Sigmapharm Laboratories, Llc

Sigmapharm Laboratories, Llc Drugs

• Ergocalciferol
  

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  Ergocalciferol

  

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  THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW. Vitamin D Resistant Rickets:

  12,000 to 500,000 USP Units daily.

  Hypoparathyroidism:

  50,000 to 200,000 USP Units daily concomitantly with calcium lactate 4 g, six times per day.

  DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.

  Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized.

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• Liothyronine Sodium
  

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  Liothyronine Sodium

  

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  The dosage of thyroid hormones is determined by the indication and must in every case be individualized according to patient response and laboratory findings.

  Liothyronine sodium tablets are intended for oral administration; once-a-day dosage is recommended. Although liothyronine sodium has a rapid cutoff, its metabolic effects persist for a few days following discontinuance.

  Mild Hypothyroidism: Recommended starting dosage is 25 mcg daily. Daily dosage then may be increased by up to 25 mcg every 1 or 2 weeks. Usual maintenance dose is 25 to 75 mcg daily.

  The rapid onset and dissipation of action of liothyronine sodium (T3), as compared with levothyroxine sodium (T4), has led some clinicians to prefer its use in patients who might be more susceptible to the untoward effects of thyroid medication. However, the wide swings in serum T3 levels that follow its administration and the possibility of more pronounced cardiovascular side effects tend to counterbalance the stated advantages.

  Liothyronine sodium tablets may be used in preference to levothyroxine (T4) during radioisotope scanning procedures, since induction of hypothyroidism in those cases is more abrupt and can be of shorter duration. It may also be preferred when impairment of peripheral conversion of T4 to T3 is suspected.

  Myxedema: Recommended starting dosage is 5 mcg daily. This may be increased by 5 to 10 mcg daily every 1 or 2 weeks. When 25 mcg daily is reached, dosage may be increased by 5 to 25 mcg every 1 or 2 weeks until a satisfactory therapeutic response is attained. Usual maintenance dose is 50 to 100 mcg daily.

  Myxedema Coma: Myxedema coma is usually precipitated in the hypothyroid patient of long standing by intercurrent illness or drugs such as sedatives and anesthetics and should be considered a medical emergency.

  An intravenous preparation of liothyronine sodium is marketed by JONES PHARMA INCORPORATED, under the trade name Triostat® for use in myxedema coma/precoma.

  Congenital Hypothyroidism: Recommended starting dosage is 5 mcg daily, with a 5 mcg increment every 3 to 4 days until the desired response is achieved. Infants a few months old may require only 20 mcg daily for maintenance. At 1 year, 50 mcg daily may be required. Above 3 years, full adult dosage may be necessary (see PRECAUTIONS, Pediatric Use).

  Simple (non-toxic) Goiter: Recommended starting dosage is 5 mcg daily. This dosage may be increased by 5 to 10 mcg daily every 1 or 2 weeks. When 25 mcg daily is reached, dosage may be increased every week or two by 12.5 or 25 mcg. Usual maintenance dosage is 75 mcg daily.

  In the elderly or in pediatric patients, therapy should be started with 5 mcg daily and increased only by 5 mcg increments at the recommended intervals.

  When switching a patient to Liothyronine Sodium tablets from thyroid, L-thyroxine or thyroglobulin, discontinue the other medication, initiate liothyronine sodium at a low dosage, and increase gradually according to the patient's response. When selecting a starting dosage, bear in mind that this drug has a rapid onset of action, and that residual effects of the other thyroid preparation may persist for the first several weeks of therapy.

  Thyroid Suppression Therapy: Administration of thyroid hormone in doses higher than those produced physiologically by the gland results in suppression of the production of endogenous hormone. This is the basis for the thyroid suppression test and is used as an aid in the diagnosis of patients with signs of mild hyperthyroidism in whom baseline laboratory tests appear normal or to demonstrate thyroid gland autonomy in patients with Graves’ ophthalmopathy. 131I uptake is determined before and after the administration of the exogenous hormone. A 50% or greater suppression of uptake indicates a normal thyroid-pituitary axis and thus rules out thyroid gland autonomy.

  Each 5 mcg tablet contains liothyronine sodium equivalent to 5 mcg of liothyronine. Each 25 mcg tablet contains liothyronine sodium equivalent to 25 mcg of liothyronine. Each 50 mcg tablet contains liothyronine sodium equivalent to 50 mcg of liothyronine.

  Liothyronine sodium tablets are given in doses of 75 to 100 mcg/day for 7 days, and radioactive iodine uptake is determined before and after administration of the hormone. If thyroid function is under normal control, the radioiodine uptake will drop significantly after treatment. Liothyronine sodium tablets should be administered cautiously to patients in whom there is a strong suspicion of thyroid gland autonomy, in view of the fact that the exogenous hormone effects will be additive to the endogenous source.

