Zacoldine Overdose

How long did you take this medication to work?
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Consists of Acetaminophen, chlorpheniramine maleate, K sulphoguaiacolate, phenylephrine

What happens if I overdose Acetaminophen (Zacoldine)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; dark urine; decreased urination; excessive sweating; extreme fatigue; nausea and vomiting; pale stools; stomach pain; unusual bruising or bleeding; yellowing of the skin or eyes.

Proper storage of Acetaminophen (Zacoldine):

Acetaminophen (Zacoldine) is usually handled and stored by a health care provider. If you are using Acetaminophen (Zacoldine) at home, store Acetaminophen (Zacoldine) as directed by your pharmacist or health care provider. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen (Zacoldine) out of the reach of children and away from pets.

Overdose of Acetaminophen (Zacoldine) in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Signs and Symptoms

In acute Acetaminophen (Zacoldine) overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur. Plasma Acetaminophen (Zacoldine) levels > 300 mcg/mL at 4 hours after oral ingestion were associated with hepatic damage in 90% of patients; minimal hepatic damage is anticipated if plasma levels at 4 hours are < 150 mcg/mL or < 37.5 mcg/mL at 12 hours after ingestion. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post- ingestion.

Treatment

If an Acetaminophen (Zacoldine) overdose is suspected, obtain a serum Acetaminophen (Zacoldine) assay as soon as possible, but no sooner than 4 hours following oral ingestion. Obtain liver function studies initially and repeat at 24-hour intervals. Administer the antidote N-acetylcysteine (NAC) as early as possible. As a guide to treatment of acute ingestion, the Acetaminophen (Zacoldine) level can be plotted against time since oral ingestion on a nomogram (Rumack-Matthew). The lower toxic line on the nomogram is equivalent to 150 mcg/mL at 4 hours and 37.5 mcg/mL at 12 hours. If serum level is above the lower line, administer the entire course of NAC treatment. Withhold NAC therapy if the Acetaminophen (Zacoldine) level is below the lower line.

For additional information, call a poison control center at 1-800-222-1222.

What should I avoid while taking Acetaminophen (Zacoldine)?

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

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

Acetaminophen (Zacoldine) warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Keep out of reach of children.

Caution is advised for this formulation with extra strength dosing of Acetaminophen (Zacoldine) due to the easily chewable gels and good taste. This is not a candy and the same caution with every medication should be applied to this product.

Hepatotoxicity

This product contains Acetaminophen (Zacoldine). Severe liver damage may occur if you take

Acetaminophen (Zacoldine) has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of Acetaminophen (Zacoldine) at doses that exceed 4,000 milligrams per day, and often involve more than one Acetaminophen (Zacoldine)-containing product. The excessive intake of Acetaminophen (Zacoldine) may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other Acetaminophen (Zacoldine)-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking Acetaminophen (Zacoldine).

Instruct patients to look for Acetaminophen (Zacoldine) or APAP on package labels and not to use more than one product that contains Acetaminophen (Zacoldine). Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of Acetaminophen (Zacoldine) per day, even if they feel well.

Serious Skin Reactions

Rarely, Acetaminophen (Zacoldine) may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Acetaminophen (Zacoldine) may cause severe skin reactions. Symptoms may include

If a skin reaction occurs, stop use and seek medical help right away. Do not use if you are allergic to Acetaminophen (Zacoldine) or any of the inactive ingredients in this product.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

What should I discuss with my healthcare provider before taking Acetaminophen (Zacoldine)?

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Acetaminophen (Zacoldine), the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Acetaminophen (Zacoldine) or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Acetaminophen (Zacoldine) in children. However, do not give over-the-counter products to children under 2 years of age unless instructed to do so by your doctor.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Acetaminophen (Zacoldine) in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Acetaminophen (Zacoldine), it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Acetaminophen (Zacoldine) with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Using Acetaminophen (Zacoldine) with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Acetaminophen (Zacoldine) with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use Acetaminophen (Zacoldine), or give you special instructions about the use of food, alcohol, or tobacco.

Using Acetaminophen (Zacoldine) with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use Acetaminophen (Zacoldine), or give you special instructions about the use of food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of Acetaminophen (Zacoldine). Make sure you tell your doctor if you have any other medical problems, especially:

Acetaminophen (Zacoldine) precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Hepatic Injury

Administration of Acetaminophen (Zacoldine) in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of Acetaminophen (Zacoldine). The maximum recommended daily dose of Acetaminophen (Zacoldine) includes all routes of Acetaminophen (Zacoldine) administration and all Acetaminophen (Zacoldine)-containing products administered, including combination products.

