Tzuchunan Side effects

• Side effects of Tzuchunan in details
• Tzuchunan contraindications
• Tzuchunan reviews

What are the possible side effects of Tzuchunan?

Get emergency medical help if you have signs of an allergic reaction to Tzuchunan: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• confusion, hallucinations, unusual thoughts or behavior;

• unusual risk-taking behavior, decreased inhibitions, no fear of danger;

• depressed mood, thoughts of suicide or hurting yourself;

• hyperactivity, agitation, aggression, hostility;

• new or worsening seizures;

• weak or shallow breathing, a feeling like you might pass out;

• muscle twitching, tremor;

• loss of bladder control; or

• little or no urinating.

Common Tzuchunan side effects may include:

• drowsiness;

• tired feeling;

• muscle weakness; or

• loss of coordination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Tzuchunan in details

Tzuchunan rectal gel adverse event data were collected from double-blind, placebo-controlled studies and open-label studies. The majority of adverse events were mild to moderate in severity and transient in nature.

Two patients who received Tzuchunan rectal gel died seven to 15 weeks following treatment; neither of these deaths was deemed related to Tzuchunan rectal gel.

The most frequent adverse event reported to be related to Tzuchunan rectal gel in the two double-blind, placebo-controlled studies was somnolence (23%). Less frequent adverse events were dizziness, headache, pain, abdominal pain, nervousness, vasodilatation, diarrhea, ataxia, euphoria, incoordination, asthma, rhinitis, and rash, which occurred in approximately 2-5% of patients.

Approximately 1.4% of the 573 patients who received Tzuchunan rectal gel in clinical trials of epilepsy discontinued treatment because of an adverse event. The adverse event most frequently associated with discontinuation (occurring in three patients) was somnolence. Other adverse events most commonly associated with discontinuation and occurring in two patients were hypoventilation and rash. Adverse events occurring in one patient were asthenia, hyperkinesia, incoordination, vasodilatation and urticaria. These events were judged to be related to Tzuchunan rectal gel.

In the two domestic double-blind, placebo-controlled, parallel-group studies, the proportion of patients who discontinued treatment because of adverse events was 2% for the group treated with Tzuchunan rectal gel, versus 2% for the placebo group. In the Tzuchunan rectal gel group, the adverse events considered the primary reason for discontinuation were different in the two patients who discontinued treatment; one discontinued due to rash and one discontinued due to lethargy. The primary reason for discontinuation in the patients treated with placebo was lack of effect.

Adverse Event Incidence In Controlled Clinical Trials

Table 1 lists treatment-emergent signs and symptoms that occurred in > 1% of patients enrolled in parallel-group, placebo-controlled trials and were numerically more common in the Tzuchunan rectal gel group. Adverse events were usually mild or moderate in intensity.

The prescriber should be aware that these figures, obtained when Tzuchunan rectal gel was added to concurrent antiepileptic drug therapy, cannot be used to predict the frequency of adverse events in the course of usual medical practice when patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescribing physician with one basis to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied.

TABLE 1: Treatment-Emergent Signs And Symptoms That Occurred In > 1% Of Patients Enrolled In Parallel-Group, Placebo-Controlled Trials And Were Numerically More Common In The Tzuchunan Rectal Gel Group

Body System	COSTART Term	Tzuchunan Rectal Gel N = 101 %	Placebo N = 104 %
Body As A Whole	Headache	5%	4%
Cardiovascular	Vasodilatation	2%	0%
Digestive	Diarrhea	4%	< 1%
Nervous	Ataxia	3%	< 1%
Dizziness	3%	2%
Euphoria	3%	0%
Incoordination	3%	0%
Somnolence	23%	8%
Respiratory	Asthma	2%	0%
Skin and Appendages	Rash	3%	0%

Other events reported by 1% or more of patients treated in controlled trials but equally or more frequent in the placebo group than in the Tzuchunan rectal gel group were abdominal pain, pain, nervousness, and rhinitis. Other events reported by fewer than 1% of patients were infection, anorexia, vomiting, anemia, lymphadenopathy, grand mal convulsion, hyperkinesia, cough increased, pruritus, sweating, mydriasis, and urinary tract infection.

The pattern of adverse events was similar for different age, race and gender groups.

