DRUGS & SUPPLEMENTS

Cedrilax

advertisement
What is the dose of the medication you are taking?

Cedrilax uses

Cedrilax consists of Acetaminophen, Caffeine, Carisoprodol, Diclofenac Sodium.

Acetaminophen:


Pharmacological action

Cedrilax 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 Cedrilax (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.

Cedrilax 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.

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

Using during pregnancy and breastfeeding

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

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

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

advertisement

Special Instructions

Cedrilax 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 Cedrilax (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).

Cedrilax (Acetaminophen) Drug Interactions

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

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

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

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

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

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

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

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

Cedrilax 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

Caffeine:



Active ingredient (in each tablet)

Cedrilax (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 Cedrilax (Caffeine) containing medications, foods, or beverages because too much Cedrilax (Caffeine) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains about as much Cedrilax (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 Cedrilax (Caffeine): 16 ct. Package

Cedrilax (Caffeine)®

CAFFEINE ALERTNESS AID

16 TABLETS

200mg each

FUNCTIONAL Cedrilax (Caffeine)® for Mental Alertness

SAFE & EFFECTIVE

One tablet is equal to about a cup of coffee

Cedrilax (Caffeine)®

Making the Most of Every Day.®

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 Cedrilax (Caffeine): 40 ct. Package

SAFE & EFFECTIVE

FUNCTIONAL Cedrilax (Caffeine)® for Mental Alertness

Cedrilax (Caffeine)®

Cedrilax (Caffeine) ALERTNESS AID

40 Tablets

200mg each

FUNCTIONAL Cedrilax (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.

Cedrilax (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

Carisoprodol:


1 INDICATIONS AND USAGE

Cedrilax (Carisoprodol) Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

Cedrilax (Carisoprodol) Tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2) ].

Cedrilax (Carisoprodol) Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions. (1)

Important Limitations:

  • Should only be used for acute treatment periods up to two or three weeks (1)
  • Not recommended in pediatric patients less than 16 years of age (8.4)

2 DOSAGE AND ADMINISTRATION

The recommended dose of Cedrilax (Carisoprodol) is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of Cedrilax (Carisoprodol) use is up to two or three weeks.

  • Recommended dose is 250 mg to 350 mg three times a day and at bedtime. (2)

3 DOSAGE FORMS AND STRENGTHS

350 mg Tablets: white, round, unscored tablets debossed "2410 V" on one side and plain on the reverse side.

Tablets: 350 mg (3)

advertisement

4 CONTRAINDICATIONS

Cedrilax (Carisoprodol) Tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.

  • Acute intermittent porphyria (4)
  • Hypersensitivity reactions to a carbamate such as meprobamate (4)

5 WARNINGS AND PRECAUTIONS

  • Due to sedative properties, may impair ability to perform hazardous tasks such as driving or operating machinery
  • Additive sedative effects when used with other CNS depressants including alcohol (5.1)
  • Cases of Drug Dependence, Withdrawal, and Abuse (5.2)
  • Seizures (5.3)

5.1 Sedation

Carisoprodol has sedative properties (in the low back pain trials, 13% to 17% of patients who received Cedrilax (Carisoprodol) experienced sedation compared to 6% of patients who received placebo) [see ADVERSE REACTIONS (6.1) ] and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery. There have been post-marketing reports of motor vehicle accidents associated with the use of Cedrilax (Carisoprodol).

Since the sedative effects of Cedrilax (Carisoprodol) and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

5.2 Drug Dependence, Withdrawal, and Abuse

In the postmarketing experience with Cedrilax, cases of dependence, withdrawal, and abuse have been reported with prolonged use. Most cases of dependence, withdrawal, and abuse occurred in patients who have had a history of addiction or who used Cedrilax (Carisoprodol) in combination with other drugs with abuse potential. However, there have been post-marketing adverse event reports of carisoprodol-associated abuse when used without other drugs with abuse potential. Withdrawal symptoms have been reported following abrupt cessation after prolonged use. To reduce the chance of Cedrilax (Carisoprodol) dependence, withdrawal, or abuse, Cedrilax (Carisoprodol) should be used with caution in addiction-prone patients and in patients taking other CNS depressants including alcohol, and Cedrilax (Carisoprodol) should not be used more than two to three weeks for the relief of acute musculoskeletal discomfort.

