Paratel-ACP

Acetaminophen:

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

Pharmacological action

Paratel-ACP 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 Paratel-ACP (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.

Paratel-ACP 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.

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

Using during pregnancy and breastfeeding

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

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

If necessary, use of Paratel-ACP (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 Paratel-ACP (Acetaminophen).

Special Instructions

Paratel-ACP 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 Paratel-ACP (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).

Paratel-ACP (Acetaminophen) Drug Interactions

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

With the simultaneous use of oral contraceptives accelerated excretion of Paratel-ACP (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 Paratel-ACP (Acetaminophen).

When Paratel-ACP (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 Paratel-ACP (Acetaminophen). A case of severe toxic liver injury.

Described cases of toxic effects of Paratel-ACP (Acetaminophen), while the use of isoniazid.

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

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

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

At simultaneous application of Paratel-ACP (Acetaminophen) with ethinylestradiol increases absorption of Paratel-ACP (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).

Paratel-ACP 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:

• Description
• Actions
• Indications
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Dosage and administration
• Overdosage
• How supplied
• Paratel-ACP (Chlorzoxazone) reviews

For Painful Musculoskeletal Conditions

DESCRIPTION

Each caplet (capsule shaped tablet) contains:

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

Paratel-ACP (Chlorzoxazone) is a centrally-acting agent for painful musculoskeletal conditions. Data available from animal experiments as well as human study indicate that Paratel-ACP (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 Paratel-ACP (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 Paratel-ACP (Chlorzoxazone). Paratel-ACP (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 Paratel-ACP (Chlorzoxazone) is excreted unchanged in the urine in 24 hours.

INDICATIONS

Paratel-ACP (Chlorzoxazone) Paratel-ACP (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. Paratel-ACP (Chlorzoxazone) does not directly relax tense skeletal muscles in man.

CONTRAINDICATIONS

Paratel-ACP (Chlorzoxazone) Paratel-ACP (Chlorzoxazone) is contraindicated in patients with known intolerance to the drug.

WARNINGS

Serious hepatocellular toxicity has been reported rarely in patients receiving Paratel-ACP (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. Paratel-ACP (Chlorzoxazone) should be discontinued immediately and a physician consulted if any of these signs or symptoms develop. Paratel-ACP (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 Paratel-ACP (Chlorzoxazone) Paratel-ACP (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

Paratel-ACP (Chlorzoxazone) Paratel-ACP (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.

ADVERSE REACTIONS

Paratel-ACP (Chlorzoxazone) containing products are usually well tolerated. It is possible in rare instances that Paratel-ACP (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 Paratel-ACP (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