Richmond Pharmaceuticals, Inc.
Manufacturer Details
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Richmond Pharmaceuticals, Inc. Drugs
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![Quinidine Gluconate Tablet, Extended Release [Richmond Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4fb02ad7-6e93-4aff-9aca-5162559b99a5&name=quinidine-02.jpg)
Quinidine Gluconate
The dose of quinidine delivered by quinidine gluconate extended-release tablets may be titrated by breaking a tablet in half. If tablets are crushed or chewed, their extended-release properties will be lost.
The dosage of quinidine varies considerably depending upon the general condition and the cardiovascular state of the patient.
Conversion of atrial fibrillation/flutter to sinus rhythm
Especially in patients with known structural heart disease or other risk factors for toxicity, initiation or dose-adjustment of treatment with quinidine gluconate should generally be performed in a setting where facilities and personnel for monitoring and resuscitation are continuously available. Patients with symptomatic atrial fibrillation/flutter should be treated with quinidine gluconate only after ventricular rate control (e.g., with digitalis or β-blockers) has failed to provide satisfactory control of symptoms.
Adequate trials have not identified an optimal regimen of quinidine gluconate for conversion of atrial fibrillation/flutter to sinus rhythm. In one reported regimen, the patient first receives two tablets (648 mg; 403 mg of quinidine base) of quinidine gluconate every eight hours. If this regimen has not resulted in conversion after 3 or 4 doses, then the dose is cautiously increased. If, at any point during administration, the QRS complex widens to 130% of its pre-treatment duration; the QTc interval widens to 130% of its pre-treatment duration and is then longer than 500 ms; P waves disappear; or the patient develops significant tachycardia, symptomatic bradycardia, or hypotension, then quinidine gluconate is discontinued, and other means of conversion (e.g., direct-current cardioversion) are considered.
In another regimen sometimes used, the patient receives one tablet (324 mg; 202 mg of quinidine base) every eight hours for two days; then two tablets every twelve hours for two days; and finally two tablets every eight hours for up to four days. The four-day stretch may come at one of the lower doses if, in the judgment of the physician, the lower dose is the highest one that will be tolerated. The criteria for discontinuation of treatment with quinidine gluconate are the same as in the other regimen.
Reduction in the frequency of relapse into atrial fibrillation/flutter
In a patient with a history of frequent symptomatic episodes of atrial fibrillation/flutter, the goal of therapy with quinidine gluconate should be an increase in the average time between episodes. In most patients, the tachyarrhythmia will recur during therapy with quinidine gluconate, and a single recurrence should not be interpreted as therapeutic failure.
Especially in patients with known structural heart disease or other risk factors for toxicity, initiation or dose-adjustment of treatment with quinidine gluconate should generally be performed in a setting where facilities and personnel for monitoring and resuscitation are continuously available. Monitoring should be continued for two or three days after initiation of the regimen on which the patient will be discharged.
Therapy with quinidine gluconate should be begun with one tablet (324 mg; 202 mg of quinidine base) every eight or twelve hours. If this regimen is well tolerated, if the serum quinidine level is still well within the laboratory's therapeutic range, and if the average time between arrhythmic episodes has not been satisfactorily increased, then the dose may be cautiously raised. The total daily dosage should be reduced if the QRS complex widens to 130% of its pre-treatment duration; the QTc interval widens to 130% of its pre-treatment duration and is then longer than 500 ms; P waves disappear; or the patient develops significant tachycardia, symptomatic bradycardia, or hypotension.
Suppression of life-threatening ventricular arrhythmias
Dosing regimens for the use of quinidine gluconate in suppressing life-threatening ventricular arrhythmias have not been adequately studied. Described regimens have generally been similar to the regimen described just above for the prophylaxis of symptomatic atrial fibrillation/flutter. Where possible, therapy should be guided by the results of programmed electrical stimulation and/or Holter monitoring with exercise.
