ODF, when using CMC-Na as a film former (F3 and F4), exhibited wider variation of film thickness compared to the other formulas. Atenolol content in ODF was analyzed using UPLC instrument. Benavides S., Villalobos-Carvajal R., Reyes J.E. The HPMC had two values of G in silico based on the 2D chemical structure depiction of HPMC (Pubchem Hydroxypropylmethilcellulose compound) resulting in two different molecular structure. The solvent casting method was used to develop ODF of atenolol. FOIA Combined use of beta-blockers and calcium channel blockers with negative inotropic effects, e.g. Caution must be exercised in patients whose cardiac reserve is poor. The FT-IR spectrum of each ODF revealed an interaction between atenolol and film former. The oral bioavailability of atenolol is approximately 4555%, due to the first-pass effect mechanism [5]. ); di.ca.ayabu.ffats@itnartupinadirtsa (A.R.P. AmerisourceBergen and McKesson are instructed to immediately stop distribution, quarantine all remaining products in their control, and return the recalled product to GSMS, Inc. Pharmacotherapeutic group: Beta-blocking agents, plain, selective, ATC code: C07A B03. Raza S.N., Kar A.H., Wani T.U., Khan N.A. Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in . The swelling index of ODF formulated with CMC-Na showed a significant value compared to the other two film formers, as seen in Figure 3. Ouda G.I., Dahmash E.Z., Alyami H., Iyire A. Hydroxypropyl methyl cellulose (HPMC) E5 pharmaceutical grade was purchased from Wuhan Senwayer Century Chemical Co., Ltd. (Wuhan, China). Stick to simple meals and do not eat rich or spicy food. Patients should be followed during withdrawal, especially those with ischaemic heart disease. ; supervision, C.A. Sorbitol (E420): This medicinal product contains 280mg sorbitol in each ml. Physical appearance of the ODF. Closure: Tamper evident, child resistant, polypropylene/polyethylene plastic cap with a LDPE liner, Dosing Device: a double ended polypropylene plastic spoon having smaller end measuring 2.5ml and larger end measuring 5ml. Centkowska K., awrecka E., Sznitowska M. Technology of orodispersible polymer films with micronized loratadineInfluence of different drug loadings on film properties. The particle shape and morphology of the ODFs were analyzed using a scanning electron microscope. Taxotere side effects include permanent hair loss, Diabetes drug Invokana lawsuit information, Problems from Essure birth control procedure. Some portion of the drug may be absorbed in the oral cavity, pharynx, and esophagus as the saliva passes down into the stomach. Kathpalia H., Patil A. Formulation and evaluation of orally disintegrating films of levocetirizine dihydrochloride. However, all of the film formers keep exhibited suitable film thickness of oral dissolving films. The film forming capacity of the polymer is described as the ability of a polymer to form a film that can be easily exfoliated from the casting surface without damage or torn [5]. Take small, frequent sips if you're being sick. The high values of swelling index indicate that the polymer can be easily penetrated by water molecule [27]. The authors declare no conflict of interest. ; investigation, F.I., F.A., and C.Y. The ODF of atenolol prepared using Na- alginate as a film former afforded the lowest film thickness and moderate swelling property. The increased of film former concentration resulted in the increase of ODF thickness, which is implicated in an increase in the weight of the formulated ODF [22]. An increased in the ODF thickness reflects an increase in drug content and variety of mass [22]. About atenolol Who can and cannot take it How and when to take it Side effects Pregnancy, breastfeeding and fertility Taking atenolol with other medicines and herbal supplements Common questions Careers, Unable to load your collection due to an error. Get an alert when a recall is issued. No other Clopidogrel or Atenolol products marketed by GSMS, Inc. are impacted. Observations of endurance on the folding process in the six formulas are presented in Figure 2. May mask the symptoms of hypoglycaemia, in particular, tachycardia. If you take contraceptive pills and you have severe diarrhoea for more than 24 hours, your contraception may not protect you from pregnancy. The .gov means its official.Federal government websites often end in .gov or .mil. Relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics. These are not all the side effects of atenolol. From the results of mechanical properties, HPMC exhibited superior film forming ability, physical appearance, and flexibility. In fact, this method can be easily applied, and sophisticated equipment is not required. Dosage requirements may be reduced, especially in patients with impaired renal function. It can help to eat and drink slowly and have smaller and more frequent meals. Effect of interaction is not clear, use caution. [10,11] Nonselective -blockers may lead to airway obstruction and severe exacerbations in asthmatic patients. Meanwhile, F5 and F6 (formulated from Na- alginate as a film former) produced rough particles with wider pores. The (#) indicates a significant different between various polymer type groups (p < 0.05); The (ns) indicates no significant different (p > 0.05). Formula 1 prepared using 4% (w/v) HPMC E5 is the most preferred formula to be developed in the further study. It might help to take your atenolol after a meal or snack. It is probably the action of atenolol in reducing cardiac rate and contractility which makes it effective in eliminating or reducing the symptoms of patients with angina. 