Betapyn syrup

Betapyn syrup Medicine

Contraindications

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What is the most important information I should know about Acetaminophen (Betapyn Syrup)?

There are many brands and forms of Acetaminophen (Betapyn Syrup) available and not all brands are listed on this leaflet.

Do not take more of this medication than is recommended. An overdose of Acetaminophen (Betapyn Syrup) can damage your liver or cause death.

Know the amount of Acetaminophen (Betapyn Syrup) 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 Acetaminophen (Betapyn Syrup).

Avoid drinking alcohol. It may increase your risk of liver damage while taking Acetaminophen (Betapyn Syrup).

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. Acetaminophen (Betapyn Syrup) (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much Acetaminophen (Betapyn Syrup) which can lead to a fatal overdose. Check the label to see if a medicine contains Acetaminophen (Betapyn Syrup) or APAP.

See also:
What is the most important information I should know about Codeine (Betapyn Syrup)?

Codeine (Betapyn Syrup) Sulfate is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy​​.

Codeine (Betapyn Syrup) Sulfate is contraindicated in patients with known hypersensitivity to Codeine (Betapyn Syrup) or any components of the product. Persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to Codeine (Betapyn Syrup).

Codeine (Betapyn Syrup) Sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment​​.

Codeine (Betapyn Syrup) Sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia.

Codeine (Betapyn Syrup) Sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus.

See also:
What is the most important information I should know about Diphenhydramine (Betapyn Syrup)?

Hypersensitivity to Diphenhydramine (Betapyn Syrup), other structurally related antihistamines, or any component of the formulation; neonates or premature infants; breast-feeding

Additional contraindications:

Parenteral: Use as a local anesthetic

OTC labeling: When used for self-medication, do not use in children <6 years, to make a child sleep, or with any other Diphenhydramine (Betapyn Syrup)-containing products (including topical products)

Undesirable effects

See also:
What are the possible side effects of Acetaminophen (Betapyn Syrup)?

Applies to Acetaminophen (Betapyn Syrup): 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, Acetaminophen (Betapyn Syrup) (the active ingredient contained in Acetaminophen (Betapyn Syrup)) 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 Acetaminophen (Betapyn Syrup):

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 Acetaminophen (Betapyn Syrup):

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

See also:
What are the possible side effects of Codeine (Betapyn Syrup)?

Applies to Codeine (Betapyn Syrup): oral solution, oral syrup, oral tablet, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by Codeine (Betapyn Syrup). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Codeine (Betapyn Syrup):

Incidence not known:

  • Bloating
  • blurred vision
  • chills
  • cold, clammy skin
  • confusion
  • constipation
  • darkened urine
  • difficult or troubled breathing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fast, weak pulse
  • feeling of warmth
  • fever
  • indigestion
  • irregular, fast or slow, or shallow breathing
  • lightheadedness
  • loss of appetite
  • nausea
  • no blood pressure or pulse
  • no breathing
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale or blue lips, fingernails, or skin
  • redness of the face, neck, arms, and occasionally, upper chest
  • shortness of breath
  • stopping of the heart
  • sweating
  • unconsciousness
  • unusual tiredness or weakness
  • vomiting
  • wheezing
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking Codeine (Betapyn Syrup), get emergency help immediately:

Symptoms of overdose:

  • Bluish lips or skin
  • change in consciousness
  • chest pain or discomfort
  • constricted, pinpoint, or small pupils (black part of the eye)
  • decreased awareness or responsiveness
  • extreme sleepiness or unusual drowsiness
  • loss of consciousness
  • no blood pressure or pulse
  • severe sleepiness
  • slow or irregular heartbeat
Minor Side Effects

Some of the side effects that can occur with Codeine (Betapyn Syrup) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

  • Drowsiness
  • relaxed and calm
Incidence not known:
  • Abdominal or stomach pain or cramps
  • blurred or loss of vision
  • diarrhea
  • disturbed color perception
  • double vision
  • dry mouth
  • false or unusual sense of well-being
  • fear or nervousness
  • feeling of constant movement of self or surroundings
  • halos around lights
  • headache
  • hives or welts
  • itching skin
  • night blindness
  • overbright appearance of lights
  • redness of the skin
  • sensation of spinning
  • shakiness
  • skin rash
  • sleeplessness
  • trouble sleeping
  • tunnel vision
  • unable to sleep
  • weight loss

See also:
What are the possible side effects of Diphenhydramine (Betapyn Syrup)?

