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What is the most important information I should know about Acetaminophen (Stona Cold Caplets)?
There are many brands and forms of Acetaminophen (Stona Cold Caplets) available and not all brands are listed on this leaflet.
Do not take more of this medication than is recommended. An overdose of Acetaminophen (Stona Cold Caplets) can damage your liver or cause death.
Know the amount of Acetaminophen (Stona Cold Caplets) 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 (Stona Cold Caplets).
Avoid drinking alcohol. It may increase your risk of liver damage while taking Acetaminophen (Stona Cold Caplets).
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 (Stona Cold Caplets) (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much Acetaminophen (Stona Cold Caplets) which can lead to a fatal overdose. Check the label to see if a medicine contains Acetaminophen (Stona Cold Caplets) or APAP.
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What is the most important information I should know about Caffeine (Stona Cold Caplets)?
Caffeine (Stona Cold Caplets) citrate should not be given to a child who has had an allergic reaction to it in the past.
Before using Caffeine (Stona Cold Caplets) citrate, tell the doctor if your child is allergic to any drugs, or has a seizure disorder, heart disease, kidney disease, liver disease, or high or low blood sugar.
Do not use the medication for longer than 12 days without the advice of your child's doctor.
Each bottle of Caffeine (Stona Cold Caplets) citrate is for one use only, even if your child does not use the entire bottle for a single dose. Throw away any medication left over in the bottle after measuring your child's dose.
Call your doctor if the child's breathing symptoms do not improve after using Caffeine (Stona Cold Caplets) citrate.
To be sure Caffeine (Stona Cold Caplets) citrate is helping your child's condition, the child's blood will need to be tested on a regular basis. Do not miss any scheduled appointments.
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What are the possible side effects of Acetaminophen (Stona Cold Caplets)?
Applies to Acetaminophen (Stona Cold Caplets): 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:
Along with its needed effects, Acetaminophen (Stona Cold Caplets) (the active ingredient contained in Acetaminophen (Stona Cold Caplets)) 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 (Stona Cold Caplets):
Rare
Get emergency help immediately if any of the following symptoms of overdose occur while taking Acetaminophen (Stona Cold Caplets):
Symptoms of overdose
See also:
What are the possible side effects of Caffeine (Stona Cold Caplets)?
Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the Caffeine (Stona Cold Caplets) citrate and placebo groups. The following table shows adverse events that occurred in the double-blind period of the controlled trial and that were more frequent in Caffeine (Stona Cold Caplets) citrate treated patients than placebo.
In addition to the cases above, three cases of necrotizing enterocolitis were diagnosed in patients receiving Caffeine (Stona Cold Caplets) citrate during the open-label phase of the study.
Three of the infants who developed necrotizing enterocolitis during the trial died. All had been exposed to Caffeine (Stona Cold Caplets). Two were randomized to Caffeine (Stona Cold Caplets), and one placebo patient was “rescued” with open-label Caffeine (Stona Cold Caplets) for uncontrolled apnea.
Adverse events described in the published literature include: central nervous system stimulation (i.e., irritability, restlessness, jitteriness), cardiovascular effects (i.e., tachycardia, increased left ventricular output, and increased stroke volume), gastrointestinal effects (i.e., increased gastric aspirate, gastrointestinal intolerance), alterations in serum glucose (hypoglycemia and hyperglycemia) and renal effects (increased urine flow rate, increased creatinine clearance, and increased sodium and calcium excretion). Published long-term follow-up studies have not shown Caffeine (Stona Cold Caplets) to adversely affect neurological development or growth parameters.
Acetaminophen (Stona Cold Caplets)® (Acetaminophen (Stona Cold Caplets)) injection is indicated for
Caffeine (Stona Cold Caplets) and Sodium Benzoate Injection has been used in conjunction with supportive measure to treat respiratory depression associated with overdosage with CNS depressant drugs (e.g., narcotic analgesics, alcohol). However, because of questionable benefit and transient action, most authorities believe Caffeine (Stona Cold Caplets) and other analeptics should not be used in these conditions and recommend other supportive therapy.
