Miyorel

Acetaminophen:

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

Pharmacological action

Miyorel 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 Miyorel (Acetaminophen) prescribed?

Pain weak and moderate intensity of different genesis (including headache, migraine, toothache, neuralgia, myalgia, algomenorrhea; pain in trauma, burns). Fever in infectious and inflammatory diseases.

Miyorel 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.

Miyorel 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 Miyorel, marked disturbances of liver function and / or kidney disease, anemia, pregnancy (I term).

Using during pregnancy and breastfeeding

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

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

If necessary, use of Miyorel (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 Miyorel (Acetaminophen).

Special Instructions

Miyorel 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 Miyorel (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 (diuretic, a derivative of xanthine) and mepyramine (Histamine H1-receptors blocker).

Miyorel (Acetaminophen) Drug Interactions

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

With the simultaneous use of oral contraceptives accelerated excretion of Miyorel (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 Miyorel (Acetaminophen).

When Miyorel (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 Miyorel (Acetaminophen). A case of severe toxic liver injury.

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

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

In applying cholestyramine a period of less than 1 h after administration of Miyorel (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 Miyorel (Acetaminophen) and its increased concentration in blood plasma.

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

At simultaneous application of Miyorel (Acetaminophen) with ethinylestradiol increases absorption of Miyorel (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).

Miyorel 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

Methocarbamol:

• Description:
• Clinical pharmacology:
• Indications and usage:
• Contraindications:
• Warnings:
• Precautions:
• Adverse reactions
• Overdosage
• Dosage and administration:
• How supplied:
• Miyorel (Methocarbamol) reviews

Miyorel (Methocarbamol) TABLETS, USP

Rev. 03/11

Rx Only

DESCRIPTION:

Miyorel (Methocarbamol) Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is:

The chemical name for Miyorel (Methocarbamol) is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C₁₁H₁₅NO₅. Its molecular weight is 241.24.

Miyorel (Methocarbamol) is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane.

Each tablet, for oral administration, contains 500 mg or 750 mg of Miyorel (Methocarbamol), USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate.

Miyorel (Methocarbamol) structural formula

CLINICAL

Pharmacology:

The mechanism of action of Miyorel in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

Pharmacokinetics :

In healthy volunteers, the plasma clearance of Miyorel (Methocarbamol) ranges between 0.20 and 0.80 L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%.

Miyorel (Methocarbamol) is metabolized via dealkylation and hydroxylation. Conjugation of Miyorel (Methocarbamol) also is likely. Essentially all Miyorel (Methocarbamol) metabolites are eliminated in the urine. Small amounts of unchanged Miyorel (Methocarbamol) also are excreted in the urine.

Special Populations :

Elderly

The mean elimination half-life of Miyorel (Methocarbamol) in elderly healthy volunteers (mean (± SD) age, 69 (± 4) years) was slightly prolonged compared to a younger (mean (± SD) age, 53.3 (± 8.8) years), healthy population (1.5 (±0.4) hours versus 1.1 (±0.27) hours, respectively). The fraction of bound Miyorel (Methocarbamol) was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively).

Renally Impaired

The clearance of Miyorel (Methocarbamol) in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (±SD) elimination half-life in these two groups was similar: 1.2 (±0.6) versus 1.1 (±0.3) hours, respectively.

Hepatically Impaired

In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of Miyorel (Methocarbamol) was reduced approximately 70% compared to that obtained in 8 age- and weight-matched normal subjects. The mean (±SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (±1.62) hours and 1.11 (±0.27) hours, respectively. The percent of Miyorel (Methocarbamol) bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects.

INDICATIONS AND USAGE:

Miyorel (Methocarbamol) Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of Miyorel (Methocarbamol) has not been clearly identified, but may be related to its sedative properties. Miyorel (Methocarbamol) does not directly relax tense skeletal muscles in man.

CONTRAINDICATIONS:

Methocarbamol Tablets are contraindicated in patients hypersensitive to Miyorel (Methocarbamol) or to any of the tablet components.

