, tachycardia, atrial fibrillation and arrhythmias have also been reported, but the frequency of their development has not been reliably established.

Some cases of intraoperative atonic pupil syndrome (narrowed pupil syndrome) during surgery for glaucoma and cataracts in patients receiving tamsulosin are described.

special instructions

Before the appointment of Adenorm, all patients are shown a medical examination to exclude other concomitant diseases that can cause the same symptoms as BPH. Before starting treatment, a rectal examination of the prostate gland is mandatory, if necessary, before starting therapy and periodically (at regular intervals) during treatment, a prostate specific antigen (PSA) test is performed.

If signs of orthostatic hypotension appear, such as weakness and dizziness, you should sit down or lie down until these symptoms disappear.

Some patients taking tamsulosin may develop atonic pupil syndrome during surgery for glaucoma and cataracts, which can lead to an increase in the number of complications during or after surgery. In this regard, at least 1-2 weeks before the expected date of the operation, Adenorm should be canceled. However, it should be borne in mind that the described syndrome is possible even in patients who stopped taking the drug long before surgery.

Studies on the effect of tamsulosin on reaction rate and ability to concentrate have not been conducted. However, patients should be warned of the possibility of dizziness.

Drug interactions

In the case of simultaneous use, cimetidine increases the concentration of tamsulosin in the blood plasma, and furosemide decreases it. But these levels remain within normal limits, so no dose adjustment of Adenorm is required.

Warfarin and diclofenac may increase the rate of elimination of tamsulosin.

Simultaneously used moderate and strong inhibitors of CYP3A4 can enhance the effect of tamsulosin. Ketoconazole increases the total (during the entire observation period) and maximum concentration of tamsulosin in the blood to 2.8 and 2.2, respectively. Therefore, CYP3A4 inhibitors should be used with caution, and patients with low CYP2D6 metabolism are advised to avoid this combination.

When combined with other α ₁ -adrenergic blockers, an increase in the hypotensive effect is possible.

Terms and conditions of storage

Store in original packaging out of reach of children at temperatures up to 25 ° C.

The shelf life is 3 years.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!