OBSIDAN. 25 mg. 50 tablets

OBSIDAN. 25 mg. 50 tablets
€ 12.00
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Angina pectoris - for prevention and treatment of angina attacks;
- Arterial hypertension of various origins - alone or in combination with other antihypertensive agents;
- Myocardial infarction - the treatment during the acute phase of the infarct, as well as for long-term secondary prophylaxis after myocardial infarction .

OBSIDAN. 25 mg. 50 tablets

 
 
PHARMACEUTICAL FORM
Tablets
 
 
CLINICAL DATA
 
1 Indications
- Angina pectoris - for prevention and treatment of angina attacks;
- Arterial hypertension of various origins - alone or in combination with other antihypertensive agents;
- Myocardial infarction - the treatment during the acute phase of the infarct, as well as for long-term secondary prophylaxis after myocardial infarction;
- Rhythm disorders of the heart - supraventricular and ventricular tachycardia as a result of increased sympathetic tone;
- In the complex treatment of thyrotoxicosis;
- In the complex treatment of pheochromocytoma;
- Prophylaxis of migraine headaches; Familial essential tremor.
 
 
4.2 Posology and method of administration
The dosage must be individualized - primarily based on the success of the treatment.
The following guidelines for dosage recommended for adults:
hypertension
Initially 25-40 mg propranolol 2-3 times daily, with a consequent increase in the dosage if the effects are insufficient to maximum 320 mg.
Angina / arrhythmias cardiac Initially 25-40 mg propranolol 3 times a day; if necessary, the dose may be increased to 160-240 mg daily.
 
 
Hyperthyroidism (with its complex treatment)
Three times the 12.5 mg three times daily 25 mg propranolol, possibly increasing to 120-160 mg daily.
 
Prophylaxis of migraine headache / tremor
25-40 mg propranolol 2-3 times daily. The daily dose may reach 160 to 240 mg.
 
 
In the prevention of myocardial infarction
Treatment should start within 5 and 21 days post-myocardial infarction 40 mg three times daily for 2 to 3 days.
Thereafter, treatment can be continued with 40-80 mg twice daily.
- In the case of very limited hepatic or renal function, elimination of propranolol is reduced, which may mean that under certain conditions a reduced dosage.
 
 
Instructions for dosage:
The tablets should be swallowed whole with some liquid after meals. Treatment is not limited to a specific period.
If after a long period of use, treatment with 25 mg OBSIDAN ® should be interrupted or discontinued, the change must be done slowly, as abrupt discontinuation may cause myocardial ischemia with an exacerbation of symptoms of angina pectoris or worsening of hypertension.
 
 
 
4.3 Contraindications
OBSIDAN ® 25 mg should not be applied to cases of:
- Hypersensitivity to propranolol, other beta-receptor blockers us or any of the other ingredients of the medicinal product;
- Decompensated congestive heart failure (NYHA III and IV);
- Cardiogenic shock;
- AV block, second and third degree; SA-block;
- Syndrome sick sinus;
- Sinus bradycardia (heart rate at rest below 50 beats per minute before treatment);
- Hypotension;
late stages of peripheral arterial diseases;
- Obstructive pulmonary disease (e.g., in the case of bronchial asthma);
metabolic acidosis
- Concomitant use of MAO inhibitors (except MAO-B inhibitors).
In patients receiving propranolol, is contraindicated intravenous administration of calcium channel blockers of the verapamil and diltiazem antiarrhythmic shi other products (such as disopyramid). Exception - intensive care.
 
 
4.4 Special warnings and special precautions for use
 
Special medical supervision is needed when:
- AV block, first degree;
- Diabetics, in particular those having a strongly varying amounts of glucose and in the case of continuous strict diet and greater performance (due to the possibility of serious hypoglycemic conditions);
- Patients with pheochromocytoma (to be introduced only after pre-treatment with alpha-receptor blockers);
- Patients with hepatic or renal insufficiency (see "Dosage" and "side effects").
In patients with psoriasis in their personal or family history, beta-blockers should be administered after careful risk-benefit. Beta-blockers may increase sensitivity to allergens and to enhance the severity of anaphylactic reactions. For this reason, a precise diagnosis of patients with significant hypersensitivity reactions in their history who have received treatment for desensitization (attention, excessive anaphylactic reactions).
It is a medicinal product to be used with caution in elderly patients, as can be observed increased or decreased sensitivity to the usual doses of the product.
Administration of propranolol rarely may lead to changes in some laboratory tests - elevated levels of serum lipoproteins and triglycerides, increased serum potassium falsely elevated levels of catecholamines and their breakdown products in urine or blood, increased levels of antinuclear antibodies, screening tests for falshivootritsatelni glaucoma.
 