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, Guaifenesin (Stona Cold Caplets) 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.Guaifenesin (Stona Cold Caplets) and hydrocodone is used to treat cough and reduce chest congestion caused by the common cold, flu, or allergies.
Acetaminophen (Stona Cold Caplets) injection is used together with other medicines (eg, narcotic pain relievers) to relieve moderate to severe pain.
Acetaminophen (Stona Cold Caplets) 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 (Stona Cold Caplets) may cause unwanted effects when taken in large doses, including liver damage.
Acetaminophen (Stona Cold Caplets) is available only with your doctor's prescription.
Caffeine (Stona Cold Caplets) is a central nervous system stimulant. It works by stimulating the brain. Caffeine (Stona Cold Caplets) is found naturally in foods and beverages such as coffee, tea, colas, energy and chocolate. Botanical sources of Caffeine (Stona Cold Caplets) include kola nuts, guarana, and yerba mate. Caffeine (Stona Cold Caplets) is also available in prescription and non-prescription medications.
Caffeine (Stona Cold Caplets) is used to restore mental alertness or wakefulness during fatigue or drowsiness. Caffeine (Stona Cold Caplets) is also found in some headache and migraine medications, in certain dietary supplements used for weight loss, and in many popular energy drinks.
Caffeine (Stona Cold Caplets) citrate (Caffeine (Stona Cold Caplets)) is available by prescription only. It is used for short-term treatment of neonatal apnea (breathing problems).
Caffeine (Stona Cold Caplets) may also be used for other conditions as determined by your health care provider.
Guaifenesin (Stona Cold Caplets) is used to reduce chest congestion caused by the common cold, flu, or chronic bronchitis.
Guaifenesin (Stona Cold Caplets) helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.
There are many brands and forms of Guaifenesin (Stona Cold Caplets) available. Not all brands are listed on this leaflet.
Guaifenesin (Stona Cold Caplets) may also be used for purposes not listed in this medication guide.
Acetaminophen (Stona Cold Caplets) (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.
A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine (Stona Cold Caplets)'s most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes smooth muscle, stimulates cardiac muscle, stimulates diuresis, and appears to be useful in the treatment of some types of headache. Several cellular actions of Caffeine (Stona Cold Caplets) have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide phosphodiesterases, antagonism of adenosine receptors, and modulation of intracellular calcium handling. [PubChem]
A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of morphine. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Guaifenesin (Stona Cold Caplets) is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)
Use Acetaminophen (Stona Cold Caplets) injection as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Acetaminophen (Stona Cold Caplets) injection.
Use Caffeine (Stona Cold Caplets) as directed by your health care provider. If the medication is OTC, check the label on the bottle for the exact dosing instructions. If you have any questions about the use of an OTC medication, ask your pharmacist.
Ask your health care provider any questions you may have about how to use Caffeine (Stona Cold Caplets).
Use Guaifenesin (Stona Cold Caplets) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Guaifenesin (Stona Cold Caplets).
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 (Stona Cold Caplets) Extra StrengthTake 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 (Stona Cold Caplets) available. Read the dosing instructions carefully for each product because the amount of Acetaminophen (Stona Cold Caplets) may be different between products. Do not take more Acetaminophen (Stona Cold Caplets) than recommended.
If you are giving Acetaminophen (Stona Cold Caplets) 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 IndicationsImmediate release:
Analgesic, antipyretic, and anti-inflammatory: For the temporary relief of headache, pain, and fever caused by colds, muscle aches and pains, menstrual pain, toothache pain, and minor aches and pains of arthritis.
Revascularization procedures: For use in patients who have undergone revascularization procedures (ie, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or carotid endarterectomy).