Applies to Diphenhydramine (Betapyn Syrup) / Diphenhydramine (Betapyn Syrup): tablets

Other dosage forms:

  • capsules, tablets

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur while taking Diphenhydramine (Betapyn Syrup) / Diphenhydramine (Betapyn Syrup):

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe or persistent loss of appetite; stomach pain; tremor; trouble sleeping; unusual fatigue; vision changes; yellowing of the skin or eyes.

Therapeutic indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, Acetaminophen (Betapyn Syrup) or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Acetaminophen (Betapyn Syrup)® (Acetaminophen (Betapyn Syrup)) 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.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, Codeine (Betapyn Syrup) or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Codeine (Betapyn Syrup) sulfate is an opioid analgesic indicated for the management of mild to moderately severe pain where the use of an opioid analgesic is appropriate.

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, Diphenhydramine (Betapyn Syrup) or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Diphenhydramine (Betapyn Syrup) in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when Diphenhydramine (Betapyn Syrup) in the oral form is impractical.

Antihistaminic

For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.

Motion sickness

For active treatment of motion sickness.

Antiparkinsonism

For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.

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

Acetaminophen (Betapyn Syrup) 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. Acetaminophen (Betapyn Syrup) may cause unwanted effects when taken in large doses, including liver damage.

Acetaminophen (Betapyn Syrup) is available only with your doctor's prescription.

Codeine (Betapyn Syrup) is an opioid pain medication. An opioid is sometimes called a narcotic.

Codeine (Betapyn Syrup) is used to treat mild to moderately severe pain.

Codeine (Betapyn Syrup) may also be used for purposes not listed in this medication guide.

Diphenhydramine (Betapyn Syrup) is an antihistamine. Diphenhydramine (Betapyn Syrup) blocks the effects of the naturally occurring chemical histamine in the body.

Diphenhydramine (Betapyn Syrup) is used to treat sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.

Diphenhydramine (Betapyn Syrup) is also used to suppress coughs, to treat motion sickness, to induce sleep, and to treat mild forms of Parkinson's disease.

Diphenhydramine (Betapyn Syrup) may also be used for purposes other than those listed in this medication guide.

Name of the medicinal product

Betapyn Syrup

Qualitative and quantitative composition

Acetaminophen (Betapyn Syrup) (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.

An opioid analgesic related to morphine but with less potent analgesic properties and mild sedative effects. It also acts centrally to suppress cough. [PubChem]

Diphenhydramine (Betapyn Syrup) is used to treat hypertension and edema. Like other thiazides, benzthiazide promotes water loss from the body (diuretics). They inhibit Na+/Cl- reabsorption from the distal convoluted tubules in the kidneys. Thiazides also cause loss of potassium and an increase in serum uric acid. Thiazides are often used to treat hypertension, but their hypotensive effects are not necessarily due to their diuretic activity. Thiazides have been shown to prevent hypertension-related morbidity and mortality although the mechanism is not fully understood. Thiazides cause vasodilation by activating calcium-activated potassium channels (large conductance) in vascular smooth muscles and inhibiting various carbonic anhydrases in vascular tissue.

