Equaline Nicotine

Equaline Nicotine Manufacturers

• Supervalu Inc
  

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  Equaline Nicotine | Save-a-lot Food Stores Ltd

  

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  • shake well before use • use dose cup • adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour as needed • do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours • use until diarrhea stops but not more than 2 days • children under 12 years: ask a doctor • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

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  Equaline Nicotine | Cardinal Health

  

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  Dosage of magnesium sulfate must be carefully adjusted according to individual requirements and response, and administration of the drug should be discontinued as soon as the desired effect is obtained.

  Both IV and IM administration are appropriate.  IM administration of the undiluted 50% solution results in therapeutic plasma levels in 60 minutes, whereas IV doses will provide a therapeutic level almost immediately.  The rate of IV injection should generally not exceed 150 mg/minute (1.5 mL of a 10% concentration or its equivalent), except in severe eclampsia with seizures (see below).  Continuous maternal administration of magnesium sulfate injection in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

  Solutions for IV infusion must be diluted to a concentration of 20% or less prior to administration.  The diluents commonly used are 5% Dextrose Injection, USP and 0.9% Sodium Chloride Injection, USP.  Deep IM injection of the undiluted (50%) solution is appropriate for adults, but the solution should be diluted to a 20% or less concentration prior to such injection in children.

  In Magnesium Deficiency
  

  In the treatment of mild magnesium deficiency, the usual adult dose is 1 g, equivalent to 8.12 mEq of magnesium (2 mL of the 50% solution) injected IM every six hours for four doses (equivalent to a total of 32.5 mEq of magnesium per 24 hours).  For severe hypomagnesemia, as much as 250 mg (approximately 2 mEq) per kg of body weight (0.5 mL of the 50% solution) may be given IM within a period of four hours if necessary.  Alternatively, 5 g (approximately 40 mEq) can be added to one liter of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP for slow IV infusion over a three-hour period.  In the treatment of deficiency states, caution must be observed to prevent exceeding the renal excretory capacity.

  In Hyperalimentation
  

  In TPN, maintenance requirements for magnesium are not precisely known.  The maintenance dose used in adults ranges from 8 to 24 mEq (1 to 3 g) daily; for infants, the range is 2 to 10 mEq (0.25 to 1.25 g) daily.

  In Pre-eclampsia or Eclampsia
  

  In severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate. Intravenously, a dose of 4 to 5 g in 250 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP may be infused.  Simultaneously, IM doses of up to 10 g (5 g or 10 mL of the undiluted 50% solution in each buttock) are given.  Alternatively, the initial IV dose of 4 g may be given by diluting the 50% solution to a 10 or 20% concentration; the diluted fluid (40 mL of a 10% solution or 20 mL of a 20% solution) may then be injected IV over a period of three to four minutes.  Subsequently, 4 to 5 g (8 to 10 mL of the 50% solution) are injected IM into alternate buttocks every four hours as needed, depending on the continuing presence of the patellar reflex and adequate respiratory function.  Alternatively, after the initial IV dose, some clinicians administer 1 to 2 g/hour by constant IV infusion.  Therapy should continue until paroxysms cease.  A serum magnesium level of 6 mg/100 mL is considered optimal for control of seizures.  A total daily (24 hr) dose of 30 to 40 g should not be exceeded.  In the presence of severe renal insufficiency, the maximum dosage of magnesium sulfate is 20 grams/48 hours and frequent serum magnesium concentrations must be obtained.  Continuous use of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

  Other uses
  

  In counteracting the muscle-stimulating effects of barium poisoning, the usual dose of magnesium sulfate is 1 to 2 g given IV.

  For controlling seizures associated with epilepsy, glomerulonephritis or hypothyroidism, the usual adult dose is 1 g administered IM or IV.

  In paroxysmal atrial tachycardia, magnesium should be used only if simpler measures have failed and there is no evidence of myocardial damage.  The usual dose is 3 to 4 g (30 to 40 mL of a 10% solution) administered IV over 30 seconds with extreme caution.

  For reduction of cerebral edema, 2.5 g (25 mL of a 10% solution) is given IV.

  Incompatibilities

  Magnesium sulfate in solution may result in a precipitate formation when mixed with solutions containing:

  Alcohol (in high concentrations)

  Heavy metals

  Alkali carbonates and bicarbonates

  Hydrocortisone sodium succinate

  Alkali hydroxides

  Phosphates

  Arsenates

  Polymyxin B sulfate

  Barium

  Procaine hydrochloride

  Calcium

  Salicylates

  Clindamycin phosphate

  Strontium

   

  Tartrates

  The potential incompatibility will often be influenced by the changes in the concentration of reactants and the pH of the solutions.

