Acetaminophen/Atropine Sulfate/Caffeine/Ergotamine Tartrate/Hyoscyamine Sulfate

Acetaminophen:

• Pharmacological action
• Why is Acetaminophen prescribed?
• Acetaminophen dosage and administration
• Acetaminophen side effects, adverse reactions
• Contraindications
• Using during pregnancy and breastfeeding
• Special Instructions
• Acetaminophen Drug Interactions
• Acetaminophen in case of emergency / overdose
• Acetaminophen reviews

Pharmacological action

Acetaminophen is an analgesic-antipyretic. It has analgesic, antipyretic and weak anti-inflammatory action. The mechanism of action is associated with inhibition of prostaglandin synthesis, the predominant influence on the thermoregulation center in the hypothalamus, enhances heat transfer.

Why is Acetaminophen prescribed?

Pain weak and moderate intensity of different genesis. Fever in infectious and inflammatory diseases.

Acetaminophen dosage and administration

Oral or rectally adults and adolescents with a body weight over 60 kg is used in a single dose of 500 mg, the multiplicity of admission - up to 4 times / Maximum duration of treatment - 5-7 days.

Maximum dose: single - 1 g, daily - 4 g.

Single dose for oral administration for children aged 6-12 years - 250-500 mg, 1-5 years - 120-250 mg, from 3 months to 1 year - 60-120 mg, up to 3 months - 10 mg / kg. Single dose rectal in children aged 6-12 years - 250-500 mg, 1-5 years - 125-250 mg.

Multiplicity - 4 at intervals of not less than 4 h. The maximum duration of treatment - 3 days.

Maximum dose: 4 single dose per day.

Acetaminophen side effects, adverse reactions

Digestive system: rarely - dyspepsia; long-term use at high doses - hepatotoxic effects, methemoglobinemia, renal dysfunction and liver, hypochromic anemia. Hemopoietic system: rarely - thrombocytopenia, leukopenia, pancytopenia, neutropenia, agranulocytosis. Allergic reactions: rarely - skin rash, itching, hives.

Contraindications

Chronic active alcoholism, increased sensitivity to Acetaminophen, marked disturbances of liver function and / or kidney disease, anemia, pregnancy.

Using during pregnancy and breastfeeding

Acetaminophen crosses the placental barrier. So far, no observed adverse effects of Acetaminophen on the fetus in humans.

Acetaminophen is excreted in breast milk: the content in milk was 0.04-0.23% of the dose adopted mother.

If necessary, use of Acetaminophen during pregnancy and lactation (breastfeeding) should carefully weigh the potential benefits of therapy for the mother and the potential risk to the fetus or child.

In experimental studies found no embryotoxic, teratogenic and mutagenic action of Acetaminophen.

Special Instructions

Acetaminophen is used with caution in patients with disorders of the liver and kidneys, with benign hyperbilirubinemia, as well as in elderly patients.

With prolonged use of Acetaminophen is necessary to monitor patterns of peripheral blood and functional state of the liver.

Used for treatment of premenstrual tension syndrome in combination with pamabrom and mepyramine (Histamine H1-receptors blocker).

Acetaminophen Drug Interactions

With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic action of Acetaminophen.

With the simultaneous use of anticoagulants may be slight to moderate increase in prothrombin time.

With the simultaneous use of anticholinergics may decrease absorption of Acetaminophen.

With the simultaneous use of oral contraceptives accelerated excretion of Acetaminophen from the body and may reduce its analgesic action.

With the simultaneous use with urological means reduced their effectiveness.

With the simultaneous use of activated charcoal reduced bioavailability of Acetaminophen.

When Acetaminophen applied simultaneously with diazepam may decrease excretion of diazepam.

There have been reports about the possibility of enhancing mielodepression effect of zidovudine while applying with Acetaminophen. A case of severe toxic liver injury.

Described cases of toxic effects of Acetaminophen, while the use of isoniazid.

When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of Acetaminophen, which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of Acetaminophen and phenobarbital.

In applying cholestyramine a period of less than 1 h after administration of Acetaminophen may decrease of its absorption.

At simultaneous application with lamotrigine moderately increased excretion of lamotrigine from the body.

With the simultaneous use of metoclopramide may increase absorption of Acetaminophen and its increased concentration in blood plasma.

