Solox

Solox may be available in the countries listed below.

Ingredient matches for Solox

Lansoprazole

Lansoprazole is reported as an ingredient of Solox in the following countries:

• New Zealand

International Drug Name Search

Panadol Plus

Panadol Plus may be available in the countries listed below.

Ingredient matches for Panadol Plus

Caffeine

Caffeine is reported as an ingredient of Panadol Plus in the following countries:

• Belgium

Paracetamol

Paracetamol is reported as an ingredient of Panadol Plus in the following countries:

• Belgium


• Netherlands

International Drug Name Search

Ditropan

Generic Name: oxybutynin (Oral route)

ox-i-bu-BUE-ti-nin KLOR-ide

Commonly used brand name(s)

In the U.S.

• Ditropan


• Ditropan XL

Available Dosage Forms:

• Tablet, Extended Release


• Tablet


• Syrup

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Oxybutynin

Uses For Ditropan

Oxybutynin is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control) or a frequent need to urinate.

Oxybutynin belongs to the group of medicines called antispasmodics. It helps decrease muscle spasms of the bladder and the frequent urge to urinate caused by these spasms.

Oxybutynin extended-release tablets is also used to treat children 6 years of age and older who have an overactive bladder caused by a certain nerve disorder (e.g., spina bifida).

This medicine is available only with your doctor's prescription.

Before Using Ditropan

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of oxybutyninextended-release tablet in children 6 years of age and older. However, oxybutynin extended-release tablet is not recommended in children who cannot swallow it whole without breaking, chewing, or crushing; or in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxybutynin in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Potassium

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Donepezil


• Galantamine


• Ketoconazole


• Rivastigmine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding, severe or


• Overactive thyroid—Oxybutynin may increase heart rate, which may make these conditions worse.

• Dementia (mental problem) or


• Dryness of the mouth (severe and continuing) or


• Enlarged prostate or


• Glaucoma or


• Heart disease or


• Hiatal hernia or


• Hypertension (high blood pressure) or


• Intestinal or stomach problems (e.g., blockage, constipation, intestinal atony, ulcerative colitis, or gastroesophageal reflux disease [GERD]) or


• Myasthenia gravis (severe muscle weakness) or


• Toxemia of pregnancy or


• Urinary problems (e.g., blockage)—Use with caution. May make these conditions worse.

• Kidney disease or


• Liver disease—Higher blood levels of oxybutynin may occur, which increases the chance of side effects.

• Narrow-angle glaucoma, uncontrolled or


• Stomach problems (e.g., gastric retention) or


• Urinary retention (hard to pass urine)—Should not be used in patients with these conditions.

Proper Use of oxybutynin

This section provides information on the proper use of a number of products that contain oxybutynin. It may not be specific to Ditropan. Please read with care.

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine is usually taken with water on an empty stomach. However, your doctor may want you to take it with food or milk to lessen stomach upset.

For patients taking the extended-release tablets:

• Swallow the tablet whole with water or any liquids. Do not break, crush, or chew it.


• You may take this medicine with or without food.


• Take it at the same time each day.


• While taking this medicine, part of the tablet may pass into your stools. This is normal and is nothing to worry about.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of bladder problems:
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 5 or 10 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 30 mg per day.
    
    
    • Children 6 years of age and older—At first, 5 mg once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 20 mg per day.
    
    
    • Children younger than 6 years of age—Use is not recommended.
    
    
  
  
  • For oral dosage forms (syrup or tablets):
    
    • Adults, teenagers, and children 12 years of age and older—5 milligrams (mg) two or three times a day.
    
    
    • Children 5 to 12 years of age—5 mg two or three times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 15 mg per day.
    
    
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Ditropan

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.

This medicine may cause a serious type of allergic reaction called angioedema. Angioedema may be life-threatening and requires immediate medical attention. Stop using this medicine and seek medical attention right away if you or your child have a rash; itching; a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; trouble with breathing; or chest tightness while you are using this medicine.

Oxybutynin may cause anxiety, confusion, irritability, sleepiness or unusual drowsiness, or hallucinations (seeing, hearing, or feeling things that are not there). These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. If you or your child have these symptoms, stop using this medicine and tell your doctor right away.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you or your child are using this medicine.

This medicine may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.

This medicine may cause some people to become dizzy, drowsy, or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy, not alert, or not able to see well.

