Infadrops

Infadrops (with the Optizorb formulation) also contains the following excipients: Pregelatinized maize starch, calcium carbonate, alginic acid, crospovidone, povidone, magnesium stearate, colloidal anhydrous silica, parahydroxybenzoates (sodium methyl, ethyl and propyl), OPADRY YS-1-7003 white, carnauba wax, purified water.

It contains no sugar, lactose or gluten.

Infadrops® (Infadrops) injection is indicated for

• the management of mild to moderate pain
• the management of moderate to severe pain with adjunctive opioid analgesics
• the reduction of fever.

Infadrops injection is used together with other medicines (eg, narcotic pain relievers) to relieve moderate to severe pain.

Infadrops is used to relieve mild to moderate pain and reduce fever in patients. It does not become habit-forming when taken for a long time. Infadrops may cause unwanted effects when taken in large doses, including liver damage.

Infadrops is available only with your doctor's prescription.

General Dosing Information

Infadrops 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 Infadrops and Infadrops dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of Infadrops is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing Infadrops. Exceeding the maximum mg/kg daily dose of Infadrops as described in Tables 1 and 2 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 Infadrops from all routes and from all credits does not exceed the maximum recommended dose.

Recommended

Dosage: Adults and Adolescents

Adults and adolescents weighing 50 kg and over: the recommended dosage of Infadrops is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Infadrops of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Infadrops of 4000 mg per day (includes all routes of administration and all Infadrops-containing products including combination products).

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

Table 1: Dosing for Adults and Adolescents

Recommended

Dosage: Children

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

Table 2: Dosing for Children

Instructions For

Intravenous Administration

For adult and adolescent patients weighing ≥ 50 kg requiring 1000 mg doses of Infadrops, administer the dose by inserting a vented intravenous set through the septum of the 100 mL vial. Infadrops may be administered without further dilution. Examine the vial 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 Infadrops for intravenous infusion. Do not add other medications to the Infadrops vial or infusion device.

For doses less than 1000 mg, the appropriate dose must be withdrawn from the vial 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 Infadrops vial 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 vial of Infadrops is not intended for use in patients weighing less than 50 kg. Infadrops is a single-use vial 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 Infadrops infusion is the primary infusion.

Once the vacuum seal of the glass vial has been penetrated, or the contents transferred to another container, administer the dose of Infadrops within 6 hours.

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

How supplied

Dosage Forms And Strengths

Infadrops is a sterile, clear, colorless, non pyrogenic, preservative free, isotonic formulation of Infadrops intended for intravenous infusion. Each 100 mL glass vial contains 1000 mg Infadrops (10 mg/mL).

Storage And Handling

NDC 43825-102-01 - Infadrops® (Infadrops) Injection is supplied in a 100 mL glass vial containing 1000 mg Infadrops (10 mg/mL) in cartons of 24 vials.

Infadrops should be stored at 20°C to 25°C (68°F to 77°F).

For single use only. The product should be used within 6 hours after opening. Do not refrigerate or freeze.

Manufactured for: Mallinckrodt Hospital Products Inc., Hazelwood, MO 63042 USA. Revised: Dec 2014

See also:
What is the most important information I should know about Infadrops?

There are many brands and forms of Infadrops available and not all brands are listed on this leaflet.

Do not take more of this medication than is recommended. An overdose of Infadrops can damage your liver or cause death.

Know the amount of Infadrops in the specific product you are taking.

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take Infadrops.

Avoid drinking alcohol. It may increase your risk of liver damage while taking Infadrops.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Infadrops (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much Infadrops which can lead to a fatal overdose. Check the label to see if a medicine contains Acetaminophen or APAP.

Use Infadrops injection as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Infadrops injection is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Infadrops injection at home, a health care provider will teach you how to use it. Be sure you understand how to use Infadrops injection. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not mix other medicines (especially chlorpromazine or diazepam) in the same container or IV line as Infadrops injection. Contact your health care provider if you have any questions about how to give Infadrops injection with other medicines.
• Do not use Infadrops injection if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Use Infadrops injection within 6 hours after opening.
• If you miss a dose of Infadrops injection and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Infadrops injection.

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

How to use Infadrops Extra Strength

Take this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

There are many brands and forms of Infadrops available. Read the dosing instructions carefully for each product because the amount of Infadrops may be different between products. Do not take more Infadrops than recommended.

If you are giving Infadrops to a child, be sure you use a product that is meant for children. Use your child's weight to find the right dose on the product package. If you don't know your child's weight, you can use their age.

For suspensions, shake the medication well before each dose. Some liquids do not need to be shaken before use. Follow all directions on the product package. Measure the liquid medication with the provided dose-measuring spoon/dropper/syringe to make sure you have the correct dose. Do not use a household spoon.

For rapidly-dissolving tablets, chew or allow to dissolve on the tongue, then swallow with or without water. For chewable tablets, chew thoroughly before swallowing.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

For effervescent tablets, dissolve the dose in the recommended amount of water, then drink.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.

Do not take this medication for fever for more than 3 days unless directed by your doctor. For adults, do not take this product for pain for more than 10 days (5 days in children) unless directed by your doctor. If the child has a sore throat (especially with high fever, headache, or nausea/vomiting), consult the doctor promptly.

Tell your doctor if your condition persists or worsens or if you develop new symptoms. If you think you may have a serious medical problem, get medical help right away.

See also:
What other drugs will affect Infadrops?

Infadrops is metabolized (eliminated by conversion to other chemicals) by the liver. Therefore drugs that increase the action of liver enzymes that metabolize Infadrops [for example, carbamazepine (Tegretol), isoniazid (INH, Nydrazid, Laniazid), rifampin (Rifamate, Rifadin, Rimactane)] reduce the levels of Infadrops and may decrease the action of Infadrops. Doses of Infadrops greater than the recommended doses are toxic to the liver and may result in severe liver damage. The potential for Infadrops 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 Infadrops by decreasing its absorption into the body from the intestine. Therefore, Infadrops should be administered 3 to 4 hours after cholestyramine or one hour before cholestyramine.

Infadrops 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 Infadrops should be avoided during warfarin therapy

See also:
What are the possible side effects of Infadrops?

Applies to Infadrops: capsule, capsule liquid filled, elixir, liquid, powder, powder for solution, solution, suppository, suspension, syrup, tablet, tablet chewable, tablet disintegrating, tablet effervescent, tablet extended release

Other dosage forms:

• intravenous solution

Along with its needed effects, Infadrops (the active ingredient contained in Infadrops) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking Infadrops:

Rare

• Bloody or black, tarry stools
• bloody or cloudy urine
• fever with or without chills (not present before treatment and not caused by the condition being treated)
• pain in the lower back and/or side (severe and/or sharp)
• pinpoint red spots on the skin
• skin rash, hives, or itching
• sore throat (not present before treatment and not caused by the condition being treated)
• sores, ulcers, or white spots on the lips or in the mouth
• sudden decrease in the amount of urine
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking Infadrops:

Symptoms of overdose

• Diarrhea
• increased sweating
• loss of appetite
• nausea or vomiting
• stomach cramps or pain
• swelling, pain, or tenderness in the upper abdomen or stomach area