When applied simultaneously with probenecid may decrease clearance of Acetaminophen, with rifampicin, sulfinpyrazone - may increase clearance of Acetaminophen due to increasing its metabolism in the liver.

At simultaneous application of Acetaminophen with ethinylestradiol increases absorption of Acetaminophen from the gut.

Enhances the effect of indirect anticoagulants (coumarin derivatives and indandione). Antipyretic and analgesic activity of caffeine increases, reduce - rifampicin, phenobarbital and alcohol (accelerated biotransformation, inducing microsomal liver enzymes).

Acetaminophen in case of emergency / overdose

At a reception in toxic doses (10-15 g in adults) may develop liver necrosis.

Symptoms of overdose may include: nausea, vomiting, loss of appetite, sweating, extreme tiredness, unusual bleeding or bruising, pain in the upper right part of the stomach, yellowing of the skin or eyes, flu-like symptoms

Atropine Sulfate:

• Atropine Sulfate reviews

Indication: For the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides.

Atropine Sulfate, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, whose activity is due almost entirely to the levo isomer of the drug. Atropine Sulfate is commonly classified as an anticholinergic or antiparasympathetic (parasympatholytic) drug. More precisely, however, it is termed an antimuscarinic agent since it antagonizes the muscarine-like actions of acetylcholine and other choline esters. Adequate doses of Atropine Sulfate abolish various types of reflex vagal cardiac slowing or asystole. The drug also prevents or abolishes bradycardia or asystole produced by injection of choline esters, anticholinesterase agents or other parasympathomimetic drugs, and cardiac arrest produced by stimulation of the vagus. Atropine Sulfate may also lessen the degree of partial heart block when vagal activity is an etiologic factor. Atropine Sulfate in clinical doses counteracts the peripheral dilatation and abrupt decrease in blood pressure produced by choline esters. However, when given by itself, Atropine Sulfate does not exert a striking or uniform effect on blood vessels or blood pressure.

Caffeine:

• Caffeine reviews

Active ingredient (in each tablet)

Caffeine 200mg

Purpose

Alertness aid

Use

• helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

For occasional use only

Do not use

• in children under 12 years of age
• as a substitute for sleep

When using this product limit the use of Caffeine containing medications, foods, or beverages because too much Caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains about as much Caffeine as a cup of coffee.

Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours.

Other information

• store at room temperature
• avoid excessive heat (greater than 100°F) or humidity

Inactive ingredients

carnauba wax, colloidal silicon dioxide, D&C yellow #10 aluminum lake, dextrose, FD&C yellow #6 aluminum lake, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, starch, titanium dioxide

Questions or comments?

Call toll-free 1-855-874-0970 weekdays

Display Panel Caffeine: 16 ct. Package

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CAFFEINE ALERTNESS AID

16 TABLETS

200mg each

FUNCTIONAL Caffeine^® for Mental Alertness

SAFE & EFFECTIVE

One tablet is equal to about a cup of coffee

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Tamper Evident Feature: individually sealed in foil for your protection. Do not

use if foil or plastic bubble is torn or punctured.

Vivarin®, Vivarin® and design, stylization and trade dress, and FUNCTIONAL

CAFFEINE® are registered trademarks of Meda AB.

Distributed by:

Meda Consumer Healthcare Inc.

Marietta, GA 30062 ©2011 Meda AB

www.vivarin.com

16 ct. Package

Display Panel Caffeine: 40 ct. Package

SAFE & EFFECTIVE

FUNCTIONAL Caffeine^® for Mental Alertness

Caffeine^®

Caffeine ALERTNESS AID

40 Tablets

200mg each

FUNCTIONAL Caffeine^® for Mental Alertness

Tamper Evident Feature: Individually sealed in foil for your protection. Do not use if foil or plastic bubble is torn or punctured.

VIVARIN® helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness (FDA approved uses), so you can accomplish all the things you want to do and all the things you need to do.

Vivarin®, Vivarin® and design, stylization and trade dress, and FUNCTIONAL

CAFFEINE® are registered trademarks of Meda AB.

Made in the U.S.A.

Caffeine^®

Making the Most of Every Day.^®

Distributed by:

Meda Consumer Healthcare Inc.

