DRUGS & SUPPLEMENTS

Intragesic-MR

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Intragesic-MR uses

Intragesic-MR consists of Acetaminophen, Chlorzoxazone, Diclofenac.

Acetaminophen:


Pharmacological action

Intragesic-MR 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 Intragesic-MR (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.

Paracetamol 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.

Intragesic-MR 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 paracetamol, marked disturbances of liver function and / or kidney disease, anemia, pregnancy.

Using during pregnancy and breastfeeding

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

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

If necessary, use of paracetamol 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 paracetamol.

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Special Instructions

Intragesic-MR 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 paracetamol 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).

Intragesic-MR (Acetaminophen) Drug Interactions

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

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 paracetamol.

With the simultaneous use of oral contraceptives accelerated excretion of paracetamol 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 paracetamol.

When Intragesic-MR (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 paracetamol. A case of severe toxic liver injury.

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

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

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

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

At simultaneous application of Intragesic-MR (Acetaminophen) with ethinylestradiol increases absorption of paracetamol 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).

Intragesic-MR 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

Chlorzoxazone:



For Painful Musculoskeletal Conditions

DESCRIPTION

Each caplet (capsule shaped tablet) contains:

Intragesic-MR (Chlorzoxazone)5-chlorobenzoxazolinone 500 mg

Inactive ingredients: FD&C Blue No. 1, microcrystalline cellulose, docusate sodium, lactose (hydrous), magnesium stearate, sodium benzoate, sodium starch glycolate, pregelatinized corn starch, D&C Yellow No. 10.

ACTIONS

Intragesic-MR (Chlorzoxazone) is a centrally-acting agent for painful musculoskeletal conditions. Data available from animal experiments as well as human study indicate that Intragesic-MR (Chlorzoxazone) acts primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. The clinical result is a reduction of the skeletal muscle spasm with relief of pain and increased mobility of the involved muscles. Blood levels of Intragesic-MR (Chlorzoxazone) can be detected in people during the first 30 minutes and peak levels may be reached, in the majority of the subjects, in about 1 to 2 hours after oral administration of Intragesic-MR (Chlorzoxazone). Intragesic-MR (Chlorzoxazone) is rapidly metabolized and is excreted in the urine, primarily in a conjugated form as the glucuronide. Less than one percent of a dose of Intragesic-MR (Chlorzoxazone) is excreted unchanged in the urine in 24 hours.

INDICATIONS

Intragesic-MR (Chlorzoxazone) Intragesic-MR (Chlorzoxazone) is 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 this drug has not been clearly identified, but may be related to its sedative properties. Intragesic-MR (Chlorzoxazone) does not directly relax tense skeletal muscles in man.

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CONTRAINDICATIONS

Intragesic-MR (Chlorzoxazone) Intragesic-MR (Chlorzoxazone) is contraindicated in patients with known intolerance to the drug.

WARNINGS

Serious hepatocellular toxicity has been reported rarely in patients receiving Intragesic-MR (Chlorzoxazone). The mechanism is unknown but appears to be idiosyncratic and unpredictable. Factors predisposing patients to this rare event are not known. Patients should be instructed to report early signs and/or symptoms of hepatotoxicity such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice. Intragesic-MR (Chlorzoxazone) should be discontinued immediately and a physician consulted if any of these signs or symptoms develop. Intragesic-MR (Chlorzoxazone) use should also be discontinued if a patient develops abnormal liver enzymes (e.g. AST, ALT, alkaline phosphatase and bilirubin).

The concomitant use of alcohol or other central nervous system depressants may have an additive effect.

Usage in Pregnancy

The safe use of Intragesic-MR (Chlorzoxazone) Intragesic-MR (Chlorzoxazone) has not been established with respect to the possible adverse effects upon fetal development. Therefore, it should be used in women of childbearing potential only when, in the judgment of the physician, the potential benefits outweigh the possible risks.

PRECAUTIONS

Intragesic-MR (Chlorzoxazone) Intragesic-MR (Chlorzoxazone) should be used with caution in patients with known allergies or with a history of allergic reactions to drugs. If a sensitivity reaction occurs such as urticaria, redness, or itching of the skin, the drug should be stopped.