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![Felodipine Tablet, Film Coated, Extended Release [Richmond Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e1824844-b6ae-4287-aef0-5a23c411d0a7&name=felodipine-02.jpg)
Felodipine
The recommended starting dose is 5 mg once a day. Depending on the patient's response, the dosage can be decreased to 2.5 mg or increased to 10 mg once a day. These adjustments should occur generally at intervals of not less than 2 weeks. The recommended dosage range is 2.5–10 mg once daily. In clinical trials, doses above 10 mg daily showed an increased blood pressure response but a large increase in the rate of peripheral edema and other vasodilatory adverse events (see ADVERSE REACTIONS). Modification of the recommended dosage is usually not required in patients with renal impairment.
Felodipine extended-release tablets should regularly be taken either without food or with a light meal (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism). Felodipine extended-release tablets should be swallowed whole and not crushed or chewed.
Geriatric Use – Patients over 65 years of age are likely to develop higher plasma concentrations of felodipine (see CLINICAL PHARMACOLOGY). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range (2.5 mg daily). Elderly patients should have their blood pressure closely monitored during any dosage adjustment.
Patients with Impaired Liver Function – Patients with impaired liver function may have elevated plasma concentrations of felodipine and may respond to lower doses of felodipine extended-release tablets; therefore, patients should have their blood pressure monitored closely during dosage adjustment of felodipine extended-release tablets (see CLINICAL PHARMACOLOGY).
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![Clonidine Hydrochloride Tablet [Richmond Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=809d8d33-9459-4e74-8cd2-5f5a9670cb95&name=clonidine-02.jpg)
Clonidine Hydrochloride
Adults
The dose of clonidine hydrochloride tablets USP must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration.
Initial Dose
0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.
Maintenance Dose
Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.
Renal Impairment
Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.
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![Ferrous Sulfate Tablet [Richmond Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5514d582-19b5-4f1e-b794-f790afb8211c&name=39803ffc-figure-01.jpg)
Ferrous Sulfate
DRUG INTERACTION PRECAUTION: Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other.
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![Diphenhydramine Hydrochloride Capsule [Richmond Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f184b2aa-91a4-44f9-b688-d4e318181984&name=215d1ac5-figure-01.jpg)
Diphenhydramine Hydrochloride
Directions
• adults and children 12 years and over: take 1 to 2 capsules every 4 to 6 hours; not more than 6 doses in 24 hours • children under 12 years: ask a doctorOther information
store at 15-30°C(59-86°F) protect from moisture -
![Zolpidem Tartrate Tablet, Extended Release [Lupin Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b1397a52-d99f-44f0-8649-8ceb8e7b9b85&name=f124afe6-5b5d-40a3-8612-afa551f6f729-02.jpg)
Zolpidem Tartrate
Under no circumstances should ribavirin capsules be opened, crushed, or broken. Ribavirin capsules should be taken with food [see Clinical Pharmacology (12.3)]. Ribavirin capsules should not be used in patients with creatinine clearance < 50 mL/min.
2.1 Ribavirin/Peginterferon alfa-2b Combination Therapy
Adult Patients
The recommended dose of peginterferon alfa-2b is 1.5 mcg/kg/week subcutaneously in combination with 800 to 1400 mg ribavirin capsules orally based on patient body weight (see Table 1). The volume of peginterferon alfa-2b to be injected depends on the strength of peginterferon alfa-2b and patient’s body weight (see Table 1).
Duration of Treatment – Interferon Alpha-naïve Patients
The treatment duration for patients with genotype 1 is 48 weeks. Discontinuation of therapy should be considered in patients who do not achieve at least a 2 log10 drop or loss of HCV-RNA at 12 weeks, or if HCV-RNA remains detectable after 24 weeks of therapy. Patients with genotype 2 and 3 should be treated for 24 weeks.
Duration of Treatment – Retreatment with Peginterferon alfa-2b/Ribavirin of Prior Treatment Failures
The treatment duration for patients who previously failed therapy is 48 weeks, regardless of HCV genotype. Re-treated patients who fail to achieve undetectable HCV-RNA at week 12 of therapy, or whose HCV-RNA remains detectable after 24 weeks of therapy, are highly unlikely to achieve SVR and discontinuation of therapy should be considered [see Clinical Studies (14.1)].