Cedrilax (Carisoprodol), and one of its metabolites, meprobamate (a controlled substance), may cause dependence [see Clinical Pharmacology (12.3) ].

5.3 Seizures

There have been postmarketing reports of seizures in patients who received Cedrilax (Carisoprodol). Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol) [see Overdosage (10) ].

advertisement

6 ADVERSE REACTIONS

Most common adverse reactions are drowsiness, dizziness, and headache (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Qualitest Pharmaceuticals at 1‑800‑444-4011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.

The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain [see Clinical Studies (14) ]. In these studies, patients were treated with 250 mg of Cedrilax (Carisoprodol), 350 mg of Cedrilax (Carisoprodol), or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74% Caucasian, 16% Black, 9% Asian, and 2% other.

There were no deaths and there were no serious adverse reactions in these two trials. In these two studies, 2.7%, 2%, and 5.4% of patients treated with placebo, 250 mg of Cedrilax (Carisoprodol), and 350 mg of Cedrilax (Carisoprodol), respectively, discontinued due to adverse events; 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of Cedrilax (Carisoprodol), and 350 mg of Cedrilax (Carisoprodol), respectively, discontinued due to central nervous system adverse reactions.

Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with Cedrilax (Carisoprodol) in the two trials described above.

Adverse

Reaction

Placebo

(n=560)

n (%)


Cedrilax (Carisoprodol) 250 mg

(n=548)

n (%)

Cedrilax (Carisoprodol) 350 mg

(n=279)

n (%)

Drowsiness 31 (6)

73 (13)

47 (17)
Dizziness 11 (2) 43 (8) 19 (7)
Headache 11 (2) 26 (5) 9 (3)

6.2 Postmarketing Experience

The following events have been reported during postapproval use of Cedrilax (Carisoprodol). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Tachycardia, postural hypotension, and facial flushing [see Overdosage (10) ].

Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures [see Overdosage (10) ].

Gastrointestinal: Nausea, vomiting, and epigastric discomfort.

Hematologic: Leukopenia, pancytopenia.

advertisement

7 DRUG INTERACTIONS

  • CNS depressants - additive sedative effects (5.1 and 7.1)

7.1 CNS Depressants

The sedative effects of Cedrilax (Carisoprodol) and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously. Concomitant use of Cedrilax (Carisoprodol) and meprobamate, a metabolite of Cedrilax (Carisoprodol), is not recommended [see Warnings and Precautions (5.1) ].

7.2 CYP2C19 Inhibitors and Inducers

Cedrilax (Carisoprodol) is metabolized in the liver by CYP2C19 to form meprobamate [see Clinical Pharmacology (12.3) ]. Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with Cedrilax (Carisoprodol) could result in increased exposure of Cedrilax (Carisoprodol) and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St. John's Wort, with Cedrilax (Carisoprodol) could result in decreased exposure of Cedrilax (Carisoprodol) and increased exposure of meprobamate. Low dose aspirin also showed an induction effect on CYP2C19. The full pharmacological impact of these potential alterations of exposures in terms of either efficacy or safety of Cedrilax (Carisoprodol) is unknown.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C. There are no data on the use of Cedrilax during human pregnancy. Animal studies indicate that Cedrilax (Carisoprodol) crosses the placenta and results in adverse effects on fetal growth and postnatal survival. The primary metabolite of Cedrilax (Carisoprodol), meprobamate, is an approved anxiolytic. Retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular congenital malformations.

Teratogenic effects: Animal studies have not adequately evaluated the teratogenic effects of Cedrilax (Carisoprodol). There was no increase in the incidence of congenital malformations noted in reproductive studies in rats, rabbits, and mice treated with meprobamate. Retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following first trimester exposure. Across studies that indicated an increased risk, the types of malformations were inconsistent.

Nonteratogenic effects: In animal studies, Cedrilax (Carisoprodol) reduced fetal weights, postnatal weight gain, and postnatal survival at maternal doses equivalent to 1–1.5 times the human dose (based on a body surface area comparison). Rats exposed to meprobamate in-utero showed behavioral alterations that persisted into adulthood. For children exposed to meprobamate in-utero, one study found no adverse effects on mental or motor development or IQ scores. Cedrilax (Carisoprodol) should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

8.2 Labor and Delivery

There is no information about the effects of Cedrilax (Carisoprodol) on the mother and the fetus during labor and delivery.

