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MedLibrary.org Medication Labels And Product Inserts

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Prescription Medications Information at MedLibrary.org

medlibrary.org provides FDA prescription medication information by product title, generic ingredient, or FDA effective date.

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MedLibrary.org: FDA Approved Prescription Medication …

Jun 21, 2022 · Doxycycline Hyclate (Doxycycline) To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used…. NuCare Pharmaceuticals,Inc. 24 June 2022.

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VIDAZA (Celgene Corporation): FDA Package Insert

May 20, 2022 · 1 INDICATIONS AND USAGE 1.1 Myelodysplastic Syndromes (MDS) VIDAZA ® is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), …

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Bebtelovimab (Eli Lilly and Company): FDA Package Insert

May 17, 2022 · Please also provide a copy of this form to Eli Lilly and Company, Global Patient Safety: Fax: 1-317-277-0853; E-mail: [email protected]; or call 1-855-LillyC19 (1-855-545-5921) to report adverse events. ( 6.4 ).——————————–DRUG INTERACTIONS—————————— Bebtelovimab is not renally excreted or ...

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ISOVUE 300 (BRACCO DIAGNOSTICS INC): FDA Package Insert

Mar 04, 2022 · Each mL of ISOVUE-300 (lopamidol Injection 61%) provides 612 mg iopamidol with 1 mg tromethamine and 0.39 mg edetate calcium disodium. The solution contains approximately 0.043 mg (0.002 mEq) sodium and 300 mg organically bound iodine per mL. Each mL of ISOVUE-370 (lopamidol Injection 76%) provides 755 mg iopamidol with 1 mg tromethamine and 0 ...

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Kimyrsa (Melinta Therapeutics, LLC): FDA Package Insert

Jul 30, 2021 · Withdraw and discard 40 mL from a 250 mL intravenous bag of 0.9% sodium chloride injection or D5W. Withdraw 40 mL of the reconstituted vial of KIMYRSA and add to the intravenous bag of 0.9% sodium chloride injection or D5W to bring the bag volume to …

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OMNIPAQUE (GE Healthcare Inc.): FDA Package Insert

May 17, 2022 · GE Healthcare Inc.: OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular …

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Paxlovid (Pfizer Laboratories Div Pfizer Inc): FDA Package Insert

Apr 27, 2022 · Dosage: 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet), with all three tablets taken together twice daily for 5 days. ( 2.1) Dose reduction for moderate renal impairment (eGFR ≥30 to

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VYVGART (Argenx US): FDA Package Insert

May 06, 2022 · The recommended dosage of VYVGART is 10 mg/kg administered as an intravenous infusion over one hour once weekly for 4 weeks. In patients weighing 120 kg or more, the recommended dose of VYVGART is 1200 mg (3 vials) per infusion. Administer subsequent treatment cycles based on clinical evaluation. The safety of initiating subsequent cycles ...

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TRODELVY (Gilead Sciences): FDA Package Insert - MedLibrary.org

Jun 10, 2022 · Reconstitution. TRODELVY is a hazardous drug. Follow applicable special handling and disposal procedures 1.; Calculate the required dose (mg) of TRODELVY based on the patient’s body weight at the beginning of each treatment cycle (or more frequently if the patient’s body weight changed by more than 10% since the previous administration) [see Dosage and Administration (2.2)].

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Varenicline (American Health Packaging): FDA Package Insert

Jan 21, 2022 · The recommended dose of varenicline tablets is 1 mg twice daily following a 1-week titration as follows: Days 1 to 3: 0.5 mg once daily. Days 4 to 7: 0.5 mg twice daily. Day 8 to end of treatment: 1 mg twice daily. Patients should be treated with varenicline tablets for 12 weeks. For patients who have successfully stopped smoking at the end of ...

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Bebtelovimab (Eli Lilly and Company): FDA Package Insert, Page 2

May 17, 2022 · The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of bebtelovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg): with positive results of direct SARS-CoV-2 viral testing ...