Vascular indications, including ischemic stroke, transient ischemic attack, acute coronary syndromes (ST-elevation myocardial infarction or non-ST-elevation acute coronary syndromes [non-ST-elevation myocardial infarction or unstable angina]), secondary prevention after acute coronary syndromes, and management of stable ischemic heart disease: To reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli; to reduce the risk of vascular mortality in patients with a suspected acute myocardial infarction (MI); to reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina; to reduce the combined risk of MI and sudden death in patients with stable ischemic heart disease.
ER capsules:
Ischemic stroke or transient ischemic attack: To reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack.
Stable ischemic heart disease: To reduce the risk of death and MI in patients with stable ischemic heart disease.
Limitations of use: Do not use ER capsules in situations for which a rapid onset of action is required (such as acute treatment of MI or before percutaneous coronary intervention); use IR formulations instead.
Off Label UsesAtherosclerotic cardiovascular disease, primary prevention
Based on the 2019 American College of Cardiology/American Heart Association (ACC/AHA) guideline on the primary prevention of cardiovascular disease and the 2020 American Diabetes Association standards of medical care in diabetes, Caffeine (Stona Cold Caplets) may be used for the primary prevention of cardiovascular disease in select patients after weighing the cardiovascular disease risk versus benefits.
Carotid artery atherosclerosis, asymptomatic or symptomaticBased on the 2012 American College of Chest Physicians (ACCP) guidelines for antithrombotic therapy and prevention of thrombosis (9th edition), daily Caffeine (Stona Cold Caplets) is suggested in patients with asymptomatic or symptomatic carotid artery atherosclerosis based on a slight reduction in total mortality observed when Caffeine (Stona Cold Caplets) is taken over 10 years (regardless of cardiovascular risk profile). The AHA/American Stroke Association guidelines for the primary prevention of stroke recommend daily Caffeine (Stona Cold Caplets) for patients with asymptomatic or symptomatic carotid atherosclerosis to reduce the risk of a first stroke.
Carotid artery stentingA randomized, controlled trial with blinded end point adjudication evaluated carotid artery stenting versus carotid endarterectomy in patients with carotid artery stenosis. In this trial, Caffeine (Stona Cold Caplets) in combination with clopidogrel was used for patients who underwent carotid artery stenting, which suggests that this antiplatelet combination is effective.
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.Guaifenesin (Stona Cold Caplets) is used to treat coughs and congestion caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin (Stona Cold Caplets) is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier.
If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you.
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. To decrease the risk for side effects, carefully follow all dosage directions. 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).
How to use 2/GTake this medication by mouth with or without food, as directed by your doctor, usually every 4 hours. If you are self-treating, follow all directions on the product package. If you are uncertain about any of the information, ask your doctor or pharmacist.
Guaifenesin (Stona Cold Caplets) may have a bitter taste. 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.
If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
For powder packets, empty the entire contents of the packet onto the tongue and swallow. To prevent a bitter taste, do not chew.
Dosage is based on your age, medical condition, and response to treatment. Do not take more than 6 doses in a day. Do not increase your dose or take this drug more often than directed.
Drink plenty of fluids while taking this medication. Fluids will help to break up mucus and clear congestion.
Tell your doctor if your cough is accompanied by fever, severe sore throat, rash, persistent headache, or if it persists, returns, or worsens after 7 days. These may be signs of a serious medical problem. Seek immediate medical attention if you think you may have a serious medical problem.
Acetaminophen (Stona Cold Caplets) 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 (Stona Cold Caplets) and Acetaminophen (Stona Cold Caplets) dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of Acetaminophen (Stona Cold Caplets) is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing Acetaminophen (Stona Cold Caplets). Exceeding the maximum mg/kg daily dose of Acetaminophen (Stona Cold Caplets) 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 (Stona Cold Caplets) from all routes and from all credits does not exceed the maximum recommended dose.