  It has been reported that magnesium may reduce the antibiotic activity of streptomycin, tetracycline and tobramycin when given together.

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

  In Magnesium Deficiency
  

  In the treatment of mild magnesium deficiency, the usual adult dose is 1 g, equivalent to 8.12 mEq of magnesium (2 mL of the 50% solution) injected IM every six hours for four doses (equivalent to a total of 32.5 mEq of magnesium per 24 hours).  For severe hypomagnesemia, as much as 250 mg (approximately 2 mEq) per kg of body weight (0.5 mL of the 50% solution) may be given IM within a period of four hours if necessary.  Alternatively, 5 g (approximately 40 mEq) can be added to one liter of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP for slow IV infusion over a three-hour period.  In the treatment of deficiency states, caution must be observed to prevent exceeding the renal excretory capacity.

  In Hyperalimentation
  

  In TPN, maintenance requirements for magnesium are not precisely known.  The maintenance dose used in adults ranges from 8 to 24 mEq (1 to 3 g) daily; for infants, the range is 2 to 10 mEq (0.25 to 1.25 g) daily.

  In Pre-eclampsia or Eclampsia
  

  In severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate. Intravenously, a dose of 4 to 5 g in 250 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP may be infused.  Simultaneously, IM doses of up to 10 g (5 g or 10 mL of the undiluted 50% solution in each buttock) are given.  Alternatively, the initial IV dose of 4 g may be given by diluting the 50% solution to a 10 or 20% concentration; the diluted fluid (40 mL of a 10% solution or 20 mL of a 20% solution) may then be injected IV over a period of three to four minutes.  Subsequently, 4 to 5 g (8 to 10 mL of the 50% solution) are injected IM into alternate buttocks every four hours as needed, depending on the continuing presence of the patellar reflex and adequate respiratory function.  Alternatively, after the initial IV dose, some clinicians administer 1 to 2 g/hour by constant IV infusion.  Therapy should continue until paroxysms cease.  A serum magnesium level of 6 mg/100 mL is considered optimal for control of seizures.  A total daily (24 hr) dose of 30 to 40 g should not be exceeded.  In the presence of severe renal insufficiency, the maximum dosage of magnesium sulfate is 20 grams/48 hours and frequent serum magnesium concentrations must be obtained.  Continuous use of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

  Other uses
  

  In counteracting the muscle-stimulating effects of barium poisoning, the usual dose of magnesium sulfate is 1 to 2 g given IV.

  For controlling seizures associated with epilepsy, glomerulonephritis or hypothyroidism, the usual adult dose is 1 g administered IM or IV.

  In paroxysmal atrial tachycardia, magnesium should be used only if simpler measures have failed and there is no evidence of myocardial damage.  The usual dose is 3 to 4 g (30 to 40 mL of a 10% solution) administered IV over 30 seconds with extreme caution.

  For reduction of cerebral edema, 2.5 g (25 mL of a 10% solution) is given IV.

  Incompatibilities

  Magnesium sulfate in solution may result in a precipitate formation when mixed with solutions containing:

  Alcohol (in high concentrations)

  Heavy metals

  Alkali carbonates and bicarbonates

  Hydrocortisone sodium succinate

  Alkali hydroxides

  Phosphates

  Arsenates

  Polymyxin B sulfate

  Barium

  Procaine hydrochloride

  Calcium

  Salicylates

  Clindamycin phosphate

  Strontium

   

  Tartrates

  The potential incompatibility will often be influenced by the changes in the concentration of reactants and the pH of the solutions.

  It has been reported that magnesium may reduce the antibiotic activity of streptomycin, tetracycline and tobramycin when given together.

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

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  Equaline Nicotine | Cvs Pharmacy

  

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  • if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the gum on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg • if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg according to the following 12 week schedule:

  Weeks 1 to 6

  Weeks 7 to 9

  Weeks 10 to 12

  1 piece every 1 to 2 hours

  1 piece every 2 to 4 hours

  1 piece every 4 to 8 hours

  • nicotine gum is a medicine and must be used a certain way to get the best results • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns. • repeat this process until most of the tingle is gone (about 30 minutes) • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. • do not use more than 24 pieces a day • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

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  Equaline Nicotine | Perrigo New York Inc

  

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  Desonide Ointment, 0.05% should be applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

  As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary.

  Desonide Ointment, 0.05% should not be used with occlusive dressings.

