Effective Depression Treatment with Primox Nortriptyline Hydrochloride

Generic Primox (Notriptyline Hydrochloride 25 mg) Medication guide:

Patients with depression or other serious mental illnesses are more likely to think about suicide or to attempt suicide. The benefit may warrant taking the drug, in spite of the potential risks. Antidepressants are used to treat depression and other illnesses. The risks should be discussed prior to taking the drug and before any adjustments made in the dosing. The risks for suicidal thinking and behaviors can occur during the early treatment but may not be evident until a considerable period of time has elapsed after initiation of the treatment.

Depression and Other Serious Mental Illnesses

Medication Guide for Primox (Nortriptyline Hydrochloride). This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised September 2010. Distributed by: Meda Pharmaceuticals, Somerset, NJ 08873-4120. Primox is a registered trademark of Valeant Pharmaceuticals International, Inc. Primox (Nortriptyline Hydrochloride) is a tricyclic antidepressant drug. A Medication Guide, which is required by the Food and Drug Administration (FDA), has been written for your information and is included with the package. Its purpose is to explain and clarify important and potentially fatal risks regarding the use of this drug.

Usage Instructions

To continue Generic PRIMOX for 3 to 12 months for sustained prevention of nocturnal voiding.

Use water voiding alarms every 2 hr if there is a delay in the initiation of voiding due to fear, anxiety, stress, pain, hypnotic medication, or allergy and then at least every 3 hr if 4 consecutive voiding alarms are delivered before their scheduled time of 4 PM halt of water intake.

To sip 8 oz of water at 8 AM in the morning, 1 PM, 6 PM, and 9 PM, but must stop drinking water from 4 PM until completion of night-time and morning voiding alarms.

To schedule night-time voiding alarms 1 hour before the usual time of bed-wetting.

The first night on PRIMOX will be in the presence of a responsible adult. No alcohol is to be consumed while taking PRIMOX.

To call the healthcare provider if signs of suicidal ideation are evident.

That primary enuresis is an idiopathic involuntary voiding due to inappropriate maturation of the vesicourethral control system, that is, bladder instability, tethered cord, occult spinal dysraphism, and excessive amounts of urine production such as diabetes mellitus, gestational age of less than 3 months, and neurogenic bladder, must be ruled out before initiating PRIMOX. Rule out anatomic obstructive causes of incontinence using appropriate tests as necessary.

Dosage

If after two weeks of therapy you feel that Primox is not helping to return to the quality of life, some other treatment or treatment strategies can really help so inform your doctor. If possible, adjust the dose of Primox and instruct the patient to take on the last day until Sunday night. On the day of drug-free treatment, the average dose may be given for men 75 mg, or for women 50 mg. On Monday, start the drug with the average dose from Friday, Saturday and Sunday. We recommend this method because many patients are sensitive to the urine so it is best not to start Primox on weekdays before he is fully active. If Primox therapy has been canceled for several consecutive days, therapy should be resumed overnight and doses of 10 to 25 mg are usually suitable.

Primox should be initiated at a dose of 25 mg, the minimal effective dose, and increased as needed by the aged patients. As with any new drug, careful dosing and adjustment of dosage recommendation are essential for patient management up to a maximum of 150 mg, unless other plans are made with your doctor. Most senior or debilitated patients may not be as tolerant of the drugs as younger people. Older patients should have their heart, liver and kidney function monitored for serious side effects at lower doses. Usually improvement can be seen within 2 weeks, while maximum improvement will generally occur after 4 weeks. If no improvement occurs within the initial 2 weeks after increasing the dose, asking your doctor to change your general treatment strategy is recommended.

Administration

Rare side effects of amitriptyline that call for immediate medical attention include: shallow or troubled breathing, aggression or agitation, worsening depression, thoughts of suicide, severe chest pain and/or jaw and/or shoulder pain; slurred speech; sudden weakness and/or numbness on one side of the body; bleeding cuts; irregular or rapid heartbeat; severe sore throat; signs of excessive production of serotonin (diarrhea, confusion, fever, shivering, heavy sweating); yellowing of the skin and/or eyes, or seizures, or convulsions.

Administration of all types of amitriptyline may induce a varied range of side effects – some mild, others serious. If any of these symptoms of overdose are recognized in a patient receiving this medication, they must be reported immediately: vomiting, rapid heartbeat, fever, confusion, weakness, dizziness, muscle stiffness, difficulty sleeping or falling asleep, change in breathing, sudden swelling and/or pain in joints, weak reflexes, fainting, and hallucinations.