 
4.5 Interactions
Must be taken into account the following interactions between drug and other substances:
- Concomitant use of OBSIDAN © 25 mg of insulin or other antidiabetic drugs may induce hypoglycaemia. The warning signs of hypoglycaemia - particularly tachycardia and tremor - can be camouflaged. It therefore needs regular blood sugar control.
- Concomitant use of OBSIDAN ® 25 mg tricyclic antidepressants, barbiturates, fenotiazidi, glyceryl trinitrate, diuretics, vasodilators, and other antihypertensive drugs can cause a further drop in blood pressure.
- In case of concomitant OBSIDAN ® 25 mg and calcium channel blockers such as nifedipine, may cause further drop in blood pressure, sometimes to the development of heart failure.
Cardiac depressant effect of OBSIDAN ® 25 mg and other antiarrhythmic products may be additive.
With concomitant administration of OBSIDAN ® 25 mg and calcium blockers of the verapamil or diltiazem, or other antiartimichni products (such disopyramid), requires careful monitoring of the patient, as may occur hypotension, bradycardia or other cardiac disorders.
Concomitant administration of 25 mg OBSIDAN ® with reserpin, clonidine, alpha-methyldopa, guanfacin or cardiac glycosides may increase cardiac depressant effect.
If the sharp break in treatment with clonidine use of propranolol, the blood pressure can be greatly increased. Therefore, administration of clonidine may be suspended only if treatment OBSIDAN ® 25 mg was suspended a few days earlier. Then clonidine may be phased out (see specialized information on clonidine).
With concomitant administration of OBSIDAN ® 25 mg with adrenaline or noradrenaline is possible to significantly increase blood pressure. Due to the increased symptoms of hypertension, MAO inhibitors should not be taken concurrently with OBSIDAN ® 25 mg. Indomethacin can reduce the antihypertensive effect of OBSIDAN ® 25 mg.
Concomitant use of OBSIDAN ® 25 mg and drugs can cause a severe drop in blood pressure. The negative inotropic effect of the above drugs may be additive.
Neuromuscular relaxation with peripheral muscle relaxants (eg tubocurarine, suxamethonium) may be increased by beta-receptor blockers.
If the adoption of propranolol can not be discontinued prior to operations involving general anesthesia or prior to administration of peripheral muscle relaxants, anestezio dogat should be informed about treatment with OBSIDAN © 25 mg. Therapeutic effects of OBSIDAN ® are amplified by cimetidine.
 
 
4.6 Pregnancy and lactation
During pregnancy, propranolol should be administered after careful risk-benefit.
Propranolol passes into breast milk. Although the amount of the drug taken by the mother's milk is probably not a danger to small children, it is recommended that nursing be discontinued (see section 5.3 Pharmacokinetic properties and 5.3 Preclinical safety data).
 
 
4.7 Effects on ability to drive and use machines
Information about drivers and other road users treat hypertension with this medicine requires patients to be closely monitored. The emergence of various individual reactions may impair the ability to actively participate in traffic, use machines or unsafe places. This is particularly important at the beginning of treatment, when changing the product and when used with alcohol.
 
 
4.8 Undesirable effects
Treatment with 25 mg OBSIDAN ® can sometimes cause an increased drop in blood pressure, bradycardia, syncope, palpitations, decreased AV-conduction or congestive heart failure.
In some cases, patients with angina pectoris, attacks of amplification can not be excluded.
Sometimes you may experience paresthesia and a feeling of coldness in the extremities or in rare cases, muscle cramps or weakness. Have also been observed in patients complaints deterioration in peripheral artery disease (including patients with Alzheimer Raynaud).
At the beginning of therapy may occur violations of central neurological character such as headache, depressed mood, sleep disturbances, nightmares and hallucinations, fatigue, vertigo, dizziness, confusion, emotional lability, sweating.
Sometimes it may appear temporary epigastric discomfort, nausea, vomiting, constipation or diarrhea.
In some cases, when an increase in serum transaminase activity (GOT, GPT).
Sometimes you might develop allergic skin reactions (erythematous rash).
As a result, a possible increase in airway resistance, in patients with a tendency to bronchospastic reactions (in particular, cases with obstructive pulmonary disease), may experience difficulty in breathing, often - laryngospasm.
In rare cases can occur agranulocytosis, netrombotsitopenichna or thrombocytopenic purpura.
In some cases involving long-term treatment with OBSIDAN ® 25 mg, can be observed arthropathy (monoarthritis or polyarthritis). Extremely rarely observed autoimmune reactions such as systemic Lupus erythematodes.
In rare cases can occur latent diabetes or worsen existing diabetes mellitus. After long periods of strict fasting and great exercise, during concomitant OBSIDAN ® 25 mg, may develop hypoglycemia. Warning signs (in particular tachycardia and tremor) may be masked.
In patients with hyperthyroidism, are treated symptomatically with OBSIDAN ® 25 mg, clinical indicators thyrotoxicosis (tachycardia and tremor) may be masked.
In cases of severe renal impairment, there are isolated reports of subsequent deterioration during treatment with OBSIDAN ® 25 mg. The use of OBSIDAN © 25 mg should be under appropriate supervision of renal function (see "Dosage").
During the treatment with 25 mg of OBSIDAN ® may occur disturbances of lipid metabolism. In cases with normal cholesterol levels were observed to decrease in HDL-cholesterol and elevated level of plasma triglycerides.
In rare cases, dry mouth, conjunctivitis or decrease lacrimation (must be borne in mind when wearing contact lenses) as well as in individual cases, a blurred vision and keratoconjunctivitis. Rarely observed disturbances in libido and potency, Alopecia, LE-like syndrome.
 