Oxybutynin may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you or your child are taking this medicine, since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you or your child are taking this medicine.

Your mouth, nose, and throat may feel very dry while you or your child are taking this medicine. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Ditropan Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Eye pain


• skin rash or hives

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Clumsiness or unsteadiness


• confusion


• convulsions


• dizziness


• drowsiness (severe)


• fainting


• fast, slow, or irregular heartbeat


• fever


• flushing or redness of the face


• hallucinations (seeing, hearing, or feeling things that are not there)


• shortness of breath or troubled breathing


• unusual excitement, nervousness, restlessness, or irritability

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach


• belching


• decreased sweating


• diarrhea


• difficulty having a bowel movement (stool)


• drowsiness


• dryness of the eyes, mouth, nose, or throat


• heartburn


• indigestion


• runny nose


• stomach discomfort, upset, or pain

Less common or rare

• Blurred vision


• decreased flow of breast milk


• decreased sexual ability


• difficulty in swallowing


• feeling of warmth or heat


• headache


• increased sensitivity of the eyes to light


• nausea or vomiting


• trouble with sleeping


• unusual tiredness or weakness

Incidence not known - Observed during clinical practice with oxybutynin; estimates of frequency cannot be determined

• Bloating or swelling of the face, arms, hands, lower legs, or feet


• decreased interest in sexual intercourse


• inability to have or keep an erection


• loss in sexual ability, desire, drive, or performance


• rapid weight gain


• tingling of the hands or feet


• unusual weight gain or loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Ditropan side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Ditropan resources

• Ditropan Side Effects (in more detail)
• Ditropan Use in Pregnancy & Breastfeeding
• Drug Images
• Ditropan Drug Interactions
• Ditropan Support Group
• 9 Reviews for Ditropan - Add your own review/rating

• Ditropan MedFacts Consumer Leaflet (Wolters Kluwer)


• Ditropan Prescribing Information (FDA)


• Ditropan Consumer Overview


• Oxybutynin Prescribing Information (FDA)


• Anturol Consumer Overview


• Ditropan XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ditropan XL Prescribing Information (FDA)


• Gelnique Prescribing Information (FDA)


• Gelnique Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Gelnique Consumer Overview


• Oxybutynin Chloride Monograph (AHFS DI)


• Oxytrol Prescribing Information (FDA)


• Oxytrol Consumer Overview


• Oxytrol System MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Ditropan with other medications

• Dysuria
• Overactive Bladder
• Urinary Incontinence

Dantrolene

Dosage Form: Capsules

Rx only

Dantrolene sodium has a potential for hepatotoxicity, and should not be used in conditions other than those recommended. Symptomatic hepatitis (fatal and non-fatal) has been reported at various dose levels of the drug. The incidence reported in patients taking up to 400 mg/day is much lower than in those taking doses of 800 mg or more per day. Even sporadic short courses of these higher dose levels within a treatment regimen markedly increased the risk of serious hepatic injury. Liver dysfunction as evidenced by blood chemical abnormalities alone (liver enzyme elevations) has been observed in patients exposed to Dantrolene sodium for varying periods of time. Overt hepatitis has occurred at varying intervals after initiation of therapy, but has been most frequently observed between the third and twelfth month of therapy. The risk of hepatic injury appears to be greater in females, in patients over 35 years of age, and in patients taking other medication(s) in addition to Dantrolene sodium.

Dantrolene sodium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of Dantrolene sodium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.

Dantrolene Description

The chemical formula of Dantrolene sodium is hydrated 1-[[[5-(4- nitrophenyl)-2-furanyl]methylene]amino]-2, 4-imidazolidinedione sodium salt. It is an orange powder, slightly soluble in water, but due to its slightly acidic nature the solubility increases somewhat in alkaline solution. The anhydrous salt has a molecular weight of 336. The hydrated salt contains approximately 15% water (3-1/2 moles) and has a molecular weight of 399. The structural formula for the hydrated salt is:

Dantrolene sodium is supplied in capsules of 25 mg, 50 mg, and 100 mg.

Inactive Ingredients

Each capsule contains croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, pharmaceutical ink, pregelatinized starch, titanium dioxide, and yellow iron oxide. In addition, the 25 mg capsule contains D&C Yellow #10 and FD&C Green #3, the 50 mg capsule contains FD&C Blue #1, and the 100 mg capsule contains FD&C Red #40 and FD&C Yellow #6.

