Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Ocifril:
Store Ocifril at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly sealed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ocifril out of the reach of children and away from pets.
Overdose of Ocifril in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic overdose. Therefore, hospital monitoring is required as soon as possible.
In U.S. clinical trials, 2 deaths occurred in 12 reported cases of acute overdosage with Ocifril either alone or in combination with other drugs. One death involved a patient suspected of ingesting a dose of 7000 mg. The second death involved a patient suspected of ingesting a dose of 5750 mg. The 10 nonfatal cases involved doses of up to 5000 mg, accompanied by plasma levels of up to 1010 ng/mL. All 10 patients completely recovered. Among reports from other countries of Ocifril overdose, the lowest dose associated with a fatality was 750 mg. Based upon postmarketing reports in the United Kingdom, CMI's lethality in overdose is considered to be similar to that reported for closely related tricyclic compounds marketed as antidepressants.
Signs and symptoms vary in severity depending upon factors such as the amount of drug absorbed, the age of the patient, and the time elapsed since drug ingestion. Critical manifestations of overdose include cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic toxicity. Other CNS manifestations may include drowsiness, stupor, ataxia, restlessness, agitation, delirium, severe perspiration, hyperactive reflexes, muscle rigidity, and athetoid and choreiform movements. Cardiac abnormalities may include tachycardia, signs of congestive heart failure, and in very rare cases, cardiac arrest. Respiratory depression, cyanosis, shock, vomiting, hyperpyrexia, mydriasis, and oliguria or anuria may also be present.
Obtain an ECG and immediately initiate cardiac monitoring. Protect the patient's airway, establish an intravenous line, and initiate gastric decontamination. A minimum of 6 hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary.
If signs of toxicity occur at any time during this period, extended monitoring is required. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination. Monitoring of plasma drug levels should not guide management of the patient.
All patients suspected of tricyclic overdose should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage. Emesis is contraindicated.
A maximal limb-lead QRS duration of ≥ 0.10 seconds may be the best indication of the severity of the overdose.
Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45 to 7.55. If the pH response is inadequate, hyperventilation may also be used. Concomitant use of hyperventilation and sodium bicarbonate should be done with extreme caution, with frequent pH monitoring. A pH > 7.60 or a pCO2 < 20 mmHg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium, or phenytoin. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide).
In rare instances, hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity. However, hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in tricyclic poisoning.
In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (e.g., phenobarbital, phenytoin). Physostigmine is not recommended except to treat lifethreatening symptoms that have been unresponsive to other therapies, and then only in consultation with a poison control center.
Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.
The principles of management of child and adult overdosages are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.
What should I avoid while taking Ocifril?
Avoid drinking alcohol. It can cause dangerous side effects when taken together with Ocifril.
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
glaucoma, prostate problems, decreased urine output, thyroid disease, breathing problems, seizure problems, alcohol use, heart disease, mental/emotional problems, liver or kidney disease, drug allergies. This medication can increase sensitivity to sunlight. Avoid prolonged sun exposure. Wear a sunscreen and protective clothing. Limit alcohol while using this drug to avoid excessive drowsiness. Though uncommon, depression itself can lead to thoughts or attempts of suicide. Tell your doctor immediately if you have any suicidal thoughts, or other mental/mood changes. Keep all medical appointments so your doctor can monitor your progress closely. Caution is advised when using this drug in the elderly, because they may be more sensitive to the effects of the drug (e.g., confusion may occur or worsen). This drug should be used during pregnancy only if clearly needed. Discuss the risks and benefits with your doctor. This drug is excreted into breast milk. The effects on the infant are not known at this time. Consult your doctor before breast-feeding.
Tricyclic agents are known to lower the convulsive threshold and Ocifril should, therefore, be used with extreme caution in patients with a history of convulsive disorders and other predisposing factors, e.g., brain damage of varying etiology, alcoholism, and concomitant use with other drugs that lower the seizure threshold. Total daily doses should not exceed the recommended total daily dose. Concurrent administration of ECT and Ocifril may be hazardous and such treatment should be limited to patints for whom it is essential. Physicians should discuss with patients the risk of taking Ocifril while engaging in activities in which a sudden loss of consciousness could result in serious injury to the patient or others e.g. the operation of complex machinery, driving, swimming, or climbing.
Tricyclic antidepressants, particularly in high doses, have been reported to produce sinus tachycardia, changes in conduction time and arrhythmias. A few instances of unexpected death have been reported in patients with cardiovascular disorders. Myocardial infarction and stroke have also been reported with drugs of this class. Therefore, Ocifril should be administered with extreme caution to patients with a history of cardiovascular disease, especially those who have a history of conduction disorders, those with circulatory lability and elderly patients. It also has a hypotensive action which may be detrimental in these circumstances. In such cases, treatment should be initiated at low doses with progressive increases only if required and tolerated, and the patients should be under close surveillance at all dosage levels. Monitoring of cardiac function and the ECG is indicated in such patients.
