DRUGS & SUPPLEMENTS
Petinimid (ethosuximide) is an anticonvulsant succinimide, chemically designated as alpha-ethyl-alpha-methyl-succinimide, with the following structural formula:
Each teaspoonful (5 mL), for oral administration, contains 250 mg Petinimid, USP. Also contains citric acid, anhydrous, USP; FD&C red No. 40; FD&C yellow No. 6; flavor; glycerin, USP; purified water, USP; saccharin sodium, USP; sodium benzoate, NF; sodium citrate, USP; sucrose, NF.
Petinimid suppresses the paroxysmal three cycle per second spike and wave activity associated with lapses of consciousness which is common in absence (petit mal) seizures. The frequency of epileptiform attacks is reduced, apparently by depression of the motor cortex and elevation of the threshold of the central nervous system to convulsive stimuli.
INDICATIONS AND USAGE
Petinimid is indicated for the control of absence (petit mal) epilepsy.
Petinimid should not be used in patients with a history of hypersensitivity to succinimides.
Blood dyscrasias, including some with fatal outcome, have been reported to be associated with the use of Petinimid; therefore, periodic blood counts should be performed. Should signs and/or symptoms of infection develop, blood counts should be considered at that point.
Effects on Liver and Kidneys
Petinimid is capable of producing morphological and functional changes in the animal liver. In humans, abnormal liver and renal function studies have been reported. Petinimid should be administered with extreme caution to patients with known liver or renal disease. Periodic urinalysis and liver function studies are advised for all patients receiving the drug.
Systemic Lupus Erythematosus
Cases of systemic lupus erythematosus have been reported with the use of Petinimid. The physician should be alert to this possibility.
Suicidal Behavior and Ideation
Antiepileptic drugs, including Petinimid, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.
The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.
The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5–100 years) in the clinical trials analyzed.
Table 1 shows absolute and relative risk by indication for all evaluated AEDs.
The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.
Anyone considering prescribing Petinimid or any other AED must balance the risk of suicidal thoughts and behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
Serious Dermatologic Reactions
Serious dermatologic reactions, including Stevens-Johnson syndrome (SJS), have been reported with Petinimid treatment. SJS can be fatal. The onset of symptoms is usually within 28 days, but can occur later. Petinimid should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS, use of this drug should not be resumed and alternative therapy should be considered.
Drug Reaction with Eosinophilia and Systemic Symptoms
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi organ hypersensitivity, has occurred with Petinimid. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis, sometimes resembling an acute viral infection. Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity (e.g. fever, lymphadenopathy) may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Petinimid should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
Usage in Pregnancy
Petinimid crosses the placenta.
Reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to phenytoin and phenobarbital, but these are also the most commonly prescribed anticonvulsants; less systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs.
Cases of birth defects have been reported with Petinimid. The reports suggesting an elevated incidence of birth defects in children of drug-treated epileptic women cannot be regarded as adequate to prove a definite cause and effect relationship. There are intrinsic methodological problems in obtaining adequate data on drug teratogenicity in humans; the possibility also exists that other factors, e.g., genetic factors or the epileptic condition itself, may be more important than drug therapy in leading to birth defects. The great majority of mothers on anticonvulsant medication deliver normal infants. It is important to note that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.
The prescribing physician will wish to weigh these considerations in treating or counseling epileptic women of childbearing potential.
Petinimid is excreted in human breast milk. Because the effects of Petinimid on the nursing infant are unknown, caution should be exercised when Petinimid is administered to a nursing mother. Petinimid should be used in nursing mothers only if the benefits clearly outweigh the risks.
Petinimid, when used alone in mixed types of epilepsy, may increase the frequency of grand mal seizures in some patients.
As with other anticonvulsants, it is important to proceed slowly when increasing or decreasing dosage, as well as when adding or eliminating other medication. Abrupt withdrawal of anticonvulsant medication may precipitate absence status.