8.3 Nursing Mothers

Very limited data in humans show that Cedrilax is present in breast milk and may reach concentrations two to four times the maternal plasma concentrations. In one case report, a breast-fed infant received about 4–6% of the maternal daily dose through breast milk and experienced no adverse effects. However, milk production was inadequate and the baby was supplemented with formula. In lactation studies in mice, female pup survival and pup weight at weaning were decreased. This information suggests that maternal use of Cedrilax (Carisoprodol) may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when Cedrilax (Carisoprodol) is administered to a nursing woman.

8.4 Pediatric Use

The efficacy, safety, and pharmacokinetics of Cedrilax (Carisoprodol) in pediatric patients less than 16 years of age have not been established.

8.5 Geriatric Use

The efficacy, safety, and pharmacokinetics of Cedrilax in patients over 65 years old have not been established.

8.6 Renal Impairment

The safety and pharmacokinetics of Cedrilax (Carisoprodol) in patients with renal impairment have not been evaluated. Since Cedrilax (Carisoprodol) is excreted by the kidney, caution should be exercised if Cedrilax (Carisoprodol) is administered to patients with impaired renal function. Cedrilax (Carisoprodol) is dialyzable by hemodialysis and peritoneal dialysis.

8.7 Hepatic Impairment

The safety and pharmacokinetics of Cedrilax in patients with hepatic impairment have not been evaluated. Since Cedrilax (Carisoprodol) is metabolized in the liver, caution should be exercised if Cedrilax (Carisoprodol) is administered to patients with impaired hepatic function.

8.8 Patients with Reduced CYP2C19 Activity

Patients with reduced CYP2C19 activity have higher exposure to Cedrilax (Carisoprodol). Therefore, caution should be exercised in administration of Cedrilax (Carisoprodol) to these patients [see Clinical Pharmacology (12.3) ].

9 DRUG ABUSE AND DEPENDENCE

Cedrilax (Carisoprodol) is not a controlled substance [see Warnings and Precautions (5.2) ]. Discontinuation of Cedrilax (Carisoprodol) in animals or in humans after chronic administration can produce withdrawal signs, and there are published case reports of human Cedrilax (Carisoprodol) dependence.

In vitro studies demonstrate that Cedrilax (Carisoprodol) elicits barbiturate-like effects. Animal behavioral studies indicate that Cedrilax (Carisoprodol) produces rewarding effects. Monkeys self administer Cedrilax (Carisoprodol). Drug discrimination studies using rats indicate that Cedrilax (Carisoprodol) has positive reinforcing and discriminative effects similar to barbital, meprobamate, and chlordiazepoxide.

10 OVERDOSAGE

Overdosage of Cedrilax (Carisoprodol) commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures, delirium, hallucinations, dystonic reactions, nystagmus, blurred vision, mydriasis, euphoria, muscular incoordination, rigidity, and/or headache have been reported with Cedrilax (Carisoprodol) overdosage. Many of the Cedrilax (Carisoprodol) overdoses have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol). The effects of an overdose of Cedrilax (Carisoprodol) and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) can be additive even when one of the drugs has been taken in the recommended dosage. Fatal accidental and non-accidental overdoses of Cedrilax (Carisoprodol) have been reported alone or in combination with CNS depressants.

Treatment of Overdosage: Basic life support measures should be instituted as dictated by the clinical presentation of the Cedrilax (Carisoprodol) overdose. Induced emesis is not recommended due to the risk of CNS and respiratory depression, which may increase the risk of aspiration pneumonia. Gastric lavage should be considered soon after ingestion (within one hour). Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support.

The following types of treatment have been used successfully with an overdose of meprobamate, a metabolite of Cedrilax (Carisoprodol): activated charcoal (oral or via nasogastric tube), forced diuresis, peritoneal dialysis, and hemodialysis (carisoprodol is also dialyzable). Careful monitoring of urinary output is necessary and overhydration should be avoided. Observe for possible relapse due to incomplete gastric emptying and delayed absorption. For more information on the management of an overdose of Cedrilax (Carisoprodol), contact a Poison Control Center.

