Amlodipine And Benazepril Hydrochloride

Amlodipine And Benazepril Hydrochloride Manufacturers

• Mylan Pharmaceuticals Inc.
  

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  Amlodipine And Benazepril Hydrochloride | Mylan Pharmaceuticals Inc.

  

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  2.1 General Considerations

  The recommended initial dose of amlodipine and benazepril hydrochloride capsules is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once-daily.

  It is usually appropriate to begin therapy with amlodipine and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once-daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 mg to 10 mg while benazepril is effective in doses of 10 mg to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 mg to 10 mg and benazepril doses of 10 mg to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage Adjustment in Renal Impairment Renal Impairment

  Amlodipine and benazepril hydrochloride capsules are not recommended in patients with creatinine clearance (CrCl) less than or equal to 30 mL/min. No dose adjustment of amlodipine and benazepril hydrochloride capsules is required in patients with CrCl greater than 30 mL/min/1.73m2 (serum creatinine roughly less than or equal to 3 mg/dL or 265 µmol/L) [see Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.3 Replacement Therapy

  Amlodipine and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Mylan Pharmaceuticals Inc.
  

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  Amlodipine And Benazepril Hydrochloride | Sagent Pharmaceuticals

  

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of Levofloxacin Injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.

  These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50mL/min)

  1 Due to the designated pathogens [see Indications and Usage (1)].

  2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

  3 Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].

  4 Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].

  5 This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.

  6 This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.

  7 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].

  8 The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.

  9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.

  Type of Infection1 Dosed Every 24 hours Duration (days)2 Nosocomial Pneumonia 750 mg 7-14 Community Acquired Pneumonia3 500 mg 7-14 Community Acquired Pneumonia4 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10-14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7-14 Uncomplicated SSSI 500 mg 7-10 Chronic Bacterial Prostatitis 500 mg 28 Complicated Urinary Tract Infection (cUTI) or
  Acute Pyelonephritis (AP)5 750 mg 5 Complicated Urinary Tract Infection (cUTI) or
  Acute Pyelonephritis (AP)6 250 mg 10
  Uncomplicated Urinary Tract Infection 250 mg 3 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg7,8
  Pediatric patients < 50 kg and ≥ 6 months of age7,8 500 mg
  
  See Table 2 below (2.2) 608
  
  608 Plague, adult and pediatric patients > 50 kg9
  Pediatric patients < 50 kg and ≥ 6 months of age
  500 mg
  see Table 2 below (2.2)
  10 to 14
  10 to 14
  2.2 Dosage in Pediatric Patients

  The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.

  Table 2: Dosage in Pediatric Patients ≥ 6 months of age

  1 Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

  2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

  3 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]

  4 The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.

  5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

  Type of Infection1 Dose Freq. Once
  every Duration2 Inhalational Anthrax (post-exposure)3,4 Pediatric Patients > 50 kg
  
  500 mg 24hr 60 days4 Pediatric Patients < 50 kg
  and ≥ 6 months of age 8 mg/kg
  (not to exceed
  250 mg per dose) 12hr 60 days4 Plague5
  Pediatric Patients > 50 kg
  500 mg
  24hr 10 to 14 days Pediatric Patients < 50 kg
  and ≥ 6 months of age 8 mg/kg
  (not to exceed
  250 mg per dose) 12hr 10 to 14 days 2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.

  No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.

  In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].

  Table 3 shows how to adjust dose based on creatinine clearance.

  Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min) Dosage in Normal Renal
  Function Every 24 hours Creatinine Clearance
  20 to 49 mL/min Creatinine Clearance
  10 to 19 mL/min Hemodialysis or Chronic
  Ambulatory Peritoneal
  Dialysis (CAPD) 750 mg 750 mg every 48 hours 750 mg initial dose, then
  500 mg every 48 hours 750 mg initial dose, then
  500 mg every 48 hours 500 mg 500 mg initial dose, then
  250 mg every 24 hours 500 mg initial dose, then
  250 mg every 48 hours 500 mg initial dose, then
  250 mg every 48 hours 250 mg No dosage adjustment
  required 250 mg every 48 hours. If
  treating uncomplicated
  UTI, then no dosage
  adjustment is required No information on dosing
  adjustment is available 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

  Levofloxacin Injection

  Levofloxacin Injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].

