Re: A warm Welcome-Dawn

[Guest guest]

I have not taken it, however my husband did afer a fall on the ice. He only

took it for about 4 days because it made him very out of it. He said he felt

like he was in a twilight zone. Gwen

drowsiness and confusion?

[Guest guest]

Flexeril makes me sleepy - it takes a couple hours to kick in, then for me it

works for about 12 hours. I can't say it does much for muscle relaxation,

except to help me sleep through the spasms.

I had no confusion with it, more of a sleep hangover type feeling. I don't take

it anymore, take Skelaxin instead, does not make me sleepy, creates more of a

" numb " feeling in my muscles.

Jami in OR

windfire130@... wrote:

>

> I am curious if anyone has taken Flexeril?

[Guest guest]

HI Dawn,

I am glad you feel more comfortable posting here

I am some what familiar with Flexeril generically called

cylcobenzaprine . Many years ago I took it for a sprained ankle. I

had a very bad reaction to it but others have not. I know of some

people who also hike, climb or are involved in even more outdoor

activities, most of them have used it and said all it did was make

them sleepy

It's related to older tricycle antidepressants there are some risk

with them I do not know if I can post a link of not I will copy and

paste some of the info for you

I hope this helps sorry for all the heavy-duty stuff.

I also have a interaction Checking thingy on my PC so if any one

needs to know if any drugs you take might interact with something

new feel free to send me a private Email

Best wishes to all for a good day

Rick

INDICATIONS AND USAGE

FLEXERIL is indicated as an adjunct to rest and physical therapy for

relief of muscle spasm associated with acute, painful musculoskeletal

conditions.

Improvement is manifested by relief of muscle spasm and its

associated signs and symptoms, namely, pain, tenderness, limitation

of motion, and restriction in activities of daily living.

FLEXERIL should be used only for short periods (up to two or three

weeks) because adequate evidence of effectiveness for more prolonged

use is not available and because muscle spasm associated with acute,

painful musculoskeletal conditions is generally of short duration and

specific therapy for longer periods is seldom warranted.

FLEXERIL has not been found effective in the treatment of spasticity

associated with cerebral or spinal cord disease, or in children with

cerebral palsy.

DOSAGE AND ADMINISTRATION

For most patients, the recommended dose of FLEXERIL is 5 mg three

times a day. Based on individual patient response, the dose may be

increased to 10 mg three times a day. Use of FLEXERIL for periods

longer than two or three weeks is not recommended. (see INDICATIONS

AND USAGE).

Less frequent dosing should be considered for hepatically impaired or

elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use

in the Elderly).

HOW SUPPLIED

FLEXERIL tablets are available in 5 mg and 10 mg dosage strengths.

The 5 mg tablets are yellow-orange, 5-sided D-shaped, film coated

tablets, coded FLEXERIL on one side and without coding on the other.

The 10 mg tablets are butterscotch yellow, 5-sided D-shaped, film

coated tablets, coded MSD 931 on one side and FLEXERIL on the other.

The two dosage strengths are supplied as follows:

5 mg 100 count bottle NDC 50580-280-10

10 mg 100 count bottle NDC 50580-874-11 STORAGE

Store at 25 & #61616;C (77 & #61616;F); excursions permitted to 15-30 & #61616;C

(59-86 & #61616;F). [see

USP Controlled Room Temperature].

For more information call 1- or visit www.flexeril.info

Manufactured by Merck & Co. Inc., West Point, PA 19486, USA.

Distributed and Marketed by McNeil Consumer & Specialty

Pharmaceuticals Fort Washington, PA 19034, Edition: February 2003,

7629220, FLEXERIL is a registered trademark of ALZA Corporation

Copyright ©ALZA Corporation, 2001 All rights reserved.

Incidence of most common adverse reactions in the 2 double-blind‡,

placebo-controlled 5 mg studies (incidence of > 3% on FLEXERIL 5 mg):

FLEXERIL 5 mg N=464 FLEXERIL 10 mg N=249 Placebo N=469

Drowsiness 29% 38% 10%

Dry Mouth 21% 32% 7%

Fatigue 6% 6% 3%

Headache 5% 5% 8%

Adverse reactions which were reported in 1% to 3% of the patients

were: abdominal pain, acid regurgitation, constipation, diarrhea,

dizziness, nausea, irritability, mental acuity decreased,

nervousness, upper respiratory infection, and pharyngitis.