Information for Patients
Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking Petinimid. Instruct patients to take Petinimid only as prescribed.
Petinimid may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or other such activity requiring alertness; therefore, the patient should be cautioned accordingly.
Patients taking Petinimid should be advised of the importance of adhering strictly to the prescribed dosage regimen.
Patients should be instructed to promptly contact their physician when they develop signs and/or symptoms suggesting an infection (e.g., sore throat, fever).
Patients, their caregivers, and families should be counseled that AEDs, including Petinimid, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
Prior to initiation of treatment with Petinimid, the patient should be instructed that a rash may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.
Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This Registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334.
Since Petinimid may interact with concurrently administered antiepileptic drugs, periodic serum level determinations of these drugs may be necessary (e.g., Petinimid may elevate phenytoin serum levels and valproic acid has been reported to both increase and decrease Petinimid levels).
To provide information regarding the effects of in utero exposure to Petinimid, physicians are advised to recommend that pregnant patients taking Petinimid enroll in the (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888- 233-2334, and must be done by patients themselves. Information on the registry can also be found at the website: http://www.aedpregnancyregistry.org/.
Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Body As A Whole: Allergic reaction, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Gastrointestinal System: Gastrointestinal symptoms occur frequently and include anorexia, vague gastric upset, nausea and vomiting, cramps, epigastric and abdominal pain, weight loss, and diarrhea. There have been reports of gum hypertrophy and swelling of the tongue.
Hemopoietic System: Hemopoietic complications associated with the administration of Petinimid have included leukopenia, agranulocytosis, pancytopenia, with or without bone marrow suppression, and eosinophilia.
Nervous System: Neurologic and sensory reactions reported during therapy with Petinimid have included drowsiness, headache, dizziness, euphoria, hiccups, irritability, hyperactivity, lethargy, fatigue, and ataxia.
Psychiatric or psychological aberrations associated with Petinimid administration have included disturbances of sleep, night terrors, inability to concentrate, and aggressiveness.
These effects may be noted particularly in patients who have previously exhibited psychological abnormalities. There have been rare reports of paranoid psychosis, increased libido, and increased state of depression with overt suicidal intentions.
Integumentary System: Dermatologic manifestations which have occurred with the administration of Petinimid have included urticaria, pruritic erythematous rashes, Stevens-Johnson syndrome, and hirsutism.
Special Senses: Myopia.
Genitourinary System: Vaginal bleeding, microscopic hematuria.
Acute overdoses may produce nausea, vomiting, and CNS depression including coma with respiratory depression. A relationship between Petinimid toxicity and its plasma levels has not been established. The therapeutic range of serum levels is 40 mcg/mL to 100 mcg/mL, although levels as high as 150 mcg/mL have been reported without signs of toxicity.
Treatment should include emesis (unless the patient is or could rapidly become obtunded, comatose, or convulsing) or gastric lavage, activated charcoal, cathartics, and general supportive measures. Hemodialysis may be useful to treat Petinimid overdose. Forced diuresis and exchange transfusions are ineffective.
DOSAGE AND ADMINISTRATION
Petinimid is administered by the oral route. The initial dose for patients 3 to 6 years of age is one teaspoonful (250 mg) per day; for patients 6 years of age and older, 2 teaspoonfuls (500 mg) per day. The dose thereafter must be individualized according to the patient's response. Dosage should be increased by small increments. One useful method is to increase the daily dose by 250 mg every four to seven days until control is achieved with minimal side effects. Dosages exceeding 1.5 g daily, in divided doses, should be administered only under the strictest supervision of the physician. The optimal dose for most pediatric patients is 20 mg/kg/day. This dose has given average plasma levels within the accepted therapeutic range of 40 to 100 mcg/mL. Subsequent dose schedules can be based on effectiveness and plasma level determinations.
Petinimid may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal). The optimal dose for most pediatric patients is 20 mg/kg/day.