11 DESCRIPTION

Cedrilax (Carisoprodol) Tablets, USP are available as 350 mg round, white tablets for oral administration. Cedrilax (Carisoprodol) is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Cedrilax (Carisoprodol) is present as a racemic mixture. Chemically, Cedrilax (Carisoprodol) is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is:

Other ingredients in Cedrilax (Carisoprodol) Tablets, USP include croscarmellose sodium, hydrogenated vegetable oil, hypromellose, magnesium stearate and microcrystalline cellulose.

This in an image of the structural formula of Cedrilax (Carisoprodol).

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The mechanism of action of Cedrilax in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified.

In animal studies, muscle relaxation induced by Cedrilax (Carisoprodol) is associated with altered interneuronal activity in the spinal cord and in the descending reticular formation of the brain.

12.2 Pharmacodynamics

Cedrilax (Carisoprodol) is a centrally acting skeletal muscle relaxant that does not directly relax skeletal muscles.

A metabolite of Cedrilax (Carisoprodol), meprobamate, has anxiolytic and sedative properties. The degree to which these properties of meprobamate contribute to the safety and efficacy of Cedrilax (Carisoprodol) is unknown.

12.3 Pharmacokinetics

The pharmacokinetics of Cedrilax (Carisoprodol) and its metabolite meprobamate were studied in a crossover study of 24 healthy subjects (12 male and 12 female) who received single doses of 250 mg and 350 mg Cedrilax (Carisoprodol). The exposure of Cedrilax (Carisoprodol) and meprobamate was dose proportional between the 250 mg and 350 mg doses. The Cmax of meprobamate was 2.5 ± 0.5 μg/mL (mean ± SD) after administration of a single 350 mg dose of Cedrilax (Carisoprodol), which is approximately 30% of the Cmax of meprobamate (approximately 8 μg/mL) after administration of a single 400 mg dose of meprobamate.

250 mg

Cedrilax (Carisoprodol)

350 mg

Cedrilax (Carisoprodol)

Cedrilax (Carisoprodol)
Cmax (μg/mL)

1.2 ± 0.5

1.8 ± 1.0
AUCinf (μg*hr/mL)

4.5 ± 3.1

7.0 ± 5.0
Tmax (hr)

1.5 ± 0.8

1.7 ± 0.8
T½ (hr)

1.7 ± 0.5

2.0 ± 0.5
Meprobamate
Cmax (μg/mL)

1.8 ± 0.3

2.5 ± 0.5
AUCinf (μg*hr/mL)

32 ± 6.2

46 ± 9.0
Tmax (hr) 3.6 ± 1.7 4.5 ± 1.9
T½ (hr)

9.7 ± 1.7

9.6 ± 1.5

Absorption: Absolute bioavailability of Cedrilax (Carisoprodol) has not been determined. The mean time to peak plasma concentrations (Tmax) of Cedrilax (Carisoprodol) was approximately 1.5 to 2 hours. Co-administration of a high-fat meal with Cedrilax (Carisoprodol) (350 mg tablet) had no effect on the pharmacokinetics of Cedrilax (Carisoprodol). Therefore, Cedrilax (Carisoprodol) may be administered with or without food.

Metabolism: The major pathway of Cedrilax (Carisoprodol) metabolism is via the liver by cytochrome enzyme CYP2C19 to form meprobamate. This enzyme exhibits genetic polymorphism.

Elimination: Carisoprodol is eliminated by both renal and non-renal routes with a terminal elimination half-life of approximately 2 hours. The half-life of meprobamate is approximately 10 hours.

Gender: Exposure of Cedrilax (Carisoprodol) is higher in female than in male subjects (approximately 30–50% on a weight adjusted basis). Overall exposure of meprobamate is comparable between female and male subjects.

Patients with Reduced CYP2C19 Activity: Carisoprodol should be used with caution in patients with reduced CYP2C19 activity. Published studies indicate that patients who are poor CYP2C19 metabolizers have a 4-fold increase in exposure to Cedrilax (Carisoprodol), and concomitant 50% reduced exposure to meprobamate compared to normal CYP2C19 metabolizers. The prevalence of poor metabolizers in Caucasians and African Americans is approximately 3–5% and in Asians is approximately 15–20%.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed to evaluate the carcinogenic potential of Cedrilax (Carisoprodol).