RecommendedDosage: Adults and Adolescents
Adults and adolescents weighing 50 kg and over: the recommended dosage of Acetaminophen (Stona Cold Caplets) is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Acetaminophen (Stona Cold Caplets) of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Stona Cold Caplets) of 4000 mg per day (includes all routes of administration and all Acetaminophen (Stona Cold Caplets)-containing products including combination products).
Adults and adolescents weighing under 50 kg: the recommended dosage of Acetaminophen (Stona Cold Caplets) is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen (Stona Cold Caplets) of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Stona Cold Caplets) of 75 mg/kg per day (includes all routes of administration and all Acetaminophen (Stona Cold Caplets)-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 (Stona Cold Caplets) (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) |
Dosage: Children
Children 2 to 12 years of age: the recommended dosage of Acetaminophen (Stona Cold Caplets) is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen (Stona Cold Caplets) of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Stona Cold Caplets) 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 (Stona Cold Caplets) (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) |
For adult and adolescent patients weighing ≥ 50 kg requiring 1000 mg doses of Acetaminophen (Stona Cold Caplets), administer the dose by inserting a vented intravenous set through the septum of the 100 mL vial. Acetaminophen (Stona Cold Caplets) 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 (Stona Cold Caplets) for intravenous infusion. Do not add other medications to the Acetaminophen (Stona Cold Caplets) 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 (Stona Cold Caplets) 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 (Stona Cold Caplets) is not intended for use in patients weighing less than 50 kg. Acetaminophen (Stona Cold Caplets) 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 (Stona Cold Caplets) 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 (Stona Cold Caplets) within 6 hours.
Do not add other medications to the Acetaminophen (Stona Cold Caplets) solution. Diazepam and chlorpromazine hydrochloride are physically incompatible with Acetaminophen (Stona Cold Caplets), therefore do not administer simultaneously.
How suppliedDosage Forms And StrengthsAcetaminophen (Stona Cold Caplets) is a sterile, clear, colorless, non pyrogenic, preservative free, isotonic formulation of Acetaminophen (Stona Cold Caplets) intended for intravenous infusion. Each 100 mL glass vial contains 1000 mg Acetaminophen (Stona Cold Caplets) (10 mg/mL).
Storage And HandlingNDC 43825-102-01 - Acetaminophen (Stona Cold Caplets)® (Acetaminophen (Stona Cold Caplets)) Injection is supplied in a 100 mL glass vial containing 1000 mg Acetaminophen (Stona Cold Caplets) (10 mg/mL) in cartons of 24 vials.
Acetaminophen (Stona Cold Caplets) 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
Usual Adult Dose for Drowsiness:
100 to 200 mg orally not more often than every 3 to 4 hours.
For occasional use only.
Not intended for use as a substitute for sleep.
Limit the use of Caffeine (Stona Cold Caplets) containing medications, foods, or beverages while taking this product because too much Caffeine (Stona Cold Caplets) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.
Usual Pediatric Dose for Drowsiness:
>= 12 years: 100 to 200 mg not more often than every 3 to 4 hours.
For occasional use only.
Not intended for use as a substitute for sleep.
Limit the use of Caffeine (Stona Cold Caplets) containing medications, foods, or beverages while taking this product because too much Caffeine (Stona Cold Caplets) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.
Usual Pediatric Dose for Apnea of Prematurity:
For short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.
Prior to initiation of Caffeine (Stona Cold Caplets) citrate, baseline serum levels of Caffeine (Stona Cold Caplets) should be measured in infants previously treated with theophylline, since preterm infants metabolize theophylline to Caffeine (Stona Cold Caplets). Likewise, baseline serum levels of Caffeine (Stona Cold Caplets) should be measured in infants born to mothers who consumed Caffeine (Stona Cold Caplets) prior to delivery, since Caffeine (Stona Cold Caplets) readily crosses the placenta.
Loading Dose: 20 mg/kg Caffeine (Stona Cold Caplets) citrate intravenous (over 30 minutes) once
Maintenance Dose: 5 mg/kg Caffeine (Stona Cold Caplets) citrate intravenous (over 10 minutes) or orally every 24 hours.