Marietta, GA 30062 ©2013 Meda AB

www.vivarin.com

40 ct. Package

Ergotamine Tartrate:

• Ergotamine Tartrate reviews

Indication: For use as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants, or so called "histaminic cephalalgia".

Ergotamine Tartrate is a vasoconstrictor and alpha adrenoreceptor antagonist. The pharmacological properties of Ergotamine Tartrate are extremely complex; some of its actions are unrelated to each other, and even mutually antagonistic. The drug has partial agonist and/or antagonist activity against tryptaminergic, dopaminergic and alpha adrenergic receptors depending upon their site, and it is a highly active uterine stimulant. It causes constriction of peripheral and cranial blood vessels and produces depression of central vasomotor centers. The pain of a migraine attack is believed to be due to greatly increased amplitude of pulsations in the cranial arteries, especially the meningeal branches of the external carotid artery. Ergotamine Tartrate reduces extracranial blood flow, causes a decline in the amplitude of pulsation in the cranial arteries, and decreases hyperperfusion of the territory of the basilar artery. It does not reduce cerebral hemispheric blood flow.

Hyoscyamine Sulfate:

• Indications and usage for urophen mb :
• Contraindications:
• Warnings:
• Precautions:
• Adverse reactions
• Drug abuse and dependence
• Overdosage
• Urophen mb dosage and administration
• How is urophen mb supplied
• Storage
• Hyoscyamine Sulfate reviews

INDICATIONS AND USAGE FOR Hyoscyamine Sulfate :

Hyoscyamine Sulfate is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures..

CONTRAINDICATIONS:

Hyoscyamine Sulfate is contraindicated in patients with a hypersensitivity to any of the ingredients. Risk- benefit should be considered when the following medical problems exist: Cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

WARNINGS:

Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs, discontinue use immediately.

Patients should be advised that urine will be colored blue when taking this medication. Do not exceed recommended dosage.

PRECAUTIONS:

Contains Methylene Blue and should NOT be taken with serotonergic psychiatric medications.

Cross sensitivity and/or related problems:

Patients intolerant of other belladonna alkaloids or other salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers.

Drug Interactions:

Although the exact mechanism of this drug interaction is unknown, methylene blue inhibits the action of monoamine oxidase A- an enzyme responsible for breaking down serotonin in the brain. It is believed that when methylene blue is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome. Signs and symptoms of Serotonin Syndrome include mental changes, muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.

Additional Information for Healthcare Professionals:

Methylene blue can interact with serotonergic psychiatric medications and cause serious CNS toxicity.

In emergency situations requiring life-threatening or urgent treatment with methylene blue (as described above), the availability of alternative interventions should be considered and the benefit of methylene blue treatment should be weighed against the risk of serotonin toxicity. If methylene blue must be administered to a patient receiving a serotonergic drug, the serotonergic drug must be immediately stopped, and the patient should be closely monitored for emergent symptoms of CNS toxicity for two weeks (five weeks if fluoxetine [Prozac] was taken), or until 24 hours after the last dose of methylene blue, whichever comes first.

In non-emergency situations when non-urgent treatment with methylene blue is contemplated and planned, the serotonergic psychiatric medication should be stopped to allow its activity in the brain to dissipate. Most serotonergic psychiatric drugs should be stopped at least 2 weeks in advance of methylene blue treatment. Fluoxetine (Prozac), which has a longer half-life compared to similar drugs, should be stopped at least 5 weeks in advance.

Treatment with the serotonergic psychiatric medication may be resumed 24 hours after the last dose of methylene blue.

Serotonergic psychiatric medications should not be started in a patient receiving methylene blue. Wait until 24 hours after the last dose of methylene blue before starting the antidepressant.

Educate your patients to recognize the symptoms of serotonin toxicity or CNS toxicity and advise them to contact a healthcare professional immediately if they experience any symptoms while taking serotonergic psychiatric medications or methylene blue.

As a result of hyoscyamine's effects on gastrointestinal motility and gastric emptying, absorption of other oral medications may be decreased during concurrent use with this combination medication.

Urinary alkalizers and thiazide diuretics:

May cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde.

Antimuscarinics:

Concurrent use may intensify antimuscarinic effects of Hyoscyamine Sulfate because of secondary antimuscarinic activities of these medications.