The following list of adverse reactions is based on the experience in

473 patients treated with FLEXERIL 10 mg in additional controlled

clinical studies, 7607 patients in the post-marketing surveillance

program, and reports received since the drug was marketed. The

overall incidence of adverse reactions among patients in the

surveillance program was less than the incidence in the controlled

clinical studies.

The adverse reactions reported most frequently with FLEXERIL were

drowsiness, dry mouth and dizziness. The incidence of these common

adverse reactions was lower in the surveillance program than in the

controlled clinical studies:

‡ Note: FLEXERIL 10 mg data are from one clinical trial. FLEXERIL 5

mg and placebo data are from two studies.

Clinical Studies With FLEXERIL 10 mg Surveillance Program

With FLEXERIL 10 mg

Drowsiness 39% 16%

Dry Mouth 27% 7%

Dizziness 11% 3%

Among the less frequent adverse reactions, there was no appreciable

difference in incidence in controlled clinical studies or in the

surveillance program. Adverse reactions which were reported in 1% to

3% of the patients were: fatigue/tiredness, asthenia, nausea,

constipation, dyspepsia, unpleasant taste, blurred vision, headache,

nervousness, and confusion.

The following adverse reactions have been reported in post-marketing

experience or with an incidence of less than 1% of patients in

clinical trials with the 10 mg tablet:

Body as a Whole: Syncope; malaise.

Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation;

hypotension.

Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain;

gastritis; thirst; flatulence; edema of the tongue; abnormal liver

function and rare reports of hepatitis, jaundice and cholestasis.

Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema;

urticaria; rash.

Musculoskeletal: Local weakness.

Nervous System and Psychiatric: Seizures, ataxia; vertigo;

dysarthria; tremors; hypertonia; convulsions; muscle twitching;

disorientation; insomnia; depressedmood; abnormal sensations;

anxiety; agitation; psychosis, abnormal thinking and dreaming;

hallucinations; excitement; paresthesia; diplopia.

Skin: Sweating.

Special Senses: Ageusia; tinnitus.

Urogenital: Urinary frequency and/or retention.

Causal Relationship Unknown

Other reactions, reported rarely for FLEXERIL under circumstances

where a causal relationship could not be established or reported for

other tricyclic drugs, are listed to serve as alerting information to

physicians:

Body as a whole: Chest pain; edema.

Cardiovascular: Hypertension; myocardial infarction; heart block;

stroke.

Digestive: Paralytic ileus, tongue discoloration; stomatitis; parotid

swelling.

Endocrine: Inappropriate ADH syndrome.

Hematic and Lymphatic: Purpura; bone marrow depression; leukopenia;

eosinophilia; thrombocytopenia.

Metabolic, Nutritional and Immune: Elevation and lowering of blood

sugar levels; weight gain or loss.

Musculoskeletal: Myalgia.

Nervous System and Psychiatric: Decreased or increased libido;

abnormal gait; delusions; aggressive behavior; paranoia; peripheral

neuropathy; Bell's palsy; alteration in EEG patterns; extrapyramidal

symptoms.

Respiratory: Dyspnea.

Skin: Photosensitization; alopecia.

Urogenital: Impaired urination; dilatation of urinary tract;

impotence; testicular swelling; gynecomastia; breast enlargement;

galactorrhea.

DRUG ABUSE AND DEPENDENCE

Pharmacologic similarities among the tricyclic drugs require that

certain withdrawal symptoms be considered when FLEXERIL is

administered, even though they have not been reported to occur with

this drug. Abrupt cessation of treatment after prolonged

administration rarely may produce nausea, headache, and malaise.

These are not indicative of addiction.

DRUG INTERACTIONS

FLEXERIL may have life-threatening interactions with MAO inhibitors.

(See CONTRAINDICATIONS.)

FLEXERIL may enhance the effects of alcohol, barbiturates, and other

CNS depressants.

Tricyclic antidepressants may block the antihypertensive action of

guanethidine and similarly acting compounds.

Tricyclic antidepressants may enhance the seizure risk in patients

taking tramadol.