Special warnings and precautions for use

Use Acetaminophen (Betapyn Syrup) injection as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Acetaminophen (Betapyn Syrup) injection is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Acetaminophen (Betapyn Syrup) injection at home, a health care provider will teach you how to use it. Be sure you understand how to use Acetaminophen (Betapyn Syrup) 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 Acetaminophen (Betapyn Syrup) injection. Contact your health care provider if you have any questions about how to give Acetaminophen (Betapyn Syrup) injection with other medicines.
  • Do not use Acetaminophen (Betapyn Syrup) injection if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Use Acetaminophen (Betapyn Syrup) injection within 6 hours after opening.
  • If you miss a dose of Acetaminophen (Betapyn Syrup) 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 Acetaminophen (Betapyn Syrup) injection.

Use Diphenhydramine (Betapyn Syrup) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Diphenhydramine (Betapyn Syrup) by mouth with or without food.
  • Do not remove the strip from the pouch until you are ready to take Diphenhydramine (Betapyn Syrup). Make sure that your hands are dry when you open Diphenhydramine (Betapyn Syrup). Remove and place the strip on the tongue. The strip dissolves quickly (and it can be swallowed with saliva). Diphenhydramine (Betapyn Syrup) may be taken with or without water. Take the strip immediately after opening the pouch. Do not store the strip for future use.
  • Use Diphenhydramine (Betapyn Syrup) exactly as directed on the package, unless instructed differently by your doctor. If you are taking Diphenhydramine (Betapyn Syrup) without a prescription, follow any warnings and precautions on the label.
  • If you miss a dose of Diphenhydramine (Betapyn Syrup) and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Diphenhydramine (Betapyn Syrup).

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

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 Acetaminophen (Betapyn Syrup) 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 Acetaminophen (Betapyn Syrup) available. Read the dosing instructions carefully for each product because the amount of Acetaminophen (Betapyn Syrup) may be different between products. Do not take more Acetaminophen (Betapyn Syrup) than recommended.

If you are giving Acetaminophen (Betapyn Syrup) 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.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications

Pain management: Management of mild- to moderately-severe pain

Limitations of use: Reserve Codeine (Betapyn Syrup) for use in patients for whom alternative treatment options (eg, nonopioid analgesics, opioid combination products) are ineffective, not tolerated, or would be otherwise inadequate.

Off Label UsesCough in select patients

In a metaanalysis of trials evaluating the treatment of chronic cough, the use of Codeine (Betapyn Syrup) demonstrated efficacy in patients with this condition.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Diphenhydramine (Betapyn Syrup) is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose, and sneezing. It is also used to prevent and treat nausea, vomiting and dizziness caused by motion sickness. Diphenhydramine (Betapyn Syrup) can also be used to help you relax and fall asleep.

This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects on such symptoms as watery eyes and runny nose are caused by blocking another natural substance made by your body (acetylcholine).

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients. Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Diphenhydramine (Betapyn Syrup) is also used alone or with other medications to treat shaking (tremor) and muscle stiffness caused by Parkinson's disease. It may also be used to treat side effects of certain psychiatric drugs such as involuntary movements and muscle stiffness (such as EPS). It works by blocking acetylcholine.

How to use Diphenhydramine (Betapyn Syrup)

Follow all directions on the product package. If your doctor has prescribed this medication, take it as directed. If you are uncertain about any of the information, consult your doctor or pharmacist.

Take the tablet, capsule, or liquid form by mouth with or without food. Measure liquid forms of this medication using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. If you have a single-dose form of this medication (such as a single-use whistle), you do not need to measure the dose.

The rapidly-dissolving tablet or strip should be allowed to dissolve on the tongue and then swallowed, with or without water. The chewable tablets should be chewed thoroughly before being swallowed.

The dosage is based on your age, medical condition, and response to treatment. There are many brands and forms of Diphenhydramine (Betapyn Syrup) available. Read the dosing instructions carefully for each product because the amount of Diphenhydramine (Betapyn Syrup) may be different between products. Do not increase your dose or take this medication more often than directed.

To prevent motion sickness, take your dose 30 minutes before starting activity such as travel. To help you sleep, take your dose about 30 minutes before bedtime. If you continue to have difficulty sleeping for longer than 2 weeks, contact your doctor.

Tell your doctor if your condition does not improve or if it worsens.

