Malarone

Malarone Manufacturers

• Pd-rx Pharmaceuticals, Inc.
  

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  Malarone | Teva Pharmaceuticals Usa Inc

  

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  Patients should be retitrated when transferred from glyburide (micronized) tablets or other oral hypoglycemic agents (see PRECAUTIONS).

  There is no fixed dosage regimen for the management of diabetes mellitus with glyburide tablets. In addition to the usual monitoring of urinary glucose, the patient’s blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient’s response to therapy.

  Short-term administration of glyburide tablets may be sufficient during periods of transient loss of control in patients usually controlled well on diet.

  Usual Starting Dose

  The usual starting dose of glyburide tablets is 2.5 to 5 mg daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1.25 mg daily. (See PRECAUTIONS section for patients at increased risk.) Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy.

  Transfer From Other Hypoglycemic Therapy Patients Receiving Other Oral Antidiabetic Therapy

  Transfer of patients from other oral antidiabetic regimens to glyburide tablets should be done conservatively and the initial daily dose should be 2.5 to 5 mg. When transferring patients from oral hypoglycemic agents other than chlorpropamide to glyburide tablets, no transition period and no initial or priming dose are necessary. When transferring patients from chlorpropamide, particular care should be exercised during the first two weeks because the prolonged retention of chlorpropamide in the body and subsequent overlapping drug effects may provoke hypoglycemia.

  Patients Receiving Insulin

  Some Type II diabetic patients being treated with insulin may respond satisfactorily to glyburide tablets. If the insulin dose is less than 20 units daily, substitution of glyburide tablets 2.5 to 5 mg as a single daily dose may be tried. If the insulin dose is between 20 and 40 units daily, the patient may be placed directly on glyburide tablets 5 mg daily as a single dose. If the insulin dose is more than 40 units daily, a transition period is required for conversion to glyburide tablets. In these patients, insulin dosage is decreased by 50% and glyburide tablets 5 mg daily is started. Please refer to Titration to Maintenance Dose for further explanation.

  Patients Receiving Colesevelam

  When colesevelam is coadministered with glyburide, maximum plasma concentration and total exposure to glyburide is reduced. Therefore, glyburide tablets should be administered at least 4 hours prior to colesevelam.

  Titration to Maintenance Dose

  The usual maintenance dose is in the range of 1.25 to 20 mg daily, which may be given as a single dose or in divided doses (see Dosage Interval section). Dosage increases should be made in increments of no more than 2.5 mg at weekly intervals based upon the patient’s blood glucose response.

  No exact dosage relationship exists between glyburide tablets and the other oral hypoglycemic agents. Although patients may be transferred from the maximum dose of other sulfonylureas, the maximum starting dose of 5 mg of glyburide tablets should be observed. A maintenance dose of 5 mg of glyburide tablets provides approximately the same degree of blood glucose control as 250 to 375 mg chlorpropamide, 250 to 375 mg tolazamide, 500 to 750 mg acetohexamide, or 1000 to 1500 mg tolbutamide.

  When transferring patients receiving more than 40 units of insulin daily, they may be started on a daily dose of glyburide tablets 5 mg concomitantly with a 50% reduction in insulin dose. Progressive withdrawal of insulin and increase of glyburide tablets in increments of 1.25 to 2.5 mg every 2 to 10 days is then carried out. During this conversion period when both insulin and glyburide tablets are being used, hypoglycemia may occur. During insulin withdrawal, patients should test their urine for glucose and acetone at least three times daily and report results to their physician. The appearance of persistent acetonuria with glycosuria indicates that the patient is a Type I diabetic who requires insulin therapy.

  Concomitant Glyburide and Metformin Therapy

  Glyburide tablets should be added gradually to the dosing regimen of patients who have not responded to the maximum dose of metformin monotherapy after four weeks (see Usual Starting Dose and Titration to Maintenance Dose). Refer to metformin package insert.

  With concomitant glyburide and metformin therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the optimal dose of each drug needed to achieve this goal. With concomitant glyburide and metformin therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken (see PRECAUTIONS section).

  Maximum Dose

  Daily doses of more than 20 mg are not recommended.

  Dosage Interval

  Once-a-day therapy is usually satisfactory. Some patients, particularly those receiving more than 10 mg daily, may have a more satisfactory response with twice-a-day dosage.

  Specific Patient Populations

  Glyburide is not recommended for use in pregnancy or for use in pediatric patients.

  In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see PRECAUTIONS section).

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• Glaxosmithkline Llc
  

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  Malarone | Glaxosmithkline Llc

  

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  The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken.

  MALARONE may be crushed and mixed with condensed milk just prior to administration to patients who may have difficulty swallowing tablets.

  2.1 Prevention of Malaria

  Start prophylactic treatment with MALARONE 1 or 2 days before entering a malaria‑endemic area and continue daily during the stay and for 7 days after return.

  Adults: One MALARONE Tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.

  Pediatric Patients: The dosage for prevention of malaria in pediatric patients is based upon body weight (Table 1).

  Table 1. Dosage for Prevention of Malaria in Pediatric Patients

  Weight

  (kg)

  Atovaquone/

  Proguanil HCl

  Total Daily Dose

  Dosage Regimen

  11-20

  62.5 mg/25 mg

  1 MALARONE Pediatric Tablet daily

  21-30

  125 mg/50 mg

  2 MALARONE Pediatric Tablets as a single daily dose

  31-40

  187.5 mg/75 mg

  3 MALARONE Pediatric Tablets as a single daily dose

  >40

  250 mg/100 mg

  1 MALARONE Tablet (adult strength) as a single daily dose

  2.2 Treatment of Acute Malaria

  Adults: Four MALARONE Tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single daily dose for 3 consecutive days.

  Pediatric Patients: The dosage for treatment of acute malaria in pediatric patients is based upon body weight (Table 2).

  Table 2. Dosage for Treatment of Acute Malaria in Pediatric Patients

  Weight

  (kg)

  Atovaquone/

  Proguanil HCl

  Total Daily Dose

  Dosage Regimen

  5-8

  125 mg/50 mg

  2 MALARONE Pediatric Tablets daily for 3 consecutive days

  9-10

  187.5 mg/75 mg

  3 MALARONE Pediatric Tablets daily for 3 consecutive days

  11-20

  250 mg/100 mg

  1 MALARONE Tablet (adult strength) daily for 3 consecutive days

  21-30

  500 mg/200 mg

  2 MALARONE Tablets (adult strength) as a single daily dose for 3 consecutive days

  31-40

  750 mg/300 mg

  3 MALARONE Tablets (adult strength) as a single daily dose for 3 consecutive days

  >40

  1 g/400 mg

  4 MALARONE Tablets (adult strength) as a single daily dose for 3 consecutive days

  2.3 Renal Impairment

  Do not use MALARONE for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min) [see Contraindications (4.2)]. Use with caution for the treatment of malaria in patients with severe renal impairment, only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure. No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) or moderate (creatinine clearance 30 to 50 mL/min) renal impairment. [See Clinical Pharmacology (12.3).]

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