Cedrilax (Carisoprodol) was not formally evaluated for genotoxicity. In published studies, Cedrilax (Carisoprodol) was mutagenic in the in vitro mouse lymphoma cell assay in the absence of metabolizing enzymes, but was not mutagenic in the presence of metabolizing enzymes. Cedrilax (Carisoprodol) was clastogenic in the in vitro chromosomal aberration assay using Chinese hamster ovary cells with or without the presence of metabolizing enzymes. Other types of genotoxic tests resulted in negative findings. Cedrilax (Carisoprodol) was not mutagenic in the Ames reverse mutation assay using S. typhimurium strains with or without metabolizing enzymes, and was not clastogenic in an in vivo mouse micronucleus assay of circulating blood cells.

Cedrilax (Carisoprodol) was not formally evaluated for effects on fertility. Published reproductive studies of Cedrilax (Carisoprodol) in mice found no alteration in fertility although an alteration in reproductive cycles characterized by a greater time spent in estrus was observed at a Cedrilax (Carisoprodol) dose of 1200 mg/kg/day. In a 13-week toxicology study that did not determine fertility, mouse testes weight and sperm motility were reduced at a dose of 1200 mg/kg/day. In both studies, the no effect level was 750 mg/kg/day, corresponding to approximately 2.6 times the human equivalent dosage of 350 mg four times a day, based on a body surface area comparison. The significance of these findings for human fertility is not known.

14 CLINICAL STUDIES

The safety and efficacy of Cedrilax (Carisoprodol) for the relief of acute, idiopathic mechanical low back pain was evaluated in two 7-day, double blind, randomized, multicenter, placebo controlled, U.S. trials (Studies 1 and 2). Patients had to be 18 to 65 years old and had to have acute back pain (≤ 3 days of duration) to be included in the trials. Patients with chronic back pain; at increased risk for vertebral fracture (e.g., history of osteoporosis); with a history of spinal pathology (e.g., herniated nucleus pulposis, spondylolisthesis or spinal stenosis); with inflammatory back pain, or with evidence of a neurologic deficit were excluded from participation. Concomitant use of analgesics (e.g., acetaminophen, NSAIDs, tramadol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic drugs was prohibited.

In Study 1, patients were randomized to one of three treatment groups (i.e., Cedrilax (Carisoprodol) 250 mg, Cedrilax (Carisoprodol) 350 mg, or placebo) and in Study 2 patients were randomized to two treatment groups (i.e., Cedrilax (Carisoprodol) 250 mg or placebo). In both studies, patients received study medication three times a day and at bedtime for seven days.

The primary endpoints were the relief from starting backache and the global impression of change, as reported by patients, on Study Day 3. Both endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome) in both studies. The primary statistical comparison was between the Cedrilax (Carisoprodol) 250 mg and placebo groups in both studies.

The proportion of patients who used concomitant acetaminophen, NSAIDs, tramadol, opioid agonists, other muscle relaxants, and benzodiazepines was similar in the treatment groups.

The results for the primary efficacy evaluations in the acute, low back pain studies are presented in Table 3.


Number of Patients


n=278

n=269

Relief from Starting Backache, Mean (SE)b


1.1 (0.1)


1.8 (0.1)


2


Difference between Cedrilax (Carisoprodol) and Placebo, Mean (SE)b (95% CI)


0.7 (0.5, 0.9)


Global Impression of Change, Mean (SE)b


1.7 (0.1)


2.2 (0.1)

Difference between Cedrilax (Carisoprodol) and Placebo, Mean (SE)b (95% CI) 0.5 (0.4, 0.7)
Study Parameter Placebo

Cedrilax (Carisoprodol) 250 mg

Cedrilax (Carisoprodol)

350 mg

Number of Patients n=269

n=264

n=273
Relief from Starting Backache, Mean (SE)b 1.4 (0.1)

1.8 (0.1)

1.8 (0.1)
1 Difference between Cedrilax (Carisoprodol) and Placebo, Mean (SE)b (95% CI)

0.4 (0.2, 0.5)

0.4 (0.2, 0.6)
Global Impression of Change, Mean (SE)b 1.9 (0.1) 2.2 (0.1) 2.2 (0.1)
Difference between Cedrilax (Carisoprodol) and Placebo, Mean (SE)b (95% CI)

0.2 (0.1, 0.4)

0.3 (0.1, 0.4)

aThe primary efficacy endpoints (Relief from Starting Backache and Global Impression of Change) were assessed by the patients on Study Day 3. These endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome).

b Mean is the least squared mean and SE is the standard error of the mean. The ANOVA model was used for the primary statistical comparison between the Cedrilax (Carisoprodol) 250 mg and placebo groups.