Dosage (Posology) and method of administration

General Dosing Information

Acetaminophen (Betapyn Syrup) 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 Acetaminophen (Betapyn Syrup) and Acetaminophen (Betapyn Syrup) dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of Acetaminophen (Betapyn Syrup) is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing Acetaminophen (Betapyn Syrup). Exceeding the maximum mg/kg daily dose of Acetaminophen (Betapyn Syrup) 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 Acetaminophen (Betapyn Syrup) 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 Acetaminophen (Betapyn Syrup) is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Acetaminophen (Betapyn Syrup) of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Betapyn Syrup) of 4000 mg per day (includes all routes of administration and all Acetaminophen (Betapyn Syrup)-containing products including combination products).

Adults and adolescents weighing under 50 kg: the recommended dosage of Acetaminophen (Betapyn Syrup) is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen (Betapyn Syrup) of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Betapyn Syrup) of 75 mg/kg per day (includes all routes of administration and all Acetaminophen (Betapyn Syrup)-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 Acetaminophen (Betapyn Syrup) (by all routes)
Adults and adolescents (13 years and older) weighing ≥ 50 kg 650 mg 1000 mg 1000 mg 4000 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 3750 mg)
Recommended

Dosage: Children

Children 2 to 12 years of age: the recommended dosage of Acetaminophen (Betapyn Syrup) is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen (Betapyn Syrup) of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Betapyn Syrup) 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 Acetaminophen (Betapyn Syrup) (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 3750 mg)
Instructions ForIntravenous Administration

For adult and adolescent patients weighing ≥ 50 kg requiring 1000 mg doses of Acetaminophen (Betapyn Syrup), administer the dose by inserting a vented intravenous set through the septum of the 100 mL vial. Acetaminophen (Betapyn Syrup) 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 Acetaminophen (Betapyn Syrup) for intravenous infusion. Do not add other medications to the Acetaminophen (Betapyn Syrup) 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 Acetaminophen (Betapyn Syrup) 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 Acetaminophen (Betapyn Syrup) is not intended for use in patients weighing less than 50 kg. Acetaminophen (Betapyn Syrup) 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 Acetaminophen (Betapyn Syrup) 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 Acetaminophen (Betapyn Syrup) within 6 hours.

Do not add other medications to the Acetaminophen (Betapyn Syrup) solution. Diazepam and chlorpromazine hydrochloride are physically incompatible with Acetaminophen (Betapyn Syrup), therefore do not administer simultaneously.

How suppliedDosage Forms And Strengths

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

Storage And Handling

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

Acetaminophen (Betapyn Syrup) 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

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet,

Oral, as sulfate:

Generic: 15 mg, 30 mg, 60 mg

Dosing: Adult

Pain management (analgesic):

Injection [Canadian product]:

Opioid-naive patients: IM, SubQ: 30 to 60 mg every 4 to 6 hours as needed (use the lowest effective dose for the shortest period of time necessary)

Conversion from oral Codeine (Betapyn Syrup) or another opioid: IM, SubQ: Refer to product labeling for dose conversions.

Oral: Note: These are guidelines and do not represent the maximum doses that may be required in all patients. Doses should be titrated to pain relief/prevention.

Immediate release (tablet, oral solution [Canadian product]): Initial: 15 to 60 mg every 4 hours as needed; maximum total daily dose: 360 mg/day; patients with prior opioid exposure may require higher initial doses. Note: The American Pain Society recommends an initial dose of 30 to 60 mg for adults with moderate pain (American Pain Society 2016).

Controlled release: Codeine (Betapyn Syrup) Contin [Canadian product]: Note: Titrate at intervals of ≥48 hours until adequate analgesia has been achieved. Daily doses >600 mg/day should not be used; patients requiring higher doses should be switched to an opioid approved for use in severe pain. In patients who receive both Codeine (Betapyn Syrup) Contin and an immediate release or combination Codeine (Betapyn Syrup) product for breakthrough pain, the rescue dose of immediate release Codeine (Betapyn Syrup) product should be ≤12.5% of the total daily Codeine (Betapyn Syrup) Contin dose.