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. Side effects often improve as your body gets used to the medicine. Both products are being recalled out of abundance of caution. A suitable oral maintenance dosage is 50-100 mg daily, given as a single dose. The interactions between atenolol and film-forming agents were determined in silico by molecular docking using Autodock 4.2 software. Adrover A., Varani G., Paolicelli P., Petralito S., Di Muzio L., Casadei M.A., Tho I. HPMC E5 revealed excellent flexibility and uniformity in the development of ODF. Atenolol crosses the placental barrier and appears in the cord blood. Ideally, the disintegration time for an ODF ranges from 530 s, though disintegration within 60 s is acceptable [16]. For 300ml: Discard 60 days after first opening. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Since Atenolol is excreted via the kidneys, dosage should be reduced in patients with a creatinine clearance of below 35 ml/min/1.73 m2. In rats, there was no effect on mating or fertility with atenolol treatment. Since it acts preferentially on beta- adrenergic receptors in the heart, Atenolol may, with care, be used successfully in the treatment of patients with respiratory disease, who cannot tolerate non-selective beta-blockers. Atenolol comes only as a tablet you take by mouth. |. Discontinuance of the drug should be considered if, according to clinical judgement, the well-being of the patient is adversely affected by any of the above reactions. Atenolol is effective and well-tolerated in most ethnic populations although the response may be less in black patients. This dosage form does not require water for administration and gives quick absorption [2]. From the organoleptic results, it can be seen that the majority of the formulas exhibited flexible film with a smooth surface. The (*) indicates a significant different among similar polymer type groups (p < 0.05); the (#) indicates a significant different between different polymer type groups (p < 0.05); and the (ns) indicates a non-significant different (p > 0.05). This publication was partially funded by the Institute for Research and Community Services at the University of Surabaya. Signs of dehydration include peeing less than usual or having dark, strong-smelling pee. The narrow dose range and early patient response ensure that the effect of the drug in individual patients is quickly demonstrated. Increasing the concentration of the film former also increases the time needed for ODF to disintegrate. For a full list, see the leaflet inside your medicine packet. Received 2021 Aug 30; Accepted 2021 Oct 14. The other study also posits that ODF thickness below 0.3 mm is still acceptable [15]. The https:// ensures that you are connecting to the The 3-D visualization of atenolol-HPMC in silico showed hydrogen bonds. 116 (include days between 7:30 AM to 4:00 PM, Pacific). View atenolol information, including dose, uses, side-effects, renal impairment, pregnancy, breast feeding, . The surface pH of ODF was evaluated to predict its possible effect on the mucous membrane of the mouth during the use of this dosage form. The affinity of the drug and excipient in silico was analyzed by the G in silico. Yir-Erong B., Bayor M.T., Ayensu I., Gbedema S.Y., Boateng J.S. Film former used in ODF formulation must exhibit the flexible film, adequate mechanical properties, good wetting, and spreading ability. The interaction of atenolol-HPMC showed hydrogen bonds, as shown in Figure 10c. 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 hydrogen bonds were between H14 atom of atenolol and O12 of CMC-Na, H15 of atenolol and O4 of CMC-Na, H21 of atenolol and O8 of CMC-Na, and H22 of atenolol and O20 and O5 of CMC-Na with binding distances of 2.02, 2.20, 2.01, 2.55, and 2.17 , respectively. The broadening absorption band of -OH group in film former was also reflected. However, it should be taken into account that occasionally dizziness or fatigue may occur. The site is secure. The following are guidelines: A starting dose of 25 mg is recommended. Absorption of atenolol following oral dosing is consistent but incomplete (approximately 4050%) with peak plasma concentrations occurring 24 hours after dosing. All authors have read and agreed to the published version of the manuscript. Bala R., Sharma S. Formulation optimization and evaluation of fast dissolving film of aprepitant by using design of experiment. In this study ODF of atenolol was developed using three different hydrophilic polymers as film former, including HPMC E5, CMC-Na, and Na-alginate. Atenolol is a drug on which extensive clinical experience has been obtained. The development of oral dissolving film (ODF) of atenolol is an attempt to enhance convenience and compliance for geriatric patients suffering from hypertension. In the fact, acidic and basic oral formulation can cause an inflammatory reaction of the oral mucosa. The G in silico for atenolol-HPMC were 3.31 for HPMC I and 4.73 kcal/mol for HPMC II. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. The results of physical characteristics evaluation such as folding endurance, swelling index, and in vitro drug dissolution were analyzed using one-way ANOVA (p < 0.05). Selectivity decreases with increasing dose. The increased of film former concentration also increased the wetting and dissolving time of ODF matrix [13]. The label and patient information leaflet for this product state the following warning: If you have ever had asthma or wheezing, you should not take this medicine unless you have discussed these symptoms with the prescribing doctor. A Novel Technique to Improve Drug Loading Capacity of Fast/Extended Release Orally Dissolving Films with Potential for Paediatric and Geriatric Drug Delivery. The film was directly fixed on a metal stub using double side adhesive tape. Propylene glycol pharmaceutical grade was purchased from Shell Chemicals (The Hague, The Netherlands). This condition probably occurred due to the more viscous casting mass of ODF when using CMC-Na as a film former. Microscopic images of ODF revealed that formulas with HPMC E5 (F1 and F2) as a film former were gritty in texture, contained small pores, and the drug crystal was deposited in small particles on the surface of ODFs. Inclusion in an NLM database does not imply endorsement of, or agreement with, In this study, atenolol was prepared as oral dissolving films by a convenient solvent casting method. The results exhibited that these polymers (HPMC E5, CMC-Na, and Na-alginate) are suitable for producing a good film thickness uniformity. 