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  • Osmo Adalat
    / Bayer


    Active Ingredient
    Nifedipine 20, 30, 60 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Prolonged-Release Tablets

    30 x 20 mg

    full basket chart 18137 15375

    Prolonged-Release Tablets

    30 x 30 mg

    full basket chart 27863 15382

    Prolonged-Release Tablets

    30 x 60 mg

    full basket chart 5307 15373

    Related information


    Dosage

    As far as possible the treatment must be tailored to the needs of the individual. Depending on the clinical picture in each case, the basic dose must be introduced gradually. Unless otherwise prescribed, the following dosage guidelines are recommended for adults: 
    For coronary heart disease:
     

    Chronic stable angina pectoris (angina of effort)
    1 Osmo-Adalat 20 mg tablet once daily (1 x 20 mg/day)
    1 Osmo-Adalat 30 mg tablet once daily (1 x 30 mg/day)
    1 Osmo-Adalat 60 mg tablet once daily (1 x 60 mg/day)
    For hypertension:
    1 Osmo-Adalat 20 mg tablet once daily (1 x 20 mg/day)
    1 Osmo-Adalat 30 mg tablet once daily (1 x 30 mg/day)
    1 Osmo-Adalat 60 mg tablet once daily (1 x 60 mg/day)
    In general therapy should be initiated with 30 mg once daily.
    Where registered a starting dose of 20 mg once daily may be considered when medically indicated.
    Depending on the severity of the disease and the patient’s response the dose can be increased in stages up to
    120mg once daily. Coadministration 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.Duration of Treatment The attending doctor will determine the duration of use. Administration As a rule Osmo-Adalat tablets are swallowed whole with a little liquid, irrespective of meal times. Grapefruit juice is to be avoided. Additional information on special populations:
    Children and adolescents: The safety and efficacy of Osmo-Adalat in children below 18 years has not been established.
    Geriatric patients: Based on pharmacokinetic data for Osmo-Adalat no dose adaptation in elderly people above 65 years is necessary.
    Patients with hepatic impairment: In patients with impaired liver function, careful monitoring and, in severe cases, a dose reduction may be necessary.
    Patients with renal impairment: Based on pharmacokinetic data no dosage adjustment is required in patients with renal impairment. The tablets must not be chewed or broken up.


    Indications

    Treatment of coronary heart disease: Chronic stable angina pectoris (angina of effort).
    Treatment of hypertension: Treatment of 6321 hypertensive patients with at least one additional risk factor followed over 3 to 4.8 years in a multi-national, randomised, double-blind, prospective study. Nifedipine (Osmo-Adalat) was shown to reduce cardiovascular and cerebrovascular events to a comparable degree as a standard diuretic combination.


    Contra-Indications

    Osmo-Adalat must not be used in cases of known hypersensitivity to nifedipine or to other dihydropyridines because of the theoretical risk of cross-reactivity or to any of the excipients Nifedipine is contraindicated in pregnancy before week 20 and during breastfeedin.Osmo-Adalat must not be used in cases of cardiogenic shock, clinically significant aortic stenosis, unstable angina, or during or within one month of a myocardial infarction. Adalat LA should not be used for the treatment of acute attacks of angina.The safety of Adalat LA in malignant hypertension has not been established. Adalat LA should not be used for secondary prevention of myocardial infarction. Owing to the duration of action of the formulation, Adalat LA should not be administered to patients with hepatic impairment. Adalat LA should not be administered to patients with a history of gastro-intestinal obstruction, oesophageal obstruction, or any degree of decreased lumen diameter of the gastro-intestinal tract. Osmo-Adalat must not be used in patients with Kock pouch (ileostomy after proctocolectomy). Adalat LA is contra-indicated in patients with inflammatory bowel disease or Crohn’s disease.Nifedipine must not be used in combination with rifampicin because no efficient plasma levels of nifedipine may be obtained due to enzyme induction.


    Special Precautions

    Care must be exercised in patients with very low blood pressure (severe hypotension with systolic pressure less than 90 mm Hg), in cases of manifest heart failure and in the case of severe aortic stenosis. There are no safety and efficacy data from well-controlled studies in pregnant women. Animal studies have shown a variety of embryotoxic, placentotoxic and fetotoxic effects when administered during and after the period of organogenesis. From the clinical evidence available a specific prenatal risk has not been identified. Although an increase in perinatal asphyxia, caesarean delivery as well as prematurity and intrauterine growth retardation have been reported. It is unclear whether these reports are due to the underlying hypertension, its treatment or to a specific drug effect. The available information is inadequate to rule out adverse drug effects on the unborn and newborn child. Therefore any use in pregnancy after week 20 requires a very careful individual risk benefit assessment and should only be considered if all other treatment options are either not indicated or have failed to be efficacious. Careful monitoring of blood pressure must be exercised, also when administered nifedipine with i.v. magnesium sulfate, owing to the possibility of an excessive fall in blood pressure which could harm both mother and fetus. As with other non-deformable material care should be used when administering Osmo-Adalat in patients with pre-existing severe gastrointestinal narrowing because obstructive symptoms may occur. Bezoars can occur in very rare cases and may require surgical intervention. In single cases obstructive symptoms have been described without known history of gastrointestinal disorders. When doing barium contrast X-ray Osmo-Adalat may cause false positive effects (e.g. filling defects interpreted as polyp).5/15 In patients with impaired liver function careful monitoring and, in severe cases, a dose reduction may be necessary. Nifedipine is metabolised via the cytochrome P450 3A4 system. Drugs that are known to either inhibit or to induce this enzyme system may therefore alter the first pass or the clearance of nifedipine. Drugs, which are inhibitors of the cytochrom P450 3A4 system and therefore may lead to increased plasma concentrations of nifedipine are, e.g.: – macrolide antibiotics (e.g., erythromycin), – anti-HIV protease inhibitors (e.g., ritonavir), – azole antimycotics (e.g., ketoconazole), – the antidepressants nefazodone and fluoxetine, – quinupristin/dalfopristin, – valproic acid, – cimetidine. Upon co-administration with these drugs, the blood pressure should be monitored and, if necessary, a reduction of the nifedipine dose should be considered. For use in special populations see section Dosage. Adalat LA may be used in combination with beta-blocking drugs and other antihypertensive agents but the possibility of an additive effect resulting in postural hypotension should be borne in mind. Adalat LA will not prevent possible rebound effects after cessation of other antihypertensive therapy. Adalat LA should be used with caution in patients whose cardiac reserve is poor. Deterioration of heart failure has occasionally been observed with nifedipine. Diabetic patients taking Adalat LA may require adjustment of their control. In dialysis patients with malignant hypertension and hypovolaemia, a marked decrease in blood pressure can occur.