Patients treated with Cedrilax (Carisoprodol) experienced improvement in function as measured by the Roland-Morris Disability Questionnaire (RMDQ) score on Days 3 and 7.

16 HOW SUPPLIED/STORAGE AND HANDLING

350 mg Tablets: white, round, unscored tablets debossed "2410 V" on one side and plain on the reverse side

49999-064-01

Storage:

Store at 20°-25°C (68°-77°F).

17 PATIENT COUNSELING INFORMATION

Patients should be advised to contact their physician if they experience any adverse reactions to Cedrilax tablets.

17.1 Sedation

Patients should be advised that Cedrilax (Carisoprodol) tablets may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking Cedrilax (Carisoprodol) before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery [see Warnings and Precautions (5.1) ].

17.2 Avoidance of Alcohol and Other CNS Depressants

Patients should be advised to avoid alcoholic beverages while taking Cedrilax tablets and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives [see Warnings and Precautions (5.1) ].

17.3 Cedrilax (Carisoprodol) Tablets Should Only Be Used for Short-Term Treatment

Patients should be advised that treatment with Cedrilax (Carisoprodol) tablets should be limited to acute use (up to two or three weeks) for the relief of acute, musculoskeletal discomfort. In the post-marketing experience with Cedrilax (Carisoprodol) tablets, cases of dependence, withdrawal, and abuse have been reported with prolonged use. If the musculoskeletal symptoms still persist, patients should contact their healthcare provider for further evaluation.

To report SUSPECTED ADVERSE REACTIONS, contact Qualitest Pharmaceuticals at 1-800-444-4011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for:

QUALITEST PHARMACEUTICALS

Huntsville, AL 35811

8181281

Revised: 10/2010

R5

image of label

Diclofenac Sodium:


Pharmacological action

NSAIDs, a derivative of phenylacetic acid, Cedrilax 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, Cedrilax (Diclofenac Sodium) 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 Cedrilax (Diclofenac Sodium).

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.

Why is Cedrilax 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.

Cedrilax (Diclofenac Sodium) 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 Cedrilax (Diclofenac Sodium).

Contraindications

known hypersensitivity to Cedrilax sodium or to any accessory ingredient that is part of the drug Cedrilax (Diclofenac Sodium);

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 Cedrilax 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 Cedrilax (Diclofenac Sodium) 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.

Cedrilax (Diclofenac Sodium) drug interactions

At simultaneous application with Cedrilax (Diclofenac Sodium) 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 Cedrilax (Diclofenac Sodium) together with hypoglycemic drugs.

When applied simultaneously with acetylsalicylic acid may decrease the concentration of Cedrilax (Diclofenac Sodium) in plasma.

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

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

The absorption of Cedrilax (Diclofenac Sodium) 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 Cedrilax (Diclofenac Sodium) could not affect the bioavailability of morphine, but the concentration of the active metabolite of morphine may be enhanced in the presence of Cedrilax (Diclofenac Sodium), 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 Cedrilax (Diclofenac Sodium) in plasma, with ceftriaxone - increases excretion of ceftriaxone in bile; with cyclosporine - may increase cyclosporine nephrotoxicity.

Cedrilax 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 Cedrilax (Diclofenac Sodium) tablets: 3 years.

Cedrilax 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.


Cedrilax 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.


Cedrilax 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.


Cedrilax 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.


Cedrilax 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.


advertisement

References

  1. Dailymed."DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."VIVARIN (CAFFEINE) TABLET [MEDA CONSUMER HEALTHCARE 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 Cedrilax?

Depending on the reaction of the Cedrilax after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Cedrilax 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 Cedrilax 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.

advertisement

Review

sDrugs.com conducted a study on Cedrilax, 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 Cedrilax 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.

Visitor reports

Visitor reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 17 here

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

© 2002 - 2020 "sDrugs.com". All Rights Reserved