  2.5 Administration Instructions

  Levofloxacin Injection

  Caution: Rapid or bolus intravenous infusion of levofloxacin has been associated with hypotension and must be avoided. Levofloxacin Injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin Injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

  Hydration for Patients Receiving Levofloxacin Injection

  Adequate hydration of patients receiving intravenous levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

  2.6 Preparation of Intravenous Product

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Because only limited data are available on the compatibility of Levofloxacin Injection with other intravenous substances, additives or other medications should not be added to Levofloxacin Injection Premix in Single-Use Flexible Containers, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of Levofloxacin Injection with an infusion solution compatible with Levofloxacin Injection and with any other drug(s) administered via this common line.

  Levofloxacin Injection Premix in Single-Use Flexible Containers (5 mg/mL)

  Levofloxacin Injection is supplied in flexible containers within a foil overwrap. These contain a premixed, ready to use levofloxacin solution in 5% dextrose (D5W) for single-use. The 100 mL premixed flexible containers contain either 250 mg/50 mL or 500 mg/100 mL of levofloxacin solution. The 150 mL flexible container contains 750 mg/150 mL of levofloxacin solution. The concentration of each container is 5 mg/mL. No further dilution of these preparations is necessary. Because the premix flexible containers are for single-use only, any unused portion should be discarded.

  Instructions for the Use of Levofloxacin Injection Premix in Flexible Containers:

  Tear outer wrap at the notch and remove solution container. Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution, as the sterility may be compromised. Do not use if the solution is cloudy or a precipitate is present. Use sterile equipment. WARNING: Do not use flexible containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

  Preparation for Administration:

  Close flow control clamp of administration set. Remove cover from port at bottom of container. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. Suspend container from hanger. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levofloxacin Injection Premix in Flexible Containers. Open flow control clamp to expel air from set. Close clamp. Regulate rate of administration with flow control clamp.

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• Aurobindo Pharma Limited
  

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  Amlodipine And Benazepril Hydrochloride | Frontline Vet Labs

  

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  NexGard is given orally once a month, at the minimum dosage of 1.14 mg/lb (2.5 mg/kg).

  Dosing Schedule:

  Body Weight Afoxolaner Per Chewable
  (mg) Chewables Administered 4.0 to 10.0 lbs. 11.3 One 10.1 to 24.0 lbs. 28.3 One 24.1 to 60.0 lbs. 68 One 60.1 to 121.0 lbs. 136 One Over 121.0 lbs. Administer the appropriate combination of chewables

  NexGard can be administered with or without food. Care should be taken that the dog consumes the complete dose, and treated animals should be observed for a few minutes to ensure that part of the dose is not lost or refused. If it is suspected that any of the dose has been lost or if vomiting occurs within two hours of administration, redose with another full dose. If a dose is missed, administer NexGard and resume a monthly dosing schedule.

  Flea Treatment and Prevention:

  Treatment with NexGard may begin at any time of the year. In areas where fleas are common year-round, monthly treatment with NexGard should continue the entire year without interruption.

  To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product.

  Tick Treatment and Control:

  Treatment with NexGard may begin at any time of the year (see Effectiveness).

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• Citron Pharma Llc
  

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  Amlodipine And Benazepril Hydrochloride | Citron Pharma Llc

  

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  2.1 General Considerations

  The recommended initial dose of amlodipine and benazepril hydrochloride capsules is 1 capsule of amlodipine 2.5 mg and benazepril 10 mg orally once-daily.
  
  It is usually appropriate to begin therapy with amlodipine and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema. 
  
  The antihypertensive effect of amlodipine and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg and benazepril 40 mg once-daily. The dosing should be individualized and adjusted according to the patient’s clinical response.
  
  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine and benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage Adjustment in Renal Impairment

  Renal Impairment: Amlodipine and benazepril hydrochloride capsules are not recommended in patients with creatinine clearance (CrCl) less than or equal to  30 mL/min. No dose adjustment of amlodipine and benazepril hydrochloride capsules is required in patients with CrCl greater than 30 mL/min/1.73m2 (serum creatinine roughly less than or equal to 3 mg/dL or 265 micromol/L) [see Warnings and Precautions (5.7), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].

  2.3 Replacement Therapy
  

  Amlodipine and benazepril hydrochloride capsules may be substituted for the titrated components.

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