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  Equaline Nicotine | Supervalu Inc

  

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  • if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the gum on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg • if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg according to the following 12 week schedule:

  Weeks 1 to 6

  Weeks 7 to 9

  Weeks 10 to 12

  1 piece every

  1 to 2 hours

  1 piece every

  2 to 4 hours

  1 piece every

  4 to 8 hours

  • nicotine gum is a medicine and must be used a certain way to get the best results • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns. • repeat this process until most of the tingle is gone (about 30 minutes) • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. • do not use more than 24 pieces a day • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

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  Equaline Nicotine | Supervalu Inc

  

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  • if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the gum on your quit day • if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg • if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg according to the following 12 week schedule:

  Weeks 1 to 6

  Weeks 7 to 9

  Weeks 10 to 12

  1 piece every

  1 to 2 hours

  1 piece every

  2 to 4 hours

  1 piece every

  4 to 8 hours

  • nicotine gum is a medicine and must be used a certain way to get the best results • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns. • repeat this process until most of the tingle is gone (about 30 minutes) • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. • do not use more than 24 pieces a day • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

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  Equaline Nicotine | Teva Pharmaceuticals Usa Inc

  

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  There is intersubject variation in the pharmacokinetics, clinical efficacy, and incidence of side effects with acitretin capsules. A number of the more common side effects are dose-related. Individualization of dosage is required to achieve sufficient therapeutic response while minimizing side effects. Therapy with acitretin capsules should be initiated at 25 to 50 mg per day, given as a single dose with the main meal. Maintenance doses of 25 to 50 mg per day may be given dependent upon an individual patient’s response to initial treatment. Relapses may be treated as outlined for initial therapy.

  When acitretin capsules are used with phototherapy, the prescriber should decrease the phototherapy dose, dependent on the patient’s individual response (see PRECAUTIONS).

  Females who have taken TEGISON (etretinate) must continue to follow the contraceptive recommendations for TEGISON. TEGISON is no longer marketed in the U.S.; for information, call 1-888-838-2872.

  Information for Pharmacists

  Acitretin capsules must only be dispensed in no more than a monthly supply. An acitretin capsules Medication Guide must be given to the patient each time acitretin capsules are dispensed, as required by law.

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  Equaline Nicotine | Supervalu Inc

  

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  • if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you. • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the lozenge on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:

  Weeks 1 to 6

  Weeks 7 to 9

  Weeks 10 to 12

  1 lozenge every

  1 to 2 hours

  1 lozenge every

  2 to 4 hours

  1 lozenge every

  4 to 8 hours

  • nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes) • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. • it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

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  Equaline Nicotine | Supervalu Inc

  

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  • if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you. • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the lozenge on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:

  Weeks 1 to 6

  Weeks 7 to 9

  Weeks 10 to 12

  1 lozenge every

  1 to 2 hours

  1 lozenge every

  2 to 4 hours

  1 lozenge every

  4 to 8 hours

  • nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes) • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. • it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

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  Equaline Nicotine | Lucid Pharma Llc

  

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  Sulfamethoxazole and trimethoprim tablets are contraindicated in pediatric patients less than 2 months of age.
  
  Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children
  
  Adults
  
  The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.
  
  Children
  
  The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:
  
  
  Children 2 months of age or older:

  
  Weight
  Dose–every 12 hours
  lb
  kg
  Tablets
  22
  10
  –
  44
  20
  1
  66
  30
  1½
  88
  40
  2 or 1 DS tablet
  
  

  For Patients with Impaired Renal Function
  
  When renal function is impaired, a reduced dosage should be employed using the following table: 

  
  Creatinine Clearance (mL/min)
  Recommended Dosage Regimen
  Above 30
  Usual standard regimen
  15–30
  ½ the usual regimen
  Below 15
  Use not recommended
  
  

  Acute Exacerbations of Chronic Bronchitis in Adults
  
  The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 14 days.
  
  Pneumocystis jiroveci Pneumonia
  
  Treatment
  
  Adults and Children
  
  The recommended dosage for treatment of patients with documented Pneumocystis jiroveci pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days.11 The following table is a guideline for the upper limit of this dosage: 

  
  Weight
  Dose–every 6 hours
  lb
  kg
  Tablets
  18
  8
  –
  35
  16
  1
  53
  24
  1½   
  70
  32
  2 or 1 DS tablet
  88
  40
  2½ 
  106
  48
  3 or 1½  DS tablets
  141
  64
  4 or 2 DS tablets
  176
  80
  5 or 2½ DS tablets
  
  

  For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.
  