Table 1: Recommended Ribavirin/Peginterferon alfa-2b Combination Therapy Dosing (Adults) * When reconstituted as directed. † For patients weighing >105 kg (>231 pounds), the peginterferon alfa-2b dose of 1.5 mcg/kg/week should be calculated based on an individual patient weight. Two vials of peginterferon alfa-2b may be necessary to provide the dose.Body weight kg (lbs)
Peginterferon alfa-2b Vial Strength to Use
Amount of Peginterferon alfa-2b (mcg) to Administer
Volume (mL)* of Peginterferon alfa-2b to Administer
Ribavirin Capsules Daily Dose
Ribavirin Number of Capsules
<40(<87)
50 mcg per0.5 mL
50
0.5
800 mg/day
2 x 200 mg capsules A.M.
2 x 200 mg capsules P.M.
40-50(87-111)
80 mcg per0.5 mL
64
0.4
800 mg/day
2 x 200 mg capsules A.M.
2 x 200 mg capsules P.M.
51-60(112-133)
80 mcg per0.5 mL
80
0.5
800 mg/day
2 x 200 mg capsules A.M.
2 x 200 mg capsules P.M.
61-65(134-144)
120 mcg per0.5 mL
96
0.4
800 mg/day
2 x 200 mg capsules A.M.
2 x 200 mg capsules P.M.
66-75(145-166)
120 mcg per0.5 mL
96
0.4
1000 mg/day
2 x 200 mg capsules A.M.
3 x 200 mg capsules P.M.
76-80(167-177)
120 mcg per0.5 mL
120
0.5
1000 mg/day
2 x 200 mg capsules A.M.
3 x 200 mg capsules P.M.
81-85(178-187)
120 mcg per0.5 mL
120
0.5
1200 mg/day
3 x 200 mg capsules A.M.
3 x 200 mg capsules P.M.
86-105(188-231)
150 mcg per0.5 mL
150
0.5
1200 mg/day
3 x 200 mg capsules A.M.
3 x 200 mg capsules P.M.
>105(>231)
†
†
†
1400 mg/day
3 x 200 mg capsules A.M.
4 x 200 mg capsules P.M.
Pediatric Patients
Dosing for pediatric patients is determined by body surface area for peginterferon alfa-2b and by body weight for ribavirin capsules. The recommended dose of peginterferon alfa-2b is 60 mcg/m2/week subcutaneously in combination with 15 mg/kg/day of ribavirin orally in two divided doses (see Table 2) for pediatric patients ages 3-17 years. Patients who reach their 18th birthday while receiving peginterferon alfa-2b/ribavirin should remain on the pediatric dosing regimen. The treatment duration for patients with genotype 1 is 48 weeks. Patients with genotype 2 and 3 should be treated for 24 weeks.
Table 2: Recommended Ribavirin Capsules* Dosing in Combination Therapy (Pediatrics) * Ribavirin capsules to be used in combination with Peginterferon alfa-2b 60 mcg/m 2 weekly.Body weight kg (lbs)
Ribavirin Capsules Daily Dose
Ribavirin Number of Capsules
47–59 (103–131)
800 mg/day
2 x 200 mg capsules A.M. 2 x 200 mg capsules P.M.
60–73 (132–162)
1000 mg/day
2 x 200 mg capsules A.M. 3 x 200 mg capsules P.M.
>73 (>162)
1200 mg/day
3 x 200 mg capsules A.M. 3 x 200 mg capsules P.M.
2.2 Ribavirin/Interferon alfa-2b Combination Therapy
Adults
Duration of Treatment – Interferon Alpha-naïve Patients
The recommended dose of interferon alfa-2b is 3 million IU three times weekly subcutaneously. The recommended dose of ribavirin depends on the patient’s body weight (refer to Table 3). The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. The duration of treatment should be individualized to the patient depending on baseline disease characteristics, response to therapy, and tolerability of the regimen [see Indications and Usage (1.1), Adverse Reactions (6.1), and Clinical Studies (14)]. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population.