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. The dose must always be adjusted to individual requirements of the patients, with the lowest possible starting dosage. An increase in the weight of the film is noted as constant predetermined time intervals until no more increase in weight [16]. Hussain A., Latif S., Abbas N., Irfan M., Arshad M.S., Bukhari N.I. F5 and F6 show significantly faster disintegration times compared to the other four formulas. Atenolol is available as 25, 50 and 100 mg tablets for oral administration. Abdelbary A., Bendas E.R., Ramadan A.A., Mostafa D.A. In this study, three different types of film former including HPMC E5 4 . Atenolol ODF formulated from HPMC E5 as film former (F1 and F2) showed gritty texture due to the deposition of drug crystals on the film surface. Bethesda, MD 20894, Web Policies 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. verapamil and diltiazem, can lead to an exaggeration of these effects particularly in patients with impaired ventricular function and/or sinoatrial or atrioventricular conduction abnormalities. Golden State Medical Supply, Inc. has voluntarily recalled 1 lot of Clopidogrel 75mg Tablets and 1 lot of Atenolol 25mg Tablets due to a report stating . The atenolol blood levels are consistent and subject to little variability. The highest drug content is in Formula 3 with 3% CMC-Na as the film former, while the lowest was in Formula 6 with 3% Na-Alginate as the film former. Accessibility The development of oral dissolving film (ODF) of atenolol is an attempt to enhance convenience and compliance for geriatric patients suffering from hypertension. Due to its negative effect on conduction time, caution must be exercised if it is given to patients with first-degree heart block. More Recalls, Market 25 mg daily or 50 mg on alternate days if eGFR less than 15 mL/minute/1.73 m 2. NDC: 0409-1162-02. The pH measurement results on the surface of the six ODFs in this study exhibited neutral pH, ranged from 6.94 to 7.4. Check the pill packet to find out what to do. Licensee MDPI, Basel, Switzerland. Samples were gold-coated at 10 mA for 20 s. Surface morphology can be obtained at 15 kV and 5 kV, respectively at 1000 and 5000 times magnification [18]. ; software, A.T.P. The swelling rate of CMC-Na hydrogel was very high in the initial period until reaching the equilibrium of swelling. 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. This mechanism can reduce the extent of the first-pass effect and food interactions during the absorption process [4]. Sep 29, 2022 | Audience: Patient, Health Professional, Pharmacy. Phone: (800) 284-8633, ext. The thickness of the film was normally measured at five different locations of the films using a micrometer screw gauge. Each of these formulas was prepared for 1 film. The drug crystal on the surface of ODF prepared using CMC Na was significantly larger than the ODFs prepared using the other formulas. 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. Maheswari K.M., Devineni P.K., Deekonda S., Shaik S., Uppala N.P., Nalluri B.N. This phenomenon occurred because CMC-Na has high swelling properties. Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. It is FDA-approved and indicated in treating hypertension, angina pectoris, and acute myocardial infarction. Homogeneity of thickness is an essential physical parameter in ODF evaluation as it has substantial implication for the precision of dose distribution of ODF [23]. Although cardioselective (beta1) beta-blockers may have less effect on lung function than non-selective beta-blockers, as with all beta-blockers, these should be avoided in patients with reversible obstructive airways disease, unless there are compelling clinical reasons for their use. Hence absorption bands at 1660.41 cm1 revealed the existence of C=O-N group. You could be having a serious allergic reaction and may need immediate treatment in hospital. The surface pH of the films must be determined because either the highly acidic or highly basic pH of ODF cause irritation and discomfort during administration. Myocardial infarction. Do not wear tight watches or bracelets. The use of Atenolol is unlikely to result in the impairment of the ability of patients to drive or operate machines. All other chemicals were of analytical grade such as sodium dihydrogen phosphate was purchased from Merck KGaA (Darmstadt, Germany), disodium hydrogen phosphate was purchased from Merck KGaA (Darmstadt, Germany), dibutylamine was purchased from Merck KGaA (Darmstadt, Germany), glacial acetic acid was purchased from Merck KGaA (Darmstadt, Germany), and sodium1- heptane sulfonate was purchased from Tokyo Chemical Industry Co. Ltd (Tokyo, Japan). The standard deviation and mean value were then calculated. The grid box covered all the molecules and spacing (Armstrong) was 0.375. For patients with a creatinine clearance of 1535 ml/min/1.73 m2 (equivalent to serum creatinine of 300600 micromol/litre), the oral dose should be 50 mg (two 5ml spoonfuls) daily and the intravenous dose should be 10 mg once every two days. These results supported FTIR spectra of atenolol-sodium alginate, indicating hydrogen bonds between -NH (amine group) of atenolol and OH group of Na-alginate. 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