Opioid-naive patients: Initial: 50 mg every 12 hours

Conversion from immediate release Codeine (Betapyn Syrup) preparations: Immediate release Codeine (Betapyn Syrup) preparations contain ~75% Codeine (Betapyn Syrup) base. Therefore, patients who are switching from immediate release Codeine (Betapyn Syrup) preparations may be transferred to a ~25% lower total daily dose of Codeine (Betapyn Syrup) Contin, equally divided into 2 daily doses every 12 hours.

Conversion from a combination Codeine (Betapyn Syrup) product (eg, Codeine (Betapyn Syrup) with Codeine (Betapyn Syrup) or aspirin): See table:

Conversion from another opioid analgesic: Using the patient's current opioid dose, calculate an equivalent daily dose of immediate release Codeine (Betapyn Syrup). A ~25% lower dose of Codeine (Betapyn Syrup) Contin should then be initiated, equally divided into 2 daily doses.

Discontinuation of therapy: When discontinuing chronic opioid therapy, the dose should be gradually tapered down. An optimal universal tapering schedule for all patients has not been established (CDC [Dowell 2016]). Proposed schedules range from slow (eg, 10% reductions per week) to rapid (eg, 25% to 50% reduction every few days) (CDC 2015). Tapering schedules should be individualized to minimize opioid withdrawal while considering patient-specific goals and concerns as well as the pharmacokinetics of the opioid being tapered. An even slower taper may be appropriate in patients who have been receiving opioids for a long duration (eg, years), particularly in the final stage of tapering, whereas more rapid tapers may be appropriate in patients experiencing severe adverse events (CDC [Dowell 2016]). Monitor carefully for signs/symptoms of withdrawal. If the patient displays withdrawal symptoms, consider slowing the taper schedule; alterations may include increasing the interval between dose reductions, decreasing amount of daily dose reduction, pausing the taper and restarting when the patient is ready, and/or coadministration of an alpha-2 agonist (eg, clonidine) to blunt withdrawal symptoms (Berna 2015; CDC [Dowell 2016]). Continue to offer nonopioid analgesics as needed for pain management during the taper; consider nonopioid adjunctive treatments for withdrawal symptoms (eg, GI complaints, muscle spasm) as needed (Berna 2015; Sevarino 2018).

Cough in select patients (off-label use):

Oral: Reported doses vary with a range of 7.5 to 120 mg/day as a single dose or in divided doses; however, evidence is of low quality (ACCP [Bolser 2006]; Smith 2010). Some experts recommend 30 to 60 mg 4 times daily in specific patient populations (eg, lung cancer) (ACCP [Molassiotis 2017]). Additional data may be necessary to further define the role of Codeine (Betapyn Syrup) in this condition.

Diarrhea (persistent) (palliative care) (off-label use):

Oral: 15 to 30 mg every 4 hours as needed (von Gunten 2013). Additional data may be necessary to further define the role of Codeine (Betapyn Syrup) in this condition.

Restless leg syndrome (off-label use):

Oral: Initial: 30 mg once daily at bedtime or during the night; may increase to 60 mg if needed; maximum dose: 180 mg in 2 to 3 divided doses. May be used alone or in combination with other medications used to treat RLS (Earley 2003; Sandyk 1987; Silbers 2013; Walters 2001).

Dosing: Geriatric

Refer to adult dosing. Use with caution and consider initiation at the low end of the dosing range; reduced initial dosages may be necessary.