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GoLYTELY (Braintree Laboratories, Inc.): FDA Package Insert

May 28, 2021 · Drink at a rate of 8 ounces every 10 minutes until the entire contents are consumed or the rectal effluent is clear. A loose watery bowel movement should result in approximately one hour. After reconstitution, keep solution refrigerated 2° to 8°C (36° to 46°F). Do not freeze. Use within 48 hours, discard unused portion.

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WEGOVY (Novo Nordisk): FDA Package Insert - MedLibrary.org

Jun 04, 2021 · 1 INDICATIONS AND USAGE . WEGOVY is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of [see Dosage and Administration ()]:. 30 kg/m 2 or greater (obesity) or 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type ...

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CIPRODEX (Novartis Pharmaceuticals Corporation): FDA Package …

Apr 19, 2022 · 1 INDICATIONS AND USAGE. CIPRODEX ® is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: . Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, …

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Carboplatin (Hospira, Inc.): FDA Package Insert - MedLibrary.org

May 23, 2022 · DESCRIPTION. Carboplatin Injection is supplied as a sterile, pyrogen-free, aqueous solution available in 50 mg/5 mL, 150 mg/15 mL, 450 mg/45 mL or 600 mg/60 mL multiple-dose vials containing 10 mg/mL of carboplatin for administration by intravenous infusion.

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MVASI (Amgen Inc): FDA Package Insert - MedLibrary.org

Nov 18, 2021 · Platinum Sensitive The recommended dosage is 15 mg/kg intravenously every 3 weeks, in combination with carboplatin and paclitaxel for 6 to 8 cycles, followed by MVASI 15 mg/kg every 3 weeks as a single agent until disease progression. The recommended dosage is 15 mg/kg intravenously every 3 weeks, in combination with carboplatin and gemcitabine for 6 to 10 cycles, followed by MVASI …

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ACTEMRA (Genentech, Inc.): FDA Package Insert - MedLibrary.org

Oct 13, 2020 · Recommended Intravenous Dosage Regimen: The recommended dosage of ACTEMRA for adult patients given as a 60-minute single intravenous drip infusion is 6 mg per kg every 4 weeks in combination with a tapering course of glucocorticoids. ACTEMRA can be used alone following discontinuation of glucocorticoids. Interruption of dosing may be needed for management of dose …

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FULVESTRANT (BluePoint Laboratories): FDA Package Insert

Nov 01, 2021 · 1 INDICATIONS AND USAGE. Monotherapy. Fulvestrant injection is indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women …

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Fluticasone Propionate HFA (Prasco Laboratories): FDA Package …

May 23, 2022 · 1 INDICATIONS AND USAGE. Fluticasone Propionate HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in …

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Aduhelm (Biogen Inc.): FDA Package Insert - MedLibrary.org

Apr 30, 2022 · After an initial titration, the recommended dosage of ADUHELM is 10 mg/kg (see Table 1 ). ADUHELM is administered as an intravenous (IV) infusion over approximately one hour every four weeks and at least 21 days apart. Table 1: Dosing Schedule. IV Infusion (every 4 weeks) ADUHELM Dosage (administered over approximately one hour) Infusion 1 and 2.

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Azacitidine (Cipla USA Inc.): FDA Package Insert - MedLibrary.org

Jun 27, 2020 · Azacitidine is a cytotoxic drug. Follow applicable special handling and disposal procedures.1. . The azacitidine for injection vial is single-dose and does not contain any preservatives. Discard unused portions of each vial properly [see How Supplied/Storage and Handling ( 16) ]. Do not save any unused portions for later administration.