If any symptoms suggestive of liver dysfunction are observed, the drug should be discontinued.

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ADVERSE REACTIONS

Intragesic-MR (Chlorzoxazone) containing products are usually well tolerated. It is possible in rare instances that Intragesic-MR (Chlorzoxazone) may have been associated with gastrointestinal bleeding. Drowsiness, dizziness, lightheadedness, malaise, or overstimulation may be noted by an occasional patient. Rarely, allergic-type skin rashes, petechiae, or ecchymoses may develop during treatment. Angioneurotic edema or anaphylactic reactions are extremely rare. There is no evidence that the drug will cause renal damage. Rarely, a patient may note discoloration of the urine resulting from a phenolic metabolite of Intragesic-MR (Chlorzoxazone). This finding is of no known clinical significance.

DOSAGE AND ADMINISTRATION

Usual Adult Dosage

One caplet three or four times daily. If adequate response is not obtained with this dose, it may be increased to 1 ½ caplets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.

OVERDOSAGE

Symptoms

Initially, gastrointestinal disturbances such as nausea, vomiting, or diarrhea together with drowsiness, dizziness, lightheadedness or headache may occur. Early in the course there may be malaise or sluggishness followed by marked loss of muscle tone, making voluntary movement impossible. The deep tendon reflexes may be decreased or absent. The sensorium remains intact, and there is no peripheral loss of sensation. Respiratory depression may occur with rapid, irregular respiration and intercostal and substernal retraction. The blood pressure is lowered, but shock has not been observed.

Treatment

Gastric lavage or induction of emesis should be carried out, followed by administration of activated charcoal. Thereafter, treatment is entirely supportive. If respirations are depressed, oxygen and artificial respiration should be employed and a patent airway assured by use of an oropharyngeal airway or endotracheal tube. Hypotension may be counteracted by use of dextran, plasma, concentrated albumin or a vasopressor agent such as norepinephrine. Cholinergic drugs or analeptic drugs are of no value and should not be used.

HOW SUPPLIED

PARAFON FORTE® DSC (chlorzoxazone) 500 mg caplets, (capsule shaped tablet, colored light green, imprinted "PARAFON FORTE DSC" and "McNEIL," scored).

NDC 50458-625-60, bottles of 100.

Dispense in tight container as defined in the official compendium.

Store at controlled room temperature (15°–30°C, 59°–86°F).

Product of Taiwan.

Manufactured by:

Janssen Ortho, LLC

Gurabo, Puerto Rico 00778

Manufactured for:

Janssen Pharmaceuticals, Inc.

Titusville, NJ 08560

© Janssen Pharmaceuticals, Inc.

Revised: March 2012

NDC 50458-625-60

Parafon

Forte® DSC

(CHLORZOXAZONE)

500 mg

100 caplets

Rx only

janssen

Diclofenac:


Pharmacological action

NSAIDs, a derivative of phenylacetic acid, Intragesic-MR has a pronounced anti-inflammatory, analgesic and mild antipyretic effect. The mechanism of action is associated with inhibition of COX activity - the main enzyme metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. Analgesic effect is due to two mechanisms: peripheral (indirectly, through suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system).

Inhibits synthesis of proteoglycan in cartilage.

In rheumatic diseases, Intragesic-MR (Diclofenac) reduces joint pain at rest and in motion, as well as morning stiffness and swelling of the joints, helps to increase range of motion; reduces post-traumatic and postoperative pain, and inflammatory edema.

Inhibits platelet aggregation. With prolonged use has a desensitizing effect.

When used topically in ophthalmology reduces swelling and pain in inflammatory processes non-infectious etiology.

Pharmacokinetics

After intake is absorbed from the gastrointestinal tract. Eating slows down the rate of absorption, extent of absorption is not changed. About 50% of the active substance is metabolized in the "first passage" through the liver. When used rectally absorption is slower. Time to reach Cmax in plasma after oral administration is 2-4 hours depending on the used dosage form, after rectal - 1 h, I.M. administration - 20 min. The concentration of active substance in plasma is a linear function of the applied dose.

Not cumulative. Plasma protein binding is 99.7% (predominantly albumin). Penetrates into synovial fluid, Cmax is achieved in 2-4 hours later than in plasma.