Use caution when administering Acetaminophen (Zacoldine) in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance ≤ 30 mL/min).

Serious Skin Reactions

Rarely, Acetaminophen (Zacoldine) may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Risk of Medication Errors

Take care when prescribing, preparing, and administering Acetaminophen (Zacoldine) in order to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

Allergy and Hypersensitivity

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of Acetaminophen (Zacoldine). Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus. There were infrequent reports of life-threatening anaphylaxis requiring emergent medical attention. Discontinue Acetaminophen (Zacoldine) immediately if symptoms associated with allergy or hypersensitivity occur. Do not use Acetaminophen (Zacoldine) in patients with Acetaminophen (Zacoldine) allergy.

What happens if I miss a dose of Acetaminophen (Zacoldine)?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Since Acetaminophen (Zacoldine) is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use Acetaminophen (Zacoldine) more often than every 4 hours.

What happens if I overdose Chlorpheniramine maleate (Zacoldine)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Chlorpheniramine maleate (Zacoldine):

Store Chlorpheniramine maleate (Zacoldine) at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chlorpheniramine maleate (Zacoldine) out of the reach of children and away from pets.

Overdose of Chlorpheniramine maleate (Zacoldine) in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: large pupils, flushing, fever, hallucinations, weakness, shaking (tremor), muscle twitching, loss of consciousness, seizures. In children, excitement may occur first, and may be followed by loss of coordination, drowsiness, loss of consciousness, seizures.

Notes

If your doctor has prescribed this medication, do not share it with others.

Keep all regular medical and laboratory appointments.

Do not take for several days before allergy testing because test results can be affected.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of your next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 59-86 degrees F (between 15-30 degrees C) away from moisture and light. Store in a tightly closed container. Do not store in the bathroom. Do not freeze liquid forms of this medication. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

What should I avoid while taking Chlorpheniramine maleate (Zacoldine)?

This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of Chlorpheniramine maleate (Zacoldine).

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlorpheniramine maleate (Zacoldine) can decrease sweating and you may be more prone to heat stroke.

Chlorpheniramine maleate (Zacoldine) warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.

Monitor

Allergy symptoms

Assess allergy symptoms (eg, cough, rhinitis, nasal congestion, sneezing, watery eyes, or itching nose, throat, or eyes) before starting therapy and periodically during therapy. Notify health care provider if symptoms are not improving or are getting worse.

Dizziness/Drowsiness

Monitor patient for dizziness and excessive drowsiness. If noted, hold therapy and notify health care provider.

Review therapy

Ensure therapy periodically is reviewed to determine if it needs to be continued without change or if a dose change (eg, increase, decrease, discontinuation) is indicated.

Pregnancy

Category C. Do not use during third trimester.

Lactation

Contraindicated in breast-feeding mothers.

Children

Overdosage may cause hallucinations, convulsions, and death. Antihistamines may diminish mental alertness. In young children, they may produce paradoxical excitation. Contraindicated in newborn or premature infants. Sustained-release form not recommended in children younger than 12 yr of age.

Elderly

Use with caution, usually starting at the low end of the dosage range because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.

Hypersensitivity

May occur. Have epinephrine 1:1,000 immediately available.

Hepatic Function

Use drug with caution in patients with cirrhosis or other liver disease.

Special Risk Patients

Use drug with caution in patients with predisposition to urinary retention, history of bronchial asthma, increased IOP, hyperthyroidism, CV disease, or hypertension. Avoid in patients with sleep apnea.

RESP disease

Generally not recommended to treat lower respiratory tract symptoms, including asthma.

What should I discuss with my healthcare provider before taking Chlorpheniramine maleate (Zacoldine)?

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Chlorpheniramine maleate (Zacoldine) precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.

Before taking Chlorpheniramine maleate (Zacoldine), tell your doctor or pharmacist if you are allergic to it; or to dexchlorpheniramine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, emphysema), a certain eye problem (glaucoma), heart problems, high blood pressure, liver disease, seizures, stomach problems (e.g., ulcers, blockage), overactive thyroid (hyperthyroidism), urination problems (e.g., trouble urinating due to enlarged prostate, urinary retention).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit the use of alcohol and certain other medications that cause drowsiness.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Liquid products may contain aspartame, sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, low blood pressure, confusion, constipation, or trouble urinating. Drowsiness, dizziness, and confusion can increase the risk of falling.