Dantrolene - Clinical Pharmacology

In isolated nerve-muscle preparation, Dantrolene sodium has been shown to produce relaxation by affecting the contractile response of the skeletal muscle at a site beyond the myoneural junction, directly on the muscle itself. In skeletal muscle, Dantrolene sodium dissociates the excitation-contraction coupling, probably by interfering with the release of Ca++ from the sarcoplasmic reticulum. This effect appears to be more pronounced in fast muscle fibers as compared to slow ones, but generally affects both. A central nervous system effect occurs, with drowsiness, dizziness, and generalized weakness occasionally present. Although Dantrolene sodium does not appear to directly affect the CNS, the extent of its indirect effect is unknown. The absorption of Dantrolene sodium after oral administration in humans is incomplete and slow but consistent, and dose-related blood levels are obtained. The duration and intensity of skeletal muscle relaxation is related to the dosage and blood levels. The mean biologic half-life of Dantrolene sodium in adults is 8.7 hours after a 100-mg dose. Specific metabolic pathways in the degradation and elimination of Dantrolene sodium in human subjects have been established. Metabolic patterns are similar in adults and pediatric patients. In addition to the parent compound, Dantrolene, which is found in measurable amounts in blood and urine, the major metabolites noted in body fluids are the 5-hydroxy analog and the acetamido analog. Since Dantrolene sodium is probably metabolized by hepatic microsomal enzymes, enhancement of its metabolism by other drugs is possible. However, neither phenobarbital nor diazepam appears to affect Dantrolene sodium metabolism.

Clinical experience in the management of fulminant human malignant hyperthermia, as well as experiments conducted in malignant hyperthermia susceptible swine, have revealed that the administration of intravenous Dantrolene, combined with indicated supportive measures, is effective in reversing the hypermetabolic process of malignant hyperthermia. Known differences between human and swine malignant hyperthermia are minor. The prophylactic administration of oral or intravenous Dantrolene to malignant hyperthermia susceptible swine will attenuate or prevent the development of signs of malignant hyperthermia in a manner dependent upon the dosage of Dantrolene administered and the intensity of the malignant hyperthermia triggering stimulus. Limited clinical experience with the administration of oral Dantrolene to patients judged malignant hyperthermia susceptible, when combined with clinical experience in the use of intravenous Dantrolene for the treatment of malignant hyperthermia and data derived from the above cited animal model experiments, suggests that oral Dantrolene will also attenuate or prevent the development of signs of human malignant hyperthermia, provided that currently accepted practices in the management of such patients are adhered to (see INDICATIONS AND USAGE); intravenous Dantrolene should also be available for use should the signs of malignant hyperthermia appear.

Indications and Usage for Dantrolene

In Chronic Spasticity

Dantrolene sodium capsules are indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrolene sodium capsules are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

If improvement occurs, it will ordinarily occur within the dosage titration (see DOSAGE AND ADMINISTRATION), and will be manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without Dantrolene sodium capsules.

Occasionally, subtle but meaningful improvement in spasticity may occur with Dantrolene sodium capsule therapy. In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him. Brief withdrawal of Dantrolene sodium capsules for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression.

A decision to continue the administration of Dantrolene sodium capsules on a long-term basis is justified if introduction of the drug into the patient's regimen:

  

produces a significant reduction in painful and/or disabling spasticity such as clonus, or

  

permits a significant reduction in the intensity and/or degree of nursing care required, or

  

rids the patient of any annoying manifestation of spasticity considered important by the patient himself.

In Malignant Hyperthermia

Oral Dantrolene sodium capsules are also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery. Currently accepted clinical practices in the management of such patients must still be adhered to (careful monitoring for early signs of malignant hyperthermia, minimizing exposure to triggering mechanisms and prompt use of intravenous Dantrolene sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for intravenous Dantrolene sodium.

Oral Dantrolene sodium capsules should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.

Contraindications

Active hepatic disease, such as hepatitis and cirrhosis, is a contraindication for use of Dantrolene sodium capsules. Dantrolene sodium capsules are contraindicated where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain or maintain increased function.

Warnings

It is important to recognize that fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with Dantrolene sodium therapy.