    Side Effects

    Peripheral oedema, hypotension, palpitations, nasal and chest congestion, shortness of breath, nausea, diarrhea, constipation, cramps, flatulence, allergic hepatitis, dizziness, light headedness, nervousness, sleep disturbances, blurred vision, headache, flushing, weakness, equilibrium disturbances, dermatitis, rash, pruritus, urticaria, thrombocytopenia, gingival hyperplasia, muscle cramps, joint stiffness, arthralgia, impotence, fever, chills, sweating, sexual difficulties.


    Drug interactions

    Drugs that affect nifedipine: Nifedipine is metabolised via the cytochrome P450 3A4 system, located both in the intestinal mucosa and in the liver. Drugs that are known to either inhibit or to induce this enzyme system may therefore alter the first pass (after oral administration) or the clearance of nifedipine. The extent as well as the duration of interactions should be taken into account when administering nifedipine together with the following drugs:6/15 Rifampicin Rifampicin strongly induces the cytochrome P450 3A4 system. Upon coadministration with rifampicin, the bioavailability of nifedipine is distinctly reduced and thus its efficacy weakened. The use of nifedipine in combination with rifampicin is therefore contra-indicated. Upon co-administration of the following weak to moderate inhibitors of the cytochrome P450 3A4 system the blood pressure should be monitored and, if necessary, a reduction in the nifedipine dose considered. Macrolide antibiotics (e.g., erythromycin) No interaction studies have been carried out between nifedipine and macrolide antibiotics. Certain macrolide antibiotics are known to inhibit the cytochrome P450 3A4 mediated metabolism of other drugs. Therefore the potential for an increase of nifedipine plasma concentrations upon co-administration of both drugs cannot be excluded. Azithromycin, although structurally related to the class of macrolide antibiotics is void of CYP3A4 inhibition.
    Grapefruit juice: Grapefruit juice inhibits the cytochrome P450 3A4 system. Administration of nifedipine together with grapefruit juice thus results in elevated plasma concentrations and prolonged action of nifedipine due to a decreased first pass metabolism or reduced clearance. As a consequence, the blood pressure lowering effect may be increased. After regular intake of grapefruit juice this effect may last for at least 3 days after the last ingestion of grapefruit juice. Ingestion of grapefruit / grapefruit juice is therefore to be avoided while taking nifedipine.
    For full details see prescribing information.


    Pregnancy and Lactation

    Nifedipine is contraindicated in pregnancy before week 20. There are no adequate and well controlled studies in pregnant women. In animal studies nifedipine has been shown to produce embryotoxicity, fetotoxicity and teratogenicity.
    Lactation Nifedipine passes into the breast milk. As there is no experience of possible effects on infants,breastfeeding should first be stopped if nifedipine treatment becomes necessary during the breastfeeding period.
    In-vitro fertilization In single cases of in vitro fertilization calcium antagonists like nifedipine have been associated with reversible biochemical changes in the spermatozoa`s head section that may result in impaired sperm function. In those men who are repeatedly unsuccessful in fathering a child by in vitro fertilization, and where no other explanation can be found, calcium antagonists like nifedipine should be considered as possible causes.
    For full details see presctibing information.


    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, tachycardiac / bradycardiac heart rhythm disturbances, hyperglycaemia, metabolic acidosis, hypoxia, cardiogenic shock with pulmonary oedema.
    Management of Overdose: As far as treatment is concerned, elimination of the active substance and the restoration of stable cardiovascular conditions have priority. After oral ingestion thorough gastric lavage is indicated, if necessary in combination with irrigation of the small intestine. Particularly in cases of intoxication with slow-release products like Osmo-Adalat elimination must be as complete as possible, including the small intestine, to prevent the otherwise inevitable subsequent absorption of the active substance. Haemodialysis serves no purpose, as nifedipine is not dialysable, but plasmapheresis is advisable (high plasma protein binding, relatively low volume of distribution).


    Manufacturer
    Bayer Pharma AG
    Licence holder
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