Duration of Treatment – Retreatment with Interferon alfa-2b/Ribavirin in Relapse Patients
In patients who relapse following nonpegylated interferon monotherapy, the recommended duration of treatment is 24 weeks.
Table 3. Recommended DosingBody weight
Ribavirin capsules
≤75 kg
2 times 200 mg capsules A.M.3 times 200 mg capsules P.M. daily orally
>75 kg
3 times 200 mg capsules A.M.3 times 200 mg capsules P.M.daily orally
Pediatrics
The recommended dose of ribavirin capsules is 15 mg/kg per day orally (divided dose A.M. and P.M.). Refer to Table 2 for Pediatric Dosing of ribavirin capsules in combination with interferon alfa-2b. Interferon alfa-2b for Injection by body weight of 25 kg to 61 kg is 3 million IU/m2 three times weekly subcutaneously. Refer to the adult dosing table for > 61 kg body weight.
The recommended duration of treatment is 48 weeks for pediatric patients with genotype 1. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by this time. The recommended duration of treatment for pediatric patients with genotype 2/3 is 24 weeks.
2.3 Laboratory Tests
The following laboratory tests are recommended for all patients treated with ribavirin capsules, prior to beginning treatment and then periodically thereafter.
• Standard hematologic tests - including hemoglobin (pretreatment, Week 2 and Week 4 of therapy, and as clinically appropriate [see Warnings and Precautions (5.2, 5.7)], complete and differential white blood cell counts, and platelet count. • Blood chemistries - liver function tests and TSH. • Pregnancy - including monthly monitoring for women of childbearing potential. • ECG [see Warnings and Precautions (5.2)].2.4 Dose Modifications
If severe adverse reactions or laboratory abnormalities develop during combination ribavirin/interferon alfa-2b therapy or ribavirin/peginterferon alfa-2b therapy, modified, or discontinue the dose until the adverse reaction abates or decreases in severity [see Warnings and Precautions (5)]. If intolerance persists after dose adjustment, combination therapy should be discontinued. Dose reduction of peginterferon alfa-2b in adult patients on ribavirin/peginterferon alfa-2b combination therapy is accomplished in a two-step process from the original starting dose of 1.5 mcg/kg/week, to 1 mcg/kg/week, then to 0.5 mcg/kg/week, if needed. Dose reduction of peginterferon alfa-2b in adults may be accomplished by utilizing a lower dose strength or administering a lesser volume as shown in Table 4.
In the adult combination therapy study 2 dose reductions occurred in 42% of subjects receiving peginterferon alfa-2b 1.5 mcg/kg plus ribavirin 800 mg daily including 57% of those subjects weighing 60 kg or less. In Study 4, 16% of subjects had a dose reduction of peginterferon alfa-2b to 1 mcg/kg in combination with ribavirin, with an additional 4% requiring the second dose reduction of peginterferon alfa-2b to 0.5 mcg/kg due to adverse events [see Adverse Reactions (6.1)].
