Pliva 434 is actually Trazodone hydrochloride 100 milligrams, marketed with the brand name of Desyrel. Trazodone is an anti-depressant belonging to the class SARI (serotonin antagonist and reuptake inhibitor. It is used to treat depressive illness and other related conditions. It acts primarily as an inhibitor of 5-HT2A receptors to produce its effect. Minor anti-depressant and anxiolytic effects of Pliva 434 are due to partial agonistic activity at 5-HT1A. It is slightly different from other tricyclic anti-depressant in having less severe anti-cholinergic effects (dry mouth, tachycardia, urinary retention and constipation) and sexual side effects. Another property of this medicine is that it does not increase appetite and weight like other anti-depressants.
Absorption of Pliva 434 is good when administered orally and peak blood levels are achieved almost one hour after ingestion. Half life of the drug is 5-9 hours. It is metabolized into three or four metabolites and the major one is mCCP. Some of the side effects like anxiety, headache, decreased appetite and depression are due to mCCP metabolite. Excretion of the drug is mainly through the kidneys.
Pliva 434 has anti-depressant, anxiolytic and hypnotic effects due to which it is being used commonly in a number of related psychiatric disorders. It is also being used in the management of chronic and neuropathic pains. It takes almost two weeks or so to get the anti-depressant effect of Pliva 434 so patient taking this medicine should keep this thing in mind. Effectiveness of Pliva 434 is proven but like other tricyclic anti-depressants, it should be given to the patients with close monitoring for the side effects. Any side effect that appears or if patient develop suicidal tendency or behavioral change, should immediate be reported to the doctor to avoid any unpleasant happening.
What is this medicine for?
As mentioned above, Pliva 434 has anti-depressant, anxiolytic and hypnotic effects so, it is used to treat a number of psychiatric illnesses. One thing should always be remembered that this medicine should only be taken under the advice and supervision of the physician. Common indications for Pliva 434 are,
- Major unipolar depression with or without anxiety
One of the most important indications for use of Pliva 434 is major depression or unipolar depression. It takes at least two weeks for the anti-depressant effects to come so, patient and the family should be well aware of this fact. Medicine is usually prescribed for many months and to get optimal benefits, doctor’s advice regarding dose, dose adjustment and duration should be strictly adhered.
- Sleep disturbances and nightmares
Hypnotic effect of Pliva 434 is used to treat sleep disturbances and nightmares in patients. It reduces the stage of sleep in which nightmare occur mostly, this is the reason for its use in the management of nightmares. Dose for sleep disturbance and control of nightmares is less than the dose used for treatment of depression.
- Depressive phase of bipolar disorder
Pliva 434 is sometimes used in the treatment of depressive phase of bipolar disorder but utmost care should be taken because it may result in switching to aggressive phase of bipolar disorder. Some antidepressant having better safety profile than Pliva 434 can be substituted for use in bipolar depression.
Other conditions in which Pliva 434 is used as off-label and on investigational basis are,
- Panic disorders
- Painful sensory neuropathy of diabetes mellitus
- OCD or obsessive compulsive disorder
- Schizophrenia and some other psychotic disorders
- Bulimia nervosa
- Alcohol withdrawal
- Complex pain syndrome and sometimes neuropathic pains not responding to usual analgesics
Side effects on Pliva 434
Side effects of Pliva 434 can be divided into more serious side effect which need urgent medical attention and least serious side effect which patients commonly experience and are easily manageable.
Most serious side effects of Pliva 434 are following
- Allergy or hypersensitivity is the first and foremost important serious side effect that may be mild or severe. Severe allergy symptoms include skin rash, hives and swelling of lips, face, throat or tongue that may result into difficult breathing. In case of allergy to Pliva 434, immediate contact with the doctor or emergency medical service should be made.
- Priapism or painful erection in the males is one of the serious side effects of Trazodone; if erection remains for more than 4 hours then immediate contact with the doctor should be made.
- Suicidal tendency or ideation, new or worsening symptoms of depression, severe anxiety, difficulty in going to sleep, aggression or irritability. Patient and his/her family should be educated about these situations. If patient experience any of the condition immediate contact with the treating physician should be made.
Other serious side effects of Pliva 434 are,
- Chest pain
- Irregularity of heart beat
- Difficulty in breathing and swallowing
- Agranulocytosis ( fever, sore throat and rash)
- Skin rash
- Decreased coordination
- Involuntary movement of any part of the body
- Numbness, burning, or tingling in the arms, legs, hands, or feet
- Dizziness or lightheadedness
Less serious side effects of Pliva 434
- Nausea or vomiting
- Dry mouth
- Stomach pain
- Diarrhea or constipation
- Changes in appetite or weight
- Poor concentration and memory
- Ringing in ears
- Muscle pain
- Blurred vision
- itchy eyes
Precautions 0n Pliva 434
- Pliva 434 is metabolized in the liver by CYP3A4 so; drugs that inhibit this enzyme may prolong the effect of Pliva 434 by increasing blood levels of this medication. Many herbs and drugs inhibit this enzyme so before starting Pliva 434 you should inform your doctor about any drug or herbal remedy already taking. Grape fruit juice should also be avoided for the same reason during use of Pliva 434.
- Suicidal tendency increases during the use of Pliva 434 so patient using Pliva 434 should not have an access to large number of tablet to avoiding suicidal intake of this medication. Moreover, family members of the patient should immediately inform the doctor or health facility if patient develops suicidal tendency.
- Trazodone or Pliva 434 is also noted to increase the risk of seizures when used concomitantly with anti-seizure medications. So use of this medication in epileptic patient should be done cautiously
- Pliva 434 should not be stopped at once rather it should be gradually tapered and then stopped otherwise discontinuation syndrome may result.
