; supervision, C.A. The ODF of atenolol formula using HPMC E5 and CMC-Na met the folding endurance requirement of ODF (>300 times), where F1 and F2 obtain excellent value. official website and that any information you provide is encrypted The FT-IR spectrum of pure drug, film former, and extruded films were recorded using an FT-IR spectrometer (Shimadzu FT-IR 4200, Kyoto, Japan) over a scan range from 4000 to 400 cm1. Despite being one of the most widely prescribed beta blockers, evidence suggests atenolol may not significantly reduce mortality, and only modestly reduce the risk of cardiovascular disease in patients with hypertension. Formula 1 exhibited the highest drug release compared to the other ODFs. Samples were taken after 30 min, and the amount of drug dissolved is shown in Figure 6. Improving sodium alginate films properties by phenolic acid addition. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. This mechanism can reduce the extent of the first-pass effect and food interactions during the absorption process [4]. Neonates born to mothers who are receiving Atenolol at parturition or breast-feeding may be at risk of hypoglycaemia and bradycardia. Similar results were found in the interaction of atenolol-HPMC II that showed hydrogen bonds between H14 and H5 atoms of atenolol with O8 atom of HPMC II, H21 of atenolol and O13 of HPMC II, and H22 of atenolol with O6 atom of HPMC with binding distances of 1.87, 2.05, 1.99, and 2.19 , respectively. and N.L.D.A. Should be used with caution in the elderly, starting with a lesser dose (see Section 4.2). ODF was placed in a petri dish, then wetted by using 0.5 mL purified water for 60 s. The pH of ODF was measured by touching a pH meter (Schott pH meter LAB 850, Mainz, Germany) electrode of with the ODF surface. Where such reasons exist, Atenolol may be used with caution. Patients who suddenly stop taking atenolol, as would happen if clopidogrel were misplaced in the atenolol-labeled bottle, are at increased risk for ischemic (angina, myocardial infarction), hypertensive and arrhythmic adverse events relating to rapid withdrawal of beta antagonism. The stationary phase used was Acquity UPLC BEH C18 1.7 m (2.1 50 mm column) and the detector was a UV detector. The atenolol blood levels are consistent and subject to little variability. Centkowska K., awrecka E., Sznitowska M. Technology of orodispersible polymer films with micronized loratadineInfluence of different drug loadings on film properties. The FT-IR spectrum of each ODF revealed an interaction between atenolol and film former. [(accessed on 23 December 2020)]. Hypertension. Therefore, these characteristics leads to a faster disintegration time of F5 and F6. ODF of atenolol prepared using HPMC E5 and CMC-Na as film former presents good folding endurance (>300 times) [13]. Meanwhile, sodium alginate as a film former produced a rough, porous structure and widely open pores. FOR IMMEDIATE RELEASE- SEPTEMBER 29, 2022, Golden State Medical Supply, Incorporated (GSMS, Inc.) - Camarillo, CA has initiated a voluntary recall of the products listed in the table below because a report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot# GS046745 was mislabeled as Atenolol 25mg Tablets. Citric acid, potassium acesulfame, methyl paraben, and orange flavor pharmaceutical grade were purchased from Merck and Co. Inc. (Kenilworth, IL, USA). nifedipine, may increase the risk of hypotension, and cardiac failure may occur in patients with latent cardiac insufficiency. by stating that Atenolol pharmaceutical grade was purchased from Refarmed Chemicals Ltd. (Lugano, Switzerland) and Poloxamer 188 pharmaceutical grade was purchased from BASF Corporation (Ludwigshafen, Germany). The surface pH of ODF should be within the normal range of salivary pH 6.87.4 [5]. Nevertheless, sodium alginate produced ODF with poor folding endurance. The weight uniformity test was carried out by weighing 20 units of ODF at a size of 2 3 cm. This analysis can predict the possible interaction between the drug and film former in ODFs. Then, 2 mL of dibutyl amine and phosphoric acid 0.8 M were added to the mixture until it reached pH 3.0. Molecular docking of (a) atenolol-sodium alginate; (b) atenolol-CMC-Na; and (c) atenolol and HPMC (left: I and right: II) indicates the presence of hydrogen and hydrophobic bonds between atenolol and the film former. Atenolol is compatible with diuretics, other hypotensive agents and antianginals (see section 4.5). Ouda G.I., Dahmash E.Z., Alyami H., Iyire A. The dosage should be withdrawn gradually over a period of 7-14 days, to facilitate a reduction in beta-blocker dosage. Signs of dehydration include peeing less than usual or having dark, strong-smelling pee. The film was directly fixed on a metal stub using double side adhesive tape. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. The solvent casting method was used to develop all of these formulas as the method is the most visible method in the optimization study of pharmaceutical ODF. The possible uses of haemodialysis or haemoperfusion may be considered. after using it; Fatty foods do not affect the effectiveness of drug; Levitra Jelly can be used by men with various health problems, such as high cholesterol, diabetes, or high blood pressure. The drug facilitates compliance by its acceptability to patients and simplicity of dosing. Further, patients who are on atenolol are frequently on concomitant anticoagulant and antiplatelet medications and would be at increased risk for bleeding if clopidogrel were added to the regimen. May cause a hypersensitivity reaction including angioedema and urticaria. Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up. ODF of atenolol produced in this study exhibited neutral pH, therefore these ODFs are safe and acceptable to be used in the oral cavity without any problem concerning irritation. Anaesthetic agents causing myocardial depression are best avoided. The next step is to evaluate the films. The dissolution medium used was 900 mL of acetate buffer pH 4.6. The FT-IR spectrum of the atenolol (pure drug), film former (HPMC, CMC-Na, and Na-alginate), and oral dissolving films were compared to determine drug-excipient interaction, especially film former [10]. Although contraindicated in uncontrolled heart failure (see section 4.3), may be used in patients whose signs of heart failure have been controlled. ODF was dissolved with 50 mL mobile phases in a glass beaker and sonicated for 5 min. Levitra Jelly is a fruit-flavored drug that has a pleasant smell/taste, and it can be added to a drink; The medicine starts working from 15 min. Lake Erie Medical Dba Quality Care Products Llc, Ncs Healthcare Of Ky, Inc Dba Vangard Labs, Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc, PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD, IN GENERAL, NOT RECEIVE BETA BLOCKERS. This method required a petri dish, plate glass, and digital analytic scale where the film was then weighed and immersed into simulated saliva solution (phosphate buffer pH 6.8). Consumers with questions regarding this recall can contact GSMS, Inc, by: The thickness uniformity is also directly associated with the dose uniformity. Films with a 25% w/v concentration of both polymers (HPMC E5 and CMC-Na) are clear, transparent, and of preferable mechanical characteristics [8]. Teva Pharmaceuticals has issued a voluntary recall of its amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets, both used to treat high blood pressure, according to the FDA. The viscosity of the film matrix increased with the increase in the concentration of film former, therefore lengthen the disintegration time of ODF [29]. Atenolol is an additional treatment to standard coronary care. The development of oral dissolving film (ODF) of atenolol is an attempt to enhance convenience and compliance for geriatric patients suffering from hypertension. Al-Ghabban F.M., Al-Ani I.H., Hassan S.F., Salan N. Formulation of Prifinium Bromide and Prifinium Bromide-Diclofenac Sodium combination as orodispersible tablets. Kumar C., Verma S., Singh B., Haque A., Satija S., Vyas M. A review on conventional and modern techniques to develop Orodispersible films. Propylene glycol pharmaceutical grade was purchased from Shell Chemicals (The Hague, The Netherlands). Thus, the disintegration time of sodium alginate based ODFs (F5 and F6) was significantly faster than the other film formers. Fourier transform infrared (FT-IR) studies were carried out to analyze the possible drug-excipient interaction. The swelling index is a parameter to describe ODF swelling property when in contact with an aqueous medium [25]. ); moc.liamg@acilegnaaitnerolf (F.A. For patients with a creatinine clearance of less than 15 ml/min/1.73 m2 (equivalent to serum creatinine of greater than 600 micromol/litre), the oral dose should be 25 mg (one 5ml spoonfuls) daily or 50 mg (two 5ml spoonfuls) on alternate days and the intravenous dose should be 10 mg once every four days. 116 (include days between 7:30 AM to 4: . Atenolol crosses the placental barrier and appears in the cord blood. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. However, HPMC E5 showed better film forming ability, physical properties, drug content homogeneity, and drug release profile compared to the other film formers. Brian Park, PharmD. To date, GSMS, Inc. has not received any reports of adverse events related to the use of the products as part of this recall. The homogeneity, drug content, and dissolution properties of ODF with HPMC exhibited better characteristics than the other formulas. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. It can be seen in Figure 4 that an increase in the concentration of the film former in the formula resulted an in an increase in the weight of the formulated ODF. All authors have read and agreed to the published version of the manuscript. Hydroxypropyl methylcellulose (HPMC) E5, carboxymethyl cellulose sodium (CMC-Na), and sodium alginate (Na-alginate) are several polymers that have film-forming abilities [7]. Putting a heat pad or covered hot water bottle on your stomach may also help. They are also instructed to provide their customers, i.e., pharmacies and consumers, a copy of GSMS, Inc.s recall notification, recall response form, and letter to consumers, patients, and caregivers. Sodium alginate also has good film properties and is non-sticky when applied as film former [11]. Consequently, various studies have reported that oral atenolol can be an alternative therapy to propranolol in IH. Clopidogrel is prescribed to lower the risk of having a stroke, blood clot, or serious heart problem for patients who have had heart attack, severe chest pain, or circulation problems as indicated in the product labeling. Ayorinde J.O., Effiong D.E., Odeniyi M.A. Sodium carboxymethyl cellulose (CMC-Na) pharmaceutical grade was purchased from Handan Yaxiang Chemical (Handan, China), Sodium alginate (Na-alginate) pharmaceutical grade (I-3 type) was purchased from Kimica Corporation (Tokyo, Japan). Sodium: This medicinal product contains 2.79mg sodium per ml, equivalent to 0.14% of the WHO recommended maximum daily intake of 2 g sodium for an adult. If the two drugs are co-administered, the beta-blocker should be withdrawn several days before discontinuing clonidine. Sleep disturbances of the type noted with other beta-blockers, Mood changes, nightmares, confusion, psychoses and hallucinations, Heart failure deterioration, precipitation of heart block, Postural hypotension which may be associated with syncope, intermittent claudication may be increased if already present, in susceptible patients Raynaud's phenomenon, Respiratory, thoracic and mediastinal disorders, Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints, Hepatic toxicity including intrahepatic cholestasis, Alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes, Hypersensitivity reactions, including angioedema and urticaria, General disorders and administration site conditions, An increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this is not clear, Musculoskeletal and connective tissue disorders. 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