Children may be more sensitive to the effects of antihistamines. In young children, this medication may cause agitation/excitement instead of drowsiness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Based on information from related drugs, this medication may pass into breast milk. Consult your doctor before breast-feeding.

What happens if I miss a dose of Chlorpheniramine maleate (Zacoldine)?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose Phenylephrine (Zacoldine)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room right away. Symptoms may include confusion; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Proper storage of Phenylephrine (Zacoldine):

Store Phenylephrine (Zacoldine) at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Phenylephrine (Zacoldine) out of the reach of children and away from pets.

Overdose of Phenylephrine (Zacoldine) in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.

Overdose of Phenylephrine (Zacoldine) (phenylephrine hydrochloride) can cause a rapid rise in blood pressure. Symptoms of overdose include headache, vomiting, hypertension, reflex bradycardia, a sensation of fullness in the head, tingling of the extremities, and cardiac arrhythmias including ventricular extrasystoles and ventricular tachycardia.

What should I avoid while taking Phenylephrine (Zacoldine)?

Do not take phenylephrine rectal rectal suppository by mouth. It is for use only in your rectum.

Ask a doctor or pharmacist before taking any cough, cold, or allergy medicine. Phenylephrine is contained in many combination medicines. Taking certain products together can cause you to get too much phenylephrine. Check the label to see if a medicine contains phenylephrine, or a decongestant.

Phenylephrine (Zacoldine) warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.

Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension

Because of its increasing blood pressure effects, Phenylephrine (Zacoldine) can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.

Peripheral and Visceral Ischemia

Phenylephrine (Zacoldine) can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.

Skin and Subcutaneous Necrosis

Extravasation of Phenylephrine (Zacoldine) can cause necrosis or sloughing of tissue. The infusion site should be checked for free flow. Care should be taken to avoid extravasation of Phenylephrine (Zacoldine).

Bradycardia

Phenylephrine (Zacoldine) can cause severe bradycardia and decreased cardiac output.

Allergic Reactions

Phenylephrine (Zacoldine) contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Renal Toxicity

Phenylephrine (Zacoldine) can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.

Risk of Augmented Pressor Affect in Patients with Autonomic Dysfunction

The increasing blood pressure response to adrenergic drugs, including Phenylephrine (Zacoldine), can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.

Pressor Effect with Concomitant Oxytocic Drugs

Oxytocic drugs potentiate the increasing blood pressure effect of sympathomimetic pressor amines including Phenylephrine (Zacoldine), with the potential for hemorrhagic stroke.

What should I discuss with my healthcare provider before taking Phenylephrine (Zacoldine)?

Some medical conditions may interact with Phenylephrine (Zacoldine). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Phenylephrine (Zacoldine). Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenylephrine (Zacoldine) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Phenylephrine (Zacoldine) precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.

Exacerbation Of Angina, Heart Failure, Or Pulmonary Arterial Hypertension

Because of its increasing blood pressure effects, Phenylephrine (Zacoldine) can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.

Peripheral And Visceral Ischemia

Phenylephrine (Zacoldine) can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.

Skin And Subcutaneous Necrosis

Extravasation of Phenylephrine (Zacoldine) can cause necrosis or sloughing of tissue. The infusion site should be checked for free flow. Care should be taken to avoid extravasation of Phenylephrine (Zacoldine).

Bradycardia

Phenylephrine (Zacoldine) can cause severe bradycardia and decreased cardiac output.

Allergic Reactions

Phenylephrine (Zacoldine) contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Renal Toxicity

Phenylephrine (Zacoldine) can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.

Risk Of Augmented Pressor Affect In Patients With Autonomic Dysfunction

The increasing blood pressure response to adrenergic drugs, including Phenylephrine (Zacoldine), can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.