Petinimid is supplied as:
NDC 0071-2418-23-1 pint bottles. Each 5 mL of oral solution contains 250 mg Petinimid in a raspberry flavored base.
Store at 20°–25°C (68° – 77°F);
Preserve in tight containers. Protect from freezing and light.
Petinimid, (Ză rŏn' tĭn)
Capsules, Oral Solution
Read this Medication Guide before you start taking Petinimid and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about Petinimid, ask your healthcare provider or pharmacist.
What is the most important information I should know about Petinimid?
Do not stop taking Petinimid without first talking to your healthcare provider.
Stopping Petinimid suddenly can cause serious problems.
Petinimid can cause serious side effects, including:
What is Petinimid?
Petinimid is a prescription medicine used to treat absence (petit mal) seizures.
Who should not take Petinimid?
Do not take Petinimid if you are allergic to succinimides (methsuximide or Petinimid), or any of the ingredients in Petinimid. See the end of this Medication Guide for a complete list of ingredients in Petinimid.
What should I tell my healthcare provider before taking Petinimid?
Before you take Petinimid, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking Petinimid with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist when you get a new medicine.
How should I take Petinimid?
What should I avoid while taking Petinimid?
What are the possible side effects of Petinimid?
Petinimid may cause other serious side effects, including:
Call your healthcare provider right away, if you have any of the symptoms listed above.
The most common side effects of Petinimid include
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all the possible side effects with Petinimid. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Petinimid?
Keep Petinimid and all medicines out of the reach of children.
General information about Petinimid
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Petinimid for a condition for which it was not prescribed. Do not give Petinimid to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about Petinimid. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Petinimid that is written for healthcare professionals.
For more information, go to www.pfizer.com or call 1-800-438-1985.
What are the ingredients in Petinimid?
Active ingredient: Petinimid
Inactive ingredients: Polyethylene glycol 400, NF; D&C yellow No. 10; FD&C red No. 3; gelatin, NF; glycerin, USP; and sorbitol.
Inactive ingredients: Each 5 ml (teaspoonful) of oral solution contains 250 mg Petinimid in a raspberry flavored base. Also contains citric acid, anhydrous, USP; FD&C red No. 40; FD&C yellow No. 6; flavor; glycerin, USP; purified water, USP; saccharin sodium, USP; sodium benzoate, NF; Sodium Citrate, USP; sucrose, NF.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
ALWAYS DISPENSE WITH
ACCOMPANYING MEDICATION GUIDE
250 mg per 5 mL
1 Pint (474 mL)
Petinimid pharmaceutical active ingredients containing related brand and generic drugs:
Active 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.
Petinimid available forms, composition, doses:
Form 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.
Petinimid destination | category:
Destination 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.
Petinimid Anatomical Therapeutic Chemical codes:
A 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.
Petinimid pharmaceutical companies:
Pharmaceutical 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.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Petinimid?
Depending on the reaction of the Petinimid after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Petinimid 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 Petinimid 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.
Reviewsdrugs.com conducted a study on Petinimid, 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 Petinimid 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 reported usefulNo survey data has been collected yet
Visitor reported side effectsNo survey data has been collected yet
One visitor reported price estimatesWhat is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Petinimid is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Two visitors reported frequency of useHow often in a day do you take the medicine?
Are you taking the Petinimid drug as prescribed by the doctor?
Few medications can be taken Twice in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Petinimid is mentioned below.
Four visitors reported dosesWhat is the dose of Petinimid drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 201-500mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
One visitor reported time for resultsWhat is the time duration Petinimid drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed 3 month to notice the result from using Petinimid drug. The time needed to show improvement in health condition after using the medicine Petinimid need not be same for all the users. It varies based on other factors.
Visitor reported administrationNo survey data has been collected yet
Two visitors reported age
The information was verified by Dr. Arunabha Ray, MD Pharmacology