Antacids/antidiarrheals:

Concurrent use may reduce absorption of Hyoscyamine Sulfate resulting in decreased therapeutic effectiveness. Concurrent use with antacids may cause urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde. Doses of these medications should be spaced 1 hour apart from doses of Hyoscyamine Sulfate.

Antimyasthenics:

Concurrent use with Hyoscyamine Sulfate may further reduce intestinal motility, therefore, caution is recommended.

Ketoconazole and Hyoscyamine Sulfate may cause increased gastrointestinal pH. Concurrent administration with Hyoscyamine Sulfate may result in marked reduction in the absorption of ketoconazole. Patients should be advised to take this combination at least 2 hours after ketoconazole.

Monoamine oxidase inhibitors:

Concurrent use with Hyoscyamine Sulfate may intensify antimuscarinic side effects.

Opioid (narcotic) analgesics may result in increased risk of severe constipation.

Sulfonamides:

These drugs may precipitate with formaldehyde in the urine increasing the danger of crystalluria.

Patients should be advised that the urine and/or stools may become blue to blue-green as a result of the excretion of methylene blue.

Pregnancy/Reproduction :

Hyoscyamine Sulfate and methenamine cross the placenta. Studies have not been done in either animals or humans. It is not known whether Hyoscyamine Sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine Sulfate should be given to a pregnant woman only if clearly needed.

Nursing mothers:

Methenamine and traces of Hyoscyamine Sulfate are excreted in breast milk. Caution should be exercised when Hyoscyamine Sulfate is administered to a nursing mother.

Prolonged use:

There have been no studies to establish the safety of prolonged use in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential.

Pediatric:

Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.

Geriatric :

Use with caution in elderly patients as they may respond to the usual doses of the belladonna alkaloids with excitement, agitation, drowsiness, or confusion.

ADVERSE REACTIONS

Cardiovascular - rapid pulse, flushing

Central Nervous System - blurred vision, dizziness, drowsiness

Respiratory - shortness of breath or troubled breathing

Genitourinary - difficult micturition, acute urinary retention

Gastrointestinal - dry mouth, nausea and vomiting

Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing.

This medication can cause urine and sometimes stools to turn blue to blue-green. This effect is harmless and will subside after medication is stopped.

Call your doctor or physician for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Burel Pharmaceuticals, Inc at 1-601-706-9819 or FDA at 1-800-FDA-1088, www.fda.gov/medwatch.

Drug Abuse And Dependence

A dependence on the use of Hyoscyamine Sulfate has not been reported and due to the nature of its ingredients, abuse of Hyoscyamine Sulfate is not expected.

OVERDOSAGE

Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children) repeated as needed in one to two hours to reverse severe antimuscarinic symptoms.

Administration of small doses of diazepam to control excitement and seizures. Artificial respiration with oxygen if needed for respiratory depression. Adequate hydration.

Symptomatic treatment as necessary.

If overdose is suspected, contact the poison control center at 1-800-222-1222, or your local emergency room immediately

Hyoscyamine Sulfate DOSAGE AND ADMINISTRATION

Adults: One tablet orally 4 times per day followed by liberal fluid intake.

Pediatric: Dosage must be individualized by physician for older children. Not recommended for use in children six years of age or younger.

HOW IS Hyoscyamine Sulfate SUPPLIED

Hyoscyamine Sulfate are blue tablets, oval, biconvex, debossed with “BL 07” with scoreline on one side and plain on the other side, available in bottles of 100 tablets, NDC 35573-307-10.

STORAGE

Store in a cool, dry place at controlled room temperature 15° to 30°C (59° to 86°F). Keep container tightly closed. Protect from moisture and direct sunlight.

Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

KEEP OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Note: Patients should be advised that urine will be colored blue when taking this medication.

Rx Only

Manufactured for:

Burel Pharmaceuticals, Inc

Richland, MS 39218

Rev. 7/2015

NDC 35573-307-10

Hyoscyamine Sulfate ^®

^{URINARY ANTISEPTIC}

Each Tablet Contains:

Rx ONLY

Buruel Pharmaceuticals

100 Tablets

Hyoscyamine Sulfate is a trademark of Burel Pharmaceuticals, Inc

Manufactured for:

Burel Pharmaceuticals, Inc

Richland, MS 39218