- Use of Pliva 434 is not safe in pregnancy and lactation as safety of this drug is not established in these situations.
- Pliva 434 should be discontinued several days before elective surgery where general anesthesia is required.
- Electro-convulsive therapy or ECT is not safe while the patient is taking Pliva 434 so it should not be applied concomitantly during use of this medication.
- Use of Pliva 434 in pediatric age group is not without risk of severe side effects so every effort should be made to avoid this medication below the age of 18 years. If at all it is to be used, close monitoring should be done.
- Patients having allergy to Trazodone should not use Pliva 434.
- Patient and the family should be vigilant regarding sudden changes in behavior or suicidal tendency in the patient during treatment with Pliva 434 and report to the doctor immediately.
Conditions that are not suitable for Pliva 434 use
Pliva 434 has effects on almost every system of the body including cardiovascular system so, before starting this drug a thorough evaluation of the patient should be done. Complete history, physical examination and necessary investigations (electrocardiography, serum levels of potassium and magnesium and other investigations) help to exclude conditions which are not suitable for Pliva 434 use. If patient is suffering from any of the below mentioned conditions, he or she should not be given Pliva 434 for treatment,
- Patients who have recent myocardial infarction (heart attack) should not use this drug otherwise mortality increases
- Patients having any cardiac arrhythmia, QT-interval prolongation, Torsades de pointes, very rapid heart rate, any structural heart disease and cardiac conduction defects from birth or acquired
- Patients having enlarged prostate
- Patients having postural hypotension due to any disease
- Priapism or its history: patient having prolonged painful erections are not suitable candidate for use of Pliva 434
- SIADH or syndrome of inappropriate antidiuretic syndrome
- Hypomagnesaemia (low levels of magnesium in the blood) due to increased risk of cardiac arrhythmias
- Hypokalemia or low blood potassium levels
- Patients having increased risk of bleeding due to some disease
- Patients having suicidal tendency or suicidal thoughts should never use this medication otherwise risk of committing suicide increases.
- Patients with previous history of allergy to Trazodone or phenylpiperazine anti-depressants should not use this medication at all otherwise severe anaphylactic reaction may result leading to serious consequences.
Above mentioned are some of the common contraindication to use of Pliva 434 more detailed discussion with the doctor should be done before starting this important medication for depression. Screening the patient for these contraindications is utmost important to avoid untoward side effects of Pliva 434.
Allergy symptoms of Pliva 434
As we know that allergy or hypersensitivity to any drug can happen so is with Pliva 434. Sometimes mild allergic symptoms appear which disappear on discontinuing the drug. Severe allergic symptoms warrant immediate contact with emergency medical service and urgent treatment of hypersensitivity.
Mild symptoms of allergy to Pliva 434
If a patient taking Pliva 434 develops itching, hives and redness of the skin and no problem with breathing occurs, these are symptoms of mild hypersensitivity which will settle on withdrawing the medication and sometime use of anti-histamine drugs. Even the mild allergy symptoms indicate that this drug no more should be used. Doctor should be informed about these symptoms.
Severe allergy symptoms of Pliva 434
Severe hypersensitivity reaction to Pliva 434 may appear within seconds to minutes after administration of this drug in patient who are allergic to Pliva 434 (Trazodone). Patients with severe hypersensitivity reaction develops following symptoms
- Skin rash all over the body
- Symptoms of angioedema, which include swelling of lips throat and chest tightness, which cause difficulty in breathing and in severe cases no breathing at all.
- Changes or loss of hearing
- Severe anxiety along with mental and mood changes
- Decreased urine output
These hypersensitivity symptoms need urgent management in medical emergency otherwise patient may die. Useful measures to overcome this life-threatening condition are use of anti-histamine drugs, steroids, adrenaline injection and maintaining the airway with passing endotracheal tube or performing emergency tracheotomy (in cases where swelling of the larynx does not allow endotracheal intubation). Patient needs admission in intensive care unit for extensive monitoring till his or her condition is out of danger.
Dosage of Pliva 434
Pliva 434 should be used only in the dose and duration prescribed by the physician. It can be taken with or without meal. Usual starting dose of Trazodone hydrochloride in adult and elderly population is 150 milligram (one and half tablet of Pliva 434) per day which can be increased gradually by fifty milligrams every third to fourth day. Maximum dose of Trazodone in adults is 400 milligrams per 24 hours in outpatient and 600 milligrams per day in hospitalized patients. Recommended dose of Pliva 434 as a sleeping aid in adults is quarter to half tablet (Trazodone 25-50 milligrams)
Use of Pliva 434 in children should be done cautiously with a starting dose of 25-50 milligrams gradually increasing to maximum dose of 150 milligrams with close monitoring for the side effects.
Pliva 434 should be taken in divided doses or a single dose in the evening to avoid postural hypotension and lightheadedness.
Missing a dose of Pliva 434
If a patient misses a dose of Pliva 434, it should be taken as soon as remembered. If time for next dose is reached, only next dose of the medicine should be taken. Patient should not take two doses at one time.
Overdose of Pliva 434
Overdose of Pliva 434 is dangerous for the patient. It may result in serious side effect (difficulty in breathing, unconsciousness, cardiac arrhythmias, etc). In such a case, patient should be immediately hospitalized or poison control service should be called. There is no specific anti-dote for Pliva 434. Some of the helpful measures for detoxification of the drug are gastric lavage, administration of activated charcoal and forced diuresis. Overdose of Pliva 434 is less dangerous than other tricyclic anti-depressants.