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• Sodium Phenylbutyrate
  

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  Sodium Phenylbutyrate

  

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  For oral use only.The use of Sodium Phenylbutyrate Tablets is indicated for children weighing more than 20 kg and for adults.The usual total daily dose of Sodium Phenylbutyrate Powder for patients with urea cycle disorders is 450 – 600 mg/kg/day in patients weighing less than 20 kg, or 9.9 – 13 g/m2/day in larger patients. The powder is to be taken in equally divided amounts with each meal or feeding (i.e., three to six times per day).Sodium Phenylbutyrate Powder is indicated for oral use (via mouth, gastrostomy, or nasogastric tube) only.   The powder is to be mixed with food (solid or liquid) for immediate use; however, when dissolved in water, Sodium Phenylbutyrate Powder has been shown to be stable for up to one week at room temperature or refrigerated. Sodium phenylbutyrate is very soluble in water (5 grams per 10 mL). When Sodium Phenylbutyrate Powder is added to a liquid, only sodium phenylbutyrate will dissolve, the excipients will not. The effect of food on sodium phenylbutyrate has not been determined. Each level yellow  teaspoon (enclosed) dispenses 3.2 grams of powder and 3 grams of sodium phenylbutyrate. Each level blue  tablespoon (enclosed) dispenses 9.1 grams of powder and 8.6 grams of sodium phenylbutyrate.Shake lightly before use.The safety or efficacy of doses in excess of 20 grams per day has not been established.

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• Atenolol
  

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  Atenolol

  

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  There is intersubject variation in the pharmacokinetics, clinical efficacy, and incidence of side effects with Acitretin Capsules, USP. 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, USP 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, USP are used with phototherapy, the prescriber should decrease the phototherapy dose, dependent on the patient’s individual response (see PRECAUTIONS: General).

  Females who have taken TEGISON (etretinate) must continue to follow the contraceptive recommendations for TEGISON. TEGISON is no longer marketed in the US; for information, call 1-855-273-0150.

  Information for Pharmacists: 

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

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• Adefovir Dipivoxil
  

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  Adefovir Dipivoxil

  

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  2.1 Chronic Hepatitis B

  The recommended dose of Adefovir Dipivoxil Tablets in chronic hepatitis B patients for patients 12 years of age and older with adequate renal function is 10 mg, once daily, taken orally, without regard to food. The optimal duration of treatment is unknown.

  Adefovir Dipivoxil Tablets is not recommended for use in children less than 12 years of age.

  2.2 Dose adjustment in Renal Impairment

  Significantly increased drug exposures were seen when Adefovir Dipivoxil Tablets were administered to adult patients with renal impairment [See Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. Therefore, the dosing interval of Adefovir Dipivoxil Tablets should be adjusted in adult patients with baseline creatinine clearance less than 50 mL per minute using the following suggested guidelines (see Table 1). The safety and effectiveness of these dosing interval adjustment guidelines have not been clinically evaluated.

  Additionally, it is important to note that these guidelines were derived from data in patients with pre-existing renal impairment at baseline. They may not be appropriate for patients in whom renal insufficiency evolves during treatment with Adefovir Dipivoxil Tablets . Therefore, clinical response to treatment and renal function should be closely monitored in these patients.

  Table 1  Dosing Interval Adjustment of Adefovir Dipivoxil Tablets in Adult Patients with Renal Impairment

  * Creatinine clearance calculated by Cockcroft-Gault method using lean or ideal body weight. Creatinine Clearance (mL/min)* Greater than or equal to 50 30 to 49 10 to 29 Hemodialysis Patients Recommended dose and dosing interval 10 mg every 24 hours 10 mg every 48 hours 10 mg every 72 hours 10 mg every 7 days following dialysis

  The pharmacokinetics of adefovir have not been evaluated in non-hemodialysis patients with creatinine clearance less than 10 mL per minute; therefore, no dosing recommendation is available for these patients.

  No clinical data are available to make dosing recommendations in adolescent patients with renal insufficiency [See Warnings and Precautions (5.2)]

  2.1 Chronic Hepatitis B

  The recommended dose of Adefovir Dipivoxil Tablets in chronic hepatitis B patients for patients 12 years of age and older with adequate renal function is 10 mg, once daily, taken orally, without regard to food. The optimal duration of treatment is unknown.

  Adefovir Dipivoxil Tablets is not recommended for use in children less than 12 years of age.

  2.2 Dose adjustment in Renal Impairment

  Significantly increased drug exposures were seen when Adefovir Dipivoxil Tablets were administered to adult patients with renal impairment [See Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. Therefore, the dosing interval of Adefovir Dipivoxil Tablets should be adjusted in adult patients with baseline creatinine clearance less than 50 mL per minute using the following suggested guidelines (see Table 1). The safety and effectiveness of these dosing interval adjustment guidelines have not been clinically evaluated.

  Additionally, it is important to note that these guidelines were derived from data in patients with pre-existing renal impairment at baseline. They may not be appropriate for patients in whom renal insufficiency evolves during treatment with Adefovir Dipivoxil Tablets . Therefore, clinical response to treatment and renal function should be closely monitored in these patients.

  Table 1  Dosing Interval Adjustment of Adefovir Dipivoxil Tablets in Adult Patients with Renal Impairment

  * Creatinine clearance calculated by Cockcroft-Gault method using lean or ideal body weight. Creatinine Clearance (mL/min)* Greater than or equal to 50 30 to 49 10 to 29 Hemodialysis Patients Recommended dose and dosing interval 10 mg every 24 hours 10 mg every 48 hours 10 mg every 72 hours 10 mg every 7 days following dialysis

  The pharmacokinetics of adefovir have not been evaluated in non-hemodialysis patients with creatinine clearance less than 10 mL per minute; therefore, no dosing recommendation is available for these patients.

  No clinical data are available to make dosing recommendations in adolescent patients with renal insufficiency [See Warnings and Precautions (5.2)]

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