Table 4: Two-Step Dose Reduction of Peginterferon alfa-2b in Combination Therapy in Adults * When reconstituted as directed † Must use vial. Minimum delivery for peginterferon alfa-2b 0.3 mLFirst Dose Reduction to Peginterferon alfa-2b 1 mcg/kg
Second Dose Reduction to Peginterferon alfa-2b 0.5 mcg/kg
Body weight kg (lbs)
Peginterferon alfa-2b Vial Strength to Use
Amount of Peginterferon alfa-2b (mcg) to Administer
Volume (mL)* of Peginterferon alfa-2b to Administer
Body weight kg (lbs)
Peginterferon alfa-2b Vial Strength to Use
Amount of Peginterferon alfa-2b (mcg) to Administer
Volume (mL)* of Peginterferon alfa-2b to Administer
<40 (<88)
50 mcg per 0.5 mL
35
0.35
<40(<88)
50 mcg per 0.5 mL†
20
0.2
40–50(88–111)
45
0.45
40–50(88–111)
25
0.25
51–60(112–133)
50
0.5
51–60(112–133)
50 mcg per 0.5 mL
30
0.3
61–75(134–166)
80 mcg per 0.5 mL
64
0.4
61–75(134–166)
35
0.35
76–85(167–187)
80
0.5
76–85(167–187)
45
0.45
86–104(188–230)
120 mcg per 0.5 mL
96
0.4
86–104(188–230)
50
0.5
105–125(231–275)
108
0.45
105–125(231–275)
80 mcg per 0.5 mL
64
0.4
>125(>275)
150 mcg per 0.5 mL
135
0.45
>125(>275)
72
0.45
Dose reduction in pediatric patients is accomplished by modifying the recommended peginterferon alfa-2b dose in a two-step process from the original starting dose of 60 mcg/m2/week, to 40 mcg/m2/week, then to 20 mcg/m2/week, if needed (see Table 5). In the pediatric combination therapy trial, dose reductions occurred in 25% of subjects receiving peginterferon alfa-2b 60 mcg/m2 weekly plus ribavirin 15 mg/kg daily. Dose reduction in pediatric patients is accomplished by modifying the recommended ribavirin dose from the original starting dose of 15 mg/kg daily in a two-step process to 12 mg/kg/day, then to 8 mg/kg/day, if needed (see Table 5).
Ribavirin capsules should not be used in patients with creatinine clearance < 50 mL/min. Subjects with impaired renal function and those over the age of 50 should be carefully monitored with respect to development of anemia [see Warnings and Precautions (5.2), Use in Specific Populations (8.5), and Clinical Pharmacology (12.3)].
Ribavirin capsules should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see Warnings and Precautions (5.2)].
For patients with a history of stable cardiovascular disease, a permanent dose reduction is required if the hemoglobin decreases by ≥ 2 g/dL during any 4-week period. In addition, for these cardiac history patients, if the hemoglobin remains < 12 g/dL after 4 weeks on a reduced dose, the patient should discontinue combination therapy.
It is recommended that a patient whose hemoglobin level falls below 10 g/dL have his/her ribavirin capsules dose modified or discontinued per Table 5[see Warnings and Precautions (5.2)].
Table 5: Guidelines for Dose Modification and Discontinuation of Peginterferon alfa-2b, Interferon alfa-2b or Peginterferon alfa-2b/Ribavirin Capsules Based on Laboratory Parameters in Adults and Pediatrics * For adult patients with a history of stable cardiac disease receiving peginterferon alfa-2b or interferon alfa-2b in combination with ribavirin, the peginterferon alfa-2b or interferon alfa-2b dose should be reduced by half and the ribavirin dose by 200 mg/day if a > 2 g/dL decrease in hemoglobin is observed during any 4-week period. Both peginterferon alfa-2b and ribavirin capsules or interferon alfa-2b and ribavirin capsules should be permanently discontinued if patients have hemoglobin levels < 12 g/dL after this ribavirin dose reduction. Pediatric patients who have pre-existing cardiac conditions and experience a hemoglobin decrease ≥ 2 g/dL during any 4-week period during treatment should have weekly evaluations and hematology testing. † 1 st dose reduction of ribavirin is by 200 mg/day, except in patients receiving the 1400 mg dose it is by 400 mg/day; 2 nd dose reduction of ribavirin (if needed) is by an additional 200 mg/day. ‡ For patients on ribavirin/peginterferon alfa-2b combination therapy: 1 st dose reduction of peginterferon alfa-2b is to 1 mcg/kg/week, 2 nd dose reduction (if needed) of peginterferon alfa-2b is to 0.5 mcg/kg/week. For patients on ribavirin/interferon alfa-2b combination therapy, reduce interferon alfa-2b dose by 50%.Laboratory Values
Adults
Pediatrics
Adults
Pediatrics
Peginterferon alfa-2b /Interferon alfa-2b
Peginterferon alfa-2b
Interferon alfa-2b
Ribavirin capsules
Hgb < 10g/dL
For patients with cardiac disease, reduce by 50%*
See footnote*
See footnote*
Adjust Dose†
1st reduction to 12 mg/kg/day2nd reduction to 8 mg/kg/day
WBC < 1.5 x 109/LNeutrophils < 0.75 x 109/LPlatelets< 50 x 109/L (Adults)< 70 x 109/L (Pediatrics)
Adjust Dose‡
1st reduction to 40 mcg/m2/week 2nd reduction to 20 mcg/m2/week
Reduce by 50%
No Dose Change
No Dose Change
Hgb < 8.5g/dL WBC < 1 x 109/L Neutrophils < 0.5 x 109/L Creatinine > 2 mg/dL (Pediatrics) Platelets < 25 x 109/L (Adults) < 50 x 109/L (Pediatrics)
Permanently Discontinue
Permanently Discontinue
Permanently Discontinue
Permanently Discontinue
Permanently Discontinue
Refer to the Intron A Package Insert or PegIntron Powder for Injection Package Insert for additional information about how to reduce an interferon alfa-2b or peginterferon alfa-2b dose.