Cyclobenzaprine is closely related to the tricyclic antidepressants,

e.g., amitriptyline and imipramine. In short term studies for

indications other than muscle spasm associated with acute

musculoskeletal conditions, and usually at doses somewhat greater

than those recommended for skeletal muscle spasm, some of the more

serious central nervous system reactions noted with the tricyclic

antidepressants have occurred (see WARNINGS, below, and ADVERSE

REACTIONS).

Tricyclic antidepressants have been reported to produce arrhythmias,

sinus tachycardia, prolongation of the conduction time leading to

myocardial infarction and stroke. FLEXERIL may enhance the effects of

alcohol, barbiturates, and other CNS depressants.

PRECAUTIONS

General

Because of its atropine-like action, FLEXERIL should be used with

caution in patients with a history of urinary retention, angle-

closure glaucoma, increased intraocular pressure, and in patients

taking anticholinergic medication.

Impaired Hepatic Function

The plasma concentration of cyclobenzaprine is increased in patients

with hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics,

Hepatic Impairment). These patients are generally more susceptible to

drugs with potentially sedating effects, including cyclobenzaprine.

FLEXERIL should be used with caution in subjects with mild hepatic

impairment starting with a 5 mg dose and titrating slowly upward. Due

to the lack of data in subjects with more severe hepatic

insufficiency, the use of FLEXERIL in subjects with moderate to

severe impairment is not recommended.

Information for Patients

FLEXERIL, especially when used with alcohol or other CNS depressants,

may impair mental and/or physical abilities required for performance

of hazardous tasks, such as operating machinery or driving a motor

vehicle. In the elderly, the frequency and severity of adverse events

associated with the use of cyclobenzaprine, with or without

concomitant medications, is increased. In elderly patients, FLEXERIL

should be initiated with a 5 mg dose and titrated slowly upward.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In rats treated with FLEXERIL for up to 67 weeks at doses of

approximately 5 to 40 times the maximum recommended human dose, pale,

sometimes enlarged, livers were noted and there was a dose-related

hepatocyte vacuolation with lipidosis. In the higher dose groups this

microscopic change was seen after 26 weeks and even earlier in rats

which died prior to 26 weeks; at lower doses, the change was not seen

until after 26 weeks.

Cyclobenzaprine did not affect the onset, incidence or distribution

of neoplasia in an 81-week study in the mouse or in a 105-week study

in the rat.

At oral doses of up to 10 times the human dose, cyclobenzaprine did

not adversely affect the reproductive performance or fertility of

male or female rats. Cyclobenzaprine did not demonstrate mutagenic

activity in the male mouse at dose levels of up to 20 times the human

dose.

Pregnancy

Pregnancy Category B

Reproduction studies have been performed in rats, mice and rabbits at

doses up to 20 times the human dose, and have revealed no evidence of

impaired fertility or harm to the fetus due to FLEXERIL. There are,

however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of

human response, this drug should be used during pregnancy only if

clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because

cyclobenzaprine is closely related to the tricyclic antidepressants,

some of which are known to be excreted in human milk, caution should

be exercised when FLEXERIL is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of FLEXERIL in pediatric patients below 15

years of age have not been established.

Use in the Elderly

The plasma concentration of cyclobenzaprine is increased in the

elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly). The

elderly may also be more at risk for CNS adverse events such as

hallucinations and confusion, cardiac events resulting in falls or

other sequelae, drug-drug and drug-disease interactions. For these

reasons, in the elderly, cyclobenzaprine should be used only if

clearly needed. In such patients FLEXERIL should be initiated with a

5 mg dose and titrated slowly upward.

REFERENCE

†ULTRAM® (tramadol HCl tablets, Ortho-McNeil Pharmaceutical)

ULTRACET® (tramadol HCl and acetaminophen tablets, Ortho-McNeil

Pharmaceutical)

OVERDOSE

Although rare, deaths may occur from overdosage with FLEXERIL.

Multiple drug ingestion (including alcohol) is common in deliberate

cyclobenzaprine overdose. As management of overdose is complex and

changing, it is recommended that the physician contact a poison

control center for current information on treatment. Signs and

symptoms of toxicity may develop rapidly after cyclobenzaprine

overdose; therefore, hospital monitoring is required as soon as

possible. The acute oral LD50 of FLEXERIL is approximately 338 and

425 mg/kg in mice and rats, respectively.