Dosing: Pediatric

Note: Codeine (Betapyn Syrup) 30 mg/5 mL oral solution has been discontinued in the US for more than 1 year. Doses should be titrated to appropriate analgesic effect; use the lowest effective dose for the shortest period of time:

Pain management; analgesia: Limited data available: Note: Use is contraindicated in pediatric patients <12 years of age and for postoperative management in pediatric patients 12 to 18 years of age who have undergone tonsillectomy and/or adenoidectomy. Avoid Codeine (Betapyn Syrup) use in all pediatric patient populations in which it is contraindicated and in pediatric patients 12 to 18 years of age who have other risk factors that increase risk for respiratory depression associated with Codeine (Betapyn Syrup) (eg, conditions associated with hypoventilation like postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, use of other medications known to depress respiratory drive); in rare cases in which Codeine (Betapyn Syrup)-containing product is the only option, consider genotype testing prior to use; use extra precaution; monitor closely for adverse effects. Codeine (Betapyn Syrup) has been associated with reports of life-threatening or fatal respiratory depression in children and adolescents; multifactorial causes have been identified; of primary concern are unrecognized ultrarapid metabolizers of CYP2D6 who may have extensive conversion of Codeine (Betapyn Syrup) (prodrug) to morphine and thus increased opioid-mediated effects. Avoid Codeine (Betapyn Syrup) use in pediatric patient populations in which it is contraindicated; in rare cases in which Codeine (Betapyn Syrup)-containing product is the only option, consider genotype testing prior to use; use extra precaution; monitor closely for adverse effects (AAP [Tobias 2016]; Dancel 2017; Gammal 2016; Goldschneider 2017; Poonai 2015).

Children and Adolescents:

Oral: 0.5 to 1 mg/kg/dose every 4 to 6 hours as needed; maximum single dose: 60 mg/dose (APS 2016)

Usual Adult Dose for Insomnia

Note: Diphenhydramine (Betapyn Syrup)-Diphenhydramine (Betapyn Syrup) is generally dosed based on the Diphenhydramine (Betapyn Syrup) component to equal 50 mg of Diphenhydramine (Betapyn Syrup) (76 mg Diphenhydramine (Betapyn Syrup) citrate) at bedtime.

Diphenhydramine (Betapyn Syrup)-Diphenhydramine (Betapyn Syrup) comes in several different dosages (500 mg-25 mg, 650 mg-50 mg, 500 mg-38 mg, 500 mg-12.5 mg, 1000 mg-50 mg, 500 mg-50 mg, 325 mg-12.5 mg) and is available as liquid, caplets, geltabs, and gelcaps. The manufacturer of these products generally advises 2 dosage units at bedtime or as directed by a healthcare professional.

Usual Adult Dose for Pain

Note: Diphenhydramine (Betapyn Syrup)-Diphenhydramine (Betapyn Syrup) is generally dosed based on the Diphenhydramine (Betapyn Syrup) component to equal 50 mg of Diphenhydramine (Betapyn Syrup) (76 mg Diphenhydramine (Betapyn Syrup) citrate) at bedtime.

Diphenhydramine (Betapyn Syrup)-Diphenhydramine (Betapyn Syrup) comes in several different dosages (500 mg-25 mg, 650 mg-50 mg, 500 mg-38 mg, 500 mg-12.5 mg, 1000 mg-50 mg, 500 mg-50 mg, 325 mg-12.5 mg) and is available as liquid, caplets, geltabs, and gelcaps. The manufacturer of these products generally advises 2 dosage units at bedtime or as directed by a healthcare professional.

Usual Adult Dose for Headache

Note: Diphenhydramine (Betapyn Syrup)-Diphenhydramine (Betapyn Syrup) is generally dosed based on the Diphenhydramine (Betapyn Syrup) component to equal 50 mg of Diphenhydramine (Betapyn Syrup) (76 mg Diphenhydramine (Betapyn Syrup) citrate) at bedtime.

Diphenhydramine (Betapyn Syrup)-Diphenhydramine (Betapyn Syrup) comes in several different dosages (500 mg-25 mg, 650 mg-50 mg, 500 mg-38 mg, 500 mg-12.5 mg, 1000 mg-50 mg, 500 mg-50 mg, 325 mg-12.5 mg) and is available as liquid, caplets, geltabs, and gelcaps. The manufacturer of these products generally advises 2 dosage units at bedtime or as directed by a healthcare professional.