Use in Concomitant Illness:
Caution should be observed in prescribing Ocifril in hyperthyroid patients or in patients receiving thyroid medication conjointly. Transient cardiac arrhythmias have occurred in rare instances in patients who have been receiving other tricyclic compounds concomitantly with thyroid medication.
Because of its anticholinergic properties, Ocifril should be used with caution in patients with increased intraocular pressure or a history of urinary retention, particularly in the presence of prostatic hypertrophy.
Particularly in the elderly and in hospitalized patients the tricyclic antidepressants may give rise to paralytic ileus and, therefore, appropriate measures should be taken if constipation occurs.
Caution is called for when employing Ocifril in patients with tumours of the adrenal medulla (e.g. pheochromocytoma, neuroblastoma) in whom the drug may provoke hypertensive crisis.
Ocifril should be kept in a safe place, well out of the reach of children.
Safe use in pregnant women has not been established. Withdrawal symptoms including tremors, convulsions, and respiratory depression have been reported in neonates whose mothers received tricyclic antidepressants during the third trimester of pregnancy. Therefore, it should not be administered to women of childbearing potential, or during pregnancy, unless, in the opinion of the physician, the expected benefit to the patient outweighs the potential risk to the fetus.
Since Ocifril passes into breast milk, nursing mothers receiving it should not breast-feed their infants.
What should I discuss with my healthcare provider before taking Ocifril?
Some medical conditions may interact with Ocifril. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you drink alcohol or have a history of alcohol abuse
if you take thyroid medicine or have a history of an overactive thyroid
if you have a history of adrenal gland problems, glaucoma or increased eye pressure, heart problems, kidney or liver problems, diabetes, seizures, trouble urinating, the blood disease porphyria, or other blood problems
if you have a history of suicidal thoughts or behavior, bipolar disorder, or any other mental disorders
if you are undergoing electroshock therapy or you are scheduled to have any surgery
if you are taking a medicine that contains methylene blue
Some MEDICINES MAY INTERACT with Ocifril. Tell your health care provider if you are taking any other medicines, especially any of the following:
Buspirone, cimetidine, fentanyl, flecainide, haloperidol, lithium, methylphenidate, phenothiazines (eg, chlorpromazine), propafenone, quinidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), St. John's wort, tramadol, triptans (eg, sumatriptan), or tryptophan because they may increase the risk of Ocifril's side effects
Linezolid or MAOIs (eg, phenelzine) because the risk of high blood pressure, serious heart problems (eg, irregular heartbeat), or seizures may be increased
Barbiturates (eg, phenobarbital) or phenytoin because they may decrease Ocifril's effectiveness
Anticholinergics (eg, benztropine), anticoagulants (eg, warfarin), carbamazepine, digoxin, or sympathomimetics (eg, phenylephrine) because the risk of their side effects may be increased by Ocifril
Clonidine, guanethidine, or guanfacine because their effectiveness may be decreased by Ocifril
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ocifril may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
The use of Ocifril has been reported to cause modest hypertension with tachycardia, minor and clinically insignificant electrocardiogram (ECG) changes and elevation of liver enzyme. On rare occasions, it has been found to cause delusions, hallucinations, psychotic episodes, confusion, paranoia, hypomania or mania and male sexual dysfunction. On very rare occasions, blood dyscrasias and hyperthermia have been reported with the use of Ocifril. Patients of obsessive compulsive disorder with depression may have suicidal tendency. The possibility of occurrence of these effects should be kept in mind and necessary precautions should be taken while prescribing Ocifril.
Ocifril should be used with caution in patients having hyperthyroidism, patients on thyroid medication and those with elevated intraocular pressure, history of narrow-angle glaucoma, urinary retention, tumors of adrenal medulla and impaired renal function.
Withdrawal Reaction: Abrupt discontinuation of treatment with Ocifril may lead to withdrawal reaction characterized by dizziness, nausea, vomiting, headache, malaise, sleep disturbance, hyperthermia, irritability and possibly worsening of psychiatric status; therefore, Ocifril should be gradually tapered and the patient carefully monitored during discontinuation of therapy.
Use in pregnancy: There are no adequate or well-controlled studies of the safety of Ocifril in pregnant women. Withdrawal symptoms, including jitterness, tremor and seizures have been reported in neonates whose mothers had taken Ocifril until delivery. Ocifril should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Ocifril has been found to appear in human milk, therefore in view of the potential for adverse reactions, a decision should be made whether to continue nursing or to discontinue Ocifril, taking into account the importance of the drug to the mother.
Use in children: Ocifril is not recommended in children.
What happens if I miss a dose of Ocifril?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.