2.5 Discontinuation of Dosing
Adults
It is recommended that HCV genotype 1 interferon-alfa-naïve patients receiving peginterferon alfa-2b in combination with ribavirin, be discontinued from therapy if there is not at least a 2 log10 drop or loss of HCV-RNA at 12 weeks of therapy, or whose HCV-RNA levels remain detectable (>10-20 IU/mL) after 24 weeks of therapy. Regardless of genotype, previously treated patients who have detectable HCV-RNA at week 12 or 24 are highly unlikely to achieve SVR and discontinuation of therapy should be considered.
Pediatrics (3-17 years of age)
It is recommended that patients receiving peginterferon alfa-2b/ribavirin combination (excluding HCV Genotype 2 and 3) be discontinued from therapy at 12 weeks if their treatment Week 12 HCV-RNA dropped < 2 log10 compared to a pretreatment or at 24 weeks if they have detectable HCV-RNA (>10-20 IU/mL) at treatment Week 24.
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![Imipramine Hydrochloride Tablet, Film Coated [Richmond Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=01e33e76-02a7-48ca-b3d0-3ba5587566bd&name=impramine-02.jpg)
Imipramine Hydrochloride
Depression
Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients as compared to hospitalized patients who will be under close supervision. Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time, at the lowest dose that will maintain remission.
Usual Adult Dose
Hospitalized Patients - Initially, 100 mg/day in divided doses gradually increased to 200 mg/day as required. If no response after two weeks, increase to 250 to 300 mg/day.
Outpatients - Initially, 75 mg/day increased to 150 mg/day. Dosages over 200 mg/day are not recommended. Maintenance, 50 to 150 mg/day.
Adolescent and Geriatric Patients - Initially, 30 to 40 mg/day; it is generally not necessary to exceed 100 mg/day.
Childhood Enuresis
Initially, an oral dose of 25 mg/day should be tried in children aged 6 and older. Medication should be given one hour before bedtime. If a satisfactory response does not occur within one week, increase the dose to 50 mg nightly in children under 12 years; children over 12 may receive up to 75 mg nightly. A daily dose greater than 75 mg does not enhance efficacy and tends to increase side effects. Evidence suggests that in early night bedwetters, the drug is more effective given earlier and in divided amounts, i.e., 25 mg in midafternoon, repeated at bedtime. Consideration should be given to instituting a drug-free period following an adequate therapeutic trial with a favorable response. Dosage should be tapered off gradually rather than abruptly discontinued; this may reduce the tendency to relapse. Children who relapse when the drug is discontinued do not always respond to a subsequent course of treatment.
A dose of 2.5 mg/kg/day should not be exceeded. ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount.
The safety and effectiveness of imipramine hydrochloride as temporary adjunctive therapy for nocturnal enuresis in children less than 6 years of age has not been established.
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