To a large extent metabolized to form several metabolites, among which two pharmacologically active, but to a lesser extent than Intragesic-MR (Diclofenac).

Systemic clearance of the active substance is about 263 ml / min. T1/2 from plasma is 1-2 h, from synovial fluid - 3-6 h. Approximately 60% of the dose was excreted as metabolites by the kidneys, less than 1% excreted in the urine as unchanged, while the rest is displayed in the form of metabolites with bile.

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Why is Intragesic-MR prescribed?

Articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), degenerative and chronic inflammatory diseases of musculoskeletal system (osteochondrosis, osteoarthritis, periartropatii), post-traumatic inflammation of soft tissue and musculoskeletal system (sprains, bruises). Pain in the spine, neuralgia, myalgia, arthralgia, pain and inflammation after surgery or injury, pain in gout, migraine, algomenorrhea, pain with Bursitis, proctitis, colic (biliary and renal), pain in infectious and inflammatory diseases of ENT organs.

For local use: the inhibition of miosis during surgery for cataract prevention of cystoid macular edema associated with removal and lens implantation, inflammatory eye non-infectious nature, post-traumatic inflammation in penetrating and nonpenetrating wound of the eyeball.

Dosage and administration

For oral use for adult single dose is 25-50 mg 2-3 times / 24 h. Frequency of admission depends on the dosage form employed, the severity of the disease and is 1-3 times / 24 h, rectally - 1 times / 24 h, for the treatment of acute conditions or the exacerbation of chronic edema use intramuscular in dose of 75 mg.

For children older than 6 years and adolescents daily dose is 2 mg / kg.

Topical applied at a dose of 2-4 g on the affected area 3-4 times / 24 h.

When used in ophthalmology frequency and duration of administration are determined individually.

The maximum oral daily dose for adults is 150 mg.

Intragesic-MR (Diclofenac) side effects

Digestive system: nausea, vomiting, anorexia, abdominal pain and discomfort in the epigastrium, flatulence, constipation, diarrhea, and in some cases - erosive-ulcerative lesions, gastrointestinal bleeding and perforation; rarely - abnormal liver function. When rectal administration - in isolated cases were observed inflammation of the colon bleeding, exacerbation of ulcerative colitis.

From the side of the central nervous system and peripheral nervous system: dizziness, headache, agitation, insomnia, irritability, fatigue, rarely - paresthesia, visual disturbances (blurred, double vision), tinnitus, insomnia, cramps, irritability, tremors, mental disorders, depression.

Hemopoietic system: rarely - anemia, leukopenia, thrombocytopenia, agranulocytosis.

Urinary system: rarely - renal failure; in predisposed patients may be swelling.

Dermatological reactions: rarely - hair loss.

Allergic reactions: skin rash, itching, when used in the form of eye drops - itching, redness, photosensitivity.

Local reactions: in the place of I.M. introducing possible burning, in some cases - the formation of infiltration, abscess, necrosis of adipose tissue in the rectal administration may be local irritation, the appearance of mucous discharge mixed with blood, painful defecation, when used externally, in rare cases - itching, redness, rash, burning sensation, when applied topically in ophthalmology may be a transient burning sensation and / or temporary blurred vision immediately after instillation.

With long-term topical use and / or drawing on a vast surface of body are possible systemic side effects due to resorptive action of Intragesic-MR (Diclofenac).

Contraindications

known hypersensitivity to Intragesic-MR sodium or to any accessory ingredient that is part of the drug Intragesic-MR (Diclofenac);

anamnestic information about the attacks of bronchial asthma, urticaria, acute rhinitis associated with the use of aspirin or other NSAIDs;

hemodyscrasia unknown origin;

children under 6 years

pregnancy (III trimester);

lactation

increased sensitivity to sulfite (for injection solution).

children under age 15 - tablets of 50 mg to 18 years - injection.

Using during pregnancy and breastfeeding

Use during pregnancy and lactation is possible in cases where the potential benefits for the mother exceeds than the potential risk to the fetus or newborn.

Special instructions

With extreme caution is used in diseases of liver, kidney, gastrointestinal history, dyspepsia, asthma, hypertension, heart failure, after major surgery, as well as elderly patients.