MANIFESTATIONS

The most common effects associated with cyclobenzaprine overdose are

drowsiness and tachycardia. Less frequent manifestations include

tremor, agitation, coma, ataxia, hypertension, slurred speech,

confusion, dizziness, nausea, vomiting, and hallucinations. Rare but

potentially critical manifestations of overdose are cardiac arrest,

chest pain, cardiac dysrhythmias, severe hypotension, seizures, and

neuroleptic malignant syndrome. Changes in the electrocardiogram,

particularly in QRS axis or width, are clinically significant

indicators of cyclobenzaprine toxicity.

Other potential effects of overdosage include any of the symptoms

listed under ADVERSE REACTIONS.

MANAGEMENT

General

As management of overdose is complex and changing, it is recommended

that the physician contact a poison control center for current

information on treatment.

In order to protect against the rare but potentially critical

manifestations described above, obtain an ECG and immediately

initiate cardiac monitoring. Protect the patient's airway, establish

an intravenous line and initiate gastric decontamination. Observation

with cardiac monitoring and observation for signs of CNS or

respiratory depression, hypotension, cardiac dysrhythmias and/or

conduction blocks, and seizures is necessary. If signs of toxicity

occur at any time during this period, extended monitoring is

required. Monitoring of plasma drug levels should not guide

management of the patient. Dialysis is probably of no value because

of low plasma concentrations of the drug.

Gastrointestinal Decontamination

All patients suspected of an overdose with FLEXERIL should receive

gastrointestinal decontamination. This should include large volume

gastric lavage followed by activated charcoal. If consciousness is

impaired, the airway should be secured prior to lavage and emesis is

contraindicated.

Cardiovascular

A maximal limb-lead QRS duration of & #61619;0.10 seconds may be the best

indication of the severity of the overdose. Serum alkalinization, to

a pH of 7.45 to 7.55, using intravenous sodium bicarbonate and

hyperventilation (as needed), should be instituted for patients with

dysrhythmias and/or QRS widening. A pH >7.60 or a pCO2 <20 mmHg is

undesirable. Dysrhythmias unresponsive to sodium bicarbonate

therapy/hyperventilation may respond to lidocaine, bretylium or

phenytoin. Type 1A and 1C antiarrhythmics are generally

contraindicated (e.g., quinidine, disopyramide, and procainamide).

CNS

In patients with CNS depression, early intubation is advised because

of the potential for abrupt deterioration. Seizures should be

controlled with benzodiazepines or, if these are ineffective, other

anticonvulsants (e.g. phenobarbital, phenytoin). Physostigmine is not

recommended except to treat life-threatening symptoms that have been

unresponsive to other therapies, and then only in close consultation

with a poison control center.

PSYCHIATRIC FOLLOW-UP

Since overdosage is often deliberate, patients may attempt suicide by

other means during the recovery phase. Psychiatric referral may be

appropriate.

PEDIATRIC MANAGEMENT

The principles of management of child and adult overdosages are

similar. It is strongly recommended that the physician contact the

local poison control center for specific pediatric treatment.

CONTRAINDICATIONS

Hypersensitivity to any component of this product.

Concomitant use of monoamine oxidase (MAO) inhibitors or within 14

days after their discontinuation. Hyperpyretic crisis seizures, and

deaths have occurred in patients receiving cyclobenzaprine (or

structurally similar tricyclic antidepressants) concomitantly with

MAO inhibitor drugs.

Acute recovery phase of myocardial infarction, and patients with

arrhythmias, heart block or conduction disturbances, or congestive

heart failure.

Hyperthyroidism.

>

> Hello Everyone,

>

> I wanted to thank you all for such a warm and generous welcome to

your group!

> >

> I am curious if anyone has taken Flexeril?

[Guest guest]

Hello Dawn,

Flexeril knocks me out for days. I can take one and the next two day I still

feel drugged. But I am really sensitive to pills in general. Maybe you could

start off with 1/2? Just a thought.

Also, it puts me in a pretty bad mood but that might just be from the

grogginess.

Good luck and sorry about your fall.

Caitlin

windfire130@... wrote:

I am curious if anyone has taken Flexeril?

---------------------------------

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