Valorin Extra Dosage

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Dosage of Valorin Extra in details

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General Dosing Information

Valorin Extra Injection may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting between oral Valorin Extra and Valorin Extra Injection dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of Valorin Extra is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing Valorin Extra. Exceeding the maximum mg/kg daily dose of Valorin Extra as described in Tables 1 to 3 may result in hepatic injury, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total amount of Valorin Extra from all routes and from all sources does not exceed the maximum recommended dose.

Recommended

Dosage: Adults and Adolescents

Adults and adolescents weighing 50 kg and over: the recommended dosage of Valorin Extra Injection is 1,000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Valorin Extra Injection of 1,000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Valorin Extra of 4,000 mg per day (includes all routes of administration and all Valorin Extra-containing products including combination products).

Adults and adolescents weighing under 50 kg: the recommended dosage of Valorin Extra Injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Valorin Extra Injection of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Valorin Extra of 75 mg/kg per day (includes all routes of administration and all Valorin Extra-containing products including combination products).

Table 1. Dosing for Adults and Adolescents
Age group

Dose given every 4 hours

Dose given every 6 hours

Maximum single dose

Maximum total daily dose of Valorin Extra (by all routes)

Adults and adolescents (13 years and older) weighing

≥ 50 kg

650 mg

1,000 mg

1,000 mg

4,000 mg in 24 hours

Adults and adolescents (13 years and older) weighing

< 50 kg

12.5 mg/kg

15 mg/kg

15 mg/kg

(up to 750 mg)

75 mg/kg in

24 hours

(up to 3,750 mg)

Recommended

Dosage: Children

Children 2 to 12 years of age: the recommended dosage of Valorin Extra Injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Valorin Extra Injection of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Valorin Extra of 75 mg/kg per day.

Table 2. Dosing for Children
Age group

Dose given every 4 hours

Dose given every 6 hours

Maximum single dose

Maximum total daily dose of Valorin Extra (by all routes)

Children 2 to 12 years of age

12.5 mg/kg

15 mg/kg

15 mg/kg

(up to 750 mg)

75 mg/kg in

24 hours

(up to 3,750 mg)

Recommended Dosage for Treatment of Fever in Neonates and Infants

Neonates, including premature neonates born at ≥ 32 weeks gestational age, up to 28 days chronological age: the recommended dosage of Valorin Extra is 12.5 mg/kg every 6 hours, to a maximum daily dose of Valorin Extra of 50 mg/kg per day, with a minimum dosing interval of 6 hours.

Infants 29 days to 2 years of age: the recommended dosage of Valorin Extra is 15 mg/kg every 6 hours, to a maximum daily dose of Valorin Extra of 60 mg/kg per day, with a minimum dosing interval of 6 hours.

Table 3. Dosing for Treatment of Fever in Neonates and Infants
Age group

Dose given every 6 hours

Maximum total daily dose of Valorin Extra (by all routes)

Neonates (birth to 28 days)

12.5 mg/kg

50 mg/kg

Infants (29 days to 2 years)

15 mg/kg

60 mg/kg

Instructions for

Intravenous Administration

For adult and adolescent patients weighing ≥ 50 kg requiring 1,000 mg doses of Valorin Extra Injection, administer the dose by inserting a vented intravenous set through the septum of the 100 mL vial. Valorin Extra Injection may be administered without further dilution. Examine the container contents before dose preparation or administering. DO NOT USE if particulate matter or discoloration is observed. Administer the contents of the vial intravenously over 15 minutes. Use aseptic technique when preparing Valorin Extra Injection for intravenous infusion. Do not add other medications to the Valorin Extra Injection vial or infusion device.

For doses less than 1,000 mg, the appropriate dose must be withdrawn from the container and placed into a separate container prior to administration. Using aseptic technique, withdraw the appropriate dose (650 mg or weight-based) from an intact sealed Valorin Extra Injection container and place the measured dose in a separate empty, sterile container (e.g., glass bottle, plastic intravenous container, or syringe) for intravenous infusion to avoid the inadvertent delivery and administration of the total volume of the commercially available container. The entire 100 mL container of Valorin Extra Injection is not intended for use in patients weighing less than 50 kg. Valorin Extra Injection is supplied in a single-dose container and the unused portion must be discarded.

Place small volume pediatric doses up to 60 mL in volume in a syringe and administer over 15 minutes using a syringe pump.

Monitor the end of the infusion in order to prevent the possibility of an air embolism, especially in cases where the Valorin Extra Injection infusion is the primary infusion.

Once the container seal has been penetrated, or the contents transferred to another container, administer the dose of Valorin Extra Injection within 6 hours.

Do not add other medications to the Valorin Extra Injection solution. Diazepam and chlorpromazine hydrochloride are physically incompatible with Valorin Extra Injection, therefore do not administer simultaneously.

What other drugs will affect Valorin Extra?

Ask a doctor or pharmacist if it is safe for you to use Valorin Extra if you are also using any of the following drugs:

This list is not complete and there may be other drugs that can interact with Valorin Extra. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Valorin Extra interactions

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Valorin Extra is metabolized (eliminated by conversion to other chemicals) by the liver. Therefore drugs that increase the action of liver enzymes that metabolize Valorin Extra [for example, carbamazepine (Tegretol), isoniazid (INH, Nydrazid, Laniazid), rifampin (Rifamate, Rifadin, Rimactane)] reduce the levels of Valorin Extra and may decrease the action of Valorin Extra. Doses of Valorin Extra greater than the recommended doses are toxic to the liver and may result in severe liver damage. The potential for Valorin Extra to harm the liver is increased when it is combined with alcohol or drugs that also harm the liver.

Cholestyramine (Questran) reduces the effect of Valorin Extra by decreasing its absorption into the body from the intestine. Therefore, Valorin Extra should be administered 3 to 4 hours after cholestyramine or one hour before cholestyramine.

Valorin Extra doses greater than 2275 mg per day may increase the blood thinning effect of warfarin (Coumadin) by an unknown mechanism. Therefore, prolonged administration or large doses of Valorin Extra should be avoided during warfarin therapy


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References

  1. DailyMed. "CAFFEINE; ERGOTAMINE TARTRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "ACETAMINOPHEN; ASPIRIN; CAFFEINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. FDA/SPL Indexing Data. "3G6A5W338E: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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