Usual Pediatric Dose for Insomnia

Greater than or equal to 12 years:

Note: Diphenhydramine (Betapyn Syrup)-Diphenhydramine (Betapyn Syrup) is generally dosed based on the Diphenhydramine (Betapyn Syrup) component to equal 50 mg of Diphenhydramine (Betapyn Syrup) (76 mg Diphenhydramine (Betapyn Syrup) citrate) at bedtime.

Diphenhydramine (Betapyn Syrup)-Diphenhydramine (Betapyn Syrup) comes in several different dosages (500 mg-25 mg, 650 mg-50 mg, 500 mg-38 mg, 500 mg-12.5 mg, 1000 mg-50 mg, 500 mg-50 mg, 325 mg-12.5 mg) and is available as liquid, caplets, geltabs, and gelcaps. The manufacturer of these products generally advises 2 dosage units at bedtime or as directed by a healthcare professional.

Usual Pediatric Dose for Pain

Greater than or equal to 12 years:

Note: Diphenhydramine (Betapyn Syrup)-Diphenhydramine (Betapyn Syrup) is generally dosed based on the Diphenhydramine (Betapyn Syrup) component to equal 50 mg of Diphenhydramine (Betapyn Syrup) (76 mg Diphenhydramine (Betapyn Syrup) citrate) at bedtime.

Diphenhydramine (Betapyn Syrup)-Diphenhydramine (Betapyn Syrup) comes in several different dosages (500 mg-25 mg, 650 mg-50 mg, 500 mg-38 mg, 500 mg-12.5 mg, 1000 mg-50 mg, 500 mg-50 mg, 325 mg-12.5 mg) and is available as liquid, caplets, geltabs, and gelcaps. The manufacturer of these products generally advises 2 dosage units at bedtime or as directed by a healthcare professional.

Usual Pediatric Dose for Headache

Greater than or equal to 12 years:

Note: Diphenhydramine (Betapyn Syrup)-Diphenhydramine (Betapyn Syrup) is generally dosed based on the Diphenhydramine (Betapyn Syrup) component to equal 50 mg of Diphenhydramine (Betapyn Syrup) (76 mg Diphenhydramine (Betapyn Syrup) citrate) at bedtime.

Diphenhydramine (Betapyn Syrup)-Diphenhydramine (Betapyn Syrup) comes in several different dosages (500 mg-25 mg, 650 mg-50 mg, 500 mg-38 mg, 500 mg-12.5 mg, 1000 mg-50 mg, 500 mg-50 mg, 325 mg-12.5 mg) and is available as liquid, caplets, geltabs, and gelcaps. The manufacturer of these products generally advises 2 dosage units at bedtime or as directed by a healthcare professional.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Use with caution in patients with liver disease. Chronic use of Diphenhydramine (Betapyn Syrup) is not recommended in patients with liver disease.

Precautions

Patients who consume three or more alcohol containing drinks per day should be informed to consult with their physician for advice on when and how to take Diphenhydramine (Betapyn Syrup). Chronic, heavy alcohol users may be at increased risk of liver damage when taking more than recommended dosages.

Patients and adults taking care of children should be advised to consult with their doctor before continuing to use Diphenhydramine (Betapyn Syrup) if symptoms of illness worsen. Although rare, there is the possibility of Diphenhydramine (Betapyn Syrup) intoxication on chronic use of the drug, and the symptoms seen during the first phase of intoxication (nausea, vomiting, anorexia, malaise, and diaphoresis) may trigger the use of more doses.

Patients should be warned of the sedative effects of Diphenhydramine (Betapyn Syrup), and advised not to take this drug with alcohol.

Due to the anticholinergic effect of Diphenhydramine (Betapyn Syrup), it should be used with caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy or bladder neck obstructions. It should also be used with caution in patients with increased intraocular pressure, hyperthyroidism, cardiovascular disease, or hypertension.