At the start of Dantrolene sodium therapy, it is desirable to do liver function studies (SGOT, SGPT, alkaline phosphatase, total bilirubin) for a baseline or to establish whether there is pre-existing liver disease. If baseline liver abnormalities exist and are confirmed, there is a clear possibility that the potential for Dantrolene sodium hepatotoxicity could be enhanced, although such a possibility has not yet been established.

Liver function studies (e.g., SGOT or SGPT) should be performed at appropriate intervals during Dantrolene sodium therapy. If such studies reveal abnormal values, therapy should generally be discontinued. Only where benefits of the drug have been of major importance to the patient, should reinitiation or continuation of therapy be considered. Some patients have revealed a return to normal laboratory values in the face of continued therapy while others have not.

If symptoms compatible with hepatitis, accompanied by abnormalities in liver function tests or jaundice appear, Dantrolene sodium should be discontinued. If caused by Dantrolene sodium and detected early, the abnormalities in liver function characteristically have reverted to normal when the drug was discontinued. Dantrolene sodium therapy has been reinstituted in a few patients who have developed clinical and/or laboratory evidence of hepatocellular injury. If such reinstitution of therapy is done, it should be attempted only in patients who clearly need Dantrolene sodium and only after previous symptoms and laboratory abnormalities have cleared. The patient should be hospitalized and the drug should be restarted in very small and gradually increasing doses. Laboratory monitoring should be frequent and the drug should be withdrawn immediately if there is any indication of recurrent liver involvement. Some patients have reacted with unmistakable signs of liver abnormality upon administration of a challenge dose, while others have not.

Dantrolene sodium should be used with particular caution in females and in patients over 35 years of age in view of apparent greater likelihood of drug-induced, potentially fatal, hepatocellular disease in these groups.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term safety of Dantrolene sodium in humans has not been established. Chronic studies in rats, dogs, and monkeys at dosages greater than 30 mg/kg/day showed growth or weight depression and signs of hepatopathy and possible occlusion nephropathy, all of which were reversible upon cessation of treatment. Sprague-Dawley female rats fed Dantrolene sodium for 18 months at dosage levels of 15, 30, and 60 mg/kg/day showed an increased incidence of benign and malignant mammary tumors compared with concurrent controls, and at the highest dosage, an increase in the incidence of hepatic lymphangiomas and hepatic angiosarcomas. These effects were not seen in 2½ year studies in Sprague-Dawley or Fischer 344 rats or in 2 year studies in mice of the HaM/ICR strain. Carcinogenicity in humans cannot be fully excluded, so that this possible risk of chronic administration must be weighed against the benefits of the drug (i.e. after a brief trial) for the individual patient.

Pregnancy

Pregnancy Category C: The safety of Dantrolene sodium in women who are or may become pregnant has not been established; hence it should be given only when the potential benefits have been weighed against possible hazard to mother and child. Dantrolene sodium should not be used in nursing mothers.

Usage in Pediatric Patients

The long-term safety of Dantrolene sodium in pediatric patients under the age of 5 years has not been established. Because of the possibility that adverse effects of the drug could become apparent only after many years, a benefit-risk consideration of the long-term use of Dantrolene sodium is particularly important in pediatric patients.

Drug Interactions

While a definite drug interaction with estrogen therapy has not yet been established, caution should be observed if the two drugs are to be given concomitantly. Hepatotoxicity has occurred more often in women over 35 years of age receiving concomitant estrogen therapy.

Precautions

Dantrolene sodium should be used with caution in patients with impaired pulmonary function, particularly those with obstructive pulmonary disease, and in patients with severely impaired cardiac function due to myocardial disease. It should be used with caution in patients with a history of previous liver disease or dysfunction (see WARNINGS).

Information for Patients

Patients should be cautioned against driving a motor vehicle or participating in hazardous occupations while taking Dantrolene sodium. Caution should be exercised in the concomitant administration of tranquilizing agents.

Dantrolene sodium might possibly evoke a photosensitivity reaction; patients should be cautioned about exposure to sunlight while taking it.

Adverse Reactions

The most frequently occurring side effects of Dantrolene sodium have been drowsiness, dizziness, weakness, general malaise, fatigue, and diarrhea. These are generally transient, occurring early in treatment, and can often be obviated by beginning with a low dose and increasing dosage gradually until an optimal regimen is established. Diarrhea may be severe and may necessitate temporary withdrawal of Dantrolene sodium therapy. If diarrhea recurs upon readministration of Dantrolene sodium, therapy should probably be withdrawn permanently.

