Marathon Pharmaceuticals, Llc

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Marathon Pharmaceuticals, Llc Drugs

Analpram E

Analpram E

Start ISUPREL injection at the lowest recommended dose and increase the rate of administration gradually if necessary while carefully monitoring the patient. The usual route of administration is by intravenous infusion or bolus intravenous injection. In dire emergencies, the drug may be administered by intracardiac injection. If time is not of the utmost importance, initial therapy by intramuscular or subcutaneous injection is preferred.
Recommended dosage for adults with heart block, Adams-Stokes attacks, and cardiac arrest:
Route of

Administration

Preparation of Dilution

Initial Dose

Subsequent

Dose Range*

Bolus

intravenous injection

Dilute 1 mL (0.2 mg) in 9 mL of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP

0.02 mg to 0.06 mg

(1 mL to 3 mL of diluted solution)

0.01 mg to 0.2 mg

(0.5 mL to 10 mL of diluted solution)

Intravenous

infusion

Dilute 10 mL (2 mg) in 500 mL of 5% Dextrose Injection, USP

5 mcg/min.

(1.25 mL of diluted solution per minute)

Intramuscular

Use Solution undiluted

0.2 mg (1 mL)

0.02 mg to 1 mg

(0.1 mL to 5 mL)

Subcutaneous

Use Solution undiluted

0.2 mg (1 mL)

0.15 mg to 0.2 mg (0.75 mL to 1 mL)

Intracardiac

Use Solution undiluted

0.02 mg (0.1 mL)

*    Subsequent dosage and method of administration depend on the ventricular rate and the rapidity with which the cardiac pacemaker can take over when the drug is gradually withdrawn.

There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min.
Recommended dosage for adults with shock and hypoperfusion states:
Route of Administration

Preparation of Dilution†

Infusion Rate††

Intravenous infusion

Dilute 5 mL (1 mg) in 500 mL of 5% Dextrose Injection, USP

0.5 mcg to 5 mcg per minute

(0.25 mL to 2.5 mL of diluted solution)

†          Concentrations up to 10 times greater have been used when limitation of volume is essential.

††        Rates over 30 mcg per minute have been used in advanced stages of shock. The rate of infusion should be adjusted on the basis of heart rate, central venous pressure, systemic blood pressure, and urine   flow. If the heart rate exceeds 110 beats per minute, it may be advisable to decrease or temporarily discontinue the infusion.
Recommended dosage for adults with bronchospasm occurring during anesthesia:
Route of

Administration

Preparation of Dilution

Initial Dose

Subsequent

Dose

Bolus

intravenous

injection

Dilute 1 mL (0.2 mg) in 9 mL of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP

0.01 mg to 0.02 mg

(0.5 mL to 1 mL of diluted solution)

The initial dose may be repeated when necessary

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Such solution should not be used.
Pepcid

Pepcid

Duodenal Ulcer

Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use PEPCID at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

Benign Gastric Ulcer

Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

Gastroesophageal Reflux Disease (GERD)

The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

See PRECAUTIONS, Pediatric Patients <1 year of age.

The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

Dosage for Pediatric Patients 1-16 years of age

See PRECAUTIONS, Pediatric Patients 1-16 years of age.

The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

The dosage of PEPCID in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

Concomitant Use of Antacids

Antacids may be given concomitantly if needed.

Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of PEPCID is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of PEPCID may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

Based on the comparison of pharmacokinetic parameters for PEPCID in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.
Amytal Sodium

Amytal Sodium

The dose of amobarbital sodium must be individualized with full knowledge of its particular characteristics and recommended rate of administration. Factors of consideration are the patient’s age, weight, and condition. The maximum single dose for an adult is 1 g.

Intramuscular Use —

Intramuscular injection of the sodium salts of barbiturates should be made deeply into a large muscle. The average intramuscular dose ranges from 65 mg to 0.5 g. A volume of 5 mL (irrespective of concentration) should not be exceeded at any one site because of possible tissue irritation. Twenty percent solutions may be used so that a small volume can contain a large dose. After IM injection of a hypnotic dose, the patient’s vital signs should be monitored. Superficial intramuscular or subcutaneous injections may be painful and may produce sterile abscesses or sloughs.

Intravenous Use —

Intravenous injection is restricted to conditions in which other routes are not feasible, either because the patient is unconscious (as in cerebral hemorrhage, eclampsia, or status epilepticus), because the patient resists (as in delirium), or because prompt action is imperative. Slow IV injection is essential, and patients should be carefully observed during administration. This requires that blood pressure, respiration, and cardiac function be maintained, vital signs be recorded and equipment for resuscitation and artificial ventilation be available. The rate of IV injection for adults should not exceed 50 mg/min to prevent sleep or sudden respiratory depression. The final dosage is determined to a great extent by the patient’s reaction to the slow administration of the drug.

Adults: a. Sedative: 30 to 50 mg given 2 or 3 times daily.b. Hypnotic: 65 to 200 mg at bedtime.

Special Patient Population —

Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to barbiturates. Dosage should be reduced for patients with impaired renal function or hepatic disease. Ordinarily, an intravenous dose of 65 mg to 0.5 g may be given to a child 6 to 12 years of age.
Opium Tincture Deodoriz...

