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  • Pressolat 10
    / Bayer


    Active Ingredient
    Nifedipine 10 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Modified-Release Tablet

    30 X 10 mg

    full basket chart 9149 16817

    Related information


    Dosage

    As far as possible the treatment must be tailored to the needs of the individual according to the severity of the disease and the patient’s response. Depending on the clinical picture in each case, the basic dose must be introduced gradually Pressolat 10 mg is particularly suitable for dose titration. Dose titration is particularly recommended for hypertensives with severe cerebrovascular disease and for patients, who because of low body weight or multiple therapies with other antihypertensive drugs, are likely to have an excessive reaction to nifedipine. In addition, patients in whom side effects in response to the nifedipine treatment make a finer dose adjustment desirable should be individually stabilized with Pressolat 10 mg.
    Unless otherwise prescribed, the following dosage guidelines apply for adults:  In hypertension: 1 Pressolat 10 mg tablet twice daily (2 x 10 mg/day); 2 Pressolat 10 mg tablet twice daily (2 x 20 mg/day).
    If higher dosages are necessary, the dose can be increased in stages up to maximum 60 mg daily.
    Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may result in the recommendation to adapt the nifedipine dose or not to use nifedipine at all.  for full details see prescribing information.


    Indications

    Treatment of hypertension.


    Contra-Indications

    Known hypersensitivity to nifedipine or to any of the excipients. Pregnancy before week 20 and during breastfeeding. Cardiovascular shock, clinically significant aortic stenosis, unstable angina pectoris, or during or within four weeks of a myocardial infarction. Should not be used in combination with rifampicin because no efficient plasma levels of nifedipine may be obtained due to enzyme induction. Should not be used for the treatment of acute attacks of angina. Should not be used for secondary prevention of MI.
    See prescribing information for full details.


    Special Precautions

    Occasional patients have had excessive and poorly tolerated hypotension during initial titration or at a time of subsequent upward dosage adjustment mostly in patients on concomitant beta blockers. Rarely increased angina and/or myocardial infarction, patients recently withdrawn from beta blockers, liver insufficiency. The tablets must only be removed from the foil immediately before use.
    See prescribing information for full details.


    Side Effects

    Common: Headache, Oedema (including peripheral oedema), Vasodilatation,
    Constipation, Feeling unwell.
    See prescribing information for full details.


    Drug interactions

    Antihypertensives: diuretics, beta blockers, ACE-inhibitors, angiotensin I, receptor-antagonists, otehr calcium anatagonists, alfa-adrenergic blocking agents, PDES inhibitors, alfa methyldopa. Digoxin, phenytoin, carbamazepine, phenobarbitane, cimetidine, rifampicin, tacrolimus, grapefruit juice.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Pressolat should not be used during pregnancy unless the clinical condition of the woman requires treatment with nifedipine.
    Breastfeeding: Nifedipine is excreted in the breast milk. The nifedipine concentration in the milk is almost comparable with mother serum concentration. For immediate release formulations, it is proposed to delay breastfeeding or milk expression for 3 to 4 hours after drug administration to decrease the nifedipine exposure to the infant.
    See prescribing information for full details.


    Overdose

    Symptoms: The following symptoms are observed in cases of severe nifedipine intoxication:
    Disturbances of consciousness to the point of coma, a drop in blood pressure, tachycardia, bradycardia, hyperglycaemia, metabolic acidosis, hypoxia, cardiogenic shock with pulmonary oedema.
    Treatment: As far as treatment is concerned, elimination of nifedipine and the restoration of stable cardiovascular conditions have priority.
    Elimination must be as complete as possible, including the small intestine, to prevent the otherwise inevitable subsequent absorption of the active substance.
    The benefit of gastric decontamination is uncertain.
    1. Consider activated charcoal (50 g for adults, 1 g/kg for children) if the patient presents within 1 hour of ingestion of a potentially toxic amount.
    Although it may seem reasonable to assume that late administration of activated charcoal may be beneficial for sustained release (SR, MR) preparations there is no evidence to support this.
    2. Alternatively consider gastric lavage in adults within 1 hour of a potentially life-threatening overdose.
    3. Consider further doses of activated charcoal every 4 hours if a clinically significant amount of a sustained release preparation has been ingested with a single dose of an osmotic laxative (e.g. sorbitol, lactulose or magnesium sulphate).
    4. Asymptomatic patients should be observed for at least 4 hours after ingestion and for 12 hours if a sustained release preparation has been taken.
    Haemodialysis serves no purpose as nifedipine is not dialysable, but plasmapheresis is advisable (high plasma protein binding, relatively low volume of distribution).
    Hypotension as a result of cardiogenic shock and arterial vasodilation can be treated with calcium (10 – 20 ml of a 10 % calcium gluconate solution administered intravenously over 5-10 minutes). If the effects are inadequate, the treatment can be continued, with ECG monitoring. If an insufficient increase in blood pressure is achieved with calcium, vasoconstricting sympathomimetics such as dopamine or noradrenaline should be administered. The dosage of these drugs should be determined by the patient’s response.
    Symptomatic bradycardia may be treated with atropine, beta- ympathomimetics or a temporary cardiac pacemaker, as required.
    Additional fluids should be administered with caution to avoid cardiac overload.


    Manufacturer
    Bayer Pharma AG
    Licence holder
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