Pressor Effect With Concomitant Oxytocic Drugs

Oxytocic drugs potentiate the increasing blood pressure effect of sympathomimetic pressor amines including Phenylephrine (Zacoldine), with the potential for hemorrhagic stroke.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis

Long-term animal studies that evaluated the carcinogenic potential of orally administered phenylephrine hydrochloride in F344/N rats and B6C3F1 mice were completed by the National Toxicology Program using the dietary route of administration. There was no evidence of carcinogenicity in mice administered approximately 270 mg/kg/day (131-times the maximum recommended daily dose of < 10 mg/day) or rats administered approximately 50 mg/kg/day (48-times the maximum recommended daily dose of < 10 mg/day) based on body surface area comparisons.

Mutagenesis

Phenylephrine hydrochloride tested negative in the in vitro bacterial reverse mutation assay (S.typhimurium strains TA98, TA100, TA1535 and TA1537), the in vitro chromosomal aberrations assay, the in vitro sister chromatid exchange assay, and the in vivo rat micronucleus assay. Positive results were reported in only one of two replicates of the in vitro mouse lymphoma assay.

Impairment of Fertility

Studies to evaluate the effect of phenylephrine on fertility have not been conducted.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Risk Summary

There are no adequate or well-controlled studies with phenylephrine hydrochloride injection in pregnant women, nor have animal reproduction studies been conducted. Published studies in normotensive pregnant rabbits report early onset labor, increased fetal lethality, and adverse placental effects with subcutaneous phenylephrine administration during gestation at doses approximately 1.9-times the total daily human dose. Published studies in normotensive pregnant sheep report decreased uterine blood flow and decreased PaO2 in the fetus with intravenous phenylephrine administration during late gestation at doses less than and similar to the human dose. It is not known whether Phenylephrine (Zacoldine), can cause fetal harm when administered to a pregnant woman. Phenylephrine (Zacoldine), should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.

Clinical Considerations

Labor and Delivery

The most common maternal adverse reactions reported in published studies of phenylephrine use during neuraxial anesthesia during Cesarean delivery include nausea and vomiting, bradycardia, reactive hypertension, and transient arrhythmias. Phenylephrine, when administered during labor or delivery, does not appear to alter either neonatal Apgar scores or umbilical artery blood-gas status.

Data

Animal Data

Studies in the published literature evaluating subcutaneously administered phenylephrine (0.33 mg/kg, TID) in normotensive pregnant rabbits reported fetal deaths, adverse histopathology findings in the placenta (necrosis, calcification and thickened vascular walls with narrowed lumen) and possible teratogenic effects (one incidence of clubbed feet, partial development of the intestine) when treatment was initiated during the first trimester or later; and premature labor when treatment was initiated at the second trimester or later. The doses administered were 1.9- times the total daily human dose of 10 mg/day based on a body surface area comparison. Published studies in pregnant normotensive sheep demonstrate that intravenous phenylephrine (4 mcg/kg/min for 30 minutes, equivalent to 3.6 to 4.1 mcg/kg/min human equivalent dose based on body surface area) administered during the third trimester of pregnancy decreased uterine blood flow by 42%. This dose is 1.1- to 1.2-times the human bolus dose of 200 mcg/60 kg person based on body surface area. Mean fetal blood pressure and heart rate fluctuated above and below controls by about 7% during the infusion. Fetal PaO2 was significantly decreased by approximately 26% of control during the infusion. Likewise, PaCO2 was increased and pH was decreased. The clinical significance of these findings is not clear; however, the results suggest the potential for cardiovascular effects on the fetus when phenylephrine is used during pregnancy.

Nursing Mothers

It is not known whether phenylephrine is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Phenylephrine (Zacoldine) and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. Exercise caution when Phenylephrine (Zacoldine) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of phenylephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Hepatic Impairment

In patients with liver cirrhosis [Child Pugh Class B and Class C], dose-response data indicate decreased responsiveness to phenylephrine. Start dosing in the recommended dose range but consider that you may need to give more phenylephrine in this population.

Renal Impairment

In patients with end stage renal disease (ESRD), dose-response data indicate increased responsiveness to phenylephrine. Consider starting at the lower end of the recommended dose range, and adjusting dose based on the target blood pressure goal.

What happens if I miss a dose of Phenylephrine (Zacoldine)?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Since phenylephrine rectal is used on an as needed basis, you are not likely to miss a dose. Do not use phenylephrine rectal more than 4 times per day.



References

  1. DailyMed. "CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: 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. DrugBank. "chlorpheniramine". http://www.drugbank.ca/drugs/DB01114 (accessed September 17, 2018).

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