Opium Tincture Deodorized

Usual Adult Dose — 0.6 mL orally 4 times a day.
Pepcid

Pepcid

Duodenal Ulcer

Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use PEPCID at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

Benign Gastric Ulcer

Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

Gastroesophageal Reflux Disease (GERD)

The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

See PRECAUTIONS, Pediatric Patients <1 year of age.

The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

Dosage for Pediatric Patients 1-16 years of age

See PRECAUTIONS, Pediatric Patients 1-16 years of age.

The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

The dosage of PEPCID in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

Concomitant Use of Antacids

Antacids may be given concomitantly if needed.

Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of PEPCID is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of PEPCID may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

Based on the comparison of pharmacokinetic parameters for PEPCID in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.
Timentin

Timentin

2.1 Recommended Dose

All patients should be evaluated for bleeding disorder risk before prophylactic administration of Iprivask [see DRUG INTERACTIONS (7)].

Initial Dosage: In patients undergoing hip replacement surgery, the recommended dose of Iprivask is 15 mg every 12 hours administered by subcutaneous injection with the initial dose given up to 5 to 15 minutes prior to surgery, but after induction of regional block anesthesia, if used [see WARNINGS AND PRECAUTIONS (5.1)]. Up to 12 days administration (average duration 9 to 12 days) of Iprivask has been well tolerated in controlled clinical trials.

2.2 Dose Adjustment in Renal Impairment

Degree of Renal Impairment

Creatinine Clearance [mL/min/1.73m2 body surface area]

aPTT Monitoring & Dosing Instructions

Moderate

≥31 to 60

Initiate therapy at 5 mg every 12 hours by subcutaneous injection. Monitor aPTT and serum creatinine at least daily. If aPTT exceeds 2 times control:1. Interrupt therapy until the value returns to less than 2 times control.2. Resume therapy at a reduced dose guided by the initial degree of aPTT abnormality

Severea

<31

Initiate therapy at 1.7 mg every 12 hours by subcutaneous injection. Monitor aPTT and serum creatinine at least daily. If aPTT exceeds 2 times control:1. Interrupt therapy until the value returns to less than 2 times control.2. Consider further dose reductions guided by the initial degree of aPTT abnormality

a See CLINICAL PHARMACOLOGY (12.3) and WARNINGS AND PRECAUTIONS(5.2).

2.3 Clinical Monitoring

Activated partial thromboplastin time (aPTT) should be monitored daily in patients with increased risk of bleeding and/or renal impairment. Serum creatinine should be monitored daily in patients with renal impairment. Adjust Iprivask dosage according to creatinine levels [see Dosage and Administration (2.2)].

Peak aPTT should not exceed two times control. Should peak aPTT exceed this level, reduce the dosage of Iprivask based on the degree of aPTT abnormality [see Dosage and Administration (2.1)]. If necessary, interrupt therapy with desirudin until aPTT falls to less than two times control, at which time treatment with desirudin can be resumed at a reduced dose. Thrombin time (TT) is not a suitable test for routine monitoring of Iprivask therapy [see Clinical Pharmacology (12.1)].

2.4 Conversion from Other Anticoagulants

If a patient is switched from oral anticoagulants to Iprivask therapy or from Iprivask to oral anticoagulants, the anticoagulant activity should continue to be closely monitored with appropriate methods [see Drug Interactions (7.2)].

2.5 Instructions for Administration

Directions on Preparation

Use Iprivask before the expiration date given on the carton and container.

1. To prepare the reconstituted aqueous solution, 0.5 mL of the mannitol diluent is added under aseptic conditions to the vial containing the sterile powder.

2. Remove plastic flip-top cap from Iprivask Vial. Remove back cover of Vial Adapter package. Attach Vial Adapter to Vial by using the outer package to handle Adapter. Push Adapter down onto Vial until spike pierces rubber stopper and snaps into place. Discard Vial Adapter package.

3. Remove Syringe cap by twisting and pulling gently. Attach Syringe to Adapter on Vial by twisting. Slowly push plunger down to completely transfer solution into Vial. Leaving Syringe connected to Vial, gently swirl. Lyophilized powder in Vial will dissolve within 10 seconds.

4. With Syringe still connected to Vial, turn Vial upside down and withdraw entire contents of Vial back into Syringe. Remove Syringe from Vial and hold it with plunger-end down.

5. You must use enclosed Eclipse™ needle. Attach Needle to Syringe by twisting. Pull pink lever down and uncap needle. You are ready to inject Iprivask. After injection, flip up pink lever to cover needle until it snaps into place. Dispose of the used Syringe in a Sharps® container.

Iprivask should not be mixed with other injections, solvents, or infusions. Iprivask is administered by subcutaneous injection. It must not be administered by intramuscular injection.

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

Subcutaneous Injection Technique:

Patients should be sitting or lying down and Iprivask injection administered by deep subcutaneous injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral thigh or abdominal wall. The whole length of the needle should be introduced into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.

2.6 Storage after Reconstitution

Once Iprivask is reconstituted it may be used for up to 24 hours, when stored at 25°C (77°F); excursions permitted to 15–30°C (59-86°F). [See USP Controlled Room Temperature.]. Protect from light. After 24 hours, discard the solution.

Marathon Pharmaceuticals, Llc

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Marathon Pharmaceuticals, Llc Drugs