WARNINGS:

Since Miyorel may possess a general CNS depressant effect, patients receiving Miyorel (Methocarbamol) Tablets should be cautioned about combined effects with alcohol and other CNS depressants.

Safe use of Miyorel (Methocarbamol) Tablets has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to Miyorel (Methocarbamol). Therefore, Miyorel (Methocarbamol) Tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see PRECAUTIONS : Pregnancy ).

Use in Activities Requiring Mental Alertness :

Miyorel (Methocarbamol) may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that Miyorel (Methocarbamol) therapy does not adversely affect their ability to engage in such activities.

PRECAUTIONS:

Information for Patients:

Patients should be cautioned that Miyorel may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery.

Because Miyorel (Methocarbamol) may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.

Drug Interactions:

See WARNINGS and PRECAUTIONS for interaction with CNS drugs and alcohol.

Miyorel (Methocarbamol) may inhibit the effect of pyridostigmine bromide. Therefore, Miyorel (Methocarbamol) should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.

Drug /Laboratory Test Interactions:

Miyorel may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) using nitrosonaphthol reagent and in screening tests for urinary vanillylmandelic acid (VMA) using the Gitlow method.

Carcinogenesis, Mutagenesis, Impairment of Fertility :

Long-term studies to evaluate the carcinogenic potential of Miyorel (Methocarbamol) have not been performed. No studies have been conducted to assess the effect of Miyorel (Methocarbamol) on mutagenesis or its potential to impair fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Miyorel. It is also not known whether Miyorel (Methocarbamol) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methocarbamol Tablets should be given to a pregnant woman only if clearly needed.

Safe use of Miyorel (Methocarbamol) Tablets has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congential abnormalities following in utero exposure to Miyorel (Methocarbamol). Therefore, Miyorel (Methocarbamol) Tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see WARNINGS ).

Nursing Mothers

Miyorel (Methocarbamol) and/or its metabolites are excreted in the milk of dogs; however, it is not known whether Miyorel (Methocarbamol) or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Miyorel (Methocarbamol) Tablets are administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Miyorel (Methocarbamol) Tablets in pediatric patients below the age of 16 have not been established.

ADVERSE REACTIONS

Adverse reactions reported coincident with the administration of Miyorel (Methocarbamol) include:

Body as a Whole : Anaphylactic reaction, angioneurotic edema, fever, headache

Car d iovascular System : Bradycardia, flushing, hypotension, syncope, thrombophlebitis

Digestive System : Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting

Hemic and Lymphatic S ystem : Leukopenia

Immune System : Hypersensitivity reactions

Nervous System : Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo

Skin and Special Senses : Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria

To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Limited information is available on the acute toxicity of Miyorel. Overdose of Miyorel (Methocarbamol) is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma.

In post-marketing experience, deaths have been reported with an overdose of Miyorel (Methocarbamol) alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.

Treatment:

Management of overdose includes symptomatic and supportive treatment. Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown.

DOSAGE AND ADMINISTRATION:

500 mg – Adults: Initial dosage, 3 tablets q.i.d.; maintenance dosage, 2 tablets q.i.d.

750 mg – Adults: Initial dosage, 2 tablets q.i.d.; maintenance dosage, 1 tablet q.4h. or 2 tablets t.i.d.

Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered.) Thereafter, the dosage can usually be reduced to approximately 4 grams a day.

HOW SUPPLIED:

Miyorel (Methocarbamol) Tablets 500 mg: White, Round Tablets; Debossed “West-ward 290” on one side and Scored on the other side.

Bottles of 100 tablets

Bottles of 500 tablets

Bottles of 1000 tablets

Unit Dose Box of 100 tablets

Miyorel (Methocarbamol) Tablets 750 mg: White, Capsule Shaped Tablets; Debossed “WEST-WARD 292” on one side and Scored on the other side.

Bottles of 100 tablets

Bottles of 500 tablets

Bottles of 1000 tablets

Unit Dose Box of 100 tablets

Store at 20-25^oC (68-77^oF). Protect from light and moisture.

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

Manufactured by:

West-ward Pharmaceutical Corp.

Eatontown, NJ 07724

Revised March 2011