Dialysis

Data not available

Interaction with other medicinal products and other forms of interaction

See also:
What other drugs will affect Acetaminophen (Betapyn Syrup)?

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

Acetaminophen (Betapyn Syrup) 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 Acetaminophen (Betapyn Syrup) should be avoided during warfarin therapy

See also:
What other drugs will affect Codeine (Betapyn Syrup)?

When this drug applied simultaneously with:

- drugs have a depressing effect on the central nervous system (including those with opioid analgesics, barbiturates, benzodiazepines, clonidine) it is possible an increase the action of Codeine (Betapyn Syrup).

- derivatives of morphine it may increased the inhibitory action on the respiratory center; ibuprofen - analgesic effect is enhanced; carbamazepine - it may increased the analgesic effect is apparently due to increased formation of Codeine (Betapyn Syrup) metabolite normorphine, which has a stronger effect.

- quinidine the analgesic effect of Codeine (Betapyn Syrup) decreased or almost disappeared.

- Codeine (Betapyn Syrup) increases the effect of ethanol on psychomotor function.

See also:
What other drugs will affect Diphenhydramine (Betapyn Syrup)?

Most reports of clinically significant drug interactions occurring with the barbiturates have involved phenobarbital

1. Anticoagulants: Diphenhydramine (Betapyn Syrup) lowers the plasma levels of dicumarol (name previously used: bishydorxycoumarin) and causes a decrease in anticoagulant activity as measured by the prothrombin time. Diphenhydramine (Betapyn Syrup) can induce hepatic microsomal enzymes resulting in increased metabolism and decreased anticoagulant response of oral anticoagulants (e.g., warfarin, acenocournarol, dicumarol, and phenprocoumon). Patients stabilized on anticoagulant therapy may require dosage adjustments if phenobarbital is added to or withdrawn from their dosage regimen

2. Corticosteroids: Diphenhydramine (Betapyn Syrup) appears to enhance the metabolism of exogenous corticosteroids probably through the induction of hepatic microsomal enzymes. Patients stabilized on corticosteroid therapy may require dosage adjustments if phenobarbital is added to or withdrawn from their dosage regimen.

3. Griseofulvin: Diphenhydramine (Betapyn Syrup) appears to interfere with the absorption of orally administered griseofulvin, thus decreasing its blood level. The effect of the resultant decreased blood levels of griseofulvin on therapeutic response has not been established. However, it would be preferable to avoid concomitant administration of these drugs.

4. Doxycycline: Diphenhydramine (Betapyn Syrup) has been shown to shorten the half- life of doxycycline for as long as 2 weeks after barbiturate therapy is discontinued. This mechanism is probably through the induction of hepatic microsomal enzymes that metabolize the antibiotic. If phenobarbital and doxycycline are administered concurrently, the clinical response to doxycycline should be monitored closely

5. Phenytoin, sodium valproate, valproic acid: The effect of phenobarbital on the metabolism of phenytoin appears to be variable. Some investigators report an accelerating effect, while others report no effect. Because the effect of phenobarbital on the metabolism of phenytoin is not predictable, phenytoin and phenobarbital blood levels should be monitored more frequently if these drugs are given concurrently. Sodium valproate and valproic acid appear to decrease phenobarbital metabolism; therefore, phenobarbital blood levels should be monitored and appropriate dosage adjustments made as indicated.

6. Central nervous system depressants: The concomitant use of other central nervous system depressants including other sedatives or hypnotics, antihistamines, tranquilizers, or alcohol, may produce additive depressant effects

7. Monoamine oxidase inhibitors (MAOIs): MAOIs prolong the effects of phenobarbital probably because metabolism of the phenobarbital is inhibited.

8. Estradiol, estrone, progesterone and other steroidal hormones: Pretreatment with or concurrent administration of phenobarbital may decrease the effect of estradiol by increasing its metabolism. There have been reports of patients treated with antiepileptic drugs (e.g., phenobarbital) who became pregnant while taking oral contraceptives. An alternate contraceptive method might be suggested to women taking phenobarbital.