 
  Special remarks:
Due to the emergence of severe liver injury during treatment with other beta-blockers, liver enzyme tests should be regularly monitored.
In some cases, beta-blockers can precipitate psoriasis, worsen the symptoms of the disease or cause psoriasiform rashes. Beta-blockers can improve the sensitivity to allergens, and may enhance the severity of anaphylactic reactions. Patients with hypersensitivity reactions expressed in their history and in patients undergoing desensitization can occur strong anaphylactic reaction.
 
 
4.9 Overdose
a) Symptoms of intoxication
The clinical picture, depending on the degree of intoxication, mainly characterized by cardiovascular symptoms and signs of central neurological nature. Overdose may cause severe hypotension, bradycardia, which can develop into cardiac arrest, heart failure and cardiogenic shock. In addition, you may experience dyspnoea, bronchospasm, vomiting, disturbance of consciousness and generalized tonic convulsions.
 
b) Treatment of overdose
If an overdose or following treatment slowed heart rate and / or blood pressure drops, the adoption of OBSIDAN ® 25 mg should be discontinued.
Apart from general measures employed in the initial elimination of toxins, vital parameters need to be monitored in terms of intensive treatment. Can be entered following antidotes:
Atropine: 0.5 - 2.0 mg intravenous bolus
Glucagon: initial 1 - 10 mg intravenously followed by 2 - 2.5 mg per hour as a continuous infusion. Sympathomimetic can apply any of these products, based on body weight: dopamine, dobutamine, isoprenaline, orciprenaline or adrenaline.
In the case of bradycardia, refractory to treatment, can be placed temporarily pacemaker.
In the case of bronchoconstriction can be administered a sympathomimetic B2 in the form of a spray (either intravenously, if the spray is not effective enough), or can be administered intravenously aminophylline.
In the case of generalized tonic seizures can be administered intravenously diazepam.
 
 
5. Pharmacological
5.1 Pharmacodynamic properties
 
Pharmacotherapeutic group: beta-receptor blocker
ATC Code: 07 AA05 Propranolol is lipophilic, kardioneselektiven beta-receptor blocker with membrane-stabilizing effect without intrinsic sympathomimetic activity (ISA). Substance inhibiraV1i and B2 receptors.
Depending on sympathetic activity, propranolol decreased heart rate and contractility / atrio-ventricular conduction and plasma renin activity. B2-receptor inhibition, propranolol increases smooth muscle tone.
 
 
5.2 Pharmacokinetic properties
Following oral administration, propranolol hydrochloride is absorbed more than 90% in the gastrointestinal tract. Propranolol hydrochloride is a marked first-pass effect. The absolute systemic availability of propranolol is about 30%. Maximum plasma levels are reached after 1-2 hours. Binding of propranolol hydrochloride in plasma protein binding is approximately 90%, the relative volume of distribution was 3,6 I / kg.
One of the metabolites (4-hydroxypropranoIol), formed by the degradation in the liver also has beta-blocking effect. Concentration and half-life, however, is negligible.
Propranolol hydrochloride and its metabolites are eliminated by 90% through the kidneys, and more than one percent is excreted unchanged. Elimination half-life of propranolol hydrochloride was on average between 3 and 4 hours of normal kidney function.
 
 
 
  other Information
Propranolol crosses the placenta and reaches kontsentratsionnni values in cord blood, which are comparable to those in maternal serum, even a little higher. There are no adequate studies on the application of propranolol during pregnancy. In some cases there are reported complications such as inhibition of intrauterine growth and premature birth, as well as bradycardia, hypotension, hypoglycemia, and respiratory depression (neonatal asphyxia) in neonates.
When treatment is close to the expected date of birth, should be carefully monitored for 48-72 hours after birth. Propranolol passes into breast milk. Although the amount of the drug that has passed into breast milk, probably does not represent a danger for newborn infants should be observed.
 
 
  5.3 Preclinical safety data
a) Acute toxicity
See section 12: Emergency medicine, symptoms and antidotes.
 
b) Chronic Toxicity
There are no toxic effects in chronic toxicity tests conducted on mice.
 
c) Mutagenicity and tumor-inducing potential
In vitro and in vivo tests provide data on relevant mutagenic effects. In long-term studies in rats and mice have revealed no evidence of tumor-inducing potential.
 
d) toxicity and reproductive activity
Embryotoxic potential of propranolol was studied on two animal species (rat and mouse). At high doses, it has been found that the treated mothers have extremely small fetuses. None of the species showed no evidence of teratogenic effects induced by propranolol.
 
 
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
 
Talcum, lactose, gelatine, highly-disperse silicon dioxide, magnesium stearate, potato starch.
 
 
6.2 Incompatibilities
He is known incompatibilities.
 
6.3 Shelf life
5 (five) years
After the expiration date, this product should no longer be used.
 
 
6.4 Special precautions for storage
No special precautions for storage.
 
6.5 Nature and contents of container
50 tablets
 
 
 
 
€ 12.00
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