Note: The dose of Caffeine (Stona Cold Caplets) base is one-half the dose when expressed as Caffeine (Stona Cold Caplets) citrate (e.g., 20 mg of Caffeine (Stona Cold Caplets) citrate is equivalent to 10 mg of Caffeine (Stona Cold Caplets) base).
Serum concentrations of Caffeine (Stona Cold Caplets) may need to be monitored periodically throughout treatment to avoid toxicity. Serious toxicity has been associated with serum levels greater than 50 mg/L.
Apnea of prematurity is a diagnosis of exclusion. Other causes of apnea (e.g., central nervous system disorders, primary lung disease, anemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnea) should be ruled out or properly treated prior to initiation of Caffeine (Stona Cold Caplets) citrate.
Caffeine (Stona Cold Caplets) citrate should be used with caution in infants with seizure disorders or cardiovascular disease.
The duration of treatment of apnea of prematurity in the placebo-controlled trial was limited to 10 to 12 days. The safety and efficacy of Caffeine (Stona Cold Caplets) citrate for longer periods of treatment have not been established.
ORGANIDIN® NR (Guaifenesin (Stona Cold Caplets))Tablets — Adults and children 12 years of age and older: One to 2 tablets (200 mg to 400 mg) every four hours, not to exceed 2400 mg (12 tablets) in 24 hours.
PATIENTS SHOULD BE ADVISED TO KEEP THESE AND ALL DRUGS OUT OF THE REACH OF CHILDREN AND TO SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY IN CASE OF ACCIDENTAL OVERDOSE.
How suppliedORGANIDIN® NR (Guaifenesin (Stona Cold Caplets))Tablets — Each round, scored, rose-colored tablet contains 200 mg Guaifenesin (Stona Cold Caplets) USP—available in bottles of 100 (NDC 0037-4312-01)
StorageStore at controlled room temperature 20°-25°C (68°-77°F). Protect tablets from moisture. Keep bottle tightly closed.
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120. Rev. 11/09
See also:
What other drugs will affect Acetaminophen (Stona Cold Caplets)?
Acetaminophen (Stona Cold Caplets) is metabolized (eliminated by conversion to other chemicals) by the liver. Therefore drugs that increase the action of liver enzymes that metabolize Acetaminophen (Stona Cold Caplets) [for example, carbamazepine (Tegretol), isoniazid (INH, Nydrazid, Laniazid), rifampin (Rifamate, Rifadin, Rimactane)] reduce the levels of Acetaminophen (Stona Cold Caplets) and may decrease the action of Acetaminophen (Stona Cold Caplets). Doses of Acetaminophen (Stona Cold Caplets) greater than the recommended doses are toxic to the liver and may result in severe liver damage. The potential for Acetaminophen (Stona Cold Caplets) 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 (Stona Cold Caplets) by decreasing its absorption into the body from the intestine. Therefore, Acetaminophen (Stona Cold Caplets) should be administered 3 to 4 hours after cholestyramine or one hour before cholestyramine.
Acetaminophen (Stona Cold Caplets) 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 (Stona Cold Caplets) should be avoided during warfarin therapy
See also:
What other drugs will affect Caffeine (Stona Cold Caplets)?