Other less frequent side effects, listed according to system, are:

Gastrointestinal: Constipation, GI bleeding, anorexia, swallowing difficulty, gastric irritation, abdominal cramps.

Hepatobiliary: Hepatitis (see WARNINGS).

Neurologic: Speech disturbance, seizure, headache, light-headedness, visual disturbance, diplopia, alteration of taste, insomnia.

Cardiovascular: Tachycardia, erratic blood pressure, phlebitis.

Psychiatric: Mental depression, mental confusion, increased nervousness.

Urogenital: Increased urinary frequency, crystalluria, hematuria, difficult erection, urinary incontinence and/or nocturia, difficult urination and/or urinary retention.

Integumentary: Abnormal hair growth, acne-like rash, pruritus, urticaria, eczematoid eruption, sweating.

Musculoskeletal: Myalgia, backache.

Respiratory: Feeling of suffocation.

Special Senses: Excessive tearing.

Hypersensitivity: Pleural effusion with pericarditis.

Other: Chills and fever.

OVERDOSE

For acute overdosage, general supportive measures should be employed along with immediate gastric lavage.

Intravenous fluids should be administered in fairly large quantities to avert the possibility of crystalluria. An adequate airway should be maintained and artificial resuscitation equipment should be at hand. Electrocardiographic monitoring should be instituted, and the patient carefully observed. To date, no experience has been reported with dialysis and its value in Dantrolene sodium overdose is not known.

Dantrolene Dosage and Administration

For Use in Chronic Spasticity

Prior to the administration of Dantrolene sodium capsules, consideration should be given to the potential response to treatment. A decrease in spasticity sufficient to allow a daily function not otherwise attainable should be the therapeutic goal of treatment with Dantrolene sodium capsules. Refer to INDICATIONS AND USAGE section for description of response to be anticipated.

It is important to establish a therapeutic goal (regain and maintain a specific function such as therapeutic exercise program, utilization of braces, transfer maneuvers, etc.) before beginning Dantrolene sodium capsule therapy. Dosage should be increased until the maximum performance compatible with the dysfunction due to underlying disease is achieved. No further increase in dosage is then indicated.

Usual Dosage

It is important that the dosage be titrated and individualized for maximum effect. The lowest dose compatible with optimal response is recommended.

In view of the potential for liver damage in long-term Dantrolene sodium capsule use, therapy should be stopped if benefits are not evident within 45 days.

Adults

Begin therapy with 25 mg once daily; increase to 25 mg two, three or four times daily and then by increments of 25 mg up to as high as 100 mg two, three or four times daily if necessary. As most patients will respond to a dose of 400 mg/day or less, rarely should doses higher than 400 mg/day be used (see BOX WARNING.)

Each dosage level should be maintained for four to seven days to determine the patient's response. The dose should not be increased beyond, and may even have to be reduced to, the amount at which the patient received maximal benefit without adverse effects.

Pediatric Patients

A similar approach should be utilized starting with 0.5 mg/kg of body weight twice daily; this is increased to 0.5 mg/kg three or four times daily then by increments of 0.5 mg/kg up to as high as 3.0 mg/kg two, three or four times daily if necessary. Doses higher than 100 mg four times daily should not be used in children.

For Malignant Hyperthermia

Preoperatively

Administer 4 to 8 mg/kg/day of oral Dantrolene sodium capsules in 3 or 4 divided doses for one or two days prior to surgery, with the last dose being given approximately 3 to 4 hours before scheduled surgery with a minimum of water.

This dosage will usually be associated with skeletal muscle weakness and sedation (sleepiness or drowsiness); adjustment can usually be made within the recommended dosage range to avoid incapacitation or excessive gastrointestinal irritation (including nausea and/or vomiting).

Post Crisis Follow-up

Oral Dantrolene sodium capsules should also be administered following a malignant hyperthermia crisis, in doses of 4 to 8 mg/kg per day in four divided doses, for a one to three day period to prevent recurrence of the manifestations of malignant hyperthermia.

How is Dantrolene Supplied

Dantrolene sodium capsules, 25 mg - Capsules with rich yellow opaque bodies and light green opaque caps. Each cap and body imprinted in black with G441.