When referring to a history of allergic reactions to NSAIDs Intragesic-MR and sulfites are used only in urgent cases. In the course of treatment requires systematic monitoring of liver function and kidney picture of peripheral blood.

Do not recommended the use for rectal patients with diseases of anorectal region or anorectal bleeding in history. Topical should be applied only to intact skin areas.

Avoid contact with Intragesic-MR (Diclofenac) in the eye (except for eye drops), or on mucous membranes. Patients who use contact lenses, eye drops should be applied no earlier than 5 minutes after removing the lenses.

Not recommended for children under 6 years.

During the period of treatment drugs for systemic use is not recommended alcohol consumption.

During the period of treatment may decrease the speed of psychomotor reactions. With worsening blurred vision after application of eye drops should not be driving and doing other potentially danger activities.

Intragesic-MR (Diclofenac) drug interactions

At simultaneous application with Intragesic-MR (Diclofenac) antihypertensive drugs may be weakening their actions.

There are few reports on the occurrence of seizures in patients taking both NSAIDs and antibacterial drugs quinolic series.

At simultaneous application with GCS and increased risk of side effects from the digestive system.

With simultaneous use of diuretics may decrease diuretic effect. With the simultaneous use of potassium-sparing diuretics may increase the concentration of potassium in the blood.

With simultaneous use with other NSAIDs may increase the risk of side effects.

There are reports of hypoglycemia or hyperglycemia in patients with diabetes who engaged in Intragesic-MR (Diclofenac) together with hypoglycemic drugs.

When applied simultaneously with acetylsalicylic acid may decrease the concentration of Intragesic-MR (Diclofenac) in plasma.

Although clinical studies have not found the influence of Intragesic-MR (Diclofenac) on the action of anticoagulants, describes the individual cases of bleeding when used with Intragesic-MR (Diclofenac) and warfarin.

With simultaneous use may increase digoxin, lithium, and phenytoin in blood plasma.

The absorption of Intragesic-MR (Diclofenac) from the gastrointestinal tract is reduced by simultaneous application with kolestiraminom, to a lesser extent - with colestipol.

With simultaneous use may increase the concentration of methotrexate in plasma and increased its toxicity.

With simultaneous application of Intragesic-MR (Diclofenac) could not affect the bioavailability of morphine, but the concentration of the active metabolite of morphine may be enhanced in the presence of Intragesic-MR (Diclofenac), which increases the risk of side effects metabolites of morphine, including respiratory depression.

When applied simultaneously with pentazocine described a case of great convulsions, and rifampicin - may decrease the concentration of Intragesic-MR (Diclofenac) in plasma, with ceftriaxone - increases excretion of ceftriaxone in bile; with cyclosporine - may increase cyclosporine nephrotoxicity.

Intragesic-MR in case of emergency / overdose

Symptoms: may cause hypotension, renal failure, convulsions, gastrointestinal irritation or respiratory depression. Treatment: There is no specific antidote. In acute poisoning as soon as possible to stop drug absorption from the gastrointestinal tract. There is indicated gastric lavage, activated charcoal appointment and conduct of other symptomatic and supportive therapy. The use of forced diuresis, dialysis or blood transfusion is not justified because NSAIDs largely associated with serum proteins and possess extensive metabolism.

Storage conditions

In a dry, protected from light place, at temperature not above 25°C.Common expiration date for Intragesic-MR (Diclofenac) tablets: 3 years.

Intragesic-MR pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Intragesic-MR available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Intragesic-MR destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Intragesic-MR Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Intragesic-MR pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."DICLOFENAC SODIUM (DICLOFENAC) SOLUTION [AMNEAL PHARMACEUTICALS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."PARAFON FORTE DSC (CHLORZOXAZONE) TABLET [JANSSEN PHARMACEUTICALS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."FEVERALL INFANTS (ACETAMINOPHEN) SUPPOSITORY [ACTAVIS MID ATLANTIC LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Intragesic-MR?

Depending on the reaction of the Intragesic-MR after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Intragesic-MR not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Intragesic-MR addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Intragesic-MR, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Intragesic-MR consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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