Acebrophylline: May enhance the stimulatory effect of CNS Stimulants. Avoid combination
Adenosine: Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products may diminish the therapeutic effect of Adenosine. Management: Monitor for decreased effect of adenosine if patient is receiving Caffeine (Stona Cold Caplets). Discontinue Caffeine (Stona Cold Caplets) in advance of scheduled diagnostic use of adenosine whenever possible. Consider therapy modification
Amifampridine: Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine. Monitor therapy
AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Broccoli: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Monitor therapy
Bromperidol: Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products may decrease the absorption of Bromperidol. Monitor therapy
BuPROPion: May enhance the neuroexcitatory and/or seizure-potentiating effect of Agents With Seizure Threshold Lowering Potential. Monitor therapy
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy
Cannabis: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Monitor therapy
CloZAPine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of CloZAPine. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Monitor therapy
Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification
CYP1A2 Inducers (Moderate): May decrease the serum concentration of Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products. Monitor therapy
CYP1A2 Inhibitors (Moderate): May increase the serum concentration of Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products. Monitor therapy
CYP1A2 Inhibitors (Strong): May increase the serum concentration of Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products. Monitor therapy
Doxofylline: Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products may enhance the adverse/toxic effect of Doxofylline. Avoid combination
Esketamine: May enhance the hypertensive effect of CNS Stimulants. Monitor therapy
Formoterol: Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products may enhance the adverse/toxic effect of Formoterol. Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products may enhance the hypokalemic effect of Formoterol. Monitor therapy
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy
Indacaterol: Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products may enhance the adverse/toxic effect of Indacaterol. Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products may enhance the hypokalemic effect of Indacaterol. Monitor therapy
Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification
Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification
Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification
Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification
Lithium: Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products may decrease the serum concentration of Lithium. Monitor therapy
Norfloxacin: May increase the serum concentration of Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products. Monitor therapy
Olodaterol: Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products may enhance the adverse/toxic effect of Olodaterol. Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products may enhance the hypokalemic effect of Olodaterol. Monitor therapy
Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification
Pipemidic Acid: May increase the serum concentration of Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products. Monitor therapy
Regadenoson: Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products may diminish the vasodilatory effect of Regadenoson. Management: Avoiding using Caffeine (Stona Cold Caplets) or other methylxanthine containing products (e.g., theophylline) for at least 12 hours prior to the administration of regadenoson. Consider therapy modification
Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Monitor therapy
Solriamfetol: CNS Stimulants may enhance the hypertensive effect of Solriamfetol. CNS Stimulants may enhance the tachycardic effect of Solriamfetol. Monitor therapy
Stiripentol: May increase the serum concentration of Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products. Avoid combination
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Theophylline Derivatives: CYP1A2 Inhibitors (Weak) may increase the serum concentration of Theophylline Derivatives. Exceptions: Dyphylline. Monitor therapy
TiZANidine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of TiZANidine. Management: Avoid these combinations when possible. If combined use is necessary, initiate tizanidine at an adult dose of 2 mg and increase in 2 to 4 mg increments based on patient response. Monitor for increased effects of tizanidine, including adverse reactions. Consider therapy modification
Tobacco (Smoked): May decrease the serum concentration of Caffeine (Stona Cold Caplets) and Caffeine (Stona Cold Caplets) Containing Products. Monitor therapy
See also:
What other drugs will affect Guaifenesin (Stona Cold Caplets)?
In vitro results suggest that methadone undergoes hepatic N-demethylation by cytochrome P450 enzymes, principally CYP3A4, CYP2B6, CYP2C19 and to a lesser extent by CYP2C9 and CYP2D6. Coadministration of methadone with CYP inducers of these enzymes may result in a more rapid metabolism and potential for decreased effects of methadone, whereas administration with CYP inhibitors may reduce metabolism and potentiate methadones effects. Although antiretroviral drugs such as efavirenz, nelfinavir, nevirapine, ritonavir, lopinavir+ritonavir combination are known to inhibit CYPs, they are shown to reduce the plasma levels of methadone, possibly due to their CYP induction activity. Therefore, drugs administered concomitantly with methadone should be evaluated for interaction potential; clinicians are advised to evaluate individual response to drug therapy.
Opioid Antagonists, Mixed Agonist/Antagonists, and Partial Agonists
As with other mu-agonists, patients maintained on methadone may experience withdrawal symptoms when given opioid antagonists, mixed agonist/antagonists, and partial agonists. Examples of such agents are naloxone, naltrexone, pentazocine, nalbuphine, butorphanol, and buprenorphine.