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Mitomycin (Accord Healthcare Inc): FDA Package Insert

Sep 10, 2020 · Each mL of reconstituted solution will contain 0.5 mg mitomycin and have a pH between 6.0 and 8.0. Mitomycin is a blue-violet crystalline powder with the molecular formula of C 15 H 18 N 4 O 5 , and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane and it has the following structural formula;

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LEMTRADA (Genzyme Corporation): FDA Package Insert

Jun 02, 2022 · Withdraw 1.2 mL of LEMTRADA from the vial into a syringe using aseptic technique and inject into a 100 mL bag of sterile 0.9% Sodium Chloride, USP or 5% Dextrose in Water, USP. Gently invert the bag to mix the solution. Ensure the sterility of the prepared solution because it contains no antimicrobial preservatives.

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DALFAMPRIDINE (Micro Labs Limited): FDA Package Insert

Dec 02, 2021 · 2.1 Dosage Information. The maximum recommended dosage of dalfampridine is one 10 mg tablet twice daily and should not be exceeded. Take doses approximately 12 hours apart. There is no evidence of additional benefit at doses greater than 10 mg twice daily. Adverse reactions, including seizures, and discontinuations because of adverse reactions ...

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Zolpidem (Unit Dose Services): FDA Package Insert - MedLibrary.org

May 23, 2022 · Zolpidem Tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies ( 14 )]. The clinical trials performed in support of efficacy were 4–5 ...

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Gastrografin (Bracco Diagnostics Inc): FDA Package Insert

Oct 04, 2021 · Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution) is a palatable lemon-flavored water-soluble iodinated radiopaque contrast medium for oral or rectal administration only. Each mL contains 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium; pH has been adjusted to 6.0 to 7.6 with sodium hydroxide.

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Molnupiravir (Merck Sharp & Dohme LLC): FDA Package Insert

May 23, 2022 · Merck Sharp & Dohme LLC: Molnupiravir is a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis and is the 5 -isobutyrate ester of the ribonucleoside analog N4-hydroxycytidine (NHC). The...

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Methylene Blue (BPI LABS LLC): FDA Package Insert

Dec 23, 2021 · DESCRIPTION. Methylene Blue Injection is a sterile solution of Phenothiazin-5-ium, 3, 7-bis (dimethylamino)-, chloride, trihydrate. Each mL contains methylene blue, 10 mg in water for injection q.s. pH adjusted with sodium hydroxide and/or hydrochloric acid when necessary.

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Bebtelovimab (Eli Lilly and Company): FDA Package Insert, Page 6

May 17, 2022 · 175 mg/2 mL (87.5 mg/mL) One vial per carton. 0002-7589-01. Storage and Handling. Bebtelovimab is preservative-free. Discard unused portion. Store unopened vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from …

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Piperacillin and Tazobactam (Sandoz Inc): FDA Package Insert, …

Aug 30, 2021 · Each vial contains 4.69 mEq (108 mg) of sodium. Supplied 10 per box – NDC 0781-9210-95. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial provides piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium.

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Oxaliplatin (Hospira, Inc.): FDA Package Insert

Aug 11, 2021 · Store diluted solution for no more than 6 hours at room temperature (20°C to 25°C [68°F to 77°F]) or 24 hours under refrigeration (2°C to 8°C [36°F to 46°F]). Protection from light is not required. Visually inspect for particulate matter and discoloration prior to administration and discard if present.

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Mitoxantrone (Hospira, Inc.): FDA Package Insert - MedLibrary.org

Apr 15, 2022 · Mitoxantrone Injection, USP (concentrate) is a synthetic antineoplastic anthracenedione for intravenous use. The molecular formula is C 22 H 28 N 4 O 6 ∙2HCl and the molecular weight is 517.41. It is supplied as a concentrate that MUST BE DILUTED PRIOR TO INJECTION.

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Phenobarbital (WINDER LABORATORIES, LLC): FDA Package Insert

May 31, 2022 · Phenobarbital, a long-acting barbiturate, is a central nervous system depressant. In ordinary doses, the drug acts as a sedative and anticonvulsant. Its onset of action occurs within 30 minutes, and the duration of action ranges from 5 to 6 hours. It is detoxified in the liver.