Bottles of 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NDC 0115-4411-01

Bottles of 500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NDC 0115-4411-02

Bottles of 1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NDC 0115-4411-03

Dantrolene sodium capsules, 50 mg - Capsules with rich yellow opaque bodies and light blue opaque caps. Each cap and body imprinted in black with G442.

Bottles of 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NDC 0115-4422-01

Bottles of 500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NDC 0115-4422-02

Bottles of 1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NDC 0115-4422-03

Dantrolene sodium capsules, 100 mg - Capsules with rich yellow opaque bodies and reddish orange opaque caps. Each cap and body imprinted in black with G443.

Bottles of 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NDC 0115-4433-01

Bottles of 500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NDC 0115-4433-02

Bottles of 1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NDC 0115-4433-03

Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature]. Protect from moisture and humidity.

Dispense in a tightly-closed, light-resistant container (USP).

Mfg. by:

IMPAX Laboratories, Inc.

Hayward, CA 94544

Dist. by:

Global Pharmaceuticals

Division of IMPAX Laboratories, Inc.

Philadelphia, PA 19124

Rx only

Rev. 06/2004

373-02

Dantrolene SODIUM  Dantrolene sodium  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0115-4411 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Dantrolene Sodium (Dantrolene) Active 25 MILLIGRAM  In 1 CAPSULE croscarmellose sodium Inactive   gelatin Inactive   lactose monohydrate Inactive   magnesium stearate Inactive   pharmaceutical ink Inactive   pregelatinized starch Inactive   titanium dioxide Inactive   yellow iron oxide Inactive   D&C Yellow #10 Inactive   FD&C Green #3 Inactive

Product Characteristics Color YELLOW (yellow opaque) , GREEN (light green opaque) Score no score Shape CAPSULE (CAPSULE) Size 16mm Flavor Imprint Code G441 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0115-4411-01 100 CAPSULE In 1 BOTTLE None 2 0115-4411-02 500 CAPSULE In 1 BOTTLE None 3 0115-4411-03 1000 CAPSULE In 1 BOTTLE None

Dantrolene SODIUM  Dantrolene sodium  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0115-4422 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Dantrolene Sodium (Dantrolene) Active 50 MILLIGRAM  In 1 CAPSULE croscarmellose sodium Inactive   gelatin Inactive   lactose monohydrate Inactive   magnesium stearate Inactive   pharmaceutical ink Inactive   pregelatinized starch Inactive   titanium dioxide Inactive   yellow iron oxide Inactive   FD&C Blue #1 Inactive

Product Characteristics Color YELLOW (yellow opaque) , BLUE (light blue opaque) Score no score Shape CAPSULE (CAPSULE) Size 18mm Flavor Imprint Code G442 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0115-4422-01 100 CAPSULE In 1 BOTTLE None 2 0115-4422-02 500 CAPSULE In 1 BOTTLE None 3 0115-4422-03 1000 CAPSULE In 1 BOTTLE None

Dantrolene SODIUM  Dantrolene sodium  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0115-4433 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Dantrolene Sodium (Dantrolene) Active 100 MILLIGRAM  In 1 CAPSULE croscarmellose sodium Inactive   gelatin Inactive   lactose monohydrate Inactive   magnesium stearate Inactive   pharmaceutical ink Inactive   pregelatinized starch Inactive   titanium dioxide Inactive   yellow iron oxide Inactive   FD&C Red #40 Inactive   FD&C Yellow #6 Inactive

Product Characteristics Color YELLOW (yellow opaque) , RED (reddish orange opaque) , ORANGE (reddish orange opaque) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code G443 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0115-4433-01 100 CAPSULE In 1 BOTTLE None 2 0115-4433-02 500 CAPSULE In 1 BOTTLE None 3 0115-4433-03 1000 CAPSULE In 1 BOTTLE None

Revised: 08/2006Global Pharmaceuticals

More Dantrolene resources

• Dantrolene Side Effects (in more detail)
• Dantrolene Dosage
• Dantrolene Use in Pregnancy & Breastfeeding
• Drug Images
• Dantrolene Drug Interactions
• Dantrolene Support Group
• 3 Reviews for Dantrolene - Add your own review/rating

• Dantrolene MedFacts Consumer Leaflet (Wolters Kluwer)


• dantrolene Concise Consumer Information (Cerner Multum)


• dantrolene Advanced Consumer (Micromedex) - Includes Dosage Information


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