Anti-retroviral Agents
Abacavir, amprenavir, efavirenz, nelfinavir, nevirapine, ritonavir, lopinavir+ritonavir combination - Coadministration of these anti-retroviral agents resulted in increased clearance or decreased plasma levels of methadone. Guaifenesin (Stona Cold Caplets)-maintained patients beginning treatment with these antiretroviral drugs should be monitored for evidence of withdrawal effects and methadone dose should be adjusted accordingly.
Didanosine and Stavudine - Experimental evidence demonstrated that methadone decreased the AUC and peak levels for didanosine and stavudine, with a more significant decrease for didanosine. Guaifenesin (Stona Cold Caplets) disposition was not substantially altered.
Zidovudine - Experimental evidence demonstrated that methadone increased the area under the concentration-time curve (AUC) of zidovudine which could result in toxic effects.
Cytochrome P450 Inducers
Guaifenesin (Stona Cold Caplets)-maintained patients beginning treatment with CYP3A4 inducers should be monitored for evidence of withdrawal effects and methadone dose should be adjusted accordingly. The following drug interactions were reported following coadministration of methadone with inducers of cytochrome P450 enzymes:
Rifampin - In patients well-stabilized on methadone, concomitant administration of rifampin resulted in a marked reduction in serum methadone levels and a concurrent appearance of withdrawal symptoms.
Phenytoin - In a pharmacokinetic study with patients on methadone maintenance therapy, phenytoin administration (250 mg b.i.d. initially for 1 day followed by 300 mg QD for 3 to 4 days) resulted in an approximately 50% reduction in methadone exposure and withdrawal symptoms occurred concurrently. Upon discontinuation of phenytoin, the incidence of withdrawal symptoms decreased and methadone exposure increased to a level comparable to that prior to phenytoin administration.
St. Johns Wort, Phenobarbital, Carbamazepin/strong>Administration of methadone along with other CYP3A4 inducers may result in withdrawal symptoms.
Cytochrome P450 Inhibitors
Since the metabolism of methadone is mediated primarily by CYP3A4 isozyme, coadministration of drugs that inhibit CYP3A4 activity may cause decreased clearance of methadone. The expected clinical results would be increased or prolonged opioid effects. Thus, methadone-treated patients coadministered strong inhibitors of CYP3A4, such as azole antifungal agents (e.g., ketoconazole) and macrolide antibiotics (e.g., erythromycin), with methadone should be carefully monitored and dosage adjustment should be undertaken if warranted. Some selective serotonin reuptake inhibitors (SSRIs) (e.g., sertraline, fluvoxamine) may increase methadone plasma levels upon coadministration with methadone and result in increased opiate effects and/or toxicity.
Voriconazole - Repeat dose administration of oral voriconazole (400mg Q12h for 1 day, then 200mg Q12h for 4 days) increased the Cmax and AUC of (R)-methadone by 31% and 47%, respectively, in subjects receiving a methadone maintenance dose (30 to 100 mg QD). The Cmax and AUC of (S)-methadone increased by 65% and 103%, respectively. Increased plasma concentrations of methadone have been associated with toxicity including QT prolongation. Frequent monitoring for adverse events and toxicity related to methadone is recommended during coadministration. Dose reduction of methadone may be needed.
Others
Monoamine Oxidase (MAO) Inhibitors - Therapeutic doses of meperidine have precipitated severe reactions in patients concurrently receiving monoamine oxidase inhibitors or those who have received such agents within 14 days. Similar reactions thus far have not been reported with methadone. However, if the use of methadone is necessary in such patients, a sensitivity test should be performed in which repeated small, incremental doses of methadone are administered over the course of several hours while the patients condition and vital signs are under careful observation.
Desipramine - Blood levels of desipramine have increased with concurrent methadone administration.
Potentially Arrhythmogenic Agents
Extreme caution is necessary when any drug known to have the potential to prolong the QT interval is prescribed in conjunction with methadone. Pharmacodynamic interactions may occur with concomitant use of methadone and potentially arrhythmogenic agents such as class I and III antiarrhythmics, some neuroleptics and tricyclic antidepressants, and calcium channel blockers.