  Prophylaxis
  
  Adults
  
  The recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet daily.12
  
  Children
  For children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim.13 The following table is a guideline for the attainment of this dosage in children: 

  
  Body Surface Area
  Dose–every 12 hours
  (m2)
  Tablets
  0.26
  –
  0.53
  ½
  1.06
  1
  
  

  Traveler’s Diarrhea in Adults
  
  For the treatment of traveler’s diarrhea, the usual adult dosage is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 5 days.

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  Equaline Nicotine | Paramesh Banerji Life Sciences Llc

  

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  Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician.

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  Equaline Nicotine | Northstar Rxllc

  

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  Hypertension

  In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of enalapril maleate tablets, USP. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with enalapril maleate tablets, USP to reduce the likelihood of hypotension (see WARNINGS). If the patient's blood pressure is not controlled with enalapril maleate tablets USP alone, diuretic therapy may be resumed.

  If the diuretic cannot be discontinued an initial dose of 2.5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS, Drug Interactions).

  The recommended initial dose in patients not on diuretics is 5 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 10 mg to 40 mg per day administered in a single dose or two divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with enalapril maleate tablets, USP alone, a diuretic may be added. Concomitant administration of enalapril maleate tablets, USP with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (see PRECAUTIONS).

  Dosage Adjustment in Hypertensive Patients with Renal Impairment

  The usual dose of enalapril maleate tablets, USP is recommended for patients with a creatinine clearance >30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance ≤30 mL/min (serum creatinine ≥3 mg/dL), the first dose is 2.5 mg once daily. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.

  * See WARNINGS, Anaphylactoid Reactions During Membrane Exposure. † Dosage on nondialysis days should be adjusted depending on the blood pressure response.

  Renal Status

  Creatinine-Clearance
  mL/min

  Initial Dose
  mg/day

  Normal Renal Function

  >80 mL/min

  5 mg

  Mild Impairment

  ≤80 >30 mL/min

  5 mg

  Moderate to Severe Impairment

  ≤30 mL/min

  2.5 mg

  Dialysis Patients*

  —

  2.5 mg on dialysis days†

  Heart Failure

  Enalapril maleate tablets, USP are indicated for the treatment of symptomatic heart failure, usually in combination with diuretics and digitalis. In the placebo-controlled studies that demonstrated improved survival, patients were titrated as tolerated up to 40 mg, administered in two divided doses.

  The recommended initial dose is 2.5 mg. The recommended dosing range is 2.5 mg to 20 mg given twice a day. Doses should be titrated upward, as tolerated, over a period of a few days or weeks. The maximum daily dose administered in clinical trials was 40 mg in divided doses.

  After the initial dose of enalapril maleate tablets USP, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS, Drug Interactions). If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of enalapril maleate tablets, USP does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

  Asymptomatic Left Ventricular Dysfunction

  In the trial that demonstrated efficacy, patients were started on 2.5 mg twice daily and were titrated as tolerated to the targeted daily dose of 20 mg (in divided doses).

  After the initial dose of enalapril maleate tablets USP, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS and PRECAUTIONS, Drug Interactions). If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of enalapril maleate tablets, USP does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

  Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia

  In patients with heart failure who have hyponatremia (serum sodium less than 130 mEq/L) or with serum creatinine greater than 1.6 mg/dL, therapy should be initiated at 2.5 mg daily under close medical supervision (see DOSAGE AND ADMINISTRATION, Heart Failure; WARNINGS; and PRECAUTIONS, Drug Interactions). The dose may be increased to 2.5 mg b.i.d., then 5 mg b.i.d. and higher as needed, usually at intervals of 4 days or more if at the time of dosage adjustment there is not excessive hypotension or significant deterioration of renal function. The maximum daily dose is 40 mg.

  Pediatric Hypertensive Patients

  The usual recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily. Dosage should be adjusted according to blood pressure response. Doses above 0.58 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients (see CLINICAL PHARMACOLOGY, Clinical Pharmacology in Pediatric Patients).

  Enalapril maleate tablets, USP are not recommended in neonates and in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2, as no data are available.

  Preparation of Suspension (for 200 mL of a 1 mg/mL Suspension)

  Add 50 mL of Bicitra®1 to a polyethylene terephthalate (PET) bottle containing ten 20 mg tablets of enalapril maleate tablets and shake for at least 2 minutes. Let concentrate stand for 60 minutes. Following the 60 minute hold time, shake the concentrate for an additional minute. Add 150 mL of Ora-Sweet SF™2 to the concentrate in the PET bottle and shake the suspension to disperse the ingredients. The suspension should be refrigerated at 2° to 8°C (36° to 46°F) and can be stored for up to 30 days. Shake the suspension before each use.

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