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ACD-A (Fenwal, Inc.): FDA Package Insert - MedLibrary.org

Feb 11, 2022 · Fenwal™. Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A. EACH 100 mL CONTAINS 2.45 g DEXTROSE (MONOHYDRATE) USP 2.2 g SODIUM CITRATE (DIHYDRATE) USP 730 mg CITRIC ACID (ANHYDROUS) USP.

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Diltiazem Hydrochloride (Teva Pharmaceuticals USA, Inc.): FDA …

Feb 28, 2021 · Diltiazem hydrochloride tablets, USP are available as: 30 mg — light orange, round, film-coated, biconvex, unscored tablets, debossed with “93” and “318” on one side and plain on the other side. Available in bottles of 100 and 500. NDC 0093-0318-01 – Bottle of 100. NDC 0093-0318-05 – Bottle of 500. 60 mg – orange, round, film ...

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KEYTRUDA (Merck Sharp & Dohme LLC): FDA Package Insert

May 20, 2022 · KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test [see Dosage and Administration (2.1) ]. KEYTRUDA, as a single agent, is indicated for the ...

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Glucagon (Fresenius Kabi USA, LLC): FDA Package Insert

Apr 01, 2022 · Fresenius Kabi USA, LLC: Glucagon for Injection is indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. Limitations of Use: Glucagon...

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Octreotide (Fresenius Kabi USA, LLC): FDA Package Insert

Apr 08, 2022 · Rx only. Prescribing Information. DESCRIPTION Octreotide Acetate Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered acetate solution for administration by deep subcutaneous (intrafat) or intravenous (IV) injection.

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Omnitrope (Sandoz Inc): FDA Package Insert - MedLibrary.org

Jun 18, 2019 · Omnitrope (somatropin) injection is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH). Omnitrope (somatropin) injection is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi Syndrome (PWS). The diagnosis of PWS should be confirmed ...

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Prescription Medications By Product Title - MedLibrary.org

Find full product information in the Prescription Medications section, listed by product title.

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Metformin (Granules Pharmaceuticals Inc.): FDA Package Insert

Nov 22, 2021 · Metformin hydrochloride, USP is a white or almost white, crystalline powder with a molecular formula of C4H11N5•HCl and a molecular weight of 165.62. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in Methylene chloride. The pKa of metformin is 12.4.

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BORTEZOMIB (Zydus Pharmaceuticals USA Inc.): FDA Package …

May 05, 2022 · Table 2: Dose Modifications During Cycles of Combination Bortezomib, Melphalan and Prednisone Therapy ; Toxicity: Dose Modification or Delay: Hematological toxicity during a cycle: If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle

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Nplate (Amgen Inc): FDA Package Insert - MedLibrary.org

Feb 17, 2022 · For Pediatric Patients with ITP. The initial dose of Nplate is 1 mcg/kg. Actual body weight at initiation of treatment should always be used when calculating initial dose. In pediatric patients, future dose adjustments are based on changes in platelet counts and changes in body weight. Reassessment of body weight is recommended every 12 weeks.

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SEMGLEE (A-S Medication Solutions): FDA Package Insert

Nov 16, 2021 · A-S Medication Solutions: SEMGLEE is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Limitations of Use. SEMGLEE is...

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Corgard (US WorldMeds, LLC): FDA Package Insert

Oct 12, 2021 · CORGARD (nadolol) is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1- ( tert -butyl-amino)-3- [ (5,6,7,8-tetrahydro- cis -6,7-dihydroxy-1-naphthyl) oxy]-2-propanol. Structural formula: Nadolol is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly ...

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Bleomycin (Meitheal Pharmaceuticals Inc.): FDA Package Insert

Jun 24, 2021 · Bleomycin for Injection, USP should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: Squamous Cell Carcinoma: Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx ...

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