Caution should also be exercised when prescribing methadone concomitantly with drugs capable of inducing electrolyte disturbances (hypomagnesemia, hypokalemia) that may prolong the QT interval. These drugs include diuretics, laxatives, and, in rare cases, mineralocorticoid hormones.
Interactions with Alcohol and Drugs of Abuse
Guaifenesin (Stona Cold Caplets) may be expected to have additive effects when used in conjunction with alcohol, other opioids or CNS depressants, or with illicit drugs that cause central nervous system depression. Deaths have been reported when methadone has been abused in conjunction with benzodiazepines.
Anxiety - Since methadone as used by tolerant patients at a constant maintenance dosage does not act as a tranquilizer, patients who are maintained on this drug will react to life problems and stresses with the same symptoms of anxiety as do other individuals. The physician should not confuse such symptoms with those of narcotic abstinence and should not attempt to treat anxiety by increasing the dose of methadone. The action of methadone in maintenance treatment is limited to the control of narcotic withdrawal symptoms and is ineffective for relief of general anxiety.
Acute Pain - Maintenance patients on a stable dose of methadone who experience physical trauma, postoperative pain or other acute pain cannot be expected to derive analgesia from their existing dose of methadone. Such patients should be administered analgesics, including opioids, in doses that would otherwise be indicated for non-methadone-treated patients with similar painful conditions. Due to the opioid tolerance induced by methadone, when opioids are required for management of acute pain in methadone patients, somewhat higher and/or more frequent doses will often be required than would be the case for non-tolerant patients.
Risk of Relapse in Patients on Guaifenesin (Stona Cold Caplets) Maintenance Treatment of Opioid Addiction
Abrupt opioid discontinuation can lead to development of opioid withdrawal symptoms. Presentation of these symptoms have been associated with an increased risk of susceptible patients to relapse to illicit drug use and should be considered when assessing the risks and benefit of methadone use.
Tolerance and Physical Dependence
Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and/or tolerance are not unusual during chronic opioid therapy.
If methadone is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
In general, chronically administered methadone should not be abruptly discontinued.
Special-Risk Patients
Guaifenesin (Stona Cold Caplets) should be given with caution and the initial dose reduced in certain patients, such as the elderly and debilitated and those with severe impairment of hepatic or renal function, hypothyroidism, Addisons disease, prostatic hypertrophy, or urethral stricture. The usual precautions appropriate to the use of parenteral opioids should be observed and the possibility of respiratory depression should always be kept in mind.
Guaifenesin (Stona Cold Caplets) side effectsSee also:
What are the possible side effects of Guaifenesin (Stona Cold Caplets)?
Applies to Guaifenesin (Stona Cold Caplets): oral capsule, oral capsule extended release, oral elixir, oral liquid, oral packet, oral solution, oral syrup, oral tablet, oral tablet extended release
In addition to its needed effects, some unwanted effects may be caused by Guaifenesin (Stona Cold Caplets) (the active ingredient contained in Guaifenesin (Stona Cold Caplets)). In the event that any of these side effects do occur, they may require medical attention.
Minor Side EffectsSome of the side effects that can occur with Guaifenesin (Stona Cold Caplets) 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:
Less common or rare:
See also:
What is the most important information I should know about Guaifenesin (Stona Cold Caplets)?
Guaifenesin (Stona Cold Caplets) is contraindicated in patients with a known hypersensitivity to methadone hydrochloride or any other ingredient in DOLOPHINE.
Guaifenesin (Stona Cold Caplets) is contraindicated in any situation where opioids are contraindicated such as: patients with respiratory depression (in the absence of resuscitative equipment or in unmonitored settings), and in patients with acute bronchial asthma or hypercarbia.
Guaifenesin (Stona Cold Caplets) is contraindicated in any patient who has or is suspected of having a paralytic ileus.