Patients may take Primox medication with or without food. Each dose of Primox solution should be administered from 15 mL of the medication, followed by a half-glass (118 mL) of water. When taking the solution, ensure the dose is measured accurately using the measuring device provided. Primox medication should be stored and administered at room temperature.

Side Effects

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects: agitation, anxiety, confusion, decreased sexual ability, decreased sexual desire, difficulty concentrating, difficulty sleeping, disinterest in sexual activity, general feeling of discomfort or illness, irritability, mood or mental changes, nightmares, ringing or buzzing noise in the ears, unusual weight loss, abnormal milk secretion (women), absent menstruation, bloody nose, eye sensitivity to light, frequent urination, hair loss, increase in body hair growth, large, hive-like swelling on the face, eyelids, lips, mouth, or throat, muscle spasms, neck stiffness or soreness, painful or difficult urination. If you develop any side effects that concern you, consult your physician or your doctor promptly.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time. Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects: decreased urination, dizziness or lightheadedness, dry mouth, eye pain, feeling of fullness in the head, rapid, fluttering or pounding heart, headache, increase in blood pressure, increased production of saliva, increased sweating, lessening of the sense of taste, muscle stiffness, nausea, unpleasant taste, vomiting. Although most of these side effects listed below don't occur very often, they could lead to serious problems if you do not seek medical attention.

Common Side Effects

Somnolence may occur, usually at lower dosages; may be minimized by a reduction in dosage in all groups.

In addition, the following adverse drug effects are noted:
Anticholinergic Effects: Dry mouth, blurred vision, constipation, occasionally dizziness, urinary retention, postural hypotension, tachycardia, loss of appetite.
Cardiovascular: Hypotension, hypertension, palpitations, tachycardias, premature ventricular contractions, heart block, stroke.
Central Nervous System: Delirium, panic states, hypomania, exacerbation of psychotic conditions, drowsiness, fatigue, weakness, insomnia, tremors, peripheral neuropathy, paresthesias, depression, anxiety, excitement, listlessness, and hallucinations.
Dermatologic: Skin rash, petechiae, photosensitivity, itching, night sweats, alopecia.
Gastrointestinal: Nausea, epigastric distress, vomiting, anorexia, stomatitis, peculiar taste, diarrhea, parotid swelling, black tongue.
Hematologic: Bone marrow depression including agranulocytosis and eosinophilia; purpura; thrombocytopenia; leukopenia; hemolytic anemia; aplastic anemia; pancytopenia. Incidence of depression may occur.
Endocrine: Gynecomastia in the male, breast enlargement and galactorrhea in the female; increased or decreased libido, impotence, testicular swelling, elevation or depression of blood sugar levels, urine test for sugar positive.
Withdrawal Symptoms: Though not indicative of addiction, abrupt cessation of treatment after prolonged administration may produce nausea, headache, and malaise.

Serious Side Effects

Allergic skin reactions: Rash (allergic skin reactions) and/or photosensitivity (increased risk of sunburn) due to nortriptyline can occur. Seizures: The risk of experiencing a seizure is increased with higher doses of nortriptyline. Visual Problems: Visual hallucinations, blurred vision, macropsia (objects appearing larger than normal), and mydriasis (excessive dilation of the pupils) have been reported with the use of nortriptyline. Gammopathy: Nortriptyline can cause an increased gamma-globulin level (a blood protein that is part of the immune system). Other blood effects: Other blood effects that have been reported with the use of nortriptyline include eosinophilia (abnormal blood levels of a type of white blood cell), agranulocytosis (dangerously low levels of specific virus and bacteria fighting white blood cells called granulocytes), and purpura. Sudden death and sudden onset of an irregular heartbeat have been reported; the role that nortriptyline played in these events is not known.

Serious side effects: Strokes and increased risk of death in elderly people with dementia-related psychosis. Antidepressant medicines may increase the risk of experiencing strokes or stroke-like events. These events have been observed in patients with and without pre-existing risk factors for pancreatitis. Neuroleptic malignant syndrome (NMS): A potentially fatal condition that affects the nervous system can occur when you take Primox®. Symptoms include high fever, stiff muscles, confusion, and changes in your breathing, heart rate, and blood pressure. Primary pulmonary hypertension: This is a rare lung disease that is characterized by increased pressure in blood vessels that supply the lungs. Symptoms of PPP in patients receiving nortriptyline can include shortness of breath, dizziness, and leg and/or ankle swelling. Hypotension (low blood pressure) and syncope (fainting or passing out) can occur during initial treatment or if dose increases are made.

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Resources: Garza, K. et al. (2015) “Framing the community data system interface,” Proceedings of the 2015 British HCI Conference. British HCI 2015: 2015 British Human Computer Interaction Conference, ACM.