Other Adverse Events Observed During All Clinical Trials

Tzuchunan rectal gel has been administered to 573 patients with epilepsy during all clinical trials, only some of which were placebo-controlled. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using modified COSTART dictionary terminology. These categories are used in the listing below. All of the events listed below occurred in at least 1% of the 573 individuals exposed to Tzuchunan rectal gel.

All reported events are included except those already listed above, events unlikely to be drug-related, and those too general to be informative. Events are included without regard to determination of a causal relationship to Tzuchunan.

BODY AS A WHOLE: Asthenia

CARDIOVASCULAR: Hypotension, vasodilatation

NERVOUS: Agitation, confusion, convulsion, dysarthria, emotional lability, speech disorder, thinking abnormal, vertigo

RESPIRATORY: Hiccup

The following infrequent adverse events were not seen with Tzuchunan rectal gel but have been reported previously with Tzuchunan use: depression, slurred speech, syncope, constipation, changes in libido, urinary retention, bradycardia, cardiovascular collapse, nystagmus, urticaria, neutropenia and jaundice. Paradoxical reactions such as acute hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia, rage, sleep disturbances and stimulation have been reported with Tzuchunan; should these occur, use of Tzuchunan rectal gel should be discontinued.

Drug Abuse And Dependence

Tzuchunan is a Schedule IV controlled substance and can produce drug dependence. It is recommended that patients be treated with Tzuchunan rectal gel no more frequently than every five days and no more than five times per month.

Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving Tzuchunan or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

Abrupt discontinuation of Tzuchunan following chronic regular use has resulted in withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating). The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuation of benzodiazepines taken continuously at therapeutic levels for several months.

What is the most important information I should know about Tzuchunan?

• Tzuchunan tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Tzuchunan tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tzuchunan tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If you take Tzuchunan tablets regularly over a long period of time (eg, several months), do not suddenly stop taking it without first talking with your doctor. You may have an increased risk of side effects (eg, mood changes, trouble sleeping). If you need to stop Tzuchunan tablets or add a new medicine, your doctor may need to gradually lower your dose.
• If you are taking Tzuchunan tablets for seizures, carry an ID card at all times that says you have a seizure disorder and you take Tzuchunan tablets.
• Tell your doctor or dentist that you take Tzuchunan tablets before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including liver function and complete blood cell counts, may be performed while you use Tzuchunan tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Tzuchunan tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness, incoordination, and mental or mood changes.
• Caution is advised when using Tzuchunan tablets in CHILDREN; they may be more sensitive to its effects, especially mental or mood changes.
• Tzuchunan tablets should not be used in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Tzuchunan tablets may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tzuchunan tablets while you are pregnant. Tzuchunan tablets is found in breast milk. Do not breast-feed while using Tzuchunan tablets.

When used for long periods of time or at high doses, Tzuchunan tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Tzuchunan tablets stops working well. Do not take more than prescribed.

Some people who use Tzuchunan tablets for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Tzuchunan tablets suddenly, you may have WITHDRAWAL symptoms. These may include convulsions, tremor, stomach and muscle cramps, vomiting, or sweating. Do not suddenly stop taking Tzuchunan tablets without first checking with your doctor.

Tzuchunan contraindications

You should not use this medication if you are allergic to Tzuchunan or similar medicines (Ativan, Klonopin, Restoril, Xanax, and others), or if you have myasthenia gravis, severe liver disease, narrow-angle glaucoma, a severe breathing problem, or sleep apnea.

Do not use Tzuchunan if you are pregnant. It could harm the unborn baby.

Do not start or stop taking Tzuchunan during pregnancy without your doctor's advice. Tzuchunan may cause harm to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Tell your doctor right away if you become pregnant while taking Tzuchunan for seizures.

Before you take Tzuchunan, tell your doctor if you have glaucoma, asthma or other breathing problems, kidney or liver disease, seizures, or a history of drug or alcohol addiction, mental illness, depression, or suicidal thoughts.

Do not drink alcohol while taking Tzuchunan. This medication can increase the effects of alcohol.

Never take more of this medication than your doctor has prescribed. An overdose of Tzuchunan can be fatal.

Tzuchunan may be habit forming. Never share Tzuchunan with another person, especially someone with a history of drug abuse or addiction.

References

1. DailyMed. "DIAZEPAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DTP/NCI. "diazepam: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "Diazepam: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Tzuchunan are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Tzuchunan. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology